chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: she developed tingling of her feet bilaterally within 15 minutes and feeling like pins and needles of legs and then arms; Limbs felt heavy; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (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: Flu shot, administration date: 13Oct2021; Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 02Dec2021, outcome "unknown", described as "she developed tingling of her feet bilaterally within 15 minutes and feeling like pins and needles of legs and then arms"; LIMB DISCOMFORT (non-serious) with onset 02Dec2021, outcome "unknown", described as "Limbs felt heavy". The events "she developed tingling of her feet bilaterally within 15 minutes and feeling like pins and needles of legs and then arms" and "limbs felt heavy" were evaluated at the physician office visit.  Additional Information: Soon after the COVID vaccine dose 2 she developed tingling of her feet bilaterally within 15 minutes. This has been on and off feeling like pins and needles of legs and then arms. Limbs felt heavy and had to leave school early today. She was evaluated by neurology today who reassured the family. But they remain concerned about the symptoms and possible etiology. Optional Information: No known relevant comorbidities. Event took place after use of product.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Migraine, Muscle spasms, Pain in extremity
Clinical narrative: horrific migraine; Chills; She is not feeling well; legs are really hurting her like cramps that's hurting; legs are really hurting her like cramps that's hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A female patient received bnt162b2 (BNT162B2), administration date 08Dec2021 14:30 (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: 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: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "horrific migraine"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "She is not feeling well"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious) all with onset 2021, outcome "unknown" and all described as "legs are really hurting her like cramps that's hurting".   Additional information: Reporter stated, "More specifically earlier my daughter had the booster for Pfizer and about 2:30 this afternoon she was okay, just had a horrific migraine and then she had chills for couple hours no fever and then she's been up for hours now because her legs are really hurting her like cramps that's hurting. Is that normal? Reporter stated "I'm more concerned right now. She is not feeling well. So that's okay, alright. Thank you." Further probing could not be done as Reporter was unwilling to file a safety report hence limited information available over the call.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (15Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0150) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high bp" (unspecified if ongoing); "PMDD" (unspecified if ongoing); "migraine w/aura," (unspecified if ongoing); "mal de debarquement" (unspecified if ongoing); "Known allergy to penicillin" (unspecified if ongoing); "Known allergy to sulfa" (unspecified if ongoing); "Known allergy to nightshades" (unspecified if ongoing), notes: Known allergy to nightshades. Concomitant medication(s) included: AMLODIPINE; SERTRALINE; NORETHISTERONE. Past drug history included: Known allergy to erythromycin, reaction(s): "Known allergy to erythromycin"; Known allergy to lanolin, reaction(s): "Known allergy to lanolin"; Known allergy to kaolin, reaction(s): "Known allergy to kaolin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "migraine". The following information was reported: MIGRAINE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Migraine". Therapeutic measures were not taken as a result of migraine. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient device date was 03DEC2021. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bedridden, Pain, Vomiting
Clinical narrative: I have been experiencing excruciating stomach pain and it is not stopping; there is no break in it.; Cannot put myself in such a position, where it does not hurt and I have been vomiting a lot; Cannot put myself in such a position, where it does not hurt and I have been vomiting a lot; can't get up right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Dec2021 15:00 (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, single), for Covid-19 Immunization; Bnt162b2 (dose 2, single), for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 08Dec2021 06:30, outcome "unknown", described as "I have been experiencing excruciating stomach pain and it is not stopping; there is no break in it."; PAIN (non-serious), VOMITING (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Cannot put myself in such a position, where it does not hurt and I have been vomiting a lot"; BEDRIDDEN (non-serious) with onset Dec2021, outcome "unknown", described as "can't get up right now".  Additional information: Consumer stated, "I took the Pfizer Vaccine (clarified as the Pfizer Covid-19 Vaccine) yesterday at 3PM and since 6:30 this morning, I have been experiencing excruciating stomach pain and it is not stopping. It will stop there is no break in it. I cannot put myself in such a position, where it does not hurt, and I have been vomiting a lot on top of it. Mostly it is stomach pain and I wanted to see if I should do anything about it or if that is normal. I have got a booster." Consumer stated that I am having extremely severe self-stomach pain, it hasn't stops from 6.30 in the morning. I can't get up right now, I am sorry. Consumer stated, "I am just having an adverse reaction to the booster vaccine and I need to know whether I should go to the hospital or not, I am having extremely severe self-stomach pain, it haven't stops from 6.30 in the morning and I took the vaccine yesterday."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: Psychological disorder; This is a spontaneous report received from a non-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) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; ziprasidone (ZIPRASIDONE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "Psychological disorder". The action taken for ziprasidone was unknown.  Additional information: The patient stated that "I'm placing to threaten Pfizer, that's my psychological disorder" (Misplaced comment).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lactation disorder, Suppressed lactation
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Lactating" (unspecified if ongoing), notes: Lactating individual. The patient's concomitant medications were not reported. The following information was reported: LACTATION DISORDER (non-serious), SUPPRESSED LACTATION (non-serious) all with onset 11Dec2021, outcome "unknown" and all described as "Decrease in my breastmilk supply / other medical history = Lactating individual". Therapeutic measures were not taken as a result of lactation disorder, suppressed lactation. Additional information: Patient has not taken any other vaccine in four weeks and patient has not taken any other medications in two weeks and patient had COVID prior to vaccination. Post vaccination Patient has not been tested for COVID. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: the FIRST on 17Apr2021, on right arm it hurt but not too much. The SECOND on 08May2021 on right arm it was sore but not too bad; arm was a little sore / sore arm.; 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 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Apr2021 (Lot number: ER8731) at the age of 67 years as dose 1, single and administered in arm right, administration date 08May2021 14:40 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "the FIRST on 17Apr2021, on right arm it hurt but not too much. The SECOND on 08May2021 on right arm it was sore but not too bad"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a little sore / sore arm.". Therapeutic measures were not taken as a result of axillary pain, pain in extremity.  Additional Information: The patient did not had a visit to emergency room or physician office. No Prior Vaccinations (within 4 weeks). Patient's Medical History(including any illness at time of vaccination) was none. Relevant tests were none. Previous two doses: the FIRST on 17Apr2021, on right arm it hurt but not too much. The SECOND on 08May2021 on right arm it was sore but not too bad. With the Booster dose on 08Dec2021, "Right arm is hurting, with red patches, itching, spread to the bicep, used a cream for the itchiness. But it's not hives. Arm was killing me and couldn't move it. On Friday or Saturday started getting redness and itches.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseous; Utimately threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: FK5618) at the age of 5 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: NAUSEA (non-serious) with onset 13Dec2021, outcome "recovered" (13Dec2021), described as "Nauseous"; VOMITING (non-serious) with onset 13Dec2021, outcome "recovered" (13Dec2021), described as "Utimately threw up".  Additional information: Patient received the Pfizer vaccine for 5-11 year old's on Friday, 10Dec2021. He was fine all weekend but woke up this morning nauseous and ultimately threw up. No other symptoms were exhibited and he is feeling fine now. Temperature is fine also.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: Received both covid vaccination doses and had major hair loss.; Dose 1- 20Jun2021 and dose 2- 12Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: FC3181) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1, Lot number=EW0178), administration date: 20Jun2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Aug2021, outcome "unknown", described as "Dose 1- 20Jun2021 and dose 2- 12Aug2021"; ALOPECIA (non-serious) with onset 13Aug2021, outcome "not recovered", described as "Received both covid vaccination doses and had major hair loss.". The event "received both covid vaccination doses and had major hair loss." was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received treatment as Needles in head to try to help hair growth. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FH8027) at the age of 52 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Verbatim: Chemotherapy" (unspecified if ongoing), notes: Verbatim: Chemotherapy, Received chemotherapy 5 years ago for a duration of 1 year. There were no concomitant medications. Vaccination history included:  measles (In college there was a measles outbreak. She got the vaccine for it and had no problems). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "pain at injection site".  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Left arm pain/ right arm was sore for 3-4 days; First dose was given on he believes 14Feb2021. The second dose was on 28Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Feb2021 (Lot number: EN6203) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Anatomical location: Left arm, Event Verbatim: the pain in the arm after the shot.  No big deal. He got it with first shot too), administration date: 14Feb2021, when the patient was 73 years old, for COVID-19 immunization, reaction(s): "pain in the arm".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Feb2021, outcome "recovering", described as "First dose was given on he believes 14Feb2021. The second dose was on 28Feb2021"; PAIN IN EXTREMITY (non-serious) with onset 01Mar2021, outcome "recovering", described as "Left arm pain/ right arm was sore for 3-4 days".  Additional information: This report was not related to a study or program.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Muscle twitching, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: felt tingling in left side of head; developed muscle twitch in left palm below thumb; developed sudden onset lower back, abdominal pain; abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Lot number: 33030BD) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: No, reaction(s): "Allergy". The following information was reported: PARAESTHESIA (non-serious) with onset 02Dec2021 12:00, outcome "unknown", described as "felt tingling in left side of head"; MUSCLE TWITCHING (non-serious) with onset 02Dec2021 12:00, outcome "unknown", described as "developed muscle twitch in left palm below thumb"; BACK PAIN (non-serious) with onset 02Dec2021 12:00, outcome "unknown", described as "developed sudden onset lower back, abdominal pain"; ABDOMINAL PAIN (non-serious) with onset 02Dec2021 12:00, outcome "recovered" (2021), described as "abdominal pain". The events "felt tingling in left side of head", "developed muscle twitch in left palm below thumb", "developed sudden onset lower back, abdominal pain" and "abdominal pain" were 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, muscle twitching, back pain, abdominal pain.  Additional information:  2 days after vaccine, 02Dec2021, felt tingling in left side of head, periodically, lasting 1-2 days. 4 days after vaccine, 04Dec2021, developed muscle twitch in left palm below thumb. 7 days after vaccine, 08Dec2021, developed sudden onset lower back, abdominal pain which improved after 2-3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had covid prior to vaccination. Patient was tested Covid post vaccination. Patient had no known allergies.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, X-ray
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 15:45 (Lot number: EN4205) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Liver Resection Surgery", start date: 17Mar2008 (unspecified if ongoing), notes: Liver Resection Surgery: To remove Liver stones; "Ventral Hernia Surgery", start date: 12Nov2008 (unspecified if ongoing), notes: Ventral Hernia Surgery; "Ventral Hernia Surgery", start date: 04Feb2017 (unspecified if ongoing), notes: Ventral Hernia Surgery. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Prior Vaccination (within 4 weeks): None. Concomitant Drugs: None. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia: None. Patient received the first dose of the Pfizer vaccine for the Corona-19 virus on left arm on 02Mar2021, patient felt some mild pain on the injection site afterwards for a few days but it went away. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Incorrect dose administered
Clinical narrative: sick; did not received the correct amount of vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A child patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 10Dec2021 (Lot number: FL0007) as dose 2, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, LOT: FK5127, EXP: documented as 31Jan2022; but caller is not sure if that's correct), administration date: 19Nov2021, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 10Dec2021, outcome "unknown", described as "did not received the correct amount of vaccine".  Additional information: Further stated that she had a patient who received their 2nd dose of the vaccine but the mother of the child said that the child moved away during the administration so she believed the child did not received the correct amount of vaccine. She stated that the mother contacted the CDC for recommendations and she was told that the child needed another injection immediately. Caller wanted to know what does "immediately" mean as the child is currently sick and cannot receive the additional dose of the vaccine as CDC recommended. Mother thinks the patient was sick and would not be able to get another dose of the vaccine for 1.5 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: lot of pain in the arm; her hand is very swollen and she cannot close it; her hand is very swollen and she cannot close it; 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 received bnt162b2 (BNT162B2), administration date 12Dec2021 13:00 (Lot number: FK5618) 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: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "lot of pain in the arm"; PERIPHERAL SWELLING (non-serious), MOVEMENT DISORDER (non-serious) all with onset Dec2021, outcome "unknown" and all described as "her hand is very swollen and she cannot close it".  Additional information: Reporter daughter got vaccinated yesterday she was 11 years old but her hand is getting swollen and she was seeing a lot of pain in the arm and the vaccine was done around noon yesterday 1 PM probably, no noon O'clock 30 but her hand was very swollen and she cannot close it.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited 2 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (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: VOMITING (non-serious) with onset 13Dec2021, outcome "recovered" (Dec2021), described as "Vomited 2 times". It was unknown if therapeutic measures were taken as a result of vomiting. Additional information: Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown, Since the vaccination, has the patient been tested for COVID-19?:Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient felt abnormal (magnetized; can feel it in her chest and it moves), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: She mentioned that she has a high blood pressure; 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 patient. An 68 year-old female patient received bnt162b2 (BNT162B2) (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: Bnt162b2 (Dose 1 of Pfizer Covid 19 Vaccine), when the patient was 68 years old, for COVID-19 Immunization. The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "She mentioned that she has a high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: a 68 year old woman is calling about to make an appointment for her booster shot.She mentioned that she has a high blood pressure and she is at high risk.She also said that her mother died recently due to Covid. And she also said that her son got a fever after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vomiting
Clinical narrative: Vomiting; fatigue; feeling ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 12:45 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VOMITING (non-serious) with onset 14Dec2021 14:30, outcome "not recovered", described as "Vomiting"; FATIGUE (non-serious) with onset 14Dec2021 14:30, outcome "not recovered", described as "fatigue"; MALAISE (non-serious) with onset 14Dec2021 14:30, outcome "not recovered", described as "feeling ill". Therapeutic measures were taken as a result of vomiting, fatigue, malaise.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was None. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 14Dec2021. Reported Events: Vomiting, fatigue, feeling ill. The patient received the treatment for the adverse events with Ibuprofen and rest.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: had soreness in the arm and stuff; had things like headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8727) at the age of 63 years as dose 1, single and administration date 15Apr2021 (Lot number: EW0151) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had soreness in the arm and stuff"; HEADACHE (non-serious), outcome "unknown", described as "had things like headache".  Additional Information: Caller explained they both, her and her daughter, received both of the covid shots and had soreness in the arm and stuff, had things like headache. This was after the first two shots. Did any AE(s) require a visit to: Emergency Room: no; Physician Office: no. Prior Vaccinations (within 4 weeks) was reported as none.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Second Shot - Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.; Second Shot - Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 10:00 (Lot number: em9009) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACCUTANE. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: el8982, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 21Jan2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "Second Shot - Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.".  Additional Information: If other vaccine in four weeks was reported as no. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no. No Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101796094 similar report from same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Muscle spasticity
Clinical narrative: side spasticity of muscles upper and lower extremities daily for 10 days lasting 5-10 minutes; Lingering memory concerns; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Aug2021 15:11 (Lot number: EW0178) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic medical condition controlled" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose at 14:27 (Batch/Lot no: EW0170) via intramuscular in Left deltoid), administration date: 15Jul2021, when the patient was 74 years old, for COVID-19 Immunization, reaction(s): "Metal taste R mouth"; Bnt162b2 (First dose at 14:27 (Batch/Lot no: EW0170) via intramuscular in Left deltoid), administration date: 15Jul2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "R paresthesias", "hand - neck pain", "hand - neck pain", "Headache", "vision impaired", "memory loss". The following information was reported: MUSCLE SPASTICITY (non-serious) with onset 2021, outcome "unknown", described as "side spasticity of muscles upper and lower extremities daily for 10 days lasting 5-10 minutes"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "Lingering memory concerns".  Additional information: The patient was 74-year-old, since her vaccine she has had a birthday and was now 75-year-old. The patient provide information to you regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event was reported by reporter. No prior vaccination. No relevant test. First injection: Metal taste R mouth, R paraesthesia, R hand - neck pain and headache, vision impaired, memory loss. Second injection: L (left) side spasticity of muscles upper and lower extremities daily for 10 days lasting 5-10 minutes, Lingering memory concerns.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: walks with a can; numbness in her hands and feet; weakness in her legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 15:00 (Lot number: EW0151) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1ST DOSE, First dose: 27Aug2021, Lot number: FD8448), administration date: 27Aug2021, when the patient was 74 years old. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "numbness in her hands and feet"; MUSCULAR WEAKNESS (non-serious) with onset Sep2021, outcome "not recovered", described as "weakness in her legs"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "walks with a can". The events "numbness in her hands and feet", "weakness in her legs", "walks with a can" and "numbness in her hands and feet" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia, muscular weakness, gait disturbance, hypoaesthesia.  Additional information: Event: Her symptoms started the week after her second dose in Sep2021. She did her research and started taking Vitamin D3 and B12. She is walking with a cane due to the weakness in her legs. Her left arm and hand is the worst. She has no numbness in her right arm, just the hand.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: FL0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "turrets" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY taken for tourette's disorder (ongoing); FLU, administration date 2021. The following information was reported: DIARRHOEA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Diarrhea".  Additional information: Reporter is the mother and is calling to report that her two sons had diarrhea after getting the COVID vaccine shot on 14Dec2021 at 13:30-14. The patient Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no and Relevant Tests: No. No additional vaccines were administered on same date of the Pfizer suspect.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797861 Same reporter/drug/event, different patient.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Diarrhea/ His diarrhea was worse than the older sons; first dose in his right thigh.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in thigh right, administration date 14Dec2021 (Lot number: FL0007) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 2021. The following information was reported: DIARRHOEA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Diarrhea/ His diarrhea was worse than the older sons"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 14Dec2021, outcome "unknown", described as "first dose in his right thigh."  Additional Context: Caller was the mother and was called to report that her two sons had diarrhea after getting the COVID vaccine shot yesterday afternoon, 14Dec2021. Both of her sons are going to the bathroom like clock work. Both sons got the vaccine at the hospital. They started having diarrhea this morning. The diarrhea started this morning. The diarrhea started slow, but has continued. His diarrhea was worse than the older sons. This was withheld first dose in his right thigh. She doesn't know his exact height, but she does know he was over 4ft. He did get a flu shot a week or two ago.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797686 Same reporter/drug/event, different patient.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Polymenorrhoea
Clinical narrative: The vaccine changed my menstrual cycle. It increased the average duration of my period from 6 days to 9 days.; It also shortened the length of time between my cycles.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: ER 8730) at the age of 39 years 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: OLIGOMENORRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "The vaccine changed my menstrual cycle. It increased the average duration of my period from 6 days to 9 days."; POLYMENORRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "It also shortened the length of time between my cycles.". The events "the vaccine changed my menstrual cycle. it increased the average duration of my period from 6 days to 9 days." and "it also shortened the length of time between my cycles." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oligomenorrhoea, polymenorrhoea.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Migraine, Neck pain, Vaccination site pain
Clinical narrative: injection-site soreness; radiating pain up neck; lymph node swelling; migraine; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 (Lot number: ER8730) at the age of 47 years as dose 1, single and administered in arm right, administration date 08May2021 (Lot number: EW0185) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hemiplegic migraines" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; PRILOSEC [OMEPRAZOLE]. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "injection-site soreness"; NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "radiating pain up neck"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "lymph node swelling"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, neck pain, lymphadenopathy, migraine, fatigue.  Additional information: Dose received: 3, Most recent dose details: product=COVID 19, brand=Pfizer, Brand unknown=False, lot number=F51620, lot unknown=False, administration date=13Dec2021, administration time=03:00 PM, dose number=3, vaccine location=Left arm. Reported Event: 1st dose - injection-site soreness, radiating pain up neck, lymph node swelling, migraine, fatigue. 2nd dose - 1st dose - injection-site soreness, radiating pain up neck, lymph node swelling, migraine, fatigue 3rd dose ; 1st dose - injection-site soreness, radiating pain up neck, migraine, fatigue, chills/sweats, arthralgia (esp in knees), leg and foot cramping, tingling in injection arm for 1 day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Nasopharyngitis
Clinical narrative: has cold/currently have a cold; 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 41 year-old female patient 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's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "has cold/currently have a cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional information: Reason for no lot number of COVID 19 Vaccine was Consumer stated, she doesn't have time, to thought but she thought this was going to be little faster, and don't have it handy, so let's just skip all of that and I am going to thank you very much for your time, Expiry Date of COVID 19 Vaccine was Unknown. She had a caller on the other line, she said that she is schedule to get the booster shot tomorrow, however she has cold, and she took a test and the test, and it was negative (further clarification unknown), so she just wanted to know that she should continue with shot tomorrow, she had a cold. Consumer stated, let me re-phrase that, I am schedule to get a booster shot tomorrow and currently have a cold, should I re-schedule my booster shot, or should I do the booster? Consumer was informed about role of Pfizer Drug Safety and informed that Pfizer Medical Information is the concerned department to answer the question that consumer have regarding the vaccine and offered the number. Consumer stated, I thought this was just about my call experience, what are the questions, let go to the question, she don't have too (Incomplete Sentence).Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: increase in tinnitus in both ears within the hour of each dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 12:45 (Lot number: 330308D) as dose 1, single and administered in arm left, administration date 15Dec2021 12:45 (Lot number: 331308A) 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: TINNITUS (non-serious) with onset 23Nov2021 13:30, outcome "recovered with sequelae", described as "increase in tinnitus in both ears within the hour of each dose". The event "increase in tinnitus in both ears within the hour of each dose" 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 tinnitus.  Additional information: The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.