chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Ongoing Throbbing in my right leg/Feels like a deep pain.; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 16:00 (Lot number: ew0173) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Ongoing Throbbing in my right leg/Feels like a deep pain."  additional information: Patient did not have Covid prior vaccination and Has not been Covid tested post vaccination .Patient did not have other vaccine in four weeks. Patient other medication in two weeks included Vitamins. Patient was Unsure if event was related to the shot, but the pain started about a week after first shot Facility type vaccine: Other.  Follow-up attempts completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Somnolence, Vaccination site pain
Clinical narrative: Muscle soreness around injection site.; Tiredness; sleepiness; Muscle soreness around injection site,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jun2021 15:00 (Lot number: EW0171) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BAYER BACK & BODY PAIN; NASACORT; WAL ITIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Jun2021 19:00, outcome "not recovered", described as "Muscle soreness around injection site."; FATIGUE (non-serious) with onset 03Jun2021 19:00, outcome "not recovered", described as "Tiredness"; SOMNOLENCE (non-serious) with onset 03Jun2021 19:00, outcome "not recovered", described as "sleepiness"; MYALGIA (non-serious) with onset 03Jun2021 19:00, outcome "not recovered", described as "Muscle soreness around injection site,". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, somnolence, myalgia.  Additional information: The patient had no known allergies. Prior to the 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 four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: Pain in muscle at site of vaccination for 2 days; Converted to swollen lymph nodes; Lethargy for 2 days; Pain in muscle at site of vaccination for 2 days; 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 left, administration date 04Jun2021 08:00 (Lot number: EW0713) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SYNTHROID; LISINOPRIL; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious) all with onset 04Jun2021 11:00, outcome "recovered" (06Jun2021) and all described as "Pain in muscle at site of vaccination for 2 days"; LYMPHADENOPATHY (non-serious) with onset 04Jun2021 11:00, outcome "recovering", described as "Converted to swollen lymph nodes"; LETHARGY (non-serious) with onset 04Jun2021 11:00, outcome "recovered" (06Jun2021), described as "Lethargy for 2 days". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy, lethargy, myalgia.  Additional information: The patient did not receive any other vaccine in four weeks. Other medications in two weeks included Metformin, Synthroid, Lisinopril, Aspirin. The patient was neither diagnosed with Covid prior vaccination, nor been tested with Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Loud ringing in ears; Head bussing sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 13:00 (Lot number: ew0172) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 12May2021 16:00, outcome "not recovered", described as "Loud ringing in ears"; FEELING ABNORMAL (non-serious) with onset 12May2021 16:00, outcome "not recovered", described as "Head bussing sensation". The events "loud ringing in ears" and "head bussing sensation" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, feeling abnormal.  Additional information: Loud ringing in ears, request head bussing sensation, for over 4 weeks. The patient did not receive any other vaccine within four weeks prior to COVID vaccine. The patient did not receive other medications in two weeks prior to COVID vaccine. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at the injection site; 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 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 62 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itching at the injection site".  Additional information: I have itching at the injection site, and I would like to know if that is normal or is that is an allergic reaction. Received call from consumer regarding the Pfizer COVID vaccine. She has itching where she got the shot at.  She would like to know if this is normal or does this mean she is having an allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: No appetite for two weeks on 1st Vax; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 09:30 (Lot number: EW0151) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: Shellfish" (unspecified if ongoing), notes: Known allergies Shellfish. Now apparently, all meat; "Allergies: all meat" (unspecified if ongoing), notes: Known allergies Shellfish. Now apparently, all meat. The patient took concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset Apr2021, outcome "unknown", described as "No appetite for two weeks on 1st Vax".  Additional information:  No appetite for two weeks on 1st Vax. Then seemed to have a sensitivity to meat. The patient did not receive any other vaccine within 4 weeks, received allergy medications in 2 weeks. prior and since vaccination patient was not tested for covid.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Violent tremor for about 10 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 10:30 (Lot number: Gw0180) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; TYLENOL; OMEPRAZOLE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0182, lot unknown=False, administration date=15May2021, administration time=10:15 AM , dose number=1, vaccine location=left arm), administration date: 15May2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: TREMOR (non-serious) with onset 06Jun2021 03:00, outcome "recovered", described as "Violent tremor for about 10 minutes". Therapeutic measures were not taken as a result of tremor. Additional information: The patient did not reported Covid prior to vaccination and did not tested for covid post vaccination. The patient did not had any allergies. No other vaccine in four weeks.  Follow-Up (19Jul2021): No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: stomach discomfort; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):.  A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach discomfort".  Additional Information: Patient received COVID Vaccine and had a reaction mostly stomach discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness
Clinical narrative: Lower back pain/tightness; Lower back pain/tightness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jun2021 15:00 (Lot number EW0182) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN D 12 HOUR; XULANE. Vaccination history included Bnt162b2 (product COVID 19, brand Pfizer-BioNTech, lot number ew0172, lot unknown False, administration date=12May2021, administration time 03:15 PM, dose number 1, Vaccine location Left arm), administration date 12May2021, when the patient was 30 years old, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 05Jun2021 07:30, outcome not recovered and all described as Lower back pain/tightness. The event lower back pain/tightness and lower back pain/tightness was evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, muscle tightness.  Additional information: Patient did not administered any vaccine in four weeks. 36hours after the second injection. Patient did not receive any treatment like acupuncture, Cupping, Physical Therapy prior covid vaccination.  Follow-up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Insomnia, Investigation, Menstrual disorder
Clinical narrative: Adrenaline feeling through whole body lasting approx. 2 weeks.; Had trouble sleeping; Menstrual period lighter than normal and lasted 15 days; 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 left, administration date 16May2021 12:30 (Lot number: 59267-1000-01) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset 19May2021 08:30, outcome "recovering", described as "Adrenaline feeling through whole body lasting approx. 2 weeks."; INSOMNIA (non-serious) with onset 19May2021 08:30, outcome "recovering", described as "Had trouble sleeping"; MENSTRUAL DISORDER (non-serious) with onset 19May2021 08:30, outcome "recovering", described as "Menstrual period lighter than normal and lasted 15 days". The events "adrenaline feeling through whole body lasting approx. 2 weeks.", "had trouble sleeping" and "menstrual period lighter than normal and lasted 15 days" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (19May2021) unknown result. Therapeutic measures were not taken as a result of hormone level abnormal, insomnia, menstrual disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient received other medications (unspecified) in two weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26May2021 10:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2020 (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Keflex, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical site: Left arm), administration date: 05May2021, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 29May2021, outcome "not recovered", described as "Tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) from unknown date and indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: due for my monthly Cycle on April 14th.  Did not receive until April 21st; extremely light in flow and bright red in color; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 14:00 (Lot number: ER8726) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: MVI [VITAMINS NOS]; LEXAPRO. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 14Apr2021, outcome "not recovered", described as "due for my monthly Cycle on April 14th.  Did not receive until April 21st"; MENSTRUAL DISORDER (non-serious) with onset 14Apr2021, outcome "not recovered", described as "extremely light in flow and bright red in color".  Additional Information: It was stated that there was no other vaccines in four weeks the patient received second dose on 28Apr21. Was 6 days late with next Cycle also very light in flow, lasting only 1 - 2 days and extremely bright red in color. Her most recent & 3rd Cycle since receiving the 1st vaccine was 5 days late and similar in nature to the previous two. Not usual for her a clearly different than normal. prior vaccination and post vaccination the patient did not test for covid.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: worst and longest migraine headache; worst and longest migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 08:15 (Lot number: EP6955) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I suspect I may have had covid-19", start date: 16Feb2020, stop date: 25Feb2020, notes: I suspect I may have had covid-19 16Feb2020-25Feb2020; "allergy" (unspecified if ongoing); "sinus" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; ADDERALL. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin. The following information was reported: MIGRAINE (non-serious), HEADACHE (non-serious) all with onset 06Apr2021 16:00, outcome "recovering" and all described as "worst and longest migraine headache". The event "worst and longest migraine headache" and "worst and longest migraine headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine, headache.  Additional information: approximately 12 days post-1st injection, I had the worst and longest migraine headache I have ever had. The first one was 5 days long and then I had at least 2-3 a week (sometimes totaling 3-4 days of headaches) thereafter for approximately 7 weeks. OTC medicines, including migraine meds, only provided at most 1-1.5 hrs of partial relief. Approximately 6 weeks after onset the frequency had decreased to approximately 2-3 days a week and I began an aggressive course of magnesium, coQ10 and B2, which helped. The patient receive other medications within 2 weeks of vaccination includes Fluoxetine, Bupropion, Adderall. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: Feeling unwell; aches; Major headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 16:30 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing), notes: known allergies: Nuts; "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: MALAISE (non-serious) with onset Jun2021, outcome "not recovered", described as "Feeling unwell"; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "aches"; HEADACHE (non-serious) with onset Jun2021, outcome "not recovered", described as "Major headache". Therapeutic measures were not taken as a result of malaise, pain, headache.  Additional information: A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration. Prior to the 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 medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Culture stool, Diarrhoea, Illness, Vomiting
Clinical narrative: He got really sick; throwing up; Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 05May2021, outcome "unknown", described as "He got really sick"; VOMITING (non-serious) with onset 05May2021, outcome "unknown", described as "throwing up"; DIARRHOEA (non-serious) with onset 05May2021, outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. The reporter considered "he got really sick", "throwing up" and "diarrhea" not related to bnt162b2. Additional information: Her and her son both had the second Pfizer shot 12May2021. Mother then stated that her first shot was on 15Apr2021, so his was after that. She was wondering if there is a connection with him throwing up and having diarrhea, if it has anything to do with it. It said on the paper that these things can happen, the vomiting and dizziness. His birthday was on (Privacy) and he got really sick, but had the second shot on 12May2021. Does not know if the first one can still be lingering. On 05May2021, he was throwing up and having diarrhea. It also happened last Saturday, the throwing up and diarrhea, and he had a little diarrhea the day before. Does not know how long it can linger. He was 38 years old and she was 58. She was able to get her first dose a week earlier than him on 15Apr2021. He got his first dose probably a little after that, but she did not know the date. States that they are trying to figure out what is going on. He has gotten blood work and given a stool sample on an unspecified date in 2021. She asked was there any knowledge or research on how long after the shot can he be affected. Wants to ask questions to see if these are linked. Is trying to figure out if it could be connected. It might not be related. How long after the first one can someone get side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events illness, vomiting and diarrhoea and the suspect drug BNT162B2 cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Early menstrual period after 1st shot, at least a week early.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Early menstrual period after 1st shot, at least a week early.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient had no covid prior vaccination. Early menstrual period after 1st shot, at least a week early. Very late menstrual period after second shot, about one month late. If covid prior vaccination and if other vaccine in four weeks were reported as no. the patient had been tested for covid post vaccination with method of Nasal Swab and covid test result was Negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Sinus headache, Vision blurred, Vitreous floaters
Clinical narrative: I am experiencing blurred vision; I am experiencing blurred vision, and a dark spot in my vision I also feel pressure behind my eye when moving my eye and when I'm bent down.; I also feel pressure behind my eye when moving my eye and when I'm bent down; I also feel headache in the area of my right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jun2021 12:30 (Lot number: EW0167) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single; Lot number: EW0167; Administration time: 02:00 PM; Vaccine location: Left arm), administration date: 21May2021, when the patient was 27 years old, for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 04Jun2021 12:00, outcome "not recovered", described as "I am experiencing blurred vision"; VITREOUS FLOATERS (non-serious) with onset 04Jun2021 12:00, outcome "not recovered", described as "I am experiencing blurred vision, and a dark spot in my vision I also feel pressure behind my eye when moving my eye and when I'm bent down. "; OCULAR DISCOMFORT (non-serious) with onset 04Jun2021 12:00, outcome "not recovered", described as "I also feel pressure behind my eye when moving my eye and when I'm bent down"; SINUS HEADACHE (non-serious) with onset 04Jun2021 12:00, outcome "not recovered", described as "I also feel headache in the area of my right eye". Therapeutic measures were not taken as a result of vision blurred, vitreous floaters, ocular discomfort, sinus headache.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Did not experience this problem before the vaccine. No known allergies. No other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Very late menstrual period after second shot, about one month late.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (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 (product: COVID 19, lot unknown: True, lot unknown reason: Misplaced/discarded, dose number: 1), for COVID-19 immunization, reaction(s): "Menstrual disorder". The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "Very late menstrual period after second shot, about one month late.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: The patient received no other vaccine in four weeks. The patient received no covid prior vaccination. The patient had been covid tested post vaccination. Adverse event: Early menstrual period after 1st shot, at least a week early. Very late menstrual period after second shot, about one month late. The patient underwent lab tests and procedures on an unspecified date which included: sars-cov-2 test: negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 1.5 weeks after 1st dose I got a red mark in the shape of the bandaid that was placed over the injection site. This only appeared once after a shower and disappeared later that day.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16May2021 13:00 (Lot number: EW0185) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (2021), described as "1.5 weeks after 1st dose I got a red mark in the shape of the bandaid that was placed over the injection site. This only appeared once after a shower and disappeared later that day. ". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: Other medication in two weeks included Carbofix. Patient did not take any other vaccine in four weeks of COVID vaccination. It was reported that 1.5 weeks after 1st dose patient got a red mark in the shape of the band aid that was placed over the injection site. Patient was not diagnosed with COVID prior to vaccination and not tested with COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Piloerection
Clinical narrative: Numbness and tingling in my arms and legs.; Numbness and tingling in my arms and legs.; tingling in my arms and legs.; Feels like I constantly have goosebumps.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 12:00 (Lot number: EW0185) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: IRON. Vaccination history included: Bnt162b2 (1st dose, Administration time:12:00 PM, Lot number: EW0186, lot unknown: False, vaccine location: Left arm), administration date: 18May2021, when the patient was 30 years old, for Covid-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 08Jun2021 12:30, outcome "unknown" and all described as "Numbness and tingling in my arms and legs."; PARAESTHESIA (non-serious) with onset 08Jun2021 12:30, outcome "unknown", described as "tingling in my arms and legs."; PILOERECTION (non-serious) with onset 08Jun2021 12:30, outcome "unknown", described as "Feels like I constantly have goosebumps.". Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia, paraesthesia, piloerection.  Additional information: The patient had no other vaccine in four weeks and not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Heart rate, Heart rate abnormal, Paraesthesia oral
Clinical narrative: Lightheaded/Dizzy; metallic taste in mouth; Rapid heart rate; tingly sensation in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Apr2021 10:55 (Lot number: EW0164) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild Asthma", start date: 1996 (ongoing), notes: Onset date: 1996; "heart murmur" (unspecified if ongoing); "Heart attack", start date: 1997 (ongoing); "known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for myocardial infarction, start date: 1997 (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 21Apr2021 10:59, outcome "recovered" (2021), described as "Lightheaded/Dizzy"; DYSGEUSIA (non-serious) with onset 21Apr2021 10:59, outcome "recovered" (2021), described as "metallic taste in mouth"; HEART RATE ABNORMAL (non-serious) with onset 21Apr2021 10:59, outcome "recovered" (2021), described as "Rapid heart rate"; PARAESTHESIA ORAL (non-serious) with onset 21Apr2021 10:59, outcome "recovered" (2021), described as "tingly sensation in mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, dysgeusia, heart rate abnormal, paraesthesia oral. Additional information: Patient did not receive any other vaccine in four weeks. Patient did not had covid prior vaccination and was not covid tested post vaccination. Approximately 3 minutes after my shot, I got a strong metallic taste in my mouth, I felt as through I might faint (which I have never done in my life), my heart started racing, I was dizzy/"Woozy". The metallic taste + wooziness passed within 15 minutes. My heart was racing/pounding for approximately an hour, as I was driving home (after the 15 minute mark), I got a weird tingly feeling in my mouth. This resolved within an hour. I did not experience any swelling and trouble breathing, which is why I did not seek medical treatment. All symptoms disappeared within a couple hours. Patient did not seek treatment afterward. patient did not require medical treatment at the site. patient just sat on patient car until patient felt it was safe to drove. Seriousness Criteria was Not serious  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache , getting very strong when I stand up. I need to be lay down in bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jun2021 10:15 (Lot number: EW0178) at the age of 15 years as dose 2, single and administered in arm right, administration date 15May2021 10:00 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 07:00, outcome "not recovered", described as "Persistent headache , getting very strong when I stand up. I need to be lay down in bed". Therapeutic measures were taken as a result of headache.  Additional information: Patient was not received any other vaccine within four weeks prior to COVID-19 vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had no known allergy. Other medication within two weeks of vaccination includes Zoloft. Vaccination facility type was Pharmacy or Drug Store. Patient was not tested for COVID-19 post vaccination. The event was treated with Tynalol.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy
Clinical narrative: Lethargy; Feeling miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 07Jun2021, outcome "unknown", described as "Lethargy"; FEELING ABNORMAL (non-serious) with onset 07Jun2021, outcome "unknown", described as "Feeling miserable". It was unknown if therapeutic measures were taken as a result of lethargy, feeling abnormal.  Additional information: It was unknown whether prior to the vaccination, the patient was diagnosed with COVID-19. Unknown if the patient received any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single and administration date 17Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) 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) with onset 2021, outcome "recovered" (2021), described as "injection site pain".  Additional information: The reporter was the Pfizer employee and had worked on development of COVID vaccine. His wife (patient) received two doses of vaccine as noted below and experiencing intermittent pain at site of injection even after 2 months of last administration. The pain was not constant but appears randomly and lasts for few minutes to hour before subsiding. It bothers her routine activities sometimes, but not always. The reporter stated that she informed him only on Monday 07Jun2021 that the pain sure to be related to vaccine injection site.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 09:30 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Esophageal acid reflux" (unspecified if ongoing), notes: Acid reflux. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 07Jun2021, outcome "not recovered", described as "Metal taste in mouth". The event "metal taste in mouth" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysgeusia.  Additional information: The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021, the patient experienced metal taste in mouth started right after vaccination and still had it after 48 hours of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were not taken as a result of the reported event.   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: Balance disorder, Gait disturbance, Headache, Hypoaesthesia, Malaise
Clinical narrative: headache/hard headache; weak legs; arm was numb; feels off-balance/she feels like she is not walking straight, she feels like it goes to one side, she's unbalanced; the whole arm, the left arm where they put the vaccination yesterday feels kind of numb; she is limping; she went to work feeling fine but she started to not feel good; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 15:15 (Lot number: EW0217) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: diagnosed probably 10 years ago. she controls it with medication but nothing else besides that. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "not recovered", described as "arm pain"; HEADACHE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "headache/hard headache"; MUSCULAR WEAKNESS (non-serious) with onset 09Jun2021, outcome "not recovered", described as "weak legs"; HYPOAESTHESIA (non-serious) with onset 09Jun2021, outcome "not recovered", described as "arm was numb"; BALANCE DISORDER (non-serious) with onset 09Jun2021, outcome "not recovered", described as "feels off-balance/she feels like she is not walking straight, she feels like it goes to one side, she's unbalanced"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 09Jun2021, outcome "not recovered", described as "the whole arm, the left arm where they put the vaccination yesterday feels kind of numb"; GAIT DISTURBANCE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "she is limping"; MALAISE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "she went to work feeling fine but she started to not feel good ".  Additional information: Caller is calling for his wife (61-yr old female) who had the first dose of the Pfizer COVID-19 vaccine yesterday (08Jun2021). She had arm pain. Today (09Jun2021), she went to work feeling fine but she started to not feel good. She has headache, weak legs, her arm was numb (same arm with the injection site), feels off-balance (can't walk straight, leans on right side). Caller wanted to know if these adverse events are normal or had been reported. He also wanted to know how long they should wait before seeing a doctor.  Caller's wife has talked with her HCP and she was advised to take a rest. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Vaccination site hypoaesthesia
Clinical narrative: headache/hard headache; weak legs; arm was numb; feels off-balance/she feels like she is not walking straight, she feels like it goes to one side, she's unbalanced; the whole arm, the left arm where they put the vaccination yesterday feels kind of numb; she is limping; she went to work feeling fine but she started to not feel good; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 15:15 (Lot number: EW0217) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: diagnosed probably 10 years ago. she controls it with medication but nothing else besides that. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "not recovered", described as "arm pain"; HEADACHE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "headache/hard headache"; MUSCULAR WEAKNESS (non-serious) with onset 09Jun2021, outcome "not recovered", described as "weak legs"; HYPOAESTHESIA (non-serious) with onset 09Jun2021, outcome "not recovered", described as "arm was numb"; BALANCE DISORDER (non-serious) with onset 09Jun2021, outcome "not recovered", described as "feels off-balance/she feels like she is not walking straight, she feels like it goes to one side, she's unbalanced"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 09Jun2021, outcome "not recovered", described as "the whole arm, the left arm where they put the vaccination yesterday feels kind of numb"; GAIT DISTURBANCE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "she is limping"; MALAISE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "she went to work feeling fine but she started to not feel good ".  Additional information: Caller is calling for his wife (61-yr old female) who had the first dose of the Pfizer COVID-19 vaccine yesterday (08Jun2021). She had arm pain. Today (09Jun2021), she went to work feeling fine but she started to not feel good. She has headache, weak legs, her arm was numb (same arm with the injection site), feels off-balance (can't walk straight, leans on right side). Caller wanted to know if these adverse events are normal or had been reported. He also wanted to know how long they should wait before seeing a doctor.  Caller's wife has talked with her HCP and she was advised to take a rest. No follow-up attempts are possible. No further information is expected.