chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Loss of consciousness
Clinical narrative: passed out/stared to black out; got really hot; had trouble breathing; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 30 years). Medical history included anxiety, depression. Concomitant medications included trazodone; phentermine (ADIPEX [PHENTERMINE]); omeprazole; citalopram; alprazolam (XANAX). The patient previously took Imitrex and experienced allergies. On 08Apr2020 (13:00), the patient stated that she felt fine and was texting. Then all of a sudden she got really hot, had trouble breathing, and stared to black out. She was blacking out. She could hear someone asking if she was okay and if she needed help. She dropped all her things and passed out. The patient was not pregnant. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Limb mass, Ultrasound testes, Urticaria
Clinical narrative: lump on wrist; extreme fatigue; hives; flushing of face from neck up from Pfizer COVID vaccine; This is a spontaneous report received from a contactable consumer. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 14:15 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included ongoing psoriasis, diagnosed 5 or more years ago, patient stated she has never been checked for psoriatic arthritis, but she has joint pain, ongoing gastrooesophageal reflux disease, ongoing epstein barr virus positive mucocutaneous ulcer, Severe allergies, atrial fibrillation, cerebrovascular accident. Concomitant medications included apremilast (OTEZLA) taken for psoriasis, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported.  The patient previously took flu vaccine VII, got really sick, never took it again got all the flu symptoms. Caller reports she had flushing and then hives that night and then extreme fatigue. Caller reports noticing a lump on left wrist on 25Mar2021. Lump was red and purplish, caller reports rubbing the lump and the lump ended up moving. Caller reports it was painful. Caller went to the doctor 07Apr2021 and diagnosed with thrombosis of left ulnar artery. Caller states that she knows there not a lot of data out of there. Caller mentioned she has psoriasis and takes Otezla. Therefore, she is autoimmune compromised. Caller went today 08Apr2021 for follow up appointment and the doctor said to report her symptoms to Pfizer because she is immunocompromised and immunocompromised people were not part of the original clinical trials. The extreme fatigue reminded her of Epstein- Barr. Otezla-stopped the day of the first shot. She started it back up a week and half later. Flushing started 4 or 5 hours after dose around 6:15 or 7:15 PM on the top of face from neck up. Caller reports that she had the same thing from a cortisone shot. Hives started 8 hours after first shot around 10:15 PM hives developed on the bottom of both arms from the elbow down on both arms. Caller states that it was very strange.  Caller states that she woke up in the night with the itching. Caller states that the hives were gone in the morning. Caller states that extreme fatigue occurred 23Mar2021 and it was hard to even open her eyes. Patient went to emergency room for ultrasound only. Patient visited physician office for event lump wrist. Outcome of event lump on wrist was not recovered, of others was unknown.   No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: just a little soreness; This is a spontaneous report from a contactable consumer (patient's wife). A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9266) as single dose for covid-19 immunization. The patient's medical history was reported as none. The was no concomitant medication. With his first shot he had nothing, just a little soreness. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Blood culture, Chest X-ray normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg.  CBC and CMP clinically unremarkable with no elevation of white blood cell count.  HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108.  No acute ST or T abnormalities.  No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative.  ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given.  A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise  MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine,  but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both...  Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Metabolic function test normal, Nephrolithiasis, Nitrite urine present, Pain
Clinical narrative: Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg.  CBC and CMP clinically unremarkable with no elevation of white blood cell count.  HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108.  No acute ST or T abnormalities.  No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative.  ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given.  A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise  MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine,  but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both...  Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyelonephritis, Pyrexia, Respiratory rate, SARS-CoV-2 test negative
Clinical narrative: Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg.  CBC and CMP clinically unremarkable with no elevation of white blood cell count.  HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108.  No acute ST or T abnormalities.  No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative.  ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given.  A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise  MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine,  but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both...  Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Ultrasound kidney abnormal, Urinary tract infection, Urine analysis abnormal, White blood cell count increased
Clinical narrative: Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg.  CBC and CMP clinically unremarkable with no elevation of white blood cell count.  HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108.  No acute ST or T abnormalities.  No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative.  ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given.  A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise  MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine,  but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both...  Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Sepsis
Clinical narrative: Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg.  CBC and CMP clinically unremarkable with no elevation of white blood cell count.  HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108.  No acute ST or T abnormalities.  No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative.  ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given.  A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise  MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine,  but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both...  Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Arm soreness, fatigue and weaknesses - symptoms next morning and lasted 48 hours
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Symptoms: one day after- slight pain at injection location, some body ache. Two days after: swollen lymph node, left underarm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling jittery
Clinical narrative: Worsened shortness of breath, feeling jittery like I had a large dose of steroids, fatigue and weakness.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Illness, Inappropriate schedule of product administration
Clinical narrative: while I was driving I blacked out and was in a accident in my car; while I was driving I blacked out and was in a accident in my car; dizzy; very sick; soreness in my joints; headache; bodyaches; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; This is a spontaneous report from a contactable other health professional (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 31Mar2021 13:00  (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 16Feb2021 12:00 PM  (at the age of 62-years-old) for COVID-19 immunization. It was reported that the first dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00. On 01Apr2021, patient experienced soreness in his joints, headache and body aches. On 06Apr2021 07:00, while driving patient blacked out and was in an accident in his car, he was also dizzy and very sick. The patient received treatment for the events "while i was driving i blacked out and was in a accident in my car" and did not receive treatment for all other events reported. Outcome of events recovered on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Off label use, Pain, Road traffic accident
Clinical narrative: while I was driving I blacked out and was in a accident in my car; while I was driving I blacked out and was in a accident in my car; dizzy; very sick; soreness in my joints; headache; bodyaches; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; This is a spontaneous report from a contactable other health professional (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 31Mar2021 13:00  (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 16Feb2021 12:00 PM  (at the age of 62-years-old) for COVID-19 immunization. It was reported that the first dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00. On 01Apr2021, patient experienced soreness in his joints, headache and body aches. On 06Apr2021 07:00, while driving patient blacked out and was in an accident in his car, he was also dizzy and very sick. The patient received treatment for the events "while i was driving i blacked out and was in a accident in my car" and did not receive treatment for all other events reported. Outcome of events recovered on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lymphadenopathy, Pain
Clinical narrative: Extremely swollen lymph node on collar bone.  Tender and fire with movement.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Rash
Clinical narrative: Moderna COVID-19 Vaccine EUA About a week after receiving the shot the site became red and painful. The pain subsided after two days but the redness grew into a rash that is, at current, expanding.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Abdominal rash, right side of body and starting to develop on the left side.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Chest discomfort, Chills, Hallucination, auditory
Clinical narrative: about 30 minutes after taking I felt some numbness in left side of face, but went away. Went home and felt fine until about 8pm when I could feel a slight headache coming on and I heard something that wasn't there. I went to sleep and had very bad headache and heard someone say my name which I knew all of this was because of the vaccine. The next day I had chills, lethargy, and bad headache and stayed in bed most of they day. That night still headache and bad, vivid dreams. Today, some ringing in the ear, headache not as bad, more energy, some tightness in the chest, flash of light.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lethargy, Photopsia, Tinnitus
Clinical narrative: about 30 minutes after taking I felt some numbness in left side of face, but went away. Went home and felt fine until about 8pm when I could feel a slight headache coming on and I heard something that wasn't there. I went to sleep and had very bad headache and heard someone say my name which I knew all of this was because of the vaccine. The next day I had chills, lethargy, and bad headache and stayed in bed most of they day. That night still headache and bad, vivid dreams. Today, some ringing in the ear, headache not as bad, more energy, some tightness in the chest, flash of light.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Haemoptysis
Clinical narrative: Blood in nostrils, coughing up blood.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Induration, Injection site bruising
Clinical narrative: Large bruise at injection site that formed a 3 inch by 3 inch red, hardened, raised welt just below it.  The welt appeared about a week and a half after the bruise. The day the welt appeared, fever, chills, and fatigue also presented. The welt is getting larger each day, and is more pronounced after showering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Large bruise at injection site that formed a 3 inch by 3 inch red, hardened, raised welt just below it.  The welt appeared about a week and a half after the bruise. The day the welt appeared, fever, chills, and fatigue also presented. The welt is getting larger each day, and is more pronounced after showering.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Hemiparesis, Musculoskeletal pain, Pain in extremity
Clinical narrative: Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; This is a spontaneous report from a contactable consumer via COVID-19 .  A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 (at the age of 22 years old) via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included shrimp allergy from an unknown date and unknown if ongoing. The patient did not have any vaccine in four weeks.  Other medications in two weeks: ADHD medication and birth control. The patient experienced "left arm, breast, butt cheek, and thigh feel sore/weak - left side only" (as reported) on 10Apr2021 15:00 with outcome of not recovered . No treatment was received. The patient did not have covid prior to vaccination, was not tested post vaccination  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Gastric disorder, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; I am sick in my stomach; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 05Apr2021, 9 o'clock (reported as today). Medical history and concomitant medication were not reported. The patient was sick in stomach, vomiting. The patient had nausea and vomiting. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Eye disorder, Feeling abnormal, Feeling hot
Clinical narrative: Not feeling good; Arm starts swollen, red, very red and hot; Arm starts swollen, red, very red/ cheek got red; Arm starts hot and it also affected the left side of patient face; cheeks like burning up; the cheek get flushed red and numb; the cheek get flushed red and numb; Eye feels like it does not want to stay open; It opens but it feel like it wants to close; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) single dose for COVID-19 immunization on 27Mar2021. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date. The patient first shot was okay and second shot was on 27Mar2021 and now had these symptoms just today after shot which was on the Sunday (28Mar2021). The patient had some unpleasant reactions about a week. The patient arm started swollen, red, very red and hot and it also affected the left side of patient face. The patient cheek got red, and cheeks like burning up. The left side of patient face, the cheek got flushed red and numb. The eyes felt like it did not want to stay open and patient couldn't keep it open. It opened but it felt like it wanted to close. Right now, patient was not feeling good. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Peripheral swelling
Clinical narrative: Not feeling good; Arm starts swollen, red, very red and hot; Arm starts swollen, red, very red/ cheek got red; Arm starts hot and it also affected the left side of patient face; cheeks like burning up; the cheek get flushed red and numb; the cheek get flushed red and numb; Eye feels like it does not want to stay open; It opens but it feel like it wants to close; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) single dose for COVID-19 immunization on 27Mar2021. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date. The patient first shot was okay and second shot was on 27Mar2021 and now had these symptoms just today after shot which was on the Sunday (28Mar2021). The patient had some unpleasant reactions about a week. The patient arm started swollen, red, very red and hot and it also affected the left side of patient face. The patient cheek got red, and cheeks like burning up. The left side of patient face, the cheek got flushed red and numb. The eyes felt like it did not want to stay open and patient couldn't keep it open. It opened but it felt like it wanted to close. Right now, patient was not feeling good. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable consumer.  A 72-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 04Feb2021 (Batch/Lot Number: EL9265) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient tested positive (vaccination failure) on 01Apr2021 with outcome of unknown. The action taken in response to the event(s) for bnt162b2 was not applicable.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable consumer (patient) reported for herself that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8729) via an unspecified route of administration, administered in upper left arm on 03Apr2021 as single dose for covid-19 immunisation. Medical history included blood pressure (disorder). Concomitant medications included couple of unspecified medications. Patient previously received first dose of BNT162B2 (lot number looked like 6205 as reported) on 13Mar2021 at the age of 72 years for covid-19 immunisation. The patient had the Covid second dose on Saturday and last night (04Mar2021) she had a reaction. She had diarrhea for all night long. Patient wondered if it's not one of the listed side effects as well as how she should handle this, if she should be taking something for it or she should see her doctor. She confirmed no treatment was taken for the side effects. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Progressive weakness legs and arms; numbness and tingling of fingers and toes; numbness and tingling of fingers and toes; This is a spontaneous report from a contactable Nurse (reported for herself).  A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing.  The patient was not pregnant. There were no concomitant medications.  The patient previously took codeine and experienced drug hypersensitivity. The patient experienced progressive weakness legs and arms, numbness and tingling of fingers and toes on an unspecified date. The patient was hospitalized 1 day as consequence of the events and no treatment was given. No other vaccine given in in four weeks and no other medications given in two weeks. The patient was not tested for covid prior vaccination. The patient was tested for covid on an unspecified date post vaccination, results unknown. The patient had not recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: Causality cannot be excluded for the reported events and the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Endoscopy, Gastric dilatation, Impaired gastric emptying
Clinical narrative: post-viral gastroparesis; nausea; stomach swelled; projectile vomiting; diarrhea; stomach pain; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female (not pregnant) patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL3248 ), via an unspecified route of administration, administered in Arm Left on 24Jan2021 10:00 (at the age of 39-years-old) as SINGLE DOSE for covid-19 immunisation.   The patient medical history was not reported. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.   The patient experienced post-viral gastroparesis on 02Feb2021 18:00 and required hospitalization, nausea on 02Feb2021 18:00, stomach swelled on 02Feb2021 18:00, projectile vomiting on 02Feb2021 18:00, diarrhea on 02Feb2021 18:00, stomach pain on 02Feb2021 18:00. Clinical outcome of the events was recovered with sequelae.  The patient was hospitalized for post-viral gastroparesis (impaired gastric emptying) for 1 days.  The patient underwent lab tests and procedures which included endoscopy: post-viral gastroparesis on 02Feb2021, sars-cov-2 test: negative on 06Feb2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vomiting projectile
Clinical narrative: post-viral gastroparesis; nausea; stomach swelled; projectile vomiting; diarrhea; stomach pain; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female (not pregnant) patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL3248 ), via an unspecified route of administration, administered in Arm Left on 24Jan2021 10:00 (at the age of 39-years-old) as SINGLE DOSE for covid-19 immunisation.   The patient medical history was not reported. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported.   The patient experienced post-viral gastroparesis on 02Feb2021 18:00 and required hospitalization, nausea on 02Feb2021 18:00, stomach swelled on 02Feb2021 18:00, projectile vomiting on 02Feb2021 18:00, diarrhea on 02Feb2021 18:00, stomach pain on 02Feb2021 18:00. Clinical outcome of the events was recovered with sequelae.  The patient was hospitalized for post-viral gastroparesis (impaired gastric emptying) for 1 days.  The patient underwent lab tests and procedures which included endoscopy: post-viral gastroparesis on 02Feb2021, sars-cov-2 test: negative on 06Feb2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: fever (100 Fahrenheit); chills; sore arm; head ache; fatigue; Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 09Apr2021 03:45 (at the age of 53-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number ER2613) on 19Mar2021 at 05:45 PM, administered in left arm. Medical history included kidney stones, over weight, vaginal birth of three live children, tubal ligation, gestational diabetes and menopause. Patient had also allergy to cefzil. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient reported that she woke up at 08:00 on 10Apr2021 and at 08:30 she had sore arm, headache, fatigue, bleeding and chills recovered after rest. At 15:00 she had fever 100 Fahrenheit. Chills, fatigue and headache lasted until 20:00 dosed with acetaminophen and Ibuprofen. On 11Apr2021 at 08:00 bleeding continued. Patient stated that she has started menopause and she had only spotted during cycles, no significant bleeding in 6 months . This bleeding was significantly heavier. The events resulted in Doctor or other healthcare professional office/clinic visit. Vaginal bleeding was not resolved, the outcome of fever was unknown and the other events were resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaginal haemorrhage
Clinical narrative: fever (100 Fahrenheit); chills; sore arm; head ache; fatigue; Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 09Apr2021 03:45 (at the age of 53-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number ER2613) on 19Mar2021 at 05:45 PM, administered in left arm. Medical history included kidney stones, over weight, vaginal birth of three live children, tubal ligation, gestational diabetes and menopause. Patient had also allergy to cefzil. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient reported that she woke up at 08:00 on 10Apr2021 and at 08:30 she had sore arm, headache, fatigue, bleeding and chills recovered after rest. At 15:00 she had fever 100 Fahrenheit. Chills, fatigue and headache lasted until 20:00 dosed with acetaminophen and Ibuprofen. On 11Apr2021 at 08:00 bleeding continued. Patient stated that she has started menopause and she had only spotted during cycles, no significant bleeding in 6 months . This bleeding was significantly heavier. The events resulted in Doctor or other healthcare professional office/clinic visit. Vaginal bleeding was not resolved, the outcome of fever was unknown and the other events were resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Ear pain, Eye inflammation, Feeling abnormal, Sinus congestion
Clinical narrative: Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tinnitus, Vertigo
Clinical narrative: Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis
Clinical narrative: Hands are periodically turning blue; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient was not pregnant. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. It was reported that patient's hands were periodically turning blue on an unspecified date. They are normal temperature when this happens. The patient had seen her health care provider and could not find any cardiac or other issues that may contribute to this symptom. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID after receiving first dose of vaccine; diagnosed with COVID after receiving first dose of vaccine; This is a spontaneous report received from a contactable consumer. A 58 year-old male patient received first dose of BNT162B2 (COMIRNATY Vaccine , solution for injection, Lot No unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunization. Patient Medical history and concomitant medication were not reported. Patient was diagnosed with COVID-19 after receiving first dose of vaccine. he patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Apr2021. Outcome of event was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; some slight fatigue; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 09Feb2021 14:30 (Lot Number: EL5318) as single dose for COVID-19 immunisation. The patient medical history included diabetes, atrial fibrillation (AFIB) of heart, high blood cholesterol, high blood pressure. Concomitant medications included metformin taken for diabetes; apixaban (ELIQUIS) taken for atrial fibrillation (AFIB) of heart; pravastatin taken for high blood cholesterol; glucosamine sulfate (MONTRA), lisinopril taken for high blood pressure. He had no other shorts-other than injections in his left eye for macular degeneration once per month on 26Jan2021 15:30. The patient previously received first dose of BNT162B2 on 22Jan2021 19:30 (lot EL3248) for COVID-19 immunization. The patient experienced sore arm and some slight fatigue on an unspecified date. He was tested for Covid 19 on 19Feb2021 before starting radiation for skin cancer on 22Feb2021. Covid-19 Test was negative. The outcome of event was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Wheezing
Clinical narrative: anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EP7534) via an unspecified route of administration in right arm on 23Mar2021 01:30PM (at the age of 53-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure, seasonal asthma and allergies, depression, stomach ulcers and allergies to nuts and seafood. Concomitant medications included losartan, omeprazole (OMEPRAZOL), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VIT C), trazodone hydrochloride (TRAZODON) and cetirizine hydrochloride (ZYRTEC). On the evening of 23Mar2021 the patient had wheezing. On 24Mar2021 09:30AM she woke with rash on right side of face, followed by hives, then itchy head and neck, then in throat. When she got to rash stage, symptoms developed quickly, leading up to anaphylactic signs in throat. She called the doctor immediately (after taking Benadryl). The event resulted in doctor or other HCP office/clinic visit. Treatments included prednisone, Benadryl, famotidine, Zyrtec - 8 days. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia, Pruritus, Rash, Rash erythematous, Throat tightness
Clinical narrative: anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EP7534) via an unspecified route of administration in right arm on 23Mar2021 01:30PM (at the age of 53-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure, seasonal asthma and allergies, depression, stomach ulcers and allergies to nuts and seafood. Concomitant medications included losartan, omeprazole (OMEPRAZOL), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VIT C), trazodone hydrochloride (TRAZODON) and cetirizine hydrochloride (ZYRTEC). On the evening of 23Mar2021 the patient had wheezing. On 24Mar2021 09:30AM she woke with rash on right side of face, followed by hives, then itchy head and neck, then in throat. When she got to rash stage, symptoms developed quickly, leading up to anaphylactic signs in throat. She called the doctor immediately (after taking Benadryl). The event resulted in doctor or other HCP office/clinic visit. Treatments included prednisone, Benadryl, famotidine, Zyrtec - 8 days. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.  Information on the lot/batch number has been requested.