chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: fatigue; weakness; grogginess; I feel drained and sick; 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-202101212191.  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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), administration date: 2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; SOMNOLENCE (non-serious) with onset 2021, outcome "not recovered", described as "grogginess"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I feel drained and sick". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Caller, reporting on the Covid vaccine and who explains that he got both shots in either February and March or in March and April. Since then he has a lot of fatigue. Caller mentions he cant test for Covid because the symptoms are more than a few days old, this seems to have been going on was since the vaccine. He is wondering if the weakness and grogginess he is feeling could be long term side effects to the vaccine. Caller declines the report explaining that he cant be accurate on the events and when they started but it feels like this has been going on since getting the vaccine; he doesn't have exact dates and doesn't know when he was faced with this exactly. He feels like he has a virus without the respiratory symptoms but he is not sure he can make absolutely certain this is attributed to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: certain reactions may take place longer than the 15 minute or 30 minute waiting period offered by the vaccination site.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient 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: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "certain reactions may take place longer than the 15 minute or 30 minute waiting period offered by the vaccination site.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypoacusis
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 89 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6205) as dose 2, single and administration date 02Feb2021 (Lot number: EL9266) 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: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart trouble"; HYPOACUSIS (non-serious), outcome "unknown", described as "Hard of hearing". Additional information: Patient took dose 2 at local hospital and dose 1 was at local pharmacy. Patient stated that she was 89 year old and has heart trouble. She was hard of hearing and is having trouble. She mentioned something about her cardiac doctor but does not provide further details. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she did have arm pain with the first shot; 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 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Mmr (she was given the second MMR shot in the hospital the day of or the day after she had given birth). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she did have arm pain with the first shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). Other case identifier: US-PFIZER INC-202101212345. A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in arm, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient felt abnormal (outcome of unknown). Additional information: Patient received the shot in his arm. He felt the jab going into his arm, and felt something odd about the circumstances. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hot flush, Personality change
Clinical narrative: made his wife mean; Hot flashes; burning in her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERSONALITY CHANGE (non-serious), outcome "unknown", described as "made his wife mean"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning in her face".  Additional Information: The caller thinks the covid vaccine made his wife mean and she has hot flashes after her vaccine. The patient got both doses. The patient is post-menopausal and it amplified what she already had. The patient had to turn down the air conditioning and there was burning in her face.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: head rush; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, 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: HEADACHE (non-serious), outcome "unknown", described as "head rush". Therapeutic measures were taken as a result of headache.  Additional information: The patient did not experience side effects from the vaccines just a head rush after the first one but was extremely poorly with covid and was on a virtual ward and needed an inhaler.  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, Nausea
Clinical narrative: experienced stomach pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "experienced stomach pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Additional information: After both COVID-19 vaccine doses, patient (female, 29) experienced stomach pain, nausea. Patient suffers from underlying condition Lyme disease (unrelated to vaccine). Reporter did not wish to be contacted for follow-up.  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: Headache
Clinical narrative: I've had a pain on the left side of my head that's  tender to the touch; 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 02Sep2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: Ibuprofen. The following information was reported: HEADACHE (non-serious) with onset 02Sep2021 18:30, outcome "not recovered", described as "I've had a pain on the left side of my head that's  tender to the touch". Therapeutic measures were not taken as a result of headache.  Additional information:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 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 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information:Patient was immunocompromised and told immunologist for the first that  had a reaction to the Pfizer covid. The previous dose felt like everyone else didn't have anything but a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Feb 2021; both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced hypoacusis (harder for her to hear), with outcome of unknown. Additional information: Patient had both COVID-19 vaccinations back in February. She also lost her husband at that time. She thinks she may have thrown out her vaccination card. Her doctor has proof of the first shot, but not the second shot. She was directed back to the facility where she received vaccine from for vaccination history. It is harder for her to hear when not on speaker phone. About a week and a half ago they were testing people for COVID-19, she hasn't heard as to whether she was positive or not. Not clarified if she had hearing issues prior to vaccine. Not clarified what symptoms she had that encouraged her to get tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: diarrhea; throwing up; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 04Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she had outpatient surgery", start date: 23Aug2021 (unspecified if ongoing); "i feel discouraged and/or depressed." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "diarrhea"; VOMITING (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "throwing up".  Additional information: Patient reported after start of therapy she had outpatient surgery 23Aug2021 and had to stop taking her medication from 14Aug2021 to 07Sep2021. Patient answered some of the time to the question how often do you run out of medicine. patient reported after start of therapy she ran out of medicine once because she was waiting for insurance approval for dosage change and received free samples from md. patient answered some of the time to the question how often do you miss taking your medicine when you feel sick. patient reported after start of therapy she had diarrhea and was throwing up after her second covid vaccine on 04Sep2021, which has resolved.  Follow-up attempts completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metallic taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Sep2021 09:15 (Lot number: FC3183) at the age of 28 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs. Concomitant medication(s) included: CIPROFLOXACIN; AZO; WELLBUTRIN. The following information was reported: DYSGEUSIA (non-serious) with onset 16Sep2021, outcome "not recovered", described as "Strong metallic taste in mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Facility type vaccine was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: headache; body aches; fatigue; injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Sep2021 16:15 (Batch/Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: juniper" (unspecified if ongoing), notes: known allergies: juniper; "known allergies: nickel" (unspecified if ongoing), notes: known allergies: nickel. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 16Sep2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 16Sep2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 16Sep2021, outcome "not recovered", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 16Sep2021, outcome "not recovered", described as "injection site soreness". Therapeutic measures were not taken as a result of headache, pain, fatigue, vaccination site pain. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This case seriousness was reported as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Malaise, Pain, Pain in extremity
Clinical narrative: body aches; chills; arm is sore; not feeling well; I feel kind of warm. I might have a low-grade fever.; I feel kind of warm. I might have a low-grade fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (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), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2021, outcome "unknown", described as "arm is sore"; MALAISE (non-serious) with onset 16Sep2021, outcome "unknown", described as "not feeling well"; PYREXIA (non-serious), FEELING HOT (non-serious) all with onset 16Sep2021, outcome "unknown" and all described as "I feel kind of warm. I might have a low-grade fever". Additional information: The patient stated that she received her second dose of Pfizer's COVID vaccine on 15Sep2021 and on 16Sep2021 the patient had body aches and chills. The patient stated that she was not sure if she had a fever. The patient felt kind of warm. The patient thought she might had a low-grade fever. The patient arm was sore. The patient was wondering if she could take Tylenol or Ibuprofen. The patient would like to provide no personal information, but she didn't had any problem telling her symptoms. The patient stated that she would call back if she gets worse which she hoped she didn't.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body aches; chills; arm is sore; not feeling well; I feel kind of warm. I might have a low-grade fever.; I feel kind of warm. I might have a low-grade fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (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), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2021, outcome "unknown", described as "arm is sore"; MALAISE (non-serious) with onset 16Sep2021, outcome "unknown", described as "not feeling well"; PYREXIA (non-serious), FEELING HOT (non-serious) all with onset 16Sep2021, outcome "unknown" and all described as "I feel kind of warm. I might have a low-grade fever". Additional information: The patient stated that she received her second dose of Pfizer's COVID vaccine on 15Sep2021 and on 16Sep2021 the patient had body aches and chills. The patient stated that she was not sure if she had a fever. The patient felt kind of warm. The patient thought she might had a low-grade fever. The patient arm was sore. The patient was wondering if she could take Tylenol or Ibuprofen. The patient would like to provide no personal information, but she didn't had any problem telling her symptoms. The patient stated that she would call back if she gets worse which she hoped she didn't.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: lump on my collar bone on the same side that the shot was given; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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), for COVID-19 Immunization. The following information was reported: CYST (non-serious), outcome "unknown", described as "lump on my collar bone on the same side that the shot was given".  Additional Information: After taking the second shot, two days after taking the second shot, patient started getting a lump, a big lump on my collar bone on the same side that the shot was given.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Early administration of the 2nd vaccine dose; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 13 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Batch/Lot number: unknown) at the age of 13 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 (Dose: 1 , Dosage text: 0.3mL, intramuscular injection in left arm , Batch/lot number: FC3182, Expiry Date: Oct2021), administration date: 07Sep2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Sep2021, outcome "unknown", described as "Early administration of the 2nd vaccine dose"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "Sore arm".  Additional Information : Patient had no prior Vaccinations (within 4 weeks) of the Covid-19 vaccination. No additional Vaccines Administered on Same Date of the Pfizer Suspect vaccine. Follow-up attempts completed. No further information is expected  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Hyperhidrosis, Infantile vomiting, Lethargy
Clinical narrative: vomiting; lethargic; sweating; Was breastfed yesterday after his mother received Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 month-old male patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 15Sep2021 20:30 (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: EXPOSURE VIA BREAST MILK (non-serious) with onset 15Sep2021, outcome "unknown", described as "Was breastfed yesterday after his mother received Covid Vaccine"; INFANTILE VOMITING (non-serious) with onset 16Sep2021, outcome "unknown", described as "vomiting"; LETHARGY (non-serious) with onset 16Sep2021, outcome "unknown", described as "lethargic"; HYPERHIDROSIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "sweating".  Additional information: Patent stated that she was calling about the Pfizer Product: Covid Vaccine. She had a concern. she got the vaccine yesterday around 20.30. Around 03:00 this morning her baby started throwing up. She had breastfed him after receiving her vaccine last night. She was concerned, could he have side effects and not her. Parent stated that her son had no symptoms prior to this. States he was a healthy 14 month old who has never been sick or thrown up in his life. Now, he was throwing up, sweating, and lethargic. Stated that her and her husband are concerned if it could be from her vaccine.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218317 Same reporter/drug, different patient/event (mother/baby case)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Throat irritation, Tongue disorder
Clinical narrative: Throat felt itchy and irritated after first vaccine; Bumps on her tongue, after first vaccine; her tongue was irritated with bumps; 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 39 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FF2588) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ear infection", start date: Jun2021 (unspecified if ongoing), notes: she went to the ENT doctor and Caller states the doctor sprayed a medication in her left ear. The patient's concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset 26Aug2021, outcome "unknown", described as "Throat felt itchy and irritated after first vaccine"; TONGUE DISORDER (non-serious) with onset 26Aug2021, outcome "unknown", described as "Bumps on her tongue, after first vaccine"; GLOSSITIS (non-serious) with onset 26Aug2021, outcome "unknown", described as "her tongue was irritated with bumps". Therapeutic measures were taken as a result of throat irritation, tongue disorder, glossitis.  Additional information: Caller stated that after the first vaccine, she waited 15 minutes and felt fine, then when she got home, her throat felt itchy and irritated. she had bumps on her tongue. she wasn't sure at that time, it was a reaction, from the vaccine. she took generic Claritin at that time, and it did help with that reaction. she was scheduled for second dose on 16Sep2021, and the provider felt uncomfortable to administer it today, 21 days from first dose, due to previous reaction.     No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in her toes and the palm of her hand; numbness and tingling in her toes and the palm of her hand; numbness and tingling in her toes and the palm of her hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 11Sep2021 (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), HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset Sep2021, outcome "unknown" and all described as "numbness and tingling in her toes and the palm of her hand".  Additional information: Caller stated her daughter had the Pfizer covid 19 vaccine 5 days ago. Caller stated her daughter said she was fine but daughter reported numbness and tingling in her toes and the palm of her hand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was just sore a little bit; 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 41-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 (Lot number: FC3182) at the age of 40 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: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Arm was just sore a little bit".  Additional information: Received first dose of Pfizer COVID vaccine on 25Aug2021. After the first dose he was fine, states his arm was just sore a little bit.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; 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 32 year-old female patient received bnt162b2 (BNT162B2), administration date 16May2021 (Lot number: EW0176) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovering", described as "arm hurt". Additional information: The patient received the first Covid vaccine 16May2021, had no side effects with the first Covid shot other than the arm hurt. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate irregular, Hyperhidrosis
Clinical narrative: Irregular heart beat/racing; Fatigue; Nausea; Headache; Muscle aches; Just don't feel good; Sweeping in my legs and hands; This is a spontaneous report received from 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 right, administration date 30Aug2021 10:00 (Lot number: FD0809) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; ALEVE. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Irregular heart beat/racing"; FATIGUE (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Muscle aches"; FEELING ABNORMAL (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Just don't feel good"; HYPERHIDROSIS (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Sweeping in my legs and hands". Therapeutic measures were not taken as a result of heart rate irregular, fatigue, nausea, headache, myalgia, feeling abnormal, hyperhidrosis.  Additional information: 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Irregular heart beat/racing; Fatigue; Nausea; Headache; Muscle aches; Just don't feel good; Sweeping in my legs and hands; This is a spontaneous report received from 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 right, administration date 30Aug2021 10:00 (Lot number: FD0809) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; ALEVE. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Irregular heart beat/racing"; FATIGUE (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Muscle aches"; FEELING ABNORMAL (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Just don't feel good"; HYPERHIDROSIS (non-serious) with onset 30Aug2021 20:00, outcome "not recovered", described as "Sweeping in my legs and hands". Therapeutic measures were not taken as a result of heart rate irregular, fatigue, nausea, headache, myalgia, feeling abnormal, hyperhidrosis.  Additional information: 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in throat; General weakness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes in throat"; ASTHENIA (non-serious), outcome "unknown", described as "General weakness".  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: Fatigue, Somnolence
Clinical narrative: still feeling very tired and drowsy; still feeling very tired and drowsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Sep2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, Lot Number:  FC3180), administration date: 06Aug2021, for COVID-19 Immunization, reaction(s): "She experienced an adverse reaction". The following information was reported: SOMNOLENCE (non-serious), FATIGUE (non-serious) all with onset 13Sep2021, outcome "not recovered" and all described as "still feeling very tired and drowsy". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Left lower eyelid involuntary twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: FF2587) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal Bronchitis" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 01, lot number: FD0809, administration time: 12:45 PM, vaccine location: Left arm), administration date: 25Aug2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "Chest pain", "Left lower eyelid involuntary twitching". The following information was reported: BLEPHAROSPASM (non-serious) with onset 29Aug2021 12:00, outcome "recovering", described as "Left lower eyelid involuntary twitching". Therapeutic measures were not taken as a result of blepharospasm.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Patient experienced chest pain for 5 days, 4 days after the first dose of Pfizer Covid 19 vaccine. Left lower eyelid involuntary twitching, 4 days after first dose of Pfizer COVID-19 vaccine, which up to the second dose still persist. Patient had covid prior vaccination. Patient was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (051529).  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 13Sep2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea".  Additional information: Verbatim and Event Description: Patient held Xeljanz doses for 2 months to get her COVID-19 vaccines and her flu shot. Just started taking the medication again on 12Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Vomiting
Clinical narrative: Tired; Light-headed; throwing up; Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: EW0179) 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: FATIGUE (non-serious), outcome "unknown", described as "Tired"; DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular periods. I get them every two weeks and used to get them every 28 days prior to vaccine; 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 03Jul2021 10:00 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 18Jul2021 11:00, outcome "not recovered", described as "Irregular periods. I get them every two weeks and used to get them every 28 days prior to vaccine". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Irregular periods. I get them every two weeks and used to get them every 28 days prior to vaccine. If treatment : No. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Tinnitus, Vertigo, light headed with both shots; Tinnitus, Vertigo, light headed with both shots; Tinnitus, Vertigo, light headed with both shots; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 16:00 (Lot number: FC3184) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: HUMIRA. Past drug history included: Humira, reaction(s): "known allergies: Humira". The following information was reported: DIZZINESS (non-serious), VERTIGO (non-serious), TINNITUS (non-serious) all with onset 24Aug2021 14:00, outcome "not recovered" and all described as "Tinnitus, Vertigo, light headed with both shots". The event "tinnitus, vertigo, light headed with both shots", "tinnitus, vertigo, light headed with both shots" and "tinnitus, vertigo, light headed with both shots" 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 dizziness, vertigo, tinnitus.Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye allergy
Clinical narrative: allergic reaction at my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE ALLERGY (non-serious), outcome "unknown", described as "allergic reaction at my eyes". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 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: DRUG HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from contactable other HCP/consumer or other non-HCP, for a Pfizer sponsored program (051529). A 29-year-old 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 developed malaise/sickness (outcome unknown). Additional information: Patient missed a couple weeks of doses due to getting the COVID-19 shot and being sick. 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-202101224414 (same patient and reporter, different product and events).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Burns second degree, Scar, Skin exfoliation, Thermal burn
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 15Sep2021 (Lot number: EW0183) at the age of 53 years 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: THERMAL BURN (non-serious) with onset 15Sep2021, outcome "unknown", described as "Became like I got burnt right there"; SKIN EXFOLIATION (non-serious) with onset 15Sep2021, outcome "unknown", described as "my skin peeled/ My skin to be peeling right there besides the shot/ my whole skin came up with the Band-Aid"; BURNS SECOND DEGREE (non-serious) with onset 15Sep2021, outcome "unknown", described as "and then I got a blister right there"; BURNING SENSATION (non-serious) with onset 15Sep2021, outcome "unknown", described as "Band-Aid was lifting up with my skin and it burned"; SCAR (non-serious) with onset 15Sep2021, outcome "unknown", described as "I developed a burn mark". Therapeutic measures were not taken as a result of thermal burn, skin exfoliation, burns second degree, burning sensation, scar. Additional information: When probed if consumer had any vaccination 4 weeks prior to COVID 19 Vaccine, Consumer stated, "No." She stated, "she was calling because she was told to let you all know that she did take the vaccination shot, the first shot Pfizer and she developed (incomplete sentence). She said she did take the shot 2 days ago and she took the shot, they put a Band-Aid on and then she developed a burn mark, it became like she got burnt right there, skin peeled and then she got a blister right there. And know she was not allergic to the Band-Aid. she have worn but she was 53 years old. She have always worn Band-Aids. And there was no other reason for her skin to be peeling right there besides the shot." She stated, "2 days ago (15Sep2021). When she got the shot, later on that day she got ready to take the Band-Aid off and that's when she noticed the Band-Aid was lifting up with her skin and it burned, whole skin came up with the Band-Aid. She did not have any marks over there." There was the date when she was supposed to get the second one." Scheduled date for the second shot: Consumer stated, "06Oct2021." Follow-up attempts are completed. No further information is expected.