chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pain in extremity
Clinical narrative: Directly after the vaccine  experienced sharp pain up and down left arm. Severe body aches and sweats.  Was in sever pain and suffering , nausea. Was unable to finish work day; Directly after the vaccine  experienced sharp pain up and down left arm. Severe body aches and sweats.  Was in sever pain and suffering , nausea. Was unable to finish work day; Directly after the vaccine  experienced sharp pain up and down left arm. Severe body aches and sweats.  Was in sever pain and suffering , nausea. Was unable to finish work day; Directly after the vaccine  experienced sharp pain up and down left arm. Severe body aches and sweats.  Was in sever pain and suffering , nausea. Was unable to finish work day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 09:00 as dose 1, single (Lot number: FP54454) at the age of 25 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (disability, life threatening), PAIN IN EXTREMITY (disability, life threatening), PAIN (disability, life threatening), HYPERHIDROSIS (disability, life threatening) all with onset 22Apr2022 at 11:00, outcome "not recovered" and all described as "Directly after the vaccine  experienced sharp pain up and down left arm. Severe body aches and sweats.  Was in sever pain and suffering , nausea. Was unable to finish work day". Therapeutic measures were taken as a result of nausea, pain in extremity, pain, hyperhidrosis.  Clinical Information: Directly after the vaccine patient experienced sharp pain up and down patient left arm. Severe body aches and sweats.  Was in sever pain and suffering, nausea. Was unable to finish her workday. No prolonged Hospitalization. No known allergies. Prior to vaccination, Patient was did not diagnosed with COVID-19. Since the vaccination, Patient has not been tested for COVID-19. Device Date: 23Apr2022. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not received any other medications received within 2 weeks of vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I got my first shot on 24Jan2022 and it IMMEDIATELY stopped my period which I had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 at 16:00 as dose 1, single (Lot number: FK9729) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "anemia" (unspecified if ongoing); "stress disorder" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LOSARTAN; AMLODIPINE. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 24Jan2022 at 16:30, outcome "not recovered", described as "I got my first shot on 24Jan2022 and it IMMEDIATELY stopped my period which I had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day". The events "i got my first shot on 24jan2022 and it immediately stopped my period which i had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day" required physician office visit. Therapeutic measures were taken as a result of menstruation irregular.  Additional information: The patient later received second dose of BNT162b2 (BNT162B2), on 14Feb2022 at 16:30 as dose 2, single (Lot number: FK9729) at the age of 47 years, in left arm for covid-19 immunisation. No other vaccine was administered in four weeks. She got her first shot on 24Jan2022 and it IMMEDIATELY stopped her period which she had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day because she got the second shot on 14Feb2022, from 24Jan2022 to 05Apr2022 she did not have a period and at her old age of 48 my periods were regular. She was not going through menopause (been did all that testing) didn't have fibroids or none of that and as of 24Apr2022 she have been on her period for 20 days since 05Apr2022. This has caused her to have severe anemia and even with medication like medroxyprogesterone 10mg it was NOT stopping. The patient was not tested for covid post vaccination. The patient did not have any known allergies.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Weight decreased
Clinical narrative: Difficulty controlling sugar levels; Has lost some weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EP7533) at the age of 64 years, on 27Apr2021 as dose 2, single (Lot number: EW0170) and on 15Nov2021 as dose 3 (booster) single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE ABNORMAL (non-serious), outcome "unknown", described as "Difficulty controlling sugar levels"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Has lost some weight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose abnormal.  Additional Information: Additional Context: Transferring agent states that the patient was asking about how to get the Prevnar 20 vaccine. The patient mentioned that he was seeking the vaccine due to difficulty controlling his sugar levels. The patient also mentioned he has had the three Covid 19 Vaccines. Transferring agent states that the procedure for the Prevnar 20 vaccine has been explained to the patient. he comes onto the line and verifies information received from the transferring agent. he states that he has been taking medications for his sugar levels for about 6 years. States his sugar levels have been harder to control since the Covid Vaccines. Difficulty controlling sugar levels:He states that it has been about a year or a year and a half since he thinks he took the vaccines in 2019. He says he has been in (Place Withheld) and has been trying to eat healthy and exercise. States he has been walking his dog and has lost some weight. He had stated that he thought he took the vaccines in 2019, but the year for his vaccines is actually 2021. He states that he is on a bunch of medications. States he takes insulin for his sugar levels and has been taking it for about 6 or 7 years. Denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. He states that the transferring agent explained to him that the doctor has to approve and request the vaccine to get it from Pfizer. He says he was thinking, he doesn't know if this is a program they have to apply for to get the Prevnar 20 through Pfizer? Does it have to be through the doctor? Says he knows that it does have to go through the doctor, but is this a program where they can get the Prevnar 20? He agrees to transfer back to the Pfizer Patient Assistance Program for clarification.  If follow-up activities cannot be or are not conducted: No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID-19; Tested Positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4365832-00.  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash started along back of her neck and continued toward front and up the hairline; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RASH (non-serious), outcome "unknown", described as "rash started along back of her neck and continued toward front and up the hairline".  Additional information: The patient reported that she was getting a rash after each dose (she had 3) of the vaccine. The rash started along back of her neck and continued toward front and up the hairline. After each dose the reaction time of the rash was quicker and more intense. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Fall, Fatigue, Nausea
Clinical narrative: G1 Stomachache; G1 Fever; G2 Fatigue/lingering G1 fatigue; G1 Nausea; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), on 22Apr2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster)), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), FALL (non-serious), TOOTH INJURY (non-serious) all with onset 22Apr2022, outcome "unknown" and all described as "Fainted and fell on the ground breaking my front incisive"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Fever"; NAUSEA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Nausea"; FATIGUE (non-serious) with onset 22Apr2022, outcome "unknown", described as "G2 Fatigue/lingering G1 fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Apr2022, outcome "unknown", described as "G1 Stomach ache".  Additional information: Within a couple of hours experienced G1 Fever, G2 Fatigue, G1 Nausea. Went to bed at 4:00pm. Woke up at 9:00pm to go pee. Fainted and fell on the ground breaking my front incisive. 23Apr2022: G1 Stomach ache and lingering G1 fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tooth injury
Clinical narrative: G1 Stomachache; G1 Fever; G2 Fatigue/lingering G1 fatigue; G1 Nausea; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), on 22Apr2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster)), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), FALL (non-serious), TOOTH INJURY (non-serious) all with onset 22Apr2022, outcome "unknown" and all described as "Fainted and fell on the ground breaking my front incisive"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Fever"; NAUSEA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Nausea"; FATIGUE (non-serious) with onset 22Apr2022, outcome "unknown", described as "G2 Fatigue/lingering G1 fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Apr2022, outcome "unknown", described as "G1 Stomach ache".  Additional information: Within a couple of hours experienced G1 Fever, G2 Fatigue, G1 Nausea. Went to bed at 4:00pm. Woke up at 9:00pm to go pee. Fainted and fell on the ground breaking my front incisive. 23Apr2022: G1 Stomach ache and lingering G1 fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: G1 Stomachache; G1 Fever; G2 Fatigue/lingering G1 fatigue; G1 Nausea; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), on 22Apr2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster)), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), FALL (non-serious), TOOTH INJURY (non-serious) all with onset 22Apr2022, outcome "unknown" and all described as "Fainted and fell on the ground breaking my front incisive"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Fever"; NAUSEA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Nausea"; FATIGUE (non-serious) with onset 22Apr2022, outcome "unknown", described as "G2 Fatigue/lingering G1 fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Apr2022, outcome "unknown", described as "G1 Stomach ache".  Additional information: Within a couple of hours experienced G1 Fever, G2 Fatigue, G1 Nausea. Went to bed at 4:00pm. Woke up at 9:00pm to go pee. Fainted and fell on the ground breaking my front incisive. 23Apr2022: G1 Stomach ache and lingering G1 fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Vaccination failure
Clinical narrative: G1 Stomachache; G1 Fever; G2 Fatigue/lingering G1 fatigue; G1 Nausea; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; Fainted and fell on the ground breaking my front incisive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), on 22Apr2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster)), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), FALL (non-serious), TOOTH INJURY (non-serious) all with onset 22Apr2022, outcome "unknown" and all described as "Fainted and fell on the ground breaking my front incisive"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Fever"; NAUSEA (non-serious) with onset 22Apr2022, outcome "unknown", described as "G1 Nausea"; FATIGUE (non-serious) with onset 22Apr2022, outcome "unknown", described as "G2 Fatigue/lingering G1 fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Apr2022, outcome "unknown", described as "G1 Stomach ache".  Additional information: Within a couple of hours experienced G1 Fever, G2 Fatigue, G1 Nausea. Went to bed at 4:00pm. Woke up at 9:00pm to go pee. Fainted and fell on the ground breaking my front incisive. 23Apr2022: G1 Stomach ache and lingering G1 fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Palpitations, Pyrexia
Clinical narrative: Racing heart; pulse rate of 154; fever of 101.4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Survivor of breast cancer and letrosole patient. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3, Pfizer Covid vaccine), for Covid-19 Immunization; Bnt162b2 (Dose: 2, Pfizer Covid vaccine), for Covid-19 Immunization; Bnt162b2 (Dose:1, Pfizer Covid vaccine), for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Racing heart"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "pulse rate of 154"; PYREXIA (non-serious), outcome "unknown", described as "fever of 101.4". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Racing heart, Pulse rate of 154, Fever of 101.4. Survivor of breast cancer and letrosole patient. Optional Information: Breast cancer survivor, Pfizer Covid vaccine from first dose to 2nd booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Racing heart; pulse rate of 154; fever of 101.4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Survivor of breast cancer and letrosole patient. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3, Pfizer Covid vaccine), for Covid-19 Immunization; Bnt162b2 (Dose: 2, Pfizer Covid vaccine), for Covid-19 Immunization; Bnt162b2 (Dose:1, Pfizer Covid vaccine), for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Racing heart"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "pulse rate of 154"; PYREXIA (non-serious), outcome "unknown", described as "fever of 101.4". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of Event: Racing heart, Pulse rate of 154, Fever of 101.4. Survivor of breast cancer and letrosole patient. Optional Information: Breast cancer survivor, Pfizer Covid vaccine from first dose to 2nd booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea, Neck pain
Clinical narrative: very Sore neck; hard to sleep; Nausea; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3; Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 22Apr2022, outcome "unknown"; CHILLS (non-serious) with onset 22Apr2022, outcome "unknown"; INSOMNIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "hard to sleep"; NECK PAIN (non-serious) with onset 22Apr2022, outcome "unknown", described as "very Sore neck".  Additional Information: Caller was a 80 year old female who received the second booster dose on 14Apr2022 and has experienced some symptoms such as very Sore neck, hard to sleep, Nausea and chills every once in a while which started on 22Apr2022 and she would like to know if its too late to develop side effects from the vaccine this long after getting the booster dose. The patient has no fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Goitre, Neck pain, Oropharyngeal pain
Clinical narrative: Goiter on his neck, like a huge ball; It hurts him; Hurts for him to talk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: GOITRE (non-serious), outcome "unknown", described as "Goiter on his neck, like a huge ball"; NECK PAIN (non-serious), outcome "unknown", described as "It hurts him"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Hurts for him to talk".  Additional Information: Caller reported that she was calling about her 18-years-old son, who got Pfizer COVID-19 booster on Thursday. He (son) woke up yesterday, with a goiter on his neck, like a huge ball. She was reading and it was common to have something like that under an armpit. No further details were provided. She had not read any information about this issue being on the side of the neck. She said it hurts him and hurts for him to talk. She asked if her son should see a doctor and also asked if anyone else had reported the similar issue. She asked if how long it would last. She declined to complete a safety report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, SARS-CoV-2 test
Clinical narrative: I start having a lot of pain on my left side of the neck, some days I have problems even moving my neck, wake up with headache; I start having a lot of pain on my left side of the neck, some days I have problems even moving my neck, wake up with headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Don't know), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Don't know), for Covid-19 Immunization. The following information was reported: NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 24Dec2021 at 12:00, outcome "not recovered" and all described as "I start having a lot of pain on my left side of the neck, some days I have problems even moving my neck, wake up with headache". The event "i start having a lot of pain on my left side of the neck, some days i have problems even moving my neck, wake up with headache" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of neck pain, headache.  Additional information:Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Generic Crestor  Losartan other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was not diagnosed with COVID-19. Since the vaccination, has the patient was tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Testicular swelling
Clinical narrative: Caller mentioned he had his 6th booster shot; after 20 minutes of getting vaccinated his balls got swollen stating that he is not a big guy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2), as dose 6 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed , Manufacturer unknown.), for covid-19 immunization; Covid-19 vaccine (Dose 3 booster, Manufacturer unknown.), for covid-19 immunization; Covid-19 vaccine (Dose 4 booster, Manufacturer unknown.), for covid-19 immunization; Covid-19 vaccine (Dose 5 booster, Manufacturer unknown.), for covid-19 immunization.  The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Caller mentioned he had his 6th booster shot"; TESTICULAR SWELLING (non-serious), outcome "unknown", described as "after 20 minutes of getting vaccinated his balls got swollen stating that he is not a big guy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Visual impairment
Clinical narrative: immediately got vision issues; non-reparable blood clot in eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset Apr2022, outcome "unknown", described as "non-reparable blood clot in eye"; VISUAL IMPAIRMENT (non-serious) with onset 24Apr2022 at 18:00, outcome "unknown", described as "immediately got vision issues".  Clinical Course: The reporter's and his wife got the second booster of the Pfizer COVID-19 Vaccine yesterday 24Apr2022. His wife immediately got vision issues and by 6 pm last night, which was approximately 6 hours after the shot, she couldn't see anything on her right eye. Reporter's wife was diagnosed with a non-reparable blood clot in eye. Reporter wanted to know if there were any reports of this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, C-reactive protein normal, Echocardiogram, Laboratory test normal, Optic disc haemorrhage
Clinical narrative: immediately got vision issues; non-reparable blood clot in eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset Apr2022, outcome "unknown", described as "non-reparable blood clot in eye"; VISUAL IMPAIRMENT (non-serious) with onset 24Apr2022 at 18:00, outcome "unknown", described as "immediately got vision issues".  Clinical Course: The reporter's and his wife got the second booster of the Pfizer COVID-19 Vaccine yesterday 24Apr2022. His wife immediately got vision issues and by 6 pm last night, which was approximately 6 hours after the shot, she couldn't see anything on her right eye. Reporter's wife was diagnosed with a non-reparable blood clot in eye. Reporter wanted to know if there were any reports of this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Optic neuritis, Retinal artery occlusion, Retinogram abnormal, Ultrasound Doppler normal, Visual field tests abnormal
Clinical narrative: immediately got vision issues; non-reparable blood clot in eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset Apr2022, outcome "unknown", described as "non-reparable blood clot in eye"; VISUAL IMPAIRMENT (non-serious) with onset 24Apr2022 at 18:00, outcome "unknown", described as "immediately got vision issues".  Clinical Course: The reporter's and his wife got the second booster of the Pfizer COVID-19 Vaccine yesterday 24Apr2022. His wife immediately got vision issues and by 6 pm last night, which was approximately 6 hours after the shot, she couldn't see anything on her right eye. Reporter's wife was diagnosed with a non-reparable blood clot in eye. Reporter wanted to know if there were any reports of this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "Heart attack". The patient date of death was unknown. Reported cause of death: "Heart attack". It was not reported if an autopsy was performed.  Clinical course: Caller stated that she had a friend whose brother died after the Pfizer shot, he died from a heart attack 7 days after and he was fine and in good health before that, but oh it could not be the shot, well that was the only thing that was different was the shot. Caller stated another friend's 19 years old son had a heart attack after the vaccine and now has myocarditis for the rest of his life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart attack
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to beef" (unspecified if ongoing), notes: She stated that she is allergic to beef, specifically beef gelatin or bovine gelatin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Third dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives".  Additional information: Reporter was a MD (Doctor of medicine) calling on behalf of herself as a consumer. Reporter explained that she had some bad reactions after receiving the second booster dose of Pfizer-BioNTech COVID-19 Vaccine. She stated that she is allergic to beef, specifically beef gelatin or bovine gelatin. She said she experienced "hives, etc.". Reporter wanted to know if the vaccine contains gelatin and what is the exact source of this gelatin. Gelatin is not used during the manufacture of the vaccine. The vaccine does not contain gelatin. However, the vaccine is not specifically manufactured to be gelatin-free. We cannot guarantee that minute amounts of substances are not contained in raw materials obtained from our suppliers. Reporter wanted to know if the vaccine contains specifically bovine-derived products. Reporter stated that it took "a little while" to report the AE. She spent about 10-15 minutes on the phone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: intermittent chest pain (stabbing pain); The severity of pain was described as high as 7 out of 10; Pain is not exercise induced (seems random); The pain is around fourth rib and lasts for 15 minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 23-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,, Batch/lot unknown=Unknown), administration date: Nov2021, when the patient was 23 years old, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "intermittent chest pain (stabbing pain); The severity of pain was described as high as 7 out of 10; Pain is not exercise induced (seems random); The pain is around fourth rib and lasts for 15 minutes". The events "intermittent chest pain (stabbing pain); the severity of pain was described as high as 7 out of 10; pain is not exercise induced (seems random); the pain is around fourth rib and lasts for 15 minutes" required physician office visit. It was unknown if therapeutic measures were taken as a result of chest pain. Additional information: The patient had not been exercising. Patient reported had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Neuropathy peripheral
Clinical narrative: Nerve sensitivity; 100.7 fever; Muscle, joint pain; Muscle, joint pain; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had COVID with multifocal pneumonia" (unspecified if ongoing), notes: I had COVID with multifocal pneumonia 3 or 4 months ago.; "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 24Apr2022, outcome "unknown", described as "100.7 fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 24Apr2022, outcome "unknown" and all described as "muscle, joint pain"; NEUROPATHY PERIPHERAL (medically significant) with onset 24Apr2022, outcome "unknown", described as "nerve sensitivity"; HEADACHE (non-serious) with onset 24Apr2022, outcome "unknown", described as "slight headache". The patient underwent the following laboratory tests and procedures: Body temperature: (25Apr2022) 100.7.  Clinical course: The patient stated that Is it normal to have a 100.7 fever the day after first dose of your Covid vaccine. Patient had Covid with multifocal pneumonia 3 or 4 months ago. Even though patient had rheumatoid arthritis, its doctor urged to vaccinate with Pfizer. patient did so yesterday and had the fever plus muscle, joint pain, and nerve sensitivity. Also, a slight headache. Thank you in advance for your response. Patient really appreciate it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nerve sensitivity; 100.7 fever; Muscle, joint pain; Muscle, joint pain; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had COVID with multifocal pneumonia" (unspecified if ongoing), notes: I had COVID with multifocal pneumonia 3 or 4 months ago.; "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 24Apr2022, outcome "unknown", described as "100.7 fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 24Apr2022, outcome "unknown" and all described as "muscle, joint pain"; NEUROPATHY PERIPHERAL (medically significant) with onset 24Apr2022, outcome "unknown", described as "nerve sensitivity"; HEADACHE (non-serious) with onset 24Apr2022, outcome "unknown", described as "slight headache". The patient underwent the following laboratory tests and procedures: Body temperature: (25Apr2022) 100.7.  Clinical course: The patient stated that Is it normal to have a 100.7 fever the day after first dose of your Covid vaccine. Patient had Covid with multifocal pneumonia 3 or 4 months ago. Even though patient had rheumatoid arthritis, its doctor urged to vaccinate with Pfizer. patient did so yesterday and had the fever plus muscle, joint pain, and nerve sensitivity. Also, a slight headache. Thank you in advance for your response. Patient really appreciate it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infections. Tested positive on 25Apr2022 for Covid using at-home test kits; Breakthrough infections. Tested positive on 25Apr2022 for Covid using at-home test kits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN6203), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 49 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Breakthrough infections. Tested positive on 25Apr2022 for Covid using at-home test kits". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: using at-home test kits. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: No covid prior vaccination, no covid tested post vaccination and patient did not have known allergies. No treatment was taken for AE. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in extremity, Product administered to patient of inappropriate age, Productive cough
Clinical narrative: 6 year old male patient who was administered 0.3mL of the undiluted Gray cap vaccine; Sore arm; Nasty cough for 7 days; Sore throat for 4 days; Headaches for 3 days; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 6-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 0.3ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE , outcome "unknown", described as "6 year old male patient who was administered 0.3mL of the undiluted Gray cap vaccine"; PRODUCTIVE COUGH , outcome "recovered", described as "Nasty cough for 7 days"; OROPHARYNGEAL PAIN outcome "recovered", described as "Sore throat for 4 days"; HEADACHE outcome "recovered", described as "Headaches for 3 days"; PAIN IN EXTREMITY outcome "unknown", described as "Sore arm".  Additional information: Patient Age: 6 years. Reporter Subtype: Pharmacist. Consumer is asking for the recommendations on the administration of an adult COVID Vaccine to a pediatric patient. They had a 6-year-old male patient who was administered 0.3mL of the undiluted Gray cap vaccine. She mentioned that the patient's grandmother reported him to have been having a nasty cough for 7 days, sore throat for 4 days, headaches for 3 days, and a sore arm. The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, PNC20
Symptoms: Condition aggravated, Fatigue, Headache, Hot flush
Clinical narrative: worsening hot flashes; worsening hot flashes; tiredness; headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE NUMBER UNKNWON, SINGLE, Primary immunization series complete.), for Covid-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN., DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: HOT FLUSH (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "worsening hot flashes"; FATIGUE (non-serious), outcome "recovered", described as "tiredness"; HEADACHE (non-serious), outcome "recovered".  Additional information: Reported worsening hot flashes after receipt of the 2nd booster. Also reported tiredness and headache starting about 24 hours after the booster both which resolved. Prevnar 20 was co-administered with the 2nd booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". The patient date of death was unknown. Reported cause of death: "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". It was not reported if an autopsy was performed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200625894 same reporter/ drug/ event, different patient;US-PFIZER INC-202200625895 same reporter/ drug/ event, different patient; Reported Cause(s) of Death: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine