chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drooling, Facial paresis, Paraesthesia, Speech disorder, Tongue movement disturbance
Clinical narrative: Tingling sensation on entire right side of face; Muscle weakness in cheeks/ right side feels very weak; Muscle weakness in tongue; Slight drooling; Impairing speech ability; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Jun2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included morphea. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23May2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 23Jun2021, the patient experienced tingling sensation on entire right side of face, muscle weakness in cheeks and tongue which resulted in drooling. The patient reported that she was able to smile but the right side felt very weak. The patient also experienced impaired speech ability. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling sensation on entire right side of face, muscle weakness in cheeks and tongue which resulted in drooling, right side felt very weak and impaired speech ability was not resolved at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: headache/ a slight headache; knot in his stomach/ a little bit of an upset stomach; threw up/ Vomited; chills; tired; not hungry for anything; he was really sick/ he's still not feeling good/ sickness; This is a spontaneous report from a contactable consumer (wife) reported for her husband that a 63-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FA6780, expiry date: 30Sep2021, code number: 59267100002), via an unknown route of administration in right arm on 18Jul2021 (at the age of 63-years-old) at 11:30 as single dose for COVID-19 immunisation at pharmacy. The patient's medical history and concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same day of the Pfizer Suspect were none. No additional vaccines administered on same date of the Pfizer Suspect. On 19Jul2021 at 00:30, the patient experienced headache/ a slight headache, knot in his stomach/ a little bit of an upset stomach, threw up/ Vomited, chills, tired, not hungry for anything, he was really sick/ he's still not feeling good/ sickness. The reporter explained that the patient received his first dose of the Pfizer COVID vaccine on Sunday 18Jul2021 then really late Sunday early Monday morning woke up with a bad reaction: headaches, knot in his stomach, threw up and had chills, he was really sick, he's still not feeling good. Caller confirms all symptoms started Sunday night at 11:30 AM, so technically on 19Jul2021 and all symptoms were still having have gotten a little better, they have improved. No adverse event required a visit to emergency Room and physician office. Prior vaccinations within 4 weeks, adverse event and relevant test were none. The outcome of the events threw up/vomiting and chills was recovered on 19Jul2021 at 21:00, while the outcome of the remaining events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: headache/ a slight headache; knot in his stomach/ a little bit of an upset stomach; threw up/ Vomited; chills; tired; not hungry for anything; he was really sick/ he's still not feeling good/ sickness; This is a spontaneous report from a contactable consumer (wife) reported for her husband that a 63-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FA6780, expiry date: 30Sep2021, code number: 59267100002), via an unknown route of administration in right arm on 18Jul2021 (at the age of 63-years-old) at 11:30 as single dose for COVID-19 immunisation at pharmacy. The patient's medical history and concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same day of the Pfizer Suspect were none. No additional vaccines administered on same date of the Pfizer Suspect. On 19Jul2021 at 00:30, the patient experienced headache/ a slight headache, knot in his stomach/ a little bit of an upset stomach, threw up/ Vomited, chills, tired, not hungry for anything, he was really sick/ he's still not feeling good/ sickness. The reporter explained that the patient received his first dose of the Pfizer COVID vaccine on Sunday 18Jul2021 then really late Sunday early Monday morning woke up with a bad reaction: headaches, knot in his stomach, threw up and had chills, he was really sick, he's still not feeling good. Caller confirms all symptoms started Sunday night at 11:30 AM, so technically on 19Jul2021 and all symptoms were still having have gotten a little better, they have improved. No adverse event required a visit to emergency Room and physician office. Prior vaccinations within 4 weeks, adverse event and relevant test were none. The outcome of the events threw up/vomiting and chills was recovered on 19Jul2021 at 21:00, while the outcome of the remaining events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: joint pain; Nausea; Massive headaches; Bouts of chronic and sudden diarrhea; Chronic outbreaks of cluster cold sores more severe and frequent than at any other time of my life; 11Jun2021=Dose 1, 11Jun2021= Dose 2; This is a spontaneous report from a contactable consumer (patient). A 60-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 11Jun2021 as dose 1, single; and received second dose of BNT162B2 (Lot Number: EW0177) via an unspecified route of administration, administered  in right arm on 11Jun2021 as dose 1, single; both (at the age of 60-years-old) for covid-19 immunization at pharmacy or drug Store. Medical history included thyroidectomy, stomach ulcer, cold sores on occasion; all from an unknown date and unknown if ongoing. Concomitant medications  in two weeks included omeprazole magnesium (PRILOSEC), levothyroxine, celecoxib (CELEXA); all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Codeine. No other vaccine in four weeks. Patient had no COVID-19 prior vaccination and no COVID-19 tested post vaccination. On 07Jul2021, the patient experienced extreme joint pain throughout body, massive headaches, bouts of chronic and sudden diarrhea, nausea, chronic outbreaks of cluster cold sores more severe and frequent than at any other time of patient's life. No treatment received for events. Patient was not recovered from the events at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: joint pain; Nausea; Massive headaches; Bouts of chronic and sudden diarrhea; Chronic outbreaks of cluster cold sores more severe and frequent than at any other time of my life; 11Jun2021=Dose 1, 11Jun2021= Dose 2; This is a spontaneous report from a contactable consumer (patient). A 60-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 11Jun2021 as dose 1, single; and received second dose of BNT162B2 (Lot Number: EW0177) via an unspecified route of administration, administered  in right arm on 11Jun2021 as dose 1, single; both (at the age of 60-years-old) for covid-19 immunization at pharmacy or drug Store. Medical history included thyroidectomy, stomach ulcer, cold sores on occasion; all from an unknown date and unknown if ongoing. Concomitant medications  in two weeks included omeprazole magnesium (PRILOSEC), levothyroxine, celecoxib (CELEXA); all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Codeine. No other vaccine in four weeks. Patient had no COVID-19 prior vaccination and no COVID-19 tested post vaccination. On 07Jul2021, the patient experienced extreme joint pain throughout body, massive headaches, bouts of chronic and sudden diarrhea, nausea, chronic outbreaks of cluster cold sores more severe and frequent than at any other time of patient's life. No treatment received for events. Patient was not recovered from the events at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache in his arm and muscle pain; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FA6780, NDC and UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 19Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced muscle ache in his arm and muscle pain. Reporter stated, just have a question. My son was 19 (not clarified) he took Pfizer earlier today and he was experienced the muscle, you know the muscle ache in his arm. If he allowed to take Tylenol. Reporter was informed about Pfizer Medical Information Department. It was reported when asked for further probing, reporter stated, No, just called to ask, patient had muscle pain so reporter need to find out if he could take the Tylenol. Reporter think that's the priority right now. If you could call me back at another time reporter will be happy to answer any questions but right now the priority was to figure out if he can take something to alleviate the muscle ache. The outcome was unknown of adverse event.  Reporter was unwilling to provide further information hence limited information available over call.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Pyrexia, Swelling face
Clinical narrative: whole chin is swelling and the rest of the face as well; Lower back pain; feel horrible; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 18Jul2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The  patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 20Jun2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation and had hyaluronic acid (MANUFACTURER UNKNOWN) filler on chin from unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had hyaluronic acid filler on chin and believed there was reaction. On 19Jul2021 at 08:00, the patient's whole chin was swelling and the rest of face as well and also had never felt lower back pain like after the second dose of Pfizer vaccine. The patient felt horrible and had chills and fever. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events whole chin was swelling and the rest of face as well, lower back pain, chills, fever and feel horrible was not recovered at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Lethargy, Lymphadenopathy, Nausea
Clinical narrative: Lymph node swelling on the lower left side of neck that's increasing in size; Lethargic; Nauseated; Fever of 102.6F; couldn't stay awake and didn't even have the energy to sit up; couldn't stay awake and didn't even have the energy to sit up; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jul2021 at 17:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and post-traumatic stress disorder; both from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included raloxifene hydrochloride (RALOXIFENE HCL), citalopram (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jun2021 (at the age of 44-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jul2021 at 11:15, approximately 18 hours after receiving the second dose, the patient was lethargic, nauseated, and had a fever of 102.6F. Once this started, the patient couldn't stay awake and didn't even have the energy to sit up for almost 24 hours. The fever lasted approximately 21 hours before finally breaking. On 16Jul2021, two days after receiving this dose, the patient experienced Lymph node swelling on the lower left side of neck that's increasing in size. Reported to PCP who suggested the patient to report the reaction. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 102.6F, couldn't stay awake and didn't even have the energy to sit up was recovered with sequelae on 16Jul2021 and of the events lethargic, nauseated and experienced Lymph node swelling on the lower left side of neck that's increasing in size was recovered with sequelae on unknown date in Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Lymph node swelling on the lower left side of neck that's increasing in size; Lethargic; Nauseated; Fever of 102.6F; couldn't stay awake and didn't even have the energy to sit up; couldn't stay awake and didn't even have the energy to sit up; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jul2021 at 17:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and post-traumatic stress disorder; both from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included raloxifene hydrochloride (RALOXIFENE HCL), citalopram (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jun2021 (at the age of 44-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jul2021 at 11:15, approximately 18 hours after receiving the second dose, the patient was lethargic, nauseated, and had a fever of 102.6F. Once this started, the patient couldn't stay awake and didn't even have the energy to sit up for almost 24 hours. The fever lasted approximately 21 hours before finally breaking. On 16Jul2021, two days after receiving this dose, the patient experienced Lymph node swelling on the lower left side of neck that's increasing in size. Reported to PCP who suggested the patient to report the reaction. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 102.6F, couldn't stay awake and didn't even have the energy to sit up was recovered with sequelae on 16Jul2021 and of the events lethargic, nauseated and experienced Lymph node swelling on the lower left side of neck that's increasing in size was recovered with sequelae on unknown date in Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Oropharyngeal pain
Clinical narrative: Throat was sore; Allergies have been more frequently than before the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 17Jul2021 at 12:00, the patient experienced "allergies have been more frequently than before the vaccine" and the day of vaccination the throat was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events allergies have been more frequently than before the vaccine and throat was sore were resolving at the time of reporting.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel very different; This is a spontaneous report from a contactable consumer reporting for himself. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 16Jul2021 16:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feel very different on an unspecified date. Patient wanted to know the symptoms that one can get after the vaccine. Patient was 33 years old but feel like a very different man from what he was, and afraid to get the last vaccine. Patient was told that on 06Aug he had to get the Pfizer Covid-19 vaccine. Asked whether the vaccine kill hormones. Upon probing, caller stated he received the Johnson & Johnson vaccine, but later said he was not sure what vaccine he received. Patient asked why if he got Johnson's vaccine then, they were wanting him to get other vaccines. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain for about 24 hours on her right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter would like to know the possible side effects of taking the Pfizer´s COVID-19 vaccine, and how long would the side effects last after receiving the second dose of the vaccine. She already received both doses of the Pfizer's COVID-19 vaccine and developed several side effects, she received the first dose on 23Jun2021, and she developed arm pain for about 24 hours on her right arm. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single  for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified for COVID-19 immunisation. The patient experienced rash on an unspecified date in 2021. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site; Nausea; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Jul2021 at 12:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), diphenhydramine hydrochloride (BENADRYL) and valproate semisodium (DEPAKOTE), all from unknown dates and for unknown indications. On 20Jul2021 at 14:00, the patient experienced pain at injection site, nausea, body aches and fever. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, nausea, body aches and fever were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Full body aches; Chills; Fever; Weakness; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jul2021 at 21:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 at 20:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 11Jul2021, the patient experienced full body aches, chills, fever, weakness, headache and nausea. The patient stated that, he had no issues first two days and each day after the first two it progressively became worse for over a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Jul2021, the patient gave nasal swab for SARS-CoV-2 test and the result was negative. The clinical outcome of the events full body aches, chills, fever, weakness, headache and nausea were resolving at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Full body aches; Chills; Fever; Weakness; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jul2021 at 21:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 at 20:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 11Jul2021, the patient experienced full body aches, chills, fever, weakness, headache and nausea. The patient stated that, he had no issues first two days and each day after the first two it progressively became worse for over a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Jul2021, the patient gave nasal swab for SARS-CoV-2 test and the result was negative. The clinical outcome of the events full body aches, chills, fever, weakness, headache and nausea were resolving at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Large swollen, itchy, red splotch at injection site; Large swollen, itchy, red splotch at injection site; Large swollen, itchy, red splotch at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Jul2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient and concomitant medication were not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021, at 09:00, the patient experienced large swollen, itchy, red splotch at injection site. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event large swollen, itchy, red splotch at injection site was ongoing at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: FIRST DOSE: Patient received a COVID-19 Vaccine dose involved in a temperature excursion; FIRST DOSE: Patient received a COVID-19 Vaccine dose involved in a temperature excursion; This is a spontaneous report from a contactable Consumer or other health care professional. A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), via an unspecified route of administration in left arm on 08Jul2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. The reporter was an office manager who reported invalid COVID-19 vaccine doses were administered to 4 patients. "PRIVACY" clarified that the office manager reported their practice had kept the COVID-19 vaccine in the freezer since 08Jun2021, past the allowed extended freezer time, and then the COVID-19 vaccine was then given to 4 patients. "PRIVACY" said the COVID-19 vaccine can only be kept in the freezer for 3 weeks. "PRIVACY" said a temperature excursion had occurred on the practices COVID-19 vaccine, and the practices office manager was being transferred to report on the 4 patients that received the COVID-19 vaccine involved in the temperature excursion. Caller stated that the patients was vaccinated with expired use by date including on 08Jul2021 and later. Caller was looked for guidance on how to proceed. Reported the patient was unaware the COVID-19 vaccine was involved in a temperature excursion, and the patient had not reported any adverse events to their office since the COVID-19 vaccine was administered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Skin exfoliation, Therapeutic response unexpected
Clinical narrative: It has improved his skin. It has improved his immune system greatly.; itching; all of the skin on head has peeled/ The skin on his shoulders have peeled.; This is a spontaneous report from a contactable consumer or other non hcp received from Pfizer sponsored Program.   A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced all of the skin on head has peeled/ the skin on his shoulders have peeled, it has improved his skin. it has improved his immune system greatly and itching on an unspecified date. It was reported: Caller adds that he spoke with a woman at the bank and it happened to a friend of hers. Caller does not have any details to provide. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924204 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After the vaccine per the caller she no longer has COPD; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) from an unspecified date. The patient's concomitant medications were not reported. It was reported she did have COPD. After the vaccine per the caller she no longer has COPD on an unspecified date. The outcome of event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Tongue discomfort
Clinical narrative: Burning tongue; Sores on sides of tongue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1605868-09765) via an unspecified route of administration in the left arm on 21May2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and unspecified reflux. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021, the patient experienced burning tongue and sores on sides of tongue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events burning tongue and sores on sides of tongue was not recovered at the time of this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Head discomfort, Headache
Clinical narrative: Fever; Chills; joint aches; upsettummy; runny nose; head congestion; headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 18Jul2021 at 14:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3) and MULTIVITAMIN. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 28Jun2021 at 17:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021 at 00:00 the patient experienced fever, chills, joint aches, upset tummy, runny nose, head congestion and headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever, chills, joint aches, upset tummy, runny nose, head congestion and headache were recovering at the time of this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever; Chills; joint aches; upsettummy; runny nose; head congestion; headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 18Jul2021 at 14:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3) and MULTIVITAMIN. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 28Jun2021 at 17:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021 at 00:00 the patient experienced fever, chills, joint aches, upset tummy, runny nose, head congestion and headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever, chills, joint aches, upset tummy, runny nose, head congestion and headache were recovering at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Arm swollen entire bicep area and under the arm; Warm and feverish; This is a spontaneous report from a contactable pharmacist.  A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA6780; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in Deltoid Left on 18Jul2021 14:00 as DOSE 2, 0.3 ML SINGLE (age at vaccination was 45 years old) for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing hypertension, ongoing seizures and overweight ongoing. Concomitant medication(s) included zonisamide (ZONEGRAN) and levetiracetam (KEPPRA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in Deltoid Left on 27Jun2021 18:00 as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. On 19Jul2021, the patient had arm swollen entire bicep area and under the arm and was warm and feverish. It was reported that the patient took the vaccination as patient was overweight, had elderly parents, seeing more Delta variant. Patient had not filled this prescription for a while, so was unsure if she was still on levetiracetam. When reporter looked up vaccine information, she said that patient got the second shot 2 days ago and not a week ago (as stated by the patient). The patient did not have any other shots the same day or within 4 weeks of the Covid vaccine. Patient did not list any prior vaccine reactions or family history on the questionnaire. The outcome of both the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Ash or medicine smell/taste in nasal passages; Ash or medicine smell/taste in nasal passages; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, dogs, feathers, mold and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced ash or medicine smell/taste in nasal passages. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ash or medicine smell/taste in nasal passages was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness, Vaccination site nerve damage
Clinical narrative: strange nerve condition  at the vaccine site/ sometimes there's a nerves that gets nicked at the vaccination site; left arm goes numb and it got very weak; my left arm can become so weak ;I can't use it; I have to be very careful walking; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6199) via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that, the patient had a strange nerve condition at the vaccine site left arm, the patient left arm goes numb and it got very weak, so when it this was an intermittent condition sometimes it was there, sometimes it goes away and patient left arm can become so weak, was that the patient can not use it. Consumer stated that I have to be very careful walking and I have gone to my pharmacy and you know they seem to think that Pfizer did not have any nerve related issues, but they did say that sometimes there was a nerve that gets nicked at the vaccination site so (Further clarification unknown, event captured conservatively). The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: Very intense and terrifying nightmares; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Jul2021 at 17:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC)  for unknown indication and ethinylestradiol, norgestimate (SPRINTEC) for birth control on an unknown date. On 20Jul2021 at 22:30, first night after receiving the first shot, the patient experienced very intense and terrifying nightmares. Therapeutic measures were not taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event very intense and terrifying nightmares was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site mass, Vaccination site pain
Clinical narrative: Large bruise (~2in diameter) formed at the injection site several days after injection.; The injection site hurt and was tender to touch; The center of the bruise, where the injection was a hard small lump; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 01Jul2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jul2021, the patient experienced large bruise (~2in diameter) formed at the injection site several days after injection. The injection site hurt and was tender to the touch. The center of the bruise, where the injection was a hard small lump. The bruise was largely yellow/green indicating in came deep within the arm and not at the surface. At 3 weeks after the first vaccine, the bruise was diminishing. Only the bottom half of the bruise remained (dark green) and the bump of the injection site remained. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large bruise (~2in diameter) formed at the injection site several days after injection, the injection site hurt and was tender to touch and the center of the bruise, where the injection was a hard small lump was resolving at the time of this report.