chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Feeling abnormal, Hallucination, auditory
Clinical narrative: Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded.  The case will be reassessed if additional information becomes 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual, Headache, Insomnia, Neck pain, Panic reaction
Clinical narrative: Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded.  The case will be reassessed if additional information becomes 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Skin burning sensation, Tachycardia, Vomiting
Clinical narrative: Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded.  The case will be reassessed if additional information becomes 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.
Sex: F
Vaccine: PNC13
Symptoms: Immunodeficiency
Clinical narrative: Immunocompromised; This is a spontaneous report from a Pfizer-sponsored program, received via a contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13,Solution for injection in pre-filled syringe, lot number/expiration date unknown) via an unspecified route of administration on 08Nov2020 at a single dose for immunization. Medical history included Crohn's. Concomitant medications included infliximab (INFLECTRA) for Crohn's. The patient was told by her doctor she should get a dose of Pneumovax 23 vaccine in 8 weeks due to her being immunocompromised. However, the pharmacist told her that she should wait for one year. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: rash; All over rash with some itching; This is a spontaneous report from a contactable Nurse reported for self. This 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan 2021 12:50 on right arm at single dose (Lot # EK4176, Expiration Date: Mar2021) for covid-19 immunisation. Medical history was not provided. Concomitant medications were none. Past drug history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 16:00 at age of 34 year old at single dose (Lot # EH9899) for covid-19 immunisation. About 30 minutes after being administered (05Jan2021 13:20) that second dose she developed all over rash with some itching. She took Benadryl and Pepcid in response. Today the all over rash with some itching came back at the same persistent level. She wants to know what kind of timeframe she can expect with the continued allergic reaction of all over rash with some itching. She was made to check into the emergency room for observation, but did not have any testing/lab work/investigations done and was not admitted to the hospital. Outcome of the events was not recovered. Reporter seriousness for All over rash with some itching was Medically significant. Drug result was related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rash and Itching cannot be totally excluded.  The case will be reassessed if additional information becomes 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Discomfort, Feeling of body temperature change, Hyperhidrosis, Pain
Clinical narrative: About 18-20 hours after the immunization I felt achy.  At 6pm evening of the Jan. 8th I ached all over and temp. of 99.6.  Took Tylenol 650mg and went to bed.  Up and down most of evening / night, hot and cold, sweating and at 11pm temp. of 100.6 and took Ibuprofen 400mg.  Miserable at 3:30am with temp. 101.4 and took Ibuprofen again.  Slept well until 9:30am when I awoke with no temp. and feeling great.   Temp.s were taken orally.  Moderately sore arm.  No nausea
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: About 18-20 hours after the immunization I felt achy.  At 6pm evening of the Jan. 8th I ached all over and temp. of 99.6.  Took Tylenol 650mg and went to bed.  Up and down most of evening / night, hot and cold, sweating and at 11pm temp. of 100.6 and took Ibuprofen 400mg.  Miserable at 3:30am with temp. 101.4 and took Ibuprofen again.  Slept well until 9:30am when I awoke with no temp. and feeling great.   Temp.s were taken orally.  Moderately sore arm.  No nausea
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate decreased, Heart rate increased
Clinical narrative: Sudden onset dizzyness 5 minutes after immunization.HR Increased 130, decreased to 90 w rest. Transported to medical Clinic for observation
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Nausea, chills resolved after 24 hrs
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: I was in a low disease state of SLE, 2 days after injection i had a severe flare of lupus requiring steroids; This is a spontaneous report from a contactable other Hcp (patient).  This 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), intramuscularly on 16Dec2020 13:30 at single dose in Arm left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included systemic lupus erythematosus (SLE) and in remission. No Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Concomitant medication received within 2 weeks of vaccination included hydroxychloroquine, topiramate (TROKENDI), prucalopride succinate (MOTEGRITY). The patient was in a low disease state of SLE, 2 days after injection and had a severe flare of lupus requiring steroids on 18Dec2020. The adverse event result in Doctor or other healthcare professional office/clinic visit. Steroids received as treatment. The outcome was recovering. The events were assessed as non-serious; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Systemic lupus erythematosus syndrome aggravated cannot be totally excluded.  The case will be reassessed if additional information becomes 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Injection site pain
Clinical narrative: Sore arm, bruise at injection site, fatigue - all lasting 3 days
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is a spontaneous report from a contactable Physician (patient). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140, Expiry Date: 31Mar2021) via an unspecified route of administration in left upper arm on 31Dec2020 13:25 at single dose for COVID-19 immunisation. Medical history included crohn's disease from Jul2005 and ongoing, ongoing psoriasis, gastrooesophageal reflux disease (GERD), hand tremor. Concomitant medication included ongoing infliximab (REMICADE) for Crohn's, ongoing esomeprazole sodium (NEXIUM) for GERD, ongoing propranolol for hand tremor, copatsol topical steroid for Psoriasis, ongoing Multivitamin, ongoing vitamin B complex (B COMPLEX), ongoing biotin, ongoing iron, ongoing Calcium/Vitamin D, ongoing curcuma longa (TURMERIC). The patient had an allergic reaction after getting the COVID vaccine. She had an allergic reaction after getting the vaccine. She had hives all over her face and neck. She already had a Medrol Dose Pack at home and some Benadryl. She contacted her doctor who prescribed an Epi Pen for her, but she did not have to use the Epi Pen. She stated she used the Benadryl for three days. She started to get hives all over her face and neck the same date she got the vaccine. It started 2 hours after she got the vaccine (31Dec2020 15:25). She confirmed this was the first dose of the COVID Vaccine. She asked that if it is safe to take the second dose after experiencing an allergic reaction to the first dose. Symptoms include hives on face and neck. Patient had no trouble breathing. Took steroids and Benadryl for 3 days or until symptoms have been managed. No any of the events require a visit to emergency room. Reporter seriousness for hives all over her face and neck was reported as medically significant. Events outcome was recovered on 03Jan2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Allergic reaction and Hives cannot be totally excluded.  The case will be reassessed if additional information becomes 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Retching
Clinical narrative: blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the 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 headache, chills, dry heaves and other reported events 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, 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the 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 headache, chills, dry heaves and other reported events 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, 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise
Clinical narrative: called in sick to work. not feeling well.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Pain in extremity, Rectal haemorrhage
Clinical narrative: Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ there are pieces of blood or something is different; This is a spontaneous report from a contactable other Health Professional (patient).  A 75-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization, also reported as for work. Medical history included ulcer (15 to 20 years before 06Jan2021). Concomitant medication included prasugrel from Apr2020 and ongoing as blood thinner, acetylsalicylic acid, ascorbic acid (ASPIRIN) from Apr2020 and ongoing as blood thinner. The patient went to the bathroom in the morning 06Jan2021, she had to poop. When she wiped, it was reddish looking. The patient stated her stool color was normal, but the tissue paper is red after wiping her anal area. At first she thought hm oh well. Then she had been to the bathroom a couple of times 06Jan2021, and that the same thing happened. She had never experienced that before. It seems to her that there were pieces of blood or something was different. She wasn't hurting or anything. She was not weak or anything at this time. Her arm was a little sore, but she expected that. She was concerned about the color. She worked in the mammography department. She didn't have a prescribing doctor. She got it at work. She had noticed a difference of color in her poop. It had been the same all day. The outcome of the reddish poop was not recovered, of sore arm was unknown. The patient asked would the vaccine cause rectal blood upon wiping after defecation?; Sender's Comments: Reported blood in stool is considered intercurrent and unrelated to BNT162B2. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen around injection site and now on 1-11-21 red ring around injection site.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait inability, Pain, X-ray
Clinical narrative: Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This is a spontaneous report from a contactable Other HCP. A 70-year-old female patient received BNT162B2(Lot Number: ET1685), via an unspecified route of administration at Deltoid Left on 23Dec2020 08:00 at the 70 years old at single dose for COVID-19 immunization.  The medical history included rheumatoid arthritis. The concomitant medications were none.  The patient received the shot on 23Dec2020 and experienced Joint pain afterward on 02Jan2021. The patient did have rheumatoid arthritis so there was that. The patient felt like it was worsening joint pain on 02Jan2021. She has had no fever, just severe pain to where she couldn't walk on 02Jan2021. The joint pain has gotten worse and it has gotten to where she is going to advise her not to take the second shot. The Reporter assessed the seriousness for the events was Disabling. The events did not require a visit to Emergency Room but required a Physician Office visit on 06Jan2021. The patient received a steroid injection on 06Jan2021. There was none History of all previous immunization with the Pfizer vaccine considered as suspect. There was none Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures, which included x-rays on 06Jan2021: unknown results (they were awaiting the X-rays). The outcome of the events was not recovered.  The information on the batch number has been requested.; Sender's Comments: Based on the available information the events worsening joint pain and walking difficulty are attributed to underlying Rheumatoid arthritis; however, based on a compatible temporal association, contributory role of BNT162B2 vaccine to events occurrence cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, malaise, sore muscles, nausea, vomiting
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 vaccine 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Vaccine recipient experienced shivering, fever, severe headache, nausea, and generalized ache 12 hours after receiving the vaccine. On a follow-up call on 1/8/2021, he reported that the symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeding disorder, Feeling abnormal, Feeling cold
Clinical narrative: her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown.  Information on lot number/batch number was requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Myalgia, Nausea, Nervousness
Clinical narrative: her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown.  Information on lot number/batch number was requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Phobia, Speech disorder
Clinical narrative: her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from contactable Other HCP. This Other HCP reported same events for 6 patients. This report is for 2nd of 6 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The other HCP was aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The event was reported as non-serious. The event outcome was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine 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.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other HCP. This Other HCP reported similar events for 6 patients. This report is for 3rd of 6 patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine 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.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Vesicular single dermatome rash consistent with shingles. Previous case of varicella as child with documented titer markers.   No eye, face, ear involvement. Rash is located around the T6 distribution on the left.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is Spontaneous report from a contactable Other HCP. This Other HCP reported similar events for 6 patients. This is 4th of six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's Palsy and BNT162B2 vaccine 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.,Linked Report(s) : US-PFIZER INC-2021007605 same reporter, same drug, same event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable other health professional (HCP). This other HCP reported similar events for 6 patients. This is the 5th of 6 patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), 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 reporter reported since the use of modified RNA in covid vaccines, he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.,Linked Report(s) : US-PFIZER INC-2021007605 Different patient, same drug/event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 01-08-21 - headache; injection site sore 01-09-21 - headache; injection site sore 01-10-21 - headache; injection site sore 01-11-21 - headache; injection site sore, injection site redness; injection site warm to touch
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 6 days post injection, arm became red, warm, hard