chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: at the injection site it is as big as a goose egg, it was swollen; at the injection site it is as big as a goose egg, it was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) at the age of 91 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 Number: 1), when the patient was 91 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 13May2021, outcome "unknown" and all described as "at the injection site it is as big as a goose egg, it was swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: The caller said he was with his mom who was 91 and got her second COVID shot half an hour ago. He said they waited 15 minutes like they were supposed to and everything was fine. He said she had an appointment at the chiropractor and she was wearing a jacket. They took the jacket off and at the injection site it is as big as a goose egg, it was swollen. He said it was not swollen when they waited the 15 minutes and she was otherwise okay. He confirmed he was talking about the Pfizer COVID-19 vaccine. He said it was not bruised, not red. He was concerned about what to do right now. She was not experiencing any other symptoms other than the injection site. He wanted to figure out what to do, she did not have any other symptoms. He said he figured we would have answers or to be able to tell him if this was unusual.  (Privacy) Communication: Call handler experienced a major power outage during the call. Call back 1 of 1 at 3:30pm: # successful. The caller is referred to his mother's primary care provider or clinic for medical advice. The caller was provided the reference number, contact number, #, option 3, and hours of operation of Monday through Friday 8AM to 8PM for COVID vaccine calls prior to attempted warm transfer to Medical Information. The caller declines to be given the weekend hours for COVID vaccine calls. Due to high call volume caller was placed in the hold queue to continue holding for an agent.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Aggravated ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 10:30 (Lot number: Unknown) at the age of 55 years as dose 2, single and administration date 12Apr2021 (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: TINNITUS (non-serious) with onset 13May2021, outcome "not recovered", described as "Aggravated ringing in ears".  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-2021546995 same reporter/drug/event, different patient;US-PFIZER INC-2021547757 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Had a little pain at the injection site afterword; Second dose 3 weeks later I never felt a needle, no pinch, no feeling of the serum hitting my muscle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Had a little pain at the injection site afterword"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Second dose 3 weeks later I never felt a needle, no pinch, no feeling of the serum hitting my muscle". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back pain/ but within 3-4 hours after, her back ache got really worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: EW0150) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe case Fibromyalgia", start date: 2006 (ongoing), notes: started more or less 15 years ago, in those days they didn't know much about it, but she was diagnosed in 2006. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 SINGLE time: 9:30  left arm injection LOT: EP6955, She took treatment as Tylenol Extra Strength.), administration date: 19Mar2021, when the patient was 60 years old, for Covid-19 immunisation, reaction(s): "severe back pain".  The following information was reported: BACK PAIN (non-serious) with onset 11Apr2021, outcome "not recovered", described as "severe back pain/ but within 3-4 hours after, her back ache got really worse.".  Additional information: It was reported that, amazingly, when she got her second vaccination on 11Apr2021, for the record, she never experienced a fever or chills, nothing, nothing that they said might happen, but within 3-4 hours after, her back ache got really worse. The pain continued on to the 2nd dose. If memory serves her right, the pain shot down her hip.  On a level of 1 to 10, it was like a 6 or a 7. The pain was tolerable, but very high. She would be exaggerating if she gave it a true number. The pain continues. Everybody says everyone gets body aches. She was 100% sure of this. It is persistent pain. Her pain tolerance is very high. No prior Vaccinations (within 4 weeks) of COVID vaccine.  Description of Product Complaint: The patient who  took Tylenol Extra Strength for pain after her first dose of the COVID vaccine, but the pain continued through until after she received her second dose and is still ongoing. No further details about the extra strength Tylenol were provided by the caller.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of the lymph node on the side of her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EW0179) at the age of 47 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, for Covid-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15May2021, outcome "unknown", described as "swelling of the lymph node on the side of her neck". No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Increased sensitivity to cold in fingers; is is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021549622 (Pfizer).  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 19:45 (Lot number: EW0158) at the age of 42 years as dose 1, single and administered in arm left, administration date 01May2021 17:45 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; TRINTELLIX; ATOMOXETINE HCL. Past drug history included: Indomethacin, reaction(s): "known allergies", notes: known allergies: Indomethacin; Nabumetone, reaction(s): "known allergies", notes: known allergies: Nabumetone. The following information was reported: PERIPHERAL COLDNESS (non-serious) with onset 12Apr2021, outcome "unknown", described as "Increased sensitivity to cold in fingers". Therapeutic measures were not taken as a result of peripheral coldness.  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 and since the vaccination, the patient not has been tested for COVID-19. Device Date is mentioned as 16May2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed illness, with outcome of unknown. A female friend of her grandson also got sick for 4 days after getting vaccinated. Clinical course: Reporter mentioned that one of her grandchildren also got the vaccine. She mentioned "it was like being hit by a mad truck," but she was okay in a few days. A female friend of her grandson also got sick for 4 days after getting vaccinated. Reporter stated their other grandson said her friend was sick for 4 days, but doesn't know she is reporting it. She wanted to be responsible and let know this happened. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Apr2021 16:00 (Lot number: EW0170) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: reported as Mild asthma, which grew out of when patient was 11 or 12. Otherwise, no health issues.; "Sulfa (medication) allergy" (ongoing), notes: known allergies: Sulfa (medication); "Saffron allergy" (ongoing), notes: known allergies: Saffron; "Cashews and Pistachios allergy" (ongoing), notes: known allergies: Cashews, Pistachios. Concomitant medication(s) included: BENADRYL; CANNABIS. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore right arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient prior to the vaccination was not diagnosed with Covid-19 and since the vaccination, he had not been tested for Covid-19. The patient didn't received any other vaccines within four weeks prior to the vaccination. Reported that side effects from first shot were not bad at all. Just sore right arm for 2 days.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased, Pain in extremity
Clinical narrative: I can't move well because my back hurts me; back in the bottom and my legs too; I can't move well because my back hurts me; back in the bottom and my legs too; I can't move well because my back hurts me; back in the bottom and my legs too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15May2021 (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: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset 16May2021, outcome "unknown" and all described as "I can't move well because my back hurts me; back in the bottom and my legs too".  Additional information: Reported that, Yesterday (at the time of reporting, 15May2021), patient (Pt) got the Pfizer Covid-19 Vaccine and today (16May2021) morning Pt back hurts and Pt do not know why, cannot move well because back hurts, back in the bottom and legs too. Pt called about an advice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Fall, Gait disturbance, Muscle tightness
Clinical narrative: her balance has been off; falling; wrist fracture; muscle tightness; Patient can not walk; pain all over the body; leg weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8733) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose administered on 01Mar2021 around 15:00 in left arm., Lot number: EN6203, NDC: Unknown , Expiry date: Unknown), administration date: 01Mar2021, when the patient was 70 years old, for covid 19 immunization. The following information was reported: BALANCE DISORDER (medically significant) with onset 2021, outcome "not recovered", described as "her balance has been off"; FALL (medically significant) with onset 2021, outcome "unknown", described as "falling"; WRIST FRACTURE (medically significant) with onset 2021, outcome "unknown", described as "wrist fracture"; MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "not recovered", described as "muscle tightness"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "Patient can not walk"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain all over the body"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "leg weakness". The events "her balance has been off", "falling", "wrist fracture", "muscle tightness", "patient can not walk", "pain all over the body" and "leg weakness" were evaluated at the physician office visit and emergency room visit.  Clinical information: Patient has been having muscle tightness: Began after the second dose of the Covid vaccine. After the first dose of the Covid vaccine, patient was okay. Patient constantly wakes up crying. Patient cannot walk: Began after the second dose of the Covid vaccine. Patient has pain all over her body: Began at least one and a half to two weeks after receiving the second dose of the Covid vaccine. Reporter does not have exact dates. Patient's legs are weak, and patient has no balance: Began at least one and a half to two weeks after receiving the second dose of the Covid vaccine. Patient fell and could not get up: Whenever patient fell and fractured her wrist that was the first time. Patient has fell again since then. Patient fell in the house. Reporter has been having to help patient get in and out of the bathtub. Reporter has been having to help patient put her clothes on. Patient is completely different than what she used to be. Patient cannot stand up, reporter has to help her. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Wrist fracture
Clinical narrative: her balance has been off; falling; wrist fracture; muscle tightness; Patient can not walk; pain all over the body; leg weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8733) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose administered on 01Mar2021 around 15:00 in left arm., Lot number: EN6203, NDC: Unknown , Expiry date: Unknown), administration date: 01Mar2021, when the patient was 70 years old, for covid 19 immunization. The following information was reported: BALANCE DISORDER (medically significant) with onset 2021, outcome "not recovered", described as "her balance has been off"; FALL (medically significant) with onset 2021, outcome "unknown", described as "falling"; WRIST FRACTURE (medically significant) with onset 2021, outcome "unknown", described as "wrist fracture"; MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "not recovered", described as "muscle tightness"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "Patient can not walk"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain all over the body"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "leg weakness". The events "her balance has been off", "falling", "wrist fracture", "muscle tightness", "patient can not walk", "pain all over the body" and "leg weakness" were evaluated at the physician office visit and emergency room visit.  Clinical information: Patient has been having muscle tightness: Began after the second dose of the Covid vaccine. After the first dose of the Covid vaccine, patient was okay. Patient constantly wakes up crying. Patient cannot walk: Began after the second dose of the Covid vaccine. Patient has pain all over her body: Began at least one and a half to two weeks after receiving the second dose of the Covid vaccine. Reporter does not have exact dates. Patient's legs are weak, and patient has no balance: Began at least one and a half to two weeks after receiving the second dose of the Covid vaccine. Patient fell and could not get up: Whenever patient fell and fractured her wrist that was the first time. Patient has fell again since then. Patient fell in the house. Reporter has been having to help patient get in and out of the bathtub. Reporter has been having to help patient put her clothes on. Patient is completely different than what she used to be. Patient cannot stand up, reporter has to help her. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Impaired work ability, Laboratory test, Malaise
Clinical narrative: I was very sick and I could not even go to work; I was very sick and I could not even go to work; I was very sick and I could not even go to work; Shivering; Shaking; Having body ache; 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 received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: MALAISE (non-serious), ILLNESS (non-serious), IMPAIRED WORK ABILITY (non-serious) all with onset May2021, outcome "unknown" and all described as "I was very sick and I could not even go to work"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Shivering"; TREMOR (non-serious) with onset May2021, outcome "unknown", described as "Shaking"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "Having body ache". The events "i was very sick and i could not even go to work", "i was very sick and i could not even go to work", "i was very sick and i could not even go to work", "shivering", "shaking" and "having body ache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, illness, impaired work ability, chills, tremor, pain.  Additional information: Reported that, Patient (Pt) took Pfizer shot on 06May2021 (also reported as 05May2021), that Monday could not even go to work because she was very sick. Pt was shaking and shivering and had body ache. Event stat date was reported as Pt had it like a day or a two. Pt was very sick today (at the time of report) and went to the doctor, and doctor told Pt can take Tylenol. Pt did not take anything other than some Tylenol. Patient was getting next one (second shot) on 29May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: I was very sick and I could not even go to work; I was very sick and I could not even go to work; I was very sick and I could not even go to work; Shivering; Shaking; Having body ache; 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 received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: MALAISE (non-serious), ILLNESS (non-serious), IMPAIRED WORK ABILITY (non-serious) all with onset May2021, outcome "unknown" and all described as "I was very sick and I could not even go to work"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Shivering"; TREMOR (non-serious) with onset May2021, outcome "unknown", described as "Shaking"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "Having body ache". The events "i was very sick and i could not even go to work", "i was very sick and i could not even go to work", "i was very sick and i could not even go to work", "shivering", "shaking" and "having body ache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, illness, impaired work ability, chills, tremor, pain.  Additional information: Reported that, Patient (Pt) took Pfizer shot on 06May2021 (also reported as 05May2021), that Monday could not even go to work because she was very sick. Pt was shaking and shivering and had body ache. Event stat date was reported as Pt had it like a day or a two. Pt was very sick today (at the time of report) and went to the doctor, and doctor told Pt can take Tylenol. Pt did not take anything other than some Tylenol. Patient was getting next one (second shot) on 29May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Fatigue, Lacrimation increased, Tremor
Clinical narrative: anxiety; exhaustion; teary; hands shaking; discombobulated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16May2021 10:00 (Lot number: ew0183) at the age of 16 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: 01, lot number: ew0176,, administration route: intramuscular, vaccine location: left arm, time: 09:30), administration date: 26Apr2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: ANXIETY (non-serious) with onset 16May2021 22:00, outcome "recovered" (May2021), described as "anxiety"; FATIGUE (non-serious) with onset 16May2021 22:00, outcome "recovered" (May2021), described as "exhaustion"; LACRIMATION INCREASED (non-serious) with onset 16May2021 22:00, outcome "recovered" (May2021), described as "teary"; TREMOR (non-serious) with onset 16May2021 22:00, outcome "recovered" (May2021), described as "hands shaking"; CONFUSIONAL STATE (non-serious) with onset 16May2021 22:00, outcome "recovered" (May2021), described as "discombobulated". Therapeutic measures were not taken as a result of anxiety, fatigue, lacrimation increased, tremor, confusional state.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - starting approximately 1 month after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: verbatim: GERD. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,, Lot Number: EM9810,, Anatomical Location: Left Arm,, Product= Pfizer/BioNTech,), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "Tinnitus - starting approximately 1 month after second vaccine". The event "tinnitus - starting approximately 1 month after second vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient did not have Covid prior vaccination or not test Covid tested post vaccination: Patient had no known allergies. Patient did not receive other vaccine in four weeks or other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Tinnitus - starting approximately 1 month after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: verbatim: GERD. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,, Lot Number: EM9810,, Anatomical Location: Left Arm,, Product= Pfizer/BioNTech,), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "Tinnitus - starting approximately 1 month after second vaccine". The event "tinnitus - starting approximately 1 month after second vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient did not have Covid prior vaccination or not test Covid tested post vaccination: Patient had no known allergies. Patient did not receive other vaccine in four weeks or other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Somnolence
Clinical narrative: A sore arm; Migraine; Slept most; 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 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 (Lot number: EW0153) at the age of 30 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), outcome "unknown", described as "A sore arm"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; SOMNOLENCE (non-serious), outcome "unknown", described as "Slept most".  Additional Information:  After receiving her second dose she began to experience the "normal" side effects on Saturday evening into Sunday. She states that after her first dose of the vaccine she experienced a sore arm, a migraine and slept most of the day. She did not experienced any sort of chest tightness after her first dose. She would like to know if there is any information regarding chest tightness as a side effect for the Pfizer COVID-19 vaccine  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu syndrome; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (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: INFLUENZA (non-serious) with onset 14May2021, outcome "recovered" (May2021), described as "Flu syndrome".  Additional information: Adverse event: Flu syndrome following Covid vaccination recovered spontaneously reported to family member. The effect has occurred after the use of product.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I will be fully vaccinated in a week and I have never been so sick before in my life; 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: ILLNESS (non-serious), outcome "unknown", described as "I will be fully vaccinated in a week and I have never been so sick before in my life".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck started hurting on one side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 (Batch/Lot number: unknown) at the age of 13 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: NECK PAIN (non-serious) with onset 17May2021 12:30, outcome "not recovered", described as "Neck started hurting on one side".  Additional information: Caller reporting on the COVID Vaccine. She is calling about both her children, one is 12 and the other is 13. They both were fine at first, but now both of their necks are hurting on one side. Her neck starting hurting today. When she turns her head it hurts more, but if not moving it it does not hurt as much. AE did not require emergency room and physician office visit. No prior vaccinations (within 4 weeks. No relevant tests reported.  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-2021559870 Same reporter/product/events, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent), for a Pfizer sponsored program (159558). A 15-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 17, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had upper abdominal pain (stomach pain/achy in the stomach area), onset May 17, 2021, with outcome of unknown. Additional information: After the vaccination, patient had stomach pain. The patient was in the waiting area for 15 minutes with an  ache in his stomach area. He wanted to know if he could take Pepto Bismol and Tylenol for the stomach pain and whether it will interact with the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: is having a lot of aches; 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).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 17May2021, outcome "unknown", described as "is having a lot of aches".  Additional information: Verbatim and Event Description: Reporter, is reporting on behalf of his girlfriend who took the Pfizer Covid-19 vaccine. His girlfriend is having a lot of aches right now and would like to confirm if she can take Tylenol or Ibuprofen.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Ear, nose and throat examination
Clinical narrative: Cyst; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Dec2020 (Lot number: EH9889) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2018 (ongoing), notes: Onset date: 2018, Stop date: ongoing, Pertinent details: Stable on medications; "Menopause", start date: 1999 (ongoing), notes: Onset date: 1999, Stop date: ongoing, Pertinent details: Stable on ERT estrogen; "Prediabetes", start date: 2018 (ongoing), notes: Onset date: 2018, Stop date: ongoing, Pertinent details: Stable on Metformin only; "Herpes HSV1", start date: 2018 (ongoing), notes: Onset date: Since childhood, Stop date: ongoing. Family history included: "Stroke" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "diabetes mellitus" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL taken for oestrogen replacement therapy (ongoing); METFORMIN taken for glucose tolerance impaired (ongoing); LOSARTIN taken for hypertension (ongoing). The following information was reported: CYST (non-serious), outcome "unknown", described as "Cyst". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient received no prior vaccination prior four weeks. It was unclear if vaccination resulted in decrease immunity to otter infection pathogens. The cyst persecuted after the first shot of Pfizer vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Anxiety disorder, Middle insomnia, Nervousness
Clinical narrative: chronic anxiety disorder; she was scared to death; woke up in the middle of the night with a powerful and debilitating anxiety attack; woke up in the middle of the night with a powerful and debilitating anxiety attack; 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 . The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 66 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: ANXIETY disorder (non-serious), outcome "unknown", described as "chronic anxiety disorder"; NERVOUSNESS (non-serious), outcome "unknown", described as "she was scared to death"; MIDDLE INSOMNIA (non-serious), ANXIETY (non-serious), outcome "unknown" and all described as "woke up in the middle of the night with a powerful and debilitating anxiety attack".  Additional information : Patient states she was super sensitive to medications, and they had a hard time treating her anxiety. The patient states that se not had anxiety before the vaccine.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101779797 same reporter, different patient/AE
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypogeusia
Clinical narrative: As she was just eating she stated that her sense of taste is dulled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 18May2021 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, 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: HYPOGEUSIA (non-serious) with onset 18May2021, outcome "unknown", described as "As she was just eating she stated that her sense of taste is dulled".  Additional information: It was reported that, Caller was a son calling in regard to his 56-year-old mother who received the Pfizer COVID 19 vaccine today, about 5 hours ago. He reported that she had been fine since having the vaccine but that as she was just eating, she stated that her sense of taste was dulled. He would like to know if this had been reported and should we seek medical care. It was reported, relayed to caller that if they were concerned with the symptoms to seek health care with an HCP or possibly an ENT doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: teeth extraction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (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: TOOTH EXTRACTION (non-serious), outcome "unknown", described as "teeth extraction".  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Her arm hurt a little; 11 days after the dose she has redness, itchiness, and it is hot at the injection site; 11 days after the dose she has redness, itchiness, and it is hot at the injection site; 11 days after the dose she has redness, itchiness, and it is hot at the injection site; Swollen; 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 43 year-old female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Lot number: EW0167) 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 May2021, outcome "unknown", described as "Her arm hurt a little"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset May2021, outcome "unknown" and all described as "11 days after the dose she has redness, itchiness, and it is hot at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset May2021, outcome "unknown", described as "Swollen".  Additional information: Patient stated that after first dose of vaccination with no reaction other than her arm hurt a little, now 11 days after the dose she has redness, itchiness, and it is hot at the injection site. She would like to know if this is common and did not know that this is a normal side effect because it says that it usually happen that in the first couple of hours not 10 days later. Patient stated that her arm is red and itchy and hot and swollen.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Loss of personal independence in daily activities, Pain
Clinical narrative: The thing is the caller got hurt and can't drive safely now for a few days; The thing is the caller got hurt and can't drive safely now for a few days; Unable to go to scheduled second dose Vaccine appointment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0173) at the age of 78 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: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "The thing is the caller got hurt and can't drive safely now for a few days"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "Unable to go to scheduled second dose Vaccine appointment".  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little pain in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.   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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "a little pain in his arm".  Additional information: Reporter calling to report AE for herself and states her son received the Pfizer Covid vaccine and doesn't have symptoms, he just has a little pain in his arm, but only for one day.   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: Nausea
Clinical narrative: she and her daughter felt very queasy (feeling nauseous) but is unable to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 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: NAUSEA (non-serious), outcome "unknown", described as "she and her daughter felt very queasy (feeling nauseous) but is unable to throw up".  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-2021562487 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity. 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