chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Allergies: Dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction: "Allergies: Benadryl allergy". The following information was reported: HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "recovering", described as "numbness in the legs"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovering", described as "numbness in the legs where they hurt"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "recovering", described as "started swelling". Additional information: After the first dose, the patient had numbness in the legs where they hurt and started swelling and patient had to keep moving throughout the day for several days to keep the circulation up. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101383394 same reporter, patient, suspect product, different event, and dose.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Immunisation, Pyrexia
Clinical narrative: temperature of 101.82 degrees F; pulse of greater than 120; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 14Oct2021 08:00 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Jan2021, for COVID-19 immunization, reaction(s): "no side effects with either dose"; Bnt162b2 (Dose 2), administration date: 29Jan2021, for COVID-19 immunization, reaction(s): "no side effects with either dose". The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021 08:00, described as "booster dose"; PYREXIA (non-serious) with onset 15Oct2021 00:07, outcome "recovered" (15Oct2021 01:07), described as "temperature of 101.82 degrees F"; HEART RATE INCREASED (non-serious) with onset 15Oct2021, outcome "unknown", described as "pulse of greater than 120". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, heart rate increased. Additional information: The patient was the reporter's brother. The patient took ibuprofen 200mg and the temperature was back to 98 degrees F within 1 hour.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased
Clinical narrative: creatinine went up for a little bit but then it came back to normal again; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single both for COVID-19 immunisation. Relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD CREATININE INCREASED (non-serious), outcome "recovered", described as "creatinine went up for a little bit but then it came back to normal again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was told to take the COVID-19 Pfizer shots so the patient took number 1 and number 2. The patient's nurse said the creatinine went up for a little bit but then it came back to normal again. It came back to where it was before the patient took the shot. The patient read in the article here that, the patient took a booster shot now (15Oct2021), it said it may go up 20 percent. The patient asked if it would come back again and if it was just temporary side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment
Clinical narrative: scale of 7 out of 10 was an increase in pain/ has been in a mild flare ever since; This is a spontaneous report received from contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "pain" (unspecified if ongoing). Concomitant medication included: XELJANZ, start date: Jan2018 (ongoing). Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation; BNT162B2 (dose 2, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovering", described as "scale of 7 out of 10 was an increase in pain/ has been in a mild flare ever since". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated scale of 7 out of 10 was an increase in pain. The patient received Pfizer booster vaccine for COVID around 3 weeks prior and has been in a mild flare ever since. The patient stated flare was starting to subside. She has not missed any doses of tofacitinib citrate (XELJANZ) while receiving booster dose per prescriber orders. The patient stated prescriber was aware of current flare.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Joint swelling, Trigger finger
Clinical narrative: At the 1st & 2nd shot had finger joint swelling and locking; At the 1st & 2nd shot had finger joint swelling and locking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE), administered in arm left, administration date 18Mar2021 (Lot number: EWG150) at the age of 72 years as dose 1, single and administered in arm left, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: FLU. Past drug history included: Statins, reaction(s): "drug allergy"; Erythromycin, reaction(s): "drug allergy". The following information was reported: JOINT SWELLING (non-serious), TRIGGER FINGER (non-serious) all with onset 2021, outcome "unknown" and all described as "At the 1st & 2nd shot had finger joint swelling and locking". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This report was received via regulatory authority. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's concomitant medications included blood pressure meds. The lot number for dose 2 was also reported as EN6 (or G) 208. The vaccine was administered in Pharmacy or Drug Store. The patient also received the 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) administered in arm left, administration date 14Oct2021 (Lot number: EWG150) and experienced 6 hours after the 3rd shot, developed finger locking and swelling in the fingers in left hand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Muscle fatigue, Pyrexia
Clinical narrative: had 101 fever; muscle fatigue; very tired; This is a spontaneous report received from a non-contactable reporter (Consumer).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization and BNT162B2 (Dose 2, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "had 101 fever"; MUSCLE FATIGUE (non-serious), outcome "recovered", described as "muscle fatigue"; FATIGUE (non-serious), outcome "recovered", described as "very tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received booster dose of Covid vaccine and had 101 fever and muscle fatigue and very tired Symptoms lasted two days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: puked; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 8-year-old male patient received bnt162b2 (BNT162B2) (Lot number: FK5127) at the age of 8 years as dose 1 (tris), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "puked". Therapeutic measures were not taken as a result of vomiting. Additional information: The reporter ("a pharmaceutical rep") stated, "I just want to report an adverse event that happen to my 8-year-old one (consumer), an hour after he got his first Pfizer dose." The reporter stated, "one hour after he got the vaccine, he puked just randomly."  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Somnolence
Clinical narrative: slept for 15+ hours; Low grade fever 100.1; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 6 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 05Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1 (TRIS), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SOMNOLENCE (non-serious) with onset 08Nov2021, outcome "recovered", described as "slept for 15+ hours"; PYREXIA (non-serious) with onset 08Nov2021, outcome "recovered", described as "Low grade fever 100.1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, pyrexia.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 03Jan2022, this case now contains all required information to be considered valid.  This is a literature report for the following literature: This study involved 179 individuals aged 12 to 18 years hospitalized for laboratory-confirmed COVID-19 and a control group of 285 adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. 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: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200007923 Same article/ drug/event and different patient;US-PFIZER INC-202200007924 Same article/ drug/event and different patient;US-PFIZER INC-202200007927 Same article/ drug/event and different patient;US-PFIZER INC-202200007926 Same article/ drug/event and different patient;US-PFIZER INC-202200007925 Same article/ drug/event and different patient;US-PFIZER INC-202200007925 Same article/ drug/event and different patient;US-PFIZER INC-202200007926 Same article/ drug/event and different patient;US-PFIZER INC-202200007927 Same article/ drug/event and different patient;US-PFIZER INC-202200007924 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 2, 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: PYREXIA (non-serious), outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: a bad headache; chills; fatigue; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 58 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "a bad headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis; This is a spontaneous report received from a non-contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Dry throat, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test, Sinus congestion
Clinical narrative: cold; sore throat; sinus; dryness in my throat; 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 75 year-old patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) at the age of 75 years 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; SINUS CONGESTION (non-serious), outcome "unknown", described as "sinus"; DRY THROAT (non-serious), outcome "unknown", described as "dryness in my throat". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Fall, Swelling face
Clinical narrative: Fell with face hitting against the wall yesterday; Fell with face hitting against the wall yesterday and bruised it and it was swollen; Fell with face hitting against the wall yesterday and bruised it and it was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: FALL (non-serious), outcome "unknown", described as "Fell with face hitting against the wall yesterday"; CONTUSION (non-serious), SWELLING FACE (non-serious), outcome "not recovered" and all described as "Fell with face hitting against the wall yesterday and bruised it and it was swollen".  Additional information: It was reported that the patient fell with face hitting against the wall yesterday and bruised it and it was swollen when discussing on show still. The reporter did not think vaccine related but submitted out of caution.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Immunisation, Interchange of vaccine products, Migraine
Clinical narrative: Pfizer booster; interchange of vaccine; heart palpitations/but they were accelerated after the Pfizer booster.; a severe headache like a migraine; dry mouth; body aches; a severe headache like a migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-173571 (Moderna).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart palpitations" (unspecified if ongoing), notes: due to her blood pressure medicine. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for COVID-19 Immunization, reaction(s): "body aches"; Moderna covid-19 vaccine (Dose 2), for COVID-19 immunization, reaction(s): "body aches". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "interchange of vaccine"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitations/but they were accelerated after the Pfizer booster."; MIGRAINE (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "a severe headache like a migraine"; DRY MOUTH (non-serious), outcome "recovered", described as "dry mouth"; PAIN (non-serious), outcome "recovered", described as "body aches".  Additional information- Patient states that her sister suffered greatly after getting a Pfizer booster after her Moderna Covid-19 Vaccine primary series. Her sister had body aches after her primary series. Four hours after her Pfizer booster she had heart palpitations. She experienced those before due to her blood pressure medicine, but they were accelerated after the Pfizer booster. She also had dry mouth, body aches, & a severe headache like a migraine after the Pfizer booster. She said these effects lasted about a day & a half after the Pfizer booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: Pfizer booster; interchange of vaccine; heart palpitations/but they were accelerated after the Pfizer booster.; a severe headache like a migraine; dry mouth; body aches; a severe headache like a migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-173571 (Moderna).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart palpitations" (unspecified if ongoing), notes: due to her blood pressure medicine. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for COVID-19 Immunization, reaction(s): "body aches"; Moderna covid-19 vaccine (Dose 2), for COVID-19 immunization, reaction(s): "body aches". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "interchange of vaccine"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitations/but they were accelerated after the Pfizer booster."; MIGRAINE (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "a severe headache like a migraine"; DRY MOUTH (non-serious), outcome "recovered", described as "dry mouth"; PAIN (non-serious), outcome "recovered", described as "body aches".  Additional information- Patient states that her sister suffered greatly after getting a Pfizer booster after her Moderna Covid-19 Vaccine primary series. Her sister had body aches after her primary series. Four hours after her Pfizer booster she had heart palpitations. She experienced those before due to her blood pressure medicine, but they were accelerated after the Pfizer booster. She also had dry mouth, body aches, & a severe headache like a migraine after the Pfizer booster. She said these effects lasted about a day & a half after the Pfizer booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Skin exfoliation, Urticaria
Clinical narrative: broke out in severe hives; booster; peeling; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2), administration date 11Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: REMICADE. 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. The following information was reported: IMMUNISATION (non-serious) with onset 11Sep2021, outcome "unknown", described as "booster"; SKIN EXFOLIATION (non-serious) with onset Sep2021, outcome "not recovered", described as "peeling"; PRURITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "itching"; URTICARIA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "broke out in severe hives". The events "peeling", "itching" and "broke out in severe hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, pruritus, urticaria. Additional information: Subject was patient assistance. Patient (wife) received the booster (3rd dose) and three days later she broke out in severe hives. She got the booster on 11Sep2021 and was still peeling, itching, and breaking out with hives. Patient was on Remicade and waited 13 weeks after the booster to get her Remicade when she normally gets it every eight weeks. Patient was very miserable and had seen three doctors to no avail. Patient needed to talk with someone that could direct her to what she needed to do to get well. Patient was told to take benedrill.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Illness, Immunisation, Interchange of vaccine products
Clinical narrative: booster after we had the J&J; booster after we had the J&J; Booster; got really sick; chest pain; hurting all over; no energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Other Case identifier(s): 20211229714 (Reference ID).  A male 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 "got really sick"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; PAIN (non-serious), outcome "unknown", described as "hurting all over"; ASTHENIA (non-serious), outcome "unknown", described as "no energy".  Additional information: On an unspecified date following BNT162 (Pfizer) vaccination, the patient got really sick. The patient had chest pain within 10 minutes and within half hour it was hurting all over and had no energy (dose number in series 2). The outcome of the sick, chest pains, hurting all over and no energy was not reported. This report was non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain
Clinical narrative: booster after we had the J&J; booster after we had the J&J; Booster; got really sick; chest pain; hurting all over; no energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Other Case identifier(s): 20211229714 (Reference ID).  A male 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 "got really sick"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; PAIN (non-serious), outcome "unknown", described as "hurting all over"; ASTHENIA (non-serious), outcome "unknown", described as "no energy".  Additional information: On an unspecified date following BNT162 (Pfizer) vaccination, the patient got really sick. The patient had chest pain within 10 minutes and within half hour it was hurting all over and had no energy (dose number in series 2). The outcome of the sick, chest pains, hurting all over and no energy was not reported. This report was non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: developed a 104 fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Dec2021 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (administration time: 01:00 PM, dose number: 1, vaccine location: left arm), administration date: 06Nov2021, when the patient was 11 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 12Dec2021 23:00, outcome "recovered", described as "developed a 104 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Clinical course: the patient developed a 104 fever that was difficult to treat. She had a steady 104 fever for 24 hours in which during that time, the lowest they could get it down to with alternating Ibuprofen and Acetaminophen was 103.6 but stayed steady at 104 the majority of the 24 hours. The patient had no Covid prior vaccination, had not tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck; Itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 15:00 (Lot number: EN6208) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Peripheral Neuropathy" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). The patient had not experienced Covid-19 prior vaccination. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity"; Valium, reaction(s): "Drug hypersensitivity". Vaccination history included: Bnt162b2 (First dose (Lot. EN6203), received at 03:00 PM, in the left arm), administration date: 21Feb2021, when the patient was 74 years old, for COVID-19 immunisation. The following information was reported: RASH PRURITIC (medically significant), RASH ERYTHEMATOUS (medically significant) all with onset Jul2021, outcome "not recovered" and all described as "Itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck". The event "itchy, red rash / lower back / left arm, near elbow and spread up and down the arm / spread to her chest / back of her neck" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash pruritic, rash erythematous (Prednisone-one shot then one course oral).  The adverse events were described as following: "itchy, red rash. Appeared first on lower back (late July 2021). Then spread in late August/early September. It started and has continued on left arm, near elbow and spread up and down the arm. Then about a month later it spread to her chest. Mostly right side; then to the back of her neck (at hair line and up into her scalp above the hairline). All rash areas-left arm, chest, and back of her neck have continued to irritate the patient. All areas are still itchy and red except lower back, which has stopped itching". Post the vaccination, the patient has not been tested for COVID-19.   Then, the patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:00 (Lot number: FH8020) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. In mid December, the patient experienced rash, a new area appeared on her lower right leg.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got Covid after your vaccine; I got Covid after your vaccine; 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) (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got Covid after your vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urinary incontinence
Clinical narrative: Booster; losing control over her urine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Jan2021 (Lot number: EL9262) at the age of 70 years as dose 1, single, intramuscular, administered in arm left, administration date 21Feb2021 (Lot number: EN6201) as dose 2, single and administered in arm, administration date 29Sep2021 (Lot number: FF2588) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 29Sep2021. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021, outcome "unknown", described as "She did get the Pfizer COVID booster on 29Sep2021"; URINARY INCONTINENCE (medically significant) with onset 01Feb2021, outcome "recovered" (13Nov2021), described as "losing control over her urine". The event "losing control over her urine" was evaluated at the physician office visit. The clinical course was reported as follows: caller had her first COVID vaccine shot 31Jan2021. On 01Feb2021, the day after, she started losing control of her urine. This has never happened to her. She has never had a problem like that in her life. This went on for 8-10 days, and then it stopped for 8-10 days. Then it would come back for 8-10 days, and then stop for 8-10 days. This went on and on. She got the second COVID vaccine on 21Feb2021. She didn't notice it change any after the second dose. She didn't have pain or anything. She just had no advance warning she had to pee. She would just be sitting there and go. Like one time she was working on a puzzle. She turned sideways and didn't know she had to go and went all over herself. She did get the Pfizer COVID booster on 29Sep2021, she got a flu shot that same day. Then, on 13Nov2021, it stopped, and she hasn't had problems since. She feels like she has recovered completely.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Immunisation, Incorrect dose administered
Clinical narrative: reported getting 4 shots; reported getting 4 shots; he still had the after-effects of a really serious concussion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Aug2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "reported getting 4 shots"; CONCUSSION (non-serious) with onset Dec2021, outcome "unknown", described as "he still had the after-effects of a really serious concussion".  Additional information: The patient reported that he still had the after-effects of a really serious concussion. The patient already got 3 shots of the vaccine and got another shot on 28Dec201 (also reported as yesterday). The patient mentioned that he could not understand and had a concussion.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: minimal soreness in arm; I had slight light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2021 10:00 (Lot number: EN5318) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2020 (unspecified if ongoing), notes: I may have had COVID-19 in January of 2020; "spurred by asymmetrical cortical thinning of the right hippocampus lobe from birth oxygen depravation" (unspecified if ongoing), notes: spurred by asymmetrical cortical thinning of right hippocampus lobe from birth oxygen depravation; "fatigue" (unspecified if ongoing); "fever" (unspecified if ongoing); "dry cough" (unspecified if ongoing); "Seizure", start date: 2000 (unspecified if ongoing), notes: I have been taking Dilantin since 2000 for a seizure I had then. Concomitant medication(s) included: DILANTIN [PHENYTOIN] taken for seizure, start date: 02Jan2000 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Jan2021 10:05, outcome "recovered" (27Jan2021), described as "minimal soreness in arm"; DIZZINESS (non-serious) with onset 27Jan2021, outcome "recovered" (Jan2021), described as "I had slight light headed". Therapeutic measures were not taken as a result of pain in extremity, dizziness.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning sensation to the left side of her arm; 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 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 13:30 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis inflammation" (unspecified if ongoing); "pain" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; ASPIRIN 81. The following information was reported: BURNING SENSATION (non-serious) with onset 12Mar2021, outcome "unknown", described as "burning sensation to the left side of her arm".  Additional information: Patient just got her 1st dose of the vaccine today, on 12Mar2021, was feeling a burning sensation on her arm and wants to know if she can take painkillers if she will feel pain later on. Patient asking if she can take a Vicodin, Tylenol, or Motrin if she has pain after getting the vaccine. She received her first vaccine dose in her right arm about 30 minutes ago and while she reports not having pain, she did report having a burring feeling to her left arm even though she received the vaccine in her right arm. She denied any other questions at this time about the vaccine or side effects. Patient asking if she can take her 800mg Ibuprofen if she had pain. Patient says she took her first dose of the Pfizer COVID-19 vaccine today around 01:30PM, and she asked people at the site questions which they answered for her, but she has questions about taking her medications for arthritis pain if pain comes from getting the shot. She says she would like to know if she can take Ibuprofen 800mg, or Aspirin 81 mg which she takes once a day to keep her from having a heart attack, or Norco, for any pain. She says she would like to know if regarding the shot it would be ok. She says she was not having pain now; she was concerned how everything will go for her, and she already takes pain medications for arthritis inflammation or pain. She says that the only problem she has really had was a burning sensation to the left side of her arm, but she took the shot on the right side, so she wants to know also if this is common. She says she just wants to find out her one question if she can take pain medication or if it will affect her shot. She says she started not to take the shot, since it was hard to get information from it, which she gets from the TV. She says her sister was 71 and she got both doses of it, and the second one was yesterday and she was ok after the first one and says that she was ok today after the second dose she got yesterday. She says that her sister just had a little pain where the shot was given.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Nausea; Chills; Body aches; Fatigue; Headache; Feeling so sick; I'm feeling so bad; Feeling so sick; I'm feeling so bad; 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 64 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN (non-serious), outcome "unknown", described as "Body aches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MALAISE (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Feeling so sick; I'm feeling so bad". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The Laboratory test SARS-CoV-2 test was reported as negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Nausea; Chills; Body aches; Fatigue; Headache; Feeling so sick; I'm feeling so bad; Feeling so sick; I'm feeling so bad; 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 64 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN (non-serious), outcome "unknown", described as "Body aches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MALAISE (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "Feeling so sick; I'm feeling so bad". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The Laboratory test SARS-CoV-2 test was reported as negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site (intense); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 15:45 (Lot number: EM9809) at the age of 56 years as dos e 1, single for covid-19 immunisation. Relevant medical history included: "herpes" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; VALACYCLOVIR [VALACICLOVIR]; DICLOFENAC SODIUM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm at injection site (intense)".  Additional information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to Pfizer COVID-19 vaccine. The patient has no history of COVID-19 infection. The patient was not tested for COVID-19 post-vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the arm that the Pfizer dose was administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness in the arm that the Pfizer dose was administered". Additional information: it was queried if after someone got the Pfizer vaccine dose in the arm, and their arm was sore, if it was ok to take medications like Tylenol and Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.