chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills but low temp (97.1); Chills but low temp (97.1); Tremors; sore arm but arm was mobile; Exhaustion; This is a spontaneous report from a non-contactable consumer. A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 10Feb2021 at 08:15 (at the age of 76-years-old) as dose 2, single for COVID-19 immunisation. Medical history included hashimotos, hypertensive and known allergies to fentanyl. Concomitant medications included pregabalin (LYRICA), levothyroxine sodium (SYNTHROID), valsartan, vitamin supplements, and nasal spray. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL0142, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 18Jan2021 at 09:00 (at the age of 76-years-old) for COVID-19 immunisation. On 10Feb2021 at 18:00, the patient experienced chills but low temp (97.1), tremors, sore arm but arm was mobile, and exhaustion. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Horrible red rash with big welts all over her head, arms, legs, back and front.; Horrible red rash with big welts all over her head, arms, legs, back and front.; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A 93-year-old non-pregnant female patient received bnt162b2 (PFIZER COVID 19, Solution for Injection, Lot Number were not reported) via an unknown route of administration, administered in arm left on 03Feb2021 14:00 (at the age of 93-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol on an unspecified date. No Known allergies. Prior to vaccination, patient had not Covid. Post vaccination, the patient had not tested Covid. The patient previously received bnt162b2 (PFIZER COVID 19, lot unknown), administered in left arm on 13Jan2021 03:30 (at the age of 93-years-old) as dose 1 for COVID-19 immunisation. No other vaccine received in four weeks. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), all for an unknown indication, from an unspecified date and unknown if ongoing. It was reported that horrible red rash with big welts all over her head, arms, legs, back and front. This came on exactly one week after the 2nd vaccine dose on 10Feb2021. Her doctor face timed her the same day and prescribe Prednisone 40 mg and Benadryl. She went to the doctors today 11Feb2021 and the doctor said it was a bad reaction to the covid 19 Pfizer vaccine. She had another patient with the exact same rash after the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment as prednisone 40 mg and Benadryl. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021187174 same reporter, product and AE, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: pain at the injection site; tiredness; headache; chills; feeling unwell; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 10Feb2021 at 13:15 (01:15 PM) (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included known allergies: penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 20Jan2021 at 12:15 PM (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. On 10Feb2021 at 20:00 (08:00 PM), the patient experienced pain at the injection site, tiredness, headache, chills, feeling unwell, muscle aches. The patient did not receive treatment for the events. Outcome of the events was recovering.  Follow-up (PRD/SRD 12May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; tiredness; headache; chills; feeling unwell; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 10Feb2021 at 13:15 (01:15 PM) (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included known allergies: penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 20Jan2021 at 12:15 PM (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. On 10Feb2021 at 20:00 (08:00 PM), the patient experienced pain at the injection site, tiredness, headache, chills, feeling unwell, muscle aches. The patient did not receive treatment for the events. Outcome of the events was recovering.  Follow-up (PRD/SRD 12May2021): Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Depression
Clinical narrative: feelings of depression; feelings of depression sparked along with lack of motivation; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, on 10Feb2021 at 15:45 (at the age of 25-year-old), as dose 2, single in left arm for COVID-19 immunization. The patient's medical history included Prolonged post-traumatic stress (PTSD) due to childhood sexual assault, which was under control and was supposed to be weaning off medication in the near future. Patient was allergic to apples and had seasonal allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, on 20Jan2021 (at the age of 25-year-old), as single dose in left arm for COVID-19 immunization. Concomitant medications in two weeks after COVID vaccine included venlafaxine hydrochloride (EFFEXOR) 150 mg; taken for unspecified indication, start and stop dates were not reported. Patient did not receive any other vaccine in four weeks after COVID vaccination. On 11Feb2021, 1 day after second dose of vaccine, the patient had feelings of depression sparked along with lack of motivation. Patient did not receive treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of both the events was not resolved.   Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: felt awful; fatigue; left arm useless; Body aches; left arm useless due to muscle pain at site of vaccine; This is a spontaneous report from a contactable physician. A 51-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on an unspecified date in Jan2021 (Batch/Lot number and Expiry date was not reported) (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have covid prior to vaccination and it was unknown if covid was tested post vaccination. On an unspecified date in Jan2021, the patient experienced felt awful, fatigue, left arm useless, body aches and left arm useless due to muscle pain at site of vaccine. It was reported as body aches and felt awful on the same day as vaccination. Day 2 fatigue and left arm useless due to muscle pain at site of vaccine. Laboratory tests on an unspecified date included SARS-CoV-2 test: unknown results. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt awful; fatigue; left arm useless; Body aches; left arm useless due to muscle pain at site of vaccine; This is a spontaneous report from a contactable physician. A 51-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on an unspecified date in Jan2021 (Batch/Lot number and Expiry date was not reported) (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have covid prior to vaccination and it was unknown if covid was tested post vaccination. On an unspecified date in Jan2021, the patient experienced felt awful, fatigue, left arm useless, body aches and left arm useless due to muscle pain at site of vaccine. It was reported as body aches and felt awful on the same day as vaccination. Day 2 fatigue and left arm useless due to muscle pain at site of vaccine. Laboratory tests on an unspecified date included SARS-CoV-2 test: unknown results. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Migraine
Clinical narrative: Loss of taste; migraine; This is a spontaneous report from a contactable nurse (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 03Feb2021 15:30 (age at the time of vaccination was 40 years) as dose 1, single for covid-19 immunisation at clinic. Medical history included asthma and Known allergies to Nuts, coffee, mustard, pineapple, melon both from an unknown date and unknown if ongoing. Concomitant medications included loratadine (LORATADINE), vortioxetine hydrobromide (TRINTELLIX), omeprazole (PRILOSEC [OMEPRAZOLE]), melatonin (MELATONIN) all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient did not have COVID prior to vaccination. On 05Feb2021 10:00, the patient experienced loss of taste and migraine. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for AE. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: After first dose the patient had a sore arm and then two days later found out she was pregnant; After first dose the patient had a sore arm and then two days later found out she was pregnant; This is a spontaneous report received from a contactable other-health care professional. This is a maternal report. A 28-years-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered on an unspecified date (at the age of 28-years-old) as dose 1, single for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medication included venlafaxine (VENLAFAXINE) daily 150 mg and cut down to half dose when she became pregnant, taken for anxiety from an unspecified start date and ongoing. Doctor and patient, who was a nurse, do not think the fetal demise was related to the vaccine, but wanted to document the loss with us for data in case we would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. On unknown date, after first dose the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient was a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The mother reported she became pregnant while taking bnt162b2. Did not see a fetal heartbeat at 6 week on u/s and 7 weeks still no heartbeat on u/s. HCG did not go down until second u/s, so fetal demise occurred between 6 -7 weeks. D and C performed and no genetic abnormalities were found in fetal tissue. The outcome of the events was reported as unknown.  Information on lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 41-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# EL9264), at vaccination age of 41, via an unspecified route of administration, left arm, on Feb 9, 2021, single dose, for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing asthma (under control). Patient has known allergies to penicillin, from an unknown date and unknown if ongoing. There were no concomitant medications. Patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# EJ1686), at vaccination age of 41, via an unspecified route of administration, left arm, on Jan 19, 2021, at 11:00 am, single dose, for COVID-19 immunisation. On Feb 10, 2021, at 07:00, patient experienced headache, chills, nausea, vomiting, general body pain (lung; back pain) when breathing, with outcome of not recovered. Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 41-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# EL9264), at vaccination age of 41, via an unspecified route of administration, left arm, on Feb 9, 2021, single dose, for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing asthma (under control). Patient has known allergies to penicillin, from an unknown date and unknown if ongoing. There were no concomitant medications. Patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# EJ1686), at vaccination age of 41, via an unspecified route of administration, left arm, on Jan 19, 2021, at 11:00 am, single dose, for COVID-19 immunisation. On Feb 10, 2021, at 07:00, patient experienced headache, chills, nausea, vomiting, general body pain (lung; back pain) when breathing, with outcome of not recovered. Follow-up attempts completed. No further information expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: last night she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single (at the age of 88-years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (Tylenol); naproxen sodium (Aleve); alprazolam (Xanax) and cetirizine hydrochloride (Zyrtec) (all taken for an unspecified indication, start and stop date were not reported) and diphenhydramine hydrochloride (Benadryl) taken for sleep, start and stop date were not reported. On 09Feb2021, patient slept in afternoon for two hours after the shot and at night (last night), patient could not sleep. Patient stated that she takes Tylenol, Aleve, Xanax takes 1/2 of one in the morning, Benadryl to sleep and Zyrtec and stated that she did not take them last night or this morning and wanted to know if she can take them. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected. Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: fever was just under 103 and close to 105; severe fatigue; muscle soreness; horrible chills through the night; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EM9809), via an unspecified route of administration in the arm right on 09Feb2021 15:45 as dose 2 single (at the age of 42-years-old) for covid-19 immunization. Medical history included mitochondrial mutation, hashimotos thyroiditis (mild-no medication) and allergy to cucumbers (mild allergy). The concomitant medications included multivitamin and Vitamin D gummies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the arm right on 19Jan2021 13:30 PM as dose 1 single (at the age of 42-years-old) for covid-19 immunization. The day patient got second dose, she felt good. On 10Feb2021 01:15 AM, during the night patient could not sleep because she had horrible chills through the night. By the next morning fever was just under 103. The patient had severe fatigue and muscle soreness. Fever kept going up, and at times was registering close to 105. The patient took acetaminophen and ibuprofen alternated before could get fever down. Patient fever broke during the following night, and she was okay the following day. The high fever did scare her a little. Patient did not regret getting the vaccine, but the high fever did scare her. Therapeutic measures were not taken for the events chills, fatigue and myalgia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have covid prior to vaccination and patient did not tested for covid post vaccination. The outcome of the event was recovered.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Musculoskeletal stiffness
Clinical narrative: stiff neck/he can hardly move his neck; woke up with a stiff neck and it has gotten worst; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Right (injection to his right shoulder once) on 08Feb2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. Medical history included issues with his neck (stated that he had issues with his neck before but it has gotten worst) from an unknown date and unknown if ongoing. There were none concomitant medications. The patient previously received first dose of BNT162B2 on 15Jan2021 for COVID-19 immunization. Patient stated that he had the second Covid vaccine on 08Feb on Monday. Stated that he woke up with a stiff neck and it has gotten worst (2021). Stated that he can hardly move his neck (2021). Patient wanted to know if this was a side effect. Stated that this happened two mornings ago. Stated that he had issues with his neck before but it had gotten worst. Stated that it was bone on bone. Stated that it was so bad that it almost brings him to his knees. Stated that he does not know if vaccine has anything to do with vaccine or not. Stated that it was so bad it brings him to his knees. Stated that he puts ice and icy hot on it. Stated that he had taken Ibuprofen. Therapeutic measures were taken as a result of stiff neck/he can hardly move his neck, woke up with a stiff neck and it has gotten worst. There was no investigation assessment. The clinical outcome of event stiff neck/he can hardly move his neck was not recovered and another event outcome was unknown.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes; Sore arm; fever; chills; sweats; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, at the age of 54 years), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jan2021 14:30 as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, depression, and food allergy to hard shellfish. Concomitant medication(s) included tramadol; modafinil and ibuprofen and migraine med. The patient previously took lamotrigine and z-pak and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Covid was not tested prior to or post vaccination. The patient experienced sore arm, fever, chills, sweats, fatigue, and swollen lymph nodes on 07Feb2021 17:15. No treatment was given to the patient. The outcome of the events was recovered on an unspecified date in 2021.     Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: swollen lymph nodes; Sore arm; fever; chills; sweats; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, at the age of 54 years), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jan2021 14:30 as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, depression, and food allergy to hard shellfish. Concomitant medication(s) included tramadol; modafinil and ibuprofen and migraine med. The patient previously took lamotrigine and z-pak and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Covid was not tested prior to or post vaccination. The patient experienced sore arm, fever, chills, sweats, fatigue, and swollen lymph nodes on 07Feb2021 17:15. No treatment was given to the patient. The outcome of the events was recovered on an unspecified date in 2021.     Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Discomfort, Pain, Pain in extremity
Clinical narrative: Chills; body eaches; soreness in left arm approx. 2 hours post dose.; Escalation in discomfort throughout the day; This is a spontaneous report from a contactable consumer. A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 10Feb2021 at 09:30 (at the age of 55-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EJ6796) as dose 1, single administered in right arm on 20Jan2021 at 15.30PM for COVID-19 immunization. Concomitant medications included cetirizine hydrochloride (ZYRTEC), curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported other medications received in two weeks. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Patient had no known allergies. No other medical history. Facility type vaccine workplace clinic. On 10Feb2021 at 02:00 PM, patient experienced soreness in left arm approximately 2 hours post dose. Escalation in discomfort throughout the day. Throughout the day on 11Feb2021 Chills around 10pm-12pm and body ashes and chills. No treatment received for the adverse events. COVID tested post vaccination reported as no. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected. Information about Lot/Batch has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills; body eaches; soreness in left arm approx. 2 hours post dose.; Escalation in discomfort throughout the day; This is a spontaneous report from a contactable consumer. A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 10Feb2021 at 09:30 (at the age of 55-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EJ6796) as dose 1, single administered in right arm on 20Jan2021 at 15.30PM for COVID-19 immunization. Concomitant medications included cetirizine hydrochloride (ZYRTEC), curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported other medications received in two weeks. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Patient had no known allergies. No other medical history. Facility type vaccine workplace clinic. On 10Feb2021 at 02:00 PM, patient experienced soreness in left arm approximately 2 hours post dose. Escalation in discomfort throughout the day. Throughout the day on 11Feb2021 Chills around 10pm-12pm and body ashes and chills. No treatment received for the adverse events. COVID tested post vaccination reported as no. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected. Information about Lot/Batch has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; body eaches; soreness in left arm approx. 2 hours post dose.; Escalation in discomfort throughout the day; This is a spontaneous report from a contactable consumer. A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 10Feb2021 at 09:30 (at the age of 55-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EJ6796) as dose 1, single administered in right arm on 20Jan2021 at 15.30PM for COVID-19 immunization. Concomitant medications included cetirizine hydrochloride (ZYRTEC), curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported other medications received in two weeks. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Patient had no known allergies. No other medical history. Facility type vaccine workplace clinic. On 10Feb2021 at 02:00 PM, patient experienced soreness in left arm approximately 2 hours post dose. Escalation in discomfort throughout the day. Throughout the day on 11Feb2021 Chills around 10pm-12pm and body ashes and chills. No treatment received for the adverse events. COVID tested post vaccination reported as no. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected. Information about Lot/Batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Diarrhea; Nausea; Headache; Abdominal pain; Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration in left arm on 26Jan2021 at 11:00 (at the age of 52 years old) as single for covid-19 immunisation. Medical history included post-traumatic stress disorder from childhood, diabetes mellitus from 2000 to an unknown date, bipolar disorder from 2012 to an unknown date, anxiety, bipolar depression, thyroid disorder, preventative vascular problems, hypersensitivity, nightmare, sleep disorder. The family medical history included her brother was afraid to get the vaccine due to her symptoms. Concomitant medications included fluoxetine hydrochloride (PROZAC), 40mg; once daily by mouth, taking form years for bipolar depression; gabapentin 300mg; take one twice daily by mouth, taking form years for anxiety; aripiprazole (ABILIFY, reporter mentions before starting Abilify she used to take Rexulti. Provides NDC 5914803913; lot BNSO1620A and expiration date Jul2022), 15mg; take once daily by mouth for bipolar disorder from Dec2020 and ongoing; levothyroxine 137mcg; take once daily by mouth for thyroid disorder from 2014 and ongoing; simvastatin, 20mg; take once daily by mouth from several years for preventative vascular problems; levocetirizine, 5mg, take once daily by mouth for hypersensitivity from 2020 and ongoing; prazosin, 2mg; take two daily by mouth, taking form several years for nightmare; levocarnitine hydrochloride (LEVAMIN), 30 units daily by injection for diabetes mellitus from 2014 and ongoing; liraglutide (VICTOZA), 1.2mg; take once daily by injection for diabetes mellitus from Aug2020 and ongoing; eszopiclone 3mg; take once daily by mouth, taking form years for sleep disorder. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not administer any other vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks. The patient didn't had illness at time of vaccination. On 26Jan2021, patient experienced fatigue. Three days later she noticed abdominal pain, nausea, headache and fever on 29Jan2021; diarrhea on 30Jan2021. Adds she went to her doctor who told her just to wait it out; to do symptom management; and to call Pfizer to report. She was asking if she should get the second shot? She was scheduled to receive the second dose of the vaccine on 23Feb2021. It was supposed to be 16Feb2021, but she changed it. No relevant tests were performed. The patient saw the primary care but no admission to hospital. The outcome of abdominal pain, diarrhea was recovering, nausea, fatigue was not recovered, fever was recovered on 01Feb2021, headache was recovered on 03Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; Nausea; Headache; Abdominal pain; Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration in left arm on 26Jan2021 at 11:00 (at the age of 52 years old) as single for covid-19 immunisation. Medical history included post-traumatic stress disorder from childhood, diabetes mellitus from 2000 to an unknown date, bipolar disorder from 2012 to an unknown date, anxiety, bipolar depression, thyroid disorder, preventative vascular problems, hypersensitivity, nightmare, sleep disorder. The family medical history included her brother was afraid to get the vaccine due to her symptoms. Concomitant medications included fluoxetine hydrochloride (PROZAC), 40mg; once daily by mouth, taking form years for bipolar depression; gabapentin 300mg; take one twice daily by mouth, taking form years for anxiety; aripiprazole (ABILIFY, reporter mentions before starting Abilify she used to take Rexulti. Provides NDC 5914803913; lot BNSO1620A and expiration date Jul2022), 15mg; take once daily by mouth for bipolar disorder from Dec2020 and ongoing; levothyroxine 137mcg; take once daily by mouth for thyroid disorder from 2014 and ongoing; simvastatin, 20mg; take once daily by mouth from several years for preventative vascular problems; levocetirizine, 5mg, take once daily by mouth for hypersensitivity from 2020 and ongoing; prazosin, 2mg; take two daily by mouth, taking form several years for nightmare; levocarnitine hydrochloride (LEVAMIN), 30 units daily by injection for diabetes mellitus from 2014 and ongoing; liraglutide (VICTOZA), 1.2mg; take once daily by injection for diabetes mellitus from Aug2020 and ongoing; eszopiclone 3mg; take once daily by mouth, taking form years for sleep disorder. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not administer any other vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks. The patient didn't had illness at time of vaccination. On 26Jan2021, patient experienced fatigue. Three days later she noticed abdominal pain, nausea, headache and fever on 29Jan2021; diarrhea on 30Jan2021. Adds she went to her doctor who told her just to wait it out; to do symptom management; and to call Pfizer to report. She was asking if she should get the second shot? She was scheduled to receive the second dose of the vaccine on 23Feb2021. It was supposed to be 16Feb2021, but she changed it. No relevant tests were performed. The patient saw the primary care but no admission to hospital. The outcome of abdominal pain, diarrhea was recovering, nausea, fatigue was not recovered, fever was recovered on 01Feb2021, headache was recovered on 03Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: elevated blood sugar levels of 200-250 mg/dL.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient wife). A 79-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunization (79 year when vaccinated). The patient medical history and concomitant medications were not reported. On an unknown date, It was reported that since the patient received vaccination his blood sugar levels were elevated. On an unknown date, the patient had his sugar level checked and results show values between 200-250 mg/dl. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: terrible headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 68 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included anticoagulant therapy (The first time he got the shot he has underlying conditions, including blood thinners, he is on 2 blood thinners. he had to wait 45 minutes after the first shot). On an unspecified date the patient experienced terrible headache. He has to be honest its kind of a disgraceful arrangement, as far as people giving the shot. The quality of the people. Giving it at a ball field is not exactly conducive to feeling confident about it. When you watch tv, they get a shot and they are in a chair, but there they had a nurse completely unprotected and these are people outside and they are massive amounts of shots and he doesn't know if it is getting applied right. It is just not a good feeling of confidence; it was poorly organized. The first time he got the shot he has underlying conditions, including blood thinners, he is on 2 blood thinners. he had to wait 45 minutes after the first shot. The outcome of the event was unknown. He does not think he had any thing else other than the terrible headache that was his only first shot incidents. He clarifies he had a headache after both the first and the second shot, he has a bad headache right now.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: injection site arm pain; sever chills; a fever for 15 hrs peak at 101.7F; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:30 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 44 Years) at Workplace clinic. Medical history included drug hypersensitivity. The patient's concomitant medications were not reported. The patient previously took doxycycline and penicillin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization (Lot number EL3247, 20Jan2021Administration time9:15 AM Vaccine location Left arm). Other medical history none. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 10Feb2021 23:30 patient experienced injection site arm pain, sever chills, a fever for 15 hrs peak at 101.7f. The patient underwent lab tests which included body temperature: 101.7 fahrenheit on 2021 a fever for 15 hrs peak at 101.7F. Therapeutic measures were taken as a result of all events includes Tylenol and Advil for pain and fever. The outcome of all events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm hurts; headaches; This is a spontaneous report from a contactable consumer. A 58-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration administered in Arm on unspecified date (age at the time of vaccination was 58-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration as single dose for COVID-19 immunization. The patient experienced arm hurts from Covid second vaccine and headaches on an unspecified date. The outcome of the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pain, Rash
Clinical narrative: it was weird; a little soreness that didn't seem to bother her very much; 8 days later she got a rash. It was red and round; 8 days later she got a rash. It was red and round; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FL1283, Expiry Date: not provided), dose 1 intramuscularly administered in Left arm on 18Jan2021 as single for covid-19 immunisation. Medical history included none. Patient has no family medical history. The patient's concomitant medications were not reported. The patient stated that the reaction to the first dose was much milder and she had no tiredness. On an unspecified date in Jan2021, it was very weird, she had a little soreness that didn't seem to bother her very much, but 8 days later she got a rash. It was red and round, but not as big as the rash with the second dose. It's still slightly there, but it's very light. No relevant tests were reported. Outcome of the events was reported as not resolved. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; fever 101; muscle aches; lethargy; This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:00 as dose 1, single (age at vaccination 54-year-old) for covid-19 immunisation. Medical history included Mild asthma from an unknown date, covid-19 from an unknown date (Prior to vaccination, the patient diagnosed with COVID-19), Shrimp allergy from an unknown date. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 11Feb2021 06:00, the patient experienced sore throat, fever 101, muscle aches, lethargy. The patient underwent lab tests and procedures which included body temperature: 101 on 11Feb2021 (fever 101). Therapeutic measures were taken as a result of events includes Tylenol. The outcome for all events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: Difficulty sleeping the night of vaccination (restless sleeping); restless sleeping; painful arm; In the morning woke up with really bad headache; Brain is very foggy/fuzzy.; entire body was sore; This is a spontaneous report from a contactable consumer reported for herself. A 24-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 3247), via an unspecified route in the left arm on 11Feb2021 at 12:45 (age at vaccination: 24-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Patient did not have allergies to medications, food, or other products. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 3247) via an unspecified route in the left arm on 20Jan2021 at 14:00 (age at vaccination: 24-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 11Feb2021 at 23:00, patient experienced difficulty sleeping the night of vaccination (restless sleeping) and painful arm. In the morning, woke up with really bad headache on right side of temple and entire body was sore besides the arm in which vaccination took place. Brain is very foggy/fuzzy. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: Difficulty sleeping the night of vaccination (restless sleeping); restless sleeping; painful arm; In the morning woke up with really bad headache; Brain is very foggy/fuzzy.; entire body was sore; This is a spontaneous report from a contactable consumer reported for herself. A 24-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 3247), via an unspecified route in the left arm on 11Feb2021 at 12:45 (age at vaccination: 24-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Patient did not have allergies to medications, food, or other products. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 3247) via an unspecified route in the left arm on 20Jan2021 at 14:00 (age at vaccination: 24-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 11Feb2021 at 23:00, patient experienced difficulty sleeping the night of vaccination (restless sleeping) and painful arm. In the morning, woke up with really bad headache on right side of temple and entire body was sore besides the arm in which vaccination took place. Brain is very foggy/fuzzy. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.