chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Nausea, Pain in extremity
Clinical narrative: Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Fatigue, Flatulence
Clinical narrative: Severe stomach pain with burning/residual stomach muscle cramps; Severe stomach pain with burning; severe headache; gas and bloating; gas and bloating; feverish; vomited once; fatigue and malaise and residual stomach muscle cramps; fatigue and malaise and residual stomach muscle cramps; This is a spontaneous report from a contactable other healthcare professional, the patient. A 54-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/batch number: EL9261) via an unspecified route of administration in the left arm, as 1ST DOSE, SINGLE DOSE on 29Jan2021 at 17:15 (at the age of 54-years) for COVID-19 immunization. Medical history included rheumatoid arthritis and crohn's disease. Concomitant medications included methotrexate sodium (METHOTREXATE INJECTION BP), mesalazine (ASACOL), fluoxetine hydrochloride (PROZAC), montelukast sodium (SINGULAIR) and XYZ (taken within 2 weeks of vaccination). The patient previously took aspirin (E.C.), celecoxib and salicylate sodium and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19 On 29Jan2021, the patient experienced severe stomach pain with burning, severe headache, gas and bloating, feverish, vomited once, fatigue, malaise and residual stomach muscle cramps. The patient did not receive any treatment for the adverse events. The clinical outcome for the events was recovered with sequel and with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: Severe stomach pain with burning/residual stomach muscle cramps; Severe stomach pain with burning; severe headache; gas and bloating; gas and bloating; feverish; vomited once; fatigue and malaise and residual stomach muscle cramps; fatigue and malaise and residual stomach muscle cramps; This is a spontaneous report from a contactable other healthcare professional, the patient. A 54-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/batch number: EL9261) via an unspecified route of administration in the left arm, as 1ST DOSE, SINGLE DOSE on 29Jan2021 at 17:15 (at the age of 54-years) for COVID-19 immunization. Medical history included rheumatoid arthritis and crohn's disease. Concomitant medications included methotrexate sodium (METHOTREXATE INJECTION BP), mesalazine (ASACOL), fluoxetine hydrochloride (PROZAC), montelukast sodium (SINGULAIR) and XYZ (taken within 2 weeks of vaccination). The patient previously took aspirin (E.C.), celecoxib and salicylate sodium and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19 On 29Jan2021, the patient experienced severe stomach pain with burning, severe headache, gas and bloating, feverish, vomited once, fatigue, malaise and residual stomach muscle cramps. The patient did not receive any treatment for the adverse events. The clinical outcome for the events was recovered with sequel and with lasting effects.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore 20 days after #1 covax; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown expiry date: unknown) via an unspecified route of administration on an unspecified date as first dose single dose for COVID-19 vaccination. The patient medical history and concomitant medication were not reported. After administration of the first dose the patient had experienced cold sore 20 days after 1 covax on 09Feb2021. The reporter pharmacist if there would be a drug interaction with a patient getting second covax today and on acyclovir. The patient was on it for cold sore developed 09Feb last dose will be on 13Feb and he is to get the second dose today, first covax was 21 days ago. The outcome of event was unknown.   Information on the Lot/Batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: a breast ultrasound revealed swollen lymph nodes on left side under armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in arm left on 01Jan2021 at 11:00 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Age at vaccination was 56 years. The patient's concomitant medications included raloxifene hydrochloride (RALOXIFENE [RALOXIFENE HYDROCHLORIDE]), vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), krill oil, levocetirizine dihydrochloride (XYZAL) and Multivit. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 20Jan2021 at 11:00 AM, the patient experienced a breast ultrasound revealed swollen lymph nodes on left side under armpit. Treatment was not received for the event. On 20Jan2021, the patient underwent lab tests and procedures which included breast ultrasound, resulted as swollen lymph nodes on left side under armpit. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in arm left on 01Feb2021 as a 2nd dose, single dose for COVID-19 immunization. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Lethargy
Clinical narrative: today feeling headaches; fatigue; dizziness; 2nd lethargic; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; sleepy on the first day; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 29Jan2021 (at the age of 80-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included tobacco(Smoker). Concomitant medications were not reported. The patient previously took buspar. Other medication in two weeks included Buspar. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 11Jan2021 13:00. No other vaccine was received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 29Jan2021 the patient experienced sleepy on the first day, 2nd lethargic, 3rd ok and 4th day, today feeling headaches fatigue and dizziness. No treatment received for AE. The outcome of the events sleepy, lethargic, headaches, fatigue, dizziness was reported as not recovered and unknown for other events.  Information on batch/lot number was requested.  Follow-up (26May2021): 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 have been completed and no further information is expected
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Somnolence
Clinical narrative: today feeling headaches; fatigue; dizziness; 2nd lethargic; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; sleepy on the first day; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 29Jan2021 (at the age of 80-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included tobacco(Smoker). Concomitant medications were not reported. The patient previously took buspar. Other medication in two weeks included Buspar. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 11Jan2021 13:00. No other vaccine was received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 29Jan2021 the patient experienced sleepy on the first day, 2nd lethargic, 3rd ok and 4th day, today feeling headaches fatigue and dizziness. No treatment received for AE. The outcome of the events sleepy, lethargic, headaches, fatigue, dizziness was reported as not recovered and unknown for other events.  Information on batch/lot number was requested.  Follow-up (26May2021): 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 have been completed and no further information is expected
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Swollen lymph nodes in armpit of arm where injection was put. Tender to touch.; Swollen lymph nodes in armpit of arm where injection was put. Tender to touch.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself).  A 26-years-old non pregnant female patient received bnt162b2 (BNT162B2¸ (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number: EL9264, Expiration date: Unknown) as 1st dose, single dose for COVID-19 immunisation. There were no known allergies. Medical history included COVID-19 from Nov2020 to an unknown date, bipolar disorder from an unknown date. Concomitant medication included duloxetine (DULOXETINE, 60mg daily) taken for an unspecified indication, start and stop date were not reported, lamotrigine (LAMOTRIGINE, 100mg daily) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. COVID was not tested post vaccination. On 01Feb2021 07:00, the patient experienced swollen lymph nodes in armpit of arm where injection was put, tender to touch. Therapeutic measures were not taken as result of events. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable consumer Patient's wife). A 64-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on right arm on an unspecified date as an unknown single dose for COVID-19 immunisation. The patient's medical history and Concomitant medications was not reported. It was reported that, patient had it also and he only had a sore arm, not bad and he was shoveling some snow today (date unspecified). Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: sharp pain in left jaw when touched; This is a spontaneous report from a contactable consumer(patient).   A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: en5318) via an unspecified route of administration in left arm on 01Feb2021 at 09:30 (at the age of 53-years-old) as 1st dose, single dose for covid-19 immunisation. Facility type vaccine was clinic. Medical history included thyroid, high blood pressure and arthritis. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No known allergies reported. The patient's concomitant medications were not reported. Other medications in two weeks reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 02Feb2021 at 08:00, the patient experienced, sharp pain in left jaw when touched. The patient did not receive any treatment for the event. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: her symptoms worsened; This is a spontaneous report from a contactable physician from a 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history included strong traumatic disorder (PTSD) (is take SSR medications). The patient's concomitant medications included SSR medications for PTSD. On an unspecified date, the patient's symptoms worsened. The physician wanted to know if that side effect was associated with the vaccine and the potential side effects of the second dose. The reporting physician assessed the event as non-serious. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 09Feb2021 at 15:30 as 2nd dose, single dose for covid-19 immunisation. Medical history included PCN (penicillin) allergy and covid-19 from an unknown date and unknown if ongoing. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and sildenafil citrate (VIAGRA). No other vaccine was received in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunisation. Covid tested post vaccination was reported as no. Patient reported that after his first vaccine, two days later he noticed that he had a cold sore. Patient was not concerned and on 12Feb2021 at 05:00 am, after the second vaccine experienced his face broke out all over with over five separate sites containing cold sores. Treatment received for the adverse events with topical ointment to put on the cold sores. The outcome of the event was not resolved.  Information on the lot/ batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Illness, Insomnia
Clinical narrative: Sweating profusely, like in a bath; Not able to sleep; sick as a dog; Then spread through whole arm and hole hand; 6-7 hours later, pain getting worse and worse; Then to other arm, neck and head; Then to other arm, neck and head/ Headache; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 29Jan2021 at 08:30Am (Batch/Lot number was not reported) as 2nd dose, single dose COVID-19 immunization. The patient medical history included unspecified cardiac history. The patient concomitant medications were not reported. Historical vaccine included 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation and experienced some pain in the arm. The patient reported she and her husband received the vaccine. For her husband everything went fine. The patient stated that, after the second vaccine last Friday morning at 8:30am, 29Jan2021, had to stay after her vaccine for 30 minutes due to previous unspecified cardiac history. Her husband was fine but stated she was disaster and sick as a dog. Did not start immediately, initially just pain in arm again. Then 6-7 hours later, pain getting worse and worse. Then spread through whole arm and hole hand. Then to other arm, neck, and head. Used Tylenol for treatment. Stated, every cell in her body was affected: toes, fingers, joints, bones, all over body. The severe reactions were approximately 8-10 hours after vaccine but caller not sure. Stated it was horrendous, never experienced such pain, could not find herself in bed. The pain was to point could not lift self out of bed and could not eat. When pain subsided, headaches persisted, and dizziness accompanied it. Up to 30 hours, Saturday night, was sweating profusely, like in a bath. The headache was there after the 30 hours but not intense enough to require pain medication. Was not able to sleep Saturday night, took melatonin. The dizziness was very scary because it came in slashes, came, and left multiple times. Sunday improved but not very function able Called her physician yesterday. Better yesterday but not herself. Today is the first day she is feeling better. Caller stated some of the time periods may not be accurate as she changed a couple times. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Sweating profusely, like in a bath; Not able to sleep; sick as a dog; Then spread through whole arm and hole hand; 6-7 hours later, pain getting worse and worse; Then to other arm, neck and head; Then to other arm, neck and head/ Headache; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 29Jan2021 at 08:30Am (Batch/Lot number was not reported) as 2nd dose, single dose COVID-19 immunization. The patient medical history included unspecified cardiac history. The patient concomitant medications were not reported. Historical vaccine included 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation and experienced some pain in the arm. The patient reported she and her husband received the vaccine. For her husband everything went fine. The patient stated that, after the second vaccine last Friday morning at 8:30am, 29Jan2021, had to stay after her vaccine for 30 minutes due to previous unspecified cardiac history. Her husband was fine but stated she was disaster and sick as a dog. Did not start immediately, initially just pain in arm again. Then 6-7 hours later, pain getting worse and worse. Then spread through whole arm and hole hand. Then to other arm, neck, and head. Used Tylenol for treatment. Stated, every cell in her body was affected: toes, fingers, joints, bones, all over body. The severe reactions were approximately 8-10 hours after vaccine but caller not sure. Stated it was horrendous, never experienced such pain, could not find herself in bed. The pain was to point could not lift self out of bed and could not eat. When pain subsided, headaches persisted, and dizziness accompanied it. Up to 30 hours, Saturday night, was sweating profusely, like in a bath. The headache was there after the 30 hours but not intense enough to require pain medication. Was not able to sleep Saturday night, took melatonin. The dizziness was very scary because it came in slashes, came, and left multiple times. Sunday improved but not very function able Called her physician yesterday. Better yesterday but not herself. Today is the first day she is feeling better. Caller stated some of the time periods may not be accurate as she changed a couple times. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Cough; Sore throat; came up positive for Covid; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported, expiry date: not provided), dose 1 via an unspecified route of administration on 23Jan2021 as 1st dose, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got a cough and sore throat. She got tested and came up positive for Covid-19 ten days after the shot. She might have had it before the shot or gotten it in-between, but she did not known. The outcome of events was unknown. The patient was supposed to get second dose of vaccine on 13Feb2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort
Clinical narrative: Get a little discomfort in her hand; This is a spontaneous report from a contactable physician (Patient herself). A 82-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, Solution for injection in pre-filled syringe) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced get a little discomfort in her hand on an unspecified date. She mentioned she initially felt some discomfort in her hand which is usual with any vaccine. Stated she was tall, but is now 5ft 3 inches. Weight was between 125-127. Events after prior vaccinations she stated she would get a little discomfort in her hand, but nothing significant. Nothing special. She did not have a fever or anything. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of [(pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [(pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] has submitted the same report to the regulatory authorities.  No follow up attempts are needed, information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: typical soreness of injection site in my Left Arm; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as 1st dose, single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included evolocumab (REPATHA SURECLICK) and lorazepam (LORAZEPAM), taken for unspecified indications. The patient was hypertensive to these medications. On an unspecified date, after her first dose of vaccine, the patient experienced typical soreness of injection site in her left arm. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Wife had pain in her arm after receiving the vaccine 75 years old; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN,SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced wife had pain in her arm after receiving the vaccine 75 years old on an unspecified date. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain
Clinical narrative: I did have COVID before in June and symptoms are very similar to that I am experiencing right now; Fever; Chills; Body aches, muscle aches pretty much everything, joint ache; Body aches, muscle aches pretty much everything, joint ache; Headache; Body aches, muscle aches pretty much everything, joint ache; This is a spontaneous report received from a contactable consumer (patient- caregiver). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9263, Expiration date: Unknown), via an unspecified route yesterday on 20Feb2021 at 12:45, as a single dose for covid-19 immunization. Medical history included covid in Jun2020 with symptoms that were very similar to what patient was experiencing right now and got 2 moles removed. Concomitant medications included birth control, fish oil, vitamin D, multivitamin, green tea and pota. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 21Feb2021 today morning since 14:00, patient experienced fever, headaches, body aches, muscle aches pretty much everything, joint ache, chills, and wanted to know this is normal, how long it will last and what she should do with these side effects. Treatment received as a result of events included Tylenol. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: I did have COVID before in June and symptoms are very similar to that I am experiencing right now; Fever; Chills; Body aches, muscle aches pretty much everything, joint ache; Body aches, muscle aches pretty much everything, joint ache; Headache; Body aches, muscle aches pretty much everything, joint ache; This is a spontaneous report received from a contactable consumer (patient- caregiver). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9263, Expiration date: Unknown), via an unspecified route yesterday on 20Feb2021 at 12:45, as a single dose for covid-19 immunization. Medical history included covid in Jun2020 with symptoms that were very similar to what patient was experiencing right now and got 2 moles removed. Concomitant medications included birth control, fish oil, vitamin D, multivitamin, green tea and pota. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 21Feb2021 today morning since 14:00, patient experienced fever, headaches, body aches, muscle aches pretty much everything, joint ache, chills, and wanted to know this is normal, how long it will last and what she should do with these side effects. Treatment received as a result of events included Tylenol. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Myalgia, Pyrexia
Clinical narrative: I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report from a contactable consumer (reported for himself). A 58-years-old male patient received second dose of BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 23Feb2021 at 08:15 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 01Feb2021 at 08:10 (at the age of 58-years-old) as single dose for COVID-19 immunisation. On 24Feb2021, at 05:00, the patient experienced she woke up in the morning feeling muscle aches, weakness and temperature 99.5. The patient underwent lab tests and procedures which included pyrexia: 99.5 on 24Feb2021. No treatment was given for the events. The outcome of the events was resolving.  Information about Lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness especially over the lips, spreading from chin to eyes sockets; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on left arm on 08Feb2021 at 19:00 (at the age of 57-years-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergies to percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] and experienced drug allergy (hypersensitivity). Concomitant medications in two weeks included loratadine (LORATADINE), thyroid (ARMOUR THYROID) both were taken for an unspecified indication and start and stop date were not reported. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021 at 06:00 The patient experienced facial numbness especially over the lips, spreading from chin to eyes sockets. The patient did not received treatment for the events. The outcome of the event was recovered on unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over; This is a spontaneous report from Team. A contactable consumer (patient) reported that a 68-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 13Jan2021 as single dose in left arm for the COVID-19 vaccination. Medical history was ongoing back pain. Concomitant medication reported was oxycodone as 5 mg, as needed for back pain. Consumer WAs calling about the Pfizer COVID-19 vaccine and said she took her first shot on 13Jan2021 and she also takes Oxycodone when she has a backache, which she hasn't taken for a while, and she took some and now she had itching all over. She said can Oxycodone have some kind of affect if she has had the vaccine. Caller said she know it expires Dec2021 and was 5mg, it was a liquid one, it was red medicine that comes in a bottle. Caller said she doesn't have her vaccine card with her to provide information from it. She said that she was given her first dose injected in her left arm. Caller said they have not had any other recent vaccinations or started any new medications. Caller stated she took Oxycodone liquid 5 mg and wanted to know if there will be an interaction with the Pfizer covid 19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Extreme chills; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left on 19Feb2021 at 16:00 (at the age of 73-years-old) as single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient did not had known allergies. Concomitant medications included verapamil, olmesartan medoxomil and dexlansoprazole (DEXILANT). Patient did not had COVID prior to vaccination and has not been tested for COVID post vaccination. On 19Feb2021 at 00:00, the patient experienced fever and extreme chills. The patient did not receive treatment for the events. The outcome of the events was resolved.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Pain in jaw, Sinusitis, Temporomandibular joint syndrome
Clinical narrative: uncomfortable swallowing; swollen lymph nodes, especially on the left side; I've had some sinus issues, sinusitis; feels like if I had TMJ; Jaw pain/right jaw is the one hurting; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 72-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included , gastrooesophageal reflux disease from an unknown date and unknown if ongoing He takes Protonix daily capsule for this, cluster headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced jaw pain/right jaw is the one hurting on 22Feb2021 with outcome of unknown, uncomfortable swallowing, swollen lymph nodes, especially on the left side , He had some sinus issues, feels like if he had temporomandibular joint syndrome on an unspecified date with outcome of unknown. Therapeutic measures were taken with Tylenol and Ibuprofen as a result of jaw pain/right jaw is the one hurting (pain in jaw), uncomfortable swallowing (dysphagia), swollen lymph nodes, especially on the left side (lymphadenopathy)  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Nausea, Pyrexia, Suspected COVID-19
Clinical narrative: I got nauseated and was not feeling good; little bit fever/fever 102.6; was not feeling good; I feel like I got COVID again; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6202, expiration date unknown)  via an unspecified route of administration administered on an unspecified date as 1st dose, single for covid-19 immunization. Medical history included covid-19. The concomitant medications were not reported. On an unknown date, patient stated that,  I had my second vaccine yesterday the Pfizer and on the first one I got nauseated and was not feeling good and little bit of fever and I told them about it. I just need to know what to do. I have fever 102.6 and I feel nauseated. I felt like I got COVID again and I know I don't but it gave me that feeling. On an unknown date, the patient underwent lab tests and procedures which included body temperature which result showed fever 102.6 (unit not provided). The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral herpes
Clinical narrative: 2 days after vaccine administration. Swollen upper lip with a fever blister; 2 days after vaccine administration. Swollen upper lip with a fever blister; This is a spontaneous report from a contactable consumer (patient).   A 65-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6209), via an unspecified route of administration in the Arm right on 23Feb2021 at 13:45, as a single dose for COVID-19 immunisation. The patient allergic to penicillin, macrodantin and morphine. The patient's concomitant medications included verapamil hydrochloride (VERAPAMIL [VERAPAMIL HYDROCHLORIDE]) 180 mg for unspecified indication (start and stop date were not reported).  Historical vaccination included Flu shot and Pneumonia shot in the Right arm on 29 Jan 2021. The patient did not test for COVID-19 after vaccination. On 25Feb2021 at 06:00, the patient experienced 2 days after vaccine administration swollen upper lip with a fever blister. The patient did not receive any treatment for the events. All the events were non-serious. The outcome of all the events was recovered on an unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2; Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown) on an unspecified date as first dose for covid-19 immunization. On an unspecified date, after vaccination the patient felt tired. It was reported that a female patient was unable to exercise the day following her second covid-19 vaccine dose because she was extremely tired. She indicted she felt better the next day. Reporter was not comfortable in a setting with 20 other people to ask for details (nor was it appropriate), so unsure that which brand she received. Many other attendees chimed in to give details of their friends /family members experience with covid-19 vaccine. They indicated that the second dose caused more AEs and that they felt it was worse if the person had been previously infected with the covid virus. None indicated the brand received. Reporter had no further details to provide. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: temporary delayed loss of taste; This is a spontaneous report from a contactable physician. A 67-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in left arm on 25Jan2021 at 19:00 (Lot number EL3247, Expiry date: Unknown) as 1st dose, single dose for COVID-19 immunisation at a hospital. Medical history included COVID-19 (in early November and did not lose sense of taste at that time) and allergic to Toradol. The patient's concomitant medications were not reported. The patient did not receive any other vaccination within 4 weeks and no medications were received within 2 weeks of vaccine administration. The patient was not tested for COVID after vaccine administration. On 03Feb2021, nine days after vaccine administration, the patient lost most of his sense of taste for two days. This was not a serious reaction just a peculiar one. There was no treatment received for the reported event. Outcome of the event was reported as recovered on an unknown date in Feb2021.  Follow-up (04Jun2021): This follow-up is being submitted to notify that follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: temporary delayed loss of taste; This is a spontaneous report from a contactable Physician. This Physician reported for similar events for 4 patients. This report is 4th of 4 reports. This physician reported for a patient of an unknown age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown), via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Patient medical history was reported as COVID-19 positive. Patient concomitant medications were not reported. On an unknown date patient was temporary delayed loss of taste. Outcome of the event was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Muscular weakness, Nervousness
Clinical narrative: weakness/ little weak; legs were shaky; legs suddenly gave out in the kitchen and she could not get up or pull herself up/ severe leg weakness; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 77-years-old female 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 06Feb2021 at 16:30 as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 15Jan2021 for COVID-19 immunization and she was mostly in bed, sleeping for 2 days and felt extremely tired but was ok after resting. On 07Feb2021 at 14:00 the patient reported that her legs suddenly gave out in the kitchen and she could not get up or pull herself up and she had severe leg weakness. Because of her weakness, she stayed on the floor from 14:00 to 21:00. She asked a friend to come over and pull her up and she had to scoot to the backdoor to let her friend in. Her friend was unable to pull her up. About 15-20 minutes after her friend had arrived, her legs were still shaky, but she was able to pull herself up. she could not get up or sit up for 6 hrs and She did not lose consciousness, she tried to reach the fridge handle to pull herself up, could not do it from 2 pm to 9 pm. After that, she drank Gatorade (electrolyte) and ate food because she did not eat anything the whole time she was on the floor. She mentioned that she was weak for 2 days. After a couple of days, she was ok again. She reported that the AEs she experienced for the 2 doses were similar. However, she did not felt weakness since she was sleeping excessively. She said her AEs were so severe that she had to report it. She wanted to know if she could get the Pfizer vaccine if there may come a time that additional doses are needed to be covered for the new strains of the virus. She heard on the news about third shot of Pfizer's vaccine and was wondering if she could receive a third booster shot once it is studied. She also wanted to know if she could switch to another kind of COVID-19 vaccine (like Moderna) after completing the Pfizer COVID-19 vaccine vaccination series. Patient took Gatorade as a treatment for the events. The outcome of all events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.