chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, SARS-CoV-2 test
Clinical narrative: sides of my head also felt "hot" a few days after the second injection; sides of my head also felt "hot" a few days after the second injection; 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), administered in arm right, administration date 12Mar2021 09:00 (Lot number: EN6203) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "meniere's disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; LISINOPRIL; HYDROCHLOROTHIAZIDE; PRAVASTATIN. Past drug history included: Ampicillin, reaction(s): "known allergies;ampicillian". Vaccination history included: Bnt162b2 (DOSE: 1st, Lot number: EL9269, Dose administration time=09:00, Vaccine location=Left arm), administration date: 19Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: HEAD DISCOMFORT (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "unknown" and all described as "sides of my head also felt "hot" a few days after the second injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, feeling hot.  Additional information: Patient stated that sides of his head also felt "hot" a few days after the second injection. Patient stated that he called his gastroenterologist as he started taking Humira 6 weeks earlier, but was informed that Humira has no such side effects by his gastroenterologist, and patient continues taking Humira with no effects.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Fever up and down 101.5, 102.5.; Not feeling well; 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. A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 (Lot number: FK5127) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date Dec2021. The following information was reported: PYREXIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Fever up and down 101.5, 102.5."; MALAISE (non-serious) with onset 22Dec2021, outcome "unknown", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The mother of the patient wants to know was fever normal. She indicates she has two children, one is 8 years of age and one is 10. Received doses the same day and youngest one was fine other is not. She was asking for treatment recommendation and asks if she should/could give her something and was this normal or not. Says she was wondering if a fever was normal 2 days after the shot or not as her child has a fever. Patient had no History of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit Emergency Room or Physician Office. No Relevant Tests.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling on right side of torso; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 29Apr2021 13:00 (Lot number: EW0170) at the age of 59 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 03Sep2020 (unspecified if ongoing); "Lyme Disease", start date: Aug2021 (unspecified if ongoing); "shingles", start date: 2006 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1; Lot number: ER 8734; 13:00 in the left arm), administration date: 01Apr2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 07May2021, outcome "not recovered", described as "tingling on right side of torso". The event "tingling on right side of torso" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a COVID-19 polymerase chain reaction (PCR) (Accula) test done on 23Nov2021 (nasal swab), which was negative.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Swelling and pain under the right armpit; Swelling and pain under the right armpit; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2021 10:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 24Feb2021, when the patient was 33 years old, for COVID-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 17Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 10:30, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 24Dec2021, outcome "recovering" and all described as "Swelling and pain under the right armpit". Therapeutic measures were not taken as a result of axillary pain, swelling. Additional information: The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination.  The patient did not have COVID prior to the vaccination. No known allergies.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: rash on the arms; booster (dose 3); 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 female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 11Nov2021 (Lot number: FC3180) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "psoriasis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 2; Lot number: EP7534), administration date: 19Mar2021, when the patient was 48 years old, for COVID-19 immunization; BNT162B2 (Dose 1; Lot number: EN6203), administration date: 26Feb2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021, outcome "unknown", described as "booster (dose 3)"; RASH (non-serious) with onset 26Nov2021, outcome "recovering", described as "rash on the arms".  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: swollen armpit with mild pain; swollen armpit with mild pain; booster (dose 3); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 23Dec2021 02:30 (Lot number: FE3598) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 2; Lot number: EW0162 in the right arm), administration date: 15Apr2021, when the patient was 53 years old, for COVID-19 immunization; BNT162B2 (Dose 1; Lot number: ER2613 in the right arm), administration date: 25Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 02:30, outcome "unknown", described as "booster (dose 3)"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 25Dec2021 01:00, outcome "unknown" and all described as "swollen armpit with mild pain".  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia, Peripheral swelling
Clinical narrative: my entire body was numb and tingling; my entire body was numb and tingling; legs felt heavy and twice their size; legs felt heavy and twice their size; left side of my face went numb; my arms went numb;   Report about Covid vaccine: Yes Reporting type: AE Reporter type: Patient Patient occupation: None of the above If other vaccine in four weeks: No  Other medications in two weeks: metoprolol tartrate BID  Adverse event: 10 minutes after the shot I got up to leave and my entire body was numb and tingling and continued until the next day. Twice overnight got up and legs felt heavy and twice their size. 2 days later the left side of my face went numb which lasted 7 or 8 days then areas of the left side of face went numb for about 2 more weeks and sometimes my arms went numb. I was the last person to get the shot at name withheld that night and the pharmacy dept. was closed when I felt the numbness and tingling so there was no one to report the side effect to.  If treatment ae: No if Covid prior vaccination: No if Covid tested post vaccination: No
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Dizziness, Illness, Immunisation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 20211229714 (Reference ID). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen Covid-19 vaccine (we had the J&J, dose, 1 total), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "booster after we had the J&J"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". Additional information: The patient reported that she and her husband took the Pfizer booster after they had the J&J and got really sick. Her husband had chest pains within 10 minutes and within half hour was hurting all over and no energy. Her AE started the next day and she was in bed for 7 days with joint pain, nausea, dizziness and no appetite, will never take another vaccine. Drug: Janssen Covid-19 vaccine (Covid-19 vaccine AD26. COV2.S) (Suspension for injection) (Covid-19 Vaccine AD26.COV2.S),1. The lot number for bnt162b2 was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nausea, Off label use
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 20211229714 (Reference ID). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen Covid-19 vaccine (we had the J&J, dose, 1 total), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "booster after we had the J&J"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". Additional information: The patient reported that she and her husband took the Pfizer booster after they had the J&J and got really sick. Her husband had chest pains within 10 minutes and within half hour was hurting all over and no energy. Her AE started the next day and she was in bed for 7 days with joint pain, nausea, dizziness and no appetite, will never take another vaccine. Drug: Janssen Covid-19 vaccine (Covid-19 vaccine AD26. COV2.S) (Suspension for injection) (Covid-19 Vaccine AD26.COV2.S),1. The lot number for bnt162b2 was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: COVID Toes; Dose 1 and Dose 2 Moderna, Dose 3 Pfizer; Dose 1 and Dose 2 Moderna, Dose 3 Pfizer; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 10:45 (Lot number: FL3197) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "high cholesterol" (unspecified if ongoing), notes: high cholesterol. The patient took concomitant medications. Vaccination history included: Moderna vaccine (Dose Number: 2, Batch/Lot No: 007B21A, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 56 years old, for COVID-19 Immunization; Moderna vaccine (Dose Number: 1, Batch/Lot No: 040A21A, Location of injection: Arm Left), administration date: 13Mar2021, when the patient was 56 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 18Dec2021 10:45, outcome "unknown" and all described as "Dose 1 and Dose 2 Moderna, Dose 3 Pfizer"; IMMUNISATION (non-serious) with onset 18Dec2021 10:45, outcome "unknown", described as "Dose received 3"; ILL-DEFINED DISORDER (non-serious) with onset 20Dec2021, outcome "not recovered", described as "COVID Toes". The event "covid toes" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of ill-defined disorder.  Additional information: Another reporter is other HCP. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Vomiting
Clinical narrative: I got the J&J vaccine; I got the J&J vaccine; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Dec2021 15:30 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "I got the J&J vaccine"; VOMITING (non-serious) with onset 24Dec2021 04:00, outcome "recovered" (Dec2021), described as "Vomiting".  Additional information: The patient did vaccine as a booster at 3:30 pm on 23Dec2021. At 4am, on the 24th the patient began vomiting until noon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Joint range of motion decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Janssen Dose Number: 1/Pfizer Dose Number: 2; Janssen Dose Number: 1/Pfizer Dose Number: 2; Sore arm; sore arm and neck; He cannot turn his head to look to the side or behind him which makes driving and operating machinery difficult. He has full range of motion in arm but not neck; He has full range of motion in arm but not neck; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Dec2021 14:30 (Lot number: fj8762) at the age of 63 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Janssen (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 06Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 13Dec2021 14:30, outcome "unknown" and all described as "Janssen Dose Number: 1/Pfizer Dose Number: 2"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Sore arm"; NECK PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "sore arm and neck"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 13Dec2021, outcome "not recovered", described as "He cannot turn his head to look to the side or behind him which makes driving and operating machinery difficult. He has full range of motion in arm but not neck"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "He has full range of motion in arm but not neck". The events "sore arm", "sore arm and neck", "he cannot turn his head to look to the side or behind him which makes driving and operating machinery difficult. he has full range of motion in arm but not neck" and "he has full range of motion in arm but not neck" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain in extremity, neck pain, joint range of motion decreased, musculoskeletal stiffness. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Janssen Dose Number: 1/Pfizer Dose Number: 2; Janssen Dose Number: 1/Pfizer Dose Number: 2; Sore arm; sore arm and neck; He cannot turn his head to look to the side or behind him which makes driving and operating machinery difficult. He has full range of motion in arm but not neck; He has full range of motion in arm but not neck; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Dec2021 14:30 (Lot number: fj8762) at the age of 63 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Janssen (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 06Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 13Dec2021 14:30, outcome "unknown" and all described as "Janssen Dose Number: 1/Pfizer Dose Number: 2"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Sore arm"; NECK PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "sore arm and neck"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 13Dec2021, outcome "not recovered", described as "He cannot turn his head to look to the side or behind him which makes driving and operating machinery difficult. He has full range of motion in arm but not neck"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "He has full range of motion in arm but not neck". The events "sore arm", "sore arm and neck", "he cannot turn his head to look to the side or behind him which makes driving and operating machinery difficult. he has full range of motion in arm but not neck" and "he has full range of motion in arm but not neck" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain in extremity, neck pain, joint range of motion decreased, musculoskeletal stiffness. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid Virus; Tested positive for Covid Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "not recovered" and all described as "Tested positive for Covid Virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test, Suspected COVID-19, Throat irritation
Clinical narrative: suspected covid-19; next day I had a little bit of body ache, and then today a little bit more; also a little bit of a scratchy throat; 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.  A female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 ANTIBODY TEST POSITIVE (medically significant), outcome "unknown" and all described as "I took an antibody test and it came out positive"; PAIN (non-serious) with onset 28Dec2021, outcome "unknown", described as "next day I had a little bit of body ache, and then today a little bit more"; THROAT IRRITATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "also a little bit of a scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Additional information: onset latency for the events was 01 day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site pain
Clinical narrative: he had Covid19 a week after the 1st dose; he had Covid19 a week after the 1st dose; he was still experiencing arm pain on his injection site (right arm) until now/pain was pretty bad sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 18:00 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "he had Covid19 a week after the 1st dose"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "he was still experiencing arm pain on his injection site (right arm) until now/pain was pretty bad sometimes". Therapeutic measures were not taken as a result of covid-19, vaccination site pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Immunisation, Infarction, Insomnia
Clinical narrative: I had an infarction; chest pain; was not able to sleep; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 10:30 (Lot number: 330308D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "known allergies: pcn" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Known allergies: vicodin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 21Apr2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 31Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021 10:30, outcome "unknown", described as "booster"; INFARCTION (medically significant) with onset 19Nov2021 12:15, outcome "not recovered", described as "I had an infarction"; CHEST PAIN (non-serious) with onset 19Nov2021 12:15, outcome "not recovered", described as "chest pain"; INSOMNIA (non-serious) with onset 19Nov2021 12:15, outcome "not recovered", described as "was not able to sleep". The events "i had an infarction", "chest pain" and "was not able to sleep" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: abnormal, notes: This time it was Abnormal, and it showed I had an infarction; normal, notes: Before the vaccinations my EKG was normal. Therapeutic measures were not taken as a result of infarction, chest pain, insomnia.  Additional information: The patient was experiencing chest pain the day of and the day after I received my booster. I was not able to sleep whatsoever. I went to the Doctor and an EKG was done. Before the vaccinations my EKG was normal However this time it was Abnormal, and it showed I had an infarction. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: anaphylactic shock; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown", described as "anaphylactic shock".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Ear pain, Headache, Hypoaesthesia, Immunisation
Clinical narrative: lymph node swelling; left arm pain; headache; neck pain; her daughter is experiencing neck pain that goes up by her ear; her symptoms are getting progressively worse.; Numbness on neck, side of face and left side arm where she had vaccine; Pfizer Booster dose; face swelling numbness/Numbness on neck, side of face and left side arm where she had vaccine; face swelling numbness; 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.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose: 1st), administration date: 15May2021, when the patient was 27 years old, for Covid-19 Immunization, reaction(s): Headache, Chills, Shaking, Racing heart rate, Swollen lymph nodes; Bnt162b2 (Dose: 2nd), administration date: 15Jun2021, when the patient was 27 years old, for Covid-19 Immunization, reaction(s) terrible headache, Chills, Shaking, Racing heart rate, lymph nodes got more swollen. Under armpits and neck all the way down to her chest, everywhere there was a lymph in neck and underarm region and groin area. The following information was reported IMMUNISATION (non-serious) with onset 20Dec2021, outcome unknown; HYPOAESTHESIA (non-serious) with onset 20Dec2021, outcome not recovered; SWELLING FACE (non-serious) with onset 20Dec2021, outcome unknown; LYMPHADENOPATHY (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; HEADACHE (non-serious), outcome unknown; NECK PAIN (non-serious), outcome unknown; EAR PAIN (non-serious), outcome unknown; CONDITION AGGRAVATED (non-serious), outcome unknown; INJECTION SITE HYPOAESTHESIA (non-serious) with onset 20Dec2021, outcome not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (29Dec2021) included This is a spontaneous follow-up report from a contactable consumer. This consumer reported for a 27-year-old female patient.  Updated Information included New event of Numbness on neck, side of face and left side arm where she had vaccine, events subsumed, Outcome of Event, Onset Date of event. Concomitant Therapy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Lymphadenopathy, Neck pain, Pain in extremity, Swelling face
Clinical narrative: lymph node swelling; left arm pain; headache; neck pain; her daughter is experiencing neck pain that goes up by her ear; her symptoms are getting progressively worse.; Numbness on neck, side of face and left side arm where she had vaccine; Pfizer Booster dose; face swelling numbness/Numbness on neck, side of face and left side arm where she had vaccine; face swelling numbness; 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.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose: 1st), administration date: 15May2021, when the patient was 27 years old, for Covid-19 Immunization, reaction(s): Headache, Chills, Shaking, Racing heart rate, Swollen lymph nodes; Bnt162b2 (Dose: 2nd), administration date: 15Jun2021, when the patient was 27 years old, for Covid-19 Immunization, reaction(s) terrible headache, Chills, Shaking, Racing heart rate, lymph nodes got more swollen. Under armpits and neck all the way down to her chest, everywhere there was a lymph in neck and underarm region and groin area. The following information was reported IMMUNISATION (non-serious) with onset 20Dec2021, outcome unknown; HYPOAESTHESIA (non-serious) with onset 20Dec2021, outcome not recovered; SWELLING FACE (non-serious) with onset 20Dec2021, outcome unknown; LYMPHADENOPATHY (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; HEADACHE (non-serious), outcome unknown; NECK PAIN (non-serious), outcome unknown; EAR PAIN (non-serious), outcome unknown; CONDITION AGGRAVATED (non-serious), outcome unknown; INJECTION SITE HYPOAESTHESIA (non-serious) with onset 20Dec2021, outcome not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (29Dec2021) included This is a spontaneous follow-up report from a contactable consumer. This consumer reported for a 27-year-old female patient.  Updated Information included New event of Numbness on neck, side of face and left side arm where she had vaccine, events subsumed, Outcome of Event, Onset Date of event. Concomitant Therapy.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Computerised tomogram head, Concussion, Confusional state, Immunisation
Clinical narrative: concussion; booster; pneumonia; heart surgery; confused; low platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3, single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "Sepsis" (unspecified if ongoing); "CLL" (unspecified if ongoing); "heart surgery" (unspecified if ongoing), notes: Caller says he has had three heart surgeries over the last 16 months. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset Aug2021, outcome "unknown", described as "booster"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "pneumonia"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart surgery"; CONCUSSION (non-serious) with onset Nov2021, outcome "unknown", described as "concussion"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "confused"; PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "low platelets". The event "concussion" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (2021) no bleeding; magnetic resonance imaging: (2021) unknown results; platelet count: (2021) 120, notes: last six months when it hasn't been 140, it has been under, with the highest being 120, and it is 88 now; (2021) 88, notes: last six months when it hasn't been 140, it has been under, with the highest being 120, and it is 88 now. Therapeutic measures were taken as a result of cardiac disorder.  Clinical course: Patient had pending hernia surgery on14Jan, next month. Patient got concussion from 6 weeks ago, got confused and went to get a fourth dose of the Pfizer COVID-19 Vaccine yesterday. Patient walked into the pharmacy and apparently their computer records weren't the best or they didn't check them and patient told them I needed my second shot. And they gave them to the patient, but the patient already had 3 shots. So that total four, but the shot they gave me they thought was shot number two.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Platelet count, Platelet count decreased, Pneumonia
Clinical narrative: concussion; booster; pneumonia; heart surgery; confused; low platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3, single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "Sepsis" (unspecified if ongoing); "CLL" (unspecified if ongoing); "heart surgery" (unspecified if ongoing), notes: Caller says he has had three heart surgeries over the last 16 months. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset Aug2021, outcome "unknown", described as "booster"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "pneumonia"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart surgery"; CONCUSSION (non-serious) with onset Nov2021, outcome "unknown", described as "concussion"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "confused"; PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "low platelets". The event "concussion" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (2021) no bleeding; magnetic resonance imaging: (2021) unknown results; platelet count: (2021) 120, notes: last six months when it hasn't been 140, it has been under, with the highest being 120, and it is 88 now; (2021) 88, notes: last six months when it hasn't been 140, it has been under, with the highest being 120, and it is 88 now. Therapeutic measures were taken as a result of cardiac disorder.  Clinical course: Patient had pending hernia surgery on14Jan, next month. Patient got concussion from 6 weeks ago, got confused and went to get a fourth dose of the Pfizer COVID-19 Vaccine yesterday. Patient walked into the pharmacy and apparently their computer records weren't the best or they didn't check them and patient told them I needed my second shot. And they gave them to the patient, but the patient already had 3 shots. So that total four, but the shot they gave me they thought was shot number two.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Immunisation, Movement disorder, Thrombosis
Clinical narrative: she is calling regarding the booster; she is in bed and can't even move.; she has blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "she has blood clots"; IMMUNISATION (medically significant), outcome "unknown", described as "she is calling regarding the booster"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "she is in bed and can't even move.". The patient underwent the following laboratory tests and procedures: chest x-ray: (2021) blood clots; echocardiogram: (2021) blood clots. Additional Context: She states that she had a horrible effect with the Pfizer booster shot, the vaccine. She states people are suffering because of taking this vaccine. Caller states that this does not sound hopeful and that maybe she will go on social media and tell people not to get the vaccine. This is not right. She states that Pfizer needs to at least, take responsibility. She was perfectly fine and this vaccine just wrecked her. She states that she is in bed and can't even move. She states that they all ready did a chest X-ray, an echocardiogram and they called her this morning and told her she has blood clots. It is not even just the heart. They are now saying they want to do a CAT scan of the lungs. Who is going to pay for all of this.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; I recently tested positive for COVID after receiving my Pfizer booster in Oct2021; I recently tested positive for COVID after receiving my Pfizer booster in Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I recently tested positive for COVID after receiving my Pfizer booster in Oct2021"; IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster".  After 3 days, most of the symptoms went away. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have had both doses of the vaccine over 6 months ago, but recently diagnosed with Covid.; I have had both doses of the vaccine over 6 months ago, but recently diagnosed with Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. 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) all with onset 2021, outcome "unknown" and all described as "I have had both doses of the vaccine over 6 months ago, but recently diagnosed with Covid.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: positive for Coronavirus; positive for Coronavirus; His wife is still ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. 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) all with onset 29Dec2021, outcome "unknown" and all described as "positive for Coronavirus"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "His wife is still ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive.  Additional information: Reporter (patient's husband) mentioned that he had an appointment at 12:30 for his second dose and wanted to reschedule it. His wife is still ill, and his wife was exposed to coronavirus. He wants information. His wife took a rapid test this morning and she got results back just now. She is positive for Coronavirus. She had Pfizer COVID vaccine months back. Caller declined to proceed with a report for himself and his wife and states he just wanted to reschedule his appointment.   The lot number for bnt162b2 was not provided and will be requested during follow up.