chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Purpura, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient herself).  A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# El1284), via an unspecified route of administration on 30Dec2020 11:45 in right arm at single dose for COVID-19 immunization. Medical history included COVID from 15May2020 to an unknown end date. Known allergies was no. Other medications in two weeks included pantoprazole, cholecalciferol (VIT D3), ascorbic acid (VIT C), zinc, fish oil, curcuma longa (TURMERIC). The patient experienced mild cold like symptoms (runny nose and sore chest) 3 days after vaccine on 02Jan2021, blood spots on right abdomen, chest 3-4 days after vaccine in Jan2021. Constant headache for a week starting 5 days after vaccine on 04Jan2021 and elevated blood pressure, racing heart, and chest pain 5 days after vaccine on 04Jan2021. All events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID positive on 15May2020. The patient had COVID test of nasal swab post vaccination and result with negative. Outcome of events were unknown. No treatment was received for events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient). A 23-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscular on 21Dec2020 16:30 at single dose in left arm, the second dose intramuscular on 12Jan2021 at single dose in left deltoid for COVID-19 immunization. Medical history was none, no known allergies. Concomitant medications included spironolactone, clindamycin, dapsone 5%, vitamin c [ascorbic acid], Multivitamin. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. The patient experienced fatigue, excessive exhaustion, left arm muscle pain, stomach upset/bowel upset on 22Dec2020 20:30. No treatment received. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Myalgia; Fever; Fatigue; The patient experienced chills overnight; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:45 at single dose for COVID-19 immunization. None Medical history included. Concomitant medication included sertraline and ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced chills overnight (06Jan2021). On 07Jan2021 02:00 am, she experienced fever, headache, myalgia, and fatigue. Self-treated with Acetaminophen. The outcome of events was recovered at unspecified time on 07Jan2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt part of the dose run down her arm or at least had that sensation.; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), 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. On an unspecified date, the patient claimed that on the first dose, she felt part of the dose run down her arm or at least had that sensation. The inoculator thinks the complete dose was injected. The patient was upset and wants a recommendation on if she should need a repeat of her first dose. The patient asked if there was any data on repeating the first dose vs. no action and proceed with the second dose in 21 days. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: bled at the injection site; This is a spontaneous report from a contactable pharmacist.  A 4-decade-old female patient received 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 was not reported.  The patient's concomitant medications were not reported.  It was reported a female in her 30's bled at the injection site and in unsure if she got the full dose of the vaccine. Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Heart rate increased, Myalgia
Clinical narrative: Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm  on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm  on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise
Clinical narrative: Generalized malaise; Chills/rigors; Diaphoresis; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left arm on 12Jan2021 (17:30) at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. Concomitant medications included minoxidil, biotin, vitamin D3 and vitamin C [ascorbic acid]. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9899; Expiration date was not reported), intramuscularly on the left arm on 23Dec2020 (when the patient was 25 years old) for COVID-19 immunization. On 13Jan2021 (02:00), the patient had generalized malaise; chills/rigors; and diaphoresis. The patient had received acetaminophen as treatment for the reported events. The outcome of the events, 'generalized malaise', 'chills/rigors' and 'diaphoresis', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is Spontaneous report from a Non-contactable Consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband received the Covid vaccine last Friday (08Jan2021) and the patient was positive for Covid 19 on Monday (11Jan2021). She was wondering whether she should get the second shot. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034217 same reporter, diff patient
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: after she has received this shot her blood sugar has increased on Jan2021; it is higher than usual; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 11Jan2021 to 11Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetic. It was reported that the patient got the COVID vaccine and she have diabetes after she has received this shot her blood sugar has increased on Jan2021; it is higher than usual. The outcome of the event was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes simplex, Influenza like illness, Peripheral swelling
Clinical narrative: "pretty big" right arm swelling; flu-like symptoms the day after vaccination; vesicle formation on his one big toe; Herpes Whitlow; This is a spontaneous report from a contactable HCP reported for self. This 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations was not provided. The patient experienced reported "pretty big" right arm swelling, and flu-like symptoms the day after vaccination (10Jan2021), both of which have resolved. He is asking about the incidence of what he described as "Herpes Whitlow" vesicle formation on his one big toe. The patient stated that it could be from beginning to run after a couple week hiatus. The patient stated he had been running which he hadn't been doing for a week or two. He has reviewed the literature and can find nothing. The outcome of events swelling in the right arm, and flu-like symptoms was resolved. The outcome of other events was unknown.   Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever blister on her lip; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 12Jan2021 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday and woke up this morning with a fever blister on her lip on 13Jan2021 . She was asking if it was okay for her to take Valtrex and if it would affect the efficacy of the vaccine. The patient was also asking if patients can take Tylenol prior to the shot as preemptive measures for side effects like fever. She also mentioned that she heard from somewhere that there were reports regarding infertility with the vaccine. She was confirming if this was true. She stated, "I get that there's still limited information, with this being all new in all, but it is kind of worrisome on our part as well because we just don't want to mess up administration of this vaccine." She mentioned that she heard from somewhere that there were reports regarding MS (Multiple Sclerosis) side effects with the vaccine. She was also confirming if this was true. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysstasia, Headache, Myalgia
Clinical narrative: low grade fever; rigors; myalgias; headache; skin hurt; unable to stand without feeling like passing out; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 11Jan2021 17:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included lichen sclerosus from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]). The patient previously had the first dose of BNT162B2 on 21Dec2020. The patient experienced low grade fever, rigors, myalgias, headache, skin hurt, unable to stand without feeling like passing out on 11Jan2021 18:00. The patient underwent lab tests and procedures which included body temperature: low grade on 11Jan2021. No treatment were received for the events. The outcome of events was recovering.  Information of lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin injury
Clinical narrative: low grade fever; rigors; myalgias; headache; skin hurt; unable to stand without feeling like passing out; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 11Jan2021 17:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included lichen sclerosus from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]). The patient previously had the first dose of BNT162B2 on 21Dec2020. The patient experienced low grade fever, rigors, myalgias, headache, skin hurt, unable to stand without feeling like passing out on 11Jan2021 18:00. The patient underwent lab tests and procedures which included body temperature: low grade on 11Jan2021. No treatment were received for the events. The outcome of events was recovering.  Information of lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very tired; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). The patient experienced very tired on 12Jan2021 with outcome of recovering.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: Caller is COVID positive after taking the first dose; Caller is COVID positive after taking the first dose; got sick; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), duloxetine hydrochloride (CYMBALTA), vitamin C, vitamin E, propanolol hcl and clonazepam (KLONOPIN). Reporter is a social worker at a community center for pediatrics. She had the first dose of the COVID-19 vaccine on 31Dec2020. However, she got sick past Sunday (03Jan2021) and tested positive for COVID-19. She was wondering if there is a chance that the vaccine caused the positive result for the COVID test. Consumer stated, "I had a question about the COVID vaccine and I had the COVID vaccine administered on let's say it was 31Dec and I felt sick over the weekend and ended up having to take a COVID test. Well, the COVID test came out positive for COVID. And so my question is because I had the vaccine could the vaccine maybe cause a false positive test?" The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date (Caller is COVID positive after taking the first dose). The outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 10:00 in the left arm, at a single dose, for COVID-19 immunization. Relevant medical history included rheumatoid arthritis, allergic rhinitis, sulfonamide allergy, and allergy to capsicum. Concomitant medications included adalimumab (HUMIRA), hydroxychloroquine, leflunomide and other unspecified medications. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FL0140; expiry date: unknown) on 22Dec2020 at 15:00 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. On 12Jan2021, at 23:00 (on the same day after the injection), the patient experienced fever, chills, headache, body aches, and extreme fatigue. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for COVID-19 since vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Muscle spasms, Nausea
Clinical narrative: Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 10:00 in the left arm, at a single dose, for COVID-19 immunization. Relevant medical history included rheumatoid arthritis, allergic rhinitis, sulfonamide allergy, and allergy to capsicum. Concomitant medications included adalimumab (HUMIRA), hydroxychloroquine, leflunomide and other unspecified medications. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FL0140; expiry date: unknown) on 22Dec2020 at 15:00 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. On 12Jan2021, at 23:00 (on the same day after the injection), the patient experienced fever, chills, headache, body aches, and extreme fatigue. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for COVID-19 since vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 10:00 in the left arm, at a single dose, for COVID-19 immunization. Relevant medical history included rheumatoid arthritis, allergic rhinitis, sulfonamide allergy, and allergy to capsicum. Concomitant medications included adalimumab (HUMIRA), hydroxychloroquine, leflunomide and other unspecified medications. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FL0140; expiry date: unknown) on 22Dec2020 at 15:00 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. On 12Jan2021, at 23:00 (on the same day after the injection), the patient experienced fever, chills, headache, body aches, and extreme fatigue. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for COVID-19 since vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration in the right arm on 08Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included ongoing ideopathic neuropathy and high cholesterol. Concomitant medications included duloxetine (DULOXETINE), acetylsalicylic acid (ASPIRIN BP), and simvastatin (ZOCOR). The patient experienced nerve pain which began in feet, arms and hands on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: heart rate went up to the 120s or 150s; chills; fever; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 31Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the first dose of the COVID-19 vaccine last 31Dec2020 and did not have any immediate adverse effect. During the night of 31Dec2020, she experienced chills and fever, but the patient wasn't concerned because she knows other people experience it too: some individuals she knew were getting, the fever (could not be clarified further). She was concerned since she had fast heartbeat. Her heart rate went up to the 120s or 150s (ranging to 120s to 140s, 150s). She was concerned if she should go to the hospital to get an IV bolus. Patient had to go to the ER and they gave her some IV Bolus. Patient asked if she should be concerned about the second dose. The outcome of the events was unknown.  Information on the batch number/lot number has been requested.; Sender's Comments: Based on a compatible temporal association, a causal relationship between event "heart rate went up to the 120s or 150s" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dizziness, Nausea, SARS-CoV-2 test positive
Clinical narrative: received COVID vaccine first dose on 21Dec2020. 10 days later I was diagnosed with COVID; received COVID vaccine first dose on 21Dec2020. 10 days later I was diagnosed with COVID; dizziness; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable pharmacist (reported for herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine first dose on 21Dec2020. 10 days later (31Dec2020), the patient was diagnosed with COVID. Her work cancelled her second COVID vaccine until she was symptom free. The patient asked when she should receive her 2nd COVID vaccine. The patient also had a reaction to the first COVID vaccine (dizziness, nausea, vomiting, diarrhea) about 1.5 hours after getting the vaccine at her work on 21Dec2020. She was worried about having strong reaction to 2nd dose since she actually had COVID. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The subject received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, and 10 days later she was diagnosed with COVID.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the reported COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: received COVID vaccine first dose on 21Dec2020. 10 days later I was diagnosed with COVID; received COVID vaccine first dose on 21Dec2020. 10 days later I was diagnosed with COVID; dizziness; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable pharmacist (reported for herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine first dose on 21Dec2020. 10 days later (31Dec2020), the patient was diagnosed with COVID. Her work cancelled her second COVID vaccine until she was symptom free. The patient asked when she should receive her 2nd COVID vaccine. The patient also had a reaction to the first COVID vaccine (dizziness, nausea, vomiting, diarrhea) about 1.5 hours after getting the vaccine at her work on 21Dec2020. She was worried about having strong reaction to 2nd dose since she actually had COVID. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The subject received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, and 10 days later she was diagnosed with COVID.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the reported COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Odynophagia, Paraesthesia, Pharyngeal swelling, Throat irritation
Clinical narrative: pain on swallowing in the throat; throat started feeling itchy; pins and needles feeling; throat was swollen; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL0140, expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021, 9:00AM at a single dose for COVID-19 immunization. The patient's medical history included asthma and allergies to Amoxicillin, Quinolones, and Sulfa drugs, all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B 12); patient received these medications with two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Jan2021, 19:00, just after evening, patient's throat started feeling itchy and had pins and needles feeling. Gradually the symptoms increased in intensity and in the night of 12Jan2021 (time unspecified), he felt like his throat was swollen. It was also reported that patient woke up today, 13Jan2021 with the same feeling and there is pain on swallowing in the throat. No therapeutic measures were taken in response to the events. Outcome of the events was reported as recovering.; Sender's Comments: Based on a chronological association, causality between events odynophagia, pharyngeal swelling and throat irritation and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  cannot 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a non-contactable nurse. An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported), intramuscularly on the left arm on 12Jan2021 (14:45) at a single dose for COVID-19 immunization at the hospital. Medical history included adult onset asthma; gastroesophageal reflux disease (GERD); and breast cancer. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142; Expiration date was not reported), intramuscularly on the left arm on 22Dec2020 for COVID-19 immunization. On 13Jan2021 (06:00), the patient had injection site soreness. The patient did not receive any treatment for the reported event. The outcome of the event, injection site soreness, was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 07Jan2021 at a single dose on the arm, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux. The patient's concomitant medication included an unspecified acid reflux medication. On 07Jan2021, the patient had sore arm at the injection site. The outcome of the event, sore arm at the injection site, was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Sensitive skin
Clinical narrative: Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), intramuscular in the left arm on 11Jan2021 12:30 at a single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), intramuscular in the left arm on 12Dec2020 11:30 at the age of 28 years old for COVID-19 immunization. The patient had not been tested for COVID-19 since the vaccination. On 11Jan2021 20:00, the patient experienced fatigue, body aches, sensitive skin, and chills. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report from a contactable pharmacist. A (23 unknown unit) female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021, at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications was not reported. Patient received the covid 19 vaccine on 04Jan2021 and tested positive on 11Jan2021, when should patient receive the second dose. The outcome of event was unknown.  Information about Lot/Batch has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 04Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID test possibly represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Sleeplessness. I could not sleep after my first and second dose; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 22Dec2020 14:45 at a single dose on left arm, and the second dose via an unspecified route of administration on 12Jan2021 11:30 (lot number and expiry date not reported) at a single dose on left arm for COVID-19 immunization. Medical history included migraine and allergic to avocados. Concomitant medication included biotin (BIOTIN), keratin (KERATIN). The patient experienced sleeplessness and stated, "I could not sleep after my first and second dose." No treatment received for the event. The outcome of the event was recovered with sequelae. The patient was not pregnant. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.  Information on the Batch/Lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia
Clinical narrative: Woke up in excruciating pain; Fever; Joint and muscle pain; Joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 21Dec2020 04:00 PM at a single dose on left arm for COVID-19 immunization. On Tuesday morning, 12Jan2021, patient woke up in excruciating pain. She had fever, joint and muscle pain. The outcome of the events was recovering. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Anger, Confusional state, Delusional perception, Diarrhoea
Clinical narrative: Vomiting; Diarrhea; Patient has become aggressive, combative; Short tempered; Up and down most of the night; delusional; confused; This is a spontaneous report from a contactable consumer. A 88-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 13:30 at a SINGLE DOSE for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and COVID-19 prior vaccination. Concomitant medication included gabapentin (GABAPENTIN), hydrocodone (HYDROCODONE), haloperidol (HALDOL), levothyroxine (LEVOTHYROXINE), insulin aspart (NOVOLOG) , lisinopril (LISINOPRIL), lorazepam (LORAZEPAM), sennoside a+b (SENNA [SENNOSIDE A+B]), trazodone (TRAZODONE). The night after the vaccine was administered (10Jan2021), the patient experienced a bad case of vomiting and diarrhea. The patient has become aggressive, combative and short tempered. She was up and down most of the night, delusional and confused. Therapeutic measures (Lorazepam) were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Vomiting
Clinical narrative: Vomiting; Diarrhea; Patient has become aggressive, combative; Short tempered; Up and down most of the night; delusional; confused; This is a spontaneous report from a contactable consumer. A 88-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 13:30 at a SINGLE DOSE for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and COVID-19 prior vaccination. Concomitant medication included gabapentin (GABAPENTIN), hydrocodone (HYDROCODONE), haloperidol (HALDOL), levothyroxine (LEVOTHYROXINE), insulin aspart (NOVOLOG) , lisinopril (LISINOPRIL), lorazepam (LORAZEPAM), sennoside a+b (SENNA [SENNOSIDE A+B]), trazodone (TRAZODONE). The night after the vaccine was administered (10Jan2021), the patient experienced a bad case of vomiting and diarrhea. The patient has become aggressive, combative and short tempered. She was up and down most of the night, delusional and confused. Therapeutic measures (Lorazepam) were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Loss of appetite; Axillary lymph nodes swollen and tender; Axillary lymph nodes swollen and tender; Chills; Headache; Body aches; Nausea; Fatigue; Fever at 102.0; This is a spontaneous report from a contactable nurse (patient). A 38-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ECL284), via an unspecified route of administration in left arm, on 06Jan2021 at 08:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin (PCN). The patient's concomitant medications included valaciclovir, zinc, ergocalciferol (VIT D), and an unspecified multivitamin. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 16Dec2020 (10 AM in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not administered with other vaccine in four weeks. The COVID-19 vaccine was administered in a hospital. On 06Jan2021 at 08:30 PM (around 12 hours later), the patient experienced chills, headache, body aches, nausea, fatigue, and fever at 102.0. Symptoms went on for three days. Fever after initial fever was low grade fever. At day 3 (09Jan2021), left axillary lymph nodes swollen and tender. Some lingering fatigue and loss of appetite 6 days post vaccine (12Jan2021). No treatment was received for the adverse events. Post-vaccination, the patient has not been tested for COVID-19. At the time of reporting, the patient recovered from the events in Jan2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Loss of appetite; Axillary lymph nodes swollen and tender; Axillary lymph nodes swollen and tender; Chills; Headache; Body aches; Nausea; Fatigue; Fever at 102.0; This is a spontaneous report from a contactable nurse (patient). A 38-year-old male patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ECL284), via an unspecified route of administration in left arm, on 06Jan2021 at 08:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin (PCN). The patient's concomitant medications included valaciclovir, zinc, ergocalciferol (VIT D), and an unspecified multivitamin. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 16Dec2020 (10 AM in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not administered with other vaccine in four weeks. The COVID-19 vaccine was administered in a hospital. On 06Jan2021 at 08:30 PM (around 12 hours later), the patient experienced chills, headache, body aches, nausea, fatigue, and fever at 102.0. Symptoms went on for three days. Fever after initial fever was low grade fever. At day 3 (09Jan2021), left axillary lymph nodes swollen and tender. Some lingering fatigue and loss of appetite 6 days post vaccine (12Jan2021). No treatment was received for the adverse events. Post-vaccination, the patient has not been tested for COVID-19. At the time of reporting, the patient recovered from the events in Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient.  This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.