chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25May2021 14:00 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Addison's disease", start date: 1995 (ongoing), notes: Addison's disease and has been on Prednisone Steroids since then. , Onset Date: 1995, Stop Date: Ongoing.; "Prinzmetal Angina" (ongoing), notes: she has Prinzmetal Angina diagnosed  2 years ago and ongoing; "Persistent AFIB" (ongoing), notes: Persistent AFIB, diagnosed 3 years ago., She has a card Heart for heart monitor and pacemaker. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 25May2021 15:00, outcome "recovered" (28May2021), described as "Migraine".  Additional information: The patient not received any other vaccinations within four weeks. The patient was not diagnosed with Covid-19 prior vaccination. Migraine 3 days. If she did not get better, she would go to the hospital, but she did not. They had headache on the paper, but not Migraine. This was her first. She has a card Heart for heart monitor and pacemaker all prior. She was trying to stay alive.  She can't make her own cortisol and has Addison's disease.  Her adrenal glands don't work. This happened before the vaccination been since 1995. She was just a little bit mad with Pfizer. Pfizer and Bristol Meyer they keep going up on the Eliquis. She has AFIB and was a haemophiliac and needs the Eliquis. They won't let anyone get generic until 2031. She was a haemophiliac and had AFIB prior to receiving the vaccination. She said she saw where people had to check with their doctor if they have heart disease and she has Prinzmetal Angina diagnosed 2 years ago and ongoing.  Persistent AFIB, diagnosed 3 years ago and ongoing. She hates both.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chilled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chilled". Therapeutic measures were taken as a result of chills.  Additional information: The patient spouse reported that her husband was chilled after his vaccine but she doesn't even know what Covid 19 vaccine he received. She covered him with a blanket and sat him on the heating pad. It was his second vaccine.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like crap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt like crap". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at & around injection site - mild swelling; soreness at & around injection site - mild swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 12:45 (Lot number: EW0180) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arythmia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 26May2021 18:00, outcome "recovering" and all described as "soreness at & around injection site - mild swelling". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Vaccination site irritation
Clinical narrative: caller had a stronger side effect reaction; she could feel where it went in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021620389 (Pfizer).  A 74 year-old female patient received bnt162b2 (BNT162B2) (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, for Covid-19 Immunization. The following information was reported: ADVERSE DRUG REACTION (non-serious), outcome "unknown", described as "caller had a stronger side effect reaction"; VACCINATION SITE IRRITATION (non-serious), outcome "unknown", described as "she could feel where it went in".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: feeling very fatigued; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26May2021 (Batch/Lot number: unknown) as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "not recovered", described as "feeling very fatigued"; DIZZINESS (non-serious) with onset May2021, outcome "not recovered", described as "dizzy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: My period has not come. The first day of my last period was 17May2021.; This is a spontaneous report received from 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 21Apr2021 09:00 (Lot number: EW0169) as dose 1, single and administered in arm left, administration date 2021 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 17May2021, outcome "not recovered", described as "My period has not come. The first day of my last period was 17May2021.". The event "my period has not come. the first day of my last period was 17may2021." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of oligomenorrhoea. Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received 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. No known allergies. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ears ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via RA. The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 15:00 (Lot number: EW0166) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: TINNITUS (non-serious) with onset 08May2021 09:00, outcome "not recovered", described as "ears ringing". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient woke up on 08May2021, with her ears ringing. Her husband and she thought that pollen or a shift in the barometric pressure may have caused. When it didn't go away by 5/12, she searched "why are my ears ringing for no reason" and the vaccine connection came up. The ringing has yet to go away as of 28May. Needless to say, she wants the issue reported as part of the vaccine's side effect. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 17:00 (Lot number: EW0162) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "benign prostatitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen feet".  Additional information: The patient had allergies with aspirin. The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included antihypertensive. Prior to the 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: injection site still sore; diarrhea; nausea; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via Database. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 12:00 (Lot number: EW020) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Kidney probelm" (unspecified if ongoing); "Heart problem" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "covid-19", start date: 15Jan2021 (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "injection site still sore"; DIARRHOEA (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "diarrhea"; NAUSEA (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 24May2021 12:00, outcome "not recovered", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, nausea, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; injection site pain; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27May2021 16:15 (Lot number: EP6955) at the age of 14 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: OROPHARYNGEAL PAIN (non-serious) with onset 28May2021 17:00, outcome "recovering", described as "Sore throat"; VACCINATION SITE PAIN (non-serious) with onset 28May2021 17:00, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 28May2021 17:00, outcome "recovering", described as "tiredness". The events "sore throat", "injection site pain" and "tiredness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, vaccination site pain, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Hyperhidrosis, Nightmare
Clinical narrative: The nightmare was a very intense; Woke up with racing heart, throbbing head and wet pillow; Woke up with racing heart, throbbing head and wet pillow/Headache; Woke up with racing heart, throbbing head and wet pillow; I felt like I had slept for hours/not feeling myself; Low energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26May2021 10:00 (Lot number: EW0187) at the age of 59 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: NIGHTMARE (non-serious) with onset 26May2021 22:00, outcome "recovering", described as "The nightmare was a very intense"; PALPITATIONS (non-serious), HYPERHIDROSIS (non-serious) all with onset 26May2021 22:00, outcome "recovering" and all described as "Woke up with racing heart, throbbing head and wet pillow"; HEADACHE (non-serious) with onset 26May2021 22:00, outcome "recovering", described as "Woke up with racing heart, throbbing head and wet pillow/Headache"; FEELING ABNORMAL (non-serious) with onset 26May2021 22:00, outcome "recovering", described as "I felt like I had slept for hours/not feeling myself"; ASTHENIA (non-serious) with onset 26May2021, outcome "recovering", described as "Low energy". Therapeutic measures were not taken as a result of nightmare, palpitations, headache, hyperhidrosis, feeling abnormal, asthenia.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of 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. The patient did not have any allergies. Other medical history included good health, no issues, hardly ever get sick. Adverse event: "nightmare, 12 hrs after injection, 1 hr into sleep was woke up with racing heart, throbbing head and wet pillow. I felt like I had slept for hours. The nightmare was a very intense, I was being visited by aliens and they were trying to get the vaccine out of my body. Several days of headache and low energy, just not feeling myself. Scared to receive second doze, may go see my doctor".   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: The nightmare was a very intense; Woke up with racing heart, throbbing head and wet pillow; Woke up with racing heart, throbbing head and wet pillow/Headache; Woke up with racing heart, throbbing head and wet pillow; I felt like I had slept for hours/not feeling myself; Low energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26May2021 10:00 (Lot number: EW0187) at the age of 59 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: NIGHTMARE (non-serious) with onset 26May2021 22:00, outcome "recovering", described as "The nightmare was a very intense"; PALPITATIONS (non-serious), HYPERHIDROSIS (non-serious) all with onset 26May2021 22:00, outcome "recovering" and all described as "Woke up with racing heart, throbbing head and wet pillow"; HEADACHE (non-serious) with onset 26May2021 22:00, outcome "recovering", described as "Woke up with racing heart, throbbing head and wet pillow/Headache"; FEELING ABNORMAL (non-serious) with onset 26May2021 22:00, outcome "recovering", described as "I felt like I had slept for hours/not feeling myself"; ASTHENIA (non-serious) with onset 26May2021, outcome "recovering", described as "Low energy". Therapeutic measures were not taken as a result of nightmare, palpitations, headache, hyperhidrosis, feeling abnormal, asthenia.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of 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. The patient did not have any allergies. Other medical history included good health, no issues, hardly ever get sick. Adverse event: "nightmare, 12 hrs after injection, 1 hr into sleep was woke up with racing heart, throbbing head and wet pillow. I felt like I had slept for hours. The nightmare was a very intense, I was being visited by aliens and they were trying to get the vaccine out of my body. Several days of headache and low energy, just not feeling myself. Scared to receive second doze, may go see my doctor".   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Salty taste in mouth; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 15:45 (Lot number: EN6201) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CHANCA PIEDRA. Vaccination history included: Covid-19 (product=COVID 19, brand=Pfizer,, lot number=EL9263,, lot unknown=False,, administration date=25Jan2021, administration time=03:00 AM, dose number=1,, vaccine location=Left arm}]), for COVID-19 immunisation. The following information was reported: DYSGEUSIA (non-serious) with onset 22Feb2021 08:30, outcome "recovering", described as "Salty taste in mouth". Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Flatulence, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Ongoing Stomach cramps; nausea; bloating; lethargy; foul smelling gas; Effecting my ability to work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:15 (Lot number: EP7534) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EP7534, Administration time: 03:15 PM, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Ongoing Stomach cramps"; NAUSEA (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "nausea"; ABDOMINAL DISTENSION (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "bloating"; LETHARGY (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "lethargy"; FLATULENCE (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "foul smelling gas"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Effecting my ability to work". The events "ongoing stomach cramps", "nausea", "bloating", "lethargy", "foul smelling gas" and "effecting my ability to work" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain upper, nausea, abdominal distension, lethargy, flatulence, loss of personal independence in daily activities.  Additional Information: Facility type vaccine was reported as Workplace clinic. The patient did not receive any vaccine in four weeks. The other medications in two weeks were none. It was reported that the patient had ongoing Stomach cramps, nausea, bloating, lethargy, and foul smelling gas. Effecting her ability to work. The reporter stated that, "three other people I know have all been complaining about the same symptoms". The symptoms were not subsiding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Ongoing Stomach cramps; nausea; bloating; lethargy; foul smelling gas; Effecting my ability to work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:15 (Lot number: EP7534) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EP7534, Administration time: 03:15 PM, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Ongoing Stomach cramps"; NAUSEA (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "nausea"; ABDOMINAL DISTENSION (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "bloating"; LETHARGY (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "lethargy"; FLATULENCE (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "foul smelling gas"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Effecting my ability to work". The events "ongoing stomach cramps", "nausea", "bloating", "lethargy", "foul smelling gas" and "effecting my ability to work" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain upper, nausea, abdominal distension, lethargy, flatulence, loss of personal independence in daily activities.  Additional Information: Facility type vaccine was reported as Workplace clinic. The patient did not receive any vaccine in four weeks. The other medications in two weeks were none. It was reported that the patient had ongoing Stomach cramps, nausea, bloating, lethargy, and foul smelling gas. Effecting her ability to work. The reporter stated that, "three other people I know have all been complaining about the same symptoms". The symptoms were not subsiding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Flatulence, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Ongoing Stomach cramps; nausia; bloating; lethargy; foul smelling gas; Effecting my ability to work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:15 (Lot number: EP7534) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Known Allergies: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand PFIZER, Lot number: EP7534, Lot unknown: False, Administration date: 31Mar2021, Administration time: 03:15 PM, Dose number: 1, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Ongoing Stomach cramps"; NAUSEA (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "nausia"; ABDOMINAL DISTENSION (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "bloating"; LETHARGY (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "lethargy"; FLATULENCE (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "foul smelling gas"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Effecting my ability to work". The events "ongoing stomach cramps", "nausia", "bloating", "lethargy", "foul smelling gas" and "effecting my ability to work" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain upper, nausea, abdominal distension, lethargy, flatulence, loss of personal independence in daily activities.  Additional information: The patient did not receive any other vaccine in four weeks. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Ongoing Stomach cramps; nausia; bloating; lethargy; foul smelling gas; Effecting my ability to work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:15 (Lot number: EP7534) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Known Allergies: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand PFIZER, Lot number: EP7534, Lot unknown: False, Administration date: 31Mar2021, Administration time: 03:15 PM, Dose number: 1, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Ongoing Stomach cramps"; NAUSEA (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "nausia"; ABDOMINAL DISTENSION (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "bloating"; LETHARGY (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "lethargy"; FLATULENCE (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "foul smelling gas"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Effecting my ability to work". The events "ongoing stomach cramps", "nausia", "bloating", "lethargy", "foul smelling gas" and "effecting my ability to work" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain upper, nausea, abdominal distension, lethargy, flatulence, loss of personal independence in daily activities.  Additional information: The patient did not receive any other vaccine in four weeks. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node under my right color bone became swollen and was tender to the touch; lymph node under my right color bone became swollen and was tender to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 18:30 (Lot number: ER8736) at the age of 57 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 (Product: COVID 19, Brand: Pfizer, Dose: 01, lot number: EW0179, administration time: 06:30 PM, vaccine location: Right arm), administration date: 28Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 22May2021 10:00, outcome "recovering" and all described as "lymph node under my right color bone became swollen and was tender to the touch". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. The patient was reported that 3 days after the 2nd vaccine, the lymph node under my right color bone became swollen and was tender to the touch. As of the day of this post, the lymph node is shrinking. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The AE did not result in emergency room or physician office visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-Up (02Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 1st dose: no side effects, temporary headache in frontal lobe area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 12:00 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Clinical depression" (unspecified if ongoing); "recovering alcoholic (last drink was Jan. 31)" (unspecified if ongoing), notes: recovering alcoholic (last drink was 31Jan). Concomitant medication(s) included: ZOLOFT; NEXPLANON. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "1st dose: no side effects, temporary headache in frontal lobe area".  Additional information- it was reported that patient did not suffer drom covid prior to vaccination and did not undergo covid test.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears, Tinnitus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 14:45 (Lot number: EN6203) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammatory Bowel Disease" (unspecified if ongoing); "AFIB" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 08Mar2021 08:30, outcome "not recovered", described as "Ringing in the ears, Tinnitus.". The event "ringing in the ears, tinnitus." was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contracture, SARS-CoV-2 test
Clinical narrative: Two days after second dose: a big contracture of the levator scapulae muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:30 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "fatty liver" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 1, Anatomical Location: Arm Left , lot number: EP7534), administration date: 23Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: MUSCLE CONTRACTURE (non-serious) with onset 15Apr2021, outcome "recovered" (Apr2021), described as "Two days after second dose: a big contracture of the levator scapulae muscle". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26May2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of muscle contracture.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medication the patient received within 2 weeks of vaccination was reported as not sure, maybe Vitamin 1 a day for women 50+, and advil. It was reported that, two days after second dose: a big contracture of the levator scapulae muscle. Next day was gone. No headache nor fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (COVID test type post vaccination: Nasal Swab, Antigen). The patient reported that her niece was skinny and no liver disease and got same reaction to vaccine. The event was reported as non-serious. Device date was reported as 30May2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623895 same reporter, vaccine and AE, different patient
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: My left arm has limited mobility and pain when limits are reached.  There are certain motions I cannot do including reaching for items.; My left arm has limited mobility and pain when limits are reached.  There are certain motions I cannot do including reaching for items.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure." (unspecified if ongoing); "divriticulitis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=10:00 AM, dose number=1, vaccine location=Left arm), administration date: 19Mar2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset 13Apr2021, outcome "not recovered" and all described as "My left arm has limited mobility and pain when limits are reached. There are certain motions I cannot do including reaching for items.". The event "my left arm has limited mobility and pain when limits are reached. there are certain motions i cannot do including reaching for items." and "my left arm has limited mobility and pain when limits are reached. there are certain motions i cannot do including reaching for items." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, mobility decreased.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle at Injection site continue to experience sourness till this day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 11:45 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EFEXOR. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELOT NUMBER: UNKNOWNADMINISTRATION SITE: ARM LEFT. Administration time=12:45 PM), administration date: 19Apr2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11May2021 13:00, outcome "not recovered", described as "Muscle at Injection site continue to experience sourness till this day". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: fluid filled blister/bubble type thing on my arm at the exact location the injection was given; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27May2021 09:45 (Lot number: EW0186) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: LEVOTHYROXINE; IBUPROFEN; TYLENOL; CETIRIZINE HYDROCHLORIDE. Past drug history included: Ciprofloxacin, reaction(s): "known allergies: Ciprofloxacin". Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer, lot_number=EW0179, lot_unknown=False, administration_date=06/May/2021, administration_time=11:00 AM, dose_number=1, vaccine_location=Right arm}]), administration date: 06May2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 28May2021 17:00, outcome "not recovered", described as "fluid filled blister/bubble type thing on my arm at the exact location the injection was given". Therapeutic measures were not taken as a result of vaccination site vesicles.  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Stated that, 24 hours after 2nd dose, the patient had a fluid filled blister/bubble type thing on my arm at the exact location the injection was given. The reporter classified the events as non-serious. The device date was on 30May2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I got tinnitus in both ears about 1 week after the first dose and it hasnt gone away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) at the age of 62 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: TINNITUS (non-serious) with onset 29Mar2021, outcome "not recovered", described as "I got tinnitus in both ears about 1 week after the first dose and it hasnt gone away.". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: My neck stiffened up and it was difficult to move it; terrible headaches; Neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 14:00 (Lot number: EW0171) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 28Apr2021 21:00, outcome "recovered" (2021), described as "My neck stiffened up and it was difficult to move it"; HEADACHE (non-serious) with onset 28Apr2021 21:00, outcome "recovered" (2021), described as "terrible headaches"; NECK PAIN (non-serious) with onset 28Apr2021 21:00, outcome "recovered" (2021), described as "Neck pain". The events "my neck stiffened up and it was difficult to move it", "terrible headaches" and "neck pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of musculoskeletal stiffness, headache, neck pain.  Additional information: The patient received Ibuprofen within 2 weeks of vaccination. No hospitalization Prolonged. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.