chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pruritus, Rash, Rash macular, Rash papular
Clinical narrative: itching got worse; rashes; maculae; papulae; possible allergy to the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on 19Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine includes the first dose of BNT162B2 on 29Dec2020 for covid-19 immunisation and experienced mild itching on an unspecified date. After initial dose, on an unspecified date the patient had some mild itching a week after. The patient suspect it was from the vaccine. The patient nevertheless completed the second dose and a week after that on an unspecified date the itching got worse with rashes then maculae and papulae. The patient went to see an allergist and he ruled possible allergy to the vaccine. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Muscle spasms, Pyrexia
Clinical narrative: Fever of 102.4; Headache; Full body chills; Then cramping in both hands; This is a spontaneous report from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: A7485) via an unspecified route of administration in the left arm on 10Aug2021 at 20:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 20:45, the patient experienced full body chills and cramping in both hands. On 11Aug2021 at 01:15, five hours after vaccination, the patient also experienced fever of 102.4 (units unspecified) and headache. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event full body chills, cramping in both hands, fever of 102.4 and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm started to itch at injection spot; arm started to itch at injection spot. I noticed by the end of the night it was red and a little puffy and sore.; arm started to itch at injection spot. I noticed by the end of the night it was red and a little puffy and sore.; arm started to itch at injection spot. I noticed by the end of the night it was red and a little puffy and sore.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 07Aug2021 at 10:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) for birth control and caffeine, paracetamol (EXCEDRIN); both started on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FA6780) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 07Aug2021 at 16:00, later on the same day as second shot, the patient's arm started to itch at injection spot and noticed by the end of the night it was red and a little puffy and sore and as days went on the area continued to get bigger and it was the size of fist on fourth day but it did seem less defined on current date. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event arm started to itch at injection spot, arm red, puffy arm and sore arm was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular, SARS-CoV-2 test
Clinical narrative: Looks like chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jul2021 at 14:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Aug2021 at 08:00, the patient experienced the event which looks like chicken pox. On 09Aug2021, the patient underwent COVID-19 virus test (nasal swab) and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with MedicRion. The clinical outcome of the event looks like chicken pox was not recovered at the time of report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Varicella
Clinical narrative: Chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jul2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 01Aug2021 at 14:00, the patient had chicken pox. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported event which included treatment with unspecified medications. The clinical outcome of event chicken pox was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: pain from broken teeth; This is a spontaneous report from a contactable physician. A 79-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was reported that patient received both doses of the Pfizer BioNtech covid 19 vaccine last on 07MAR2021, seeking information on when he can get the third booster dose as he had various health issues, namely pain from broken teeth that he needs to visit his dentist to have fixed. The outcome of the event was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Audiogram, Tinnitus
Clinical narrative: Went for audio hearing test and normal hearing; Tinnitus following 2nd injection; This is a spontaneous report from a contactable other HCP, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 07May2021 at 18:15 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, for many years which was regular and no problem. The patient had allergy to wheat gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 18:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021, following the second injection, the patient experienced tinnitus. The events resulted in doctor or other health care professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported event. On an unknown date in 2021, the patient underwent audio hearing test and the result was normal hearing. The clinical outcome of the event tinnitus following second injection was not recovered at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on feet and legs; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 04Aug2021 at 13:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovary syndrome, endometriosis and hysterectomy which was not ongoing. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient received amoxicillin; clavulanic acid (AUGMENTIN) on an unknown date and experienced allergy to antibiotic, also received varenicline tartrate (CHANTIX) and paracetamol; oxycodone hydrochloride (PERCOCET) on unknown dates and experienced drug allergy. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 14Jul2021 at 13:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. On 05Aug2021, the patient experienced rash on feet and legs. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event rash on feet and legs was not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 06Aug2021 at 16:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021 the patient experienced tinnitus. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event tinnitus was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Pain, Sensitive skin
Clinical narrative: A cyst has increased at least 5 times in size since receiving second dose; Cyst became sensitive; Painful to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 17Jul2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke in 2012, high blood pressure (HBP) and high cholesterol. The patient had sulfonamide allergy and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received nifedipine (MANUFACTURER UNKNOWN) and experienced drug allergy.  On 19Jul2021, the patient experienced a cyst which increased at least 5 times in size since receiving second dose of vaccine. Cyst became sensitive and was sometimes painful to the touch. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cyst which increased at least 5 times in size, cyst became sensitive and painful to touch were not resolved at the time of report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in right pinky and wrist (pinky side, right arm); This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 09Aug2021 at 12:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 19Jul2021 at 15:00, as a single dose for COVID-19 immunisation. On 10Aug2021, the patient experienced tingling in right pinky and wrist (pinky side, right arm). Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tingling in right pinky and wrist (pinky side, right arm) was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Fever; Chills; Dizziness randomly; This is a spontaneous report from a contactable consumer, the patient. A 57-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 in the right arm on 06Jul2021 at 12:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. 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. Concomitant medications were not reported. On 07Jul2021, the patient experienced fever, chills and dizziness randomly. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills and dizziness randomly were resolved with sequelae on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Discomfort, Fatigue
Clinical narrative: tired; flu-like sympotom; headache; discomfort; cold/chill; cold/chill; illness; lost an appetite; weak; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included dry eye and sinus infection (reported as every spring, have allergy (dry eye and sinus infection) during the flower blooming season around May time). There were no concomitant medications. The patient didn't take any medication 4 weeks prior to the 1st dose.   On an unspecified date in May2021, the patient experienced flu-like symptom, was tired, headache, discomfort, cold/chill. On an unspecified date in 2021, the patient experienced illness, lost an appetite, weak. It was reported that on 3rd week after the 1st dose (week may be 16 2021), the patient had headache, discomfort, flu-like symptoms, like fatigue, but didn't take any medication. These were mild symptoms which got resolved after rest and sleep. Prior to the 2nd dose during the week of 16-20May2021, the patient had experienced a flu like symptom, very mild, felt a bit under weather, cold/chill, tired.   The patient suspected the AEs related could an infection prior to the 2nd dose. Vaccine dose interval was too close, 3 weeks apart, could it be dose related accumulative side effect. If we look at the AE profile overall, after the 2nd dose, it triples the incidence rate: fever, chill and fatigue (>50-70%), which is very high, even it is mild. It was further reported that the patient didn't had a chronic condition that required for medical treatment. Every spring, the patient have allergy (dry eye and sinus infection) during the flower blooming season around May time. This year the patient took Claritin for 2-3 weeks in May (one tablet per day) and had an add-on of steroid nasal spray (sinus) for about a week during the peak. The patient used over the counter eyedrops to treat the eye itching and dry symptom (patient is an eye doctor) about 6 weeks (May-early Jun). On 16Aug2021, the patient underwent lab tests and procedures which included rapid test: false positive, on 19Aug2021, PCR test: negative. The patient did not received treatment for adverse events. The outcome of events lost an appetite, illness and weak was unknown and outcome of all other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Illness, Influenza like illness, SARS-CoV-2 test
Clinical narrative: tired; flu-like sympotom; headache; discomfort; cold/chill; cold/chill; illness; lost an appetite; weak; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included dry eye and sinus infection (reported as every spring, have allergy (dry eye and sinus infection) during the flower blooming season around May time). There were no concomitant medications. The patient didn't take any medication 4 weeks prior to the 1st dose.   On an unspecified date in May2021, the patient experienced flu-like symptom, was tired, headache, discomfort, cold/chill. On an unspecified date in 2021, the patient experienced illness, lost an appetite, weak. It was reported that on 3rd week after the 1st dose (week may be 16 2021), the patient had headache, discomfort, flu-like symptoms, like fatigue, but didn't take any medication. These were mild symptoms which got resolved after rest and sleep. Prior to the 2nd dose during the week of 16-20May2021, the patient had experienced a flu like symptom, very mild, felt a bit under weather, cold/chill, tired.   The patient suspected the AEs related could an infection prior to the 2nd dose. Vaccine dose interval was too close, 3 weeks apart, could it be dose related accumulative side effect. If we look at the AE profile overall, after the 2nd dose, it triples the incidence rate: fever, chill and fatigue (>50-70%), which is very high, even it is mild. It was further reported that the patient didn't had a chronic condition that required for medical treatment. Every spring, the patient have allergy (dry eye and sinus infection) during the flower blooming season around May time. This year the patient took Claritin for 2-3 weeks in May (one tablet per day) and had an add-on of steroid nasal spray (sinus) for about a week during the peak. The patient used over the counter eyedrops to treat the eye itching and dry symptom (patient is an eye doctor) about 6 weeks (May-early Jun). On 16Aug2021, the patient underwent lab tests and procedures which included rapid test: false positive, on 19Aug2021, PCR test: negative. The patient did not received treatment for adverse events. The outcome of events lost an appetite, illness and weak was unknown and outcome of all other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EYO584) via an unspecified route of administration in the left arm on 09Aug2021 at 10:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EYO584) via an unspecified route of administration in the left arm on 19Jul2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 10Aug2021 at 23:00, the patient experienced headache. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Eye pruritus, Eyelid rash
Clinical narrative: Right bottom eye lid began to twitch/  5th day after the shot and it is still twitching; Both top eyelids itched; Had welts on top of them; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 07Aug2021 at 13:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included birth control medication (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); both from unknown dates for unspecified indications. On 08Aug2021 at 08:00, the patient experienced right bottom eye lid began to twitch, not constantly, but periodically throughout the day. 5th day after the shot it is still twitching. Also, both top eyelids itched for about 3 days after and had whelps on top of them. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right bottom eye lid began to twitch/ 5th day after the shot and it is still twitching, both top eyelids itched and had whelps on top of them were not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Rash
Clinical narrative: Weight loss; Fever of 103; Chills; Skin rash; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 22Jul2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergy to sulfa medication. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021, the patient had weight loss, fever of 103 (units unspecified), chills, skin rash and fatigue. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weight loss, fever of 103, chills, skin rash and fatigue were recovered on an unknown date in 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weight loss; Fever of 103; Chills; Skin rash; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 22Jul2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergy to sulfa medication. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021, the patient had weight loss, fever of 103 (units unspecified), chills, skin rash and fatigue. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weight loss, fever of 103, chills, skin rash and fatigue were recovered on an unknown date in 2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip pruritus, Lymphadenopathy, Oral pruritus, Pain in extremity
Clinical narrative: Itchy mouth and lips; Itchy mouth and lips; Itchiness; Sore arm; Headache; sinus pain for one day; Enlarged lymph nodes under arm, right breast, under neck and down sides of neck; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 01Aug2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood pressure high and unspecified allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had known (unspecified) allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 13:30, the patient experienced itchy mouth and lips, itchiness, sore arm, headache, sinus pain for one day, enlarged lymph nodes under arm, right breast, under neck and down sides of neck. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sinus pain for one day was recovered on unknown date in Aug2021 and of the itchy mouth and lips, itchiness, sore arm, headache and enlarged lymph nodes under arm, right breast, under neck and down sides of neck was not recovered at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sinus pain
Clinical narrative: Itchy mouth and lips; Itchy mouth and lips; Itchiness; Sore arm; Headache; sinus pain for one day; Enlarged lymph nodes under arm, right breast, under neck and down sides of neck; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 01Aug2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood pressure high and unspecified allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had known (unspecified) allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 13:30, the patient experienced itchy mouth and lips, itchiness, sore arm, headache, sinus pain for one day, enlarged lymph nodes under arm, right breast, under neck and down sides of neck. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sinus pain for one day was recovered on unknown date in Aug2021 and of the itchy mouth and lips, itchiness, sore arm, headache and enlarged lymph nodes under arm, right breast, under neck and down sides of neck was not recovered at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia since day 2 after vaccine can only sleep an hour or 2 at a time with sleep meds. Get jolted awake, never experienced anything like this.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 14Jul2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. 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 patient did not take any concomitant medications within 2 weeks of vaccination. The patient previously received cefalexin (KEFLEX) and erythromycin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 16Jul2021 at 23:00, since day 2 after the vaccine the patient experienced insomnia can only sleep an hour or 2 at a time with sleep medicines. Get jolted awake, never experienced anything like this. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with Trazodone for sleep but it didn't help. The clinical outcome of the event insomnia was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She was still feeling very tired 6 days after her first dose of the Pfizer Covid-19 vaccine,; This is a spontaneous report from a contactable consumer. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Aug2021, the patient was feeling very tired 6 days after her first dose of the Pfizer Covid-19 vaccine, and that she wondered if that could be the cause. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event feeling very tired was unknown at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Body ache; Headaches; Nausea; Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Aug2021 at 14:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 16:00, the patient experienced body ache, headaches, nausea and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, headaches, nausea and swollen lymph nodes were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Fatigue, Flatulence
Clinical narrative: Tired; horrible stomach pain; Bloating; Gas; awake all night with stomach pain; Chills; keep getting headache off and on; terrible pain; just felt extremely horrible; I am sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Tired, horrible stomach pain, Bloating, Gas, awake all night with stomach pain, Chills, keep getting headache off and on, terrible pain, just felt extremely horrible, and I am sick. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Insomnia, Malaise, Pain
Clinical narrative: Tired; horrible stomach pain; Bloating; Gas; awake all night with stomach pain; Chills; keep getting headache off and on; terrible pain; just felt extremely horrible; I am sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Tired, horrible stomach pain, Bloating, Gas, awake all night with stomach pain, Chills, keep getting headache off and on, terrible pain, just felt extremely horrible, and I am sick. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Constant migraines; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-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 in the left arm on 09Aug2021 at 12:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 COVID-19 vaccine. Concomitant medications were not reported. On 09Aug2021, the patient experienced constant migraines since the first dose. It was reported that the patient never experienced migraines before. Will last for hours before subsiding. 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 event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event constant migraines was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, SARS-CoV-2 test, Ventricular extrasystoles
Clinical narrative: developed PVC's - premature ventricular contractions.; use wife's cardiac device, and, never had an abnormal EKG before; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 19Mar2021 at 17:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included patient likely had COVID-19 during the week of 14Feb2021 and hematologist was sure the patient had it, in retrospect. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 12Febr2021 at 16:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 08:00, the 4th day after the second dose the patient developed PVC's - premature ventricular contractions. The patient never had this before. In fact the patient  also used his wife's cardiac device and never had an abnormal EKG before. This included his annual check-up with physicians as well. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 viral test (Nasal Swab) and the result was negative. The clinical outcome of the event  PVC's - premature ventricular contractions and abnormal EKG was recovering at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Musculoskeletal stiffness
Clinical narrative: Neck stiffness; Headache; Dull pain in eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration on 19Jul2021(at the age of 51-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration on 09Aug2021 at 17:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced neck stiffness, headache and dull pain in eyes. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events neck stiffness, headache and dull pain in eyes were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ligament sprain, Pain, Peripheral swelling
Clinical narrative: Aching/pain in both shoulders; Pain 6 inches right of belly button; Swollen right hand feels sprained.; Swollen right hand feels sprained; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 08Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, after 2 weeks of second dose vaccination, the patient experienced aching/ pain in both shoulders and 6 inches right of belly button. On an unknown date in 2021, the patient experienced swollen right hand feels sprained with certain actions after approximately 4 months. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, aching/ pain in both shoulders, pain 6 inches right of belly button and swollen right hand feels sprained were not resolved at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Respiratory symptom
Clinical narrative: cold congestion; minor respiratory symptoms; This is a spontaneous report from a contactable consumer, the patient. A 47-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 in the left arm on 23Jul2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy, petroleum allergy, penicillin allergy, battery, assault in 2017, and puncture wound (2017 assault and battery under anesthesia puncture wounds to the abdomen and spine). 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 COVID-19 vaccine. Concomitant medication included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL XR) 20 mg from an unknown date for an unspecified indication. Four days afterwards on 27Jul2021 at 08:00, the patient experienced cold congestion and minor respiratory symptoms that have not abated. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events cold congestion and minor respiratory symptoms was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up