chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade temp 99.2; Extreme arm discomfort.; Pounding headache.; Extreme tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient).   A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in right arm on 04Jun2021 at 19:15 PM (Age at Vaccination 35-years-old) as dose 2, single for Covid-19 immunization at Pharmacy or Drug Store. Medical history included allergies with latex, Benadryl, bee venom. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173) via an unspecified route of administration, administered in right arm on 14May2021 at 19:45 PM (Age at Vaccination 35-years-old) as dose 1, single for Covid-19 immunization. Patient did not take any prior Covid vaccination, and she did not get tested for Covid post vaccination. On 05Jun2021 patient experienced Extreme arm discomfort, pounding headache, extreme tiredness, body aches and low-grade temp 99.2, she did not take any treatment and no other medications in 2 weeks. The patient underwent lab data and procedure which include Body temperature abnormal Low-grade Temp 99.2 on 05Jun2021. Outcome of all events was recovering.  Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: fever; chills; vomiting; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 13-year-old Male patient that:  A 13-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), intramuscular on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No known allergies. It was unknown, the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and whether the patient received other medications within 2 weeks of vaccination. On unspecified date in May202, the patient had experienced fever, chills and vomiting.  It was unknown if the patient received treatment  in response to the adverse events. It was unknown, the patient was covid prior vaccination or if covid tested post vaccination. On an unspecified date in 2021, the events were recovered.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Mobility decreased
Clinical narrative: Strong joint pain in right arm at the elbow, upper shoulder blade and collarbone.; Pain has subsided, but still feeling the effects; unable to lie down on my right side or lift/carry light; This is a spontaneous report from a contactable consumer and other non-health care professional. A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613, Expiry date not reported) via an unspecified route of administration, administered in right arm on 03Apr2021 at 12:15 (at age of 68-years-old) as dose 2, single for COVID-19 immunisation. Medical history include Spinal osteoarthritis and Covid-19. There are no known allergies. Patient did not receive any other medication within two weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Solution for injection, Lot Number: EN6199, Expiry date not reported) via an unspecified route of administration, administered in Right arm on 13Mar2021 (at age of 68-years-old) as single dose for COVID-19 immunisation. On 06May2021 at 05:00 (1 month 2 days 16 hrs 45 min after vaccination), Patient experienced strong joint pain in right arm at the elbow, upper shoulder blade and collarbone. Pain has subsided, but still feeling the effects. I am unable to lie down on my right side or lift/carry light items. If I do, I experience the pain. Patient did not receive any treatment for the events. The Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Pyrexia
Clinical narrative: body aches; horrible pounding migraine that lasted 2 days for 1st dose; 24 hours after injection I have gotten a 102F+ fever; uncontrollable body chills; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0168) via an unspecified route of administration on 15May2021 at 01:00 PM on left arm as dose 1, single (Age at vaccination: 35-year-old) for Covid-19 immunization. The patient did not receive any other vaccine in four weeks of Covid-19 vaccine. The patient has no known allergies. The patient was neither had Covid 19 prior vaccination nor tested post vaccination. Medical history included disability due to back injury and nerve damage in both legs. Concomitant medications included: Buprenorphine, Oxycodone, Etodolac, and Baclofen (in two weeks of Covid-19 vaccine). 24 hours after injection (on 16May2021), the patient had gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine that lasted 2 days for 1st dose. The patient did not receive any treatment for adverse events. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0187) on 05Jun2021 at 01: 00 pm on right arm as dose 2, single for Covid-19 immunization. Outcome of migraine was recovered on an unspecified date in May2021, and other events were recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Papule, Pruritus, Urticaria
Clinical narrative: feel this is some sort of allergic reaction; began to develop itchy, sore welts; began to develop itchy, sore welts; I developed a persistent itch on both of my hands on the skin between my thumb and fore finger.; Within 9 days of the 2nd dose I began to develop itching lumps on the back of my head approximately 1 inch above my hair line.; Within 9 days of the 2nd dose I began to develop itching lumps on the back of my head approximately 1 inch above my hair line.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248), second dose via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 at 14:00 as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing Sufla related drugs. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), first dose via an unspecified route of administration, administered in right arm on an unspecified date in 04Feb2021 at 08:30 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced within 9 days of the 2nd dose I began to develop itching lumps on the back of my head approximately 1 inch above my hair line on 08Mar2021 at 20:00, I developed a persistent itch on both of my hands on the skin between my thumb and fore finger on 12Mar2021, began to develop itchy, sore welts on 17Mar2021. It was reported that, within 9 days of the 2nd dose, I began to develop itching lumps on the back of my head approximately 1 inch above my hair line. On 12Mar2021 I developed a persistent itch on both of my hands on the skin between my thumb and fore finger. On 17Mar2021 I began to develop itchy, sore welts on about 45% of my body. On an unspecified date, the Doctors, ER and others feel this is some sort of allergic reaction. Prior to receiving the vaccine my only allergy was to Sulfa type drugs. Adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. Adverse events treatment included IV therapy and ongoing Prednisone. The outcome of all the events was reported as not resolved and outcome of the event feel this is some sort of allergic reaction was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: slightly raised itchy  bright pink rash starting on chest spreading to L side of neck.; slightly raised itchy  bright pink rash starting on chest spreading to L side of neck.; slightly raised itchy  bright pink rash starting on chest spreading to L side of neck.; itch scalp and arms; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 53-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ew0176, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Jun2021 at 19:30 pm (age at vaccination was 53 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any known allergies. Concomitant medication the patient received in two weeks included multi vitamin. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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 had been tested for COVID-19. The patient underwent lab test which included COVID test (rapid, nasal swab): negative on 04Jun2021. On 06Jun2021 at 21:00 pm, the patient experienced slightly raised itchy bright pink rash, starting on chest spreading to L side of neck also noted on fingers and lower extremities, itch scalp and arms. No treatment was received for the adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: fever at above 102 degrees F; Chills; lethargy; This is a spontaneous report from a contactable consumer. This consumer reported for a 13-year-old male patient that:  A 13-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167), intramuscular, administered in Arm Left on 05Jun2021 12:00PM (At the age of 13 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously  received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167), intramuscular, administered in Arm Left on 15May2021 05:00PM (At the age of 13 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. On 06Jun2021 09:00AM, the patient experienced fever at above 102 degrees, chills and lethargy. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Lip swelling, Pruritus, Swelling face
Clinical narrative: headache; itching; hives on my lower back and shoulders; swelling of my face especially around eyes and lips; swelling of my face especially around eyes and lips; swelling of my face especially around eyes and lips; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer reported for herself. A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0182), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (at the age of 62-years-old) as a single dose for covid-19 immunization. Medical history included dermal filler injection from Aug2020 to an unknown date. Concomitant medication(s) in two weeks included phyllanthus emblica, terminalia bellirica, terminalia chebula (TRIPHALA); vitamin d3; curcuma longa (TURMERIC [CURCUMA LONGA]); magnesium; ammonium chloride, betaine hydrochloride, pancreas extract, pancreatin, pepsin, spleen, stearic acid (ZYPAN). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26May2021 06:00, the patient awoke on Day 21 with headache and itching. Realized she had hives on her lower back and shoulders. When she looked in mirror, noticed swelling of face especially around eyes and lips. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Outcome of the event was recovered on an unspecified date in 2021, at the time of this report. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: headache; itching; hives on my lower back and shoulders; swelling of my face especially around eyes and lips; swelling of my face especially around eyes and lips; swelling of my face especially around eyes and lips; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer reported for herself. A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0182), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (at the age of 62-years-old) as a single dose for covid-19 immunization. Medical history included dermal filler injection from Aug2020 to an unknown date. Concomitant medication(s) in two weeks included phyllanthus emblica, terminalia bellirica, terminalia chebula (TRIPHALA); vitamin d3; curcuma longa (TURMERIC [CURCUMA LONGA]); magnesium; ammonium chloride, betaine hydrochloride, pancreas extract, pancreatin, pepsin, spleen, stearic acid (ZYPAN). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26May2021 06:00, the patient awoke on Day 21 with headache and itching. Realized she had hives on her lower back and shoulders. When she looked in mirror, noticed swelling of face especially around eyes and lips. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Outcome of the event was recovered on an unspecified date in 2021, at the time of this report. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Pyrexia
Clinical narrative: Migraine; My headache is bad; Fever; The initial case was missing the following minimum criteria: identifiable Event. Upon receipt of follow-up information on 08Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date as dose 1, single for covid-19 immunization. Consumer stated, I just have a question, I got a second dose of Pfizer and on last Saturday it is a 06Jun2021 about two days ago and on Sunday I got a fever on 07Jun2021 but today on 08Jun2021 I have a migraine and today I think my migraine my headache is bad. She just wanted to know if you could take I think migraine medicine after the COVID Shot. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold-stimulus headache, Dizziness, Feeling cold, Insomnia
Clinical narrative: Terrible Migraine headache; nausea; light sensitivity; Cold down my arm, then up my arm, & up my neck; felt like a cold blanket was wrapped around my lungs; Felt like I got a halls lozenge stuck in my lungs overnight; What felt like a cold spot in the middle of my brain; Dizziness; Nose was just pouring; Tossing and turning all night couldn't sleep; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 43 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 12:30 (Batch/Lot Number: Ew0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included coeliac disease from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing known allergies to Penecillin, codeine, morphine,  neosporin, gluten. Concomitant medication(s) included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity, neosporine and experienced drug hypersensitivity, gluten and experienced drug hypersensitivity. The patient experienced cold down her arm, then up her arm, & up her neck with feeling cold on 18May2021 13:00 with outcome of unknown, felt like a cold blanket was wrapped around her lungs on 18May2021 13:00 with outcome of unknown, nose was just pouring causing rhinorrhoea on 18May2021 with outcome of recovered , terrible migraine headache on 18May2021 13:00 with outcome of unknown , nausea on 18May2021 13:00 with outcome of unknown,,light sensitivity causing photophobia on 18May2021 13:00 with outcome of unknown , tossing and turning all night couldn't sleep causing insomnia on 18May2021 with outcome of unknown , felt like she got a halls lozenge stuck in her lungs overnight causing chest discomfort on 18May2021 13:00 with outcome of unknown, what felt like a cold spot in the middle of her brain causing cold-stimulus headache on 18May2021 with outcome of unknown and dizziness on 18May2021 with outcome of unknown.  Follow-up (14Jul2021): Follow-up attempts are completed. No further information is expected  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Photophobia, Rhinorrhoea
Clinical narrative: Terrible Migraine headache; nausea; light sensitivity; Cold down my arm, then up my arm, & up my neck; felt like a cold blanket was wrapped around my lungs; Felt like I got a halls lozenge stuck in my lungs overnight; What felt like a cold spot in the middle of my brain; Dizziness; Nose was just pouring; Tossing and turning all night couldn't sleep; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 43 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 12:30 (Batch/Lot Number: Ew0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included coeliac disease from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing known allergies to Penecillin, codeine, morphine,  neosporin, gluten. Concomitant medication(s) included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity, neosporine and experienced drug hypersensitivity, gluten and experienced drug hypersensitivity. The patient experienced cold down her arm, then up her arm, & up her neck with feeling cold on 18May2021 13:00 with outcome of unknown, felt like a cold blanket was wrapped around her lungs on 18May2021 13:00 with outcome of unknown, nose was just pouring causing rhinorrhoea on 18May2021 with outcome of recovered , terrible migraine headache on 18May2021 13:00 with outcome of unknown , nausea on 18May2021 13:00 with outcome of unknown,,light sensitivity causing photophobia on 18May2021 13:00 with outcome of unknown , tossing and turning all night couldn't sleep causing insomnia on 18May2021 with outcome of unknown , felt like she got a halls lozenge stuck in her lungs overnight causing chest discomfort on 18May2021 13:00 with outcome of unknown, what felt like a cold spot in the middle of her brain causing cold-stimulus headache on 18May2021 with outcome of unknown and dizziness on 18May2021 with outcome of unknown.  Follow-up (14Jul2021): Follow-up attempts are completed. No further information is expected  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 12-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0181), at the vaccination age of 12, via an unspecified route of administration, in left arm, on Jun 6, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0187), at the vaccination age of 12, via an unspecified route of administration, in left arm, on May 16, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient did not take any other vaccine in four weeks. The patient did not have COVID-19 prior to the vaccination. The patient has not tested for COVID-19 post vaccination. On Jun 7, 2021, at 07:00, patient experienced fever for 24 hours (varying between 99ºF and 101.6ºF), nausea and general malaise. The patient did not take any therapeutic treatment for the adverse events. The outcome of the events resolved on an unspecified date in 2021. Follow-up (Jul 15, 2021): Follow-up attempts completed. No further information expected. Follow-up (Aug 2, 2021): Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Nausea, Pyrexia
Clinical narrative: Fever lasting about 24 hours between 99 and 101 degrees F; Nausea; General malaise; This is a spontaneous report from a contactable consumer or other non healthcare professional (parent). A 12-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0181, expiry date : not reported), via an unspecified route of administration in the left arm on 06Jun2021 12:15 (at the age of 12-years old) as DOSE 2, SINGLE for covid-19 immunisation at a pharmacy or drug store. The patient had no medical history and there was no known allergies. Concomitant medications were not reported. 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. Patient did not receive any other medication within 2 weeks of vaccination. Post vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0187, expiry date : not reported), via an unspecified route of administration in the left arm on 16May2021 12:15 (at the age of 12-years old) as DOSE 1, SINGLE for covid-19 immunisation. On 07Jun2021 07:00, the patient experienced fever lasting about 24 hours between 99 and 101 degrees Fahrenheit, nausea, general malaise. The patient underwent lab tests and procedures which included Fever: 99 and 101 degrees Fahrenheit on 07Jun2021. No treatment was received for all the reported events. The outcome of the events was recovered in Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed within a couple hours after both vaccines; This is a spontaneous report from a contactable consumer (patient). A 12-year-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0172) via an unspecified route of administration, administered in Arm Left on 18May2021 18:00 as DOSE 1, SINGLE and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0177) via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:15 as DOSE 2, SINGLE (age at vaccination 12 year old) for covid-19 immunisation. Medical history included asthma, anxiety, depression, von Willebrand's disease from an unknown date and unknown if ongoing. Concomitant medication included hydroxyzine hydrochloride (ADARIL); cetirizine hydrochloride (ZYRTEC ALLERGY); escitalopram oxalate (LEXAPRO); montelukast sodium (SINGULA); melatonin (MELATONIN) taken within two weeks. No other vaccine was taken within four weeks. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient was not pregnant at the time of vaccination. No known allergies. On 18May2021 at 20:00 patient experienced nosebleed within a couple of hours after both vaccines. She has mild von wilibrands but has not had a nosebleed in a while and it may be coincidence but she got a nose bleed within a couple hours after both vaccines. No treatment received for adverse event. Outcome of the event was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives appeared from my hips to my face 24 hours after the first dose.; This is a spontaneous report from a non-contactable consumer. This 25-year-old non-pregnant female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 04Jun2021 at 02:45 PM on right arm (at 25-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The past drug event included Nitrofurantoin allergy. No other vaccine was received in four weeks. The patient did not have Covid prior to vaccination and was not tested for covid tested post vaccination. On 05Jun2021 at 05:00 PM the patient experienced hives that appeared from my hips to my face 24 hours after the first dose. No additional symptoms were reported. No treatment was received. The patient was recovering.  No follow-up attempts were possible. No further information was expected.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling of body temperature change, Head discomfort, Nausea
Clinical narrative: Head pressure; short of breath; Hot and cold; dizzy; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0191), via an unspecified route of administration, administered in arm left on 03Jun2021 08:30 as dose 1, single (at the age of 34-years-old) for covid-19 immunization. Medical history included reported as none. There were no known allergies. The patient concomitant medications were not reported. The patient did receive any other vaccine in four weeks. The patient did not have covid prior to the vaccination and patient did not test for covid post vaccination. On 07Jun2021 20:45, the patient experienced head pressure, short of breath, hot and cold, dizzy and nausea. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tiredness; 100F fever; This is a spontaneous report from a contactable consumer or other non-health care professional.    A 12-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177) via intramuscularly, in left arm on 07Jun2021, at 17:15 (at the age of 12-years-old) as dose 2, single for covid-19 immunization. The patient medical history included seasonal allergies. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179) via intramuscularly, in left arm on 15May2021 at 01:30 PM (at the age of 12-years-old) as dose 1, single for covid-19 immunization. Patient had not received any other vaccines within 4 weeks. Patient had not received any other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. patient had no Known allergies. On 08Jun2021 at 15:00, patient experienced tiredness and 100F fever. Therapeutic measures were taken as a result of the events and treatment included 200mg Advil, taken once. The patient underwent lab test and procedure which included SARS-CoV-2 test Negative (Nasal Swab) on an unspecified date in Aug2020, body temperature 100 Fahrenheit on 08Jun2021. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Headache, Lymphadenopathy, Pain in extremity, Pharyngeal swelling
Clinical narrative: measles - like rash on face cheeks and between eyebrows (worse on right side); Throat and tongue swelling; Throat and tongue swelling; headache; sore arm; dry and flaky skin; dry and flaky skin; swollen red itchy and painful oval and circular red bumps; Swollen neck lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0182) via an unspecified route of administration at arm left on 16May2021 11:00 A.M. (at the age of 45-years-old) as DOSE 2, SINGLE and first dose via an unspecified route of administration at arm left on 25Apr2021 at 11:00 A.M. (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunisation. The relevant medical history included multiple sclerosis. The prior vaccinations within 4 weeks were reported as none. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications included baclofen, valaciclovir (VALACYCLOVIR), fampridine (AMPYRA), gabapentin and dextromethorphan hydrobromide monohydrate, quinidine sulfate dihydrate (NUEDEXTA); all from an unspecified date for an unspecified indication. Past drug history included allergies to morphine, codeine and gadolinium. On 27Apr2021 at 12: 00 P.M, the patient experienced throat and tongue swelling, swollen neck lymph nodes, headache, sore arm, measles - like rash on face cheeks and between eyebrows (worse on right side) characterized by swollen red itchy and painful oval and circular red bumps, dry and flaky skin. The patient underwent doctor or other healthcare professional office/clinic visit for claimed events. Therapeutic measures were taken as a result of events included diphenhydramine (BENADRYL), topical corticosteroids, ibuprofen, ice. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder, Skin exfoliation, Swollen tongue
Clinical narrative: measles - like rash on face cheeks and between eyebrows (worse on right side); Throat and tongue swelling; Throat and tongue swelling; headache; sore arm; dry and flaky skin; dry and flaky skin; swollen red itchy and painful oval and circular red bumps; Swollen neck lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0182) via an unspecified route of administration at arm left on 16May2021 11:00 A.M. (at the age of 45-years-old) as DOSE 2, SINGLE and first dose via an unspecified route of administration at arm left on 25Apr2021 at 11:00 A.M. (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunisation. The relevant medical history included multiple sclerosis. The prior vaccinations within 4 weeks were reported as none. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications included baclofen, valaciclovir (VALACYCLOVIR), fampridine (AMPYRA), gabapentin and dextromethorphan hydrobromide monohydrate, quinidine sulfate dihydrate (NUEDEXTA); all from an unspecified date for an unspecified indication. Past drug history included allergies to morphine, codeine and gadolinium. On 27Apr2021 at 12: 00 P.M, the patient experienced throat and tongue swelling, swollen neck lymph nodes, headache, sore arm, measles - like rash on face cheeks and between eyebrows (worse on right side) characterized by swollen red itchy and painful oval and circular red bumps, dry and flaky skin. The patient underwent doctor or other healthcare professional office/clinic visit for claimed events. Therapeutic measures were taken as a result of events included diphenhydramine (BENADRYL), topical corticosteroids, ibuprofen, ice. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Muscle tightness, Pruritus, Swelling face
Clinical narrative: Harden chin; Swelling upper lip; Swelling face; Itchy legs; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 45-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 11Apr2021 at 10:00 (at the age of 45-year-old) (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot number: EP6955, vaccine location: Left arm) on 21Mar2021 for covid-19 immunisation. Patient had no known allergies. On 12Apr2021 at 02:00 the patient experienced harden chin, swelling upper lip, swelling face and itchy legs. Patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient received treatment for the events. The treating medications was 2 doses of Allegra. Outcome of all the events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: experiencing shortness of breath; elevated heart rate when she walks; This is a spontaneous report from a contactable consumer. A 63-years-old female patient reported pfizer-biontech covid-19 vaccine (Formulation: Solution for injection, Batch/Lot Number was EW0168, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration, administer in Left arm on 24May2021 (age at vaccination 63-years-old ) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date a few days later, patient started experiencing shortness of breath and an elevated heart rate when she walks. The symptoms were still ongoing and have worsened, Heart racing when walking was reported as worsened. Patient also added that She was due for her second shot Monday. Ever since the first shot she has had shortness of breath. When she was walking, her heart also races. She was wondering if she should get the second shot. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise on arm of injection above and center of the wrist that is the size of a half dollar; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported for herself. A 73-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: unknown) via unknown route of administration in right arm on 08Jun2021 at 04:00 PM (at the age of 73 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included high blood pressure, vertigo, spinal stenosis, psoriasis and Known allergies. The patient concomitant medications included Methotrexate for an unknown indication from an unknown date, OTCS and Zoninazin. The patient did not receive other vaccine in four weeks. On 09Jun2021 at 09:00 AM, the patient experienced bruise on arm of injection above and center of the wrist that is the size of a half dollar. Patient did not have Covid prior vaccination and not tested for covid post vaccination. The patient did not receive treatment for the event. At the time of this report the outcome of the event was recovering.  Information on the lot/batch number has been requested.  Follow-up (12Jul2021): This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Headache, SARS-CoV-1 test
Clinical narrative: lost sense of taste; Headache; Dizzy; This is a spontaneous report from a Pfizer sponsored program. A female patient reported for herself:  A 40-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736) via intramuscularly, in right arm on 29Apr2021 as DOSE 2, SINGLE (at the age of 40-years-old) for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0162), via unspecified route of administration, in right arm on 08Apr2021 as a DOSE 1, SINGLE for covid-19 immunization. On 29Apr2021 the patient experienced headache and dizzy. The patient stated that headache and the dizziness are not there all of the time. They come and go. On an unspecified date of Jun2021 the patient experienced lost sense of taste. On an unspecified date the patient underwent lab tests and procedures twice which included SARS-CoV-1 test (she had Covid) which results in negative (patient went and got the at home Covid test thinking that she had Covid because she lost her sense of taste but said that she has taken them twice and they came back negative for Covid). Outcome for all the reported events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lip blister, Pyrexia
Clinical narrative: I have had 3 outbreaks of fever blisters on my lips since the 2nd dose of the vaccine and I hadn't had one in years.; I have had 3 outbreaks of fever blisters on my lips since the 2nd dose of the vaccine and I hadn't had one in years.; This is a spontaneous report from a contactable consumer (patient himself).   A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534, expiration date: not reported, dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (at the age of 43 years) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: not reported, expiration date: not reported, dose 1 via an unspecified route of administration, administered in Arm left on 17Mar2021 (at the age of 43 years) as dose 1, single for covid-19 immunization. On an unspecified date, the patient had 3 outbreaks of fever blisters on my lips since the 2nd dose of the vaccine and i hadn't had one in years. Clinical outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Insomnia
Clinical narrative: I get headaches almost everyday; Fatigue; Hard time sleeping at night; Diarrhea 3 to 4 times a week; Sore jaw; Coughing; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: er8733) via an unspecified route of administration in left arm on 08Apr2021 at 08:30 (at the age of 70 years-old) as dose 2, single for COVID-19 immunization in other facility. Patient medical history included high blood pressure. The concomitant medications included ramipril, hydrochlorothiazide, amlodipine, omeprazole all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin [benzylpenicillin] and experienced drug hypersensitivity (Known allergies: penicillin). Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number: en6207) via an unspecified route of administration in right arm on 18Mar2021 at 08:30 as dose 1, single for COVID-19 immunization in other facility. No other vaccines in four weeks reported. The patient experienced, he gets headaches almost every day, fatigue, hard time sleeping at night, diarrhea 3 to 4 times a week, sore jaw, coughing on 16Apr2021 at 08:00. It was unknown that, the patient had covid prior vaccination and post vaccination. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: I get headaches almost everyday; Fatigue; Hard time sleeping at night; Diarrhea 3 to 4 times a week; Sore jaw; Coughing; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: er8733) via an unspecified route of administration in left arm on 08Apr2021 at 08:30 (at the age of 70 years-old) as dose 2, single for COVID-19 immunization in other facility. Patient medical history included high blood pressure. The concomitant medications included ramipril, hydrochlorothiazide, amlodipine, omeprazole all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin [benzylpenicillin] and experienced drug hypersensitivity (Known allergies: penicillin). Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number: en6207) via an unspecified route of administration in right arm on 18Mar2021 at 08:30 as dose 1, single for COVID-19 immunization in other facility. No other vaccines in four weeks reported. The patient experienced, he gets headaches almost every day, fatigue, hard time sleeping at night, diarrhea 3 to 4 times a week, sore jaw, coughing on 16Apr2021 at 08:00. It was unknown that, the patient had covid prior vaccination and post vaccination. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: massive rash; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 12:00 AM (Age at Vaccination: 60-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility type Vaccine was Pharmacy or Drug Store. The patient took no other vaccine in four weeks, had no Covid prior vaccination and was not Covid tested post vaccination. Medical history included cancer diagnosed on 18May2021 and unknown if ongoing, the patient had no known allergies. There were no other medications in two weeks. It was reported that the patient took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 12:00 AM (Age at Vaccination: 60-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. On 13Apr2021 at 12:00 AM, the patient experienced massive rash. The adverse event resulted in doctor or other healthcare professional office/clinic visit. For Adverse event treatment was done with steroids, doxyclicine. Outcome of event was not recovered.   Follow-up attempts are completed. No further information is expected.