chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Breast soreness for three weeks; Menstrual cycle began on 5/18/21. I have not had a cycle since 2019.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0161) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2019 (unspecified if ongoing); "high cholesterol", start date: 2019 (unspecified if ongoing); "Sulfanamide allergy", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: TRIAMTEREEN; ROSUVASTATIN; AMLODIPINE BESILATE; TRIAMCINOLON COMPO. Past drug history included: Daypro, reaction(s): "Drug allergy"; Gluten, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (dose_number=1,, vaccine_location=Left arm, lot_number=EN6203,), administration date: 23Mar2021, for Covid-19 immunization. The following information was reported: BREAST PAIN (non-serious) with onset 18May2021, outcome "recovering", described as "Breast soreness for three weeks"; MENSTRUAL DISORDER (non-serious) with onset 18May2021, outcome "recovering", described as "Menstrual cycle began on 5/18/21. I have not had a cycle since 2019.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain, menstrual disorder.  Additional information: It was reported that, patient had breast soreness for three weeks. Menstrual cycle began on 18May2021. She have not had a cycle since 2019. Patient did not receive any other vaccines within 4 weeks prior and received other specified medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Paraesthesia
Clinical narrative: She has felt pins and needles and tingling on her both legs especially in her kneecaps down. She described it as not numb as she can still feel her skin and it feels cold.; She has felt pins and needles and tingling on her both legs especially in her kneecaps down. She described it as not numb as she can still feel her skin and it feels cold.; 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 61 year-old female patient received bnt162b2 (BNT162B2), administration date 19May2021 09:30 (Batch/Lot number: unknown) at the age of 61 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 (First dose), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), FEELING COLD (non-serious) all with onset 19May2021, outcome "unknown" and all described as "She has felt pins and needles and tingling on her both legs especially in her kneecaps down. She described it as not numb as she can still feel her skin and it feels cold.".  Additional information: Reporter was a female and got the second shot of the Pfizer COVID Vaccine today, 19May2021 at 9:30am. She was felt pins and needles and tingling on her both legs especially in her kneecaps down. She described it was not numb as she can still feel her skin and it feels cold. She was asking if this was normal. Reporter hanged up before survey could be offered. Reporter stated that she got the Pfizer vaccine and an hour later had pens and needles, tingling in both legs. Stated that she was been walking around and from her kneecaps down that she was cold and tingling in her legs. Wanted to know was that normal. Clarified that it was for Pfizer Covid vaccine. Stated that this is for the second shot. Stated that she had no reaction to the first shot. Patient declined to complete a report at this time. Unable to obtain further details.   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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: "got sick" after receiving a dose of the vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 70 year-old 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: ILLNESS (non-serious), outcome "unknown", described as ""got sick" after receiving a dose of the vaccine.".  Additional information: Caller is a consumer who wants to know the ingredients of the Pfizer BioNTech COVID 19 Vaccine and why this vaccine make people "sick and hurt". She also mentioned that her male cousin who is around 70y/o (caller wasn't sure of the exact age) "got sick" after receiving a dose of the vaccine. Caller stated that she has not received, and is not planning to receive, a dose of the Pfizer BioNTech COVID 19 Vaccine because she is only in her 30s and do not want to fall ill. It was reported that "During the clinical study some people did not have any side effects, but the vaccine was 95 percent effective in prevention of COVID-19 disease after receiving 2 doses. If a vaccine does not cause any side effects, to our knowledge, this is not related to the dose being less effective than what would be expected in a patient who did have side effects."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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). The reporter is the parent.  A 17-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: NAUSEA (non-serious), outcome "unknown", described as "she and her daughter felt very queasy (feeling nauseous) but is unable to throw up".  Additional information: Reporter and daughter received both doses of the PFIZER-BioNTech COVID-19 VACCINE. The reporter was scheduled to have the 2nd dose today but was calling on behalf of her daughter. The reporter mentioned that she and her daughter felt very queasy (feeling nauseous) but was unable to throw up. She was not alarmed for herself but she was quite worried about her daughter. She mentioned that her daughter did not develop any fever and sense of state was still intact. She wanted to know if feeling queasy (nauseous) was a commonly reported side effect of the vaccine. No information from prescribing physician was captured as the call. The patient was not the reporter. The dates for queasy were from unspecified to ongoing. Reporter seriousness for queasy was unspecified. It was unspecified COVID vaccine was a Pfizer product. COVID vaccine manufacturer was unspecified. The start and stop dates for the COVID vaccine are unspecified. NDC number of COVID vaccine were not provided. The reason for no lot number of COVID vaccine was reported as reporter unwilling to complete the report. Expiry date of the COVID vaccine was not provided. Other Products were not provided. An investigation assessment was not provided. The reporter daughter was 17 years old. Three weeks ago or so the reporter got her vaccine. Her daughter got hers 2 weeks ago. Her daughter has been complaining about feeling queasy for a while now since this weekend. She just wanted to find out if this is a side effect. The reporter had been feeling queasy too. The reporter was older, and was just dealing with it, and she was just hoping it will go away. Her daughter was struggling. Her daughter had no fever or any other weird symptoms. The daughter feels nauseated, but cannot throw up. The reporter just wants to know if it a side effect. She did not know if it was a side effect or not so she did not want to report it yet. She did not want to file a false thing.  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-2021564088 same reporter/drug/event, different patient.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 17:30 (Lot number: EW0172) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: TINNITUS (non-serious) with onset 30Apr2021, outcome "not recovered", described as "tinnitus was reported as worsened".  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This was an unexpected therapeutic/reduction in pain, better sleep, reduction in neuropathy, clearer cognition and better appetite after his first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 12May2021, outcome "unknown", described as "This was an unexpected therapeutic/reduction in pain, better sleep, reduction in neuropathy, clearer cognition and better appetite after his first shot". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information:This was an unexpected therapeutic effect.  (Name withheld), my brother, suffers from chronic Lyme Disease and reported to me on 17May2021 that he experienced a reduction in pain, better sleep, reduction in neuropathy, clearer cognition and better appetite after his first shot of the vaccine on 12May2021. He stated that there are others in his Lyme support group sharing similar stories after vaccination. Patient receive dany other vaccines within 4 weeks prior to the COVID vaccine: Unknown. 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting/Can't keep any food or liquid down; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 15:30 (Batch/Lot number: unknown) at the age of 19 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: VOMITING (non-serious) with onset 13May2021, outcome "unknown", described as "vomiting/Can't keep any food or liquid down"; NAUSEA (non-serious) with onset 13May2021, outcome "unknown", described as "nausea".  Additional information: Caller reported that usually when she gets her period, the same thing happens where she gets a lot of nausea and throws up a lot. Caller reported that she doesn't know if the nausea and vomiting she is experiencing are a symptom of the Covid-19 vaccine or her period that is coming up Thursday, 20May2021. Caller reported that she didn't have her physician's information. Caller reported that she hasn't been able to keep anything down. Caller reported that she can only keep down ginger ale, not even water. Caller reported that she thinks that the nausea and not being able to keep any food or liquid down have gradually gotten worse. Caller reported that she is not sure if that is from the Covid-19 vaccine or from her period. Caller reported that she gets nausea and throws up from her period symptoms. Patient does not take any other vaccine within 4 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: a foot injury that happened while playing sports.; 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 parent.  A 16 year-old male 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: LIMB INJURY (non-serious) with onset Apr2021, outcome "unknown", described as "a foot injury that happened while playing sports.". Therapeutic measures were taken as a result of limb injury.  Additional information: The report was not related to a study or programme. The reporter's 16 year old son was scheduled to get his second Pfizer Biontech Covid 19 vaccine at 4pm today (18May2021); At 7:30 am this morning he had been taking a prescription of ibuprofen 800 mg for a foot injury that happened while playing sports. At the time of report, the date of the injury was unavailable to the reporter, but she confirmed it was sometime after his first dose. The reporter queried if it was OK to take ibuprofen at 7: 30 am on same day as the second Pfizer Covid 19 vaccination, scheduled at 4 pm or does it interfere with the injection and the reporter does not know if the ibuprofen would still be in patient system. She just read that Ibuprofen or Tylenol should be not taken prior getting the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: She was feeling extremely tired and she hardly can keep her eyes open; Sleeping all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "She was feeling extremely tired and she hardly can keep her eyes open"; SOMNOLENCE (non-serious) with onset May2021, outcome "unknown", described as "Sleeping all day".  Additional information: The caller was calling about the Pfizer covid vaccine. The caller had her last vaccine on Sunday. Caller got the second dose of the Pfizer COVID-19 vaccine on Sunday (16May2021). Since then, she was feeling extremely tired and she hardly can keep her eyes open. She wanted to know if that was normal. Caller wanted to know how long can she expect her adverse event to occur. Response received as Responded per attached document; Referred to HCP. The caller has been feeling extremely tired and has been sleeping all day. The caller slept all day yesterday and today she already had two naps since she got up. How long will this normally last. How long has this lasted for other people. Other products, patient history and investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: A increased Anxiety; 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 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "A increased Anxiety". Therapeutic measures were taken as a result of anxiety.  Additional information: The patient wanted to know if he should reschedule his second shot. He said he finished a Pretnizone medication saturday after having a increased Anxiety. Gathered some demographics. Failed to read ISI. Transferred to PMI. AE reported. Transferred to Fact Sheet  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: pain in legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 10:30 (Lot number: EW0172) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; AMLODIPINE; LISINOPRIL. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Apr2021, outcome "not recovered", described as "pain in legs". The event "pain in legs" was 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 pain in extremity.  Additional Information: The adverse event was treated with steroid shot and prescription of Prednisone 10mg. Prior vaccination, the patient had no covid. The patient tested covid post vaccination. The patient had no other vaccine in four weeks.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0170) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Gastric Ulcers" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "Pyelonephritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; PROTONIX [OMEPRAZOLE]; ERTAPENEM. The following information was reported: VERTIGO (non-serious) with onset 12May2021, outcome "not recovered", described as "Vertigo". Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient had no known allergies. Patient diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Patient received Amolodipine 10mg, Protonix 40mg, Ertapenem 1g in two weeks prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Lymphadenopathy, Vaccination site pain
Clinical narrative: she has slept all Sunday and Monday/I could not wake myself up on Sunday; experienced extreme fatigue; she has zero energy; hard and swollen lymph nodes; Injection site pain; 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 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 (Lot number: ER8732) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing), notes: I have chronic pain. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; ZOLOFT; LAMICTAL; LIPITOR [ATORVASTATIN]; OXYCODONE taken for pain. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunization. The following information was reported: HYPERSOMNIA (non-serious) with onset 16May2021, outcome "not recovered", described as "she has slept all Sunday and Monday/I could not wake myself up on Sunday"; ASTHENIA (non-serious) with onset 15May2021, outcome "not recovered", described as "she has zero energy"; FATIGUE (non-serious) with onset 16May2021, outcome "unknown", described as "experienced extreme fatigue"; LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "hard and swollen lymph nodes"; VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of hypersomnia, asthenia, fatigue, lymphadenopathy, vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Lethargy, Nasopharyngitis
Clinical narrative: Very tired; Feeling like she is fighting off a cold; Stomach upset for four days; She is normally not this lethargic; headaches; This 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-2021562659 (Pfizer).  A female patient in her 60's received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) at the age of 7 decade 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 "not recovered", described as "Very tired"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Feeling like she is fighting off a cold"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as "Stomach upset for four days"; LETHARGY (non-serious), outcome "not recovered", described as "She is normally not this lethargic"; HEADACHE (non-serious), outcome "not recovered", described as "headaches".  Additional Context: Caller states she took the first dose of the Pfizer Covid vaccine on 04May2021 which was two weeks ago, concerned of any side effects that are still lingering, could this be related to the vaccine. Caller states that from the time she got the vaccine she started to feel very tired, feeling like she is fighting off a cold, states last week she had stomach upset for four days, unsure if it is associated with that. Caller states she has the second dose coming up next week and she is extremely wary. Caller declines to provide any further information for a report, does not want to give out any personal information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Constant headache started second after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13May2021 16:00 (Lot number: Ew0168) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (lot Number:  Ee0158, administration route: Intramuscular, Administration time: 12:00 PM, vaccination Location: Left arm, Dose : 01), administration date: 22Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 15May2021, outcome "unknown", described as "Constant headache started second after the vaccine". Therapeutic measures were not taken as a result of headache.  Additional information: Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. Patient has no medical history. Patient has not taken other vaccine in four weeks. Patient has taken other medications in two weeks.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac; After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac; After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Apr2021 12:30 (Lot number: EW 0172) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE taken for seasonal allergy. Vaccination history included: Bnt162b2 (COVID 19, Brand: Pfizer , Lot number: ER8737, Administration time: 12:30 PM, Vaccine location: Right arm, Dose number 1), administration date: 05Apr2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 26Apr2021 13:30, outcome "not recovered" and all described as "After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac". The event "after receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  the tingling sensation has now spread to my entire fac", "after receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  the tingling sensation has now spread to my entire fac" and "after receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  the tingling sensation has now spread to my entire fac" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscular weakness, paraesthesia, hypoaesthesia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 2 weeks of vaccination, she received Cetirizine Hydrochloride (for seasonal allergy). Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Lacrimation increased, Migraine, Nausea
Clinical narrative: Very small headache.; Massive migraine; Extremely nauseous; Vertigo; My eyes are still watering and very very sensitive to the light; I did vomit when in a moving vehicle; I felt my balance was off; My eyes are still watering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 11:00 (Lot number: EW0182) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have an intolerance to eggs" (unspecified if ongoing), notes: I have an intolerance to eggs. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (13May2021), described as "Very small headache."; MIGRAINE (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "Massive migraine"; NAUSEA (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (14May2021), described as "Extremely nauseous"; VERTIGO (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "Vertigo"; PHOTOPHOBIA (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (18May2021), described as "My eyes are still watering and very very sensitive to the light"; VOMITING (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "I did vomit when in a moving vehicle"; BALANCE DISORDER (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "I felt my balance was off"; LACRIMATION INCREASED (non-serious) with onset 12May2021, outcome "recovered with sequelae", described as "My eyes are still watering". Therapeutic measures were not taken as a result of headache, migraine, nausea, vertigo, photophobia, vomiting, balance disorder, lacrimation increased.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient didn't have any other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient driving to work around 10:45 am it was bright and sunny outside had eyes watering and headache starting to get a little worse. By 11:40 had a massive migraine and extremely nauseous. Patient was not able to drive home due to the intensity of the migraine.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vertigo, Vomiting
Clinical narrative: Very small headache.; Massive migraine; Extremely nauseous; Vertigo; My eyes are still watering and very very sensitive to the light; I did vomit when in a moving vehicle; I felt my balance was off; My eyes are still watering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 11:00 (Lot number: EW0182) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have an intolerance to eggs" (unspecified if ongoing), notes: I have an intolerance to eggs. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (13May2021), described as "Very small headache."; MIGRAINE (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "Massive migraine"; NAUSEA (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (14May2021), described as "Extremely nauseous"; VERTIGO (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "Vertigo"; PHOTOPHOBIA (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (18May2021), described as "My eyes are still watering and very very sensitive to the light"; VOMITING (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "I did vomit when in a moving vehicle"; BALANCE DISORDER (non-serious) with onset 12May2021 10:00, outcome "recovered with sequelae" (2021), described as "I felt my balance was off"; LACRIMATION INCREASED (non-serious) with onset 12May2021, outcome "recovered with sequelae", described as "My eyes are still watering". Therapeutic measures were not taken as a result of headache, migraine, nausea, vertigo, photophobia, vomiting, balance disorder, lacrimation increased.  Additional information: Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient didn't have any other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient driving to work around 10:45 am it was bright and sunny outside had eyes watering and headache starting to get a little worse. By 11:40 had a massive migraine and extremely nauseous. Patient was not able to drive home due to the intensity of the migraine.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: burning in hands; painful hands; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: BURNING SENSATION (non-serious) with onset Feb2021, outcome "not recovered", described as "burning in hands"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "painful hands".  Additional information: Patient was received other medications Advil, muscle relaxer within 2 weeks of vaccination. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Administration time was reported 03:00 PM.COVID-19 vaccine was administered at other facility.Prior to vaccination, was not the patient diagnosed with COVID-19. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine.   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-2021563745 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity, Panic reaction
Clinical narrative: When I was sleeping, I felt like pressure on my left arm; I feel like when you have a panic thing like and I have been feeling like that; It feels like, it is just a weird pressure and pain going all the way down like to my arm fingers; It feels like, it is just a weird pressure and pain going all the way down like to my arm fingers; 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) (Lot number: EW0183, Expiration Date: 31Aug2021) 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: 1st dose, Batch number: EW0158, Expiration date: 31Jul2021), for Covid-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "When I was sleeping, I felt like pressure on my left arm"; PANIC REACTION (non-serious), outcome "unknown", described as "I feel like when you have a panic thing like and I have been feeling like that"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "It feels like, it is just a weird pressure and pain going all the way down like to my arm fingers".  Additional Information: It was reported that, Consumer stated, I am just wondering is it some normal symptom? I just got my second dose of the Pfizer vaccine and what I noticed is like at night, when I was sleeping, I felt like pressure on my left arm and when I woke up, I feel like when you have a panic thing like and I have been feeling like that, it feels like, it is just a weird pressure and pain going all the way down like to my arm fingers.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Burning in hands; Painful hands; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "Burning in hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Painful hands". 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-2021563277 Same reporter/drug/event, different patient.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Dizziness, Euphoric mood, Feeling drunk, Inappropriate affect
Clinical narrative: I was giddy and giggling; Thought process was delayed / slight delay in standard processing; racing thoughts; Reaction was similar to being drunk or high; Reaction was similar to being drunk or high; At first, I was giddy and giggling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17May2021 14:45 (Batch/Lot number: unknown) at the age of 47 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: DIZZINESS (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "I was giddy and giggling"; BRADYPHRENIA (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "Thought process was delayed / slight delay in standard processing"; TACHYPHRENIA (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "racing thoughts"; EUPHORIC MOOD (non-serious), FEELING DRUNK (non-serious) all with onset 17May2021 15:15, outcome "recovered" (2021) and all described as "Reaction was similar to being drunk or high"; INAPPROPRIATE AFFECT (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "At first, I was giddy and giggling". Therapeutic measures were not taken as a result of dizziness, bradyphrenia, tachyphrenia, euphoric mood, feeling drunk, inappropriate affect.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reaction the patient experienced was similar to being drunk or high. At first, the patient was giddy and giggling. Thought process was delayed. By end of evening, was having racing thoughts. Next day, still slight delay in standard processing. Just wanted to report, so others with similar experience aren't surprised.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tachyphrenia
Clinical narrative: I was giddy and giggling; Thought process was delayed / slight delay in standard processing; racing thoughts; Reaction was similar to being drunk or high; Reaction was similar to being drunk or high; At first, I was giddy and giggling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17May2021 14:45 (Batch/Lot number: unknown) at the age of 47 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: DIZZINESS (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "I was giddy and giggling"; BRADYPHRENIA (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "Thought process was delayed / slight delay in standard processing"; TACHYPHRENIA (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "racing thoughts"; EUPHORIC MOOD (non-serious), FEELING DRUNK (non-serious) all with onset 17May2021 15:15, outcome "recovered" (2021) and all described as "Reaction was similar to being drunk or high"; INAPPROPRIATE AFFECT (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "At first, I was giddy and giggling". Therapeutic measures were not taken as a result of dizziness, bradyphrenia, tachyphrenia, euphoric mood, feeling drunk, inappropriate affect.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reaction the patient experienced was similar to being drunk or high. At first, the patient was giddy and giggling. Thought process was delayed. By end of evening, was having racing thoughts. Next day, still slight delay in standard processing. Just wanted to report, so others with similar experience aren't surprised.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 4, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient developed a vaccination site mass (a red bump over injection site), and pain in extremity (sore arm), with outcome of unknown. Additional information: The patient wondered if she should be concerned. She got her second dose of the COVID-19 shot on May 4, 2021, and it was still sore. There was a red bump over her injection site.  No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 17:30 (Lot number: EW0187) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VOMITING (non-serious) with onset 18May2021 19:00, outcome "recovering", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting.  Additional Information: It was reported that there was no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: This is a spontaneous report received from a contactable other HCP. A 56-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730), at the age of 56, intramuscularly, in left arm, on Apr 13, 2021, at 08:30, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: vaccination site discomfort (slight discomfort at injection site for two days post vaccine), onset Apr 13, 2021, at 08:30, with outcome of unknown. It was unknown whether patient was diagnosed with COVID-19 prior or since vaccination. It was also unknown, if patient received any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: sore throat; congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Lot number: Unknown) 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: OROPHARYNGEAL PAIN (non-serious) with onset 15May2021, outcome "not recovered", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 15May2021, outcome "not recovered", described as "congestion". The events "sore throat" and "congestion" were evaluated at the physician office visit and emergency room visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. 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 any list of any other medications the patient received within 2 weeks of vaccination were reported. Patient administered their most recent covid-19 vaccine at Doctor's office/urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.