chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible.  Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Late/Irregular period; This is a spontaneous report from a non-contactable consumer (patient). A 21-years-old female patient received bnt162b2 (BNT162B2) at the age of 21-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 23May2021 (Batch/Lot Number: TW0187) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 (Batch/Lot Number: TW0196) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history was not reported. The COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced late/irregular period on 2021 with outcome of unknown. Reported Event: Late/Irregular period (she had tracked period for years, so she can tell when it should have come, and that there are no other factors that would cause this sudden change). No treatment was received. The report was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts possible. No further information expected. Information about batch number has been obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Nausea, Pain, Pyrexia
Clinical narrative: vomiting multiple times; Nausea; Chills; Fever; Body aches; Chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 22-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine) at the age of 22-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 05Jul2021 15:45 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 Immunization on 14Jun2021 at the age of 22-years-old (1st Dose, Batch/lot number: EW0196, Anatomical Location: Arm left, Administration time: 11:00 AM). Reported Adverse Events: Nausea, vomiting multiple times, chills, fever, body aches and chest pain since 06Jul2021 05:00AM. No treatment received. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Case received as non-serious.  No follow-up attempts possible. No further information expected. Information about batch number has been obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting multiple times; Nausea; Chills; Fever; Body aches; Chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 22-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine) at the age of 22-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 05Jul2021 15:45 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 Immunization on 14Jun2021 at the age of 22-years-old (1st Dose, Batch/lot number: EW0196, Anatomical Location: Arm left, Administration time: 11:00 AM). Reported Adverse Events: Nausea, vomiting multiple times, chills, fever, body aches and chest pain since 06Jul2021 05:00AM. No treatment received. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Case received as non-serious.  No follow-up attempts possible. No further information expected. Information about batch number has been obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Oropharyngeal pain, Sinusitis
Clinical narrative: I have a horrible sinus infection; Painful sore throat (puss in throat red it's gross); Painful sore throat (puss in throat red it's gross); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 19-year-old female patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 02Jul2021 at 10:30AM (at age of 19-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no medical history, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol / norgestrel (ELINEST). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 on 02Jun2021 at 10:30AM (at age of 19-year-old) for covid-19 immunisation. The patient had been dealing with a painful sore throat (puss in throat red it's gross) and she had a horrible sinus infection on 05Jul2021 at 01:15 PM. No treatment was received for the event. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythromelalgia
Clinical narrative: Erythromelalgia; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er2613) at the age of 28-years, via an unspecified route of administration in left arm on 20Mar2021 at 14:00 at single dose for COVID-19 immunization, in public health clinic. Medical history included asthma. Patient had no known allergies, was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and spironolactone. On 24Mar2021, onset of burning red feet and hands 4 days after vaccination, with patches on legs (flare up after walking, pressure such as standing, heat, and at night). Diagnosis of Erythromelalgia. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received nifedipine, sildenafil citrate (VIAGRA), multiple compound creams as treatment for the adverse event. Outcome was not recovered. Seriousness criteria was provided as disabling/incapacitating. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiomegaly, Heart rate, Heart rate increased, Illness, Interchange of vaccine products
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Partial seizures
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blindness, Blindness unilateral, Cardiomegaly, Computerised tomogram, Electrocardiogram abnormal
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypertension, Ocular discomfort, Product substitution
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Blood pressure increased, Blood test, Chest X-ray, Computerised tomogram
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Gait inability, Hypertension
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Malaise, Ophthalmological examination, Urinary tract infection, Wrong product administered
Clinical narrative: focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Hyperhidrosis, Syncope
Clinical narrative: she wanted to pass out; Sweating; she felt weak; middle of her stomach it hurts/Stomach ache; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (daughter).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jun2021 (As reported: lot number: 'E06180', or 00180; Expiry Date of Covid-19 Vaccine: Unknown) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced she wanted to pass out (syncope) on 06Jul2021 with outcome of unknown , sweating (hyperhidrosis) (non-serious) on 06Jul2021 with outcome of unknown , she felt weak (asthenia) (non-serious) on 06Jul2021 with outcome of unknown , middle of her stomach it hurts/stomach ache (abdominal pain upper) (non-serious) on 06Jul2021 with outcome of unknown.   No follow up attempts are possible. information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed, Pregnancy test
Clinical narrative: After the first dose I had a large blood clot during menstruation; now I'm 6 days late with negative pregnancy tests; and with the next 2 cycles in May and June had no LH peak/ May and June periods were lighter than usual.; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: TW0158, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 at 11:30 hours as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. The patient also received other vaccine (Lot Number: EW0179, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 as dose 2 for immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. Patient always had a consistent and predictable period. On 12May2021, after the first dose, patient had a large blood clot during menstruation, size of a walnut, patient also had blood clot test, for which results were unknown and with the next 2 cycles in May and June had no luteinizing hormone (LH) peak; although patient always had one for all prior cycles, patient had tested. Patient had gone to a fertility specialist and had been deemed more than ok to convince prior to vaccine. Nothing in her life had changed much and now, patient was 6 days late with negative pregnancy tests. Also, May and June periods were lighter than usual. Patient received no treatment for all the events. The outcome of all the events was unknown.   Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: had a miscarriage after being around someone that had the Pfizer vaccine: Unspecified; had a miscarriage after being around someone that had the Pfizer vaccine: Unspecified; This is a spontaneous report from a contactable consumer or other non hcp. This is a spontaneous report received from a contactable consumer. This consumer reported for a female (neighbour patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number and expiration date 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 had a miscarriage after being around someone that had the pfizer vaccine on an unspecified date. The mother reported she became pregnant while taking bnt162b2. Reporter is calling regarding the Pfizer Covid 19 vaccine. She has been doing some research and her neighbour and her mother had the Pfizer covid virus vaccine. Reporter gave them a ride to pick up their car, which is about 15 minutes from her house. Ever since she gave them a ride , she (caller) has been having really horrible and very massive headaches. She has never had so much pain over her head in her life. Reporter had done some research and unfortunately, she was supposed to stay away from them. They were in her car. She got their spiked proteins and now could have inflammation in her brain, which is causing neurological brain damage by being in a confined area with someone who got the Pfizer vaccine. Report 3 of 3 is for the female that had a miscarriage after being around someone who had the Pfizer vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested  Follow-up (14Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Poor quality product administered
Clinical narrative: Unable to verify if two patients received the correct valid dose of Pfizer Covid 19 vaccine or only diluent; Unable to verify if two patients received the correct valid dose of Pfizer Covid 19 vaccine or only diluent; This is a spontaneous report from a contactable pharmacist. A 12-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jul2021 17:00 (age at vaccination 12-years) (Batch/Lot Number: EW0198; Expiration Date: Sep2021) as single dose for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jun2021 (Batch/Lot Number: EW0217; NDC/expiration: 59267100001) as single dose for COVID-19 immunization. Pharmacist reported a potential invalid dose of the Pfizer Covid 19 vaccine administered to two patients. Pharmacist is unable to verify if two patients received the correct valid dose of Pfizer Covid 19 vaccine or only diluent.  Per the Pharmacist there is no concrete information at this time. The two patients would have been receiving the second dose of the Pfizer Covid 19 vaccine series when this event occurred. Pharmacist shared that additionally, one of the doses of the vaccine may have been a lower than authorized dose (unable to determine if extra diluent used/unable to estimate/thinks it was lower dose). Still unable to provide which patient got potential invalid dose vs. actual dose of vaccine. On 07JUL2021 it was reported that it is unknown if patient got full dose of vaccine or mostly diluent, for second dose. Caller states he called Medical Information earlier to report that, reclarified, the vaccine was given to two people, and they were unsure if one patient got the full vaccine, and one person may have gotten diluent. Further states they used up a vial, and someone tried to mix a new dose with a small amount of vaccine, he estimates less than 5 or 1 percent, of vaccine. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No AEs was following prior vaccinations. The outcome of events was unknown.  Information about lot/batch number is available. Follow-up attempts are needed
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Visual impairment
Clinical narrative: I can't even see it, my eyes are so bad; I am feeling really achy; This is a spontaneous report from Consumer or other non health professional (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 3099, Expiry Date: Unknown), via an unspecified route of administration on arm right on 07Jul2021 (Age at Vaccination: 61 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Other products was reported as no. The patient Concomitant medications were not reported (No, I don't take other medication at all). On 08Jul2021, the patient experienced I am feeling really achy. It was reported that patient stated "Yes, I got shot yesterday and I woke this morning and I am feeling really achy. I know they said that might be some of the side effect, I am just wondering how long it does last?" On an unspecified date, the patient reported that "I can't even see it, my eyes are so bad. I have my glasses on and I can't see it." The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Nasal septum deviation
Clinical narrative: Has a "deviated septum"; This is a spontaneous report from a contactable consumer (reporter's son).   A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient historical vaccine included first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. He got the first dose of Trumenba last 25Jul2019. Her son never went to get the second dose. Her son had both doses of his Pfizer-BioNTech COVID-19 Vaccine. He was a college student. He was advised not to get the second dose of Trumenba. On an unspecified date, patient has a "deviated septum". The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Pain, Paraesthesia, Tinnitus
Clinical narrative: One nurse also had the same symptom as she had/ Started with a headache; One nurse also had the same symptom as she had; One nurse also had the same symptom as she had; One nurse also had the same symptom as she had; One nurse also had the same symptom as she had; This is a spontaneous report from a contactable consumer via a team. This is 2nd case of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, her daughter got her first dose of the Pfizer Covid 19 vaccine last April. Three days later she experienced horrible headache all the way down to her body. Also added that she experienced nerve twitching, nerve touching in her legs and left arm that went to her right arm. When she went to her doctor, they said that they don't even think that the side effects she is experiencing is from the Pfizer COVID vaccine. That it's all in her head. One nurse (patient) also had the same symptom as she (daughter) had. The patient experienced the similar events of headache, pulsating tinnitus, General body pain, Twitching of limbs, Tingling sensation.The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Illness, Limb discomfort, Peripheral swelling
Clinical narrative: My right arm where I just got my second shot is twice the size of my left arm; I've taken pictures of my arm and my arm is twice the size its red and hot; I've taken pictures of my arm and my arm is twice the size its red and hot; I've been sick for days and this is disturbing; my whole arm is red and swollen; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Previously, the patient received first dose of BNT162B2 for COVID-19 immunization. On an unknown date, the patient experienced right arm where the patent just got my second shot was twice the size of my left arm, the patient had taken pictures of my arm and my arm was twice the size it was red and hot, the patient had been sick for days and this was disturbing and my whole arm was red and swollen. The reporter was vocally frustrated, stated this had affected the patient's life. The patient know that people lives don't mean anything to anybody and people around here who the patient live around would not get the injection. Response was received by the Pfizer team that confirmed Pfizer Covid vaccine. Offered to provide website for more information, caller declined. Referred to HCP for evaluation and discussion. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: arms hurt worse; every muscle aches; This is a spontaneous report from a contactable consumer (patient's mother).   A 30-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 28Apr2021 (at the age of 30-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation and experienced arm hurt, head feels swooshy and ears were clogged up. On an unspecified date in 2021, after receiving second dose, patient experienced arms hurt worse and every muscle aches. it was reported that Caller proceeded to share AE information regarding herself, her son, and her girlfriend. She said her "son's arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. Her girlfriend experienced the same thing".  After the second dose, she reported that "our arms hurt worse". Her son told her "every muscle aches". He went on a walk with a friend and "felt 100% better". Caller shared she was told by the vaccine nurse to "overly hydrate herself. I got body armor and drank one before and one after. I took a couple doses of Tylenol and felt better". Caller also shared that she doesn't drive because she has narcolepsy. Son is male, 30 years. Girlfriend is female, age not asked. Response received as Spoke from the attached FAQ document: The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. (2)The Centers for Disease Control and Prevention (CDC) states that information about the characteristics of these variants is rapidly emerging. Scientists are working to learn more about how easily they spread, whether they could cause more severe illness, and whether currently authorized vaccines will protect people against them: This variant was first detected in Mar2021. It was initially identified in Dec2020. So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. Outcome of the events were unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms hurt worse; This is a spontaneous report from a contactable consumer (patient).   A female patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 28Apr2021, at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), on  via an unspecified route of administration on 07Apr2021, for COVID-19 immunization. Medical history was not reported. No concomitant medicaton was reported. She  proceeded to share AE information regarding herself, her son, and her girlfriend. She said her "son's arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. Her girlfriend experienced the same thing".  After the second dose, she reported that "our arms hurt worse". Her son told her "every muscle aches". He went on a walk with a friend and "felt 100% better". She shared she was told by the vaccine nurse to "overly hydrate herself. I got body armor and drank one before and one after. I took a couple doses of Tylenol and felt better". She also shared that she doesn't drive because she has narcolepsy. The outcome of Event was unknown.   Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021861933 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Developed a mullbilliform rash; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 14-year-old patient of an unknown gender received second dose of BNT162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously, the patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and no reaction on previous exposure to drug was reported. On an unknown date, the patient developed a mullbilliform rash after the 2nd dose of the Pfizer COVID-19 vaccine. The outcome of the event was unknown.  Follow-up attempts are needed. Information on Lot/Batch number can be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Consumer reported not being able to move lips the way they want to after first CoVax dose; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program.  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient reported not being able to move lips the way he wanted to after first  dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified
Clinical narrative: pregnant; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 38-year-old pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 38-year-old and pregnant at the time of vaccination), via an unspecified route of administration on 13Apr2021 at 09:48 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 24Mar2021 at 10:41 as single dose for covid-19 immunisation. On an unspecified date, the patient experienced pregnant. The mother reported she became pregnant while taking BNT162B2. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :PFIZER INC-2021868616 same reporter, drug/ fetus case