chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at injection site - white lump with redness swelling going down my arm; Swelling at injection site - white lump with redness swelling going down my arm; Swelling at injection site - white lump with redness swelling going down my arm; Fatigue; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old-non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration, administered in left arm on 14May2021 at 14:30 (at the age of 54-year-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included known Sulfa drugs allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration in left arm on 20Apr2021 at 13: 30, (at the age of 54-year-old) as DOSE 1, SINGLE, for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. The patient experienced swelling at injection site, white lump with redness swelling going down my arm; fatigue, muscle aches and chills on 17May2021 at 06:00. The patient was not received any treatment for events. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: next day rash appeared behind her leg, behind her knee and leg it doesn't hurt but its itches; She developed a rash about 6-8 inches on the back of her right knee; This is spontaneous report received from a contactable consumer. This consumer (patient's parent) reported for a female patient (daughter) that a 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: GW0186), via an unspecified route of administration on 14May2021 (Friday) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 15May2021, the next day on Saturday, the patient developed a rash about 6-8 inches on the back of her right knee. The next day (16May2021) rash appeared behind her leg, behind her knee and leg it doesn't hurt but its itches. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: This is a spontaneous report recieved from a contactable consumer (patient) from Pfizer sponsored program. A female patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient also received desvenlafaxine succinate (PRISTIQ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patients medical history included PTSD. The concomitant medications were not reported. On an unspecified date the patient experienced congestion. The patient reported that she had PTSD after my husband passed away and its not a good feeling and the one she was one she took off of it. Patient explained how prescription is at pharmacy now does not have funds to pick it up so she does not have medication. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Skin exfoliation
Clinical narrative: Left sided joint pain; Itching; skin peeling left and right armpits. Left armpit worse than right; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 14May2021 13:30 (at the age of 31-year-old) as DOSE 2, SINGLE for covid-19 immunisation  .  Medical history included dysmenorrhea, left side sciatica. Concomitant medication(s) included herbal NOS (HERBAL NOS) and Chinese medicine. Patient was not pregnant at time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0158) at left arm on 16Apr2021 at 13:30 (at the age of 31-year-old) as dose 1, single for covid-19 immunization. No other vaccine in four weeks. 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 not been tested for COVID-19. On 17May2021, the patient experienced Itching, skin peeling left and right armpits. Left armpit worse than right. Left sided joint pain. Reporter assessed case as non-serious. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment for event. No Covid prior vaccination and no Covid tested post vaccination. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hot flush, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: started having brownish vaginal discharge; started having irregular vaginal bleeding; Heavy fatigue; brain fog; hot flashes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Ew0178) via an unspecified route of administration, in arm left on 15May2021 at 15:45 (at the age of 34-years-old) as dose 2, single, for COVID-19 immunization. The patient medical history was not reported. The patient had known allergies to Sulfer and penicillin. The concomitant medications of the patient included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0161), via an unspecified route of administration in arm left on 23Apr2021 at 03:30 PM (at the age of 34-years-old) as dose 1, single, for COVID-19 immunization. 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 not been tested with covid-19. On 16May2021 at 08:00 AM, the patient started having brownish vaginal discharge and started having irregular vaginal bleeding. The patient reported that she finished her period a week before her second vaccine; so this was not normal. She also had heavy fatigue, brain fog and hot flashes as well. No treatment was given for the adverse events. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Pruritus
Clinical narrative: Eczema flare up; Skin itches between thighs, stomach, hands, neck; Eczema flare up; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm right on 13May2021 at 16:15 as dose 1, single (age at vaccination 34 years) for covid-19 immunisation. Medical history included eczema and asthma since an unknown date. The patient did not have any known allergies. Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13May2021 at 16:15 the patient experienced eczema flare up and skin itch between thighs, stomach, hands, neck. The patient did not receive any therapeutic treatment for the events. The events were reported as non serious. The outcome of the events was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyskinesia, Dysphagia, Ear discomfort
Clinical narrative: Fatigue; Dull headache; Small lump behind right ear; Dull sensation in right ear area; Nausea; Extreme dizziness; Tightness in chest; Slight weakness in legs; Dry lips; Hazy vision in right eye; Difficulty swallowing; Involuntary jerky movements in legs; Waves of nausea and brain fog; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 10May2021 11:00 (Batch/Lot Number: EW0168) as single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; vitamin D3 taken for an unspecified indication, start and stop date were not reported; vitamin C taken for an unspecified indication, start and stop date were not reported; rhodiola rosea (RHODIOLA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:30 (Lot Number: 8735) for COVID-19 immunisation. On 13May2021 17:30, the patient experienced dull sensation in right ear area, nausea, extreme dizziness, tightness in chest, slight weakness in legs, dry lips, hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog. At 6:45PM brain fog lifted. At 19:15 small lump behind right ear appeared. Pulse was 72-75. Similar experience on 14May2021 starting roughly same time with dull headache. On 15May2021, similar symptoms starting at 15:00 with lower intensity; very fatigued throughout. On 17May2021, fatigue and dizziness. All the events were non-serious. The events hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog, small lump behind right ear, dull headache and fatigue required Emergency Room visit. The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate, Lip dry
Clinical narrative: Fatigue; Dull headache; Small lump behind right ear; Dull sensation in right ear area; Nausea; Extreme dizziness; Tightness in chest; Slight weakness in legs; Dry lips; Hazy vision in right eye; Difficulty swallowing; Involuntary jerky movements in legs; Waves of nausea and brain fog; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 10May2021 11:00 (Batch/Lot Number: EW0168) as single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; vitamin D3 taken for an unspecified indication, start and stop date were not reported; vitamin C taken for an unspecified indication, start and stop date were not reported; rhodiola rosea (RHODIOLA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:30 (Lot Number: 8735) for COVID-19 immunisation. On 13May2021 17:30, the patient experienced dull sensation in right ear area, nausea, extreme dizziness, tightness in chest, slight weakness in legs, dry lips, hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog. At 6:45PM brain fog lifted. At 19:15 small lump behind right ear appeared. Pulse was 72-75. Similar experience on 14May2021 starting roughly same time with dull headache. On 15May2021, similar symptoms starting at 15:00 with lower intensity; very fatigued throughout. On 17May2021, fatigue and dizziness. All the events were non-serious. The events hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog, small lump behind right ear, dull headache and fatigue required Emergency Room visit. The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Mastoid disorder, Muscular weakness, Nausea, Vision blurred
Clinical narrative: Fatigue; Dull headache; Small lump behind right ear; Dull sensation in right ear area; Nausea; Extreme dizziness; Tightness in chest; Slight weakness in legs; Dry lips; Hazy vision in right eye; Difficulty swallowing; Involuntary jerky movements in legs; Waves of nausea and brain fog; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 10May2021 11:00 (Batch/Lot Number: EW0168) as single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; vitamin D3 taken for an unspecified indication, start and stop date were not reported; vitamin C taken for an unspecified indication, start and stop date were not reported; rhodiola rosea (RHODIOLA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:30 (Lot Number: 8735) for COVID-19 immunisation. On 13May2021 17:30, the patient experienced dull sensation in right ear area, nausea, extreme dizziness, tightness in chest, slight weakness in legs, dry lips, hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog. At 6:45PM brain fog lifted. At 19:15 small lump behind right ear appeared. Pulse was 72-75. Similar experience on 14May2021 starting roughly same time with dull headache. On 15May2021, similar symptoms starting at 15:00 with lower intensity; very fatigued throughout. On 17May2021, fatigue and dizziness. All the events were non-serious. The events hazy vision in right eye, difficulty swallowing, involuntary jerky movements in legs, waves of nausea and brain fog, small lump behind right ear, dull headache and fatigue required Emergency Room visit. The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Myalgia
Clinical narrative: rapid breathing; Chills; Fever (102) lasting 36 hours; headache; muscle aches; malaise; nausea; Pain in injection site; arm pain; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0161), via an unspecified route of administration on 14May2021 at 10:00 (at the age of 62-years-old) in left arm as dose number unknown, single for covid-19 immunisation. Medical history included thyroid disorder, penicillin allergy both from an unknown date and unknown if ongoing, covid-19 in Dec2020 when she had 17 days of fever and severe cough. Concomitant medications received within 2 weeks of vaccination included l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE]) and multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. On 14May2021 at 20:00, the patient experienced chills, fever (102) lasting 36 hours, headache, muscle aches, rapid breathing, malaise, nausea, pain in injection site, and arm pain. Symptoms were similar to when she had contracted covid (positive test) in Dec2020 when she had 17 days of fever and severe cough. Patient had not been tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 14May2021, covid-19 test: positive in Dec2020. The outcome of the events chills and pyrexia was recovered on 16May2021 and for all other events was recovered on an unspecified date in May2021.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Respiratory rate increased, SARS-CoV-2 antibody test
Clinical narrative: rapid breathing; Chills; Fever (102) lasting 36 hours; headache; muscle aches; malaise; nausea; Pain in injection site; arm pain; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0161), via an unspecified route of administration on 14May2021 at 10:00 (at the age of 62-years-old) in left arm as dose number unknown, single for covid-19 immunisation. Medical history included thyroid disorder, penicillin allergy both from an unknown date and unknown if ongoing, covid-19 in Dec2020 when she had 17 days of fever and severe cough. Concomitant medications received within 2 weeks of vaccination included l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE]) and multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. On 14May2021 at 20:00, the patient experienced chills, fever (102) lasting 36 hours, headache, muscle aches, rapid breathing, malaise, nausea, pain in injection site, and arm pain. Symptoms were similar to when she had contracted covid (positive test) in Dec2020 when she had 17 days of fever and severe cough. Patient had not been tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 14May2021, covid-19 test: positive in Dec2020. The outcome of the events chills and pyrexia was recovered on 16May2021 and for all other events was recovered on an unspecified date in May2021.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: rapid breathing; Chills; Fever (102) lasting 36 hours; headache; muscle aches; malaise; nausea; Pain in injection site; arm pain; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0161), via an unspecified route of administration on 14May2021 at 10:00 (at the age of 62-years-old) in left arm as dose number unknown, single for covid-19 immunisation. Medical history included thyroid disorder, penicillin allergy both from an unknown date and unknown if ongoing, covid-19 in Dec2020 when she had 17 days of fever and severe cough. Concomitant medications received within 2 weeks of vaccination included l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE]) and multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. On 14May2021 at 20:00, the patient experienced chills, fever (102) lasting 36 hours, headache, muscle aches, rapid breathing, malaise, nausea, pain in injection site, and arm pain. Symptoms were similar to when she had contracted covid (positive test) in Dec2020 when she had 17 days of fever and severe cough. Patient had not been tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 14May2021, covid-19 test: positive in Dec2020. The outcome of the events chills and pyrexia was recovered on 16May2021 and for all other events was recovered on an unspecified date in May2021.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Oral herpes
Clinical narrative: Start Date/Time: [Pfizer-BioNTech] 26Apr2021 17:00. Start Date/Time: [Pfizer-BioNTech] 10May2021 17:00; Developed cold sore on my lower lip 48hrs after receiving second dose of vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0173), via an unspecified route of administration, administered in left arm on 10May2021 at 17:00 (at the age of 29 years old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccinations within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have any allergies. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EW 0161) via an unspecified route of administration, administered in left arm on 26Apr2021 at 05:00 for covid-19 immunization.  On an unspecified date the patient experienced Inappropriate schedule of vaccine administered while on 13May2021 the patient experienced cold sore on lower lip 48hrs after receiving second dose of vaccine. The patient did not receive any treatment for the events.  The clinical outcome for Cold sores lip was not recovered.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspepsia, Headache, Hot flush
Clinical narrative: Chills; headache; muscle pain; chest pain from muscles; heartburn; fever not sure how high; hot flashes; body aches; dizziness; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 2 via an unspecified route of administration, administered in left arm on 15May2021 at 08:00 (AM) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunization. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing labetalol dosage lowered, and sulfa allergy. Concomitant medications included labetalol taken for high blood pressure; and buspirone. The patient previously took cabergoline for pituitary tumour but at time of report, was clear of cabergoline meds. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration, administered in right arm on 24Apr2021 at 08:00 (AM) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunization. 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 has not been tested for COVID-19. On 15May2021 at 16:00, the patient experienced chills, headache, muscle pain, chest pain from muscles, heartburn, fever not sure how high, hot flashes, body aches, and dizziness. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The adverse events were reported as non-serious. The patient did not receive treatment for the events. The patient was recovering from all the events.  Information about lot/batch number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Myalgia, Pain, Pyrexia
Clinical narrative: Chills; headache; muscle pain; chest pain from muscles; heartburn; fever not sure how high; hot flashes; body aches; dizziness; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 2 via an unspecified route of administration, administered in left arm on 15May2021 at 08:00 (AM) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunization. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing labetalol dosage lowered, and sulfa allergy. Concomitant medications included labetalol taken for high blood pressure; and buspirone. The patient previously took cabergoline for pituitary tumour but at time of report, was clear of cabergoline meds. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration, administered in right arm on 24Apr2021 at 08:00 (AM) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunization. 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 has not been tested for COVID-19. On 15May2021 at 16:00, the patient experienced chills, headache, muscle pain, chest pain from muscles, heartburn, fever not sure how high, hot flashes, body aches, and dizziness. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The adverse events were reported as non-serious. The patient did not receive treatment for the events. The patient was recovering from all the events.  Information about lot/batch number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: they are still running a low grade temperature of 99.5 F to 101 F.; This is a spontaneous report from a contactable consumer (Patients mother) via Medical Information Team. This consumer reported similar events for two patients. This is a second of two reports.  A 19-years-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number : EW0183), via an unspecified route of administration , administered in right arm on 14May2021, at 13:15 pm (at the age of 19-year-old) as DOSE 2, 0.3 ML SINGLE  for Covid-19 immunisation at Covid shot clinic. The patient medical history was none. Concomitant medications were reported as none. Historical Vaccine include bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number : EW0150), via an unspecified route of administration , administered in right arm on 22Apr2021 (at the age of 19 year old) as DOSE 1, 0.3 ML SINGLE  for Covid-19 immunisation. There is no prior Vaccinations received (within 4 weeks) and no adverse event occurred for the same. On 15May2021, it was reported patient had  still running a low grade temperature of 99.5 F to 101 F. She said they have already went past 24 to 48 hours. It seems like the patient is getting better, then all of the sudden the temperature comes back out of nowhere. The patient underwent lab tests and procedures which included body temperature (low grade fever) of 99.5 to 101 fahrenheit on 15May2021. Outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021556537 Same reporter/drug/AE, different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dehydration, Dizziness, Feeding disorder
Clinical narrative: horribly sick; Fever; chills; can't stay awake; dehydrared; can't eat; can't eat (nausea); headache; dizziness; cannot get out of bed; This is a spontaneous report from a contactable consumer or other non-health-care professional (Patient herself).  A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 15May2021 12:00 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Vaccination facility type was Pharmacy or Drug Store. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown Expiration Date: Unknown) on 24Apr2021 12:30 as DOSE 1, SINGLE for COVID-19 immunization. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Patients Medical history included iron deficiency anaemia and asthma. The patient's concomitant medications were not reported. Patient stated she had diarrhea since her first dose. and treatment received with diarrhea medication, ibuprofen. She had COVID so expected to be ill after the first vaccine. Patient was horribly sick after the second dose too on an unspecified date in May2021. She experienced Fever, chills, can't stay awake, dehydrared, can't eat (nausea) headache, dizziness unable to go into work on an unspecified date in May2021. That was the 2nd day she could not get out of bed on an unspecified date in May2021. Patient received no treatment for reported events. Outcome of all events was resolving.   Additional information about batch/lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pyrexia, Somnolence
Clinical narrative: horribly sick; Fever; chills; can't stay awake; dehydrared; can't eat; can't eat (nausea); headache; dizziness; cannot get out of bed; This is a spontaneous report from a contactable consumer or other non-health-care professional (Patient herself).  A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 15May2021 12:00 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Vaccination facility type was Pharmacy or Drug Store. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown Expiration Date: Unknown) on 24Apr2021 12:30 as DOSE 1, SINGLE for COVID-19 immunization. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Patients Medical history included iron deficiency anaemia and asthma. The patient's concomitant medications were not reported. Patient stated she had diarrhea since her first dose. and treatment received with diarrhea medication, ibuprofen. She had COVID so expected to be ill after the first vaccine. Patient was horribly sick after the second dose too on an unspecified date in May2021. She experienced Fever, chills, can't stay awake, dehydrared, can't eat (nausea) headache, dizziness unable to go into work on an unspecified date in May2021. That was the 2nd day she could not get out of bed on an unspecified date in May2021. Patient received no treatment for reported events. Outcome of all events was resolving.   Additional information about batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: she had a sore arm after the first vaccine, described as being a little heavy at injection site; she had a sore arm after the first vaccine, described as being a little heavy at injection site; This is a spontaneous report from contactable consumer (patient, self-reported).  A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0170 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 23Apr2021, as DOSE 1, SINGLE for COVID-19 immunization at Workplace Clinic (age at vaccination: 44 years). The patient medical history included carpal tunnel and she had it for approximately 10 years. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced a sore arm after the first vaccine, described as being a little heavy at injection site and it lasted about a day or two. She went with her husband and son to get the first vaccine and she felt nothing when she got the shot and even asked the pharmacist if she got the shot. No additional details provided regarding this statement. Outcome of the events were recovered on an unspecified date.   Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Back pain, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: tired; slight fever; back pain; This is a spontaneous report from a contactable consumer (patient's wife). This case is for dose 1. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 13Apr2021 15:00 (at the age of 46-Years-old) (Batch/Lot Number: ER8731) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history included Sinus surgery in Dec2014, covid-19 from 11Jan2021 and was recovered on an unknown date in 2021, ongoing Cholesterol, ongoing Blood pressure, ongoing Hair loss. Concomitant medication included propranolol taken for Blood pressure, rosuvastatin taken for cholesterol, finasteride taken for hair loss and ongoing multivitamins. On an unknown date in 2021, the patient experienced tired, slight fever, back pain. The patient underwent lab tests and procedures which included acoustic stimulation tests and showed results on 10May2021 with High frequency SNHL RSL muffled hearing, sars-cov-2 test was positive on 11Jan2021. At the time of this report, the outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Skin exfoliation
Clinical narrative: dry skin and scaling inside to the outside of the ear after receiving the first dose/From the first one not the last one her ears are itching more since the second one; dry skin and scaling inside to the outside of the ear after receiving the first dose/From the first one not the last one her ears are itching more since the second one; From the first one not the last one her ears are itching more since the second one; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot Number and Expiration Date: not reported), via an unspecified route of administration on 22Apr2021 (at the age of 51-years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none .Additional vaccines administered on same date of the pfizer suspect was reported as none. Adverse event following prior vaccinations was reported as none. Patient Medical History (including any illness at time of vaccination)was reported as none. Family medical history relevant to adverse event was reported as none.The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient has received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot Number: EW0182 and Expiration Date: 31Aug2021), via an unspecified route of administration on left arm on 13May2021 18:30 as DOSE 2, SINGLE for covid-19 immunisation. In Apr2021, the patient experienced dry skin, scaling inside to the outside of the ear after receiving the first dose of vaccine, she mentioned it was getting worst since the second dose and from the first one not the last one her ears are itching more since the second one. She has mentioned it to her cousin and her cousin mentioned she felt terrible as well and has Hives on her ears. They both had the same thing- dry skin and scaly-ness from the inside of the canal to the outside. She would like to know how to treat it. She has been putting things on it and its not going away and she wanted to know if someone else had the same thing. Therapeutic measures were taken as a result of dry skin and scaling inside to the outside of the ear (Steroid cream). No emergency room and physician office visit was reported. Relevant test was reported as none. The outcome of the events dry skin and scaling inside to the outside of the ear was not recovered.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Feeling abnormal, Urticaria
Clinical narrative: her cousin mentioned she felt terrible as well and has Hives on her ears; her cousin mentioned she felt terrible as well and has Hives on her ears; They both had the same thing- dry skin and scaly-ness from the inside of the canal to the outside; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. She received bnt162b2 (BNT162B2), via an unspecified route of administration on 13May2021 Left arm(Batch/Lot number EW0182) Expiration date:31AUG2021 at 18:30 as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced that her cousin mentioned she felt terrible as well has hives on her ears and felt abnormal on an unspecified date with outcome of unknown, her cousin mentioned she felt terrible as well and has hives on her ears causing urticaria on an unspecified date with outcome of unknown, they both had the same thing- dry skin and scaly-ness from the inside of the canal to the outside causing dry skin on an unspecified date with outcome of unknown. Therapeutic measures were taken with Steroid cream.  Follow-up (17May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a female  patient (reporter's cousin) that: additional information regarding adverse events were added  Information on the lot/batch number has been requested.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling abnormal, Glossodynia
Clinical narrative: She is concerned about her pain in the tongue/ she has pain in the side of her tongue; She said that she is losing taste; She is freaking out; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 13May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced that she was concerned about her pain in the tongue, she said that she was losing taste and she had pain in the side of her tongue as well and she is freaking out on an unspecified date in May2021. It was reported that she had pain in her tongue, however it was not swollen. The outcome of the events was unknown.   Follow up attempts are needed. Further information is expected. No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site erythema
Clinical narrative: big red blotch on injection site; it's really itchy; big red blotch on injection site; This is a spontaneous report from a sponsored program via a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received past drug BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced big red blotch on injection site and it was really itchy on an unspecified date. It was reported that she wanted to know if she can put ice on it. It was getting bigger. Her arm where she got was turned all red and itching like hell and it was driving her crazy. The outcome of the events was unknown.   No follow up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Weight
Clinical narrative: Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; This is a spontaneous report from a contactable consumer (Patient). A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0173) via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (At the age of 20-year-old) as dose 1, single for COVID-19 immunisation. The Patient's medical history was none. The patient's concomitant medications were not reported. Prior Vaccinations within 4 weeks was none. On 06May2021 the patient experienced every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills. The patient received the first dose of the covid vaccine, she has been sick three different times. This has reoccurred three times now. She was asking if it was normal to have reoccurring symptoms after the covid vaccine. The patient work was to get tested for covid. The patient second dose was scheduled for 28May2021. The patient underwent lab tests and procedures which included weight: 120 to 130 lbs. The outcome of the event were not recovered.  Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pyrexia
Clinical narrative: Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; Every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills; This is a spontaneous report from a contactable consumer (Patient). A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0173) via an unspecified route of administration, administered in Arm Right on 05May2021 10:00 (At the age of 20-year-old) as dose 1, single for COVID-19 immunisation. The Patient's medical history was none. The patient's concomitant medications were not reported. Prior Vaccinations within 4 weeks was none. On 06May2021 the patient experienced every few days, she gets sick with the same symptoms, which are nausea, fever, headache and chills. The patient received the first dose of the covid vaccine, she has been sick three different times. This has reoccurred three times now. She was asking if it was normal to have reoccurring symptoms after the covid vaccine. The patient work was to get tested for covid. The patient second dose was scheduled for 28May2021. The patient underwent lab tests and procedures which included weight: 120 to 130 lbs. The outcome of the event were not recovered.  Follow-up attempts completed. No further information expected.