chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia, Vitamin D
Clinical narrative: And is experiencing a fever of 102.5/temp is 102; Doesn't feel good; This is a spontaneous report from a contactable consumer (Caregiver). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in right arm on 17Jun2021 as 2nd dose, single (at the age of 15-years-old); and previously received BNT162B2 (Lot/batch number: ER8733), dose 1 via an unspecified route of administration in right arm on 27May2021(at the age of 15-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included MELATONIN 10 mg, gummy, one at night. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no family medical history relevant to adverse event (AE). On 18Jun2021 12:00 (Today, around noon), patient doesn't feel good and experienced fever of 102/102.5. It was reported patient received Tylenol last about 15 minutes after temperature measurement. Patient had laboratory test included Vitamin D and some kind of hormone: Vitamin D is within normal limit on unknown date; and body temperature on 18Jun2021: 102/102.5. Therapeutic measures were taken as a result of events with Tylenol. The outcome of events was recovered on an unspecified date in Jun2021.  Information on the lot/batch was available, Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Sciatica, Vaccination site discomfort, Vaccination site erythema
Clinical narrative: Sciatic Pain; Injection site is very red and feels like she has 5 different beestings in her arm; Injection site is very red and feels like she has 5 different beestings in her arm; Coughing up phlegm; Fever of over 100 degrees; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 56-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. The patient medical history was not reported. The concomitant medications of the patient included risdiplam, loratadine, ursodiol, colecalciferol (REPLESTA), l-methylfolate and salbutamol sulfate (PROAIR), all taken for an unspecified indication, start and stop date not specified. On an unspecified date the patient experienced sciatic pain, injection site is very red and feels like she has 5 different bee stings in her arm, coughing up phlegm and fever of over 100 degrees. The patient underwent lab tests and procedures which included fever of over 100 degrees. The outcome of all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Computerised tomogram, Diarrhoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0168 and expiry date was not provided), via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes. Concomitant medications included metformin, pravastatin, losartan and glimepiride. Patient received first dose of BNT162B2 (at age of 52-years-old) for COVID-19 immunization and no reaction on previous exposure to vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination included metformin, pravastatin, losartan and glimepiride. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 03May2021, patient experienced chills, diarrhea, nausea, vomiting, headache, abdominal pain. The adverse event result in visit to emergency room/ department or urgent care. Patient was hospitalized due to events. Treatment received was Sueros, zofran, lactic acid, CT Scan, promethazine. Lab test included CT Scan: unknown. The outcome of all events was recovered. Follow-up attempts are possible. Further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0168 and expiry date was not provided), via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes. Concomitant medications included metformin, pravastatin, losartan and glimepiride. Patient received first dose of BNT162B2 (at age of 52-years-old) for COVID-19 immunization and no reaction on previous exposure to vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination included metformin, pravastatin, losartan and glimepiride. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 03May2021, patient experienced chills, diarrhea, nausea, vomiting, headache, abdominal pain. The adverse event result in visit to emergency room/ department or urgent care. Patient was hospitalized due to events. Treatment received was Sueros, zofran, lactic acid, CT Scan, promethazine. Lab test included CT Scan: unknown. The outcome of all events was recovered. Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypermetropia, Myopia, Visual impairment
Clinical narrative: vision problems; nearsightedness; farsightedness; This is a Spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 09Jun2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and no reaction with first dose. On 10Jun2021, patient experienced vision problems. Her nearsightedness has been affected & her farsightedness has also been affected. She reported blurred vision by the end of the day. Event took place after use of product. The outcome of the events was unknown.    Information about Lot/batch number has been requested.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Carbon dioxide normal, Dizziness, Dizziness postural, Insomnia
Clinical narrative: dizziness, Light-headed; I feel like when I walk for sometime or when I stand up I feel that I have to sit and I am feeling that things are moving; Sleeplessness; This is a spontaneous report from a contactable consumer (patient). A 32-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EW0183 and expiration date was not reported), dose 2 via an intramuscular route of administration, administered in arm right on 13Jun2021 at 16:00 (last Sunday) as 2nd dose, single (age at vaccination was 32 years) for COVID-19 immunization. No medical history and concomitant medications were reported. Previously patient received of bnt162b2 first dose (lot number was EW0178 and expiration date was not reported) for COVID-19 immunization on 25May2021. The other vaccines were not reported. The patient experienced dizziness, light-headed, "I feel like when I walk for sometime or when I stand up I feel that I have to sit and I am feeling that things are moving", and sleeplessness on an unspecified date. The clinical course of the narrative was reported as: the patient had taken this Pfizer COVID 19 BioNTech vaccine last Sunday, it was good done Sunday, Monday, and Tuesday from Wednesday, the patient started feeling dizziness, little dizziness, the patient thought it was due to sleeplessness and something so patient managed Wednesday and it was there yesterday and it was, the patient still feeling it today (as reported) as well. So, patient felt like when patient walk for sometime or when patient stand up and felt that patient had to sit and patient was feeling that things were moving and this kind of things patient could say light headed or something. The patient said that already had asked for a PCP (primary care physician since 01May and it had been one and half month now and there had not been anyone assigned to her. The patient inquired ant tablet or pill that patient should had it. The patient wanted to take some support either a wall or any nearby feeling those kind of and patient had verified CO2 percentage and the BP (blood pressure) those were all normal but not sure why patient was feeling dizziness. The events persisting, patient mean from these four days only the earlier days were no such symptoms happening. Reporter seriousness for the events was reported as unspecified. The outcome of the events was not resolved.  Follow-up attempts are possible. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Accident, Malaise
Clinical narrative: Recently had an accident; Not feeling very well; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (reporters uncle).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as FIRST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. As per report it was reported that the patient was scheduled to take 2nd dose of covid vaccine but just recently had an accident. The patient was not feeling very well after visiting the hospital. The reporter would like to know if appointment can be rescheduled. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Viral pharyngitis
Clinical narrative: Viral sore throat; Complete loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9265) via an unspecified route of administration in the left arm on 16Feb2021 at 13:00 (at the age 76-year-old) as a single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left arm on 19Jan2021 at 13:00 (at the age 76-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced viral sore throat and complete loss of taste on 14June2021 at 15:00. The clinical outcome of the events viral sore throat and complete loss of taste was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Somnolence, Vomiting
Clinical narrative: vomited; She developed a fever that night through morning of 12Jun2021; She was lethargic; slept for 2 days; This is a spontaneous report received from a contactable consumer. A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, Lot number: unknown), via an unspecified route of administration on 10Jun2021 at 12:00 (at the age of 14-years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 14-years) as single dose for covid-19 immunisation and had no reaction on previous exposure to vaccine. On 10Jun2021 at 12:00, the patient received second shot and developed a fever that night through morning of 12Jun2021. On an unspecified date in Jun2021, the patient was lethargic and slept for 2 days. On 11Jun2021, the patient vomited. Event took place after use of product. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Illness
Clinical narrative: 2 strokes back to back; She got sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 14:18 (Batch/Lot Number: EN0207) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient had 2 strokes back-to-back. The patient wanted to let know what happened after her Covid vaccine shot on 18Mar2021. She had 2 strokes back to back. She had to fly out of where she lives, and there were really bad things wrong with her. It was reported that the patient had one dose of the vaccine, and then she got sick. She was there that previous Friday evening, but she didn't make it because she got sick and had that stroke. She had the shot at 1418 at a drive thru at the hospital. She was in the hospital in (withheld) for 5 days. They brought her back and she went to rehab for 6 weeks. She had a breathing tube and it has been awful. She was just now getting to where she could walk. Her left side was affected. She had been through heck and back. She was perfectly healthy and doesn't remember what happened. She wanted to know what Pfizer was going to do about her side effects after the Covid vaccine. She had all of her records of what happened. She had been out so much money. She said her husband could take her to (withheld), but the doctor said no she needed to fly. She couldn't open her mouth or talk or eat. She is working hard and in rehab. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Pyrexia
Clinical narrative: Horrific joint pain; fever; headache; dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0180) via an unspecified route of in the left arm on 15Jun2021 at 1215 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not included. The patient past drug history included sulfa drugs (MANUFACTURER UNKNOWN) for an unspecified indication. No other medications were received by the patient 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 positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0186) via an unspecified route of in the left arm on 21May2021 at 1715 as a single dose for COVID-19 immunisation. On 15Jun2021, the patient experienced horrific joint pain, including fingers and toes, fever, dizziness and headache. For the events patient took ibuprofen (MANUFACTURER UNKNOWN) and tylenol (MANUFACTURER UNKNOWN) as treatment. The clinical outcome of the events horrific joint pain, fever, dizziness and headache were 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: Rash
Clinical narrative: Developed a dark rough patch on my inner right arm near the elbow and a second smaller patch farther up on the inner right arm.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the left arm on 22Apr2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 03May2021 at 20:00, the patient developed a dark rough patch on inner right arm near the elbow and a second smaller patch farther up on the inner right arm. The clinical outcome of the dark rough patch on inner right arm near the elbow and a second smaller patch farther up on the inner right arm was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Investigation, Nausea, Pain in extremity
Clinical narrative: Low-grade fever; fatigue; headache/nausea; headache/nausea; sore arm; red mark about a half-dollar side; red mark about a half-dollar side with itching for 2 days post-2nd dose; This is a spontaneous report from a non-contactable consumer via sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. Patient medical history included obese, depression and anxiety. Concomitant medications included multiple unspecified herbal remedies for depression and anxiety. No prescription medication. She did not medicate when side effect occurred with either OTC pain relievers or any other alternative remedy. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and no reaction on previous exposure to vaccine. The patient experienced several side effects with 2nd dose of BNT162B2. The patient experienced low-grade fever for 12 hours, fatigue, and headache/nausea. She also had sore arm and red mark about a half-dollar side with itching for 2 days post-2nd dose. The reporter stated no lingering remaining side effects. Outcome of the events was unknown. No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Low-grade fever; fatigue; headache/nausea; headache/nausea; sore arm; red mark about a half-dollar side; red mark about a half-dollar side with itching for 2 days post-2nd dose; This is a spontaneous report from a non-contactable consumer via sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. Patient medical history included obese, depression and anxiety. Concomitant medications included multiple unspecified herbal remedies for depression and anxiety. No prescription medication. She did not medicate when side effect occurred with either OTC pain relievers or any other alternative remedy. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and no reaction on previous exposure to vaccine. The patient experienced several side effects with 2nd dose of BNT162B2. The patient experienced low-grade fever for 12 hours, fatigue, and headache/nausea. She also had sore arm and red mark about a half-dollar side with itching for 2 days post-2nd dose. The reporter stated no lingering remaining side effects. Outcome of the events was unknown. No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: radiating to shoulder blade and up the left side; shoulder joint pain; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an  unspecified route of administration in the left arm on 01May2021 at 13:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation and patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0182) via  an unspecified route of administration in the left arm on 24May2021 at 14:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, GBS, IGA deficient and  atrial fibrillation. Concomitant medication included Nexium (MANUFACTURER UNKNOWN), Losartan (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date. 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 didn't  received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 02May2021 at 5:30, patient experienced shoulder joint pain. On an unknown date, patient had radiating pain. Its reported that the next day, resulted in shoulder joint pain after the first shot. Almost 8 weeks after the first dose and pain had not gone away. In fact the joint pain had gotten worse in the left shoulder and radiating to shoulder blade and up the left side of the neck. The clinical outcome  of the event of  shoulder joint pain was not recovered while outcome of radiating pain was unknown. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Muscular weakness, Pain in extremity
Clinical narrative: feeling some pain on my right leg; gradually I feel some weakness on my legs and its increasing; feel some dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as 2 ND DOSE, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date It was reported that after receiving the second shot of vaccine patient stated that he/she experienced some pain on right leg, some and gradually felt some weakness on legs and it was increasing and lately felt some dizziness. Patient went to doctor who told patient to do a blood chemistry and on an unknown date. The patient underwent lab tests and procedures which included blood chemistry which result showed that everything seems to be normal and hence doctor told patient to report this experience to Pfizer. The outcome of the events was unknown.  Follow up needed; Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his neck and his face and is raised up; This is a spontaneous report from a contactable consumer (grandparent) reported for a 15-year-old male patient (grandson). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/lot number was not reported) via an unspecified route of administration in the arm left on 16Jun2021 04:15 as unknown, single for COVID-19 immunisation. The patient medical history included allergies and sinuses. Concomitant medications included loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported and consumer stated it as a mood stabilizer; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. Consumer stated, he was taking a SSRI. (Later clarified as Lexapro) and asked, whether lot number is, is it EW01. On 16Jun2021 at around 4:15, yesterday, Wednesday, his grandson had the Pfizer COVID shot (Pfizer COVID-19 Vaccine). On 18Jun2021, a day after vaccine administration he experienced a rash on his neck and his face and is raised up and stated, this is probably a reaction not a side effect. It started to appear at around 11 AM clock right when I woke up in the morning and it remained the same still tonight. There is a difference in reaction and the reaction is worse. And asked is this normal to have a rash around the neck and face. No treatment was received. The clinical outcome of the event was not resolved.  Information regarding the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Pulmonary pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid test; tested positive for Covid test; had severe chest pains; right lung pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 05Feb2021 17:00 (Batch/Lot number was not reported) as dose 1, single and then on 25Feb2021 17:00 (Batch/Lot number was not reported) as dose 2, single, all at the age of 50-year-old for covid-19 immunization. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe chest pains and right lung pain the day after 2nd shot (26Feb2021). The patient was tested positive for Covid test on 16Jun2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. The patient underwent lab tests and procedures which included tested positive for Covid test on 16Jun2021. The outcome of events was not recovered.  Information on the Lot/Batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Back pain, Muscle spasms
Clinical narrative: Lower down bad ache; Muscle cramp one on my leg; Weakness; Arm ache not at the shot but right the down lower/both of my arm aches real bad; Muscle cramp one on my leg and one on my stomach; I do have a 'dental sleep' issue; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient)   A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 02Jun2021 1:30 pm (at the age of 67-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history includes migraine and anxiety. Patient family history reported as nothing or weakness. Concomitant medications include sumatriptan succinate (IMITREX) for migraine headache, clonazepam (KLONOPIN) for anxiety, calcium, colecalciferol (CALCIUM + D3) for normal things. Patient historical vaccine includes flu short for influenza immunization on an unspecified date, shingles shot and pneumonia shot for immunization on unspecified dates. Patient did not received other vaccine 4 weeks prior to Covid-19 vaccination. On an unspecified date in Jun2021 after the vaccination, the patient experienced lower down bad ache, muscle cramp one leg and stomach, weakness for two and half weeks, arm ache not at the shot but right the down lower and dental sleep. It was stated patient did not do any exercise but lower down her ache was very bad and 3 days later she had a muscle cramp one on my leg and one on her stomach, she had weakness and she was going on two and a half weeks now, there was a muscles cramp in her stomach area and in her leg and I had arm ache not at the shot but right the down lower at her arms and she had general weakness right now and she had this for two and a half weeks getting ready for my second shot on 26Jun2021." She had a 'dental sleep' issue. Treatment options patient took include aspirin or NSAID just diclofenac sodium topical get lidocaine (2%) and "bupivacaine" (further not clarified) (1%), the lotion I had for muscle pain. Consumer stated, she had weakness, lying on bed and trying to get best immune system that would really help better, she doesn't have any shortness of breath, just curious if someone experienced weakness or any felt like in the arm. The events assessed as non-serious. The outcome of the events pain, muscle spasm, abdominal pain and sleep disorder was unknown. The outcome of event asthenia was not recovered, pain in extremity was recovered on Jun2021 and unknown for all other events.  No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Lower down bad ache; Muscle cramp one on my leg; Weakness; Arm ache not at the shot but right the down lower/both of my arm aches real bad; Muscle cramp one on my leg and one on my stomach; I do have a 'dental sleep' issue; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient)   A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 02Jun2021 1:30 pm (at the age of 67-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history includes migraine and anxiety. Patient family history reported as nothing or weakness. Concomitant medications include sumatriptan succinate (IMITREX) for migraine headache, clonazepam (KLONOPIN) for anxiety, calcium, colecalciferol (CALCIUM + D3) for normal things. Patient historical vaccine includes flu short for influenza immunization on an unspecified date, shingles shot and pneumonia shot for immunization on unspecified dates. Patient did not received other vaccine 4 weeks prior to Covid-19 vaccination. On an unspecified date in Jun2021 after the vaccination, the patient experienced lower down bad ache, muscle cramp one leg and stomach, weakness for two and half weeks, arm ache not at the shot but right the down lower and dental sleep. It was stated patient did not do any exercise but lower down her ache was very bad and 3 days later she had a muscle cramp one on my leg and one on her stomach, she had weakness and she was going on two and a half weeks now, there was a muscles cramp in her stomach area and in her leg and I had arm ache not at the shot but right the down lower at her arms and she had general weakness right now and she had this for two and a half weeks getting ready for my second shot on 26Jun2021." She had a 'dental sleep' issue. Treatment options patient took include aspirin or NSAID just diclofenac sodium topical get lidocaine (2%) and "bupivacaine" (further not clarified) (1%), the lotion I had for muscle pain. Consumer stated, she had weakness, lying on bed and trying to get best immune system that would really help better, she doesn't have any shortness of breath, just curious if someone experienced weakness or any felt like in the arm. The events assessed as non-serious. The outcome of the events pain, muscle spasm, abdominal pain and sleep disorder was unknown. The outcome of event asthenia was not recovered, pain in extremity was recovered on Jun2021 and unknown for all other events.  No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Eructation, Nausea
Clinical narrative: felt like she had been hit by a two by four in her lumbar; dizzy; Nauseous; Burping; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6205 and Expire Date: unknown) via unspecified route of administration in left arm on 04Mar2021 as 1st dose, single (at the age of 49-years-old) for COVID-19 immunisation. Vaccination was not administered at a facility. There was no prior vaccination taken and adverse events taking place within 4 weeks of Covid-19 vaccination. There was no illness at time of vaccination. Medical history included ongoing asthma and anaphylactic food allergies from an unspecified date. Concomitant medications were none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. After vaccination, patient had a strange reaction. On the same day of vaccination, 04Mar2021, she felt dizzy and nauseous which all of this happened a half hour after the shot since the facility made her wait a half hour after because of her history with food allergies. Then she started burping after the first shot and the burping went on for 1 hour or 2 hours. She got the shot in the afternoon and it went on until 8 o'clock at night and it was not one burp it was a lot of burps. It was reported that she does not have a history champion burper in the family. On 25Mar2021, Patient felt like she had been hit by a two by four in her lumbar and stated this stopped 2 or 3 days after. Patient took Advil for her back pain. Patient did not visit emergency room and physician's office. The patient did not undergo any relevant tests. No Investigation Assessment. The outcome of event for dizziness and nausea was recovered on 04Mar2021, and burping and back pain on an unspecified date in Mar2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Eructation, Nausea
Clinical narrative: dizzy; Nauseous; Burping; felt like she had been hit by a two by four in her lumbar; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727, Expiration date was unknown), via an unspecified route of administration, in left arm, on 25Mar2021 in the afternoon (at the age of 49-years-old), as second dose, single for COVID-19 immunization. The patient medical history included asthma and anaphylactic food allergies and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration, in left arm, on 04Mar2021 in the afternoon (at the age of 49-years-old), as a single dose for covid-19 immunisation. After the first dose patient had experienced dizzy, nausea and burping. Patient received 1st dose because, patient had asthma and everyone should be vaccinated. Patient wants to know if there has been reports of a similar reaction since patient had asthma. The patient did not receive any additional vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not have adverse event prior to the vaccination. Patient did not have any illness at time of vaccination. Patient did not have history champion burper in the family. Patient did not perform any relevant test. Patient did not have history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Patient History and Investigation Assessment. On 04Mar2021, after second shot about a half hour, the patient had dizzy, nauseous, and burping but the burping went on for hours. Patient got the shot in the afternoon and it went on until 8 o'clock at night and it was not one burp it was a lot of burps and patient felt like patient had been hit by a two by four in lumbar and patient had that pain for several days and stopped 2 or 3 days. Facility where the vaccine administered at the military was running it. Patient think, patient did take Advil for patients back. Adverse events didn't require visit to emergency room/physician office. The outcome of the event back pain was recovered on an unknown date in Mar2021 while rest of the events were recovered on 25Mar2021. Reporter seriousness for dizzy, Nauseous, Burping, felt like she had been hit by a two by four in her lumbar was unspecified.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: She had pain at the injection site and a sore arm; sore arm; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced pain at the injection site and a sore arm on an unspecified date after use of product. The outcome of events was unknown.   Information on the Lot/Batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Fatigue; He feels drowsy whenever he wakes up; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187, Expiration date: Unknown), via an unspecified route, administered in Left Arm on 01Jun2021 at 11:00 (52-year-old of age at vaccination) as a 2nd dose, single for COVID-19 immunization. The patient's medical history included mononucleosis from 1996 (he had heard that mono virus remains in a body dormant). He was not fatigue like this since 1996.The patient's family history was reported as none. The patient's concomitant medication was reported as none. The patient was not related to a study or program. Vaccination facility was reported as pharmacy. The patient was not administered with any additional vaccine on same date of the Covid-19 vaccine. The patient was not administered with any other vaccine within 4 weeks prior to Covid-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0168, Expiration date: Unknown), via an unspecified route, administered in Left Arm on 11May2021 at 11:30 (52-year-old of age at vaccination) as a 1st dose, single for COVID-19 immunization. On unknown date in Jun2021, the patient experienced fatigue. He stated that, he still had fatigue. He was not depressed and was eating well. He had a fair amount of daily activity. Two times a day (time not specified by reporter) was whenever it suddenly comes over him, and he takes a nap. He felt drowsy whenever he wakes up, like he was coming off a sleeping pill: Began two or three days after the second dose of the Covid-19 vaccine. It was about the same, but not as strong as two weeks ago. Two hours ago, he fell asleep and took a nap. He took vaccine as he thought it was smart thing to do on a society level. The patient had neither visited physician office nor emergency room. The patient had neither undergone any relevant test and procedure not any investigation assessment. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information had been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigue; He feels drowsy whenever he wakes up; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187, Expiration date: Unknown), via an unspecified route, administered in Left Arm on 01Jun2021 at 11:00 (52-year-old of age at vaccination) as a 2nd dose, single for COVID-19 immunization. The patient's medical history included mononucleosis from 1996 (he had heard that mono virus remains in a body dormant). He was not fatigue like this since 1996.The patient's family history was reported as none. The patient's concomitant medication was reported as none. The patient was not related to a study or program. Vaccination facility was reported as pharmacy. The patient was not administered with any additional vaccine on same date of the Covid-19 vaccine. The patient was not administered with any other vaccine within 4 weeks prior to Covid-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0168, Expiration date: Unknown), via an unspecified route, administered in Left Arm on 11May2021 at 11:30 (52-year-old of age at vaccination) as a 1st dose, single for COVID-19 immunization. On unknown date in Jun2021, the patient experienced fatigue. He stated that, he still had fatigue. He was not depressed and was eating well. He had a fair amount of daily activity. Two times a day (time not specified by reporter) was whenever it suddenly comes over him, and he takes a nap. He felt drowsy whenever he wakes up, like he was coming off a sleeping pill: Began two or three days after the second dose of the Covid-19 vaccine. It was about the same, but not as strong as two weeks ago. Two hours ago, he fell asleep and took a nap. He took vaccine as he thought it was smart thing to do on a society level. The patient had neither visited physician office nor emergency room. The patient had neither undergone any relevant test and procedure not any investigation assessment. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information had been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Unevaluable event
Clinical narrative: six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization with no reaction. Caller stated she read on the internet an article published specifically on 21Apr2021, "A Herpes Infection May Be Linked to the COVID Vaccine" from health.com. The researchers found that six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. The Agency also said that it's triggered by the same virus that causes chickenpox. Caller is asking if she should take a Shingles shot before getting the vaccine. Caller is surprised that we don't have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these and her daughter also experienced it. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Drug screen, Ear pain, Electrocardiogram
Clinical narrative: I have small fiber neuropathy; I have other symptoms; it hurt really bad and I told him to take it out of my arm and he did, but I believe he hit a nerve or something in my arm; Pain in the ears; Headache; Pain you know the fire in my feet and my legs; Heart beats fast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration and administered in left arm on 05Apr2021 (at the age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took the Pfizer vaccine (COVID Vaccine) on 05Apr2021 and she went to the emergency room not long after that and then she went to ask a doctor not long after that and just went to a neurologist. She told that she had small fiber neuropathy (on an unspecified date in Apr2021) and called the Pharmacist at pharmacy where she had the vaccine and told them what had happened. When the man gave her the vaccine it hurt really bad (on an unspecified date in Apr2021). The patient told him to take it out of her arm and he did, but she believed he hit a nerve or something in her arm, pain in the ears, headache, pain you know the fire in her feet and legs, heart beats fast, shot in her left arm, it hurt really bad (on an unspecified date in Apr2021). The patient stated the patient did not take the second vaccine because of this problem. She did not have any of these problems until and after she took the vaccine, whole day 'without any side' effects. The patient was  taking medication, Gabapentin (treatment). She had to go back in two weeks. She did not know why all this was happening. The patient was fine until she took the vaccine. The patient underwent lab tests and procedures which included she took 5 or 6 vials of blood when reporter was there on Thursday, not sure what all she was testing with unknown result. Was in the hospital (further clarification unknown) in April they did do a CBC, Differential Metabolic Panel, Urinalysis, Drug screen, EKG, Chest x-ray. They did all sort of stuff. When reporter went to the (voice not clear) doctor they did an ultrasound on her legs and said that her veins were okay and then the neurologist said that the nerves (incomplete sentence). Therapeutic measures were taken as a result of events with gabapentin take 100 mg three times a day for a week and then (voice not clear) it up to more than that for the second week and more than that for the third week (further not clarified). The outcome of events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021744526 similar report from same reporter