chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Injection site swelling, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: hallucinating; hands are very swollen; fever; she was also 'really swollen' not just on the injection site but on her hands and face.; she was also 'really swollen' not just on the injection site but on her hands and face.; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982), via an unspecified route of administration on an unspecified date single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hallucinating, hands are very swollen, fever, she was also 'really swollen' not just on the injection site but on her hands and face, all on an unknown date. The events outcome was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dysgeusia, Hypoaesthesia oral, Pain, Pain in extremity
Clinical narrative: Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain in the injection site; Soreness in lower part of his leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) 36 hours before the 1st shot of vaccine. Patient called in because he took acetylsalicylic acid 36 hours before the 1st shot of vaccine. Asking how much it will effect the efficacy. Mentioned he felt a little bit of pain in the injection site and soreness in lower part of his leg an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood bilirubin, Blood magnesium, Blood magnesium decreased, Blood phosphorus
Clinical narrative: Pain in the injection site; Soreness in lower part of his leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) 36 hours before the 1st shot of vaccine. Patient called in because he took acetylsalicylic acid 36 hours before the 1st shot of vaccine. Asking how much it will effect the efficacy. Mentioned he felt a little bit of pain in the injection site and soreness in lower part of his leg an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium, Discomfort, Glomerular filtration rate, Glomerular filtration rate decreased, Inappropriate schedule of product administration
Clinical narrative: Pain in the injection site; Soreness in lower part of his leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) 36 hours before the 1st shot of vaccine. Patient called in because he took acetylsalicylic acid 36 hours before the 1st shot of vaccine. Asking how much it will effect the efficacy. Mentioned he felt a little bit of pain in the injection site and soreness in lower part of his leg an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mineral deficiency, Monocyte count, Renal disorder
Clinical narrative: Pain in the injection site; Soreness in lower part of his leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) 36 hours before the 1st shot of vaccine. Patient called in because he took acetylsalicylic acid 36 hours before the 1st shot of vaccine. Asking how much it will effect the efficacy. Mentioned he felt a little bit of pain in the injection site and soreness in lower part of his leg an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Chills; fever; Injection site pain; muscle aches; vomiting; nausea; This is a spontaneous report from a non-contactable consumer (patient).  A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiration date not reported), via an unspecified route of administration, on the left arm, on 15Jan2021 at 11:00, at a single dose for Covid-19 immunization.  Medical history included allergies to penicillin. The patient did not receive other vaccines in four weeks. The patient is not pregnant. Concomitant medications included metformin, omeprazole, melatonin, iron and ethinylestradiol, levonorgestrel (SRONYX).  The patient previously took first dose of bnt162b2 (lot number EH9899) on 28Dec2020 at 11:15 AM, on the left arm, at a single dose for Covid-19 immunization, cephalosporin and Imitrex and experienced allergies. On 16Jan2021 at 01:00, the patient experienced chills, injection site pain, fever, muscle aches, and nausea/vomiting. No treatment was given for the adverse events. The patient has no Covid prior to vaccination and not Covid tested post vaccination. The patient recovered from the events in Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; fever; Injection site pain; muscle aches; vomiting; nausea; This is a spontaneous report from a non-contactable consumer (patient).  A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiration date not reported), via an unspecified route of administration, on the left arm, on 15Jan2021 at 11:00, at a single dose for Covid-19 immunization.  Medical history included allergies to penicillin. The patient did not receive other vaccines in four weeks. The patient is not pregnant. Concomitant medications included metformin, omeprazole, melatonin, iron and ethinylestradiol, levonorgestrel (SRONYX).  The patient previously took first dose of bnt162b2 (lot number EH9899) on 28Dec2020 at 11:15 AM, on the left arm, at a single dose for Covid-19 immunization, cephalosporin and Imitrex and experienced allergies. On 16Jan2021 at 01:00, the patient experienced chills, injection site pain, fever, muscle aches, and nausea/vomiting. No treatment was given for the adverse events. The patient has no Covid prior to vaccination and not Covid tested post vaccination. The patient recovered from the events in Jan2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: trouble breathing; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I need to ask about, I need to ask about shortness of breath, I'm having a hard time breathing. I had the vaccine last night and having trouble breathing" on an unspecified date. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid test which came back positive; covid test which came back positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she received the vaccine and then took Covid test which came back positive (unknown date). The patient would like to know if it is safe for her to get second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Pyrexia, Rash erythematous
Clinical narrative: red raised rash over body; fever; fatigue; diarrhea; intestinal stomach pain; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection on 12Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. The patient received BNT162B2 dose number 1 in Dec2020. Medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced fever, fatigue, diarrhea and intestinal stomach pain. On 18Jan2021, the patient experienced red raised rash over body. The outcome of the events fever, fatigue, diarrhea, intestinal stomach pain and red raised rash over body was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, COVID-19, Fatigue
Clinical narrative: tested positive for COVID; tested positive for COVID; back pain; heavy cold symptoms; fatigue; Experienced a sore arm for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine in the left arm deltoid on 23Dec2020. The patient experienced a sore arm for 24 hours in Dec2021. On 31Dec2020, she experienced back pain, heavy cold symptoms and fatigue. On 05Jan2021, the patient was tested positive for COVID. On 09Jan2021 she lost taste and smell. On 14Jan2021, she tested negative for COVID. As of today, 19Jan2021, she has not been able to go back to work. Event took place after use of product. The outcome of event sore arm was recovered on an unspecified date. The outcome of event COVID-19 was recovered on 14Jan2021. The outcome of the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; back pain; heavy cold symptoms; fatigue; Experienced a sore arm for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine in the left arm deltoid on 23Dec2020. The patient experienced a sore arm for 24 hours in Dec2021. On 31Dec2020, she experienced back pain, heavy cold symptoms and fatigue. On 05Jan2021, the patient was tested positive for COVID. On 09Jan2021 she lost taste and smell. On 14Jan2021, she tested negative for COVID. As of today, 19Jan2021, she has not been able to go back to work. Event took place after use of product. The outcome of event sore arm was recovered on an unspecified date. The outcome of event COVID-19 was recovered on 14Jan2021. The outcome of the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness on his arm/He said his left arm was barely sore after receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer reporting for himself. A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1283/expiration date: Apr2021), via an unspecified route of administration, on 18Jan2021 16:00 (at the age of 23 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were reported as none. Past vaccine history included the patient received a flu vaccine injection on Oct2020 and he could barely lift his arm up after receiving a flu vaccine injection and on Nov2020 approximately 5 weeks ago, the patient received PPSV23 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jan2021, the patient experienced soreness on his arm, started slowly, about 2 hours post COVID-19 vaccination. He said his left arm was barely sore after receiving the COVID-19 Vaccine. The soreness went away completely on 19Jan2021. The patient did not receive any treatment for the event. The outcome of the event soreness on his arm was recovered on 19Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia, Raynaud's phenomenon
Clinical narrative: arm pain; chills; low grade fever; myalgia; Raynaud's Syndrome (vasoconstriction of the fingers); This is a spontaneous report from a contactable other health professional.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number, via an unspecified route of administration on 29Dec2020 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 30Dec2020, the day after receiving the first dose of the vaccine, the patient experienced arm pain, chills, low grade fever, myalgia, Raynaud's syndrome, then they resolved completely. Events are non-serious. The clinical outcome of the events arm pain, chills, low grade fever, myalgia, Raynaud's syndrome was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for self that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller is due for a second dose of covid vaccine tomorrow. She has tested positive for covid before second dose. Outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Headache which she described as more of starting on her neck going up to her head/ She feels a little bit of a headache, more neck than head; Headache which she described as more of starting on her neck going up to her head/ She feels a little bit of a headache, more neck than head; This is a spontaneous report from a contactable consumer, the patient. A 84 years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown) on Jan2021 as a single dose, for COVID-19 vaccination. The patient medical history and  concomitant medications were not reported. On Jan2021,the patient experienced  headache which she described as more of starting on her neck going up to her head/ she feels a little bit of a headache, more neck than head. Patient stated  this is normal for her, she often gets headaches. Consumer commented that she thinks it is not necessary for her to call her HCP about it when it is something that she can take care of herself.  'Wants to know if taking either Tylenol or Advil would interact with the vaccine and did mention that she has taken the medications yesterday (unclear if patient had taken medications before or after receiving vaccine). The consumer (patient) unwilling to complete the report. The clinical outcome of headache and neck pain was unknown.    Information about Lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Poor quality sleep
Clinical narrative: Poor sleep; Nausea; Fever; Fatigue; headache; pain/soreness all over; itch at injection site; Pain at injection site; redness at injection site; Lump at injection site; warm skin at injection site; This is a spontaneous report from a contactable healthcare professional (the patient).  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686), via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 34-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included HTN (hypertension), depression, ADHD (attention deficit hyperactivity disorder), vitamin D deficiency. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, clonazepam, escitalopram oxalate (LEXAPRO), pantoprazole, lisdexamfetamine mesilate (VYVANSE), all for unknown indications from unknown dates and unknown if ongoing. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 at 09:00 AM (at the age of 34-years-old), in the right arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took and had allergies to atomoxetine hydrochloride (STRATTERA). On 20Jan2021 at 12 AM, the patient experienced poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, warm skin at injection site. The patient did not receive any treatment for the events. The clinical outcome of poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, and warm skin at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Poor sleep; Nausea; Fever; Fatigue; headache; pain/soreness all over; itch at injection site; Pain at injection site; redness at injection site; Lump at injection site; warm skin at injection site; This is a spontaneous report from a contactable healthcare professional (the patient).  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686), via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 34-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included HTN (hypertension), depression, ADHD (attention deficit hyperactivity disorder), vitamin D deficiency. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, clonazepam, escitalopram oxalate (LEXAPRO), pantoprazole, lisdexamfetamine mesilate (VYVANSE), all for unknown indications from unknown dates and unknown if ongoing. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 at 09:00 AM (at the age of 34-years-old), in the right arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took and had allergies to atomoxetine hydrochloride (STRATTERA). On 20Jan2021 at 12 AM, the patient experienced poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, warm skin at injection site. The patient did not receive any treatment for the events. The clinical outcome of poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, and warm skin at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Poor sleep; Nausea; Fever; Fatigue; headache; pain/soreness all over; itch at injection site; Pain at injection site; redness at injection site; Lump at injection site; warm skin at injection site; This is a spontaneous report from a contactable healthcare professional (the patient).  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686), via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 34-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included HTN (hypertension), depression, ADHD (attention deficit hyperactivity disorder), vitamin D deficiency. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, clonazepam, escitalopram oxalate (LEXAPRO), pantoprazole, lisdexamfetamine mesilate (VYVANSE), all for unknown indications from unknown dates and unknown if ongoing. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 at 09:00 AM (at the age of 34-years-old), in the right arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took and had allergies to atomoxetine hydrochloride (STRATTERA). On 20Jan2021 at 12 AM, the patient experienced poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, warm skin at injection site. The patient did not receive any treatment for the events. The clinical outcome of poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, and warm skin at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram abnormal, Dysarthria, Echocardiogram
Clinical narrative: Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as "Couldn't speak, slurring words, stuttering, couldn't formulate a sentence" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021.    Information of lot/batch number has been requested.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging brain abnormal
Clinical narrative: Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as "Couldn't speak, slurring words, stuttering, couldn't formulate a sentence" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021.    Information of lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: had COVID symptoms and tested positive for Covid; had COVID symptoms and tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US Support.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date not provided) on 28Dec2020 17:30 at single dose in the left arm via an unspecified route of administration for COVID-19 immunisation .  There were no relevant medical history and no concomitant medications. The patient took the first dose of the vaccine on 28Dec2020 and by the end of that week she had COVID symptoms. She got tested on that Saturday (02Jan2021) and it was negative, so she went to an urgent care to get tested again on 04Jan2021 and she was positive. She was not visit physician office or emergency room. She was out of quarantine on 14Jan2021, and was due to go get her second dose of the vaccine on 18Jan2021. She was calling to make sure if it's okay to get it. The outcome was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event "had COVID symptoms and tested positive for Covid" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: his wrist started hurting; This is a spontaneous report from a contactable consumer (patient). An elderly male patient of unspecified age (he is turning 93) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient called earlier this morning about the Covid-19 vaccine and reported that he got inoculated on Friday 15Jan2021 and everything went fine. He said that all of a sudden today, his wrist started hurting. He said that he thought it was from the vaccine, but kept doing things around the house and said that it was cracked or dislocated or something, and has nothing to do with the vaccine itself. He said that he is going to see someone about it. He wanted to let Pfizer know this. When asked for his email the patient said that he is turning 93 and has forgotten a lot more than he can remember and began laughing. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported event his wrist started hurting is likely an intercurrent condition  considering the patient's age ( elderly) and not related to  BNT162B2 .
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Oropharyngeal pain
Clinical narrative: Ear was hurting; throat hurting too.; This is a spontaneous report from a Pfizer-sponsored program via a non-contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included she was a little hoarse and acid reflux problems for the past year. The patient's concomitant medications were not reported.  Called before having her first vaccine and had another question. Caller was a little hoarse. Had acid reflux problems for the past year, but she woke up this morning (on 18Jan2021) and her ear was hurting and throat hurting too. Inquiring if she could take the vaccine with those symptoms. Caller indicated that this is not related to the vaccine. It was reported that she was hoarse today (on 18Jan2021), plus her ear and throat were both hurting as well.  The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship.   There is limited information provided in this report.  This case will be reassessed once additional information is available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: had chills; body aches; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 10Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Jan2021 at 21:00 the patient had chills and body aches and had to call off work on the following day. The patient felt 100% fine when she woke up on 12Jan2021. The reported events resolved on 12Jan2021 without any treatment.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Vertigo
Clinical narrative: dizziness/lightheadedness; the room was spinning; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Jan2021 the patient experienced arm soreness and on 17Jan2021 developed dizziness, lightheadedness, and the room was spinning. The patient wanted to know if she can take Tylenol. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; Headache; fatigue; muscle aches; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO142), via an unspecified route of administration on 09Jan2021 09:45 single dose for covid-19 immunisation. Vaccine location was right arm. No other vaccine was received in four weeks.  Medical history included seasonal allergy. Historical vaccine included BNT162B2 first dose at unknown date. Concomitant medication included ergocalciferol (VIT D) and multivitamin. The patient experienced sore throat on 10Jan2021 02:00, headache on 10Jan2021 02:00, fatigue on 10Jan2021 02:00, muscle aches on 10Jan2021 02:00. Patient was treated with ibuprofen and tylenol. The events outcome was recovered in Jan2021
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a non-contactable consumer (patient herself). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization, given by the retirement home and administered at the nursing home/senior living facility. Relevant medical history included pre-diabetic, obesity, high lipids, and allergies to some psychiatric (psych) medications (meds) only. Concomitant medications included risperidone, calcium levomefolate (DEPLIN), travoprost (TRAVATAN), ibuprofen, and famotidine. 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 had not been tested for COVID-19. On 19Jan2021 at 15:30 (also reported as "beginning around 3 pm"), the patient experienced muscle aches, joint aches, exhausted feeling, and slight headache mainly in the afternoon. The reporter assessed all the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue; Muscle aches; Fever; This is a spontaneous report from a contactable consumer, reporting on behalf of their co-worker. This female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient experienced fatigue, muscle aches and fever. It was unknown if treatment was received. The clinical outcomes of the events fatigue, muscle aches and fever were unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Pruritus, Rash papular, SARS-CoV-2 test
Clinical narrative: papular rash with petechiae; papular rash with petechiae; itching; This is a spontaneous report from a contactable other hcp.  A 38-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), first dose, intramuscular on 07Jan2021 single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included drug hypersensitivity to pertussis vaccine, erytrhromycin, sulfacetamide. Concomitant medications included celecoxib (CELEXA), ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced papular rash with petechiae on 17Jan2021, itching on 17Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jan2021. The events outcome was unknown  Information on the Batch/Lot number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: The patient experienced itching after the first dose of the COVID-19 vaccine.; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscularly on 20Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced itching after the first dose of the covid-19 vaccine in Dec2020 with outcome of unknown.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: feeling short of breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 20Jan2021 at 11:30 AM at a single dose for COVID-19 immunization administered at the public health department. Relevant medical history included high blood pressure, which was under control with medications (meds). The patient had no allergies to medications, food, or other products. Concomitant medications included hydralazine, carvedilol, rosuvastatin, alendronate sodium (ALENDRONAT), and unspecified meds for high blood pressure. 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 had not been tested for COVID-19. On 20Jan2021 at 12:00 PM, the patient experienced feeling short of breath for a few minutes soon after leaving the vaccine site. It passed and then happened again a few hours later, but it passed after inhaling some warm mist. The patient assessed the event as non-serious. Therapeutic measures were taken as a result of feeling short of breath, which included inhaling some warm mist. The patient recovered from the event on an unspecified date in Jan2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site rash
Clinical narrative: Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; This is a spontaneous report from a contactable other healthcare professional reported for a female patient. A 28-year-old female patient receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), intramuscular (anatomical location: arm left) on 19Jan2021 at 13:00 at SINGLE DOSE for covid-19 immunization. Patient's medical history included birth control. Concomitant medications included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) as birth control, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone nasal spray, and probiotics.  The patient previously took first dose of bnt162b2 (lot number: EH9899; expiration date not reported), intramuscular (anatomical location: left arm) on 29Dec2020 at 09:30 am for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. It was also reported that patient was not pregnant at the time of vaccination. On 20Jan2021 at 07:00, the patient experienced skin rash/redness at injection site and in axilla on side of injection. It was reported that no treatment was provided for the events. The events were assessed as non-serious. Outcome of the events was recovering.