chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Speech disorder
Clinical narrative: phlegm in my throat; causes problem talking until I clear my throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 01:00 (Lot number: EN6198) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Heart problems" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Cholestrol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATENENOL; VENLAFAXINE HYDROCHLORIDE; LORAZEPAM; CLONAZEPAM. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer-BioNTech, Lot number: EN5318, Lot number: False, Administration date: 02Feb2021, Dose number: 1, vaccine location: Left arm), administration date: 02Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: PRODUCTIVE COUGH (non-serious) with onset 23Feb2021, outcome "not recovered", described as "phlegm in my throat"; SPEECH DISORDER (non-serious) with onset 23Feb2021, outcome "not recovered", described as "causes problem talking until I clear my throat". Therapeutic measures were not taken as a result of productive cough, speech disorder.  Additional information: There was no other vaccine in four weeks. Other medications in two weeks included lisinopril, atenenol, venlafaxine, lorazepam, clonazep. Adverse events was Ever since shot have phlegm in my throat that does not come up, but causes problem talking until I clear my throat. Takes 2 or 3 tries to clear the throat, Happens throughout the day and night. If treatment ae was no. There was no COVID prior vaccination. No COVID tested post vaccination. Known allergies was n/a.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test
Clinical narrative: migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 10:15 (Lot number: EW0173) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19 , brand: Pfizer, lot number: Ew0172, lot unknown: False, administration date: 21May2021, administration time: 10:15 AM, dose number: 1, vaccine location: Left arm), administration date: 21May2021, when the patient was 29 years old, for covid 19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 01Jul2021, outcome "not recovered", described as "migraines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine.  Additional information: I have been having migraines at least once a week since I have gotten the vaccine. I asked a colleague who also had gotten Pfizer and they have the same effects. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient tested covid post vaccination. Covid test post vaccination: test type post vaccination: Nasal Swab. Known allergies: No.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 62-year-old male patient received the 1st dose 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 had a headache (after the first dose, experienced adverse events; nothing life-threatening or anything), felt abnormal (brain fog), dizziness and arthralgia (maybe a little joint pain), 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: Antibody test, Burning sensation, Paraesthesia, Platelet factor 4
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). Other case identifier: US-PFIZER INC-202101234704). A 66-year-old female patient received the 1st dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 28, 2021, single dose, for COVID-19 immunisation. Medical history included high blood pressure (ongoing) and cholesterol (ongoing). The patient's concomitant medications not reported. The patient experienced paresthesia (tingling in both legs), with outcome of not recovered; and burning sensation (sort of strange burning in the front of both legs, below knees to the foot of both legs), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: This report not related to a study or program. Patient took the first dose; had tingling of both legs and still has it. Symptoms eased up for a little while, but now back. It was like having a low dose of electrical shock. It was intense, but now has eased up. Patient wanted to know does it ever go away and should she take the second shot. This happened within a couple of days or so after vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm did get sore; felt bad for a day or two; 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 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: EL9261) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chicken pox" (unspecified if ongoing), notes: had Chicken pox when he was small. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot: EL3248, Route of administration: Left arm), administration date: 11Jan2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "arm to get sore", "feeling bad". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm did get sore"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt bad for a day or two". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After receiving first and second dose Pfizer Covid Vaccine, caller's arm did get sore and the caller felt bad for a day or two. Caller states this is also possibly expected after receiving the booster vaccine. Caller clarifies he is referring to his first and second dose Pfizer Covid Vaccine causing his arm to get sore and feeling bad for a day or two. On an unspecified date, patient underwent  covid test and result was negative.  . No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: Experienced a numbing sensation in her head and forehead; Burning sensation in her chest; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (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: HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Experienced a numbing sensation in her head and forehead"; BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "Burning sensation in her chest".  Additional Information:  Caller received the first dose of the Pfizer Biontech COVID19 vaccine on 19Aug2021 and has not yet received the second dose. Caller experienced a numbing sensation in her head and forehead as well as a burning sensation in her chest that comes and go. Caller wants to know if it is safe for her to receive the second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fall
Clinical narrative: extreme dizziness/ got extremely dizzy; caused a fall, when in the shower.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101367174 (Pfizer).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arachnoid cyst" (ongoing), notes: arachnoid cyst on the brain, 20-25 years ago. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 15Mar2021 14:00, outcome "recovered" (Mar2021), described as "extreme dizziness/ got extremely dizzy"; FALL (non-serious) with onset 15Mar2021, outcome "unknown", described as "caused a fall, when in the shower.". The event "extreme dizziness/ got extremely dizzy" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient 20-25 years ago had an arachnoid cyst on his brain and they always kept an eye on it but maybe this was making him dizzy and it was 20-25 years ago and nothing came from it but it was a spot on his brain that was nothing. Vaccination Facility Type was Park. The patient has not received any other vaccines within 4 weeks prior to vaccination. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No relevant Family Medical History. The patient on 15Mar2021 at 1400 in the afternoon, got out of bed and the dizziness started and caused a fall, when in the shower and woke up the next morning. He experienced extreme dizziness which lasted three weeks. He was scared, so he did not get the second dose. He does want to get the second dose, as he believes in science. He also said that his general doctor has no clue. No Emergency Room visit. The reporter states he just went to his primary care physician and an ENT and they just did an Emply manuver and he really wants the 2nd dose of the Pfizer Covid vaccine but it scared him so much and he never went for the 2nd shot and it may be a coincidence that happened but it affected him so badly. Patient didn't know if it is normal what he experienced or an allergic reaction, He has no antibodies in him, he did the bloodwork. He wants to be protected. He knows the second dose needs to be given 21 to 30 days after the first, and his General Practitioner doesn't know what he should do. He wishes that someone would let him know what to do. For now, he will keep wearing his mask and get a flu shot. Dizziness has now completely resolved but he does not know when it resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: arm went sore but was not indicated whether it was on her first or second shot; On her first shot, she experienced increased heart rate (reached 133) and stomach ache; On her first shot, she experienced increased heart rate (reached 133) and stomach ache; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood disorder " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm went sore but was not indicated whether it was on her first or second shot"; HEART RATE INCREASED (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "On her first shot, she experienced increased heart rate (reached 133) and stomach ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she was on a blood thinner. On her first shot, she experienced increased heart rate (reached 133) and stomach ache. Caller also stated that her arm went sore but was not indicated whether it was on her first or second shot. Caller said that she was on a blood thinner and has been for 2 years and they never mentioned anything about it when they gave her the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraines".  Additional information: Facility type Vaccine: Others. If other vaccine in four weeks: No. Other medications in two weeks: No. Patient have been having migraines at least once a week since I have gotten the vaccine. Asked a colleague who also had gotten Pfizer and they have the same effects.  Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Skin discomfort, Somnolence
Clinical narrative: two days later she developed slight numbness in her legs; like her skin feels weird on both legs; developing grogginess; feeling tired; head felt dizzy; 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 42 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: EW0173) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "two days later she developed slight numbness in her legs"; SKIN DISCOMFORT (non-serious) with onset 28Aug2021, outcome "not recovered", described as "like her skin feels weird on both legs"; SOMNOLENCE (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "developing grogginess"; FATIGUE (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "feeling tired"; DIZZINESS (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "head felt dizzy".  Additional information: Reporter Details: She works in the emergency room and runs the registration department but was not one of the HCPs listed by this agency. Declined mailing address. she was usually very healthy. She takes vitamins and stuff and she is not one to complain. She doesn't get sick and she also doesn't see her doctor on a regular basis.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Peripheral swelling
Clinical narrative: 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 60 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0186) at the age of 60 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "beside her left ankle that she injured that has a plate in it and she is now disabled" (unspecified if ongoing), notes: beside her left ankle that she injured that has a plate in it and she is now disabled. The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her left arm felt like a water balloon"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes". Additional information: 60 year old, 165 pound weighing female who is in very good health, beside her left ankle that she injured that has a plate in it and she is now disabled. She considers herself a healthy girl and only takes a stupid cholesterol pill. She is not a person who does this. She received her first dose of the Pfizer Covid-19 Vaccine. She was normal, she experienced no other side effect than her left arm felt like a water balloon, but that went away after 4 days. But in turn, she began to experience hot flashes. A good amount of them during the day. They did start at night, when one would come on she would rip her clothes off and check her temperature, but this was all coming from her inside. She added that they have subsided but do continue. She has never had a hysterectomy. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Pain in his right testicles; 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 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 16:00 (Lot number: FE3592) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies to trees and dust mites" (unspecified if ongoing); "Allergies to trees and dust mites" (unspecified if ongoing); "Lyme disease" (ongoing), notes: Has ongoing issues with Lyme disease. There were no concomitant medications. Vaccination history included: Bnt162b2 (His first dose was on 28Aug2021, with lot number FC3182, in his Left arm.), administration date: 28Aug2021, when the patient was 51 years old, for covid-19 immunization. The following information was reported: TESTICULAR PAIN (non-serious) with onset 19Sep2021 23:00, outcome "not recovered", described as "Pain in his right testicles".  Additional information: Caller just had the second Pfizer COVID Comirnaty shot yesterday around 4 pm. Since then he has had a lot of pain in his right testicle. He did not have a prescribing doctor. He just got it at pharmacy. He got his second shot yesterday at 4 o'clock. He has not went to the doctor or ER. He called the doctor's office and talked to the nurse. The doctor is supposed to contact him tomorrow. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No relevant tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: pain in my left hand; tingling / tickling sensation / felt the tingling/tickling in my left hand; My left hand went numb/left foot numb/left half of her face was numb; 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 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Sep2021 (Batch/Lot number: unknown) at the age of 36 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: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "pain in my left hand"; PARAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "tingling / tickling sensation / felt the tingling/tickling in my left hand"; HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "My left hand went numb/left foot numb/left half of her face was numb".  Additional information: Caller stated she received Pfizer COVID-19 vaccine first dose on 06SEP2021, received the injection in my left arm. A week after she received the vaccine started feeling pain in my left hand and numbness. The pain was not going away; afterwards I felt like my left hand went numb, not completely like anesthesia, but more like a tingling/tickling sensation. Then I felt the tingling/tickling in my left hand, and the next day the tingling/tickling started in my whole left foot, and then tingling/tickling in the left half of my face. After that, her left foot and the left half of her face was also numb.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Lethargy, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping; My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping; lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EY0584) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 19Aug2021, outcome "not recovered" and all described as "My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping"; LETHARGY (non-serious) with onset 19Aug2021, outcome "not recovered", described as "lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, lethargy.  Additional information:Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Adverse event: My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping. Feeling fatigued, lethargic. Fatigue began 2 weeks after the second dose. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination: [covid test type post vaccination, Nasal Swab, covid test name post vaccination=Pcr, covid test date=16Sep2021, covid test result=Negative]. No Known allergies.  Follow-up attempts are completed. No further information is expected.No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: Heavier cramps; longer cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EN6208,, dose number=1,, vaccine_location=Left arm), administration date: 26Mar2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 01May2021, outcome "not recovered", described as "Heavier cramps"; OLIGOMENORRHOEA (non-serious) with onset 01May2021, outcome "not recovered", described as "longer cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain, oligomenorrhoea.  Additional information: No other medications the patient received within 2 weeks of vaccination. patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was tested Nasal Swab covid test result Negative.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 15:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic rhinitis (severe)" (unspecified if ongoing), notes: other medical history: allergic rhinitis (severe); "asthma" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing); "known allergies: possibly some IV contrast dyes" (unspecified if ongoing), notes: known allergies: possibly some IV contrast dyes; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Injection site pain".  Additional information:Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, has the patient been tested for COVID-19?:No  The Lot number for BNT162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Oct2021): 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: Illness
Clinical narrative: I believe the Pfizer vaccine got me and my 12 year old daughter sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient 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: ILLNESS (non-serious), outcome "unknown", described as "I believe the Pfizer vaccine got me and my 12 year old daughter sick".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  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: Pain
Clinical narrative: Caller is experiencing some pain; 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.  A female patient received bnt162b2 (BNT162B2), administration date 20Sep2021 (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: PAIN (non-serious) with onset 20Sep2021, outcome "unknown", described as "Caller is experiencing some pain".  Additional information: Patient wanted know if she can take Tylenol, because she spoke with her healthcare provider, but would like to know if there are other pain medications, she can take as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 78 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus. Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for arthralgia. The following information was reported: DIARRHEA (non-serious) with onset 19Sep2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 19Sep2021, outcome "unknown", described as "Headache"; WEIGHT DECREASED (non-serious) with onset Sep2021, outcome "unknown", described as "I have lost a lot of weight recently". Therapeutic measures were not taken as a result of diarrhoea, headache, weight decreased. Additional information: Are there any prior vaccinations (within 4 weeks) reported as no. 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: Feeling abnormal, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable 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. The patient's medical history and concomitant medications not reported. The patient felt abnormal (didn't feel so good) and had lymphadenopathy (enlarged lymph node under her arm), with outcome of unknown. Additional information: Patient's husband had a side effect after the 2nd dose of Pfizer COVID-19 vaccine. She also didn't feel so good. She was ok. It was minor. She had an enlarged lymph node under her arm. She declined to make a report on herself. She stated she is younger. Her husband is 62. She is frustrated from the bill and the hospital. She was about to go with Johnson & Johnson and was lucky enough to read an article about thrombosis. She is prone to thrombosis and thanked God she didn't do Johnson & Johnson. She thought Pfizer was perfectly safe. She was ok, she does not complain. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 46-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0191),  at the age of 46, in right arm, on Aug 27, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced fatigue (first dose: tiredness), onset Aug 28, 2021, with outcome of recovered (Aug 30, 2021). Additional information: Expiry date of Pfizer COVID-19 vaccine unknown. Prior vaccinations (within 4 weeks) reported as none. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Paraesthesia
Clinical narrative: Her left knee to her hip is completely numb/ It is sending a numbness and tingling sensation and she can not pick her foot up; It is sending a numbness and tingling sensation and she can not pick her foot up; Hot flashes; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Sep2021 (Lot number: EW0186) 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 no: 1), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "Hot flashes", "Her left arm felt like a water balloon". The following information was reported: HYPOAESTHESIA (non-serious) with onset 18Sep2021, outcome "unknown", described as "Her left knee to her hip is completely numb/ It is sending a numbness and tingling sensation and she can not pick her foot up"; HOT FLUSH (non-serious) with onset Sep2021, outcome "unknown", described as "Hot flashes"; PARAESTHESIA (non-serious) with onset 18Sep2021, outcome "unknown", described as "It is sending a numbness and tingling sensation and she can not pick her foot up". Additional information: Patient who was in very good health, beside her left ankle that she injured that has a plate in it and she was now disabled. She considers herself a healthy girl and only takes a stupid cholesterol pill. She was not a person who does this. She received her first dose of the Pfizer Covid-19 Vaccine. She was normal, she experienced no other side effect than her left arm felt like a water balloon, but that went away after 4 days. But in turn, she began to experience hot flashes. A good amount of them during the day. They did start at night, when one would come on, she would rip her clothes off and check her temperature, but this was all coming from her inside. She added that they have subsided but do continue. She has never had a hysterectomy. She received her second dose on 15Sep2021, and she asked to receive it in her right arm because she is left-handed. She continues with her hot flashes after the second dose, but on 18Sep2021, her left knee to her hip was completely numb. It began as the size of an orange that was numb, but now the area was the size of a watermelon. It now runs into her ankle and foot. It was sending a numbness and tingling sensation and she cannot pick her foot up. She wants to nip this in the butt and not second guess herself. Caller was asking if any of the symptoms she has experienced have been reported by others.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  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: MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  Additional information: The patient had a question concerning how, for the second dose if the patient was not feeling well, should take the second dose and what if the second dose cannot be provided on 21 days. The patient had a question, if not feeling well should take the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: My right arm started to get tingly/My arm tingled down to my fingers and it went numb; My right arm started to get tingly/My arm tingled down to my fingers and it went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:30 (Batch/Lot number: unknown) at the age of 38 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: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 24Aug2021 21:00, outcome "unknown" and all described as "My right arm started to get tingly/My arm tingled down to my fingers and it went numb". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: Facility type vaccine was Pharmacy or Drug Store. patient did not receive other vaccine in four weeks. prior vaccination, patient was not tested for Covid. Post vaccination tested for Covid. Patient was worried about getting second dose.   Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101238398 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced hypoesthesia (right arm started to get tingly/arm tingled down to fingers and went numb) and paresthesia, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101238322 same reporter/drug/AE, different patient.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 63, in left arm, on Aug 2, 2021, at 15:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced fatigue (extreme fatigue continued from first vaccine), onset Aug 3, 2021, at 09:00, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. No therapeutic measures taken as a result of fatigue. Follow-up (Oct 25, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea
Clinical narrative: nausea; arm soreness; 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 80 year-old female patient received bnt162b2 (BNT162B2), administration date 20Sep2021 11:15 (Lot number: FC3182) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 2020; LORAZEPAM taken for anxiety; ASPIRIN 81 taken for anticoagulant therapy. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 20Sep2021, outcome "unknown", described as "arm soreness"; NAUSEA (non-serious) with onset 21Sep2021, outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of limb discomfort, nausea.  Additional information: Patient wants to know if nausea can be a side effect of the vaccine, and what she should do to treat it. Reporter says she called to query a question about one side effect that she had after getting her first dose of the Pfizer COVID-19 vaccine, which was nausea. She says she got her first dose yesterday and she only had soreness in her arm, it was just the nausea bothering her this morning. She says she got up and drank some Pedialyte, which she drinks that if she was nauseated. She says she got the dose around 11:15-11:20 in the afternoon, and her right arm started to be sore in the evening. Reporter says she put alcohol on it, and it was about the same soreness as yesterday. She says when it gets sore she puts alcohol on it. Reporter says she got nauseated for the first time early this morning when she got up, so she drank some Pedialyte and water and it calmed down for a little while, but then it came back. Reporter says she takes medications concomitantly, but she was not sure if they would be relevant to the report or had anything to do with her arm soreness and nausea. She says she takes Losartan 25mg, 0.5 Lorazepam, and Aspirin once a day. She says that she goes off the Losartan for 2-3 years when her blood pressure goes down, they keep her blood pressure under control, she doesn't had really high blood pressure. She says she her blood pressure will go down and then it will come back up again after a while off of the medication so then she goes back on it. No further details provided about her Losartan. She says she had been taking medicine for quite some time. She says that she had been taking the Lorazepam off and on for a long time. No further details provided about this. She says she was prescribed the Aspirin because they do that as people get older to prevent stroke as a blood thinner type medication. She says she doesn't take it every day, sometimes she skips some days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6198), on Feb 24, 2021, and received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EM9809), on Feb 3, 2021; both single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient had  pain in extremity (sore arm), with outcome of recovered (2021). No follow-up attempts possible. No further information expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Fatigue, Myalgia
Clinical narrative: Aphtha; muscle pain on his left deltoid bicep, left upper arm, the same site where he got the vaccine; Strange amount of fatigue in arm where vaccine was administered/ Caller would say it is persisting and has also worsened; 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. Other Case identifier(s): US-PFIZER INC-202101240940 (Pfizer).  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 17Sep2021 14:00 (Lot number: FC3183) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 21Sep2021, outcome "unknown", described as "Strange amount of fatigue in arm where vaccine was administered/ Caller would say it is persisting and has also worsened"; APHTHOUS ULCER (non-serious), outcome "unknown", described as "Aphtha"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain on his left deltoid bicep, left upper arm, the same site where he got the vaccine".  Additional information: patient did not receive any other vaccine within four weeks prior to the first administration date of the suspect vaccine. patient reported massaging the area as well but was not able to resolve it. He also reported that around the same day he got the vaccine he developed mouth ulcer or what he labeled as "Aphtha" on his left inner teeth (Same side where he got the vaccine).  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: first and second dose: sugar level went up; 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 76 year-old male patient received bnt162b2 (BNT162B2), administration date 23Aug2021 08:30 (Lot number: EW0175) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Additional Information for Other Conditions: diagnosed about 5 or 6 years ago. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (AE(s) following prior vaccinations: None, he does get his flu shot each year and had both pneumonia shots), for Immunization; Pneumonia shots (AE(s) following prior vaccinations: None, he does get his flu shot each year and had both pneumonia shots), for Immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "first and second dose: sugar level went up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He checked his blood glucose the same day and it was 250 mg/dL and received the second dose on 20Sep2021 and states that his blood glucose was 189 mg/dL afterwards. Caller is asking if increased blood glucose levels was a side effect of the Pfizer Covid-19 vaccine. Dose was injected in left shoulder. He just got his second covid shot through a local clinic, he got the first shot 3 or 4 weeks ago. Both times it got his sugar up to dangerous levels. He was a diabetic. Asking if that was a common side effect or was it rare. His sugar level was not like a coma or life threatening but for several hours it is staying over 200. He checks his sugar in the morning fasting, at that was scary with numbers like that and he was fasting. This morning when he was fasting he checked it and it was at 189. He checked his sugar a few minutes ago and it is 220. He has not had any carbs or sugar today. With the first dose it went up to 250 and after few days came back down and was around 150. He said the vaccine is probably what did it. With the second dose he is more concerned since he does not know if other people are experiencing worse sugar levels than he is.   No follow-up attempts are possible. No further information is expected.