chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Dry mouth, Dry throat, Dysarthria, Erythema
Clinical narrative: slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose; mouth was dry; nose was dry; dry throat; almost "drunk"; Only abnormal finding was BP 159/94; This is a spontaneous report from contactable pharmacist. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283 and Expiration Date unknown) via Intramuscular on 08Jan2021 11:25 at single dose for COVID-19 immunisation. The patient's medical history was reported toradol made him feel lightheaded and foggy (similar to his first Pfizer BioNTech covid vaccine), Attention deficit hyperactivity disorder (ADHD). History vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number =EK5730 and Expiration Date unknown) via Intramuscular on 18Dec2020 at single dose for COVID-19 immunisation. Patient did report that on first vaccine it made him feel a little sluggish, tired and foggy minded. The concomitant medications were reported as amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall XR) at 25mg twice a day (BID) and escitalopram oxalate (LEXAPRO) oral (PO) at 10mg every day. No other vaccine in four weeks. Patient was vaccinated at 11:25. Patient was observed for 30 minutes. Pharmacist checked on patient at 17 minutes after vaccination - he was fine able to communicate and showed no signs of distress. Pharmacist came back and checked on patient at 25 minutes after vaccination (11:50)  and patient was slurring speech, had developed rash around his neck and upper chest, his earlobes were bright red, as was his nose - mouth was dry, reported dry throat - no visible swelling of the lips or tongue. Patient was transported to ED (2 min) Home meds: Adderall XR 25mg BID [Twice a day], Lexapro 10mg Q [every]PM. Only abnormal finding was BP 159/94 - after initial workup patient was noted to be almost "drunk" as reported by Emergency Room (ER Doc). Patient was offered diphenhydramine declined several times but eventually agreed. Approx 30 min after diphenhydramine patient fully recovered and stated "I'm back". The second dose reaction was much more exaggerated and lasted much longer. No COVID prior vaccination and no COVID tested post vaccination. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered in Jan2021 after treatment was given.; Sender's Comments: Based on the time association, all events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling drunk, Rash
Clinical narrative: slurring speech; rash around his neck and upper chest; his earlobes were bright red, as was his nose; mouth was dry; nose was dry; dry throat; almost "drunk"; Only abnormal finding was BP 159/94; This is a spontaneous report from contactable pharmacist. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283 and Expiration Date unknown) via Intramuscular on 08Jan2021 11:25 at single dose for COVID-19 immunisation. The patient's medical history was reported toradol made him feel lightheaded and foggy (similar to his first Pfizer BioNTech covid vaccine), Attention deficit hyperactivity disorder (ADHD). History vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number =EK5730 and Expiration Date unknown) via Intramuscular on 18Dec2020 at single dose for COVID-19 immunisation. Patient did report that on first vaccine it made him feel a little sluggish, tired and foggy minded. The concomitant medications were reported as amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall XR) at 25mg twice a day (BID) and escitalopram oxalate (LEXAPRO) oral (PO) at 10mg every day. No other vaccine in four weeks. Patient was vaccinated at 11:25. Patient was observed for 30 minutes. Pharmacist checked on patient at 17 minutes after vaccination - he was fine able to communicate and showed no signs of distress. Pharmacist came back and checked on patient at 25 minutes after vaccination (11:50)  and patient was slurring speech, had developed rash around his neck and upper chest, his earlobes were bright red, as was his nose - mouth was dry, reported dry throat - no visible swelling of the lips or tongue. Patient was transported to ED (2 min) Home meds: Adderall XR 25mg BID [Twice a day], Lexapro 10mg Q [every]PM. Only abnormal finding was BP 159/94 - after initial workup patient was noted to be almost "drunk" as reported by Emergency Room (ER Doc). Patient was offered diphenhydramine declined several times but eventually agreed. Approx 30 min after diphenhydramine patient fully recovered and stated "I'm back". The second dose reaction was much more exaggerated and lasted much longer. No COVID prior vaccination and no COVID tested post vaccination. The adverse event result in Emergency room/department or urgent care. The outcome of events was recovered in Jan2021 after treatment was given.; Sender's Comments: Based on the time association, all events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Discomfort, Ear pain, Injection site pain, Musculoskeletal chest pain
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Neuralgia, Night sweats, Oropharyngeal pain, Pain
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw, Painful respiration, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Tenderness
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysgeusia, Fatigue, Influenza virus test negative, Mobility decreased
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal chest pain, Nasal congestion, Pharyngeal swelling, SARS-CoV-2 test negative
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test negative
Clinical narrative: She experienced- neuropathy down her left arm approximately 20 minutes following the injection; that resolved.  The next day, she had left rib pain that lasted for 3 days. Then she experienced increased congestion, a funny taste, and chills.  The right side of her throat swelled. Fatigue was experienced during the entire ordeal. Approximately 1 week after the injection, she began to experience left deltoid weakness that limited the mobility of her shoulder.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Rash, Rash erythematous, Rash pruritic, Tremor
Clinical narrative: allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration (lot number: EL1283) in the arm right on 07Jan2021 09:00; at single doses for COVID-19 immunization. Medical history included known allergies: latex. Concomitant medications included magnesium oxide (MAG OXIDE) at 200 mg, daily (every day) and cetirizine hydrochloride (ZYRTEC) at 10 mg, daily (every day); and toprolol at 25 mg, every day (pending clarification for the drug). The patient previously received first dose of BNT162B2 on 17Dec2020 (lot number: EK5730) for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination; and has not been tested for COVID-19 since vaccination. Within the 15-minute observation period on 07Jan2021, the patient developed a large red itchy rash on her neck and chest area; she stated she felt fine but was observed trembling. She was transported to ED (emergency department, 5 min transport). She was treated with diphenhydramine hydrochloride (BENADRYL) at 25mg IV X1 (intravenous), and methylprednisolone (SOLUMEDROL) at 60mg IV X1 and famotidine 20mg IV X 1. Patient diagnosis was allergic reaction on 07Jan2021. Patient improved after treatment and was discharged (after being in Emergency room/department or urgent care) as she was observed from 09:11 until 10:33. Final outcome of the events was all recovered on unspecified date.; Sender's Comments: Based on the time association, the allergic reaction, rash erythematous and trembling are possibly related to suspect BNT62B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Heart rate increased, Peripheral coldness, Tremor
Clinical narrative: 14:12 PM-HAD MODERNA VACCINE AT THE TIME OF THE INCIDENT. 14:25 PM -REPORTED SHAKING/ FAST HR/ BOTH HANDS ARE COLD/ SHAKY / SWEATY/ FEELS WARM. ASSISTED TO GURNEY, V/S WAS MONITORED. HR SUSTAINED @  > 100. RRT WAS PAGED FOR FURTHER EVAL SINCE HR WAS NOT IMPROVING. DENIES SOB/ ITCHING/ DIFFICULTY SWALLOWING.. APPEARS FLUSHED FROM FACE DOWN TO HER NECK AREA. RRT ARRIVED @ 14:50 PM - ASSESSED BY RN- BENADRYL PO WAS GIVEN BY RN AND WAS WHEELED DOWN TO ER.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Feeling hot, Flushing, Heart rate increased, Hyperhidrosis
Clinical narrative: 14:12 PM-HAD MODERNA VACCINE AT THE TIME OF THE INCIDENT. 14:25 PM -REPORTED SHAKING/ FAST HR/ BOTH HANDS ARE COLD/ SHAKY / SWEATY/ FEELS WARM. ASSISTED TO GURNEY, V/S WAS MONITORED. HR SUSTAINED @  > 100. RRT WAS PAGED FOR FURTHER EVAL SINCE HR WAS NOT IMPROVING. DENIES SOB/ ITCHING/ DIFFICULTY SWALLOWING.. APPEARS FLUSHED FROM FACE DOWN TO HER NECK AREA. RRT ARRIVED @ 14:50 PM - ASSESSED BY RN- BENADRYL PO WAS GIVEN BY RN AND WAS WHEELED DOWN TO ER.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: 14:12 PM-HAD MODERNA VACCINE AT THE TIME OF THE INCIDENT. 14:25 PM -REPORTED SHAKING/ FAST HR/ BOTH HANDS ARE COLD/ SHAKY / SWEATY/ FEELS WARM. ASSISTED TO GURNEY, V/S WAS MONITORED. HR SUSTAINED @  > 100. RRT WAS PAGED FOR FURTHER EVAL SINCE HR WAS NOT IMPROVING. DENIES SOB/ ITCHING/ DIFFICULTY SWALLOWING.. APPEARS FLUSHED FROM FACE DOWN TO HER NECK AREA. RRT ARRIVED @ 14:50 PM - ASSESSED BY RN- BENADRYL PO WAS GIVEN BY RN AND WAS WHEELED DOWN TO ER.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Lip swelling
Clinical narrative: Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself).  A 36-year-old female patient received bnt162b2 (COVID-19 Vaccine by Pfizer, lot EK9231, expiry date was not reported), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for Covid-19 immunisation (to prevent the COVID). Medical history was none. There were no concomitant medications. The patient experienced facial paralysis on the left side of her face upon waking up on 09Jan2021. The outcome of event was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself).  A 36-year-old female patient received bnt162b2 (COVID-19 Vaccine by Pfizer, lot EK9231, expiry date was not reported), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for Covid-19 immunisation (to prevent the COVID). Medical history was none. There were no concomitant medications. The patient experienced facial paralysis on the left side of her face upon waking up on 09Jan2021. The outcome of event was not recovered.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Salivary hypersecretion, Tongue discomfort
Clinical narrative: 15 minutes following administration of Moderna vaccine, patient felt funny feeling on left side of her head, had increased saliva in mouth and her tongue began to burn.  Patient denied shortness of breath, chest pain or swelling.  No swelling to lips or mouth was noted and patient was able to swallow secretions without difficulty.  Benadryl 25mg was given and patient's symptoms resolved after about 30 minutes.  Patient was able to be discharged home with her daughter
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Skin Rash - square, erythematous, swollen patch on R upper outer arm - not tender or itchy. Occurred at site of Moderna Vaccine ~ 2 weeks ago.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Skin Rash - square, erythematous, swollen patch on R upper outer arm - not tender or itchy. Occurred at site of Moderna Vaccine ~ 2 weeks ago.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Fatigue, Headache, Presyncope
Clinical narrative: difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation.  Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM  for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious.     Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Mental impairment
Clinical narrative: difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation.  Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM  for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious.     Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Magnetic resonance imaging, Magnetic resonance imaging head, Nausea
Clinical narrative: difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation.  Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM  for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious.     Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 1. Redness and induration that increased to 6 cm by day day 8 after vaccine 2. Itching about 15-20 minutes after vaccination around site that evolved into intense itching by day 8.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Induration, Pruritus, Swelling, Vaccination site reaction
Clinical narrative: 1. Redness and induration that increased to 6 cm by day day 8 after vaccine 2. Itching about 15-20 minutes after vaccination around site that evolved into intense itching by day 8.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's palsy onset within 48 hours of second vaccine, R side of face; First dose of vaccine on 20Dec2020 and second dose received on 06Jan2021; First dose of vaccine on 20Dec2020 and second dose received on 06Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for himself from a Pfizer sponsored program. A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EJ1686) via an unspecified route of administration, on 06Jan2021 at 11:30am on left arm, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140) at right arm on 20Dec2020 10:30am for COVID-19 immunization. On 08Jan2021 at 12:00pm, the patient experienced facial droop 2 days after taking the 2nd dose of the vaccine. The patient went to the hospital for doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and were advised to take Valtrex and Prednisone and told its Bell's palsy. Bell's palsy onset within 48 hours of second vaccine, R side of face. Wanted to confirm if there will be a problem once they take these drugs since the paient have just received the vaccine recently or wanted to know if the new medications prescribed will affect the vaccine's effectivity. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Outcome of the event Bell's palsy was not recovered.; Sender's Comments: Facial droop/ Bell's palsy occurred 2 days after taking the 2nd dose of the BNT162B2 vaccine, a possible causal association between administration of BNT162B2 and the event onset thus might not be fully excluded, considering the plausible temporal relationship. 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: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy onset within 48 hours of second vaccine, R side of face; First dose of vaccine on 20Dec2020 and second dose received on 06Jan2021; First dose of vaccine on 20Dec2020 and second dose received on 06Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for himself from a Pfizer sponsored program. A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EJ1686) via an unspecified route of administration, on 06Jan2021 at 11:30am on left arm, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140) at right arm on 20Dec2020 10:30am for COVID-19 immunization. On 08Jan2021 at 12:00pm, the patient experienced facial droop 2 days after taking the 2nd dose of the vaccine. The patient went to the hospital for doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and were advised to take Valtrex and Prednisone and told its Bell's palsy. Bell's palsy onset within 48 hours of second vaccine, R side of face. Wanted to confirm if there will be a problem once they take these drugs since the paient have just received the vaccine recently or wanted to know if the new medications prescribed will affect the vaccine's effectivity. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Outcome of the event Bell's palsy was not recovered.; Sender's Comments: Facial droop/ Bell's palsy occurred 2 days after taking the 2nd dose of the BNT162B2 vaccine, a possible causal association between administration of BNT162B2 and the event onset thus might not be fully excluded, considering the plausible temporal relationship. 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: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Headache, joint pain, tiredness
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Flushing, Paraesthesia oral
Clinical narrative: Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain  Benadryl 50mgm, Epinephrine, Observation,
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Dizziness, Feeling abnormal, Hypersensitivity
Clinical narrative: Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain  Benadryl 50mgm, Epinephrine, Observation,
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain  Benadryl 50mgm, Epinephrine, Observation,
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anxiety, Burning sensation, Diarrhoea, Dizziness
Clinical narrative: Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain  Benadryl 50mgm, Epinephrine, Observation,
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Paraesthesia oral, Swollen tongue
Clinical narrative: Dizzy, burning sensation over body, lips tingling and tongue swelling, abdominal cramps and diarrhea, impending doom feeling that something was really wrong, foggy brain  Benadryl 50mgm, Epinephrine, Observation,
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Product prescribing error, Pruritus, Rash
Clinical narrative: She had rashes all over the body; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she had rashes all over the body  on an unspecified date with outcome of unknown.  Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: She had rashes all over the body; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she had rashes all over the body  on an unspecified date with outcome of unknown.  Information about lot and batch number was requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chills, Lymphadenopathy, Myalgia
Clinical narrative: Patient received first dose Moderna vaccine 1/5/21 on the left arm.  She experienced several days of fever, chills and body ache.  No fever since.  She then developed bilateral axillary swelling and pain.  She was seen in ER and prescribed 4 days of Medrol 50mg on 1/10.  She was admitted from 1/17-18 for left axillary adenopathy and skin necrosis with purulent drainage.  She was treated with solumedrol and Unasyn with improvement.  She was discharged to finish total of 4 days of steroids and antibiotics. She was instructed to continue top treatment of the exfoliating skin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient received first dose Moderna vaccine 1/5/21 on the left arm.  She experienced several days of fever, chills and body ache.  No fever since.  She then developed bilateral axillary swelling and pain.  She was seen in ER and prescribed 4 days of Medrol 50mg on 1/10.  She was admitted from 1/17-18 for left axillary adenopathy and skin necrosis with purulent drainage.  She was treated with solumedrol and Unasyn with improvement.  She was discharged to finish total of 4 days of steroids and antibiotics. She was instructed to continue top treatment of the exfoliating skin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Bartonella test, Chills, Computerised tomogram thorax abnormal, Cytomegalovirus test
Clinical narrative: Patient received first dose Moderna vaccine 1/5/21 on the left arm.  She experienced several days of fever, chills and body ache.  No fever since.  She then developed bilateral axillary swelling and pain.  She was seen in ER and prescribed 4 days of Medrol 50mg on 1/10.  She was admitted from 1/17-18 for left axillary adenopathy and skin necrosis with purulent drainage.  She was treated with solumedrol and Unasyn with improvement.  She was discharged to finish total of 4 days of steroids and antibiotics. She was instructed to continue top treatment of the exfoliating skin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epstein-Barr virus test, HIV test, Lymphadenopathy, Mycobacterium test, Oedema peripheral
Clinical narrative: Patient received first dose Moderna vaccine 1/5/21 on the left arm.  She experienced several days of fever, chills and body ache.  No fever since.  She then developed bilateral axillary swelling and pain.  She was seen in ER and prescribed 4 days of Medrol 50mg on 1/10.  She was admitted from 1/17-18 for left axillary adenopathy and skin necrosis with purulent drainage.  She was treated with solumedrol and Unasyn with improvement.  She was discharged to finish total of 4 days of steroids and antibiotics. She was instructed to continue top treatment of the exfoliating skin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Purulent discharge, Pyrexia, Scan with contrast abnormal, Skin necrosis
Clinical narrative: Patient received first dose Moderna vaccine 1/5/21 on the left arm.  She experienced several days of fever, chills and body ache.  No fever since.  She then developed bilateral axillary swelling and pain.  She was seen in ER and prescribed 4 days of Medrol 50mg on 1/10.  She was admitted from 1/17-18 for left axillary adenopathy and skin necrosis with purulent drainage.  She was treated with solumedrol and Unasyn with improvement.  She was discharged to finish total of 4 days of steroids and antibiotics. She was instructed to continue top treatment of the exfoliating skin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Staphylococcus test negative, Toxoplasma serology, Treponema test, White blood cell count increased
Clinical narrative: Patient received first dose Moderna vaccine 1/5/21 on the left arm.  She experienced several days of fever, chills and body ache.  No fever since.  She then developed bilateral axillary swelling and pain.  She was seen in ER and prescribed 4 days of Medrol 50mg on 1/10.  She was admitted from 1/17-18 for left axillary adenopathy and skin necrosis with purulent drainage.  She was treated with solumedrol and Unasyn with improvement.  She was discharged to finish total of 4 days of steroids and antibiotics. She was instructed to continue top treatment of the exfoliating skin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Throat irritation
Clinical narrative: Tachycardia, throat burning, chest tightness, hypertension. Started immediately on 1/11/21. Patient comes back on 1/18/21 with similar symptoms starting 1 hour prior to arrival at UTC.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Immediate post-injection reaction, Tachycardia, Throat irritation
Clinical narrative: Tachycardia, throat burning, chest tightness, hypertension. Started immediately on 1/11/21. Patient comes back on 1/18/21 with similar symptoms starting 1 hour prior to arrival at UTC.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Headache, Hemiparesis, Musculoskeletal stiffness
Clinical narrative: Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right tricep and scapula. Took OTC acetaminophen and NDAIDs. Visited employees health who sent me to urgent care for neurological exam. Urgent care physician noted right arm weaker than left and recorded report of bilateral upper extremity paresthesia. Recommended follow up exam and cervical MRI if symptoms worsen or do not resolve within 7 days. Neck pain has improved but still present. Paresthesias still present. Right arm (dominant arm) still weaker than left. Will follow up with primary care physician this week if symptoms continue.  Additional side effects: headache, dizziness, nausea, shivers, fatigue, joint pain (all resolved within 72 hours).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right tricep and scapula. Took OTC acetaminophen and NDAIDs. Visited employees health who sent me to urgent care for neurological exam. Urgent care physician noted right arm weaker than left and recorded report of bilateral upper extremity paresthesia. Recommended follow up exam and cervical MRI if symptoms worsen or do not resolve within 7 days. Neck pain has improved but still present. Paresthesias still present. Right arm (dominant arm) still weaker than left. Will follow up with primary care physician this week if symptoms continue.  Additional side effects: headache, dizziness, nausea, shivers, fatigue, joint pain (all resolved within 72 hours).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right tricep and scapula. Took OTC acetaminophen and NDAIDs. Visited employees health who sent me to urgent care for neurological exam. Urgent care physician noted right arm weaker than left and recorded report of bilateral upper extremity paresthesia. Recommended follow up exam and cervical MRI if symptoms worsen or do not resolve within 7 days. Neck pain has improved but still present. Paresthesias still present. Right arm (dominant arm) still weaker than left. Will follow up with primary care physician this week if symptoms continue.  Additional side effects: headache, dizziness, nausea, shivers, fatigue, joint pain (all resolved within 72 hours).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscular weakness, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right tricep and scapula. Took OTC acetaminophen and NDAIDs. Visited employees health who sent me to urgent care for neurological exam. Urgent care physician noted right arm weaker than left and recorded report of bilateral upper extremity paresthesia. Recommended follow up exam and cervical MRI if symptoms worsen or do not resolve within 7 days. Neck pain has improved but still present. Paresthesias still present. Right arm (dominant arm) still weaker than left. Will follow up with primary care physician this week if symptoms continue.  Additional side effects: headache, dizziness, nausea, shivers, fatigue, joint pain (all resolved within 72 hours).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Spinal pain
Clinical narrative: Severe cervical spine pain and stiffness with paresthesias in bilateral arms and weakness in right tricep and scapula. Took OTC acetaminophen and NDAIDs. Visited employees health who sent me to urgent care for neurological exam. Urgent care physician noted right arm weaker than left and recorded report of bilateral upper extremity paresthesia. Recommended follow up exam and cervical MRI if symptoms worsen or do not resolve within 7 days. Neck pain has improved but still present. Paresthesias still present. Right arm (dominant arm) still weaker than left. Will follow up with primary care physician this week if symptoms continue.  Additional side effects: headache, dizziness, nausea, shivers, fatigue, joint pain (all resolved within 72 hours).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cold sweat, Dysphagia, Hyperhidrosis, Swelling face, Throat tightness
Clinical narrative: staff RN, came in for an appointment to receive her first dose of COVID vaccine on 1/14/21.  Less than 10 minutes after receiving the vaccine, it was noted by onsite EMS/paramedic that she was having difficulty swallowing and feeling of throat tightness, along with sweaty, clammy skin.  History of:Received first dose of COVID vaccine at 13:03 today (1/14/2021). No history of severe allergic reactions to anything.  Patient monitored by onsite EMS/paramedic. Vital signs stable:BP 110/74, pulse 74 and O2 sats at 99% on room air. Paramedic gave Benadryl 50 mg IM at 1:41 when noted redness at base of neck and upper chest. No resolution of symptoms. Emergency Rapid Response Team (RRT) was called to respond. Patient reported continued difficulty swallowing, tightness in throat and clammy skin.Paramedic administered  Epinephrine via EpiPen 0.3 mg intramuscular at 1:52 while awaiting RRT arrival. RRT arrived at 14:00. Patient continued to report difficulty swallowing, throat tightness, and noted new swelling under bilateral eyes despite the one dose of Epi given. After further assessment, RRT recommended patient be transferred to ED for further evaluation/treatment and patient was transported by wheelchair, escorted by RRT.  She was transported to the emergency department via wheel chair at 14:10. In the ED, patient was given dexamethasone, famotidine and IV fluids.  Basic labs were obtained including tryptase. Patient discharged home in stable condition after 6 hours in the ED.  At approximately 7:30 PM on 1/15/21, patient was at home and had a biphasic anaphylactic  reaction. She began to experience tongue swelling, eye swelling, coughing, and difficulty swallowing. Patient took 50 mg oral Benadryl, 10 mg Zyrtec and administered one api-pen prior to reporting back to the ED. While in the ED, she was given oral dexamethasoneand placed under observation for 4 hours prior to discharge.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Blood count normal, Cold sweat, Eye swelling
Clinical narrative: staff RN, came in for an appointment to receive her first dose of COVID vaccine on 1/14/21.  Less than 10 minutes after receiving the vaccine, it was noted by onsite EMS/paramedic that she was having difficulty swallowing and feeling of throat tightness, along with sweaty, clammy skin.  History of:Received first dose of COVID vaccine at 13:03 today (1/14/2021). No history of severe allergic reactions to anything.  Patient monitored by onsite EMS/paramedic. Vital signs stable:BP 110/74, pulse 74 and O2 sats at 99% on room air. Paramedic gave Benadryl 50 mg IM at 1:41 when noted redness at base of neck and upper chest. No resolution of symptoms. Emergency Rapid Response Team (RRT) was called to respond. Patient reported continued difficulty swallowing, tightness in throat and clammy skin.Paramedic administered  Epinephrine via EpiPen 0.3 mg intramuscular at 1:52 while awaiting RRT arrival. RRT arrived at 14:00. Patient continued to report difficulty swallowing, throat tightness, and noted new swelling under bilateral eyes despite the one dose of Epi given. After further assessment, RRT recommended patient be transferred to ED for further evaluation/treatment and patient was transported by wheelchair, escorted by RRT.  She was transported to the emergency department via wheel chair at 14:10. In the ED, patient was given dexamethasone, famotidine and IV fluids.  Basic labs were obtained including tryptase. Patient discharged home in stable condition after 6 hours in the ED.  At approximately 7:30 PM on 1/15/21, patient was at home and had a biphasic anaphylactic  reaction. She began to experience tongue swelling, eye swelling, coughing, and difficulty swallowing. Patient took 50 mg oral Benadryl, 10 mg Zyrtec and administered one api-pen prior to reporting back to the ED. While in the ED, she was given oral dexamethasoneand placed under observation for 4 hours prior to discharge.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Lip swelling, Pharyngeal swelling, Rash, Rash erythematous
Clinical narrative: staff RN, came in for an appointment to receive her first dose of COVID vaccine on 1/14/21.  Less than 10 minutes after receiving the vaccine, it was noted by onsite EMS/paramedic that she was having difficulty swallowing and feeling of throat tightness, along with sweaty, clammy skin.  History of:Received first dose of COVID vaccine at 13:03 today (1/14/2021). No history of severe allergic reactions to anything.  Patient monitored by onsite EMS/paramedic. Vital signs stable:BP 110/74, pulse 74 and O2 sats at 99% on room air. Paramedic gave Benadryl 50 mg IM at 1:41 when noted redness at base of neck and upper chest. No resolution of symptoms. Emergency Rapid Response Team (RRT) was called to respond. Patient reported continued difficulty swallowing, tightness in throat and clammy skin.Paramedic administered  Epinephrine via EpiPen 0.3 mg intramuscular at 1:52 while awaiting RRT arrival. RRT arrived at 14:00. Patient continued to report difficulty swallowing, throat tightness, and noted new swelling under bilateral eyes despite the one dose of Epi given. After further assessment, RRT recommended patient be transferred to ED for further evaluation/treatment and patient was transported by wheelchair, escorted by RRT.  She was transported to the emergency department via wheel chair at 14:10. In the ED, patient was given dexamethasone, famotidine and IV fluids.  Basic labs were obtained including tryptase. Patient discharged home in stable condition after 6 hours in the ED.  At approximately 7:30 PM on 1/15/21, patient was at home and had a biphasic anaphylactic  reaction. She began to experience tongue swelling, eye swelling, coughing, and difficulty swallowing. Patient took 50 mg oral Benadryl, 10 mg Zyrtec and administered one api-pen prior to reporting back to the ED. While in the ED, she was given oral dexamethasoneand placed under observation for 4 hours prior to discharge.