chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Lip swelling, Skin warm
Clinical narrative: Right after the vaccine I had major swelling in my face and lips and a burning sensation as well. I went back into the urgent care i had received the vaccine and they immediately took me to the ER. I was admitted and they gave me prednisone and benadryl and they gave me an epipen to take home. They sent me home and told me to use the epipen and call 911 if I couldn't breathe. My face was still swollen, red, and burning when I left the hospital. I still have the facial burning and swelling. I am putting cold compresses and taking benadryl. My neck and chest are also red and hot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Right after the vaccine I had major swelling in my face and lips and a burning sensation as well. I went back into the urgent care i had received the vaccine and they immediately took me to the ER. I was admitted and they gave me prednisone and benadryl and they gave me an epipen to take home. They sent me home and told me to use the epipen and call 911 if I couldn't breathe. My face was still swollen, red, and burning when I left the hospital. I still have the facial burning and swelling. I am putting cold compresses and taking benadryl. My neck and chest are also red and hot.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Computerised tomogram abdomen, Computerised tomogram thorax, Diarrhoea
Clinical narrative: I started having several symptoms of COVID-19.  I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping,  and slight headache for about 3 or 4 days.  Then, I was having sharp, severe shooting pains in my ring finger and elbow.  I talked to my primary care doctor's office 3 times.  I went to the emergency room on Thursday, March 18th.  The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc.  I also had a COVID-19 test on both March 18th and March 21st.  They were both negative.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Muscle spasms, Pain, Pyrexia
Clinical narrative: I started having several symptoms of COVID-19.  I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping,  and slight headache for about 3 or 4 days.  Then, I was having sharp, severe shooting pains in my ring finger and elbow.  I talked to my primary care doctor's office 3 times.  I went to the emergency room on Thursday, March 18th.  The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc.  I also had a COVID-19 test on both March 18th and March 21st.  They were both negative.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Urine analysis
Clinical narrative: I started having several symptoms of COVID-19.  I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping,  and slight headache for about 3 or 4 days.  Then, I was having sharp, severe shooting pains in my ring finger and elbow.  I talked to my primary care doctor's office 3 times.  I went to the emergency room on Thursday, March 18th.  The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc.  I also had a COVID-19 test on both March 18th and March 21st.  They were both negative.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Emotional distress, Throat tightness
Clinical narrative: Fifteen minutes after the shot I noticed that I couldn?t breathe. I had informed the staff of my allergies. My throat started to close and I couldn't  swallow. I tried to relax but I started to feel distressed. I was taken into the Emergency. I was given Benadryl Zofran and Hydrocortisone. I was prescribed Benadryl and an EpiPen and a Steroid in case it reoccurred. The medication seemed to work and I did not go into shock again. I have not had the second dose of the vaccine.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Cardiomegaly, Chest X-ray abnormal, Erythema, Flushing
Clinical narrative: Within 15-minutes of vaccination, the patient reported pruritic, erythematous hives on his face and chest. EMS evaluated the patient on-site. EMS administered 50mg IM Benadryl and placed patient on O2lpm via nasal cannula. Patient was hypertensive (161/84) with a FSBG of 134mg/dl. EMS transported the patient to Emergency Department for further evaluation. In the ED, the patient reported that after receiving the IV Benadryl, their facial flushing, redness, and hives have disappeared. The patient did continue to have some generalized itching. The patient remained hypertensive (163/83).  Physician administered 20mg IV Pepcid and 125mg IV SoluMedrol. Patient reported improvement and was discharged with a diagnosis of allergic reaction - improved. Physician prescribed Benadryl 25mg PO QID, Pepcid 20mg PO BID, and Prednisone 40mg PO QD for 4-days.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypertension, Pruritus, Urticaria
Clinical narrative: Within 15-minutes of vaccination, the patient reported pruritic, erythematous hives on his face and chest. EMS evaluated the patient on-site. EMS administered 50mg IM Benadryl and placed patient on O2lpm via nasal cannula. Patient was hypertensive (161/84) with a FSBG of 134mg/dl. EMS transported the patient to Emergency Department for further evaluation. In the ED, the patient reported that after receiving the IV Benadryl, their facial flushing, redness, and hives have disappeared. The patient did continue to have some generalized itching. The patient remained hypertensive (163/83).  Physician administered 20mg IV Pepcid and 125mg IV SoluMedrol. Patient reported improvement and was discharged with a diagnosis of allergic reaction - improved. Physician prescribed Benadryl 25mg PO QID, Pepcid 20mg PO BID, and Prednisone 40mg PO QD for 4-days.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Received vac. on 2/10/2021 and on 2/15/2021 had a stroke with no warning. Hospital and Rehab ever since.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Urticaria
Clinical narrative: 4 days post vaccination, recipient developed hives on entire body except head area that are painful and severely itchy. The rash lasts for 4 hours or so than subsides for a few hours only to re-surface again. No other symptoms reported. Recipient was seen in the ER, Dermatologist, ENT, and Allergist and put on a steroid tapering dose + antihistamines on 3/24.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Patient was administered improperly stored VARlVAX on 03/15/2021; This spontaneous report was received from a healthcare business professional referring to an 1 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.   On 15-MAR-2021, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not provided; lot number was T010315 and expiration date was 24-MAR-2022) for prophylaxis (product storage error). The healthcare business professional had limited information at call time. No additional adverse event was reported (no adverse event).  The administered dose of vaccine experienced -13 degree Celsius temperature excursion for 2 hours and 19 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger.    This is one of the two cases from the same reporter.; Sender's Comments:  US-009507513-2103USA004345:
Sex: U
Vaccine: VARZOS
Symptoms: Facial neuralgia, Herpes zoster, Post herpetic neuralgia, Trigeminal neuralgia
Clinical narrative: herpes zoster; post herpetic neuralgia; facial neuralgia; postherpetic trigeminal neuralgia; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 16-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On or about 12-FEB-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX), plaintiff suffered of herpes zoster, post herpetic neuralgia, facial neuralgia and postherpetic trigeminal neuralgia. As a result of this symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to vaccination. As a result, patient sustained severe, serious, progressive, permanent and incurable personal injuries. At the reporting time, the outcome of herpes zoster, post herpetic neuralgia, facial neuralgia and postherpetic trigeminal neuralgia was considered as not recovered. The reporters considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered all the events to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular
Clinical narrative: slight case of shingles; couple bumps; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles and papular rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the shingles and papular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced a very slight case of shingles. The patient stated It was just a couple bumps and he/she had shingles twice before so recognized it right away. The patient asked could he/she get his/her 2nd dose of Shingrix while he/she had this slight outbreak and what were the side effects if he/she get 2nd Shingrix shot. The patient stated he/she had read the side effects but could not find anything on if you get the shot while having an outbreak.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles never had them till I took the shots / Suspected vaccination failure; Got the shingles never had them till I took the shots; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The reporter mentioned that, when he/she got the shingles shot, he/she got the shingles never had them till he/she took the shots. This case was considered as suspected vaccination failure, as information about Shingles vaccine dose number, laboratory test confirmation for shingles infection and time to event onset was unknown. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Shot was very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as an adult as per vaccine indication.  The age at vaccination was not reported. The patient stated shingles shot was very painful. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hypoacusis, Loss of consciousness, Pyrexia, Speech disorder
Clinical narrative: passing out; almost like I was deaf for a second; couldn't talk; couldn't get off the couch; red spots over it; arm was swollen; low grade fever; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing decreased, speech impairment, NOS, loss of consciousness, gait inability, vaccination site erythema, vaccination site swelling and pyrexia.   The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On 09 Feb 2021, about 10 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 027L20A) through unknown route in the right arm for prophylaxis of COVID-19 infection. Nine days after the shot (18 Feb 2021) she had the following symptoms: arm was swollen, red spots over it, low grade fever, passing out, couldn't talk, couldn't get up off the couch and hearing decreased for a second. She had ibuprofen 2 tablets on 18 Feb 2021 and 19 Feb 2021.  Action taken with mRNA-1273 in response to the events was not applicable  The events, hearing decreased, speech impairment NOS, passing out, couldn't get off the couch, vaccination site erythema, vaccination site swelling, low grade fever,and were considered recovered on 19 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: passing out; almost like I was deaf for a second; couldn't talk; couldn't get off the couch; red spots over it; arm was swollen; low grade fever; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hearing decreased, speech impairment, NOS, loss of consciousness, gait inability, vaccination site erythema, vaccination site swelling and pyrexia.   The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On 09 Feb 2021, about 10 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 027L20A) through unknown route in the right arm for prophylaxis of COVID-19 infection. Nine days after the shot (18 Feb 2021) she had the following symptoms: arm was swollen, red spots over it, low grade fever, passing out, couldn't talk, couldn't get up off the couch and hearing decreased for a second. She had ibuprofen 2 tablets on 18 Feb 2021 and 19 Feb 2021.  Action taken with mRNA-1273 in response to the events was not applicable  The events, hearing decreased, speech impairment NOS, passing out, couldn't get off the couch, vaccination site erythema, vaccination site swelling, low grade fever,and were considered recovered on 19 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pelvic venous thrombosis, Pulmonary embolism
Clinical narrative: Blood clot in his left lung and right lung; Blood clots in his right groin; Terrible pain on the left side of his upper body,It hurts so much; A spontaneous report was received from a consumer concerning a 78 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible pain on the left side of his upper body, it hurt so much, blood clot in his left and right lung and blood clots in right groin.  The patient's medical history was reported by the reporter as high blood pressure, prediabetes and hepatitis C due to a bad blood transfusion (treated with Mavyret). Concomitant medication was not reported.  On 11 Feb 2021, three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route at left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, 3 days after vaccination, patient had a terrible pain on the left side of his upper body and was hospitalized, the tests revealed blood clot in his left and right lung as well as in right groin, which was treated by Eliquis. Patient was observed overnight and discharged with a follow up in 3-6 months.   Action taken with mRNA-1273 in response to the events was unknown.  The reporting physician assessed the events as not related to the product, but did not recommend second of vaccine.  The outcome of events was unknown.; Reporter's Comments: Based on reporter's causality and history of diabetes and Hepatitis C infection, the event is assessed as unlikely related to mRNA-1273.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Vomiting
Clinical narrative: vomiting; diarrhea; not his true self; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced vomiting, diarrhea, and not being his true self (feeling abnormal).   The patient's medical history was not provided.  No relevant concomitant medications were reported    On 01 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified date, the patient was hospitalized overnight due to vomiting and diarrhea. The reporter stated that the patient was not his true self. The patient missed his second dose appointment that was due on 01 Mar 2021.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was unknown.   The events of vomiting, diarrhea, and feeling abnormal  were considered resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: Emergency surgery of gallbladder two days after receiving the 1st dose of the vaccine; A spontaneous report was received from a consumer concerning herself, a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had emergency surgery of gallbladder two days after receiving the first dose of the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, two days after the vaccination, the patient had an emergency surgery of gallbladder and was hospitalized. Treatment for the event included surgery.  Action taken with mRNA-1273 in response to the event was not provided.    The outcome of the event, emergency surgery of gallbladder two days after receiving the first dose of the vaccine, was considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure measurement, Heart rate increased, Hypertension
Clinical narrative: blood pressure of 53/0 mm of Hg; Blood glucose was high; Her pulse was high; bowels had stopped; blood pressure was high; A spontaneous report  was received from a consumer, who is a female patient, of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and her bowels had stopped(intestinal obstruction), blood pressure was high (hypertension), blood pressure of 53/0mmHg and 43/31mmHg(hypotension), blood glucose high (blood glucose increased) and her pulse was high (Heart rate increased).  The patient's medication history was not reported. Concomitant medications included estrogens conjugated, thyroid, montelukast sodium, folic acid, dexlansoprazole, nadolol, diltiazem, atorvastatin, clozapine and mometasone furoate.  On 09 Feb 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Feb 2021, approximately 7 days after receiving vaccine, the patient was taken to the hospital because her bowels had stopped (medically significant). She was in the hospital for 23 hours where her blood pressure was high, blood glucose was high, and her pulse was high.   On 08 Mar 2021, she was found to have a blood pressure of 53/0mmHg, and after the paramedics arrived, it was found to be 43/31 mmHg.  On 10 Mar 2021, the patient received her second of the two planned vaccine doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events, her bowels had stopped, blood pressure was high and blood pressure of 53/0mmHg and 43/31mmHg, was not applicable as patient received both the doses.  The outcome of the events, her bowels had stopped, blood pressure was high, blood pressure of 53/0mmHg and 43/31mmHg(hypotension), blood glucose high and her pulse was high, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Hypertension, Hypotension, blood glucose increased and Heart rate increased, a causal relationship cannot be excluded.  The events of Intestinal obstruction in this subject was assessed as Unlikely Related, based on the limited information provided at this time and based on the biological plausibility.
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Intestinal obstruction, Pulse abnormal
Clinical narrative: blood pressure of 53/0 mm of Hg; Blood glucose was high; Her pulse was high; bowels had stopped; blood pressure was high; A spontaneous report  was received from a consumer, who is a female patient, of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and her bowels had stopped(intestinal obstruction), blood pressure was high (hypertension), blood pressure of 53/0mmHg and 43/31mmHg(hypotension), blood glucose high (blood glucose increased) and her pulse was high (Heart rate increased).  The patient's medication history was not reported. Concomitant medications included estrogens conjugated, thyroid, montelukast sodium, folic acid, dexlansoprazole, nadolol, diltiazem, atorvastatin, clozapine and mometasone furoate.  On 09 Feb 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Feb 2021, approximately 7 days after receiving vaccine, the patient was taken to the hospital because her bowels had stopped (medically significant). She was in the hospital for 23 hours where her blood pressure was high, blood glucose was high, and her pulse was high.   On 08 Mar 2021, she was found to have a blood pressure of 53/0mmHg, and after the paramedics arrived, it was found to be 43/31 mmHg.  On 10 Mar 2021, the patient received her second of the two planned vaccine doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events, her bowels had stopped, blood pressure was high and blood pressure of 53/0mmHg and 43/31mmHg, was not applicable as patient received both the doses.  The outcome of the events, her bowels had stopped, blood pressure was high, blood pressure of 53/0mmHg and 43/31mmHg(hypotension), blood glucose high and her pulse was high, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Hypertension, Hypotension, blood glucose increased and Heart rate increased, a causal relationship cannot be excluded.  The events of Intestinal obstruction in this subject was assessed as Unlikely Related, based on the limited information provided at this time and based on the biological plausibility.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Left hip and knee joint pain and swelling; A spontaneous report was received from a consumer concerning a 28-year-old  male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced psoriatic arthritis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, approximately 4-5 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On an unknown date, approximately 4-5 days after receiving the vaccine, the patient experienced the events of Hip joint pain, Left hip swelling, Knee joint pain, left knee swelling. The side effects lasted about 16 days. Patient went to his doctor and was diagnosed with psoriatic arthritis.The events were medically significant. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, psoriatic arthritis,was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Cholestasis
Clinical narrative: minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician.   A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol  (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI.  The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events  due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Echocardiogram, Fatigue, Hepatitis, Investigation
Clinical narrative: minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician.   A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol  (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI.  The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events  due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician.   A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol  (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI.  The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events  due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Fatigue, Laryngitis, Sinus disorder
Clinical narrative: Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip; minimal raspy voice/Mild hoarseness; This is a spontaneous report from a contactable Nurse reporting for herself.    A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 25Feb2021 13:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation  .  Medical history included diabetes mellitus from 2017 (Diabetes diagnosed 4 years ago) , obesity (Obesity has been 10 years or more) , hypersensitivity (Allergies for lifetime) , arthritis  (Arthritis diagnosed 20 some years ago) , hypertension from 2011 (High blood pressure diagnosed 10 years ago) , depression  (Depression diagnosed 30 years ago) , breast cancer female from 2019  , breast conserving surgery. Concomitant medication included anastrozole (ANASTROZOLE) taken for breast cancer.  The patient experienced terrible laryngitis on 28Feb2021 with outcome of not recovered , fatigue  on 01Mar2021 with outcome of recovering , sinus drainage with cough on 04Mar2021 09:00 with outcome of not recovered , post nasal drip  on 2021 with outcome of unknown , minimal raspy voice/mild hoarseness. All the reported events were considered Important Medical Events.  Course of the events: the patient received the vaccine on 25Feb2021, and 3-4 days after, she started getting terrible Laryngitis. It is a little better. She also was fatigued. She did not run a fever. She did develop a little sinus drainage and cough within the last 4 days. She can smell and taste. She called her doctor and he said it is a side effect or reaction to the COVID vaccine. She wanted to know if that was likely or if there had been reports of any others having this reaction. He told her not to get second vaccine. The patient  was difficult to understand due to minimal raspy voice.  Follow up information has been requested; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported  events cannot be totally excluded.  Case will be reassessed if additional information is  received.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Sinus drainage with cough; Sinus drainage with cough; fatigue; Terrible Laryngitis; post nasal drip; minimal raspy voice/Mild hoarseness; This is a spontaneous report from a contactable Nurse reporting for herself.    A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 25Feb2021 13:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation  .  Medical history included diabetes mellitus from 2017 (Diabetes diagnosed 4 years ago) , obesity (Obesity has been 10 years or more) , hypersensitivity (Allergies for lifetime) , arthritis  (Arthritis diagnosed 20 some years ago) , hypertension from 2011 (High blood pressure diagnosed 10 years ago) , depression  (Depression diagnosed 30 years ago) , breast cancer female from 2019  , breast conserving surgery. Concomitant medication included anastrozole (ANASTROZOLE) taken for breast cancer.  The patient experienced terrible laryngitis on 28Feb2021 with outcome of not recovered , fatigue  on 01Mar2021 with outcome of recovering , sinus drainage with cough on 04Mar2021 09:00 with outcome of not recovered , post nasal drip  on 2021 with outcome of unknown , minimal raspy voice/mild hoarseness. All the reported events were considered Important Medical Events.  Course of the events: the patient received the vaccine on 25Feb2021, and 3-4 days after, she started getting terrible Laryngitis. It is a little better. She also was fatigued. She did not run a fever. She did develop a little sinus drainage and cough within the last 4 days. She can smell and taste. She called her doctor and he said it is a side effect or reaction to the COVID vaccine. She wanted to know if that was likely or if there had been reports of any others having this reaction. He told her not to get second vaccine. The patient  was difficult to understand due to minimal raspy voice.  Follow up information has been requested; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported  events cannot be totally excluded.  Case will be reassessed if additional information is  received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pneumonia
Clinical narrative: pneumonia; a little painful in the chest; This is a spontaneous report from a contactable consumer (patient).  This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Feb2021 at a single dose for COVID-19 immunisation. The second shot was planned for 12Mar2021. Relevant medical history included coughing (she had been coughing prior to receiving the dose). No relevant concomitant medications were provided. On 23Feb2021, she went to visit the doctor after it got a little painful in the chest. It was diagnosed as pneumonia for which she was given levofloxacin for 12 days. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Loss of consciousness
Clinical narrative: Passed out; cardiac event; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program COVAX Support. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 05Feb2021 15:30 (Batch/Lot Number: EL9269) as a single dose for COVID-19 immunisation. Medical history included defibrillator insertion from 2014 to an unknown date (has never had it go off), blood pressure abnormal, heart disorder, blood cholesterol increased (Lipitor indication: to lower cholesterol), and eye disorder. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3246), on 15Jan2021, at 15:30 PM in the left arm, for COVID-19 immunization. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for heart from 2010 and ongoing; carvedilol taken for heart from 2014 and ongoing; ubidecarenone (CO Q 10) helps with the statin for his heart from 2014 and ongoing; atorvastatin (LIPITOR) taken to lower cholesterol from 2014 and ongoing; lisinopril taken for blood pressure from 2014 and ongoing; xantofyl (LUTEIN) taken for eye from an unspecified start date and ongoing; and warfarin taken as blood thinner from 2010 and ongoing. The patient reported that 2 hours and 15 minutes after the second dose on 05Feb2021, he passed out and his defibrillator kicked in and he had a cardiac event but was not sure what kind of cardiac event. He stated it was probably unrelated, but the doctor said to call Pfizer to notify. He said he has had the defibrillator since 2014 and has never had it go off. He is having a stress test to check it all out. He added he felt great by about two hours after the defibrillator kicked in and went golfing. The outcome of the events was recovered on 05Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Diarrhoea, Dizziness, Headache, Loss of consciousness
Clinical narrative: passed out; felt dizzy all day long; concussion in her head; felt very nauseous; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at single dose in Feb2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In  Feb2021, the patient experienced passed out (medically significant), felt dizzy all day long, concussion in her head, felt very nauseous, diarrhea, headache, all with outcome of unknown.  Clinical course was described as follows: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine approximately 3 weeks ago, she's scheduled for her second dose on Saturday. When she received the first dose of the vaccine she felt dizzy all day long and when she went to the bathroom she passed out and had a concussion in her head, she also felt very nauseous, had diarrhea and a headache. Her doctor told her that she passed out from the injection and then her headache was from the concussion, he recommended her that for her second dose there's someone with her because she lives alone. Patient would like to know if this dosage of the vaccine could have caused her the reaction.   Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: passed out; felt dizzy all day long; concussion in her head; felt very nauseous; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at single dose in Feb2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In  Feb2021, the patient experienced passed out (medically significant), felt dizzy all day long, concussion in her head, felt very nauseous, diarrhea, headache, all with outcome of unknown.  Clinical course was described as follows: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine approximately 3 weeks ago, she's scheduled for her second dose on Saturday. When she received the first dose of the vaccine she felt dizzy all day long and when she went to the bathroom she passed out and had a concussion in her head, she also felt very nauseous, had diarrhea and a headache. Her doctor told her that she passed out from the injection and then her headache was from the concussion, he recommended her that for her second dose there's someone with her because she lives alone. Patient would like to know if this dosage of the vaccine could have caused her the reaction.   Information on lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: hearing loss; This is a spontaneous report from a contactable Pharmacist.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced hearing loss on an unspecified date after the first dose in one of his ears. Outcome of the event was not recovered.    Information on lot number/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided.