chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal
Clinical narrative: Like a truck hit me a day later BP up to 86/85; Like a truck hit me a day later BP up to 86/85; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El 3248), via an unspecified route of administration at the right arm on 13Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered in a hospital. The patient's medical history included breast cancer, thyroid low, and known allergies to bee sting, shellfish, codeine and sulfur. The patient's concomitant medication included thyroid (as reported) that the patient received in two weeks. The patient had no other vaccine in four weeks. The patient had no COVID prior to the vaccination and has not tested for COVID post vaccination. The patient is not pregnant. The patient experienced "like a truck hit me a day later bp up to 86/85" on 15Jan2021 at 09:15 AM. Treatment received for the events was reported as "Emergency" (pending clarification). The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival erythema, Gingival swelling, Hyperaesthesia teeth
Clinical narrative: swelling on his lower gums; sensitivity to his teeth; redness on his gums; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via intramuscular route of administration on 14Jan2021 at 12:40 at 0.3 mL, single in the deltoid left for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 23Dec2020 at 0.3 ml IM injection for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021, the patient experienced swelling on his lower gums in the front of his mouth and sensitivity to his teeth, no other symptoms. The swelling gums went away, it was mild and it went away. A few hours after, there was redness on his gums, no drainage or anything and then the teeth sensitivity went away through the day. He was wondering if those things have been associated with the product or maybe just a coincidence. The patient recovered from the events swelling on his lower gums and sensitivity to his teeth on 15Jan2021 while unknown for the other event.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: feeling crappy; my muscles hurt; This is a spontaneous report from a contactable Other Health Professional (patient) via the Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine in the morning of 20Jan2021 and she was feeling crappy and her muscles hurt in Jan2021. She stated that she read if you have Covid you should take TYLENOL instead of Ibuprofen. She was wondering if this was the same with the vaccine or if it was okay to take ibuprofen. The outcome of the events feeling crappy and my muscles hurt was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: contracted Covid 07Jan2021; contracted Covid 07Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was unknown), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose on 02Jan2021 and contracted Covid 07Jan2021. She was out of isolation since 17Jan2021 and currently have no symptoms. She is scheduled to receive the vaccine this coming Saturday (23Jan2021). The patient wanted to know if she can receive the second dose or should she postpone her appointment. The patient asked what would happen if she decided to get the second dose in 3 months after dose 1 and asked if she would need to start the vaccine series from the beginning. The outcome of the event was recovered on Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Pain in extremity
Clinical narrative: numbness of left hand and fingers; Pain on forearm (Pressure feeling); Pain on forearm (Pressure feeling); This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 30Dec2020 at 12:30 on left arm at a single dose for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient started feeling numbness of left hand and fingers after 10 minutes (30Dec2020 at 12:40) and pain on forearm (pressure feeling) 30Dec2020 at 12:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Erythema, Urticaria
Clinical narrative: hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; This is a spontaneous report from a contactable nurse. A 36-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular in left arm on 12Jan2021 11:00 to at a single dose for COVID-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On 12Jan2021 11:00, hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe. The outcome of the events was recovered with sequelae. The events resulted in an emergency room/department or urgent care. Treatment for the events included Benadryl, Ativan, Pepcid, NS Bolus and EpiPen. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including physical examination with vitals and chest x-ray, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lethargy, Nausea
Clinical narrative: Headache; diarrhea; nausea; lethargy; This is a spontaneous report from a contactable other healthcare professional (hcp reported for self). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot EK9231, expiry date not reported), via an unspecified route of administration on 16Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included known allergies to poultry and egg. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included ethinylestradiol, norethisterone (CYCLAFEM 0.5/35), riboflavin (VIT B2), colecalciferol (D3), magnesium, and bifidobacterium lactis (PROBIOTIC); all reported as other medications in two weeks. Patient had no other vaccine in four weeks. On an unspecified date in Jan2021 (also reported as 03Jan2021; pending clarification), the patient experienced headache, diarrhea, nausea, and lethargy continued after 4 days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events headache, diarrhea, nausea, and lethargy were not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye irritation, Fatigue, Headache, Nausea
Clinical narrative: Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin.  Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Swelling, Swelling face
Clinical narrative: Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin.  Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: pain and numbness on left forearm near the injection site; pain and numbness on left forearm near the injection site; mild hypertension; tachycardia; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3249 and expiry date unknown) intramuscular at the left arm on 10Jan2021 at single dose for Covid-19 immunization in a hospital. Medical history was none. It was unknown if the patient was pregnant. The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. In Jan2021, the patient experienced pain and numbness on left forearm near the injection site, mild hypertension and tachycardia. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events pain and numbness on left forearm near the injection site was recovered in Jan2021, while mild hypertension and tachycardia was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Inappropriate schedule of product administration, Initial insomnia
Clinical narrative: felt confused/ sent emails and text which were very abnormal and confusing. Not making lots of sense; I was tired; mild headache; neck pain; acutely drowsy; completed several notes and had no memory of completing the notes at all; Unable to fall asleep to pain; Unable to fall asleep to pain; 1st dose of BNT162B2 on 23Dec2020/ received the second dose on 18Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 18Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included migraine headaches and depression. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 23Dec2020 for COVID-19 immunisation (lot number EJ1685, right arm). On 19Jan2021 19:45, the patient felt confused, thought she was tired and was trying to push through and write notes, she knew something wasn't quite right. She experienced mild headache and neck pain. I was making a lot of errors while writing notes and I was aware. This night I also sent emails and text which were very abnormal and confusing. Not making lots of sense. I received text asking me "what?" Because what she was sending made no sense. She was acutely drowsy and fell asleep mid text. She woke up mid morning with severe neck pain unable to touch chin to chest. Unable to fall asleep to pain. Took Tylenol and muscle relaxer. Went to work as PA. She forgot she had written notes night before. Thinking notes were not complete logged into hospital to write notes and she completed several notes and had no memory of completing the notes at all. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Outcome of the event mild headache was resolved on 21Jan2021, neck pain was recovering, while unknown for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Neck pain, Pain, Somnolence
Clinical narrative: felt confused/ sent emails and text which were very abnormal and confusing. Not making lots of sense; I was tired; mild headache; neck pain; acutely drowsy; completed several notes and had no memory of completing the notes at all; Unable to fall asleep to pain; Unable to fall asleep to pain; 1st dose of BNT162B2 on 23Dec2020/ received the second dose on 18Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 18Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included migraine headaches and depression. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 23Dec2020 for COVID-19 immunisation (lot number EJ1685, right arm). On 19Jan2021 19:45, the patient felt confused, thought she was tired and was trying to push through and write notes, she knew something wasn't quite right. She experienced mild headache and neck pain. I was making a lot of errors while writing notes and I was aware. This night I also sent emails and text which were very abnormal and confusing. Not making lots of sense. I received text asking me "what?" Because what she was sending made no sense. She was acutely drowsy and fell asleep mid text. She woke up mid morning with severe neck pain unable to touch chin to chest. Unable to fall asleep to pain. Took Tylenol and muscle relaxer. Went to work as PA. She forgot she had written notes night before. Thinking notes were not complete logged into hospital to write notes and she completed several notes and had no memory of completing the notes at all. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Outcome of the event mild headache was resolved on 21Jan2021, neck pain was recovering, while unknown for the other events.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: High fever after 2nd dose (103.7); This is a spontaneous report from a contactable pharmacist(patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:ELI283), via an unspecified route of administration into the left arm on 19Jan2021 09:30 at a single dose for covid-19 immunisation. Medical history was reported as none.  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and gabapentin (GABAPENTIN). The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EH9899), via an unspecified route of administration into the left arm on 29Dec2020 11:00 AM at a single dose for covid-19 immunization. The patient experienced high fever after 2nd dose (103.7; units unspecified) on 20Jan2021 03:00. The event was reported as non-serious and the patient did not receive treatment. Outcome of event recovered on an unspecified date.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contactable Physician. A 77-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported),  via an unspecified route of administration on an unspecified date at single dose (2nd dose) for covid-19 immunization.  Medical history included high cholesterol and has no known allergies.  The patient's concomitant medications were not reported.  The patient had her first dose on left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685) at 12:00 on 22Dec2020 but had slight discomfort site injection and occasional soreness site injection over the subsequent 3 weeks. For vaccine dose 2, it was reported that after 30-36 hr, patient developed chills, low grade fever 99.4 orally, fatigue, weakness and took ibuprofen. She slept normal by 42 hrs and no further complications. The outcome of events recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in a school clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness site starting on 12th hour to 36th hr post the 1st dose; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age (reported as age: 37, unit: unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had 1st dose of COVID 19 vaccine on an unspecified date and that the only thing he experienced was "arm soreness site starting on 12th hour to 36th hr (hour) post the 1st dose". The outcome of the event arm soreness site was unknown.   No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Vaccination site pain
Clinical narrative: pain at the injection site, left arm; so stressed; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular in the left arm on 18Jan2021 at 15:00 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to sulfa. Concomitant medications were not reported. Past drug history included drug allergy: ciprofloxacin (CIPRO) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021, the patient experienced pain at the injection site, left arm and so stressed. There was no emergency room or physician office visit. No treatment was provided for event pain at the injection site. The outcome of the event pain at the injection site was not recovered. The outcome of the event stressed was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of the two reports.  A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. This patient was vaccinated and has tested positive for Covid-19 on an unspecified date, not sure when he tested positive for the Covid-19. He was asymptomatic. It was also reported that he got sick on 03Jan2021. The second dose is due 21Jan2021, is it ok for him to receive it? How long can he wait if he does not get the vaccine at 21 days? The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021035296 same reporter/product, similar events and different patient
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vertigo
Clinical narrative: Dizziness; vertigo; nausea; headache; This is a spontaneous report from a contactable physician reporting for himself. A 69-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date not reported) on an unspecified date in Dec2020 12:45 via an unspecified route of administration in the left arm, and the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3246, expiry date not reported) on 11Jan2021 13:30 via an unspecified route of administration in the left arm, for COVID-19 immunization. Medical history included penicillin allergy, mild hypothyroidism, gastrooesophageal reflux disease (GERD) and benign prostatic hyperplasia (BPH), unspecified if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE), famotidine, dutasteride, from an unspecified date to an unspecified date (received in two weeks, as reported); simvastatin, tadalafil, herbal pollen nos/quercetin (PROSTATE PQ), and "Supplements Prostagenix", from an unspecified date and ongoing. The patient had not had COVID piror to the vaccination, and had not tested post the vaccination. The patient experienced dizziness/vertigo with nausea and headache beginning 1-2 weeks (unspecified date in Jan2021) after the initial vaccination and worse after the second dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received scopolamine 1mg/3 day patch x 5 for the events. The events were not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue; Massive headache; Aches; Fever; This case has been considered invalid: no first-hand knowledge of adverse events    This is a spontaneous report from a non-contactable consumer. This consumer reported for a 44-year-old female patient that:  I learned from a friend yesterday that her friend had told her through text message that she experienced side effects as a result of the second dose of the Pfizer COVID 19 vaccine.   As an employee of Pfizer, I know it is my responsibility to report side effects and learned of these during a meal. The report came up during conversation.   The patient, 44 you F, received Pfizer vaccine at her work and reported the following side effects via text message:  "Felt great after first dose, second dose, rough, fever, aches, massive headache, fatigue."  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at left arm, on 22Dec2020 10:15 at single dose for covid-19 immunisation. Medical history included having COVID prior vaccination. Patient has no known allergies. Patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamins nos (MULTIVITAMIN). Patient did not receive other vaccine in four weeks. Patient experienced fever 99.9, body aches, Injection site tenderness, swelling, redness x 10 days, all on 23Dec2020 08:00. No treatment received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at left arm, on 22Dec2020 10:15 at single dose for covid-19 immunisation. Medical history included having COVID prior vaccination. Patient has no known allergies. Patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamins nos (MULTIVITAMIN). Patient did not receive other vaccine in four weeks. Patient experienced fever 99.9, body aches, Injection site tenderness, swelling, redness x 10 days, all on 23Dec2020 08:00. No treatment received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Pain
Clinical narrative: fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain; Fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient.  A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, in the left arm on 15Jan2021 at 08:50 AM  (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination On 15Jan2021, the patient experienced injection site pain. On 18Jan2021, the patient experienced fever 99.1 Fahrenheit, shivers and chills, body aches, headache, dull chest pain, fatigue,. The patient had lab tests which included: 18Jan2021: pyrexia: 99.1 Fahrenheit, 19Jan2021: pyrexia: 98.9 Fahrenheit.  Treatment for the body aches included with Theraflu, and ibuprofen liquids for the headache. The clinical outcome of the event injection site pain was recovered on 16Jan2021, fever 99.1 Fahrenheit, and dull chest pain was recovered on 19Jan2021, shivers and chills was recovered on 20Jan2021. The clinical outcome of the body aches, headache, fatigue, was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 19Jan2021, the results of which was negative.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vaccination site pain
Clinical narrative: fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain; Fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient.  A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, in the left arm on 15Jan2021 at 08:50 AM  (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination On 15Jan2021, the patient experienced injection site pain. On 18Jan2021, the patient experienced fever 99.1 Fahrenheit, shivers and chills, body aches, headache, dull chest pain, fatigue,. The patient had lab tests which included: 18Jan2021: pyrexia: 99.1 Fahrenheit, 19Jan2021: pyrexia: 98.9 Fahrenheit.  Treatment for the body aches included with Theraflu, and ibuprofen liquids for the headache. The clinical outcome of the event injection site pain was recovered on 16Jan2021, fever 99.1 Fahrenheit, and dull chest pain was recovered on 19Jan2021, shivers and chills was recovered on 20Jan2021. The clinical outcome of the body aches, headache, fatigue, was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 19Jan2021, the results of which was negative.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Insomnia, Oropharyngeal pain
Clinical narrative: My throat is very muffled, like a sore throat but it doesn't hurt; weakness; I woke up dizzy like I have vertigo/dizziness; I work the night shift from 11-7/Yesterday morning (come home from work), I was wide awake, fell asleep at 4pm; My throat is very muffled, like a sore throat but it doesn't hurt; I woke up dizzy like I have vertigo; My throat is like I have a frog in my throat; my arm was sore; upset stomach; This is a spontaneous report received from a contactable other healthcare professional (patient). A female patient of an unspecified age (reported as 53, unit not provided, pending clarification) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 14Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization for which the patient experienced upset stomach, cried al day/cried event at work for a whole 24 hours/crying for no reason like she was depressed. The patient stated, "I received the second shot Thursday morning (14Jan2021), I went to work (I work the night shift from 11-7). I was fine; my arm was sore. I had an upset stomach. On 15Jan2021, yesterday morning (come home from work), I was wide awake and fell asleep at 4pm. I woke up dizzy like I have vertigo. My throat is like I have a frog in my throat. The dizziness and weakness, since 9pm last night (15Jan2021). My throat is very muffled, like a sore throat but it doesn't hurt. I have dizziness. I knew there were side effects to the shot. ". The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal disorder, Sensation of foreign body, Vertigo
Clinical narrative: My throat is very muffled, like a sore throat but it doesn't hurt; weakness; I woke up dizzy like I have vertigo/dizziness; I work the night shift from 11-7/Yesterday morning (come home from work), I was wide awake, fell asleep at 4pm; My throat is very muffled, like a sore throat but it doesn't hurt; I woke up dizzy like I have vertigo; My throat is like I have a frog in my throat; my arm was sore; upset stomach; This is a spontaneous report received from a contactable other healthcare professional (patient). A female patient of an unspecified age (reported as 53, unit not provided, pending clarification) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 14Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization for which the patient experienced upset stomach, cried al day/cried event at work for a whole 24 hours/crying for no reason like she was depressed. The patient stated, "I received the second shot Thursday morning (14Jan2021), I went to work (I work the night shift from 11-7). I was fine; my arm was sore. I had an upset stomach. On 15Jan2021, yesterday morning (come home from work), I was wide awake and fell asleep at 4pm. I woke up dizzy like I have vertigo. My throat is like I have a frog in my throat. The dizziness and weakness, since 9pm last night (15Jan2021). My throat is very muffled, like a sore throat but it doesn't hurt. I have dizziness. I knew there were side effects to the shot. ". The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Bilirubin urine present, Blood test, Blood urine present, Dehydration, Off label use
Clinical narrative: Bloody urine; UA indicated red blood cells and bilirubin in urine; UA indicated red blood cells and bilirubin in urine; Basic Metabolic Panel indicated dehydration; Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); This is a spontaneous report from a contactable pharmacist. This 32-year-old male pharmacist (Patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284), via unspecified route at left arm on 13Jan2021 10:00am at single dose for COVID-19 immunization. Medical history was not reported. Concomitant drugs included Vitamin D3. Historical vaccine included the first dose of BNT162B2 (lot number= EH9899) on 21Dec2020 02:30 pm at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine in four weeks. On 15Jan2021 01:30 pm, patient had bloody urine, he was otherwise normal health, he visited healthcare provider within 3 hours of the incident. Point of care urine analysis (UA) and blood draw was done. UA indicated red blood cells and bilirubin in urine. Basic Metabolic Panel indicated dehydration, otherwise unremarkable. Events resulted in emergency room/department or urgent care. No treatment was received. Outcome of events was recovered in Jan2021. No COVID prior vaccination. No COVID tested post vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Red blood cells urine positive, Urine analysis
Clinical narrative: Bloody urine; UA indicated red blood cells and bilirubin in urine; UA indicated red blood cells and bilirubin in urine; Basic Metabolic Panel indicated dehydration; Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); This is a spontaneous report from a contactable pharmacist. This 32-year-old male pharmacist (Patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284), via unspecified route at left arm on 13Jan2021 10:00am at single dose for COVID-19 immunization. Medical history was not reported. Concomitant drugs included Vitamin D3. Historical vaccine included the first dose of BNT162B2 (lot number= EH9899) on 21Dec2020 02:30 pm at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine in four weeks. On 15Jan2021 01:30 pm, patient had bloody urine, he was otherwise normal health, he visited healthcare provider within 3 hours of the incident. Point of care urine analysis (UA) and blood draw was done. UA indicated red blood cells and bilirubin in urine. Basic Metabolic Panel indicated dehydration, otherwise unremarkable. Events resulted in emergency room/department or urgent care. No treatment was received. Outcome of events was recovered in Jan2021. No COVID prior vaccination. No COVID tested post vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Scratch
Clinical narrative: 2 hours after receiving vaccine, I became itchy all over body and could not stop. My head, legs, arms, ears, eyes, up my nose, etc were itchy.; I did not have hives., just redness from scratching non stop; I did not have hives., just redness from scratching non stop; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via Intramuscular on 07Jan2021 12:30 PM (vaccine location: Arm Left) at single dose for COVID-19 immunisation. The patient's medical history was reported as Endometreosis, Polycystic ovary (PCOS), anxiety and known allergies to Penicillin. The concomitant medications included duloxetine hydrochloride (CYMBALTA), topiramate (TOPAMAX), Spironolactone, Gabapentin, cetirizine hydrochloride (ZYRTEC), birth control. 2 hours after receiving vaccine on 07Jan2021 02:30 PM, patient became itchy all over body and could not stop. Her head, legs, arms, ears, eyes, up nose, etc were itchy. Patient did not have hives, just redness from scratching non stop, she went home and took Benadryl 50mg, and was still itchy, but not constantly. On 08Jan2021, patient was still itchy all day, but only needed 25 mg of Benadryl to help symptoms and it wasn't nearly as bad as day before. By 09Jan2021, the itching was gone. The outcome of event was recovered on 09Jan2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: terrible headache lasting 3 days after injection; elevated temperature on day 2 of 102; sore and red arm at injection site; sore and red arm at injection site; body aches; This is a spontaneous report from a contactable Consumer.  A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number PFREL3246), via an unspecified route of administration on 09Jan2021 11:00 at single dose for covid-19 immunisation.  Medical history included COPD, Asthma, Atrial Fib, Hypertension, covid-19.  The patient previously took levaquin and underwent allergies:Levaquin. The patient experienced body aches, elevated temperature on day 2 of 102, sore and red arm at injection site, terrible headache lasting 3 days after injection. No treatment received. No Covid tested post vaccination. The outcome of the events was resolved.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: elbow pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he experienced elbow pain from his vaccine on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Neck pain
Clinical narrative: He will get his second dose on 30Jun2021; Pain in the back of his neck going up towards his head; Pain in the back of his neck going up towards his head; This is a spontaneous report from a contactable consumer (patient himself). A 90-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 30Dec2020 in right arm at single dose for covid-19 immunisation.  Medical history included none. Patient just took his regular medications. Caller said that he had his vaccine done on 30Dec2020 and two days ago (15Jan2021) he started to get pain in the back of his neck going up towards his head. He has had no other problems. It could be he had been sitting too long from watching TV most of the day. But he wanted to mention this. It started a little bit on Friday 15Jan2021, then a lot on Saturday 16Jan2021, and then today it started to go up towards his head. When he bended down more and moved around it would go away for a while, then come back. He would move it back and fourth and down and up. Then it would feel good. But then if he touched it, he can feel the pain. He thought it would get better. This was his first dose. He will get his second dose on 30Jun2021. Outcome of pain in the back of his neck going up towards his head was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: very fatigued a few hours after the vaccination; He had a very large abnormal headache; He thinks he had a fever; His arm hurt; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously 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 an unspecified date at a single dose for COVID-19 immunization. After his second dose of the Pfizer vaccine, the patient became very fatigued a few hours after the vaccination. He had a very large abnormal headache. He thinks he had a fever. His arm hurt. The start date of events was on an unspecified date in Jan2021. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Jan2021. Facility type vaccine was Workplace clinic. Unknown if other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Unknown if COVID tested post vaccination.  No follow-up attempts are possible; Information on lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hyperhidrosis
Clinical narrative: go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating profusel; Product use for unapproved combination; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration in the right arm on 19Jan2021 at 09:15 at single dose for COVID-19 immunisation. The patient was not pregnant. She received another vaccine (unspecified) in the left forearm on the same date of BNT162B2. Relevant medical history included allergies to tape and potential basal cell cancer. Concomitant medications included melatonin and multi vitamins. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 21Dec2020, second dose in the left arm. The patient reported that she felt great after the shot at 9:30 am on 19Jan2021 and, at 13:30, she had a potential basil cell cancer removed, and she felt great. On 20Jan2021, at 1:55 am, she got up to go to the bathroom, she remembered wiping and then her husband standing over her on the floor. On 20Jan2021 at 01:45 am, she was sweating profusely; after a minute, she got herself off the floor, back in bed, and she had no feelings of any illness. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the events on an unspecified date.