chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood alcohol abnormal, Blood ethanol
Clinical narrative: states she has a device that detects ethanol content of her blood and after she received the vaccine; This is a spontaneous report from a contactable other health care professional (patient) via medical information team. A female patient of an unspecified age received bnt162b2 (COMIRNATY, 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's medical history and concomitant medications were not reported. Reporter stated she had a device that detected ethanol content of her blood and after she received the vaccine her device showed a reading, which to her, was unexpected. Reporter was asking if ethanol was an ingredient in the Pfizer BioNTech Covid-19 Vaccine. Reporter asking how the ethanol was removed. The patient underwent lab tests and procedures which included blood ethanol (ethanol content of her blood) resulted as unexpected on an unspecified date. Outcome of the event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Ecchymosis, Immunisation, Off label use, Pyrexia
Clinical narrative: Had the booster vaccine on the 13th of this month; Had the booster vaccine on the 13th of this month; Got fever for four days, low grade fever; Got a black and blue mark that came out on arm; Rash on arm; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported and stated that do not have anything, had it done on 13 and had nothing; Expiry date: Unknown) as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2 single and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. On 13 Sep2021, the patient reported off label use and immunization.In Sep2021, got fever for four days, low grade fever and a rash on arm, after the rash patient got a black and blue mark that came out. Patient was concerned about the black and blue mark, mean patient did not bang itself or anything it just came out on arm. The patient underwent lab tests and procedures which included body temperature: low grade fever in Sep 2021. The outcome of the events was reported as unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had the booster vaccine on the 13th of this month; Had the booster vaccine on the 13th of this month; Got fever for four days, low grade fever; Got a black and blue mark that came out on arm; Rash on arm; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported and stated that do not have anything, had it done on 13 and had nothing; Expiry date: Unknown) as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2 single and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. On 13 Sep2021, the patient reported off label use and immunization.In Sep2021, got fever for four days, low grade fever and a rash on arm, after the rash patient got a black and blue mark that came out. Patient was concerned about the black and blue mark, mean patient did not bang itself or anything it just came out on arm. The patient underwent lab tests and procedures which included body temperature: low grade fever in Sep 2021. The outcome of the events was reported as unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female age patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: Not reported), dose 2 via an unspecified route of administration, administered on unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccines include bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. No prior vaccination within 4 weeks. On an unspecified date patient experienced fever. Consumer stated, patient had not side effects with the first shot but with second one had fever. The outcome of the event was Unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (10Nov2021): 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: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chills, Computerised tomogram abdomen, Computerised tomogram spine
Clinical narrative: sporadic chills after booster; sporadic chills; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter sent via follow up letter activity.  An 86-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: FF2588 and expiry date was not reported), via intramuscular route of administration in arm left, on 11Sep2021 at 16:30 PM, (Age at vaccination 86 year) as a Dose 3 (booster) single for COVID-19 immunization. The patient's medical history includes diastolic heart failure (Onset date: Dec2016 to Stop date: Ongoing), macular degeneration (Onset date: 10-15 years to Stop date: Ongoing) pertinent details (Include surgical procedures and dates): Injection lucentis, arthritis (Onset date: 15 years to Stop date: Ongoing). The patient concomitant medications include levothyroxine sodium (synthroid) for indication hypothyroid (therapy ongoing) reportedly on an unspecified date synthroid dose was lowered to 175 mcg, furosemide for diastolic heart failure (therapy ongoing), spironolactone for diastolic heart failure (therapy ongoing). The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EK4176 and expiry date was not reported), via intramuscular route of administration in left deltoid, on 22Jan2021, as a Dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EM9810 and expiry date was not reported), via intramuscular route of administration in left deltoid, on 12Feb2021 at 11:15 AM, as a Dose 2, single for COVID-19 immunization. Reportedly the patient had no side effect from first and second vaccine shot. On an unspecified date in Sep2021, the patient experience sporadic chills for a few days of the booster. Reportedly on an unspecified date in Jul2021 the patient underwent lab test and procedure includes COVID test resulted negative. On 28May2021 the patient underwent lab test and procedure includes CT scan-Abdomen resulted normal. 13Jul2021 the patient underwent lab test and procedure includes CT Scan spine resulted spinal stenosis scoliosis. On 20Sep2021 the patient underwent lab test and procedure includes all kinds of Blood tests CBC metabolic panel result all good. Reportedly the patient had no adverse bad or serious reactions to any of the 3 vaccinations. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation
Clinical narrative: sporadic chills after booster; sporadic chills; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter sent via follow up letter activity.  An 86-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: FF2588 and expiry date was not reported), via intramuscular route of administration in arm left, on 11Sep2021 at 16:30 PM, (Age at vaccination 86 year) as a Dose 3 (booster) single for COVID-19 immunization. The patient's medical history includes diastolic heart failure (Onset date: Dec2016 to Stop date: Ongoing), macular degeneration (Onset date: 10-15 years to Stop date: Ongoing) pertinent details (Include surgical procedures and dates): Injection lucentis, arthritis (Onset date: 15 years to Stop date: Ongoing). The patient concomitant medications include levothyroxine sodium (synthroid) for indication hypothyroid (therapy ongoing) reportedly on an unspecified date synthroid dose was lowered to 175 mcg, furosemide for diastolic heart failure (therapy ongoing), spironolactone for diastolic heart failure (therapy ongoing). The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EK4176 and expiry date was not reported), via intramuscular route of administration in left deltoid, on 22Jan2021, as a Dose 1, single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EM9810 and expiry date was not reported), via intramuscular route of administration in left deltoid, on 12Feb2021 at 11:15 AM, as a Dose 2, single for COVID-19 immunization. Reportedly the patient had no side effect from first and second vaccine shot. On an unspecified date in Sep2021, the patient experience sporadic chills for a few days of the booster. Reportedly on an unspecified date in Jul2021 the patient underwent lab test and procedure includes COVID test resulted negative. On 28May2021 the patient underwent lab test and procedure includes CT scan-Abdomen resulted normal. 13Jul2021 the patient underwent lab test and procedure includes CT Scan spine resulted spinal stenosis scoliosis. On 20Sep2021 the patient underwent lab test and procedure includes all kinds of Blood tests CBC metabolic panel result all good. Reportedly the patient had no adverse bad or serious reactions to any of the 3 vaccinations. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: having trouble breathing; This is a spontaneous report from a contactable consumer(patient himself). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: Unknown, Expiration Date: Unknown), via an unspecified route of administration on 29Sep2021, as dose 1,(at the age of 50-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced having trouble breathing on 29Sep2021. The clinical outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness occurred on right side of body for a couple of days after first dose.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 04Aug2021 as dose 1, single for COVID-19 immunization (at the age of 37-year-old). Medical history included ongoing asthmatic (Currently asthmatic). No known allergies. No other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination: Vitamins, ibuterol and anti-histamine. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT). The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 04Aug2021, the patient experienced itchiness occurred on right side of body for a couple of days after first dose. It was reported that after second dose, rashes in addition to itchiness occurred at various locations throughout the body. Has been ongoing for a month. The height of the affects are usually in the morning and then taper off throughout the day. Have been taking antihistamine every now and then to help calm the rashes. No idea if this is an allergic reaction to vaccine but am certain these rashes and itchiness did not occur before getting vaccinated. No treatment received for the event. The clinical outcome of the event was not resolved. Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 102-105 for 12+ hours; This is a spontaneous report from a contactable consumer or other non hcp.  A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/Lot number: Unknown), via an unspecified route of administration on 30Sep2021 15:00 PM (At the age of 41 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history was reported as none from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multivitamin within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. On 01Oct2021 02:00 AM patient experienced fever of 102-105 for 12+ hours. The patient treated the event with Advil, patient didn't have relevant medical history and concurrent conditions, Relevant past drug history, No known allergies.  On 01Oct2021 patient underwent lab tests and procedures which included body temperature: 102-105. Therapeutic measures were taken because of fever of 102-105 for 12+ hours. The outcome of the event was recovered on 01Oct2021 (14.00).    Batch/lot number not available for [Vaccine BNT162B2], no further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: My face was really red and started to get swollen and today I woke up and my face is swollen and my neck seems red; My face was really red and started to get swollen; This is a spontaneous report from a contactable consumer or other non hcp reported for herself (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), via an unspecified route of administration, administered in arm left on 29Sep2021 (Batch/Lot number was not reported; Expiry date: unknown, age at the time of vaccination: 58-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient reported regarding the lot number as it looks like 30/35BA (further not clarified). The patient medical history was not reported. Concomitant medications included vitamins (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. On 29Sep2021, the patient received her Pfizer vaccination and she did not get any allergic reactions, she waited for 15 minutes after administering the shot, then she reported, yesterday last night (02Oct2021), the patient noticed that her face was really red and started to get swollen and today she woke up and her face is swollen and her neck seems red. The patient not received treatment for the events. Investigation Assessment was No. The outcome of the events was unknown at the time of report.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pyrexia
Clinical narrative: shivering for hours; high temperature; dose number=3; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 58-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF2587) via an unspecified route of administration, administered in Arm Left on 02Oct2021 at 14:00 (at the age of 58-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included bipolar disorder (type I); obesity. Concomitant medications included influenza vaccine (FLU) taken for immunisation from 16Sep2021 to 16Sep2021; clonazepam; levothyroxine; lovastatin; oxcarbazepine all taken for unspecified indication start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 14:00 (at the age of 57-year-old) as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:00 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation and experienced put me out for the next day with all over body aches, muscle soreness, headache, fever after dose 2. The patient previously took Codeine and Ultracet and had allergies (known allergies: Codeine and Ultracet are meds that affect me badly). On 03Oct2021 at 02:00, 12 hrs after vaccination the patient experienced shivering for hours, high temperature. The patient underwent lab tests and procedures which included body temperature: high on 03Oct2021.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient received treatment for the events shivering for hours, high temperature with alka seltzer and ES Tylenol. Outcome of the events shivering for hours, high temperature was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A constant and persistent ringing in both ears; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) intramuscular, administered in Arm Right on 03May2021 11:00 (at the age of 63 years old) (Batch/Lot Number: ER8736) as dose 2, single for COVID-19 immunisation. No COVID prior vaccination. Patient has no known allergies. Medical history and concomitant medications were none. Relevant tests: None. Specific relevant test for thromboembolic with thrombocytopenia: None. No COVID test post vaccination. No other vaccine in four weeks. No other medications in two weeks. The patient took the first dose of BNT162B2 on 12Apr2021 11:00 (at the age of 63 years old, Batch/Lot No: ER8729 Intramuscular administered to Right Arm for COVID-19 immunization. On 06May2021 06:00, three days after the second shot, patient has had a constant and persistent ringing in both ears. Patient waited for a few months for it to go away but it never did. No treatment was given. The event was reported as serious, Persistent/Significant/Disability/Incapacity. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Muscle aches; vomiting; nausea; headache; chills; Maternal Exposure During Pregnancy; Dose number=3; This is a spontaneous report from a contactable consumer (patient) reported information for both mother and fetus/baby. This is a mother report. A 30-year-old pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 10:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy, type-1 diabetic and hashimotos thyroiditis. Concomitant medications included insulin aspart (NOVOLOG); insulin detemir (LEVEMIR); levothyroxine sodium (LEVOXYL) and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 10:00 (at the age of 30-year-old) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 10:00 (at the age of 30-year-old), both as a single dose for COVID-19 immunisation and exposed during pregnancy. 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 was not tested for COVID-19. The patient was pregnant, gestational period: 34, Last menstrual date was in Feb2021, and due date of delivery is 16Nov2021. On 06Oct2021 at 23:00 the patient was pregnant and experienced muscle aches, vomiting, nausea, headache and chills. Patient did not receive treatment for the event. The clinical outcome of the muscle aches, vomiting, nausea, headache, chills, booster was not recovered and other, event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Muscle aches; vomiting; nausea; headache; chills; Maternal Exposure During Pregnancy; Dose number=3; This is a spontaneous report from a contactable consumer (patient) reported information for both mother and fetus/baby. This is a mother report. A 30-year-old pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 10:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy, type-1 diabetic and hashimotos thyroiditis. Concomitant medications included insulin aspart (NOVOLOG); insulin detemir (LEVEMIR); levothyroxine sodium (LEVOXYL) and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 10:00 (at the age of 30-year-old) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 10:00 (at the age of 30-year-old), both as a single dose for COVID-19 immunisation and exposed during pregnancy. 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 was not tested for COVID-19. The patient was pregnant, gestational period: 34, Last menstrual date was in Feb2021, and due date of delivery is 16Nov2021. On 06Oct2021 at 23:00 the patient was pregnant and experienced muscle aches, vomiting, nausea, headache and chills. Patient did not receive treatment for the event. The clinical outcome of the muscle aches, vomiting, nausea, headache, chills, booster was not recovered and other, event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Ear discomfort, Ear pain, Occipital neuralgia
Clinical narrative: Vestibular neuritis; ear fullness/pain; ear fullness/pain; eyesight changes; vertigo; dizziness; occipital neuralgia; This is a spontaneous report from a contactable other hcp.  A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via intramuscular, administered in arm left on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history included sinus pain, hpv (oropharyngeal squamous cell carcinoma), osteoporosis from an unknown date and unknown if ongoing. No Known allergies was reported. Concomitant medication(s) included simvastatin (SIMVASTATIN), diphenhydramine hydrochloride (BENADRYL), vitamins nos (VITAMINS NOS), naproxen (NAPROXEN), taken for an unspecified indication, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via intramuscular, administered in arm left on Jan2021 as dose 1, single for COVID-19 immunization. It is reported that dose lot unknown reason: Unable to locate or read the details. No other vaccine in four weeks. No COVID prior to vaccination. COVID was tested post vaccination. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. On an unspecified date in Apr2021, the patient experienced vestibular neuritis (medically significant), ear fullness/pain, eyesight changes, vertigo, dizziness, occipital neuralgia. The patient underwent lab tests and procedures which included COVID-19: negative on Sep2021 COVID test name post vaccination: Biofire. Therapeutic measures were taken as a result of all the events with AE treatment: antibiotics, physical therapy. The outcome of the events was not recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Vestibular neuronitis, ear discomfort, ear pain, visual impairment, vertigo, dizziness, occipital neuralgia and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vestibular neuronitis, Visual impairment
Clinical narrative: Vestibular neuritis; ear fullness/pain; ear fullness/pain; eyesight changes; vertigo; dizziness; occipital neuralgia; This is a spontaneous report from a contactable other hcp.  A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via intramuscular, administered in arm left on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history included sinus pain, hpv (oropharyngeal squamous cell carcinoma), osteoporosis from an unknown date and unknown if ongoing. No Known allergies was reported. Concomitant medication(s) included simvastatin (SIMVASTATIN), diphenhydramine hydrochloride (BENADRYL), vitamins nos (VITAMINS NOS), naproxen (NAPROXEN), taken for an unspecified indication, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via intramuscular, administered in arm left on Jan2021 as dose 1, single for COVID-19 immunization. It is reported that dose lot unknown reason: Unable to locate or read the details. No other vaccine in four weeks. No COVID prior to vaccination. COVID was tested post vaccination. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. On an unspecified date in Apr2021, the patient experienced vestibular neuritis (medically significant), ear fullness/pain, eyesight changes, vertigo, dizziness, occipital neuralgia. The patient underwent lab tests and procedures which included COVID-19: negative on Sep2021 COVID test name post vaccination: Biofire. Therapeutic measures were taken as a result of all the events with AE treatment: antibiotics, physical therapy. The outcome of the events was not recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Vestibular neuronitis, ear discomfort, ear pain, visual impairment, vertigo, dizziness, occipital neuralgia and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use, Pain in extremity
Clinical narrative: received her booster shot; received her booster shot; arm soreness; feeling exceptionally tired; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for his wife. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Oct2021, as DOSE 3, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, the patient received second dose of 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 2, SINGLE and received first dose of 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 1, SINGLE for COVID-19 immunization. On 07Oct2021, the patient experienced who was a nurse received her booster shot that morning was reporting arm soreness and feeling exceptionally tired. No other symptoms. The clinical outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Myalgia
Clinical narrative: Dose received 3; Just tired; Muscle pain; This is a spontaneous report from a contactable consumer (other healthcare professional) reported for herself. A 28-year-old non-pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in right arm on 05Oct2021 (at the age of 28-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 13Jan2021 (at the age of 27-year-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 27-years-old) both as a single dose for covid-19 immunization. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, patient experienced muscle pain and was just tired. Facility was reported as other. Prior to the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Immunisation, Lymphadenopathy
Clinical narrative: swollen lymph nodes under both arms particularly on left side where he got the shot is the size of an eggplant almost; rapid elevated heartbeat; Why was the patient taking Pfizer Covid 19 (booster) (Verbatim): eligible; Covid 19 Virus; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in left arm (left shoulder) on 07Oct2021 (at the age of 65-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included ongoing high blood pressure (Stated that it was quite some time ago before the shot. Is hereditary and runs in his family. Is a marathoner. Stated that he got back on it just last month after being off of it for years because he managed it well. Patient clarified that he was never diagnosed as hypertension because he was always high number and stated that recently parameters for high blood pressure has changed). Concomitant medications included enalapril maleate (VASOTEC [ENALAPRIL MALEATE]) taken for high blood pressure, start and stop date were not reported; amlodipine (MANUFACTURER UNKNOWN) taken for high blood pressure from 21Sep2021 and ongoing. The patient previously took first and second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN) on an unspecified date for COVID-19 immunisation. The patient took Pfizer Covid 19 (booster), eligible for Covid 19 Virus. Patient received the booster on Thursday of last week (07Oct2021), and on 08Oct2021, within 24 hours of vaccination, that patient experienced swollen lymph nodes under both arms particularly on left side where he got the shot is size of eggplant almost and rapid elevated heartbeat. The patient stated that he was having some side effects. Stated that he got the booster on Thursday of last week. Stated that he had swollen lymph nodes under both arms particularly on left side where he got the shot is size of eggplant almost and rapid and elevated heartbeat. Clarified that it is for the Pfizer Covid 19 booster. Stated that he was concerned because he contacted his physician but he is out of the office for the remainder of the week. Stated that it is severe with swollen lymph nodes. Stated that he had no issues previously. Wanted to know if the first two shots are similar to the booster. He was a runner and went for a Saturday run and it settled a bit. Stated that he woke up this morning and it is still elevated. Stated that he was on Vasotec intermittently when his blood pressure was elevated. Stated that it was managed and he stopped taking it. The patient underwent lab tests and procedures which included heartbeat: rapid elevated on an unspecified date. Treatment was not received. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Pain
Clinical narrative: Strong headache that lasted through the day; slight fever; had chills; Dizziness; lack of appetite; aching all over body, especially the spine; aching all over body, especially the spine; Arm where shot was received was very sore and painul to move; This is a spontaneous report from a contactable consumer. This 23-year-old male consumer reported for himself.  A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0181), dose 3 via an unspecified route of administration, administered in left arm on 11Oct2021 as DOSE 3, (BOOSTER) SINGLE for COVID-19 immunization; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), via an unspecified route of administration, administered in right arm on 11Oct2021 (Batch/Lot Number: UT7347JA), as single dose for an unspecified indication (both at the age of 23-years-old). The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in left arm on 26Dec2020, as DOSE 1, SINGLE; and bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) dose 2, via an unspecified route of administration, administered in left arm on 19Jan2021, as DOSE 2, SINGLE (both at the age of 22-years-old) and both for COVID-19 immunization. The patient had no other vaccine within four weeks, and no other medications in two weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 12Oct2021, the patient experienced strong headache that lasted through the day until pain meds taken in the mid-afternoon. On 12Oct2021, the patient ran a slight fever and had chills, experienced dizziness, lack of appetite, aching all over body, especially the spine. The arm where shot was received was very sore and painful to move. The adverse event did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included slight fever: slight on 12Oct2021. Therapeutic measures were taken as a result of strong headache that lasted through the day (headache). Treatment was not provided for other adverse events. The action taken in response to the events for influenza vaccine was not applicable. The clinical outcome of the events was recovered on an unspecified date in Oct2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: Strong headache that lasted through the day; slight fever; had chills; Dizziness; lack of appetite; aching all over body, especially the spine; aching all over body, especially the spine; Arm where shot was received was very sore and painul to move; This is a spontaneous report from a contactable consumer. This 23-year-old male consumer reported for himself.  A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0181), dose 3 via an unspecified route of administration, administered in left arm on 11Oct2021 as DOSE 3, (BOOSTER) SINGLE for COVID-19 immunization; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), via an unspecified route of administration, administered in right arm on 11Oct2021 (Batch/Lot Number: UT7347JA), as single dose for an unspecified indication (both at the age of 23-years-old). The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in left arm on 26Dec2020, as DOSE 1, SINGLE; and bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) dose 2, via an unspecified route of administration, administered in left arm on 19Jan2021, as DOSE 2, SINGLE (both at the age of 22-years-old) and both for COVID-19 immunization. The patient had no other vaccine within four weeks, and no other medications in two weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 12Oct2021, the patient experienced strong headache that lasted through the day until pain meds taken in the mid-afternoon. On 12Oct2021, the patient ran a slight fever and had chills, experienced dizziness, lack of appetite, aching all over body, especially the spine. The arm where shot was received was very sore and painful to move. The adverse event did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included slight fever: slight on 12Oct2021. Therapeutic measures were taken as a result of strong headache that lasted through the day (headache). Treatment was not provided for other adverse events. The action taken in response to the events for influenza vaccine was not applicable. The clinical outcome of the events was recovered on an unspecified date in Oct2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Influenza like illness, Vaccination site pain
Clinical narrative: flu like symptoms; pain in the right arm; received the COVID 19 Booster; This is a spontaneous report from a contactable consumer (patient). This consumer reported for self that: A patient of an unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number were not reported) via unspecified route of administration, in right arm on 11Oct2021 09:12 as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number were not reported), both via unspecified route of administration, on an unspecified date as a dose 1 and dose 2, single for COVID-19 immunization. On an unspecified date the patient experienced flu like symptoms, pain in the right arm and patient received the COVID 19 booster on 11Oct2021 09:12. The right arm was the injection arm. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Fatigue
Clinical narrative: With previous two doses, was tired within a few hours of the vaccinations; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FH8020, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 (at the age of 51-years-old) as Dose 1, Single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP6955, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as Dose 2, Single for COVID-19 immunization. Medical history included ongoing Asthma was diagnosed 6-7 years ago on an unspecified date. The patient concomitant medications were not reported. On Mar2021, patient experienced with previous two doses, was tired within a few hours of the vaccinations. The event was reported as non-serious. The patient underwent lab tests and procedures which included BMI was high on an unspecified date. The outcome of the event was unknown.   Follow-up attempts were completed. No further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; body aches; soreness at injection site; Dose-03; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: FF8839), via an unspecified route of administration, administered in Arm Left on 20Oct2021 11:30 (at the age 44-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included asthma. Concomitant medication(s) included influenza vaccine (FLU) taken in the left arm for immunization on 29Sep2021 (at the age of 44-year-old); multi vitamin. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), first dose on 14Jan2021 (Lot Number: EL3247) and second dose on 04Feb2021 (Lot Number: EL3247via an unspecified route of administration, administered in arm Left as single dose, both at the age of 43-year-old for covid-19 immunization. The patient also took penicillin before and had allergy. The patient had no covid prior vaccination and had not been tested post vaccination. On 21Oct2021, the patient experienced fever, body aches, and soreness at injection site. The patient did not receive any treatment for AE. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.