VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1045597
Sex: F
Age:
State: MI

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
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Symptoms: I started having intense chills; developed a fever of 102.5; I had a big headache as well; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3248), via an unspecified route of administration right arm on 04Feb2021 06:45 at single dose for covid-19 immunization. Age at vaccination was 25 Years. Patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products included Penicillin allergy. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included Ovasitol. Historical vaccine included first dose of bnt162b2(COVID19, Pfizer, Lot number: EL3248) via an unspecified route of administration on right arm on 13Jan2021 06:45 at single dose for covid-19 immunization. On 04Feb2021 at 18:00, the night after she received the vaccine (12 hours afterward) she started having intense chills and developed a fever of 102.5. She had a big headache as well. Tylenol was received as treatment for the events. Outcome was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1045598
Sex: F
Age:
State: DE

Vax Date: 01/16/2021
Onset Date: 01/30/2021
Rec V Date: 02/22/2021
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Symptoms: She tested positive for Covid 19 two weeks later; She tested positive for Covid 19 two weeks later; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said that she was tested COVID-19 positive two weeks after (30Jan2021) the first dose on 16Jan2021. The patient said that she was fully recovered today and advised by their health department that she was fit to work. The patient was scheduled to have her second dose tomorrow 06Feb2021, concerning if there was a problem or if it was okay to take the second dose tomorrow. The outcome of the events was recovered. Information on Lot/Batch has been requested.; Sender's Comments: The reported tested positive for SARS-Cov-2 two weeks after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.

Other Meds:

Current Illness:

ID: 1045599
Sex: M
Age:
State: OH

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/22/2021
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Symptoms: It just about wiped out cognitive function; shallow breathing; panting; Not being able to get around; he shrunk from 6 foot getting older; exhausted; Hungover feeling/he felt like in his eye sockets and in his neck and everywhere that there was something in him, some unfamiliar sensation; The caller stated a few days ago he had an intense dizziness after he got the first dose of the vaccine.; little anxiety; change in heart rhythm/change in his pulse rate/His normal is usually 60 but in this case it was 56 to 60; slight headache; This is a spontaneous report from a contactable consumer and a consumer via Pfizer-sponsored program Pfizer First Connect. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EZ5138), via an unspecified route of administration in the left arm on 29Jan2021 12:01 (age at time of vaccination: 75 years) at first single dose for COVID-19 immunization; Vaccination Facility: community clinic. Medical history included bone marrow donor from an unknown date and unknown if ongoing (about 20 years ago). There were no concomitant medications. The patient experienced the following events and outcomes: the caller stated a few days ago he had an intense dizziness after he got the first dose of the vaccine. on 01Feb2021 at 11:30 with outcome of recovering, it just about wiped out cognitive function on an unspecified date with outcome of unknown, slight headache on 29Jan2021 with outcome of unknown, little anxiety on 01Feb2021 with outcome of recovered on 02Feb2021, shallow breathing on an unspecified date with outcome of unknown, change in heart rhythm/change in his pulse rate/his normal is usually 60 but in this case it was 56 to 60 on 01Feb2021 with outcome of recovered on 02Feb2021, exhausted on 02Feb2021 with outcome of recovering, panting on an unspecified date with outcome of unknown, hungover feeling/he felt like in his eye sockets and in his neck and everywhere that there was something in him, some unfamiliar sensation on 02Feb2021 with outcome of recovering, not being able to get around on an unspecified date with outcome of unknown, he shrunk from 6 foot getting older on an unspecified date with outcome of unknown; all of which were medically significant. The events did not require a visit to a physician office or emergency room (ER). The patient did not receive any prior vaccinations within four weeks of the bnt162b2; and there were no additional vaccines administered on the same date of the Pfizer Suspect. The patient underwent lab tests and procedures which included blood pressure: good on an unspecified date, height: shrunk from 6 foot getting older on an unspecified date, heart rate: good on an unspecified date, pulse rate: 56 to 60 on an unspecified date. The caller stated a few days ago he had an intense dizziness after he got the first dose of the vaccine. This was 72 hours after the shot. He had the shot around 12:01 last Friday (29Jan2021). Monday (01Feb2021), about the same time, he had a very very intense dizziness that came on suddenly (came on in about 30 seconds) and it was full blown and it lasted for pretty much 24 hours. It slightly lessened after 20 hours but it was a day before he could stand up. It was not gradual, he knew right then he was in trouble, he couldn't sit up or roll over. He stated he was in great health but if he was taking medication or had a heart condition he doesn't think he would be available for this conversation. It stressed him out and he didn't know he could go that far and come back. He stated it was comparable to cardiac arrest and was a life threatening experience. If other people may have this reaction (if intoxicated or on drugs) they may not survive it. It was very very severe and scary. He stated his reaction seems extreme to everybody he knows. It just about wiped out cognitive function. He stated around here it doesn't seem that people are having severe reactions. He knows a couple people getting the shot, one who drinks, one who had diabetes and he let them know about this. Additional Context: The patient stated he wanted to report his experience and ask a question. The patient stated he received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 12:01 in the left arm. The patient did not use drugs or alcohol and did not have any medication and had good health. The patient's heart rate and blood pressure were good. The patient had a slight headache. Then 72 hours later on Monday at about 11:30 he started to get dizzy, suddenly, and it was very intense. The patient took about 12 steps and recognized it and got to the bed. By the time he got there he knew he was in trouble, he had little anxiety and noticed a change in heart rhythm. The dizziness was very intense and intensified when he went to bed and continued. Tuesday morning it lightened a bit and then around 11:30 on Tuesday it withdrew; exactly 72 hours from the vaccination. The patient felt okay now, except he was kind of exhausted and had a hungover feeling, not totally clear but he was walking around. The patient felt if a person had been intoxicated or on medication or had a heart condition, he did not think they would survive this. The patient was physically challenged to get through it with shallow breathing, really panting, and not being able to get around. The patient had to focus on his breathing, panting to get through it. It was serious for him. Initially he noticed the change in his pulse rate and kept checking his pulse. His normal is usually 60 but in this case, it was 56 to 60. The anxiety was mild, he was concentrating to keep calm. The patient stated: "This is a world crisis, a year old and it is not ideal conditions but this might be a critical issue in terms of the negative effects being more severe than anticipated for certain groups of people and he wanted to discuss this concern with someone at Pfizer." The patient added he wanted to make sure that Pfizer knew that the intensity of the experience was a 100, it was very extreme. The patient added he felt like in his eye sockets and in his neck and everywhere that there was something in him, some unfamiliar sensation that has now gone away. When he bent over yesterday, he was mindful that that the dizziness had gone away. The patient added he still felt tired. The patient mentioned he did not eat for a while with that dizziness. The patient was scheduled for the next dose on 19Feb2021 but was a little unsure about getting it. Follow-up (05Feb2021): New information reported from a contactable consumer includes: suspect vaccine (lot number; anatomical location, vaccination facility, Time), concomitant medications, reaction data (added events: Headache, Anxiety, Shallow breathing, Pulse abnormal, Exhaustion, Abnormal breathing, Feeling abnormal, Activities of daily living impaired, Body height decreased), outcomes updated and clinical course.

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Current Illness:

ID: 1045600
Sex: M
Age:
State: FL

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/22/2021
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Symptoms: night vision improved the night after he took the vaccine and seemed to be a stable improvement; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9526, expiration date was unknown), via an unspecified route of administration on the left arm on 02Feb2021 at 09:30 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the public health clinic/veterans administration facility. Relevant medical history included that the patient had beginnings of cataracts and his night vision was beginning to diminish from an unknown date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. He was not tested for COVID post vaccination. The patient reported that it was not an adverse event, but his night vision improved the night after he took the vaccine on 03Feb2021 at 02:00, and seemed to be a stable improvement. The patient did not receive any treatment for the event. The outcome of the event was unknown.

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Current Illness:

ID: 1045601
Sex: F
Age:
State: CA

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
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Symptoms: severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer (self-reported). A 77-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration, at Left Arm on 03Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 11), hypertension and hypothyroidism. Concomitant medication included metformin, levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (DIU) and blood pressure medication (unspecified). The patient previously took ibuprofen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination, included; blood pressure Med, metformin, synthroid, DIU. The patient was the not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 04Feb2021, the patient woke up at 3 AM with severe overall headache and nasal congestion. At 6: 30 am took Tylenol tabs 2. Had head and nasal congestion as well and no treatment was taken for nasal congestion. Symptoms did not clear up for nearly 10 hours. Outcome of the events was recovered on an unknown date in Feb2021.

Other Meds: METFORMIN; SYNTHROID; DIU

Current Illness:

ID: 1045602
Sex: M
Age:
State:

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Rec V Date: 02/22/2021
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Symptoms: Felt like an old man; Gout flare/gout attack; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got Pfizer vaccine and a huge gout flare/ gout attack the next day. Felt like an old man, but better now. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1045603
Sex: F
Age:
State: WA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
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Symptoms: Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.

Other Meds: VIT D; AREDS; DOXYCYCLINE; ROSUVASTATIN; MINOXIDIL

Current Illness:

ID: 1045604
Sex: F
Age:
State: MO

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA 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. On an unspecified date, the patient experienced: diverticulitis (medically significant). The clinical course was reported as follows: The patient reported that she received the first dose of the vaccine on 25Jan2021. The patient was scheduled to take the second shot on 15Feb2021. The patient contracted diverticulitis and mentioned that it was "nothing serious" and was prescribed with "common" antibiotics such as metronidazole and "cipro" (ciprofloxacin). Therapeutic measures were taken as a result of diverticulitis. The clinical outcome of the event, diverticulitis, was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1045605
Sex: F
Age:
State:

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/22/2021
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Symptoms: woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021. The outcome of events was recovering. The reporter assessed the events as not serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1045606
Sex: F
Age:
State: FL

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: felt like she had COVID all over again which last 48 hours; felt like she had COVID all over again which last 48 hours; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of COVID-19 vaccine on 30Jan2021 and stated that after her first COVID-19 vaccine she felt like she had COVID all over again which last 48 hours. She is asking if she has to get the second COVID-19 vaccine after having the virus. The patient recovered from the event on unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1045607
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: fever; This is a spontaneous report from a non-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 02Feb2021 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 developed a fever after getting her second COVID vaccine yesterday. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1045608
Sex: F
Age:
State: KY

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 02/22/2021
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Symptoms: Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient's son). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on 24Jan2021 13:30 at a single dose for COVID-19 immunization. The patient had no medical history and family medical history. There were no concomitant medications. On 24Jan2021, the patient experienced sore arm and tiredness. Right after the vaccine she noticed her arm was sore. Later she also felt a tiredness. She was scheduled to receive the second dose 14Feb2021, but she was unsure if she will get it. The events did not require a visit to physician or ER. There were no additional vaccines administered on same date of Pfizer suspect. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was in a hospital. No relevant tests done. The event sore arm recovered on 28Jan2021, while the event tiredness on 26Jan2021.

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Current Illness:

ID: 1045609
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 and had minor symptoms on an unspecified date. Outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111850 same reporter/drug, similar events, different patient.

Other Meds:

Current Illness:

ID: 1045610
Sex: M
Age:
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
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Symptoms: severe headache 8hours after second shot; chills at 12hours; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot_number El3248), via an unspecified route of administration at single dose in the left arm on 04Feb2021 07:00 AM for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 14Jan2021 08:00 AM in the left arm for covid-19 immunisation. On 04Feb2021, the patient experienced severe headache 8hours after second shot, chills at 12hours. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1045611
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 02/22/2021
Hospital: Y

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Symptoms: large quarter sized hives all over; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration on left arm on 05Feb2021 at 08:30 AM at single dose for COVID-19 immunization. The relevant medical history included known allergies: lyrica, possibly cilantro, pollens; insulin resistance; vitamin D def (Vitamin D deficiency); GERD (Gastrooesophageal reflux disease). Concomitant medications included metformin, famotidine (PEPCID), clarithromycin (CLARTIN), topirmate, diphenhydramine hydrochloride (BENEDRYL). The patient previously received first dose of BNT162B2 (lot number: EH9899) at the age of 35 years old, via unspecified route of administration on left arm on 11Jan2021 at 03:30 PM for COVID-19 immunization (first vaccine administered and was fine then had hives and swollen eye on the day the second was to be administered. Delayed shot- received solumedrol shot and prednisone oral with benedryl/pepcid/atarax). The patient took second shot 1 week later on Friday with prednisone on board - woke up on Sunday AM with large quarter sized hives all over. The event resulted in emergency room/department or urgent care. The event was reported serious due to hospitalization. Treatment received included urgent care- Solumedrol shot- RXs. No other vaccine in four weeks. The outcome of the event was recovering.; Sender's Comments: Based on available information and plausible temporal association, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported event large quarter sized hives all over. 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: METFORMIN; PEPCID [FAMOTIDINE]; CLARITIN [CLARITHROMYCIN]; TOPIRAMATE; BENADRYL

Current Illness:

ID: 1045613
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/22/2021
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Symptoms: chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.

Other Meds: BUPROPION; LEVOTHYROXINE; IMITREX; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1045614
Sex: F
Age:
State: CO

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 02/22/2021
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Symptoms: shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EN5318; expiration date: unknown), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunisation . The patient 's medical history was none. Concomitant medication included NP [pending clarification]. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she did not have side effects from the shot. The patient added that 2 days after the shot (01Feb2021 08:00 AM), she got shingles. The patient reported that the event as non-serious. She received treatment for the event (medicine) and the adverse event result in doctor or other healthcare professional office/clinic visit. The patient has not been for COVID-19 since the vaccination. The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 1045615
Sex: F
Age:
State: OR

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/22/2021
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Symptoms: Left hand, specifically thumb, has numbness and tingling; Left hand, specifically thumb, has numbness and tingling; Unable to perform daily activities with this hand after vaccination.; muscle weakness in right thigh.; This is a spontaneous report from a contactable Other HCP (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in right arm on 06Feb2021 07:45 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included isotretinoin (ACCUTANE). The patient previously received first dose of BNT162B2 on unknown date 11:15 on right arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. On 06Feb2021 14:00, the patient had Left hand, specifically thumb, has numbness and tingling. Unable to perform daily activities with this hand after vaccination. Also muscle weakness in right thigh. It was unknown if treatment was received for the events. The events resulted in Disability or permanent damage. The outcome of all events was not resolved. Information about lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to reported events cannot be fully excluded based on the temporal relationship and lack of alternate explanation at this time. Case will be reassessed if additional information is received 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: ACCUTANE

Current Illness:

ID: 1045616
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: a recurrence of cellulitis in her right arm; a recurrence of cellulitis in her right arm; headache; sore arm; Lymphoedema; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program, Pfizer First Connect. A 78-year-old female patient received the first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Jan2021 at a single dose as COVID vaccine. Medical history included cancer survivor and cellulitis in her right arm from being a cancer patient. Concomitant medication included quinine sulfate (LEXIQUIN). It was reported that after the 1st dose of the vaccine, the patient experienced a very bad headache and a sore arm on 2021 and didn't want to miss her 2nd dose. She wanted to know if it's still alright to get her 2nd dose and had some other questions. Her 1st dose of the Pfizer COVID vaccine was 2 weeks ago, afterwards on 2021, a recurrence of cellulitis in her right arm from being a cancer patient; she was put on Levaquin and her doctor told her she may absolutely not get her 2nd dose until at least 15 days after her Levaquin treatment. She's supposed to go for second shot this Saturday (also reported as Friday) but ended up coming down with lymphoedema on 2021. She also came down with cellulitis in her arm after receiving the first injection, which happens a lot to her. She's still on Levaquin and would be done in 3 days. She would like to know how many days she needed to wait to get the vaccine after stopping that. She would like to know how long she could wait in between doses and whether the effects of the 2nd dose of the COVID vaccine would be worse than the 1st. She would also like to know if she has to wait too long, what would happen. Would she need to start all over again? She also wanted to know about getting a new appointment. She spoke to the CDC yesterday and they told her 45 days, and she wanted to know if that was alright or not. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: LEXIQUIN

Current Illness:

ID: 1045617
Sex: M
Age:
State:

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Rec V Date: 02/22/2021
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Symptoms: passed-out/he fell; light-headed; passed-out/he fell; This is a spontaneous report from a contactable other healthcare professional reported that an 82-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and stents. He was on a blood thinner medication. On unspecified date, he felt light-headed. He passed-out a week and a day after the first injection, when he bent over to get something out of the dishwasher. He was found on the ground with broken dishes and he didn't recall how he fell. He was sent to his cardiologist who did an EKG, a blood pressure reading then took his heartrate, and everything was fine. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1045618
Sex: F
Age:
State: NM

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/22/2021
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Symptoms: she was so miserable; terrible headache; lips and tongue were burning; lips and tongue were burning; anaphylactic event; little nauseas/severe nausea/she was so nauseas/nausea was overwhelming; This is a spontaneous report from a contactable consumer (patient). A elderly (reported as almost 80 years old) female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 02Feb2021 13:30 at single dose for covid-19 immunization. Medical history included allergy to latex and shellfish (iodine), cancer, anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. The patient's concomitant medications were not reported. Patient received her 1st dose of the Pfizer covid vaccine. She is reported to have experienced severe nausea and terrible headache, lips and tongue were burning which she says reminds her of an anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. Patient would like to know whether her side effects are normal and her side effects post- vaccine whether they have been reported before. Patient would like to know if the 2nd shot of the covid vaccine is going to be worse and if the side effects after the 1st dose are going to be worse. She received the first COVID-19 vaccine on 02Feb2021. She felt fine until late that evening. She got a little nauseas. It just so happens the next day she was scheduled for her 3 month check-up with her internist. She told the doctor she was a little nauseas that last night, but was fine that day. She clarified further she received the COVID-19 vaccine on 1:30pm on 02Feb2021. Around 3:00pm on 03Feb2021, she was so nauseas, she was so miserable. She called the pharmacist and asked what could she possibly take. The pharmacist told her to drinks lots of water, drink Gatorade, and have her doctor order something to treat the nausea. Caller states she couldn't get a hold of her doctor. However, she did what the pharmacist told her to do by drinking water and Gatorade. The nausea was overwhelming. She got this terrible headache. Later in the day, her lips and tongue were burning. She thought to herself "oh my gosh, I'm having an anaphylactic event". She does keep an EpiPen on her. She took 2 Benadryl. She didn't know if she could take Advil and Benadryl at the same time, so she didn't do that. She is in sort of panic to get the second shot. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1045619
Sex: F
Age:
State: TN

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/22/2021
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Symptoms: The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.

Other Meds:

Current Illness:

ID: 1045620
Sex: F
Age:
State:

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: She experienced a sudden deafness in her right ear in between receiving both her shots.; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 16Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a sudden deafness in her right ear in between receiving both her shots. Her second dose was on 06Feb2021. The outcome of event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1045621
Sex: M
Age:
State: AZ

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/22/2021
Hospital:

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Symptoms: vision loss; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: 183599) solution for injection, via an unspecified route of administration in left arm on 20Jan2021 at a single dose for Covid-19 immunization. Medical history included pacemaker, vitiligo, psoriasis, blood pressure, and autoimmune disorder. Concomitant medications included blood thinners and blood pressure medications. The patient experienced vision loss on an unspecified date. It was reported that patient went for an office/clinic visit to a doctor or other healthcare professional. Also went emergency room/department or urgent care. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 since vaccination. Covid-19 virus test: negative. The event was reported as non-serious however it caused disability. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1045622
Sex: F
Age:
State: CO

Vax Date: 02/03/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
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Symptoms: phrenic nerve damage resulting in unilateral diaphragm paralysis; phrenic nerve damage resulting in unilateral diaphragm paralysis; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 03Feb2021 11:45 (lot number EN9581 and expiry date unknown) at single dose for Covid-19 immunization in the physician office (doctor's office/urgent care). Medical history included anxiety, scoliosis, milk thistle allergies, laundry detergent fragrance allergies. The patient has no covid prior vaccination. Concomitant medication included clonazepam (KLONOPIN), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP) and "multi-vita"; all from unspecified date for unspecified indication. The patient previously took diflucan and experienced allergies. The patient had no other vaccine in four weeks. On 05Feb2021 (two days after receiving vaccination), the patient experienced phrenic nerve damage resulting in unilateral diaphragm paralysis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment due to the events. The patient was not covid tested post vaccination. The outcome of the events was recovering. Follow-up activities are possible, information on the batch number has been requested.

Other Meds: KLONOPIN; BONE UP

Current Illness:

ID: 1045624
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital: Y

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Symptoms: Patient passed hit her head; Stroke; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A 68-year-old female patient received single dose of BNT162B2(Solution for injection, lot number and exp date not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient did not have COVID prior vaccination. On an unspecified date, the patient passed hit her head and had emergency surgery; and stroke. The adverse events resulted in: Hospitalization (date/s unspecified). The patient was not covid tested post vaccination. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1045625
Sex: F
Age:
State: VA

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

Vax Type:
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Symptoms: Syncopal episodes X 4; Fever; chills; pain/aches; Condition Aggravated; This is a spontaneous report from a non-contactable consumer. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284) intramuscularly in left arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included traumatic brain injury from 2019 and ongoing, syncope from 2019 and ongoing (both reported as current Illness: traumatic brain injury? 2019 syncope? 2019). Concomitant medication included midodrine. The patient experienced fever, chills, pain/aches, on 22Jan2021 pm, condition aggravated on 22Jan2021, syncopal episodes X 4 on 23Jan2021 - transferred to ed - admitted. Events categories per reporter was permanent disability, hospitalized (3 days in hospital), emergency room visited. No office visited. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: MIDODRINE

Current Illness: Syncope (Current Illness: Traumatic Brain Injury ? 2019 Syncope ? 2019); Traumatic brain injury (Current Illness: Traumatic Brain Injury ? 2019 Syncope ? 2019)

ID: 1045626
Sex: F
Age:
State: AL

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/22/2021
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Symptoms: My left and right arms have began to tingle; left and right arms go slightly numb 3-4 times per day for about an hour in length.; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration in the left arm, on 06Feb2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified birth control and venlafaxine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) on 29Jan2021 at 13:15, in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient reported that on an unspecified date, her left and right arms began to tingle and went slightly numb 3-4 times per day for about an hour in length. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events "My left and right arms have began to tingle" and "left and right arms go slightly numb 3-4 times per day for about an hour in length" was not recovered. The patient has not been tested for COVID-19 since vaccination.

Other Meds: VENLAFAXINE

Current Illness:

ID: 1045627
Sex: F
Age:
State:

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

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Symptoms: rash; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient experienced rash on Jan2021. It was unknown if treatment was received for the adverse event. Clinical 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: 1045628
Sex: F
Age:
State: OH

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/22/2021
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Symptoms: Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269; Expiration date was not reported) on 05Feb2021 (16:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included asthma, high cholesterol and high blood pressure. The patient's concomitant medications were not reported. The patient previously took prochlorperazine maleate (COMPAZINE), and had drug allergy. The patient was not pregnant at the time of vaccination. On 05Feb2021 (18:00), two hours after the vaccination, the patient had intense itching throughout the entire body. There were no hives or rash, just the unbearable itching. The patient had received diphenhydramine (BENADRYL) as treatment for the event. The outcome of the event, intense itching throughout the entire body, was recovered in Feb2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.

Other Meds:

Current Illness:

ID: 1045629
Sex: F
Age:
State: MA

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

Vax Type:
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Symptoms: Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. 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: CYMBALTA; TRAZODONE; BUSPAR; VYVANSE; METHYLFOLATE

Current Illness:

ID: 1045631
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
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Vax Type:
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Symptoms: anaphylactic reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways received by a contactable consumer(patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction to the first dose of the vaccine on an unspecified date and went to the hospital with outcome of unknown. Information on the Lot/Batch Number has been requested.

Other Meds:

Current Illness:

ID: 1045632
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
Hospital: Y

Vax Type:
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Symptoms: swollen tongue; swollen tongue and lips; worsened; rash; This is a spontaneous report from a contactable consumer (patient) via pharmacist. This adult female patient (age late 50) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 15 mins after the 1st dose Pfizer Covid vaccine, the patient had runny ones swollen tongue and lips. Benedryl was administered, symptoms improved then worsened. Transport was called to hospital epi administered. RX steroids at the time of reporting was day 9 post vacc administration, the patient was still on steroids and continued rash. The patient described blood dripping from arm post stick. The patient wonder if administration was not IM. Event took place after use of product. Outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1045633
Sex: M
Age:
State: TX

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 02/22/2021
Hospital: Y

Vax Type:
Manufacturer:
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Symptom List:

Symptoms: Has been hospitalized with COVID for 10 days now; Has been hospitalized with COVID for 10 days now; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient had no underlying condition. The patient's concomitant medications were not reported. The patient's wife reported that the patient has been hospitalized with COVID for 10 days now since an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1045634
Sex: M
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/22/2021
Hospital: Y

Vax Type:
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Symptom List:

Symptoms: Acute arm pain; chills; fever 40?C; loss of oxygen and conscience/diagnosed with pneumonia; loss of oxygen and conscience; This is a spontaneous report from a contactable consumer (patient). An 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: el9263) via an unspecified route of administration on 06Feb2021 14:15 at single dose in left arm for COVID-19 immunisation. Medical history included severe COPD (chronic obstructive pulmonary disease), atrial fibrillation, reflux gastritis, and was allergic to Penicillin. On 07Feb2021, the patient experienced acute arm pain, 2 days later chills, and 5 days later fever 40?C, loss of oxygen and conscience, 911 call diagnosed with pneumonia. Later they gave another diagnosis, the next day, no fever and no pain in the arm. The patient received antibiotics and steroids as treatment. Events resulted in visit to physician's office or another health professional, emergency room, hospitalization, potential mortal disease (immediate risk of death due to event). Events outcome was recovered on Feb2021. The patient hospitalized due to events for 4 days. The patient underwent lab tests and procedures which included body temperature 40?C on 07Feb2021, COVID test via nasal swab on 11Feb2021 with result of Negative.

Other Meds:

Current Illness:

Date Died: 02/11/2021

ID: 1045635
Sex: M
Age:
State: MO

Vax Date: 02/04/2021
Onset Date: 02/09/2021
Rec V Date: 02/22/2021
Hospital:

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Symptom List:

Symptoms: Death; Passed out; Stomach was bothering; Constipated; Difficulty breathing; Weakness/Event: Weakness was reported as worsened; a temperature of 99.4 degrees; Sweaty; Cold; Muscle ache; Body Aches; Diarrhea; Nausea; Vomiting; Fatigue/Tiredness; His raspy throat felt like he had mucus stuck in his throat; Cough; Raspy throat/worsened; This is a spontaneous report from a contactable consumer reporting her husband. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EM9810, Expiry Date: Jun2021) at the age of 74- year-old via an unspecified route of administration on 04Feb2021 09:15 at single dose in Arm, Right for COVID-19 immunisation. Medical history included type 2 diabetes mellitus for about 20-25 years, ongoing kidney disease from 2005, ongoing chronic kidney disease, cardiac pacemaker insertion. The patient was diagnosed with kidney disease in 2005, but it was about 1 to 1-1/2 years ago that his kidney disease progressed to Stage 4 Kidney Disease. She said the Veterans Administration diagnosed her husband with his kidney disease, but her husband saw a private doctor, as well as, a VA doctor for his care. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EL3248; Expiration Date: Apr2021) at the age of 74- year-old Intramuscularly at approximately 08:45AM on 15Jan2021 in right arm for COVID-19 immunisation and had no reaction. There were no additional vaccines administered on same date of the Pfizer suspect. There were no Prior Vaccinations within 4 weeks. The patient had symptoms start earlier in the day of Tuesday, 09Feb2021, after his second COVID-19 Vaccine shot (04Feb2021). The reporter said she and her husband didn't think anything of his symptoms at first. The patient had a temperature of 99.4 degrees on 09Feb2021. She didn't check her husband's temperature again after that time because the nurse at her husband's doctor's office said her husband's temperature was not at an area of concern. The patient was sweaty, off and on, starting 09Feb2021. She clarified he would be sweaty and the cold, but nothing extreme. The patient developed muscle aches, body aches, diarrhea, nausea, and vomiting on 09Feb2021. She clarified her husband had fatigue, tiredness, and had trouble with a raspy throat. His raspy throat started Tuesday evening (09Feb2021). His raspy throat felt like he had mucus stuck in his throat, and he was unable to clear the mucus from his throat. The reporter called her husband's primary care doctor on the morning of 10Feb2021 because her husband was having trouble with a raspy throat, and difficulty breathing. She said on Tuesday night (09Feb2021) her husband had to sleep sitting up because he couldn't lay down with his breathing. He was able to eat breakfast (clarified as oatmeal and an orange), lunch (clarified as soup and a salad), and dinner (clarified as soup and half a sandwich. She said her husband ate all the meat and half of the bread on the sandwich) on 10Feb2021. Her husband's primary care doctor wasn't available to speak to on Wednesday morning (10Feb2021), but the doctor's nurse said it sounded like her husband was having a reaction to his second COVID-19 Vaccine shot. The reporter said her husband's doctor instructed her later in the day to take her husband to the Emergency Room or Urgent Care if he didn't feel any better. Her husband's throat raspiness got worse in the evening of 10Feb2021. His breathing also became worse after dinner in the evening of 10Feb2021. The patient leaned forward over a couple pillows while sitting on their couch as it was easier for him to breath by doing that. They decided at 11:00PM that her husband should go to the Emergency Room. She said her husband was getting very weak, so she and her husband debated if she should call # for an ambulance, or if she should drive him to the Emergency Room. She said her husband was able to dress himself, but with some difficulty, and she assisted walking him from their house to their car. She said she had turned to walk away from her husband while he was at the side of their car, and then she heard her husband make a noise. He had appeared to have passed out. She clarified in the past, her husband had passed out prior to his pacemaker. She said she dialed #, and the # operator told her how to tell if her husband was still breathing. She said she couldn't tell if her husband was still breathing. She said when the ambulance arrived at her house, the ambulance staff worked on her husband for a long time. The reporter thought her husband had died at the time he had collapsed at the side of their car. The patient took a sugar free cough syrup Tuesday night (09Feb2021), and then again a couple times on Wednesday (10Feb2021) as treatment. The patient had thrown up a couple times, but found that the sugar free cough syrup soothed his cough the night before (09Feb2021). She said her husband had taken 2 TUMS early on Wednesday morning at approximately 2:00AM (10Feb2021). He had said his stomach was bothering him on 10Feb2021. He said he thought he may be constipated, so he took 1 Senokot (Clarified as GeriCare Senna-Plus Natural Vegetable Laxative with Stool Softener) on 10Feb2021. She clarified her husband had diarrhea on 09Feb2021, but felt on 10Feb2021 he may have been constipated. There were no adverse events required a visit to Emergency Room since Patient's wife stated she was getting her husband to their car, so she could drive him to the Emergency Room, when her husband collapsed and died or to Physician Office as they spoke with the nurse at her husband's primary care doctor's office. Weakness was reported as worsened. The outcome of events Sweaty, Cold, Muscle ache, Body Aches, Fatigue/Tiredness, Raspy throat/worsened, Difficulty breathing, Weakness was not recovered; and of the remaining events was unknown. The patient died on 11Feb2021. The patient's official time of death was Thursday, 11Feb2021, at 12:08AM. Cause of death was unknown. An autopsy was not performed and it would take 3 weeks for a death certificate to be issued. The reporter stated she thought it was important to notify Pfizer of her husband's passing because his side effects fell within the expected time period after receiving his second COVID-19 Vaccine.; Reported Cause(s) of Death: Death

Other Meds:

Current Illness: Chronic kidney disease stage 4; Kidney disorder

ID: 1045636
Sex: M
Age:
State: MS

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

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Symptoms: diagnosed with vertigo; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Allergic reaction which elevated patient's spinal cord pressure and brain stem swelling; Very hard time focusing my eyes; Extreme burning and tingling sensation over his entire body; Extreme burning and tingling sensation over his entire body; extremely dizzy; confused; nauseous; uncontrollably shaking; Headache; This is a spontaneous report from a contactable consumer reporting for himself. A 33-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021 at 11:00 AM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient had no known allergies and did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. On 01Feb2021 at 12:00 PM the patient developed a headache. Over the next few hours the headache moved to the back of his neck and base of his skull. On 03Feb2021 the patient experienced very hard time focusing his eyes and extreme burning and tingling sensation over his entire body, he was extremely dizzy, confused, nauseous and uncontrollably shaking. Patient went to his family doctor and was diagnosed with vertigo on 05Feb2021. Patient took meclizine with no relief. On 10Feb2021 the patient was visited by another doctor and went under two days of testing including acoustic stimulation tests, balance test, visual acuity tests, CT scan and MRI all with unknown result. The doctor said the vaccine shot caused an allergic reaction which elevated patient's spinal cord pressure and brain stem swelling. Therapeutic measures were taken as a result of spinal cord pressure and included treatment with Diamox. Outcome of the events was not resolved. The events were considered serious as life-threatening and as per disability. Patient was not tested positive for COVID-19 after vaccination. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1045637
Sex: F
Age:
State: MI

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

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Symptoms: I passed out, I was unconscious on the floor, my eyes were open and looked very strange he said, I was making gurgling sound.; I was unconscious on the floor/Tried to wake me up but it didn't work; Lethargic; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration at left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: " I passed out the next morning for about 8 minutes my husband said, I was unconscious on the floor, my eyes were open and looked very strange he said, I was making gurgling sound. He threw water on me and he tried to wake me up but it didn't work. I came out of it I was very lethargic the whole day but the next day I was feeling a little bit better". No therapeutic measures were taken as a result of events. The patient outcome of lethargic was recovering; the outcome of the other events was recovered. The information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1045638
Sex: F
Age:
State: TX

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

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Symptoms: I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood sugar dropped in the middle of the night; Sleeping a lot; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on an unspecified date (at 48 years of age) as a SINGLE DOSE for Covid-19 Vaccination , insulin (INSULIN) 'regular Insulin for sliding scale' Lot Number Unknown 'number under the bar code C:1011:1030310691833329. via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin detemir (LEVEMIR) Lot Number 310018652576, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin aspart (NOVOLOG) Lot Number 374934031098, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , semaglutide (OZEMPIC) weekly, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose, weekly for diabetes mellitus. Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL). The patient reported I am diabetic and my blood sugar dropped in the middle of the night, so my husband had to get up and give me something (Unspecified Medication) and then I am sleeping a lot and I do have some confusion on an unspecified date. The patient underwent lab tests that included blood glucose: dropped on an unspecified date. Treatment was given for diabetic and blood sugar dropping. Consumer also stated, No, it is not that severe The clinical outcome of the events diabetic, blood sugar dropped in the middle of the night, Sleeping a lot and Confusion was Unknown. The action taken in response to the event(s) for insulin was unknown, for insulin detemir was unknown, for insulin aspart was unknown, for semaglutide was unknown. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.

Other Meds: LISINOPRIL; INSULIN; OZEMPIC; LEVEMIR, NOVOLOG

Current Illness:

ID: 1045639
Sex: F
Age:
State: MO

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/22/2021
Hospital:

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Symptoms: Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.

Other Meds: FAMOTIDINE; TYLENOL; CABERGOLINE; VITAMIN D [ERGOCALCIFEROL]

Current Illness:

ID: 1045640
Sex: F
Age:
State: NJ

Vax Date: 01/31/2021
Onset Date: 02/01/2021
Rec V Date: 02/22/2021
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Symptoms: began to hallucinate; Dizzy; bed nightmare; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Expiration Date: May2021), via an unspecified route of administration on 31Jan2021 at 79-years-old at a single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing, shrunk a little from an unknown date and unknown if ongoing ("about 5'9 and I was always 5'10 but I think I shrunk a little"). Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure high from an unspecified date to an unspecified date ("I have blood pressure, high blood pressure. I am taking a blood thinner. I was taking the other one, but they told me to look the other one (BYSTOLIC). It (BYSTOLIC) is a new drug I would say."). The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date and experienced adverse event ("no problem, nothing happened, there were minor things here and there"). On an unspecified date in Feb2021, the patient began to hallucinate (medically significant), dizzy (non-serious), and bed nightmare (non-serious). The patient did not receive treatment due to the events; "No, I just ignored it." The clinical course was reported as follows: The patient stated, "I took the virus vaccination shot (clarified as COVID 19 vaccine). The first one, there was no problem, nothing happened, there were minor things here and there. The second one I took was just this past Sunday. Something weird happened not right away, not the first day but probably it was second day, second or the third day, I am pretty sure I am not sure exactly, I think. I was not keeping track of all of that." The patient began to hallucinate; and when she got out of her bed, she suddenly had a feeling that she should look back. The patient stated that she looked back and there was her deceased sister (who died 37 years ago; according to the patient) and her daughter who was still alive; both were looking at her. The patient further reported the following: "They remained in my bed beside me. Okay, I ignored it and thought it was kind of funny because I know that my daughter is in (place name) and my sister is deceased. So, I am having a bed nightmare or something, so I ignored it. Then next thing it happened for a few days and then the dog that we just had euthanized, my daughter (name) had cancer and it was euthanized and what happened is, I was sitting on my sofa and I have seen the dog come out of my bedroom going to the bathroom but only the back of her and she disappeared. Then I spent the night at my other daughter's house and somewhere in the middle of the night I was awake in my something and I woke up and I looked over into my sistert's dining room and there was my brother standing there looking at me and there was two of his children sitting at the table also. I thought this is getting a little weird." The patient reported that nothing like this happened before. The patient wanted to understand the event because she "never had been dizzy from my drug, taking the drug (unspecified medication) that made me dizzy but that not the same thing what is going on here." The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

Other Meds: BYSTOLIC

Current Illness:

ID: 1045641
Sex: M
Age:
State: FL

Vax Date: 01/23/2021
Onset Date: 01/27/2021
Rec V Date: 02/22/2021
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Symptoms: Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284; Expiration date: 30Apr2021), via an unspecified route of administration in the right arm, on 23Jan2021 (at the age of 72-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure (HBP) and COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization and influenza vaccine (FLU) on 05Jan2021 for immunization. The patient experienced positive COVID-19 test on 27Jan2021 and Bell's palsy - reactivate herpes simplex scars right eye on 01Feb2021. The patient underwent lab tests and procedures which included COVID-19 nasal swab: positive on 27Jan2021. Therapeutic measures were taken as a result of Bell's palsy - reactivate herpes simplex scars right eye, which included ganciclovir (ZIRGAN). The clinical outcome of positive COVID-19 test was unknown and of Bell's palsy - reactivate herpes simplex scars right eye was not recovered.

Other Meds:

Current Illness:

ID: 1045642
Sex: U
Age:
State:

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

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Symptoms: got the flu; Got very sick; Initial information was received on 09-Feb-2021 regarding an unsolicited valid non-serious case from a consumer. This case involves patient (unknown demography) who had the flu (influenza) and got very sick (illness), while the patient received INFLUENZA VACCINE. Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious had the flu (influenza) and got very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for both the events.

Other Meds:

Current Illness:

ID: 1045643
Sex: U
Age:
State:

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

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Symptoms: patient had tingling at the injection site; arm hurt to lift it; red patch on the lower arm; felt warm to the touch; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional. This case involves patient (unknown demographics) who had tingling at the injection site (injection site paraesthesia), arm hurt while lifting (pain in extremity), red patch on the lower arm (rash erythematous) and felt warm to the touch (feeling hot), after receiving INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) 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 unknown route in the upper arm near the shoulder for prophylactic vaccination On an unknown date, the patient developed a non-serious tingling at the injection site (injection site paraesthesia), next day of vaccination arm hurt while lifting (pain in extremity), red patch on the lower arm (rash erythematous) and felt warm to the touch (feeling hot) (Unknown latency), following the administration of INFLUENZA VACCINE. No laboratory data reported. It was not reported if the patient received a corrective treatment. The patient got recovered from all the events on an unknown date as it reported that the patient was feeling much better and did not take any of the medicines as directed.

Other Meds:

Current Illness:

ID: 1045644
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: covid; feeling ill; Initial information was received on 10-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-health care professional. This case involves a female patient (age unspecified) who experienced Corona virus disease (COVID-19), after she received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination. On an unknown date, the patient developed a non-serious ill feeling (malaise), (unknown latency) following the administration of INFLUENZA VACCINE and 1 week later patient tested positive for COVID (COVID-19). It was unknown if the patient experienced any additional symptoms/events. Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment. At the time of reporting, event outcome was not reported for reported events.

Other Meds:

Current Illness:

ID: 1045645
Sex: U
Age:
State:

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

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Symptoms: very allergic; Initial information was received on 10-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or Non-health care professional. This case involves an adult patient (unknown age and unknown gender) who experienced very allergic, (hypersensitivity) while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(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 not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious very allergic (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was not provided. Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome of event was unknown. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1045646
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: patient had allergic reation; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case from non-healthcare professional. This case involves patient (unknown demographics) who had allergic reaction (hypersensitivity), after receiving vaccine INFLUENZA VACCINE. Medical treatment(s), vaccination(s), concomitant medication(s) 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 unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) (Unknown latency), following the administration of INFLUENZA VACCINE. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome is unknown for hypersensitivity.

Other Meds:

Current Illness:

Date Died:

ID: 1045647
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/22/2021
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Symptoms: patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media. This case is linked to case 2021SA056035. (same reporter) This case involves a male patient (reporter's father in-law) (age unspecified) who died (death), after he received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination. On an unknown date, the patient died from a flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events before death. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment before death. It was unknown if an autopsy was done. The cause of death was reported as, the patient died from a flu shot. At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine. There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot

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ID: 1045648
Sex: M
Age: 1
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/22/2021
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Symptoms: expired Pentacel by mistake; Initial information was received on 03-Feb-2021 regarding an unsolicited valid non-serious case from an other health professional (Agency Inquiry Number: 00459652). It was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was expired and administered to a patient by mistake on an unknown date for prophylactic vaccination (Expired product administered). It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on batch number for this case.

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Current Illness:

ID: 1045649
Sex: F
Age:
State: IN

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/22/2021
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Symptoms: a four year-old child was administered Menactra, rather than the intended MMR vaccine/no AE;Initial information regarding an unsolicited valid non-serious case was received from another health professional via medical information (Reference number- 00472867) and transmitted on 12-Feb-2021. This case involves a 4 year old female who received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] once, [injection, lot number: U6828AB, expiry date: 29-Jan-2022] via intramuscular route at right thigh on 28-Feb-2021 for prophylactic vaccination, rather than the intended MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] [lot number, expiry date and other dosing details not applicable] (wrong product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), INFLUENZA VACCINE and HEPATITIS A VACCINE. It was a case of actual medication error due to wrong vaccine administered. No adverse effect had been reported after vaccination. At the time of reporting it was reported that, the suspect was used first time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PENTACEL; INFLUENZA VACCINE; HEPATITIS A VACCINE

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm