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**
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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: 0996735
Sex: F
Age:
State: NC

Vax Date: 01/13/2021
Onset Date: 01/17/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous report from a contactable pharmacist. A 77-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730) via an unspecified route of administration on 13Jan2021 12:30 single dose for covid-19 immunisation. Vaccine location was left arm. Patient did not receive any other vaccines that day and none 4 weeks prior. Medical history was none. There were no concomitant medications. The patient experienced burning pain going down into the forearm on the same side vaccine given on 17Jan2021. She has never experienced anything like this before having that vaccine. The event was reported as medically significant. The outcome was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering he known safety profile of COVID-19 vaccine, BNT162B2, the Company considers there is a reasonable possibility that the reported "burning pain going down into the forearm on the same side vaccine given" is related to 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 RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 0996736
Sex: F
Age:
State: NJ

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:elevated; Comments: 08:15 PM; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:elevated; Comments: 08:15 PM

Allergies:

Symptoms: felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. 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: PROBIOTICS

Current Illness:

ID: 0996738
Sex: F
Age:
State: CA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: blood pressure; Result Unstructured Data: Test Result:high

Allergies:

Symptoms: swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. 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:

Current Illness:

ID: 0996739
Sex: F
Age:
State: CA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: blood sugar; Result Unstructured Data: Test Result:No change; Comments: No fever or change in blood sugar.

Allergies:

Symptoms: Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar.; This is a spontaneous report from a contactable Physician. A 75-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 18Jan2021 19:30 at single dose on left arm for COVID-19 immunization. Medical history included Stroke, diabetes, hypertension, anaphylaxis to bee stings. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sitagliptin phosphate (JANUVIA), hydrochlorothiazide, telmisartan, rivaroxaban (XARELTO), gabapentin and baclofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to Morphine and experienced Hives. Approximately 22 hours after vaccination the patient had a seizure on 19Jan2021 17:15. She felt fine up until the seizure occurred. She never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar. No treatment was received for the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolved. Information on the lot/Batch number has been requested.; Sender's Comments: Based on the time association and previously allergic reactions to bee stings and other drugs, the possible contribution of suspect BNT162B2 to the event seizure cannot be excluded in this elderly patient with multiple medical histories including stroke, diabetes and hypertension. 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: JANUVIA [SITAGLIPTIN PHOSPHATE]; HYDROCHLOROTHIAZIDE; TELMISARTAN; XARELTO; GABAPENTIN; BACLOFEN

Current Illness:

ID: 0996740
Sex: F
Age:
State: IL

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 02/03/2021
Hospital: Y

Lab Data: Test Date: 20210110; Test Name: COVID-19 PCR test (Nasal Swab); Test Result: Negative

Allergies:

Symptoms: Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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: 0996741
Sex: F
Age:
State: IL

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is a spontaneous report from a contactable other Health Professional (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 18Jan2021 08:15 at single dose in left arm for COVID-19 immunization. Medical history included non allergic rhinitis and vestibular migraines. The patient had not known allergic, but very sensitive to SE. Concomitant medications included "sensimist", naproxen sodium (ALEVE), progesterone, estradiol. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 28Dec2020 08:45 at single dose in left arm for COVID-19 immunization. No other vaccine was received in four weeks. The patient experienced roscia-major flare occurred in eyes within 2 hours of second vaccine on 18Jan2021 09:00. Continued to worsen over next 24 hours. Necessitated a trip to eye dr. Have never had a flare this serious. In addition, severe itchiness day vaccine given. Took antihistamine (Allegra) second day which solved issue. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received Neomycin & Polymyxin B Sulfates & Dexamethasone Op as treatment. The outcome of the events was recovering.; 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: ALEVE; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 0996742
Sex: F
Age:
State: MI

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: CT head; Result Unstructured Data: Test Result:Unknown result; Test Name: echocardiogram; Result Unstructured Data: Test Result:Unknown result; Test Name: lab work; Result Unstructured Data: Test Result:Unknown result; Test Date: 20201224; Test Name: Nasal Swab; Test Result: Negative ; Test Name: carotid doppler; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptoms: Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events due to temporal relationship. However, the events may likely possibly represent concurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: 0996743
Sex: F
Age:
State: NM

Vax Date: 12/17/2020
Onset Date: 01/15/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular in the left arm on 17Dec2020 16:15 at a single dose for COVID-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, Factor V Leiden, GERD (Gastroesophageal reflux disease), DVT (deep vein thrombosis), hypertension, neck pain on left side, rhinitis, and rhomboid muscle strain. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone nasal spray, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone, and sodium chloride nasal spray. The patient had no other vaccines in four weeks before covid vaccine. The patient had no prior vaccination and she had not been tested post vaccination. The patient noticed some numbness on the right side of face after receiving the first dose of vaccine on an unknown date. She was concerned for early Bell's Palsy on 15Jan2021 at 09:00 AM. She will be treated with valganciclovir and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events early Bell's Palsy and some numbness on the right side of face was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "concerned for early Bell's palsy". 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: FLUOXETINE; EXCEDRIN MIGRAINE; FLUTICASONE; HYDROCHLOROTHIAZIDE; LISINOPRIL; LORATADINE; MELOXICAM; OMEPRAZOLE; OXYCODONE; SODIUM CHLORIDE

Current Illness:

ID: 0996744
Sex: F
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL0140) via an unspecified route of administration on left arm on an unspecified date at a single dose for covid-19 immunization. The patient had a heart condition and a stroke. The patient concomitant medications were not reported. The patient stated that she had a when I had the shot on the 13th (not clarified) and end up going to urgent care on Friday. She had a huge swelling around her eyes and redness and tenderness and her left eye was swollen shut. She went to urgent care and got some antibiotics and some cream to put on it. The patient had not any lab test. However, she did have microblading done to her eyebrows, three days before she had the shot. The patient wanted to know if it was because she had the microblading done and then she got the shot. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0996745
Sex: M
Age:
State:

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Knee joint swelled 3 times the size; Bruising that is not at the injection site that just came up; Looks yellow, like jaundiced; does not feel well; he looks a little pale; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL3249, expiry date unknown) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, resident at the Nursing Home received the vaccine on 15Jan2021. On an unspecified date, his knee joint swelled 3 times the size. He has a bruising that is not at the injection site that just came up. Overall, he does not feel well and looks a little pale and jaundiced. He almost looks like yellow, like jaundiced. Should he go to the ER or should he wait? The reporter and the doctor did not know what to do. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0996746
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: Covid test; Result Unstructured Data: Covid test

Allergies:

Symptoms: asthma symptoms; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional [under reference number: US-SA-SAC20210128000259]. This case involves an adult patient who experienced asthma symptoms (asthma), while the patient received INFLUENZA VACCINE. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor. 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 a non-serious asthma symptoms (asthma) unknown latency following the administration of INFLUENZA VACCINE. It is unknown if the patient experienced any additional symptoms/events. Relevant laboratory test results included: On an unknown date SARS-CoV-2 test [Covid test] was done. It is unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the event outcome was unknown. There will be no information on batch number of this case.

Other Meds:

Current Illness:

ID: 0996747
Sex: F
Age: 0
State:

Vax Date: 09/01/2019
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the 8 month old patient recived 2 doses of Menactra 2 month and 6 days apart, no AE; the patient received first dose of Menactra when she was 8 month and 18 days old, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00437336) and transmitted to Sanofi on 20-Jan-2021. This case involved an 8 month and 18 days old female patient who was vaccinated with the first dose (one dosage form) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on an unknown date of Sep-2019 (product administered to patient of inappropriate age) and the second dose (one dosage form) of same vaccine received at the age of 10 months and 14 days (total duration 2 months and 6 days) (Inappropriate schedule of product administration) on an unknown date of Nov-2019 (batch number and other dosing details were not reported) for prophylactic vaccination. The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. This was an actual medication error due to drug dose administration interval too short and Inappropriate age at vaccine administration (latency same day). At the time of reporting, no adverse event reported to the patient. The reporter wanted to know if this vaccination was enough. 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 the batch number for this case.

Other Meds:

Current Illness:

ID: 0996748
Sex: U
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: medication error with Pentacel described as the DTap-IPV portion was given and the Hib powder portion not given with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist and transmitted to Sanofi on 21-Jan-2021. The case involved an unknown age patient who received Pentacel which was described as the DTap-IPV portion was given and the HIB powder portion was not given (Product preparation issue). Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report was 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 Disclaimer: Practices. The classification as a medical error was 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 had contributed to or was to be held liable for the occurrence of this medication error. There would be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 0996749
Sex: F
Age:
State: MN

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient had received an expired Fluzone HD vaccine/ No AE; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 57 year old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] inadvertently (expired product administered). Medical history, medical treatment, vaccination, concomitant medications and family history were not provided. On 21-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ249AA and expiry date: 30-Apr-2020) via unknown route in unknown administration site. It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event was 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.

Other Meds:

Current Illness:

ID: 0996750
Sex: F
Age: 53
State: GU

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: 0920 Cleared to leave 0930 Started feeling tired /fatigued 1900 Arms started to become sore, Migraine Headache 2330 Took Tylenol PM 0100 -0300 Restless sleep , body temperature hot & cold but no fever; arm sore; took ibuprofen Sun, 31 Jan 21 0900 Woke up with Migraine headache, arms still sore , tired ..stayed in bed all day Mon, 1 Feb 21 Feeling much better; no migraines

Other Meds: Levothyroxine, Liothyronine, Calcitriol, curcumin, Tylenol

Current Illness: None

ID: 0996751
Sex: F
Age: 39
State: OR

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: Levoquin Demerol

Symptoms: Vomiting, Fever >102, diarrhea, arthralgia, myalgia, migraine

Other Meds: Armour Thyroid

Current Illness: None

ID: 0996752
Sex: F
Age: 41
State:

Vax Date: 01/29/2021
Onset Date: 01/31/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: Food allergies

Symptoms: Large swelling of lumphatic system. Lymph nodes are visibility swollen all along arm and immensely painful when moving arm.

Other Meds:

Current Illness: None

ID: 0996753
Sex: M
Age: 29
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: none

Allergies: raw carrot skin, pollen, dust, cat hair

Symptoms: Chill, lethargy, nausea, slight fever of 98.6F, muscle soreness lasted about 20 hours symptoms improved after taking Advil, a total of 4 pills, each with 4~6 hours apart

Other Meds: antihistamine

Current Illness: none

ID: 0996754
Sex: F
Age: 24
State: NH

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: CT scan 1/28 with no remarkable findings. Lumbar puncture 1/29 with no abnormal findings

Allergies: no known allergies

Symptoms: About 2 hrs after second dose shortness of breath and throat starting to swell for around 15 min then went away on its own. Next morning 1/28 very sore leg muscles, hot flashes, headache. As day went on my limbs were tingling and had some numbness. Increasingly getting fatigue and wasn't able to keep my head up for more than 30sec with out it falling. By 5p I could not move left arm at all and called PCP office and went to ER. Over 5 hours I got feeling back in left arm and left ER at 10:30p. CT was done to rule out stroke or other injury. Next day around 2p my right arm started to get more numb and I wasn't able to move it much. SOB and throat tightening came back briefly. Later that day lumbar puncture done to rule out guillain barre syndrome. Numbness is not as severe now 2/3 and each day since 1/28 it gets increasingly less

Other Meds: Bupropion 150mg and nitrofurantoin 100mg bid

Current Illness: UTI

ID: 0996771
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: he exhibited nonprotective IgG titers to Hemophilus influenzae type B; 3-year-old boy received a repeat immunization to H influenzae type B. This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 3-year-old, male patient (boy), with a history of infections: recurrent acute otitis media and one occurrence of pneumonia, that required hospitalization. Complement factor I (CFI) deficiency was a rare disorder with 38 reported cases worldwide. The immune system had adaptive and innate pathways. The complement system was part of the innate pathway, which, through proteolytic reactions, cleared immune complexes and opsonized and kills microbial pathogens. The deficiency of CFI led to complement dysregulation through C3 convertase overactivation and low C3 levels, resulting in decreased bacterial opsonization, phagocytosis, and macrophage activation complex killing. In addition, CFI deficiency caused increased susceptibility to autoimmune/autoinflammatory ailments such as systemic lupus erythematosus, atypical hemolytic uremic syndrome (aHUS), glomerulonephritis, encephalitis, and macular degeneration. On an unknown date before the presentation, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unspecified date, the patient presented to the immunology clinic for decreased complement component 3 (C3) levels with glomerulonephritis. Previously, during evaluation for chronic constipation, he was found to have microscopic hematuria. He had normal kidney function, complete blood cell count, and blood pressure. A pediatric nephrology evaluation revealed, that he had low levels of C3 at 28 to 36 mg/dL on 3 different laboratory samples. Notably, antinuclear (ANA) antibody, antistreptolysin O, and C4 were normal. Renal biopsy result was also normal, thus excluding glomerulopathy or C3 nephritic factor as diagnoses. It was reported, that the patient's mother had ulcerative colitis and asthma. There was no other family history of atopic disease, immunodeficiencies, or autoimmune disorders. At the presentation time, immunologic evaluation revealed normal serum levels of immunoglobulin G (IgG), immunoglobulin A, and immunoglobulin M. He had normal IgG antibody titers to diphtheria toxoid and tetanus toxoid. He exhibited nonprotective IgG titers to Hemophilus influenzae type B (antibody test abnormal) and Streptococcus pneumoniae. Flow cytometry revealed normal memory and class-switched B cells. The patient had a decreased C3 level of 36 mg/dL and undetectable levels in total hemolytic complement (CH50) and serum complement, alternate pathway (AH50) assays. The C4 level was normal. An evaluation performed at the laboratory revealed decreased complement components 5, 8, and 9 (C5, C8, and C9) and complement factors B, H, and I, indicating a likelihood of alternative pathway overactivation. The results were as followed (microgram/mL): C1q of 111, C1r of 73, C1s of 117, C2 of 21.5, C5 of below 17 (low (L)), C6 of 31, C7 of 97.8, C8 of 36 (L), C9 of 17 (L), factor B of below 114 (L), factor D of 2.32, factor H of 75 (L), factor I of below 13 (L). Other results included: C3 of 36 (mg/dL) (L), C4 of 20 (mg/dL), CH50 of below 17 (U/mL) (L) and AH50 of 0 (U/mL) (L). Subsequently, genetic studies of C5 and factors I, B, and H, identified compound heterozygous mutations of complement factor 1 (CFI), c1253A >T (p.his418leu) and c.772G >A (p.ala258thr), which have been previously reported as pathogenic. The c.1253A >T mutation in exon 11 caused reduced protein expression, whereas the c.772G4A mutation of exon 5 led to erroneous mRNA. Thus, the patient's clinical, laboratory, and genetic manifestations confirmed a CFI deficiency. On an unknown date, the patient was prescribed daily amoxicillin, as prophylaxis for infection. On an unspecified date, he also received a repeat immunization to Haemophilus influenzae (H. influenzae) type B with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). The patient also received his first pneumococcal polysaccharide vaccine (reported as PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT) (Injection, , ) (PNEUMOVAX23) or "PPSV23") and unspecified "meningococcal conjugate vaccine". After immunizations, he exhibited protective antibody titers to H. influenzae type B and Streptococcus pneumoniae. He had regular follow-ups with the pediatric immunology and nephrology clinic and was monitored closely for infections, progressive renal disease, and in particular, atypical hemolytic uremic syndrome (aHUS). The outcome of the event of antibody test abnormal was recovered/resolved. The CFI deficiency was a rare primary immunodeficiency, that led to increased susceptibility to encapsulated bacterial infections and non-infectious presentations such as rheumatologic, renal, dermatologic, and neurologic disease. The CFI gene was located on chromosome 4q25 and generates a 88 kDa glycoprotein, that was principally produced by the liver. Furthermore, CFI was an acute-phase reactant, and it's expression was up-regulated by interleukin-6 in hepatocytes. The patients with CFI deficiency were susceptible to invasive bacterial infections, with up to 81 % of affected individuals presenting in such a manner. Among genetically confirmed cases, there was a slight preponderance in women (2.2:1) and childhood onset. No clear relationship currently existed between CFI mutations and the resulting clinical phenotype of CFI deficiency. Of note, there were cases of siblings, who shared a CFI genotype, but even though the proband developed pathogenic manifestations, the sibling remained asymptomatic. Autoimmune ailments were associated with CFI deficiency, some of which could be life-threatening. An example of such an ailment was aHUS, which was characterized by hemolytic anemia, thrombocytopenia, and acute kidney injury resulting from microthrombi in the small blood vessels. The penetrance of aHUS in patients with CFI mutations was approximately 50 %. The prognosis for aHUS was extremely poor, with approximately 60 % of patients progressing to end-stage renal failure. Renal transplantation in patients with aHUS who had CFI mutations has been associated with a high recurrence rate and especially poor prognosis. In CFI deficiency, there was unregulated activation of the alternative complement pathway, that subsequently activated the terminal complement pathway, with C5 activation and generation of C5a and C5b-9 membrane attack complex (MAC), leading to elevations in plasma levels of C5a and C5b-9. The C5b-9 MAC complex might have been caused inflammation, endothelial cell activation, neutrophil activation, hemolysis, or thrombosis. Eculizumab is a humanized anti-C5 monoclonal antibody that binds to the alfa chain of C5 and prevents the generation of C5a and C5b by the C5 convertase, causing down-regulation of C5a anaphylatoxin and C5b-C9 MAC, thereby decreasing inflammation. The eculizumab has been approved for the treatment of aHUS. Currently, the treatment for CFI deficiency was limited to antimicrobial prophylaxis through vaccination against encapsulated bacterial pathogens. Although there was no empirical evidence demonstrating the effectiveness of antibiotic prophylaxis in CFI deficiency, this was commonly used to prevent serious infections. Direct replacement of CFI using fresh frozen plasma or purified CFI had resulted in transient correction of in vitro assays of complement activity. However, fresh frozen plasma infusions were associated with anaphylaxis, and long-term clinical outcomes have not been reported. Bone marrow transplantation was not a potentially curative strategy given that CFI synthesis occurred in the liver. Of note, CFI deficiency was a rare but likely un

Other Meds:

Current Illness: Constipation chronic; Factor I deficiency; Glomerulonephritis; Microscopic haematuria

ID: 0996772
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/01/2005
Rec V Date: 02/03/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: she got full blown pneumonia after received pneumonia vaccine; Her doctor gave her a 3rd of a test dose of a pneumonia vaccine; This spontaneous report was received from a 54 years old female patient referring to herself via Pfizer, Inc. On an unspecified date in 1976, she got German measles from head to toe (also reported as rubella) after delivering her daughter and receiving with the German measles vaccine. The patient's concomitant medications and drug allergies were not reported. On an unknown date in 2005, the patient was vaccinated with the 3rd (extra dose administered) of a test dose of pneumonia vaccine (manufacturer unknown) (dose, strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in May 2005 (also reported as after the shot), she had ended up in the hospital with 103 + Fahrenheit fever with full blown pneumonia. She had a 100.3 (unit not provided) fever for 8 days. She was in the hospital for 2 days and as soon as she was taken off intravenous (IV) therapy and switched to pills, she begged to go home. She promised she would take the pills. She was allowed to go home in May 2005. That Friday morning, her temperature finally broke to 99 (unit not provided). She researched the components of the pneumonia vaccine and saw there was several strains of pneumonia in the vaccine. Her body for some reason, took any bit of it. Ever since then, she has stayed away from vaccine. It could have been deadly if she received the full dose of the pneumonia vaccine considering the way her body reacted to a 3rd of a dose. The outcome of pneumonia was not reported. The causality between pneumonia and pneumonia vaccine (manufacturer unknown) was not reported. Upon internal review, pneumonia was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0996773
Sex: F
Age:
State: MD

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

Lab Data: Test Date: 2020; Test Name: Body temperature; Result Unstructured Data: (Test Result:99,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: chills; fever, described as 99.0; injection site was hot to the touch; injection site was hot to the touch, appeared red; unspecified rash under the neck and upper chest area; Dose 2 was given in the right thigh; This case was reported by a other health professional and described the occurrence of chills in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CB4K, expiry date 23rd August 2023) for prophylaxis. On 3rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced chills, fever, injection site warmth, injection site erythema and rash. On an unknown date, the outcome of the chills, fever and rash were recovered/resolved and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the chills, fever, injection site warmth, injection site erythema and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix on right thigh and patient experienced chills,fever of 99 degree F. also patient stated injection site was hot to the touch and appeared red. Patient experiened an unspecified rash under the neck and upper chest area. It was reported that patient received the vaccine in right thigh instead of deltoid muscle which led to vaccine administered at inappropriate site. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020248611:Same reporter

Other Meds:

Current Illness: Pain

ID: 0996774
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Name: SARS-COv-2; Test Result: Positive

Allergies:

Symptoms: Caller looking for information on second dose administration following a positive SARS-Cov-2; Caller looking for information on second dose administration following a positive SARS-Cov-2; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), 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. Caller looking for information on second dose administration following a positive SARS-COv-2 on an unspecified date. The outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.

Other Meds:

Current Illness:

ID: 0996775
Sex: F
Age:
State: MO

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 15Jan2021 07:40 at a single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Concomitant medications were not reported. The patient reported that she was having some side effects from the second dose of the Covid vaccine. On 15Jan2021, within 1 hour, the patient started having a low-grade fever and very nauseous. Also, the patient stated that she "feels awful". She didn't experience this with my first dose. The outcome of the event feels awful was unknown, while the outcome of low-grade fever and very nauseous was not recovered.

Other Meds:

Current Illness:

ID: 0996776
Sex: F
Age:
State: MI

Vax Date: 01/07/2021
Onset Date: 01/16/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: itching around noon on 16Jan2021 to her right arm/injection site; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included Low Thyroid Function, High Blood Pressure, IBS, High cholesterol. Concomitant medication included simvastatin for high cholesterol, metoprolol tartrate (METOPROLOL) for high blood pressure, levothyroxine sodium (SYNTHROID) for thyroid. Patient received the first dose of the bnt162b2 on 07Jan2021 on her right arm. She started to experience itching around noon on 16Jan2021 to her right arm/injection site and reported the area was red, swollen, warm, and measured about 5 inches in diameter. Also reported as starting 16Jan2021 she started to experience in the same injection site area warmth, redness, swelling, itching and she reported that it was measured about 5 inches in diameter around the injection site. She reported taking Benadryl and icing the affected area and stated it felt a little better as of 17Jan2021. The outcome of the events was recovering.

Other Meds: SIMVASTATIN; METOPROLOL [METOPROLOL TARTRATE]; SYNTHROID

Current Illness:

ID: 0996777
Sex: F
Age:
State: CA

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report. A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]; ZINC

Current Illness:

ID: 0996778
Sex: F
Age: 43
State:

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: Not known.

Symptoms: Patient with generalized body flushing advancing to numbness and tingling to right side of mouth, lips and cheek. Diffuse flushing over body. Vaccine given at 8:15a - and symptoms began 10 minutes post injection. Patient requested 911. HR120. Able to speak and breath without difficulty. Benadryl administered IM x 1. No throat tightness.

Other Meds:

Current Illness:

ID: 0996779
Sex: F
Age: 59
State: MI

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

Lab Data: none

Allergies: cat/dog dander, seasonal allergies

Symptoms: Body aches, chills, fever. Started 14 hours after vaccine, and lasted 36 hours. Used tylenol for symptoms.

Other Meds: amlodipine-benazepril, daily multi vitamin

Current Illness: none

ID: 0996780
Sex: F
Age: 43
State:

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

Lab Data:

Allergies: not known

Symptoms: patient with complaint of feeling tightness in jaw and throat, nausea, dizziness, and heart palpitations immediately following the vaccine. resolved after 30 minutes of observation.

Other Meds:

Current Illness:

ID: 0996781
Sex: F
Age: 27
State: PA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: May have received a higher dose of vaccine due to insufficient diluent being inserted into the vial. A total of two doses were able to be drawn from the vial instead of five. The individual was notified by phone that day and a report was made in our city immunization information system. No side effects were identified during the time in clinic or reported by the patient during the call.

Other Meds:

Current Illness:

ID: 0996782
Sex: M
Age: 41
State: PA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: May have received a higher dose of vaccine due to insufficient diluent being inserted into the vial. A total of two doses were able to be drawn from the vial instead of five. The individual was notified by phone that day and a report was made in our city immunization information system. No side effects were identified during the time in clinic or reported by the patient during the call.

Other Meds:

Current Illness:

ID: 0996783
Sex: F
Age: 22
State: VA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Light headedness, weakness, injection site tenderness

Other Meds: None

Current Illness:

ID: 0996784
Sex: F
Age: 19
State: PA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: May have received a higher dose of vaccine due to insufficient diluent. The individual was unable to be reached by phone. A report was made in the city immunization information system. No side effects were identified during the observation period.

Other Meds:

Current Illness:

ID: 0996785
Sex: F
Age: 54
State:

Vax Date: 01/21/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: none

Allergies: None

Symptoms: Initially day two there was swelling and pain at injection site which subsided in two days. On day 10, after a workout, arm swelled - hard knot at site, unable to determine redness as there is dark tatoo in the area. Burning and very hot - applied ice packs and this lasted two days. Extremely uncomfortable. Still has small not but bearable.

Other Meds: Covrax, Calcium, Vitamin D

Current Illness: None

ID: 0996795
Sex: M
Age:
State: CA

Vax Date: 11/30/2020
Onset Date: 12/01/2020
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: night cramps in both right and lleft calf muscle; very painful; Mobility decreased; ringing of ears; sore arm; fever; chills; fatigue; This case was reported by a consumer and described the occurrence of ringing in ears in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th November 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 1 days after receiving Shingrix, the patient experienced ringing in ears, pain in arm, fever, chills and fatigue. On 2nd December 2020, the patient experienced muscle cramp, pain and mobility decreased. On an unknown date, the outcome of the ringing in ears, pain in arm, fever, chills, fatigue, pain and mobility decreased were unknown and the outcome of the muscle cramp was not recovered/not resolved. It was unknown if the reporter considered the ringing in ears, pain in arm, fever, chills, fatigue, muscle cramp, pain and mobility decreased to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. On 30th November 2020, the patient received 1st dose of Shingrix on left arm. The patient experienced ringing of ears, sore arm, fever, chills, fatigue, night cramps in both right and lleft calf muscle at same time and behind knees at same time. The cramps were very painful and the patient could not move for 15 minuteswhen he got cramps.

Other Meds:

Current Illness:

ID: 0996796
Sex: M
Age:
State: NJ

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: Blood Work; Result Unstructured Data: Test Result:Normal; Test Date: 20210114; Test Name: lipids; Result Unstructured Data: Test Result:a bit elevated

Allergies:

Symptoms: bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds: LISINOPRIL; VITAMIN D [COLECALCIFEROL]; DULOXETINE

Current Illness: Hypertension

ID: 0996797
Sex: F
Age: 46
State: PA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Body aches, joint pain, dizziness,nausea and headache

Other Meds: None

Current Illness: None

ID: 0996798
Sex: F
Age: 26
State: MO

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None

Allergies: Opioids, Shrimp, Eggs, Iodine

Symptoms: Started ~10:00 PM - Current: Fever (101 F), Chills, Severe night sweats, Nausea and vomiting all night, Abdominal pain

Other Meds: Zyrtec, Multivitamin, Wellbutrin

Current Illness: None

ID: 0996799
Sex: M
Age: 75
State: FL

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: Denies

Symptoms: Client reported numbness and burning sensation to lips 10 minutes after vaccination. Evaluated by EMS on site. No medical intervention initiated. Client observed for 40 minutes. Client reported decreased numbness and burning. Awake, alert, verbally responsive. Client released by EMS. No distress noted.

Other Meds:

Current Illness:

ID: 0996800
Sex: F
Age: 43
State: MD

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Current fever of 101.0F, headache, sweat/chills.

Other Meds: None

Current Illness: None

ID: 0996801
Sex: M
Age: 55
State: PA

Vax Date: 01/31/2021
Onset Date: 02/01/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Very fatigued. Slept all day after vaccine. Broke out in drenching sweats and then chills.

Other Meds: Metformin, Glipizide, Atorvastatin, Valsartan, 81 mg baby aspirin Symbicort

Current Illness: Tested positive for Covid-19 late December. Loss of smell as a symptom. Other than that no other symptoms.

ID: 0996802
Sex: F
Age: 78
State: IN

Vax Date: 01/31/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Resident with c/o nausea and vomiting.

Other Meds:

Current Illness:

ID: 0996803
Sex: M
Age: 67
State: FL

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

Lab Data:

Allergies: Sulfa drugs and fire ants

Symptoms: Mild headache, mild chills and slight fever, queasy stomach

Other Meds: Lumigan, Timool

Current Illness: none

ID: 0996804
Sex: M
Age: 27
State: WA

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 103 degree fever, chills, fatigue, and muscle aches

Other Meds:

Current Illness:

ID: 0996805
Sex: F
Age: 57
State: VA

Vax Date: 01/22/2021
Onset Date: 01/31/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: environmental mold

Symptoms: Burning sensation raised rash all over back appeared 1/31/2021 around 8:30pm. I took one 200mg ibuprofen tablet. The rash was gone the next day but the sensation of pins and needles was still present on 2/1/2021. I then took benedryl and the sensation went away.

Other Meds: Multivitamin, fish oil capsule

Current Illness: cold symptoms 2 weeks prior to vaccine

ID: 0996806
Sex: F
Age: 52
State: GA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shingles vaccine Headache Chills Muscle aches Nausea

Other Meds: Prilosec

Current Illness:

ID: 0996807
Sex: F
Age: 69
State: FL

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

Lab Data:

Allergies: Codeine, mangos

Symptoms: Aches, general malaise, fever, lasting 30 hrs

Other Meds: Bio identical hormones, Celebrex, losartan, vitamins B, D, Lysine, glucosamine, calcium, zinc

Current Illness: Positive for Covid December

ID: 0996808
Sex: F
Age: 42
State: IA

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 20 hours after my first injection my entire body broke out into a rash. My skin was warm to the touch and itched. The rash lasted about 8 hours

Other Meds:

Current Illness:

ID: 0996809
Sex: F
Age: 35
State: MA

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

Lab Data: None.

Allergies: Pertussis vaccine and biaxin

Symptoms: 15 weeks pregnant, expected date of delivery is July 24, 2021. Dizziness to the point of almost fainting, sudden chills, low grade temperature of 99, muscle aches, no appetite, severe tiredness. Lasting from noon 02/02/2021 until time of form submission. Have been resting, drinking liquids, and taking Tylenol every 4-6 hours since symptom onset.

Other Meds: Zoloft, prenatal vitamins

Current Illness: None

ID: 0996810
Sex: F
Age: 29
State: MA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/03/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches

Other Meds: zyrtec proair vitamin D

Current Illness: None

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm