VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1023338
Sex: F
Age:
State: WI

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salty/rotten; Diarrhea; Vomiting; intestinal discomfort; Cough with some shortness of breath (relieved with asthma inhaler); Cough with some shortness of breath (relieved with asthma inhaler); This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Solution for injection; lot number: EL3249, expiration date: unknown) via unspecified route of administration in the arm left on 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included asthma, multifocal myoclonus, IBS/lynch syndrome, hypothyroidism, Allergy: Dairy (milk allergy), allergies, alcohol allergy, Allergy: beef (meat allergy), and allergy: adhesives (dermatitis contact). Patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: urgent care center (also reported as Doctor's office). The patient experienced mental foggyness/forgetful, chills, migraine, dizziness, fatigue, loss of appetite, food tasted salty/rotten, diarrhea, vomiting, intestinal discomfort, and cough with some shortness of breath (relieved with asthma inhaler); all on 23Jan2021 at 06:00. The events resulted to: Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken in response to all events (unspecified). Patient also had teleconference with doctor. Outcome of all events was recovering.

Other Meds:

Current Illness:

ID: 1023339
Sex: F
Age:
State: TN

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: BUPROPION

Current Illness:

ID: 1023340
Sex: F
Age:
State: MO

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.

Other Meds: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ADVIL [IBUPROFEN]; QNASL; BENADRYL; UNISOM [DOXYLAMINE SUCCINATE]

Current Illness:

ID: 1023341
Sex: M
Age:
State: NY

Vax Date: 01/25/2021
Onset Date: 01/28/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Recurrence of Atrial fibrillation; Recurrence of Atrial fibrillation; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 25Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD (gastrooesophageal reflux disease), and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient had prior ablations for Afib. The patient had no allergies to medications, food, or other products. On 04Jan2021, 18:00, the patient took the first dose of BNT162B2 (lot number and expiry date unknown) via an unspecified route of administration on the right arm at a single dose for COVID-19 immunization. Concomitant medications included dofetilide, diltiazem, loratadine, rosuvastatin calcium (CRESTOR), and omeprazole (OMEPRA); the patient received these medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 28Jan2021 02:00, the patient experienced recurrence of atrial fibrillation after 6 months, the last episode was within a month after an ablation. No treatment was received in response tot eh event. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The reported recurrence of atrial fibrillation was more likely due to natural recurrence of underlying atrial fibrillation, and unlikely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Other Meds: DOFETILIDE; DILTIAZEM; LORATADINE; CRESTOR; OMEPRA

Current Illness:

ID: 1023342
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: respiratory distress; hard time breathing; felt a lump in her throat; making it hard to swallow; This is a spontaneous report from a contactable nurse (patient's daughter). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on unspecified date at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient's daughter reported that her mother received the first dose of the Covid vaccine and 2 hours later, her mother had a hard time breathing and felt a lump in her throat, making it hard to swallow. The respiratory distress only lasted a few minutes, but the feeling of a lump in her throat lasted 4 days. The patient's daughter wanted to know if it is ok and safe for her mother to receive the second dose of the vaccine. The patient recovered from the event respiratory distress on an unspecified date. Outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023343
Sex: F
Age:
State: MN

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: FERROUS SULFATE; VITAMIN C [ASCORBIC ACID]; GLUCOSAMINE CHONDROITIN SULFATE

Current Illness:

ID: 1023344
Sex: M
Age:
State: MI

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210116; Test Name: Blood count; Result Unstructured Data: Test Result:went down

Allergies:

Symptoms: heart attack; kidneys were compromised; muscles were tightening; could hardly walk; cough; lethargic; chills; reflux in his chest; blood count went down; severe cramping in leg; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history cardiac bypass surgery years ago. The patient's concomitant medications were not reported. The reporter stated that on 14Jan2021, the reporter and the patient had the first Pfizer vaccine dose, their second dose is scheduled on 04Feb2021. She stated that 2 days after the first dose, on 16Jan2021, the patient's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was compalaining of having reflux in his chest. She stated that they had appointments that day with their Internist and their Cardiologist. Both physicians felt "all his symptoms" were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac cath and had one of two stents put in. His "kidneys were compromised" and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the "blood count went down." She added that her husband had cardiac bypass surgery years ago. They were concerned that he had a heart attack and asked if he should get the second dose. She added that on 16Jan2021, the patient had severe cramping in the leg, lethargic, chills, and difficulty breathing and he ended up going to the doctor. They had the vaccine on the 14Jan2021. Saturday it just hit him like a ton of bricks. He got worse on Saturday and worse on Sunday and even more worse on Monday. She took him to the Internist and the Cardiologist, they checked him and found he was okay, just lethargic. He also complained of reflux in chest. Around 11:00 that night he had a heart attack and she had to get EMS. He ended up getting a stent and they have to do another one and they had to do something with his kidneys. She wanted to know if he should get the second vaccine. She would hate to put him in a tailspin again. They were trying to get over this huge problem with his heart and then kidneys. They had to hydrate his kidneys in order for dye to go through so it wouldn't damage his kidney during catherization. She knows that one of the things the vaccine does is it activates the immune system to keep you from getting Covid. She wanted to know if it activates other stuff in the body. She asked if it would be recommended for him to slow it down since he just had the first dose. He is going to the Cardiologist and they say to discuss with the Internist, but she would like to speak with someone. She declined report and asked about the wait time to speak with someone since she does not want to leave him alone for long since he just got home from hospital. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1023345
Sex: F
Age:
State: HI

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Got sick; Headache; Shortness of breath; Passed out; Dizzy/ Dizziness; Tightness in her chest; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, first dose, intramuscular on 26Jan2021 at single dose on right arm for COVID-19 immunization. Medical history included mastectomy, surgery for metaplastic carcinoma. She received 4 units of blood and reacted to the blood and itched from her head to toe and they treated her with prednisone for that. She said that the metaplastic carcinoma was 10 inches big and half of her front was removed. Other medical history and past drugs included allergic to Bactrim, Sulfa drugs, Cortisone, Zocor, Keflex, Macrodantin, Penicillin, Vicodin (took three times and thought she was going to die; coughed for a year and couldn't even sleep because she developed Pericarditis), Benazepril, Levaquin, Losartan, Niaspan (whole body turned red), Pravastatin. On 07Jan2021, she had an appointment with her doctor who first advised her not to take the vaccine because of all of her allergies but she said there is an antidote if she has a reaction so she said she could take it. She had the first dose of the vaccine on 26Jan2021 and had a bad reaction. She was very dizzy and got sick. They didn't catch it at the vaccination site because they only had the patients wait 15 minutes. Her drive home takes 10-15 minutes. She thought she couldn't drive home because of the dizziness. She got a tightness in her chest and started getting so dizzy that she ran into the living room and slept on the sofa because she couldn't handle it anymore. It was reported that she passed out from about 12:00-15:00. She was completely out. She took a Tylenol right after the shot for dizziness and sick because when she told her healthcare professional about the symptoms, she said to take a Tylenol. She also had shortness of breath on 27Jan2021. This morning (28Jan2021) she had a headache but she was feeling much better. The caller asked if she should get the second dose due to her reaction. The patient stated she has a whole list of allergies that she gave the other agent. The patient stated that she doesn't think she will take the second shot. She also stated she takes Tylenol after the Flu shot so she doesn't get so sick. The patient mentioned that her physician does not know about any of this and said that she received the vaccine at a hospital. She said that she only contacted her doctor to notify her that she was dizzy. She was directed to take Tylenol. She said that she did take Tylenol as directed by the people administering the vaccines too and she did get sick. The patient said that it helped a little and she knows that it was not the Tylenol that caused this. She does not want to get the second shot if she gets sick like this. The patient said that the fact sheet said to call 911. The shot did not hurt her at all, and she did not know that she even received it. She said that the person who administered the vaccine was very good. The outcome of the event headache was recovering, dizziness, shortness of breath recovered on 27Jan2021, Tightness in her chest, passed out was recovered on 26Jan2021 and sick was unknown. Information about Lot/ Batch has been requested.

Other Meds:

Current Illness:

ID: 1023346
Sex: F
Age:
State: FL

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Brain scans and MRI's; Result Unstructured Data: Test Result:Unknown results; Test Name: Brain scans and MRI's; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look up, down, left or right/It was like her neck was frozen or paralyzed, the muscles would not move; the muscles would not move/She was doing anything to loosen the muscles; shooting pain in her head; She was in a lot of pain in her head and neck.; her neurologist confirmed it was a muscle issue; This is a spontaneous report from a contactable consumer who reported for herself, a 72-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the left arm, on 21Jan2021 at the age of 72 years, at around 16:00 at a single dose for COVID-19 immunization. Medical history included her left eye had a virus that was finally taken care of back in Mar2020 but took a year and a half to heal. She had 5 surgery on that eye from an unspecified date. Also, her left lymph node got filled with fluid and was swollen but the doctors were not concerned about it. She would see an ENT for this. The patient has been seeing a neurologist who has done brain scans and MRI's due to the loss of peripheral vision do to eye problems. The patient has no allergies and is basically healthy. Concomitant medications include unspecified "natural stuff". The reporter stated she had a pretty bad reaction with the vaccine and it took 3 days to get over, her neck froze up. She woke on 22Jan2021 with the frozen neck. She got the first shot on Thursday, 21Jan2021, and on Friday morning, 22Jan2021, when she woke up she could not look up, down, left or right. It was like her neck was frozen or paralyzed, the muscles would not move. Any effort to move her neck would send shooting pain in her head. She applied a heating pad, took Aleve, she took a couple of them, a massager, biofreeze, and stayed in bed. She was doing anything to loosen the muscles. The next morning she was able to look up and down but still not left or right. She did the same thing for treatment that day. On Sunday, 24Jan2021, she was better, was able to move her head 3 of 4 directions. She continued with the treatment she had been using and by Monday, 25Jan2021, her muscles loosed up and her neck worked again. She was sure it is muscles and when she called her neurologist confirmed it was a muscle issue. She was in a lot of pain in her head and neck. The patient was under care for her neck and head and wondered if this happened because this was a weak area, she did not know if related. The patient remarked she was scared to get the second dose due to the problems she had with the first. She heard that the second dose was the one with worse side effects. She was in bed 3 days with this first one. It was reported that the events did not require a visit to Emergency Room, and required visit to physician office. Patient called the neurologist due to the pain and was told to go to acute care to evaluate but she didn't go. The patient stated that this was scary like waking up with Bells palsy and was wondering if she would ever get better. She has never had anything like this happen to her before. She has to be attributed it to the shot. The patient needed guidance on getting the second dose, and had questions about side effects. The outcome of the events was recovering. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1023347
Sex: F
Age:
State: AZ

Vax Date: 01/14/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Facial nerve pain; This is a spontaneous report from a contactable pharmacist (patient). This 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 14Jan2021 16:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received the first dose on 23Dec2020 13:00 on the left arm. Patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 21:00, one week after second shot, the patient started experiencing facial nerve pain. Patient has no medical history of any pain before. Negative etiology from dentist. Patient received 5 day course of prednisone 50 mg, daily which resolved the pain, however, one day after finishing course, the pain returned. It was worse at night with bouts of pain every 30 minutes when trying to sleep. Patient received steroids and carbamazepine 100 mg from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023348
Sex: F
Age:
State: OH

Vax Date: 01/08/2021
Onset Date: 01/10/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EK9231), via an unspecified route of administration in right arm on 08Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included psoriatic arthritis, sub clinical hyperthyroidism and allergy to bees. She had her first dose of bnt162b2 (lot EK5730) on 18Dec2020 in her right arm. No other vaccine in four weeks and no Covid prior vaccination. Concomitant medications included methimazole, meloxicam (MOBIC), apremilast (OTEZLA), atenolol and melatonin. She previously took Ceclor and Biaxin and had drug hypersensitivity. Her psoriatic arthritis was starting to have a flare prior to her first injection. She believed the second injection caused her flare to worsen to the point she had difficulty working due to fatigue and multiple joint pain on 10Jan2021. Tramadol was given as treatment. The events were reported as serious- disability or permanent damage. The outcome of events was not recovered.

Other Meds: METHIMAZOLE; MOBIC; OTEZLA; ATENOLOL; MELATONIN

Current Illness:

ID: 1023349
Sex: F
Age:
State: TN

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023350
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 01/16/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Name: tested; Test Result: Negative ; Comments: tested negative in the hospital when she had the broken hip; Test Name: tested; Test Result: Negative ; Comments: also negative when she went into the hospital for the call

Allergies:

Symptoms: had a fall; This is a spontaneous report from a contactable nurse who reported for her grandmother. A 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 29Dec2020, at the age of 94 years, at a single dose for COVID-19 immunization. Medical history included patient was admitted for a broken hip on 19Nov2020, and was then transferred to another institution on 24Nov2020; and patient does have a diagnosis of dementia. There were no prior vaccinations within 4 weeks. There were no concomitant medications. The reporter is a Pfizer Employee calling in regards to the COVID-19 vaccine. She was calling in regards to her grandmother who is in an inpatient rehabilitation facility. On the 16Jan2021, the patient had a fall in the rehab facility and was admitted into the hospital as a part of the facility's fall protocol. The patient was on Lovenox. The patient was admitted into the hospital on 16Jan2021 and was evaluated and discharged on 18Jan2021. At that point on 18Jan2021, Lovenox was stopped. The event was reported as serious per hospitalization. The facility has also been testing residents weekly. The patient was tested negative in the hospital when she had the broken hip and also negative when she went into the hospital for the call. The outcome of the event was recovered on 18Jan2021. No follow-up attempts are possible; information on lot/batch cannot be obtained.; Sender's Comments: The reported fall likely represents an intercurrent medical condition in this 94-year-old female, and is considered unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023351
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She has concerns that it could be a blood clot as it is on her left side (pain) and near her neck.; Clavicle pain; Swelling of her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021 the patient experienced clavical pain and swelling of lymph nodes and she had concerns that it could be a blood clot as it was on her left side (pain) and near her neck. The final outcome of the event was unknown.Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1023352
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's palsy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy from COVID 19 vaccine on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1023353
Sex: M
Age:
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: dead arm; arm pain; This is a spontaneous report from a non-contactable consumer reported for himself. A 39-year-old male patient received bnt162b2, via an unspecified route of administration on 22Jan2021 at 05:00 PM in the right arm (dose: 01) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 at 08:00 PM, the patient had dead arm and patient thought they were exaggerating the extent of the arm pain and thought he was obligated to report. Patient did not receive treatment for the adverse events. The outcome of the events was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1023354
Sex: F
Age:
State: CA

Vax Date: 01/22/2021
Onset Date: 01/28/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cellulitis from covid vaccine injection site; I developed injection site pain and swelling post 6 days of vaccination; I developed injection site pain and swelling post 6 days of vaccination; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (COVID 19, Pfizer Covid Vaccine, Solution for injection, Lot number: EL9263), via an unspecified route of administration on left arm on 22Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine, aspirin [acetylsalicylic acid], pregabalin (LYRICA), gelatine hydrolysate (GENACOL), collagen, ginkgo biloba, vitamin D3, vitamin b complex, vit C [ascorbic acid], vit E [tocopherol], fish oil, zinc (Tablet), magnesium (Tablet). On 28Jan2021 at 20:00, the patient developed injection site pain and swelling post 6 days of vaccination and her PCP put her on Keflex for Cellulitis from covid vaccine injection site. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of cellulitis from covid vaccine injection site and Keflex was prescribed. Prior to vaccination the patient was not diagnosed with COVID-19. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.

Other Meds: AMLODIPINE; ASPIRIN; LYRICA; GENACOL; COLLAGEN; GINGKO BILOBA; VITAMIN D3; VITAMIN B COMPLEX; VIT C; VIT E; FISH OIL; ZINC; MAGNESIUM

Current Illness:

ID: 1023355
Sex: M
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's Palsy right side of face; This is a spontaneous report from a contactable physician and consumer. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular first dose on 12Jan2021 14.00 at a single dose for COVID-19 immunisation. The patient medical history included DM (diabetes mellitus), hypertension, CAD (Coronary artery disease) and Atrial Fib (Atrial fibrillation). The patient concomitant medication was not reported. The patient visited physician office and it was reported that patient experienced bell's palsy right side of face on 27Jan2021 06.00. The patient did not receive therapeutic measures for the event. The patient did not have COVID prior vaccination and not tested COVID post vaccination. The patient had not received any vaccine in four weeks (as reported). The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNt162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023356
Sex: F
Age:
State: KY

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/89; Test Date: 202101; Test Name: HR; Result Unstructured Data: Test Result:68; Test Date: 202101; Test Name: SaO2; Result Unstructured Data: Test Result:100% on RA %; Test Date: 202101; Test Name: Physical exam; Result Unstructured Data: Test Result:did not show any recurrent signs of wheezing or; Comments: Physical exam did not show any recurrent signs of wheezing or tongue edema.

Allergies:

Symptoms: Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023357
Sex: F
Age:
State: IN

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; This is a spontaneous report from a contactable nurse (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not reported), via an unspecified route of administration on right arm on 29Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, ongoing osteoarthritis, CAD (coronary artery disease), hypertension, GERD (gastrooesophageal reflux disease), osteoporosis, lumbar stenosis, lumbar degenerative disc and Allergies: Sulfa. Concomitant medication included carvedilol (COREG), prednisone, methotrexate, adalimumab (HUMIRA), fluoxetine hydrochloride (PROZAC) and risedronate sodium (RISEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19 prior to vaccination. On 29Jan2021, 12:00 patient had rheumatoid and osteoarthritis. Always have some pain but it increased dramatically and almost unbearably. The patient pain med did help some. Lasted about 11 hours. The seriousness criteria were considered as non-serious. Since the vaccination, the patient been not tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug on reported Rheumatoid Arthritis aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: COREG; PREDNISONE; METHOTREXATE; HUMIRA; PROZAC; RISEDRIN

Current Illness: Osteoarthritis (osteo arthritis); Rheumatoid arthritis

ID: 1023358
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210103; Test Name: electrolytes; Result Unstructured Data: Test Result:WNL (within normal limits); Test Date: 20210103; Test Name: BP; Result Unstructured Data: Test Result:elevated BP; Test Date: 20210108; Test Name: BP; Result Unstructured Data: Test Result:elevated SBP 190-200; Test Date: 20210103; Test Name: DDimer; Result Unstructured Data: Test Result:elevated; Test Date: 20210108; Test Name: CT head; Result Unstructured Data: Test Result:CT head negative; Test Date: 20210103; Test Name: CT Scan of Chest/Abdomen; Result Unstructured Data: Test Result:L axilla lymphadenopathy; Test Date: 20210103; Test Name: CBC, Electrolytes; Result Unstructured Data: Test Result:WNL (within normal limits); Comments: CBC, Electrolytes WNL (within normal limits).; Test Date: 20210108; Test Name: pheochromocytoma; Test Result: Negative ; Test Date: 20210108; Test Name: MRI; Result Unstructured Data: Test Result:MRI negative; Test Name: Brain MRI; Result Unstructured Data: Test Result:Unknown result; Comments: no diagnosis has been yet identified; Test Date: 20210103; Test Name: PE; Test Result: Negative ; Test Date: 20210108; Test Name: COVID tests; Test Result: Negative

Allergies:

Symptoms: encephalitis-like symptoms; Hearing loss; memory loss; parathesias; visual disturbances; taste disturbances; dizziness; Lsided chest pain; staggering; elevated SBP 190-200; severe L-sided chest tightness; pre-syncope; elevated BP; DDimer was elevated; fell; intermittent memory lapses; nausea episodes; cant smell that last 1-2 hrs; L neck /head pain; L neck /head pain; Left axilla lymphadenopathy; rhinitis; lightheaded/lightheadedness; had an episode of pain all over; SOB; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration from on 19Dec2020 at a single dose for COVID-19 immunization. Medical history included ovarian cancer at age 29, food allergy to clams and escargot, and allergy to sulfa. The patient's concomitant medications were not reported. The patient previously took bactrim and experienced allergies. On 19Dec2020, immediately after vaccine had rhinitis, lightheaded, given Zyrtec and water and observed for a duration of 30 min. Three hours postvaccination on 19Dec2020, at home had an episode of pain all over and SOB (shortness of breath). 3 days later (22Dec2020), patient had L (left) neck /head pain and left axilla lymphadenopathy. On 23Dec2020, she fell in the shower. On the same day (23Dec2020) the patient had intermittent memory lapses, lightheadedness, nausea episodes, can't smell that last 1-2 hours a few times a day. Symptoms worsened on 03Jan2021, with severe L-sided chest tightness, pre-syncope, was seen in the ER with elevated BP. DDimer was elevated, CT Scan of Chest/Abdomen showed L axilla lymphadenopathy, negative for PE. CBC, Electrolytes WNL (within normal limits), still on 03Jan2021. Observed in ER for 7 hrs. and then discharged home. Intermittent symptoms continued. On 08Jan2021, patient had another severe episode while at work. She was noted to be staggering, and again was complaining of left-sided chest pain. She was taken to the ER by her colleagues on 08Jan2021 and noted to have elevated SBP 190-200. On 08Jan2021, patient underwent CT head negative, MRI negative, w/u (workup) for pheochromocytoma negative and COVID negative. She was started on prednisone and Norvasc and discharged home. She continues to have intermittent episodes however they have decreased in intensity and last for about 1 hour. She described her symptoms as encephalitis-like symptoms. These include memory loss, paresthesia, visual disturbances, hearing loss, taste disturbances, and dizziness. These symptoms when severe have been incapacitating. She had been hospitalized for a neurological and infectious work up (including Brain MRI and multiple COVID tests) but no diagnosis has been yet identified. This symptom kcomplex (unspecified) has persisted to now. She has not received the second dose of vaccine. She is asking how long mRNA, the lipid nanoparticles and the protein spike lasts in the body. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the implied temporal association. However, underlying medical conditions may provide the alternate explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023359
Sex: F
Age:
State: OK

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Seizure; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included being immunocompromised from an unknown date and was taking a lot of medications. Concomitant medication includes a lot of medications (unspecified). The patient was previously vaccinated with the first dose of BNT162B2 on an unspecified date. It was reported that the patient received the second dose of COVID-19 vaccine on the afternoon of 28Jan2021 and experienced seizure. The reporter wanted to know if he needed to seek a doctor early this morning for the patient. The outcome of the event was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1023360
Sex: M
Age:
State: GA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210127; Test Name: B/P; Result Unstructured Data: Test Result:143/92; Comments: At 1:10 pm; Test Date: 20210127; Test Name: B/P; Result Unstructured Data: Test Result:125/90; Comments: At 1:15 pm; Test Date: 20210127; Test Name: B/P; Result Unstructured Data: Test Result:131/89; Comments: At 1:20 pm; Test Date: 20210127; Test Name: B/P; Result Unstructured Data: Test Result:135/81; Comments: At 1:25 pm; Test Date: 20210127; Test Name: B/P; Result Unstructured Data: Test Result:130/89; Comments: While standing upright; Test Date: 20210127; Test Name: Temp; Result Unstructured Data: Test Result:98.6; Comments: At 1:10 pm; Test Date: 20210127; Test Name: Temp; Result Unstructured Data: Test Result:99.0; Comments: At 1:25 pm; Test Date: 20210127; Test Name: Temp; Result Unstructured Data: Test Result:98.6 (oral); Comments: While standing upright: (oral); Test Date: 20210127; Test Name: HR; Result Unstructured Data: Test Result:74; Comments: At 1:10 pm; Test Date: 20210127; Test Name: HR; Result Unstructured Data: Test Result:81; Comments: At 1:15 pm; Test Date: 20210127; Test Name: HR; Result Unstructured Data: Test Result:85; Comments: At 1:20 pm; Test Date: 20210127; Test Name: HR; Result Unstructured Data: Test Result:79; Comments: At 1:25 pm; Test Date: 20210127; Test Name: HR; Result Unstructured Data: Test Result:72; Comments: While standing upright; Test Date: 20210127; Test Name: O2; Test Result: 96 %; Comments: At 1:10 pm; Test Date: 20210127; Test Name: O2; Test Result: 99 %; Comments: At 1:15 pm; Test Date: 20210127; Test Name: O2; Test Result: 97 %; Comments: At 1:25 pm; Test Date: 20210127; Test Name: O2; Test Result: 96 %; Comments: While standing upright; Test Date: 20210127; Test Name: Resp; Result Unstructured Data: Test Result:20; Comments: At 1:10 pm; Test Date: 20210127; Test Name: Resp; Result Unstructured Data: Test Result:20; Comments: At 1:15 pm; Test Date: 20210127; Test Name: Resp; Result Unstructured Data: Test Result:20; Comments: At 1:20 pm; Test Date: 20210127; Test Name: Resp; Result Unstructured Data: Test Result:20; Comments: At 1:25 pm; Test Date: 20210127; Test Name: Resp; Result Unstructured Data: Test Result:18; Comments: While standing upright

Allergies:

Symptoms: blood pressure (1:10 PM): 143/92; Syncopal episode; Patient was pale; Diaphoretic; feeling light-headed; This is a spontaneous report from a contactable nurse. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EL8982), intramuscularly into the left arm on 27Jan2021 13:00 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Jan2021 13:05 patient had a syncopal episode but regained consciousness immediately and was assessed for injury and other reactions. The patient was pale, diaphoretic and reported feeling light-headed on 27Jan2021 13:05. The patient underwent lab tests and procedures on 27Jan2021 which included blood pressure measurement (units unspecified): 143/92 (1:10 pm), 125/90 (1:15 pm), 131/89 (1:20 pm), 135/81 (1:25 pm) and 130/89 (while standing upright); body temperature (unit unspecified): 98.6 (1:10 pm), 99.0 (1:25 pm) and 98.6 (oral; while standing upright); heart rate (unit unspecified): 74 (1:10 pm), 81 (1:15 pm), heart rate: 85 (1:20 pm), 79 (1:25 pm), 72 (while standing upright); oxygen saturation: 96% (1:10 pm), 99% (1:15 pm), 97% (1:25 pm), 96% (while standing upright); respiratory rate (unit unspecified): 20 (1:10 pm), 20 (1:15 pm), 20 (1:20 pm), 20 (1:25 pm), 18 (while standing up). Outcome of events recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1023361
Sex: F
Age:
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:160 something over 101; Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased to 104 over 80 something; Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:increased to 202 systolic; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: Doppler; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: GABAPENTIN

Current Illness:

ID: 1023362
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/16/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210122; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210122; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: dental pain; fatigue; headache; loss of taste; loss of smell; body aches; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (BNT162B2), via intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing ankylosing spondylitis and potentially being exposed to COVID. The patient's concomitant medications was not reported. Patient began to have symptoms of COVID on 16Jan2021. The symptoms include Body aches, headache, loss of taste, loss of smell, dental pain, and fatigue. Hence on 22Jan2021 the patient hospitalized and same day had discharge, the patient had, blood sampling, X-ray, oxygen, and intravenous fluid. The patient underwent lab tests and procedures which included blood test: unknown result on 22Jan2021, x-ray: unknown result on 22Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Ankylosing spondylitis

ID: 1023364
Sex: F
Age:
State: UT

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:higher than my normal of 120/80; Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: Test Result:170/84; Test Date: 20210129; Test Name: blood labs; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210129; Test Name: CT of head; Result Unstructured Data: Test Result:No cause of incident or evidence of TIA seen; Test Date: 20210129; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210129; Test Name: MRI of head; Result Unstructured Data: Test Result:No cause of incident or evidence of TIA seen

Allergies:

Symptoms: Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: TYLENOL

Current Illness:

ID: 1023365
Sex: U
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data: Test Date: 20210127; Test Name: blood pressure; Result Unstructured Data: Test Result:shot up to 180 over 100; Test Date: 20210127; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210127; Test Name: chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210127; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: When got up I passed out; blood pressure shoot up to 180 over 100; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the covid dose yesterday and after he/she took it, he/she sat there for few minutes and then when he/she got up he/she just passed out. The patient mentioned that they called the code blue in the hospital, they tried to, they were going to, he/she doesn't know what they were going to do but they ended up taking the patient to the emergency room where they ran every test possible blood work they did chest X-ray, they did EKG. The patient stated that the only thing that was consistent was that after the vaccine his/her blood pressure shot up to 180 over 100 and they were trying to get it down, they gave the patient some fluid (unspecified) which stayed for over two hours. The patient added that he/she have never had any blood pressure issues, as he/she was not even on any medications. The patient mentioned that he/she was now afraid to take the second dose. The events occurred on 27Jan2021 with outcome of unknown. Unknown results for blood work, EKG and chest X-ray. The reporter considered the events serious per hospitalization on 27Jan2021. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1023366
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: numbness and heaviness in her whole arm/given in her right upper arm and that was the arm that was numb and heavy feeling; heaviness in her whole arm / discomfort at the site of injection; This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration in the right upper arm on 21Jan2021 at 1:30 or 2pm at a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included medication for high blood pressure. The patient received the first dose on 21Jan2021 and has experienced numbness and heaviness in her whole arm on 25Jan2021. She was calling because she wanted to know what to should she do about it. She was leery about getting the second dose. The patient was asking if this is normal, it doesn't feel normal. She has called her doctor and was waiting to hear back from them. On 21Jan2021, on the day she got the injection, she noticed discomfort at the site of injection but that only lasted that day and that has resolved. Now she only has the heaviness and numbness, this started on 25Jan2021, 4 days later and was still ongoing. The vaccine was given in her right upper arm and that was the arm that was numb and heavy feeling. Outcome of the events was not recovered. The event numbness and heaviness in her whole arm was reported as serious (medically significant).; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events vaccination site hypoaesthesia and vaccination site discomfort cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Blood pressure high

ID: 1023367
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210127; Test Name: CAT scan; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1023368
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cannot get flu shot, allergic to them; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media. This case involves a patient (unknown demographics) who could not get INFLUENZA VACCINE as he/she was allergic to it (allergy to vaccine). It was unknown if the patient had any concomitant disease or risk factor. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed allergy (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were lab data/results available. It was unknown if the patient experienced any additional symptoms/events. The details medication and reason for taking the medicine were not provided. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the event. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1023371
Sex: U
Age:
State: AL

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse event, and no further information provided; Nurse called to report a dose of VAQTA that was inadvertently administered after its labeled expiry date. Involved VAQTA expired on 11-JAN-2021 and was administered on 18-JAN-2021; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported. On 18-JAN-2021, the patient was inadvertent vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 dose of 0.5 milliliter (route of administration, anatomical location and vaccine scheme were not provided), lot number S032359 has been verified to be a valid lot number, expiration date was on 11-JAN-2021, as prophylaxis (expired product administered).There was no prior temperature excursions reported. The nurse inquired about need for revaccination. No additional adverse event, and no further information provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1023372
Sex: F
Age: 31
State: NJ

Vax Date: 01/03/2021
Onset Date: 01/04/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Heart rate; Result Unstructured Data: increased; Comments: increased; Test Name: Heart rate; Result Unstructured Data: increased; Comments: experienced increased

Allergies:

Symptoms: INCREASED HEART RATE; NUMBNESS; TINGLING; SLURRED SPEECH; CONFUSION; OUT OF BREATH; A spontaneous report has been received from a consumer. The report concerns a female patient (age 31 years, height 60 in, weight 160 lb). No medical history was reported. Concomitant medication included Cosentyx for psoriatic arthritis, autoimmune condition. The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for prevention on 03-JAN-2021. On 04-JAN-2021, the patient experienced increased heart rate (preferred term: Heart rate increased), numbness (preferred term: Hypoaesthesia), tingling (preferred term: Paraesthesia), slurred speech (preferred term: Dysarthria) and confusion (preferred term: Confusional state). On an unknown date, the patient experienced out of breath (preferred term: Dyspnoea). At the time of reporting, the event of out of breath was ongoing. At the time of reporting, the event of increased heart rate was improving. The outcome of the event(s) of numbness, tingling, slurred speech and confusion was unknown. The events were considered non-serious. Laboratory values are available.

Other Meds:

Current Illness:

ID: 1023373
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm; fever; chills; muscle pain; Fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in an unspecified number of an adult patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever, chills, muscle pain and fatigue. On an unknown date, the outcome of the pain in arm, fever, chills, muscle pain and fatigue were unknown. It was unknown if the reporter considered the pain in arm, fever, chills, muscle pain and fatigue to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not applicable for this report. It was reported that two dose Shingrix vaccine, for instance which protects older adults against the virus that causes painful shingles, results in sore arms in 78 percent of patients and muscle pain and fatigue in more than 40 percent of patients. The vaccine also caused fever and chills. This case has been linked with the case US2020AMR248304, reported by reporter.

Other Meds:

Current Illness:

ID: 1023374
Sex: F
Age: 78
State: AZ

Vax Date: 01/08/2021
Onset Date: 01/12/2021
Rec V Date: 02/11/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a day; A spontaneous report was received from a health care professional concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family. The patient's medical history included Alzheimer's disease. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium. On 08 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the reporter states the patient went into a sharp decline, diarrhea, nausea, headache and sleeping 24 hours a day. A few days later, the patient was not eating much and did not recognize her husband or family. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family, were considered unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient with a medical history of Alzheimer's disease, who experienced unexpected events of diarrhea, hypersomnia, decreased appetite, confusional state and expected events of nausea and headache. The events of diarrhea, nausea, headache and hypersomnia occurred 5 days after the first dose of mRNA-1273 (Lot 025J20-2A) and, the events of decreased appetite and confusional state occurred unspecified number of days later. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Very limited information regarding this event has been provided at this time. Alzheimer's disease is a confounding factor too. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds: SYNTHROID

Current Illness:

ID: 1023375
Sex: F
Age: 35
State: IA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20201229; Test Name: Blood pressure; Result Unstructured Data: Extremely low; Test Date: 20201229; Test Name: Heart rate; Result Unstructured Data: Extremely low

Allergies:

Symptoms: Became unresponsive; Looked like having a seizure; Felt light headed; BP extremely low; Profusely sweating; Heart rate extremely low; A spontaneous report was received from a pharmacist, concerning a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt light headed, became unresponsive, looked like having a seizure, BP extremely low, heart rate extremely low, and profusely sweating. The patient's medical history, as provided by the reporter, included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide/lisinopril. On 29 Jan 2021, five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient felt light-headed five minutes after receiving the vaccine. He then became unresponsive but was breathing and had a pulse. The reporter stated it looked like the patient was having a seizure; his eyes rolled upward, his left arm shook, and he did not respond to touch or voice. It was reported that 911 was immediately called and responded within a couple of minutes. The patient's blood pressure and heart rate were extremely low, and he was profusely sweating. The reporter stated that the patient came to and still felt very light-headed. The patient was then taken to the emergency department. Medical tests and laboratory results were unknown, but the reporter stated that a magnetic resonance imaging (MRI) was possibly performed. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, became unresponsive and looked like having a seizure, were resolved on 29 Jan 2021. The outcome for the events, felt light headed, BP extremely low, heart rate extremely low, and profusely sweating, was unknown.; Reporter's Comments: This case concerns a 35-year-old, female, with medical history of high blood pressure, who experienced a serious unexpected event of syncope, seizure, and non-serious unexpected events of dizziness, hypotension, hyperhidrosis, and heart rate decreased. The events occurred 1 day (5 min) after mRNA-1273 (Lot# 025L20A). Treatment information was not provided. Concomitant medications included: hydrochlorothiazide/lisinopril. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds: LISINOPRIL/HCTZ

Current Illness: Hypertension

ID: 1023376
Sex: F
Age:
State: AL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; aches; chills; headache; This is a spontaneous report from a contactable other healthcare professional, the patient. This 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1686, dose 2, single dose via unknown route of administration in the left arm on 19Jan2021 at 09:15 AM (at the age of 51 years-old) for COVID-19 vaccination. Medical history included gastroesophageal reflux disease (GERD). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EH9899, dose 1 via unknown route of administration in the left arm on an unknown date at 09: 45 AM. The patient was not pregnant at the time of vaccination. The patient had no known medication allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MOTRIN), dextromethorphan, doxylamine, ephedrine, ethanol, paracetamol (NYQUIL) and omeprazole. On 19Jan2021 at 20:00, about twelve hours following the second injection, the patient developed a fever, aches, chills and headache that lasted for approximately 24 hours. The clinical outcome of fever, aches, chills and headache was recovered on an unknown date in Jan2021. Treatment received for fever, aches, chills and headache included an unknown over the counter medication without relief. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: MOTRIN (IBUPROFEN); NYQUIL; OMEPRAZOLE

Current Illness:

ID: 1023377
Sex: M
Age:
State: CT

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain the next day at site of injection; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, via an unknown route of administration in the right arm on 23Jan2021 at 15:30 (at the age of 75-years-old) as a single dose for Covid-19 immunization. Medical history included aneurysm and pacemaker from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It is unknown if patient received any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced pain at the site of injection. Treatment was not given for the event. The clinical outcome of the event vaccination site pain was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1023378
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe tension/pain on left side of head; severe tension/pain on left side of head; This is a spontaneous report from a contactable healthcare professional. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration right arm on 21Jan2021 as single dose for covid-19 immunization. No medical history was noted. No allergies to medications, food, or other products. Concomitant medication included celecoxib (CELEXA). On 24Jan2021, at 08:00, the patient experienced severe tension/pain on left side of head. This was elaborated as behind the eye and above brow bone, radiates to back of neck. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of severe tension/pain on left side of head was not recovered.

Other Meds: CELEXA [CELECOXIB]

Current Illness:

ID: 1023379
Sex: M
Age:
State: TX

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Red mark on his shot mark; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL9262, via an unspecified route of administration in the right arm on 22Jan2021 at SINGLE DOSE for covid-19 immunization. The patient has no other relevant medical history. The patient's concomitant medications were not reported. The patient experienced red mark on his shot mark on 24Jan2021. The mark was not raised, and it is about the size of a pencil eraser. Patient does not have any feeling or pain (in this mark). The outcome of event was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1023380
Sex: F
Age:
State: NY

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: Pain; Result Unstructured Data: Test Result:2/10; Test Date: 20201231; Test Name: Pain; Result Unstructured Data: Test Result:4/10; Test Date: 20210106; Test Name: Nasal Swab/PCR & Rapid; Test Result: Negative

Allergies:

Symptoms: This is a spontaneous report from a contactable other health professional (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ELO140, intramuscular in the left arm the age of 55-years on 30Dec2020 14:00 at SINGLE DOSE for COVID-19 immunization. Medical history included penicillin allergy, GERD (gastrooesophageal reflux disease), osteoarthritis and spinal stenosis. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included dorzolamide hydrochloride, ketorolac tromethamine and timolol maleate. On 31Dec2020 08:00, patient woke up with muscle soreness in both quads it was a 4/10 pain. It lasted for 24 hours in the left. Since 31Dec2020, she still has soreness in the right quad, initially it was the entire muscle and then it settles to proximal & lateral to hip. The pain level was 2/10. Outcome of events was not recovered. The patient did not received treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: DORZOLAMIDE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; TIMOLOL MALEATE

Current Illness:

ID: 1023381
Sex: F
Age:
State: VA

Vax Date: 12/23/2020
Onset Date: 01/03/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: back pain upper mid back, spread to left & right side; lower back muscles on the left & right side; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on her right arm, via an unspecified route of administration on 23Dec2020 10:00 at a single dose for covid-19 immunization. Medical history included hypertension (HTN), asthma, obesity, postmenopause, hay fever, pre diabetic and allergy to sulfa. Concomitant medication included chlorthalidone, carvedilol (COREG), fexofenadine hydrochloride (ALLEGRA) and phytomenadione (VITAMIN K). The patient experienced back pain upper mid back, spread to left & right side and lower back muscles on the left & right side.; both on 03Jan2021 11:00 AM. The patient received lidocaine, methacarbamol, T3, prednisolone dosepak as treatment for the events. The outcome of the events was recovering.

Other Meds: CHLORTHALIDONE; COREG; ALLEGRA; VITAMIN K

Current Illness:

ID: 1023382
Sex: F
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe contraction of chest muscles and neck lasting about 20 minutes; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 25Jan2021 at 10:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to bee stings from an unknown date and unknown if ongoing. Concomitant medication included salbutamol sulfate (ALBUTEROL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25Jan2021 at 11:30, one hour after injection the had severe contraction of chest muscles and neck lasting about 20 minutes. The patient did not receive treatment for the event. The outcome of the event was recovered. The event was reported as non-serious.

Other Meds: ALBUTEROL

Current Illness:

ID: 1023383
Sex: F
Age:
State: SD

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Muscle aches; joints ache; slight head ache; This is a spontaneous report from a contactable consumer. A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Jan2021 at 13:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), montelukast (MANUFACTURER UNKNOWN), and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) from unknown dates for an unknown indication and experienced drug allergy. On 25Jan2021 at 19:00, the patient experienced muscle aches, joints ache, and slight headache (reported as in the morning). The patient did not receive any treatment for the events. The clinical outcomes of muscle aches, joints ache, and slight headache were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; MONTELUKAST; OMEPRAZOLE

Current Illness:

ID: 1023384
Sex: F
Age:
State: NJ

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: Nasal swab; Test Result: Negative

Allergies:

Symptoms: Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1023385
Sex: F
Age:
State:

Vax Date: 01/25/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe chills; vomiting; Diarrhea; lots of nausea; her whole body was trembling violently; she was very cold; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started experiencing severe chills and her whole body was trembling violently, she was very cold. Followed with vomiting, diarrhea and lots of nausea. The outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1023386
Sex: F
Age:
State: MN

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: first dose was administred on 28Dec2020 and second dose on 21Jan2021; Sore arm at injection site; body aches during the second shot for a full 24 hours; This is a spontaneous report from a contactable pharmacist (the patient). A non-pregnant 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the left arm on 21Jan2021 as a single dose for COVID-19 immunization. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included spironolactone, ethinylestradiol, levonorgestrel (AVIANE), cholecalciferol. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine include the first dose of BNT162B2, lot #EK9231, intramuscular in the left arm on 28Dec2020 at the age of 26-year-old for COVID-19 immunization. On 22Jan2021, the patient experienced sore arm at injection site, (but not as severe in comparison to the flu shot), and body aches during the second shot for a full 24 hours. The events were reported as non-serious. Treatment for the events included acetaminophen 500 mg - 2 tablets by mouth twice daily. The clinical outcome of the events sore arm at injection site, and body aches during the second shot for a full 24 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: SPIRONOLACTONE; AVIANE; CHOLECALCIFEROL

Current Illness:

ID: 1023387
Sex: F
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Joint pain in her fingers, hands, and wrists; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 14Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient had joint pain in her fingers, hands and wrists. The outcome of the event, pain in her fingers, hands and wrists, was unknown. Information regarding lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1023388
Sex: M
Age:
State: FL

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache; Chills; Body aches; Nausea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 19Jan2021 08:28 at 0.3 mL, single for COVID-19 immunization. Medical history included Open heart surgery in Jan2003 and in Jan2018 (he had two open heart surgeries, the first one in Jan2003, and the last one in Jan2018);Stent placement (he has had 14 stents placed over a period of time, the last stents were done when open heart surgery was done, they put in 3 that time, in Jan2018); and Gallbladder removal on 16Jun2020. The patient's concomitant medications were not reported. The patient previously took influenza vaccine (flu vaccine) in Sep2020. The patient had a reaction to the COVID-19 vaccine two days (on 21Jan2021) after getting it. He had a really bad headache, chills, body aches and nausea, a whole series of things went wrong. He woke up at 04:00 21Jan2021 with an intense headache. The reaction happened all together, his headache, body aches, chills, and very bad nausea started about the same time, he contacted his doctor that day. At time of report was the first day he was starting to feel better. It was the first day he didn't have a headache, he was feeling better now, he was basically in bed from Thursday on. He got up a little bit yesterday, and at the time of report he was feeling much better, it lasted 4 to 5 days (as reported). He took Tylenol 500mg, two of them, and kept taking it 6 hours apart, it was all he had to take, and it barely touched it (UPC: 30043739 LOT SMA115, EXP Sep2022). The outcome of the event headache recovered on 26Jan2021; and recovering outcome for the other events.

Other Meds:

Current Illness:

ID: 1023389
Sex: F
Age:
State: MO

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Anatomical site of vaccine administration: Left Arm, swelling on the arm like a hard notch/My arm is swelled up; Anatomical site of vaccine administration: Left Arm, There was really tender; Anatomical site of vaccine administration: Left Arm, swelling on the arm like a hard notch/My arm is swelled up; felt feverish; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL8982), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE (first dose, left arm) for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of the vaccine on 13Jan2021. Anatomical site of vaccine administration was the left arm. The patient experienced a reaction afterwards which made her miss 2 days of work and work with her patients as she do home care (Jan2021). She experienced swelling on the arm like a hard notch/arm is swelled up and felt feverish and by the next day she could not move her arm at all/move her arms up the following day. She reported that there was really tender. She was supposed to get the 2nd dose of the vaccine on 03Feb2021 and was asking if she can take it on the 05Feb2021 so as she cannot miss work in the event, she experiences the reaction again. No Physician Office/ Emergency Room visit involved. Treatment included Tylenol to help with the pain and then put ice on it to break it keep swelling down. Outcome of the events was unknown. The case was reported as non-serious.

Other Meds:

Current Illness:

ID: 1023390
Sex: M
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: allergic reaction; redness at the injection site; swelling at the injection site; redness and swelling at the injection site that moved down his arm/then it traveled; redness and swelling at the injection site that moved down his arm/then it traveled; itching at injection site; pain at injection site; several hours before checking infection site; bump, it was typical like what it says in the brochure, as time went on, it got red, in a spot by injection site, then it traveled/middle of injection site there was a white area, raised; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 75-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 09:15 at a single dose for covid-19 immunization. Medical history included cholesterol (blood cholesterol abnormal) and blood pressure blood pressure abnormal). Concomitant medication included hydrochlorothiazide for blood pressure, atorvastatin for cholesterol, fish oil and vitamins NOS (MULTIVITAMIN). The patient reported that he got the first dose of the covid vaccine on Friday (22Jan2021) and he had symptoms following the injection which included redness and swelling at the injection site that moved down his arm. The patient also mentioned that he experienced like a bump, it was typical like what it says in the brochure, as time went on, it got red, in a spot by injection site, then it traveled. The patient mentioned that he was seen at his PCP and reports that he was told he had an allergic reaction to the shot, hopefully it would not spread any further, and states his doctor seemed to be very concerned his physician prescribed him with an epi pen to have for if he gets the second dose of the vaccine and the reporter stated that he has never diagnosed with allergies. The patient inquired if the injection wasn't put in correctly and it was put in the tissue and not the muscle. The reporter mentioned that his wife said the needle didn't go in as much as when she got her injection, so he was wondering if it was administered in the right way and also asking if part of the needle could have broken off and if that is what is causing the redness and swelling to his arm. His doctor assured him the needle could not break and stated that his said that it did not look like the injection was as deep as hers since she was watching him get his vaccine. The reporter also inquired if that could have caused an issue if it was not administered deep enough. He mentioned that he waited several hours before checking infection site [pending clarification] and noticing the swelling and redness. States it is also itchy and painful, not a painful to the touch but an itchy, knifey kind of pain, states sometimes it feels like he needs to rub it and sometimes it feels like someone is stabbing him. The outcome of the event allergic reaction was unknown while the outcome of the other events was not recovered. The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077371 Same reporter/drug, similar events, different patient

Other Meds: HYDROCHLOROTHIAZIDE; ATORVASTATIN; FISH OIL; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm