chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Lethargy, Malaise
Clinical narrative: extreme tried; diarrhea; in bed and can hardly walk/she is very unsteady when she is walking; she has lost of appetite; dizzy; chills; not feeling well; very weak; very lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021748849 (Pfizer).  A 72-year-old female patient received bnt162b2 (BNT162B2), administration date 16Jun2021 (Lot number: EW0183) at the age of 72 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: FATIGUE (non-serious), outcome "unknown", described as "extreme tried"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "in bed and can hardly walk/she is very unsteady when she is walking"; DECREASED APPETITE (non-serious), outcome "unknown", described as "she has lost of appetite"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ASTHENIA (non-serious), outcome "unknown", described as "very weak"; LETHARGY (non-serious), outcome "unknown", described as "very lethargic".  Additional information: Reporter stated he is calling for his wife the Pfizer COVID 19 vaccine with the number of EW0183. Reporter stated she took the vaccine on 16Jun2021 and a day later she had extreme tried, diarrhea, in bed and can hardly walk, no appetite, very lethargic and dizzy. Reporter stated his wife is scheduled for the second dose on 07Jul2021. Reporter stated he is not sure if she will get the second dose. Caller stated that his wife got the first dose of the pfizer covid-19 vaccine on 16JUN2021. She started experiencing extreme tiredness, chills, diarrhea, she can hardly walk, she has lost of appetite, very weak and not feeling well, she is very unsteady when she is walking.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired after the first one but not really; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0185, Expiration Date: Aug2021) 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: FATIGUE (non-serious), outcome "unknown", described as "tired after the first one but not really".  Additional information: number of Covid-19 Vaccine was unknown. Reporter stated 3 weeks ago he took his first dose of Pfizer, after this first dose he said he was tired.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021738239 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in her ear; 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 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: TINNITUS (non-serious), outcome "not recovered", described as "Ringing in her ear". The event "ringing in her ear" was evaluated at the physician office visit.  Additional information: Patient has been to 8 doctors and has not been able to receive relief from this side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Extremity impairment/lost grip of her hand, unable to feed herself, and unable to hold a spoon; Extremity impairment/lost grip of her hand, unable to feed herself, and unable to hold a spoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93 year-old female patient received bnt162b2 (BNT162B2), administration date 21May2021 (Lot number: EW0183) 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, single, Lot/batch number: EW0167, No events reported), administration date: 21May2021, when the patient was 93 years old, for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 18Jun2021, outcome "not recovered" and all described as "Extremity impairment/lost grip of her hand, unable to feed herself, and unable to hold a spoon".  Additional information: Caller (Patient's son) wanted to know if the extremity impairment that his mother was experiencing was among the listed side effects after getting the Pfizer BioNTech Covid-19 Vaccine. The report was not related to a study or program. The patient was not the reporter. Reporter stated he was calling on behalf of his mother. Reporter sated he just wants to go over some side effects that maybe his mom has because she was 93 years old. Reporter stated after his mom got the second vaccine on Wednesday that next done on Thursday and ever since she lost the use of her hands where she cannot feed herself and hold a spoon or whatever. Reporter stated he was wondering if this was something from the vaccine or if he should be concerned. Reporter confirmed vaccine he was referring to the COVID 19 vaccine. Reporter declined to complete report at this time wished to be transferred to MI for his question. Investigation assessment was not provided.  Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: headache; nausea; vomiting; extreme fatigue; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jun2021 14:00 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Date: 25May2021, Route of administration: Intramuscular, Batch/Lot number: Not available), administration date: 25May2021, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "vomiting"; FATIGUE (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "extreme fatigue"; DIARRHOEA (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of headache, nausea, vomiting, fatigue, diarrhoea.  Additional information: The patient did not taken any prior vaccinations. The patient had Covid prior vaccination. The patient was not tested for Covid post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Tendonitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2021 (Lot number: EL3246) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Anatomical Location- Right arm, Lot number- EL1284), administration date: 30Dec2020, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Cellulitis", "Periodic pain in arms at injection site". The following information was reported: TENDONITIS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Tendonitis". Additional information: Patient age at time of vaccination was reported as 37 years. Vaccine facility type was reported as Hospital. Vaccine was administered at a facility. Patient medical history and concomitant medications were reported as None.  Prior vaccinations were reported as None. On 15Jan2021, patient experienced Cellulitis and received antibiotics as treatment for it and the event Cellulitis resulted in physician office visit. Patient experienced periodic pain in arms at injection site on an unspecified date. On 04Mar2021, patient experienced Tendonitis. The outcome of the event Tendonitis was not resolved.   No follow-up attempts are possible. No further information is expected.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: pain in left arm; soreness in left arm; having trouble reaching things, and pain with movement in a certain way; First dose: arm was a little swollen; 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 (159559). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021755432 (Pfizer).  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0175) at the age of 60 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain in left arm; soreness in left arm"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "having trouble reaching things, and pain with movement in a certain way"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "First dose: arm was a little swollen".  Additional information: She received her second Covid 19 vaccine on 17May2021 in her right arm which was fine and had no pain. There was nothing wrong with the second dose, only the left arm with the first dose and sometimes reaching with her left arm hurts or turning a certain way with her left arm hurts. If she moves her left arm it was so much pain. She was left handed and it was very frustrating. She could not remember exactly what day her left arm began bothering her. Vaccine was not Administered at Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), Additional Vaccines Administered on Same Date of the Pfizer Suspect, all vaccines administered on same date with the Pfizer vaccine considered as suspect, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations, Relevant Tests was none. The AE(s) did not require a visit to Emergency Room/Physician Office. Caller seeked information if the continued pain and soreness in her left arm from her first vaccine is normal. Response received and Spoke from attached document In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Referred caller to primary HCP for medical treatment.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: she has had a lot of cold symptoms and nasal congestion since yesterday; she has had a lot of cold symptoms and nasal congestion since yesterday; 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) (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: NASAL CONGESTION (non-serious), NASOPHARYNGITIS (non-serious) all with onset 21Jun2021, outcome "unknown" and all described as "she has had a lot of cold symptoms and nasal congestion since yesterday".  Event details: Patient is reporting because she is scheduled for her last dose of Pfizer's COVID-19 vaccine today, but she has had a lot of cold symptoms and nasal congestion since yesterday. She's been told that when you have a cold or nasal congestion, you can't get the vaccine. Can she change the date or day of the vaccine? Today was the last day when she should get the second dose. AE info is transmitted electronically.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Immediate test of strong metal in my mouth/ same strong metal taste/ following each shot iI tasted metal (strong taste); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 10:00 (Lot number: ER8727) as dose 1, single and administered in arm right, administration date 05May2021 (Lot number: EW0171) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DYSGEUSIA (non-serious) with onset 19Apr2021 10:00, outcome "recovered" (2021), described as "Immediate test of strong metal in my mouth/ same strong metal taste/ following each shot iI tasted metal (strong taste)". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Immediately following each shot I tasted metal (strong taste) it has since subsided gradually. No other reaction. The patient had no known allergies and other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Facility type of vaccine is Hospital. Vaccine was administered at Facility  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Malaise
Clinical narrative: I do not feel well; heart has a burning sensation; 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 male 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: MALAISE (non-serious), outcome "unknown", described as "I do not feel well"; BURNING SENSATION (non-serious), outcome "unknown", described as "heart has a burning sensation".  Additional information: Questionnaires included that the patient received the vaccine and he did not feel well. His heart had a burning sensation for a few weeks now. He requested that he need help because he had no money or good doctors.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she had Myalgic Encephalomyelitis syndrome for many many years and was mostly wheelchair bound. Shortly after the covid vaccine she is remarkably better.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. Relevant medical history included: "Myalgic Encephalomyelitis syndrome" (unspecified if ongoing); "mostly wheelchair bound" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she had Myalgic Encephalomyelitis syndrome for many many years and was mostly wheelchair bound. Shortly after the covid vaccine she is remarkably better.".  Additional information: Reporter reported of an amazing effect someone reporter know had with the Pfizer vaccine. She has had Myalgic Encephalomyelitis syndrome for many years and was mostly wheelchair bound. Shortly after the COVID vaccine she is remarkably better. Amazingly better. Reporter trying to have someone in Pfizer involved with the COVID vaccine to talk to her or her doctor in regard to this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Lymph node pain, Lymphadenopathy
Clinical narrative: felt bad, feels like something strange in body; felt bad, feels like something strange in body; lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers; lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers; lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers; 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 male patient received bnt162b2 (BNT162B2), administration date 05Jun2021 (Batch/Lot number: unknown) at the age of 53 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: FEELING ABNORMAL (non-serious), FEELING ABNORMAL (non-serious), outcome "not recovered" and all described as "felt bad, feels like something strange in body"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), DISCOMFORT (non-serious), outcome "not recovered" and all described as "lymph node growing near his rectum and it is uncomfortable and painful when he is sitting or when he is pushing on it with his fingers".  Additional information: Reporter states that he was calling about the Pfizer COVID 19 vaccine and provided a number of E100187. Reporter was not sure what this number was for.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4326469.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Fatigue" (ongoing). Concomitant medication(s) included: OCREVUS; RITUXAN. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: On unknown date, patient started therapy with Pfizer covid 19 vaccine. On unknown date, it was reported that patient experienced: Fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Nasal congestion, Parosmia, Tongue disorder
Clinical narrative: Smell & taste became altered with a chemical and metallic taste/odor; Smell & taste became altered with a chemical and metallic taste/odor; Thick/white post nasal drip (congestion); also have a somewhat numb and thick-feeling tongue; also have a somewhat numb and thick-feeling tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:00 (Lot number: EN6200) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications include Just one-a-day womens vitamin. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 31Mar2021 15:00, outcome "not recovered" and all described as "Smell & taste became altered with a chemical and metallic taste/odor"; NASAL CONGESTION (non-serious) with onset 31Mar2021 15:00, outcome "not recovered", described as "Thick/white post nasal drip (congestion)"; TONGUE DISORDER (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 31Mar2021 15:00, outcome "not recovered" and all described as "also have a somewhat numb and thick-feeling tongue". Therapeutic measures were not taken as a result of dysgeusia, parosmia, nasal congestion, tongue disorder, hypoaesthesia oral.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Hypersomnia, Influenza, Pain
Clinical narrative: Low grade "flu" after the first dose; Body aches after the first dose; Sleeping a lot after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 09:00 (Lot number: EN6202) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Reflux", start date: 2019 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Height had shrunk" (unspecified if ongoing), notes: stated this occurred prior to getting the vaccine. Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing); FAMOTIDINE taken for reflux gastritis, start date: 2019 (ongoing). The following information was reported: INFLUENZA (non-serious) with onset 04Mar2021, outcome "recovered" (11Mar2021), described as "Low grade "flu" after the first dose"; PAIN (non-serious) with onset 04Mar2021, outcome "recovered" (11Mar2021), described as "Body aches after the first dose"; HYPERSOMNIA (non-serious) with onset 04Mar2021, outcome "recovered" (11Mar2021), described as "Sleeping a lot after the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant Lisinopril, Simvastatin taking for over 10 years, famotidine: used to take Zantac which was pulled from the market. It was reported that, he had ongoing symptoms for 3 months. He was calling to give feedback. After receiving the first dose caller experienced a low grade "flu". This lasted for 8 days. He also had body aches. This was not constant. He slept a lot. He bounced back and was able to go out and do yard work. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer Suspect. Adverse event did not require a visit to: Emergency Room or Physician Office. Relevant Tests: None. Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations, Family Medical History Relevant to AE(s) was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: trouble with our voice/couldn't hit high notes/could no longer speak in a high tone; 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 53 year-old 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: DYSPHONIA (non-serious), outcome "unknown", described as "trouble with our voice/couldn't hit high notes/could no longer speak in a high tone".  Additional information: Reporter seriousness for trouble with our voice was unspecified  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021756268 same reporter/drug/AE, different patient.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm
Clinical narrative: Aneurysm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 43 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: ANEURYSM (non-serious) with onset 04Apr2021, outcome "unknown", described as "Aneurysm". The event "aneurysm" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of aneurysm.  Additional information: Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Prior to vaccination the patient was diagnosed with COVID-19, any other medications the patient received within 2 weeks of vaccination no. Prior to vaccination, the patient was diagnosed with COVID-19. Reported stated that Another report was of a local anesthesiologist having any aneurysm immediately after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Throat hurting; Headache; Little lightheaded; She knows it is not like a sore throat, she hasn't had a sore throat and she is not sick. It doesn't feel like that, it is like a weird tingly sensation.; now she is experiencing a dull ache in the same area. The dull ache started just recently maybe a week or 2 ago and is now moving down to her hand.; she had a hurt arm for a couple days; 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. Other Case identifier(s): US-PFIZER INC-2021766605 (Pfizer).  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 16:00 (Lot number: EW0185) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Throat hurting"; HEADACHE (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Little lightheaded"; PHARYNGEAL PARAESTHESIA (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "She knows it is not like a sore throat, she hasn't had a sore throat and she is not sick. It doesn't feel like that, it is like a weird tingly sensation."; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovered" (2021), described as "she had a hurt arm for a couple days"; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "now she is experiencing a dull ache in the same area. The dull ache started just recently maybe a week or 2 ago and is now moving down to her hand.".  Additional information: The patient's concomitant products women's multivitamin. She just takes women's multivitamins daily. There were none additional vaccines administered on same date of the Pfizer suspect. She did not visit emergency room and physician visit. There were none any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient's Medical History (including any illness at time of vaccination), other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Illness/AE was none. Family Medical History Relevant to AE(s) was none.  Follow-up attempts are completed. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Throat hurting; Headache; Little lightheaded; She knows it is not like a sore throat, she hasn't had a sore throat and she is not sick. It doesn't feel like that, it is like a weird tingly sensation.; now she is experiencing a dull ache in the same area. The dull ache started just recently maybe a week or 2 ago and is now moving down to her hand.; she had a hurt arm for a couple days; 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. Other Case identifier(s): US-PFIZER INC-2021766605 (Pfizer).  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 16:00 (Lot number: EW0185) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Throat hurting"; HEADACHE (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Little lightheaded"; PHARYNGEAL PARAESTHESIA (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "She knows it is not like a sore throat, she hasn't had a sore throat and she is not sick. It doesn't feel like that, it is like a weird tingly sensation."; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovered" (2021), described as "she had a hurt arm for a couple days"; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "now she is experiencing a dull ache in the same area. The dull ache started just recently maybe a week or 2 ago and is now moving down to her hand.".  Additional information: The patient's concomitant products women's multivitamin. She just takes women's multivitamins daily. There were none additional vaccines administered on same date of the Pfizer suspect. She did not visit emergency room and physician visit. There were none any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient's Medical History (including any illness at time of vaccination), other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Illness/AE was none. Family Medical History Relevant to AE(s) was none.  Follow-up attempts are completed. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscle pain; tiredness; 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-2021766644 (Pfizer).  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0164) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, LOT: ER8703, NDC: Unknown, Expiry Date: Unknown, injection, left arm, unknown dosage, time: in the morning), administration date: 11May2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 02Jun2021, outcome "not recovered", described as "tiredness".  Additional information: Caller stated that she was not sure about her height, maybe 5 ft 2 in. Caller stated that she just wanted to know how long this would be going on, she was not sure. Caller stated that it started after she took the last vaccine. Second dose on 01Jun2021, LOT: EW0164, NDC: Unknown, Expiry Date: Unknown, Injection, left arm, unknown dosage, time the vaccination was given in the afternoon. Caller stated that she felt it 2 days after. Stated that she did not want her kids to get the vaccine if they were going to feel the way that she felt. No emergency room or physician office required for AE. No prior vaccinations (within 4 weeks) or other vaccinations was given within four weeks prior to the first. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Feeling abnormal
Clinical narrative: Felt terrible the day after the second dose of the vaccine; Received dose of the Covid Vaccine that had been expired for one hour; This is a spontaneous report from a Pfizer sponsored marketing Program. A contactable 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EE7938), (33-years-old at the time of vaccination), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. Reported that patient received a call from the pharmacy stating that her second dose received on that day was given to her after it was expired for one hour. She felt terrible the next day after the second dose. She heard that was a sign of a strong immune response. The pharmacy told her that she needs to come in and get another second dose and patient think if her vaccine was actually ineffective and wants to know was it safe to get another one as the pharmacy suggested. On 03Jun2021, the patient received dose of the covid vaccine that had been expired for one hour, on 04Jun2021, the patient felt terrible the day after the second dose of the vaccine. It was reported that seriousness for the events was unspecified. On 23Jun2021 patient was asking if the vaccine was ineffective to get another get 2nd dose shot. The outcome of events was unknown.  Information about lot/batch number is available. Follow-up attempts are needed  Follow-up(23Jun2021):This is a Follow-up spontaneous report from a Pfizer sponsored marketing Program. A contactable female patient reported for herself that included: new event, clinical course added and narrative amended.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021766790 Pfizer
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: her period is here and it has been the whole month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 (Lot number: EW0185, Expiration Date: 31Aug2021) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, lot number: EW0175   , Anatomical Location: left arm, Expiry date: 31Aug2021, NDC number: Unknown), administration date: 26Apr2021, for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 02Jun2021 03:00, outcome "not recovered", described as "her period is here and it has been the whole month".  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No Family Medical History Relevant to AE. No AE(s) following prior vaccinations. Patient was calling about the covid vaccine.  She took her first shot then after the second one. It had been 3 months and her period is here and it had been the whole month. On 02Jun2021 was the first day it came and it was still here today.  She called her doctor and they said to wait it out and they could not  do anything because it was currently on her so she just has to wait. Time of event onset: (24-hour clock): around 3 o'clock on 02Jun2021. No additional vaccines administered on same date of the pfizer suspect. No other products received. She works in a hospital, she works in covid vaccination. No Emergency Room visit. No Physician Office visit. She just had a Teladoc visit over the phone. Relevant  tests conducted was reported as none. Information on Lot/Batch number was available. Additional information has been requested  Follow-Up 21Jul2021: Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: Period cramps and flow got much worse after vaccine.; Period cramps and flow got much worse after vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 16:45 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if Covid prior vaccination: YES. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 18May2021, outcome "recovered with sequelae" (2021) and all described as "Period cramps and flow got much worse after vaccine.". Therapeutic measures were not taken as a result of dysmenorrhoea, menstrual disorder.  Additional information: No known allergies. No other vaccine in four weeks. No Other medications in two weeks. Patient was not pregnant at the time of vaccination. Patient recovered with lasting effects. No Covid tested post vaccination. Received BNT162B2 (Lot number: Not reported), administered in arm left on 24Mar2021 as dose 2, single for covid-19 immunisation. Facility type vaccine: Other.  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: Therapeutic response unexpected
Clinical narrative: Hardly adverse. Reported lifting of 'brain fog' and improved ability to spell and recall words; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient (not pregnant) 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Hardly adverse. Reported lifting of 'brain fog' and improved ability to spell and recall words". Therapeutic measures were not taken as a result of therapeutic response unexpected.  The reporter considered "hardly adverse. reported lifting of 'brain fog' and improved ability to spell and recall words" not related to bnt162b2.  Additional information: Reporter states she previously called to report on an acquaintance about her Covid vaccine, it was hardly an AE, she reported that she was able to think more clearly which was a benefit. Caller states she received a multipage questionnaire and has tried calling her acquaintance and left phone messages for her but has no information to provide. Caller is asking what she should do now as she has no further information to provide. Caller states will this be the next Viagra. States she has no idea if it was after the 1st or 2nd dose or how long after but that she was happy. It was unknown, if patient received any other vaccines within 4 weeks prior to covid vaccine. It was unknown, if patient was tested positive for covid 19 prior to vaccination and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A 69-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 69, on Jun 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had discoloured feces (green stool/poop is a green color after first dose of Pfizer COVID-19 vaccine), onset Jun 22, 2021, with outcome of unknown. Additional information: Patient said her poop is green in color and wanted to know if that is normal. Her stool color is not normally green, but when she took the COVID-19 vaccine yesterday it turned into green.  Yesterday, Jun 22, 2021, was the first dose of the vaccine. The second dose is due Jul 13, 2021. Details of patient: She stated she was 69 and will be 70 in October. No follow-up attempts possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Trismus
Clinical narrative: Lockjaw; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Jun2021 11:30 (Lot number: EW0187) at the age of 36 years as dose 1, single and administered in arm right, administration date 22Jun2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: She just took over the counter medicine for it as she needs to. The patient's concomitant medications were not reported. Vaccination history included: Tetanus vaccine (Verbatim: Injections site swollen and tender), for Immunisation, reaction(s): "Injection site swollen"; Tetanus vaccine (Verbatim: Injection site swollen and tender), for Immunisation, reaction(s): "Injection site tender". The following information was reported: TRISMUS (non-serious) with onset 01Jun2021, outcome "recovered" (02Jun2021), described as "Lockjaw".  Additional information: Caller states that she was calling about the Covid Vaccine. States she has been a (Privacy) for 12 years so she tends to minimize a lot of her sickness. States the two times that she had the Covid Vaccine she experienced lockjaw and thought it was something that she should report. She declines to provide HCP information. States she never sees her primary care provider. States she just goes in when she needs to and sees whatever doctor was available. Caller states that the lockjaw she was having yesterday and today seems to have gone away. States it stopped about a half an hour ago. States she doesn't know that it won't come back; but for now it is gone. Caller denies any medical conditions, medications, labs, testing or treatments relevant to these events. States she gets migraines at times and just takes over the counter medicine for it as she needs to. No other information provided by the caller. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as None. Patient did not visit emergency room and physician office visit for the events. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None  Follow-up attempts are completed. No further information is expected.