chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: my menses are now 20 days apart. thanks a lot pfizer; my menses are now 20 days apart. thanks a lot pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Aug2021 (Lot number: FA6780) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "my menses are now 20 days apart. thanks a lot pfizer". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder.  Additional information: Other medical history was reported as no. The patient had no known allergies. Patient did not receive any other vaccine in four weeks and not received any other medications in two weeks. COVID prior vaccination and COVID tested post vaccination was reported as no. Adverse event start date: 29Jul2021. Adverse event did not result in Emergency room or physician office visit.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mood altered
Clinical narrative: tiredness; not in the mood of doing anything; 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 male patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (Lot number: EW0181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Appendix removal", start date: 2013 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "tiredness"; MOOD ALTERED (non-serious) with onset 2021, outcome "unknown", described as "not in the mood of doing anything".  Additional information: Caller reported that this all started happening after the first dose of the Covid shot, he started feeling tired, not in the mood of doing anything. The tiredness started after the first shot, and he has been tired since. Right now he is dealing with Side effects.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: numbness on her right arm, shoulder, and her neck; arm was sore; 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 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 (Lot number: FA7484) at the age of 68 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: HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "not recovered", described as "numbness on her right arm, shoulder, and her neck"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "arm was sore". Therapeutic measures were not taken as a result of hypoesthesia.  Additional information: Patient did not receive other products. Patient confirms above details and says at first her arm was sore then a couple days after she got it, maybe 3 days afterwards it was numb and she thought it would go away but it hasn't gone yet, and it has stayed the same. She says she is supposed to get her second dose tomorrow. She says she has done no treatment for the numbness, she hasn't spoken to her doctor, and she doesn't know if she should have the second dose since she still has the numbness.    Follow-up attempts are completed. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Caused hard changes in my period also in both my daughters periods age 12 and 13; Caused hard changes in my period also in both my daughters periods age 12 and 13; 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 15Jan2021 (Lot number: El9261) at the age of 38 years as dose 2, single and administered in arm left, administration date 15Jan2021 (Lot number: Ek4176) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "Caused hard changes in my period also in both my daughters periods age 12 and 13". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder.  Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination and not tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110603 Same reporter/, Different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Dizziness, Electroencephalogram, Heart rate
Clinical narrative: Very weak for 2-3 weeks after - still weak now.; Also having intense sun sensitivity, especially on scalp.; Feels like needles; lightheadedness./dizziness; nausea; increased heart rate; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 13:00 (Lot number: E8730) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing); "known allergis: penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: cipro, reaction(s): "allergy"; Known allergies: bactrim, reaction(s): "Allergy". The following information was reported: ASTHENIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Very weak for 2-3 weeks after - still weak now."; PHOTOSENSITIVITY REACTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Also having intense sun sensitivity, especially on scalp."; PARAESTHESIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Feels like needles"; DIZZINESS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "lightheadedness./dizziness"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "nausea"; HEART RATE INCREASED (non-serious) with onset 30Mar2021, outcome "not recovered", described as "increased heart rate"; PALPITATIONS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "palpitations". The events "very weak for 2-3 weeks after - still weak now.", "also having intense sun sensitivity, especially on scalp.", "feels like needles", "lightheadedness./dizziness", "nausea", "increased heart rate" and "palpitations" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, photosensitivity reaction, paraesthesia, dizziness, nausea, heart rate increased, palpitations.  Additional Information: Very weak for 2-3 weeks after still weak now. Also having intense sun sensitivity, especially on scalp. Feels like needles upon brief sun exposure and dizziness, lightheadedness, nausea. Also, increased heart rate palpitations. The Patient did not receive any vaccine with in 4 weeks and received medication within last 2 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Palpitations, Paraesthesia, Photosensitivity reaction
Clinical narrative: Very weak for 2-3 weeks after - still weak now.; Also having intense sun sensitivity, especially on scalp.; Feels like needles; lightheadedness./dizziness; nausea; increased heart rate; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 13:00 (Lot number: E8730) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing); "known allergis: penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: cipro, reaction(s): "allergy"; Known allergies: bactrim, reaction(s): "Allergy". The following information was reported: ASTHENIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Very weak for 2-3 weeks after - still weak now."; PHOTOSENSITIVITY REACTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Also having intense sun sensitivity, especially on scalp."; PARAESTHESIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Feels like needles"; DIZZINESS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "lightheadedness./dizziness"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "nausea"; HEART RATE INCREASED (non-serious) with onset 30Mar2021, outcome "not recovered", described as "increased heart rate"; PALPITATIONS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "palpitations". The events "very weak for 2-3 weeks after - still weak now.", "also having intense sun sensitivity, especially on scalp.", "feels like needles", "lightheadedness./dizziness", "nausea", "increased heart rate" and "palpitations" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, photosensitivity reaction, paraesthesia, dizziness, nausea, heart rate increased, palpitations.  Additional Information: Very weak for 2-3 weeks after still weak now. Also having intense sun sensitivity, especially on scalp. Feels like needles upon brief sun exposure and dizziness, lightheadedness, nausea. Also, increased heart rate palpitations. The Patient did not receive any vaccine with in 4 weeks and received medication within last 2 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Very weak for 2-3 weeks after - still weak now.; Also having intense sun sensitivity, especially on scalp.; Feels like needles; lightheadedness./dizziness; nausea; increased heart rate; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 13:00 (Lot number: E8730) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing); "known allergis: penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: cipro, reaction(s): "allergy"; Known allergies: bactrim, reaction(s): "Allergy". The following information was reported: ASTHENIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Very weak for 2-3 weeks after - still weak now."; PHOTOSENSITIVITY REACTION (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Also having intense sun sensitivity, especially on scalp."; PARAESTHESIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Feels like needles"; DIZZINESS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "lightheadedness./dizziness"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "nausea"; HEART RATE INCREASED (non-serious) with onset 30Mar2021, outcome "not recovered", described as "increased heart rate"; PALPITATIONS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "palpitations". The events "very weak for 2-3 weeks after - still weak now.", "also having intense sun sensitivity, especially on scalp.", "feels like needles", "lightheadedness./dizziness", "nausea", "increased heart rate" and "palpitations" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, photosensitivity reaction, paraesthesia, dizziness, nausea, heart rate increased, palpitations.  Additional Information: Very weak for 2-3 weeks after still weak now. Also having intense sun sensitivity, especially on scalp. Feels like needles upon brief sun exposure and dizziness, lightheadedness, nausea. Also, increased heart rate palpitations. The Patient did not receive any vaccine with in 4 weeks and received medication within last 2 weeks.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Caused hard changes in my period also in both my daughters periods age 12 and 13; Caused hard changes in my period also in both my daughters periods age 12 and 13; 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: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "Caused hard changes in my period also in both my daughters periods age 12 and 13". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110603 Same reporter, Different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Feeling abnormal, Magnetic resonance imaging, Nausea
Clinical narrative: Dizziness/Light headedness; brain fog/feeling off/Feeling over all off; nausea goes along when you start feeling dizzy; 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 57-year-old male patient received bnt162b2 (BNT162B2), administration date 26Jul2021 (Lot number: ER8736) at the age of 57 years 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: DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness/Light headedness"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog/feeling off/Feeling over all off"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea goes along when you start feeling dizzy". The events "dizziness/light headedness", "brain fog/feeling off/feeling over all off" and "nausea goes along when you start feeling dizzy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, feeling abnormal, nausea.  Additional information: Caller states that he received the first dose of the Pfizer COVID 19 vaccine a month ago and began to feel side effects. He states that the side effects include dizziness, light-headedness, brain fog, and feeling off. He relays that he is a 57-year-old male and has never had these issues before. He relays that he works for a pharmaceutical company other than Pfizer and they are starting to mandate the employees to be vaccinated but that he is scared to get the second dose because of the effects he has experienced since the first dose. He states that he is looking at the FDA website and that it mentions around 4,000 reports of dizziness with the VAERS for the Pfizer Covid 19 vaccine. Well, I think nausea goes along when you start feeling dizzy and all, not vomiting and all just nausea. I was scheduled 3 weeks, but we had covid in the house, 4 different people got covid. (Further details unknown) So, I haven't still got my 2nd shot because you have to wait 14 days, The pharmacist said to wait 14 days after the last person had Covid in the house. So, I haven't received the 2nd shot yet and that's why I am concerned, I'm experiencing dizziness and light headedness, I don't know if I want to get the 2nd one. Consumer stated, haven't done anything, been to the doctor, had an MRI and blood work (Not clarified further) done but nothing has shown there.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Intense pain on left side of head near temple lasting 5 days after the 2nd dose.; Vertigo started 2nd night of the 2nd dose. Vertigo lasted for days before clearing out with body movement exercises; 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 18May2021 18:30 (Lot number: EW0185) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS-D" (unspecified if ongoing); "vertigo" (unspecified if ongoing), notes: Last episode of vertigo was 10 years ago for unrelated reasons. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, lot number=EW0171, administration time=06:15 PM, vaccine location=Left arm), administration date: 27Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19May2021, outcome "recovered" (24May2021), described as "Intense pain on left side of head near temple lasting 5 days after the 2nd dose."; VERTIGO (non-serious) with onset 19May2021, outcome "recovered" (2021), described as "Vertigo started 2nd night of the 2nd dose. Vertigo lasted for days before clearing out with body movement exercises". Therapeutic measures were not taken as a result of headache, vertigo.  Additional information: Intense pain on left side of head near temple lasting 5 days after the 2nd dose. Vertigo started 2nd night of the 2nd dose. Vertigo lasted for days before clearing out with body movement exercises. Asked medical professional for guidance and was told to rest. Last episode of vertigo was 10 years ago for unrelated reasons. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient wasn't tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in her fingers; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 26Aug2021 10:30 (Lot number: FC3182, Expiration Date: 31Oct2021) at the age of 60 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 26Aug2021, outcome "unknown", described as "tingling in her fingers".  Additional Information: It was reported that, after administering first dose to the patient, couple minutes later while the patient was waiting, there was tingling in her fingers. The caller did not  know if event was from the vaccine as the patient was leaning on her arm on a table and she was nervous prior to receiving the vaccine. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer suspect were none. Adverse event did not result in emergency room visit or physician office visit. Prior vaccinations within 4 weeks and hence, adverse events following prior vaccinations were none. relevant laboratory tests were none. Family medical history relevant to adverse event was none. Vaccination Facility Type was Pharmacy. The reporter considered "tingling in her fingers" as unrelated.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: got the 1st dose of the Pfizer COVID Vaccine on 26Apr2021 and then got sick; got sick with a cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got the 1st dose of the Pfizer COVID Vaccine on 26Apr2021 and then got sick"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "got sick with a cold". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient got first dose of the Pfizer COVID Vaccine on 26Apr2021 and then got sick and asked if she would need to get first dose again or could she get the second dose. Stated her being sick was not associated with the Pfizer Covid vaccine and it had been four months since her first dose.  Stated when she got sick it was not an issue of the Pfizer vaccine and what happened was she had her second dose appointment scheduled and got sick with a cold and not covid and tested negative for covid. Caller stated that she did not feel the need to take a report and she had no adverse reaction but it was just timing related to her vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Malaise
Clinical narrative: I am not feeling good at all; I am very dizzy; My hands are numb and my teeth are numb too; My hands are numb and my teeth are numb too; 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), administration date 25Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 25Aug2021, outcome "unknown", described as "I am not feeling good at all"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "unknown", described as "I am very dizzy"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA (non-serious) all with onset 25Aug2021, outcome "unknown" and all described as "My hands are numb and my teeth are numb too".  Additional information: It was reported that the patient took the second dose of the vaccine yesterday and  was not feeling good at all, like very dizzy and hands are numb and teeth are numb too and asked if it was normal  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Headache, Pain
Clinical narrative: Pain left deltoid / biceps, headache, low-grade temperature; Pain left deltoid / biceps, headache, low-grade temperature; Pain left deltoid / biceps, headache, low-grade temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: EW0217) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "known allergy: Morphine". The following information was reported: PAIN (non-serious), HEADACHE (non-serious), BODY TEMPERATURE DECREASED (non-serious) all with onset 27Aug2021 05:00, outcome "recovering" and all described as "Pain left deltoid / biceps, headache, low-grade temperature". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, body temperature decreased.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. Events were treated with Advil 400 mg. Vaccine administration time=03:00 PM.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hypokinesia, Musculoskeletal chest pain, Pain, Paraesthesia
Clinical narrative: Hot all over body; Everything aches; Ribs are very painful; Spondyloarthritis flare up; Decrease in moving and raising his arms; Tingling sensation; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 42 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EVRYSDI; HUMIRA; ATIVAN. The following information was reported: FEELING HOT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Hot all over body"; PAIN (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Everything aches"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ribs are very painful"; SPINAL OSTEOARTHRITIS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Spondyloarthritis flare up"; HYPOKINESIA (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Decrease in moving and raising his arms"; PARAESTHESIA (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Tingling sensation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal osteoarthritis
Clinical narrative: Hot all over body; Everything aches; Ribs are very painful; Spondyloarthritis flare up; Decrease in moving and raising his arms; Tingling sensation; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 42 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EVRYSDI; HUMIRA; ATIVAN. The following information was reported: FEELING HOT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Hot all over body"; PAIN (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Everything aches"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ribs are very painful"; SPINAL OSTEOARTHRITIS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Spondyloarthritis flare up"; HYPOKINESIA (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Decrease in moving and raising his arms"; PARAESTHESIA (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Tingling sensation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Migraine, Pain, Tinnitus
Clinical narrative: Fatigue; Malaise; Periodic migraine headaches; arm pain; Increased ringing of affected ear; 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), administration date 12Jan2021 (Lot number: EL0142) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing); "meniere's diseas" (unspecified if ongoing); "Polypharmacy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 12Jan2021, outcome "unknown", described as "arm pain"; FATIGUE (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021), described as "Fatigue"; MALAISE (non-serious) with onset 12Jan2021, outcome "recovered" (Jan2021), described as "Malaise"; MIGRAINE (non-serious) with onset 12Jan2021, outcome "recovered" (Jan2021), described as "Periodic migraine headaches"; TINNITUS (non-serious) with onset Jan2021, outcome "unknown", described as "Increased ringing of affected ear".  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Increased appetite, Pain in extremity, Weight
Clinical narrative: arm pain; really tired; really hungry; She experienced arm pain and chills after the first dose and a headache after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 13:00 (Lot number: EWU175) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "environmental allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm pain"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "really tired"; INCREASED APPETITE (non-serious) with onset 2021, outcome "recovered" (2021), described as "really hungry"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "She experienced arm pain and chills after the first dose and a headache after second dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The arm pain started about 5 or 6pm after getting the shot. She reports she was really tired then and the following day. Also, she was really hungry the next day too which is not normal. This all only lasted about 2 days and then went away. The caller also explains she has environmental allergies like pollen and has noticed, after the vaccines, they get severe. They have stopped but there are times she feels they more severe now when she does get them, where they were light before the vaccines.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116701 similar report from same reporter
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 22-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3182), at the age of 22, in left arm, on Aug 27, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing); and sulfonamide allergy (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced vaccination site pain (injection site pain for 15 minutes), onset 2021, with outcome of recovered (2021). No therapeutic measures taken as a result of vaccination site pain. Additional information: Patient did not receive any other vaccine prior 4 weeks of COVID-19 vaccination. The patient did not have COVID-19 prior to vaccination. The patient not tested for COVID-19 post vaccination. Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Illness
Clinical narrative: feel bad; tiredness; weakness; headache; his arms and feet are cramped; feel sick; feel pain in his 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 42 year-old male patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Batch/Lot number: unknown) at the age of 42 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 10Aug2021, outcome "unknown", described as "feel pain in his arm"; FEELING ABNORMAL (non-serious) with onset 20Aug2021, outcome "unknown", described as "feel bad"; FATIGUE (non-serious) with onset 20Aug2021, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset 20Aug2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 20Aug2021, outcome "unknown", described as "headache"; MUSCLE SPASMS (non-serious) with onset 20Aug2021, outcome "unknown", described as "his arms and feet are cramped"; ILLNESS (non-serious) with onset 20Aug2021, outcome "unknown", described as "feel sick".  Additional Information: Caller received the first dose of the Pfizer Covid-19 vaccine on 09Aug2021, the next day he started to feel pain in his arm and on Friday 20Aug2021 began to feel bad, he has felt tiredness, weakness, headache and his arms and feet are cramped. He would like to know if this is normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: feel bad; tiredness; weakness; headache; his arms and feet are cramped; feel sick; feel pain in his 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 42 year-old male patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Batch/Lot number: unknown) at the age of 42 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 10Aug2021, outcome "unknown", described as "feel pain in his arm"; FEELING ABNORMAL (non-serious) with onset 20Aug2021, outcome "unknown", described as "feel bad"; FATIGUE (non-serious) with onset 20Aug2021, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset 20Aug2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 20Aug2021, outcome "unknown", described as "headache"; MUSCLE SPASMS (non-serious) with onset 20Aug2021, outcome "unknown", described as "his arms and feet are cramped"; ILLNESS (non-serious) with onset 20Aug2021, outcome "unknown", described as "feel sick".  Additional Information: Caller received the first dose of the Pfizer Covid-19 vaccine on 09Aug2021, the next day he started to feel pain in his arm and on Friday 20Aug2021 began to feel bad, he has felt tiredness, weakness, headache and his arms and feet are cramped. He would like to know if this is normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Numbness and tingling in my lips and tongue on same side as injection; Numbness and tingling in my lips and tongue on same side as injection; 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 55 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 14:00 (Lot number: FC3182) at the age of 55 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 ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 27Aug2021 14:15, outcome "unknown" and all described as "Numbness and tingling in my lips and tongue on same side as injection".  Additional information: The agency number and Expiry Date for suspect were not provided. The patient got the first Pfizer Covid 19 shot around 2pm this afternoon and she waited the 15 minutes (after receiving the injection) and left. Shortly after she noticed numbness, tingling around her lips and tongue on the same side as the injection site. She did not know if this was a concern or possible side effect from the vaccine and would like to know. Investigation Assessment was not provided.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Frontal sinus operation, Oropharyngeal pain, Sinus disorder
Clinical narrative: Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1ST, Product=COVID 19, Brand=Pfizer, Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=26Jun2021, Administration time=01:00 PM, Dose number=1), administration date: 26Jul2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: SINUS DISORDER (non-serious), FRONTAL SINUS OPERATION (non-serious), DIZZINESS (non-serious), OROPHARYNGEAL PAIN (non-serious), DYSPHONIA (non-serious) all with onset 25Aug2021, outcome "recovered with sequelae" (Aug2021) and all described as "Within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat". The event "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat", "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat", "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat", "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat" and "within 4 days after the second shot my sinus began to drain  and getting horsed  and light headed and sore throat" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sinus disorder, frontal sinus operation, dizziness, oropharyngeal pain, dysphonia.  Additional information: No other vaccine in four weeks. AE treatment: Antibiotics and antihistamines. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Neck pain
Clinical narrative: I have a bad headache and feel nauseous.; I have a bad headache and feel nauseous.; Friday My neck felt sore/Saturday my neck still hurts; Thursday I felt like one does when coming down with something, just achy and tired; Thursday I felt like one does when coming down with something, just achy and tired; Thursday I felt like one does when coming down with something, just achy and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 15:00 (Lot number: EWU165) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "CML" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 26Aug2021 09:00, outcome "not recovered" and all described as "Thursday I felt like one does when coming down with something, just achy and tired"; NECK PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Friday My neck felt sore/Saturday my neck still hurts"; HEADACHE (non-serious), NAUSEA (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "I have a bad headache and feel nauseous.". Therapeutic measures were not taken as a result of malaise, pain, fatigue, neck pain, headache, nausea.  Additional information: 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 tested for COVID-19. The patient had no known allergies. Thursday, patient felt like one does when coming down with something, just achy and tired. Friday patient neck felt sore. Saturday patient neck still hurts, patient had a bad headache and feel nauseous.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I have a bad headache and feel nauseous.; I have a bad headache and feel nauseous.; Friday My neck felt sore/Saturday my neck still hurts; Thursday I felt like one does when coming down with something, just achy and tired; Thursday I felt like one does when coming down with something, just achy and tired; Thursday I felt like one does when coming down with something, just achy and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 15:00 (Lot number: EWU165) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "CML" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 26Aug2021 09:00, outcome "not recovered" and all described as "Thursday I felt like one does when coming down with something, just achy and tired"; NECK PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Friday My neck felt sore/Saturday my neck still hurts"; HEADACHE (non-serious), NAUSEA (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "I have a bad headache and feel nauseous.". Therapeutic measures were not taken as a result of malaise, pain, fatigue, neck pain, headache, nausea.  Additional information: 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 tested for COVID-19. The patient had no known allergies. Thursday, patient felt like one does when coming down with something, just achy and tired. Friday patient neck felt sore. Saturday patient neck still hurts, patient had a bad headache and feel nauseous.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Mammogram abnormal
Clinical narrative: Abnormal mammogram images; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jul2021 17:30 (Lot number: FA6780) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, lot number=EW0217, lot unknown=False, administration date=16Jun2021, administration time=07:15 PM, vaccine_location=Left arm), administration date: 16Jun2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: MAMMOGRAM ABNORMAL (non-serious) with onset 25Aug2021, outcome "unknown", described as "Abnormal mammogram images". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of mammogram abnormal.  Additional Information: The patient did not receive any other vaccines within 4 weeks. Patient received other medication in 2 weeks was Sertraline. Patient did not received treatment for AE. The patient did not had COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient had no known allergies and other medical history.  Follow-up attempts are completed. No further information is expected.