chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Urticaria, Vomiting
Clinical narrative: Within 1 hour of immunization, patient developed vomiting and diffuse urticaria with fussiness. She was taken to the Emergency Department and IM epinephrine and IM diphenhydramine were administered approximately 1 hour after symptom onset. All symptoms resolved within 30 minutes. Patient observed for several hours without return of symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Sensation of foreign body
Clinical narrative: Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccine to monitor for reaction. Around 6:30 pm she went out to her car and came back into the clinic stating that she had pressure in her chest and a lump in her throat. 911 was called and client when to the emergency room where it was determined that she had an allergic reaction to the vaccine. We have called client to follow up but she has not returned our voicemail.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site abscess, Injection site discharge, Urticaria
Clinical narrative: Appearance of spontaneous circular epidermal ulcerative lesion 4cm adjacent to injection site.  Lesion is 1cm in diameter, limited to upper/superficial  layers of epidermis, oozing serous fluid. Lesion was noticed approximately 26 hours after second vaccine dose was administered. Area of erythema surrounding lesion present.  Urticaria present.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia
Clinical narrative: Generalized joint pain, abdominal cramping without nausea or diarrhea. Lasted 12 hours. Took 2 doses of Tylenol .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Lymph node pain, Migraine, Pain
Clinical narrative: Severe migraine Brain fog Lymph node under left arm is extremely painful to touch Body aches
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Headache, Pyrexia, Somnolence
Clinical narrative: Severe chills began at about 11 hours (11:30 pm) and lasted 4 hours(3 am). Following morning (6:00 am) severe headache, drowsiness, heartburn, low grade fever.  Drowsiness, heartburn, fever lasted until around 11 pm. Headache is still present, but very minor.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching and redness around and below the injection site also slight swelling in same area. No treatment. Still occurring. Started 9 days after injection. Also not sure if related to vaccine but get slightly winded in daily activities. Started a day after vaccine and still occurring. No treatment
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site paraesthesia, Pain in extremity
Clinical narrative: I felt instantaneous numbness/tingling from the injection site down to the fingers in my left hand upon receiving the vaccine around 3:40 p.m. During the 15 minute wait period, the numbness persisted. The nurses on staff said that several other people had reported the same. Within about 30-40 minutes after leaving the clinic, I also had bilateral facial numbness and tingling lips. The arm and facial numbness lasted for about 5 hours and lessened right before I went to bed and this morning only my arm hurts (normal vaccine site pain).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: I felt instantaneous numbness/tingling from the injection site down to the fingers in my left hand upon receiving the vaccine around 3:40 p.m. During the 15 minute wait period, the numbness persisted. The nurses on staff said that several other people had reported the same. Within about 30-40 minutes after leaving the clinic, I also had bilateral facial numbness and tingling lips. The arm and facial numbness lasted for about 5 hours and lessened right before I went to bed and this morning only my arm hurts (normal vaccine site pain).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Widespread body rash. Received shot in left arm, spotty rash on left arm observed. Rash/welts observed on face, entire right arm. Reports entire trunk with same symptom.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given incorrect dose; 1.0 mL instead of 0.5 mL of vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: On day 10, developed red, raised, itchy rash on shoulder of injection site. Approximately, 3" x 4". Treated with topical hydrocortisone cream. Resolved by day 12.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Throat irritation
Clinical narrative: THROUT ITCHINESS , SWELLING FEELING  TREATED WITH  EPI AND PREDNISONE.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurred vision, will check with optometrist
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Area of injection turned red 2-3 inch diameter and itches. Been putting aquaphor cream on the area. Started treatment yesterday and it looks the same. Not itching quit as much but still is itchy.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Next day (1/18) noticed three small rash spots on inside upper right thigh. Wasn't sure if related. Since then more rash spots have occurred on upper right thigh and across lower back.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Fatigue, Nasal congestion, Pain in extremity
Clinical narrative: I had arm soreness about three hours after that was progressively worse the first three days then started going away. On the fourth day and I woke up sneezing and could not stop. I had a lot of nasal congestion and a low grade fever (100.8), I also had a lot of fatigue. I had a little bit of a cough as well. This all lasted for about five days.  I also got a Covid test and that came back negative.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Sneezing
Clinical narrative: I had arm soreness about three hours after that was progressively worse the first three days then started going away. On the fourth day and I woke up sneezing and could not stop. I had a lot of nasal congestion and a low grade fever (100.8), I also had a lot of fatigue. I had a little bit of a cough as well. This all lasted for about five days.  I also got a Covid test and that came back negative.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash, Tachycardia, Tremor
Clinical narrative: Pruritis, shaking, nausea, tachycardia, rash to arms, chest and back.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Hyperhidrosis, Pallor
Clinical narrative: At approximately 1350, patient reported feeling anxious. Upon assessment, pt was pale, diaphoretic and shaky. At approximately 1340, he c/o chest pain and SOA. RRT called. Pt reports that he took 0.5 mg Ativan right after he received the injection (1340). 1359 - Pt no longer pale, diaphoretic. 1351 - 160/100 HR 103 (R) 1352 -163/90 HR 96 (L) 1356 - 145/93 HR 96 (L) 1359 - 140/88 HR 90 (L) 1400 - Pt denies chest pain, SOA, palpitations. Reports that he does not need to be seen in ED for further treatment.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vital signs measurement
Clinical narrative: At approximately 1350, patient reported feeling anxious. Upon assessment, pt was pale, diaphoretic and shaky. At approximately 1340, he c/o chest pain and SOA. RRT called. Pt reports that he took 0.5 mg Ativan right after he received the injection (1340). 1359 - Pt no longer pale, diaphoretic. 1351 - 160/100 HR 103 (R) 1352 -163/90 HR 96 (L) 1356 - 145/93 HR 96 (L) 1359 - 140/88 HR 90 (L) 1400 - Pt denies chest pain, SOA, palpitations. Reports that he does not need to be seen in ED for further treatment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: 1st covid vaccine 1-13-2021-left arm-one day after injection slight redness/irritation/itching and small amount of bruising, all but bruise resolved within a day, since Wednesday 1-20-2021 left upper arm has been itching, small bruise at injection site remains, reported swelling to left upper arm as well, took benadryl last night, reports a cold pack does help with sxs, no fever, no body aches, no respiratory sxs, no lip/tongue numbness or tingling noted. known HTN, elevated in office, no acute s/s, reports typical to elevate in providers office
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Pt was waking 1/21/21 and legs calapsed. Lowered to ground by relative and taken home. Remained alert and po c/o pain. Currently @ 230pm able to walk. Daughter seeking follow up. Vaccine give at a covid 19 vaccination clinic. given by the county
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Confusional state, Feeling cold, Headache
Clinical narrative: passed out; almost like a seizure; fainted; saw sparks; pain of back; my whole body shook/shaking from cold; shaking from cold; teeth chattered; pain in the back of my head; This spontaneous report was received from a 88-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown. Her concurrent condition included an unknown condition that she did not want to disclose (ill-defined disorder).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prevention of pneumonia. On an unknown date, the patient experienced "a severe reaction" to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), described as follows: immediately after receiving the vaccination the patient got up, saw sparks and fainted. She was put in a room where she had pain in the back of her head and small of her back, and she passed out. The patient's granddaughter picked her up in a car and the patient's body shook and her teeth chattered. She was put under three blankets for about three hours before it wore off. The patient's daughter "looked it up" and said she might have sore arms and chills but the patient reported she had none of that. The patient reported she never fainted before and it was almost like a seizure, she was shaking from cold so bad. On an unknown date (reported as 10 days later), she had bloodwork performed and it was all good. The patient's doctor did not know why the patient reacted this way but she is now afraid to take the COVID shot. The patient seemed confused by questions and repeated symptoms twice. She stated that the blood work was taken for another condition but did not want to disclose that condition. The patient did not seek medical attention. The outcome of the events was reported as recovered.  The patient assessed the events as related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review the events of fainted, passed out and almost like a seizure were assessed as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Loss of consciousness, Photopsia, Seizure like phenomena, Syncope
Clinical narrative: passed out; almost like a seizure; fainted; saw sparks; pain of back; my whole body shook/shaking from cold; shaking from cold; teeth chattered; pain in the back of my head; This spontaneous report was received from a 88-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown. Her concurrent condition included an unknown condition that she did not want to disclose (ill-defined disorder).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prevention of pneumonia. On an unknown date, the patient experienced "a severe reaction" to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), described as follows: immediately after receiving the vaccination the patient got up, saw sparks and fainted. She was put in a room where she had pain in the back of her head and small of her back, and she passed out. The patient's granddaughter picked her up in a car and the patient's body shook and her teeth chattered. She was put under three blankets for about three hours before it wore off. The patient's daughter "looked it up" and said she might have sore arms and chills but the patient reported she had none of that. The patient reported she never fainted before and it was almost like a seizure, she was shaking from cold so bad. On an unknown date (reported as 10 days later), she had bloodwork performed and it was all good. The patient's doctor did not know why the patient reacted this way but she is now afraid to take the COVID shot. The patient seemed confused by questions and repeated symptoms twice. She stated that the blood work was taken for another condition but did not want to disclose that condition. The patient did not seek medical attention. The outcome of the events was reported as recovered.  The patient assessed the events as related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review the events of fainted, passed out and almost like a seizure were assessed as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: passed out; almost like a seizure; fainted; saw sparks; pain of back; my whole body shook/shaking from cold; shaking from cold; teeth chattered; pain in the back of my head; This spontaneous report was received from a 88-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown. Her concurrent condition included an unknown condition that she did not want to disclose (ill-defined disorder).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prevention of pneumonia. On an unknown date, the patient experienced "a severe reaction" to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), described as follows: immediately after receiving the vaccination the patient got up, saw sparks and fainted. She was put in a room where she had pain in the back of her head and small of her back, and she passed out. The patient's granddaughter picked her up in a car and the patient's body shook and her teeth chattered. She was put under three blankets for about three hours before it wore off. The patient's daughter "looked it up" and said she might have sore arms and chills but the patient reported she had none of that. The patient reported she never fainted before and it was almost like a seizure, she was shaking from cold so bad. On an unknown date (reported as 10 days later), she had bloodwork performed and it was all good. The patient's doctor did not know why the patient reacted this way but she is now afraid to take the COVID shot. The patient seemed confused by questions and repeated symptoms twice. She stated that the blood work was taken for another condition but did not want to disclose that condition. The patient did not seek medical attention. The outcome of the events was reported as recovered.  The patient assessed the events as related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review the events of fainted, passed out and almost like a seizure were assessed as medically significant.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia
Clinical narrative: is still experiencing myalgia; some days feels really weak; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) (batch number 592EB, expiry date 20th May 2022) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced myalgia and weakness. On an unknown date, the outcome of the myalgia and weakness were not recovered/not resolved.   It was unknown if the reporter considered the myalgia and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 60 or 61 years. The patient was still experiencing myalgia till the date of reporting and the reporter said that it was known that it was a common reaction but wanted to know why it persisted this long.  Some days the patient felt okay and some days felt really weak.  The reporter did not consent to follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old was administered the vaccine; A spontaneous report was received from a physician concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 17-year-old was administered the vaccine.  The patient's medical history was not provided. Concomitant product use was not reported.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the mRNA-1273 vaccine was administered to a 17-year-old. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, 17-year-old was administered the vaccine, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17 year old, male patient.  The patient's medical history is not provided.  The event occurred on 06 Jan 2021, during administration of the first dose of the mRNA-1273(Lot number: 012L20A). This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: resident coded and expired; This is a spontaneous report from a non-contactable consumer via Pfizer Sponsored Program.  A 63-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) intramuscular at single dose at left arm on 28Dec2020 for Covid-19 immunisation.  Medical history included no current Illness, no known allergies, but preexisting conditions: dysphagia, violent behaviors, depressive disorder, schizophrenia, aspiration, gastrooesophageal reflux disease (GERD), hyperlipidaemia, bipolar disorder, rectal bleeding, hypertension. The patient had no birth defect. Concomitant medication included asa (ASA) at 81mg, lisinopril (LISINOPRIL) at 10mg daily, ferrous sulfate (FERROUS SULFATE) at 325 (unit unknown), olanzapine (ZYPREXA) at 20mg, morniflumate (FLOMAX [MORNIFLUMATE]) at 0.4 (unit unknown), famotidine (FAMOTIDINE) at 20mg, ascorbic acid (VIT C), carbamazepine (CARBAMAZEPINE) at 250mg bid, valproate semisodium (DEPAKOTE) at 750mg bid, metformin (METFORMIN) at 1000 (unit unknown) bid, sertraline (SERTRALINE) at 100 (unit unknown) bid, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), buspirone hydrochloride (BUSPAR) at 10mg tid, polycarbophil calcium (FIBERCON).  The patient died on 29Dec2020. The patient had no ER or Doctor visit and was not hospitalized. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: resident coded and expired
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from non-contactable consumers received via a Pfizer-sponsored program An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration on 30Dec2020 at a single dose (1 dose) in the left arm (LA) (administered by: senior living) as Covid vaccine. Medical history included patient was 14 plus days post COVID and unresponsive. The patient had no listed allergies. Concomitant medications were not reported. The patient passed away with an hour and half of receiving vaccine on 30Dec2020. Per nursing staff, they did not expect the patient to make it many more days. She was unresponsive in the room when shot was given. It was unknown if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash in the face that is itchy symmetric and bilateral; Rash in the face that is itchy symmetric and bilateral; This is a spontaneous report from a contactable physician (patient).  A 68-years-old male patient received first dose bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK5730) in Left arm, intramuscular on 06Jan2021 around 11:00 at SINGLE DOSE to prevent COVID, famotidine, oral from an unspecified date and ongoing at 40 mg, 2x/day for gastritis .  Medical history included gastritis, ongoing diabetes (diagnosed 3 years ago), ongoing hyperparathyroidism (diagnosed many, many years ago), ongoing sjogren's syndrome (diagnosed recently this year), gout from 2010 and ongoing , coronary atherosclerosis from Nov2020 and ongoing, ongoing chronic obstructive pulmonary disease (diagnosed many years ago), asthma from 2020 and ongoing , sleep apnoea from 2019 and ongoing, crohn's disease from 1981 and ongoing, and abdominal pain. The patient's concomitant medications included ongoing ASPIRIN [ACETYLSALICYLIC ACID] (reported he takes aspirin everyday and the aspirin causes him to have some abdominal pain).   The patient was administered with the first dose of the vaccine on 06Jan2021 and after that he developed a rash in the face that was itchy symmetric and bilateral on 08Jan2021. The rash was bilateral and symmetrical. The event was reported serious due to medically significant. Upon transfer, the caller clarifies he did not take steroids for the rash. A few days prior to receiving the COVID-19 vaccine, he started taking a new oral medication. So, he doesn't know if the rash is from the new medication or the vaccine, but he decided to call and report this event just in case. He clarifies the name of the new medication was famotidine. Today (12Jan2021) was the first day it was much better. Caller confirmed he did not take any steroids, the only medication he took was an antihistamine for the management of the symptoms. The outcome of the events was recovering.; Sender's Comments: The reported rash in the face that was itchy symmetric and bilateral occurred two days after the first dose of COVID 19 Vaccine, BNT162B2.  Based on the plausible temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Neuropathy peripheral, Peripheral swelling, Pyrexia
Clinical narrative: Swelling and Neuropathy in left extremities; Highest fever 103.5/febrile; Severe Nausea Vomiting; Severe Nausea Vomiting; Swelling and Neuropathy in left extremities; Vertigo; Severe migraine headache; This is a spontaneous report from a contactable Nurse (patient). A 43-years-old female patient received second dose of bnt162b2 (BNT162B2, lot_number=EL1284), intramuscular on 11Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Hyperlipidemia, Mild Obesity (Treating with Medication), and Known- allergies: Strawberries - CT contrast, shellfish, iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included liraglutide (SAXENDA) and Medication for Mild Obesity. The patient historically received first dose of bnt162b2 for covid-19 immunisation. Details: (product=Covid 19, brand=Pfizer, lot_number=EH9899, administration_date=22Dec2020, administration_time=12:00 PM, administrator_route=Intramuscular, vaccine_location=Left arm, dose_number=1). After received second dose, the patient reported adverse-event included: Highest fever 103.5 - Severe Nausea Vomiting, Swelling and Neuropathy in left extremities, vertigo and severe migraine headache - continued to be febrile an additional 36hrs from injection time. Adverse-event-start-date: 11Jan2021. Adverse-event-start-time: 11:30 PM. Required medical management of nausea/vomiting with ondansetron 4mg; oxycodone 10mg for migraine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included body temperature: Highest fever 103.5. The event outcome was recovering. This reported was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Swelling and Neuropathy in left extremities; Highest fever 103.5/febrile; Severe Nausea Vomiting; Severe Nausea Vomiting; Swelling and Neuropathy in left extremities; Vertigo; Severe migraine headache; This is a spontaneous report from a contactable Nurse (patient). A 43-years-old female patient received second dose of bnt162b2 (BNT162B2, lot_number=EL1284), intramuscular on 11Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Hyperlipidemia, Mild Obesity (Treating with Medication), and Known- allergies: Strawberries - CT contrast, shellfish, iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included liraglutide (SAXENDA) and Medication for Mild Obesity. The patient historically received first dose of bnt162b2 for covid-19 immunisation. Details: (product=Covid 19, brand=Pfizer, lot_number=EH9899, administration_date=22Dec2020, administration_time=12:00 PM, administrator_route=Intramuscular, vaccine_location=Left arm, dose_number=1). After received second dose, the patient reported adverse-event included: Highest fever 103.5 - Severe Nausea Vomiting, Swelling and Neuropathy in left extremities, vertigo and severe migraine headache - continued to be febrile an additional 36hrs from injection time. Adverse-event-start-date: 11Jan2021. Adverse-event-start-time: 11:30 PM. Required medical management of nausea/vomiting with ondansetron 4mg; oxycodone 10mg for migraine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included body temperature: Highest fever 103.5. The event outcome was recovering. This reported was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Appendicitis, Malaise, Nausea, Surgery
Clinical narrative: acute appendicitis; nausea; belly bloating; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose or covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 23Dec2020 and on 10Jan2021 (as reported) was admitted for acute appendicitis with abdominal complaints 2-3 days prior. His second dose was scheduled today (13Jan2021) but had not yet taken it due to this AE. He was looking for information on age range and timeframe of appendicitis reports related to covid. General concern was whether he can still take the shot today. Additionally, physician reported that around the 06Jan2021 he started experiencing nausea and belly bloating. On 09Jan2021 (as reported) he was admitted with very acute appendicitis and had to have surgery in the OR. He just got home yesterday (12Jan2021). It seemed to him that the appendicitis occurred too close to receive the vaccine for him not have to consider that it could have been a vaccine related issue for him. He was pretty sick from this and he was happy that he was back home. He was asking if it was safe for him to take the second vaccine given what happened with the first dose. The outcome of events was unknown.; Sender's Comments: Based on the temporal relationship, the association between the event appendicitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Computerised tomogram normal, Dizziness, Hypoaesthesia, Laboratory test normal
Clinical narrative: Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast normal
Clinical narrative: Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling hot, Limb discomfort, Loss of consciousness
Clinical narrative: dizziness; leg heaviness; feeling hot; tremors; feeling hot with heavy feeling in chest; lost consciousness; This is spontaneous report from a contactable pharmacist. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 11:45, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Dec2020, 20 minutes post vaccination, the patient reported dizziness. The patient was sitting in chair with head down with no improvement. When assisting patient to lie down, she lost consciousness. Patient's head and neck were supported so she did not hit head. The patient recovered consciousness and was alert and oriented with c/o leg heaviness and feeling hot. The patient denied difficulty breathing and chest heaviness. No rash noted. She lost consciousness a second time while lying flat. When she recovered consciousness, she was alert and oriented but had c/o leg heaviness, tremors and feeling hot with heavy feeling in chest. No rash noted. Blood pressure: 135/84, pulse: 70, O2 saturation: 99-100. Medical alert was called and the patient was transported to ED. Lost consciousness resolved on an unknown date. The other events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Posture abnormal, Tremor
Clinical narrative: dizziness; leg heaviness; feeling hot; tremors; feeling hot with heavy feeling in chest; lost consciousness; This is spontaneous report from a contactable pharmacist. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 11:45, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Dec2020, 20 minutes post vaccination, the patient reported dizziness. The patient was sitting in chair with head down with no improvement. When assisting patient to lie down, she lost consciousness. Patient's head and neck were supported so she did not hit head. The patient recovered consciousness and was alert and oriented with c/o leg heaviness and feeling hot. The patient denied difficulty breathing and chest heaviness. No rash noted. She lost consciousness a second time while lying flat. When she recovered consciousness, she was alert and oriented but had c/o leg heaviness, tremors and feeling hot with heavy feeling in chest. No rash noted. Blood pressure: 135/84, pulse: 70, O2 saturation: 99-100. Medical alert was called and the patient was transported to ED. Lost consciousness resolved on an unknown date. The other events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Presyncope
Clinical narrative: 3 near syncopal episodes; Arm soreness at injection site; Chills; muscle aches; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. A 49-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number=EL1283 via intramuscularly on 12Jan2021 10:30 at single dose Vaccine location: Right arm for covid-19 immunisation ,facility type vaccine: hospital. Medical history included hypertension and the first dose of BNT162B2 Lot number=EK5730 in Dec2020 10:00 Intramuscular, Vaccine location Right arm Facility type vaccine Hospital. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and multi-vitamin. On 12Jan2021 22:00 the patient experienced 3 near syncopal episodes, arm soreness at injection site, chills and muscle aches. No treatment received. The event outcome was recovered and action taken is not applicable.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event near syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable nurse (patient). This pregnant 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK5730), intramuscular at single dose in the left arm on 20Dec2020 for COVID-19 immunisation. Medical history included none. Concomitant medication included venlafaxine. The patient experienced miscarriage (medically significant) on 09Jan2021 with outcome of recovering. Treatment unknown. The event required a visit to the emergency room. The patient was pregnant while taking BNT162B2. The patient was 4 weeks pregnant at the onset of the event. Patient last menstrual period date was 27Nov2020. The pregnancy due to deliver was on 03Sep2021. The vaccine was administered at Workplace Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. She received the second dose of BNT162B2 (Lot number EL0142), intramuscular in the left arm on 13Jan2021.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be complete excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depressed level of consciousness, Dizziness, Erythema, Feeling abnormal
Clinical narrative: I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself.   A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on  18Dec2020 12:15 at single dose for Covid-19 immunisation .  The patient medical history  and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced  got red rash on my neck and chest  on 18Dec2020 12:15 with outcome of recovering ,  felt lightheaded  on 18Dec2020 12:15 with outcome of recovering ,  face and ears got red and  begin to feel warm  on 18Dec2020 12:15 with outcome of recovering , then  whole body felt really weird  on 18Dec2020 12:15 with outcome of recovering ,  lips went numb  on 18Dec2020 12:15 with outcome of recovering ,  begin to lose consciousness  on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours  could barely talk or open my eyes  on 18Dec2020 12:15 with outcome of recovering , felt so weak,  could not move my body on 18Dec2020 12:15 with outcome of recovering.  The patient was hospitalized for one day for all the reported events.   The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 18Dec2020  .   The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia oral, Mobility decreased, Rash, Rash erythematous
Clinical narrative: I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself.   A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on  18Dec2020 12:15 at single dose for Covid-19 immunisation .  The patient medical history  and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced  got red rash on my neck and chest  on 18Dec2020 12:15 with outcome of recovering ,  felt lightheaded  on 18Dec2020 12:15 with outcome of recovering ,  face and ears got red and  begin to feel warm  on 18Dec2020 12:15 with outcome of recovering , then  whole body felt really weird  on 18Dec2020 12:15 with outcome of recovering ,  lips went numb  on 18Dec2020 12:15 with outcome of recovering ,  begin to lose consciousness  on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours  could barely talk or open my eyes  on 18Dec2020 12:15 with outcome of recovering , felt so weak,  could not move my body on 18Dec2020 12:15 with outcome of recovering.  The patient was hospitalized for one day for all the reported events.   The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 18Dec2020  .   The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.