chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Product administered at inappropriate site
Clinical narrative: the injection went too low on his deltoid; got a bruise, a fairly good size of bruise; A spontaneous report was received from a healthcare professional concerning a 65-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fairly good size of bruise.  The medical history was not provided. Concomitant product use was not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the injection went too low on his deltoid, and he suspected that it did not hit the deltoid muscle but the muscle below that, and that was why he got a bruise. He got a fairly good size of bruise. He also stated that he didn't have a lot of muscle mass.  On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection and he had no issue.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event vaccine administered at inappropriate site was considered resolved on 07 Jan 2021. The outcome of the event fairly good size of bruise was unknown.; Reporter's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknown) with reported non-serious unlisted event of contusion. Based on the current available information and temporal association between the use of the product and the start date of the event of contusion, a causal relationship cannot be excluded
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Hallucination, Sleep disorder
Clinical narrative: Hallucinating, seeing things; Was in overdrive; Couldn't sleep, she was awake for 24 hours; A spontaneous report was received from a consumer calling in regards to her 90 year old mother who "started hallucinating, seeing things, she was talking to people who weren't there". "She was awake for 24 hours", "she was in overdrive".  The patient's medical history included, Dementia, High blood pressure and Low blood pressure.  On 05-Feb-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 vaccine, Lot # 038K20A,  intramuscularly into her left upper arm for prophylaxis of Covid-19 infection.  On the night of 06-Feb-2021, the patient started hallucinating, "She was seeing things", "she was talking to people who weren't there".  She "couldn't sleep, she was awake for 24 hours. "She was in overdrive". She was reaching for things that weren't there,"hearing babies crying", "people knocking at the door", " stay couldn't stay still, she was arranging things". "Things that didn't bother her before were now a big problem". She was , "out of her mind".   The reporter further stated, she was stronger, "didn't need her walker anymore". Finally yesterday (07-Feb-2021) she slept for 24 hours straight. She stated her mother is now back to her "dementia" self.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events, Hallucinating, seeing things,talking to people who weren't there, Couldn't sleep,  Awake for 24 hours, in overdrive,  reaching for things that weren't there,  hearing babies crying, people knocking at the door,  couldn't stay still,  arranging things. Things that didn't bother her before were now a big problem, out of her mind. stronger, didn't need her walker anymore", were considered recovered/resolved.  Company comment:   the reported events Hallucinations, Abnormal Behavior, and Sleep disorder" were considered possibly related to mRNA-1273.; Reporter's Comments: This report concerns a 90--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 038K2A  and started hallucinating, seeing things, she was talking to people who weren't there". "She was awake for 24 hours", "she was in overdrive". Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Pain
Clinical narrative: Cellulitis infection; Right ankle pain; Body pain; Joint pain; A spontaneous report  was received from healthcare professional concerning a 59-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis infection, joint pain and right ankle pain, and body pain.  The patient's medical history included hypertension, cirrhosis of the liver, splenomegaly, sarcoidosis of the lung, diabetes, and having varicose veins in the stomach.   No relevant concomitant medications were reported.  On 22 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the right upper arm.   On 19-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left upper arm for prophylaxis of Covid-19 infection.   On 22 Jan 2021, the patient experienced a joint pain and body pain. On 25 Jan 2021, the patient experienced right ankle pain.   On 28 Jan 2021, the patient experienced a severe cellulitis infection in his arm and was hospitalized from 28 Jan 2021. The patient was discharged from hospital on 08 Jan 2021.  Treatment for the events included Cetaphil (reported as IV) and cephalexin (antibiotic).  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events joint pain and body pain were resolved on 25 Jan 2021. The outcome of the event right ankle pain was resolved on 28 Jan 2021. The outcome for the event of cellulitis infection was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; Seizure; A spontaneous report was received from a physician assistant  concerning a patient of unknown age who experienced seizures.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.       On 11JAN2021, approximately 16 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 26JAN2021 and 29JAN2021, the patient experienced seizures. The patient does not have history of seizures. The patient was transported to the ER for treatment and they had a consult with a neurologist on 08FEB2021. The neurologist advised the patient that it would be ok to get the second dose of the vaccine.  The events seizures, was considered resolved on 26 Jan 2021 and 29 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of seizure (twice) after receiving first dose of mRNA-1273 (Lot# unknown).  Very limited information has been provided at this time. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram head, Diarrhoea, Diplopia, Headache
Clinical narrative: Passed out/ Status post syncopal episode; Double vision; Diagnosis of static vision; Hypothyroid; Diarrhea; Injection site pain; Headache; A spontaneous report was received from a healthcare professional concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothyroidism, passed out/status post syncopal episode, diarrhea, injection site pain, headache, static vision/double vision.  The patient's medical history was not provided.  Concomitant medication history was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: unknown) on 24 DEC 2020.  On 21 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (batch number:  028L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient developed injection site pain and diarrhea after the second dose. She continued to have the headache from the first dose that was administered. On 03 FEB 2021, the patient experienced double vision and dizziness while driving to work. The patient passed out at work and was admitted to the hospital. A CT of the brain showed no acute findings and her CT angiography was normal. The patient was discharged in less than 24 hours with the diagnosis of static vision, hypothyroid and status post syncopal episode.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event passed out/status post syncopal episode and static vision/double vision were resolved. The outcome of the events hypothyroidism, diarrhea, injection site pain, and headache were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD21-024368:Crosslinked: Same reporter MOD21-024340:Crosslinked: Same reporter MOD21-024343:Crosslinked: Same reporter MOD210-24360:Crosslinked: Same reporter MOD21-024387:Crosslinked: Same reporter MOD21-024396:Crosslinked: Same reporter MOD21-024411:Crosslinked: Same reporter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism, Injection site pain, Loss of consciousness, Visual snow syndrome
Clinical narrative: Passed out/ Status post syncopal episode; Double vision; Diagnosis of static vision; Hypothyroid; Diarrhea; Injection site pain; Headache; A spontaneous report was received from a healthcare professional concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothyroidism, passed out/status post syncopal episode, diarrhea, injection site pain, headache, static vision/double vision.  The patient's medical history was not provided.  Concomitant medication history was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: unknown) on 24 DEC 2020.  On 21 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (batch number:  028L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient developed injection site pain and diarrhea after the second dose. She continued to have the headache from the first dose that was administered. On 03 FEB 2021, the patient experienced double vision and dizziness while driving to work. The patient passed out at work and was admitted to the hospital. A CT of the brain showed no acute findings and her CT angiography was normal. The patient was discharged in less than 24 hours with the diagnosis of static vision, hypothyroid and status post syncopal episode.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event passed out/status post syncopal episode and static vision/double vision were resolved. The outcome of the events hypothyroidism, diarrhea, injection site pain, and headache were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD21-024368:Crosslinked: Same reporter MOD21-024340:Crosslinked: Same reporter MOD21-024343:Crosslinked: Same reporter MOD210-24360:Crosslinked: Same reporter MOD21-024387:Crosslinked: Same reporter MOD21-024396:Crosslinked: Same reporter MOD21-024411:Crosslinked: Same reporter
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Oxygen level was down; Tested positive for COVID; 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 who experienced oxygen level was down and tested positive for COVID-19.   The patient's medical history included heart disease and atrial fibrillation. The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 18 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 012120A] intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced low oxygen levels.  On 08 Feb 2021, the patient tested positive for COVID-19. Treatment for the event included hospitalization.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events oxygen level was down and tested positive for COVID were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Was like hallucinating; A spontaneous report was received from a consumer, a 90 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced was like hallucinating/hallucination.   The patient's medical history was not provided.  Concomitant product use was not provided.   On 09 Feb 2021, the same day of the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  After getting the vaccine, the patient had lunch and went home.  The patient arrived home two hours after receiving the vaccine and fell asleep.  When the patient opened her eyes after the nap, she saw her phone in front of her and reported the letters were moving as if she was writing; however, the patient reported that she was not even holding the phone and that the phone was still plugged in.  The patient stated, "I was like hallucinating".  Treatment for the event included was not reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event 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. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain, Trigeminal nerve disorder
Clinical narrative: Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered.  Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal Neuralgia; Nausea; Chills; Body aches; Lightheadedness; Trigeminal nerve disorder; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot: EL1284/expiration date not provided) via intramuscular route of administration, in left arm, on 19Jan2021 (at the age of 63 years old) as a single dose for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included losartan, amlodipine, metoprolol, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date not provided) on 29Dec2020 (at the age of 63 years old) as a single dose in the left arm for COVID-19 immunization. On 20Jan2021, the patient experienced nausea, chills, body aches, lightheadedness, trigeminal nerve disorder. On 22Jan2021, the patient was diagnosed with trigeminal neuralgia. The events resulted in a physician office visit and Emergency Room visit. The seriousness criteria was disabling/incapacitating. The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been not been tested for COVID-19. Treatment received for the events included steroids, anti-convulsant and pain relievers. The outcome of the events was not recovered.  Follow-up (08Feb2021): New information from a contactable nurse (patient) includes: new event (trigeminal neuralgia), event details, seriousness criteria, treatment received and events outcome.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, nausea, chills, body aches, lightheadedness, trigeminal nerve disorder, Trigeminal Neuralgia and the administration of the COVID-19 vaccine, BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acarodermatitis, Blister, Pruritus, Rash, Scar
Clinical narrative: Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Scarring; This is a spontaneous report from a contactable nurse (patient herself). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK4176), via an unspecified route of administration in the left arm on 19Jan2021 at 10:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any other vaccine in four weeks, did not have other medications in two weeks, did not have COVID prior to vaccination, has no known allergies, and was not pregnant. There were no concomitant medications. On 24Jan2021 at 08:00, the patient experienced pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on the vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm erupted after 4 more days. Scarring and itching up for two weeks. The patient was not tested for COVID after vaccination. As treatment, Permethrin cream was used to see if it was scabies to "no eff". The adverse events resulted in a doctor or other healthcare professional office/clinic visit and disability or permanent damage. Outcome of the events was recovering.; Sender's Comments: Based on temporal association  and/or known drug profile 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Epistaxis, Fall, Loss of consciousness
Clinical narrative: passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm  she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to  vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report.   Information about lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Dry mouth, Loss of consciousness
Clinical narrative: I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thought maybe I may have been dehydrated; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at Left arm on 06Feb2021 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included High blood pressure. Concomitant medications included losartan, atorvastatin calcium (LIPITOR) and vitamins. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up 1:30 am 07Feb2021very dry mouth, used restroom, felt very lightheaded, went back to room, next thing she heard was glass breaking. She had passed out hitting a table bumped head and back. Her boyfriend was with she helped she up. Said her legs went out from under her. Thought maybe she may have been dehydrated though she had drunk water throughout the day and before bedtime. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Chronic myeloid leukaemia recurrent, Inappropriate schedule of product administration, Off label use, Oxygen saturation
Clinical narrative: he has chronic myeloid leukemia - white blood cell count is higher; His oxygen is low; Blood clot in his legs; first dose on 19Jan2021 and second dose on 02Feb2021; first dose on 19Jan2021 and second dose on 02Feb2021; This is a spontaneous report from a contactable nurse reported for her father that an 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included chronic myeloid leukemia (CML). Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 19Jan2021 at single dose for covid-19 immunisation. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 19Jan2021 and second dose on 02Feb2021. Two days after second dose (04Feb2021) he had to go to the hospital - he had chronic myeloid leukemia - white blood cell count was higher (Feb2021), he had been in the hospital for the last 3 days as of 08Feb2021, his oxygen was low, had a blood clot in his legs, had a bone marrow biopsy, all on an unspecified date in Feb2021. The nurse is taking its related to this vaccine and assessed this case as not serious.  Outcome of the events was unknown.   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.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Thrombosis, White blood cell count
Clinical narrative: he has chronic myeloid leukemia - white blood cell count is higher; His oxygen is low; Blood clot in his legs; first dose on 19Jan2021 and second dose on 02Feb2021; first dose on 19Jan2021 and second dose on 02Feb2021; This is a spontaneous report from a contactable nurse reported for her father that an 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included chronic myeloid leukemia (CML). Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 19Jan2021 at single dose for covid-19 immunisation. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 19Jan2021 and second dose on 02Feb2021. Two days after second dose (04Feb2021) he had to go to the hospital - he had chronic myeloid leukemia - white blood cell count was higher (Feb2021), he had been in the hospital for the last 3 days as of 08Feb2021, his oxygen was low, had a blood clot in his legs, had a bone marrow biopsy, all on an unspecified date in Feb2021. The nurse is taking its related to this vaccine and assessed this case as not serious.  Outcome of the events was unknown.   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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lip pruritus, Lip swelling, Menstruation delayed, Swollen tongue
Clinical narrative: numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor.  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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Electrocardiogram, Heart rate, Loss of consciousness
Clinical narrative: passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Renal atrophy, Renal function test, Renal haemorrhage, Renal impairment
Clinical narrative: Bleeding from right kidney; Bleeding from right kidney; Left kidney is shrunken and function at about 10%; Left kidney is shrunken and function at about 10%; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982), via an unspecified route of administration on an unspecified date in Feb2021 (19:00) at single dose (at the age of 89-year-old on Left arm) for COVID-19 immunization. Medical history included arthritic knees and shoulder, prostate cancer, macro degeneration, hearing loss, congestive heart failure, Last right kidney bleed one a year ago (2020 to 2020). The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies to medications, food, or other products. Patient had Bleeding from right kidney into nephoscimy bag. No noticeable bold from bladder. Left kidney is shrunken and function at about 10%. All events from 06Feb2021 04:00. No treatment was received in response to the events. The outcome of the events was recovering.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Headache
Clinical narrative: lightheaded; experience funny feeling in face; HA; Vaccine Related Anxiety; This is spontaneous report from a Non-contactable Other Health Professional. An 87-year-old female patient received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot# EM9809), intramuscularly in right arm on 04Feb2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  During her 15 minutes waiting period after the injection, the patient experienced funny feeling in face, lightheaded and HA (headache) on an unspecified date with outcome of unknown. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine Related Anxiety (include misc mental health). Patient left at 15:40pm accompanied by husband. Follow up with PMP regarding blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: Cellulitis, Lymphadenopathy, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Site is painful to touch; looks like cellulitis/possible cellulitis; body aches; swollen at injection site; red at injection site; warm at injection site; armpit lymph node still swollen; This is a spontaneous report from a contactable nurse (patient).  A female patient not pregnant of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in right arm on 05Feb2021 18:00 at single dose for COVID-19 immunization. Medical history included Allergies: sulfa. Other medical history: none. Concomitant medication in two weeks included trazodone, omeprazole and BCP.  The patient previously took oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced Allergies, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular 18Jan2021 12:00 PM in right arm for COVID-19 immunization.  Facility type vaccine: Workplace clinic. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. After second injection, right arm became red, warm and swollen at injection site 6 hrs later. After 12 hours, increased redness, warmth, swelling and total body aches. After 24 hours, same as above. After 42 hours, injection site right arm very red, swollen. looks like cellulitis. 72 hours later saw PCp for possible cellulitis vs site reaction. Site is painful to touch, very red, hot, swollen. armpit lymph node still swollen but only pink in color. Script for Keflex sent to pharmacy. Event treatment: cefalexin (KEFLEX) Po. All the events were not recovered. AE resulted in Doctor or other healthcare professional office/clinic visit.; Sender's Comments: The reported event of suspected cellulitis with injection site reactions was possibly related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Site is painful to touch; looks like cellulitis/possible cellulitis; body aches; swollen at injection site; red at injection site; warm at injection site; armpit lymph node still swollen; This is a spontaneous report from a contactable nurse (patient).  A female patient not pregnant of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in right arm on 05Feb2021 18:00 at single dose for COVID-19 immunization. Medical history included Allergies: sulfa. Other medical history: none. Concomitant medication in two weeks included trazodone, omeprazole and BCP.  The patient previously took oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced Allergies, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular 18Jan2021 12:00 PM in right arm for COVID-19 immunization.  Facility type vaccine: Workplace clinic. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. After second injection, right arm became red, warm and swollen at injection site 6 hrs later. After 12 hours, increased redness, warmth, swelling and total body aches. After 24 hours, same as above. After 42 hours, injection site right arm very red, swollen. looks like cellulitis. 72 hours later saw PCp for possible cellulitis vs site reaction. Site is painful to touch, very red, hot, swollen. armpit lymph node still swollen but only pink in color. Script for Keflex sent to pharmacy. Event treatment: cefalexin (KEFLEX) Po. All the events were not recovered. AE resulted in Doctor or other healthcare professional office/clinic visit.; Sender's Comments: The reported event of suspected cellulitis with injection site reactions was possibly related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Cerebrovascular accident, Deafness
Clinical narrative: Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure.  Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events.  It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eyelid ptosis, SARS-CoV-2 test
Clinical narrative: Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure.  Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events.  It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Diet refusal
Clinical narrative: Stopped eating and drinking and died