chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: experienced constipation since; This is a spontaneous report from a contactable consumer (Patient) reporting himself. A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Jul2021 as dose 1, single (at the age of 24-years-old) for covid-19 immunisation. Patients Weight (kg): 69.4 and Height (cm): 160 were reported. The patient medical history and concomitant medications were not reported. Other products, patient history and investigation assessment were not provided. On an unspecified date the patient experienced constipation. It was reported that, since getting the vaccine patient has been unable to go to the bathroom that well. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Spondylitis
Clinical narrative: loose taste/lose taste; cannot smell anymore/lost his smell and cannot smell anymore; Back has been inflamed; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A male 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 06Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced loose taste/lose taste, cannot smell anymore/lost his smell and cannot smell anymore, back has been inflamed on Aug2021. Patient wants to know Is it common to lose taste after the shot or should he get a coronavirus test. The clinical outcome of the event back has been inflamed was unknown while that of the others was not recovered.  Follow-up (09Aug2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that: clinical information is merged and updated with the initial narrative.  Information about lot/batch has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Underdose, Wrong technique in product usage process
Clinical narrative: She states that her partner gave the dose and noticed that part of it went in, but part of it went out of the patient's arm; She states that her partner gave the dose and noticed that part of it went in, but part of it went out of the patient's arm; a fever of 99 F; This is a spontaneous report from a contactable pharmacist. A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in arm on 06Aug2021 (at age of 28-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was a pharmacist who stated that they had a 28 year old male who may not have received a full dose of the bnt162b2 vaccine on (06Aug2021) Friday, and she wanted to know how to move forward with that. She stated that her partner gave the dose and noticed that part of it went in, but part of it went out of the patient's arm and based on the amount of liquid on his arm, they were estimating that it was less than half the dose. On that day, the patient wanted to wait and not get revaccinated. On an unspecified date in 2021, he had a fever of 99 F on Saturday, took Tylenol, and then felt fine on Sunday. Caller stated that with flu vaccines, if less than half the dose was given, they re-administered, so she wanted to double check regarding the covid vaccine. The patient underwent lab tests and procedures which included body temperature: 99 fahrenheit on an unspecified date in 2021. Therapeutic measures were taken as a result of the event fever of 99 f. Outcome of the event fever was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: still has pain at the injection site; continues pain in the arm, not as intense as initially, but still quite painful; This is a spontaneous report received from a contactable consumer (patient).  A 55-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 02Mar2021 (age at vaccination 55-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at an age of 55 years as single dose for COVID-19 immunisation and had no reaction on previous exposure to drug. The patient had still pain in the injection site, continues pain in the arm, not as intense as initially, but still quite painful, it had been 4 months. The outcome of the event was not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Headache
Clinical narrative: had awful headaches and couldn't move from the bed; Couldnt move from the bed; This is a spontaneous report from a contactable lawyer. This lawyer reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The caller stated there was a woman in her building who had the first dose of the Pfizer Covid vaccine and had awful headaches and couldn't move from the bed on an unspecified date and didn't do the second dose. Caller stated they gave her a strong dose of antihistamine before the vaccine. Investigation Assessment was No. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Impaired work ability
Clinical narrative: Neighbor shared that after her son had the 2nd dose, he developed severe symptoms described as "an electric current" constantly running through his body.; may not be able to resume normal activities for a while; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date in May2021, the consumer reported that, after her son had the second dose, he developed severe symptoms described as "an electric current" constantly running through his body. While improving, he is still experiencing symptoms and may not be able to resume normal activities for a while. The reporter classified the events as non-serious and stated the events result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events. The outcome of the events was resolving.  This follow-up is being submitted to notify theta 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.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Headache, Hypoaesthesia, Pain
Clinical narrative: body aches; feeling brain fogginess; losing balance; arm started feeling numb; rashes; massive headache; This is a spontaneous report from a contactable consumer (patient) reported for self.  A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on 22May2021 as dose 2, single for COVID-19 immunization. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unknown date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was lean and healthy diet person. The patient experienced severe symptoms after a day such as massive headache, body aches and rashes, feeling brain fogginess, losing balance and my left arm started feeling numb on May2021, reported that "which they were never happy to me before". The patient believed these symptoms suddenly happened to me after took the shots are related to the effect of the shots. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (17Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: body aches; feeling brain fogginess; losing balance; arm started feeling numb; rashes; massive headache; This is a spontaneous report from a contactable consumer (patient) reported for self.  A patient of an unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on 22May2021 as dose 2, single for COVID-19 immunization. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unknown date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was lean and healthy diet person. The patient experienced severe symptoms after a day such as massive headache, body aches and rashes, feeling brain fogginess, losing balance and my left arm started feeling numb on May2021, reported that "which they were never happy to me before". The patient believed these symptoms suddenly happened to me after took the shots are related to the effect of the shots. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (17Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Swelling, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously took the first dose of BNT162B2, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient took the first Pfizer shot and never had any symptoms or anything. On an unspecified date in 2021 (reported as Friday), patient went to get the shot. The next day, patient had a soreness on left arm where they did it. In the evening, patient felt a little chill. On an unspecified date in 2021 (reported as Sunday), underneath the armpit, patient felt soreness and now it was swollen-up (getting reaction to it). Underneath the armpit, next to chest was swollen-up. The outcome of the events: unknown. Batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed and no further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (friend). A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number and NDC number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Investigation assessment was not provided. The patient medical history and concomitant medication was not reported. On an unspecified date the patient experienced fever. Reported as her friend got their first shot of the  BioNtech Covid 19 vaccine. The day after first dose the patient had started to have adverse reactions. The caller only said he had fever. She  did not provide additional details about the other adverse events.  The patient has had these adverse events since the day after the dose  The clinical outcome of the event was reported as unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Pyrexia, Rash
Clinical narrative: Got a rash on my right calf; small amount of injection site pain; tiredness; fever; feeling unwell; some joint pain; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration on 05Aug2021 20:00 as dose 1, single (at the age of 58 years) for covid-19 immunisation. Medical history included renal disorder, type 2 diabetes mellitus and hypertension. Concomitant medications included furosemide; sacubitril valsartan sodium hydrate (ENTRESTO); dulaglutide (TRULICITY) and rosuvastatin. No other vaccine in four weeks. Other medications received in two weeks were Entresto, Trulicity, Rosuvastatin and Furosemide. No known allergies. The patient did not receive any treatment for the events. Patient not had covid prior and post vaccination. It was reported that, the patient experienced rash on his right calf, small amount of injection site pain, tiredness, fever, feeling unwell and some joint pain other than that he seemed to be ok on 07Aug2021 10:00. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Got a rash on my right calf; small amount of injection site pain; tiredness; fever; feeling unwell; some joint pain; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration on 05Aug2021 20:00 as dose 1, single (at the age of 58 years) for covid-19 immunisation. Medical history included renal disorder, type 2 diabetes mellitus and hypertension. Concomitant medications included furosemide; sacubitril valsartan sodium hydrate (ENTRESTO); dulaglutide (TRULICITY) and rosuvastatin. No other vaccine in four weeks. Other medications received in two weeks were Entresto, Trulicity, Rosuvastatin and Furosemide. No known allergies. The patient did not receive any treatment for the events. Patient not had covid prior and post vaccination. It was reported that, the patient experienced rash on his right calf, small amount of injection site pain, tiredness, fever, feeling unwell and some joint pain other than that he seemed to be ok on 07Aug2021 10:00. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: herpes; This is a spontaneous report from a contactable consumer (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, NDC number was not reported), via an unspecified route of administration, administered in Arm Right on 27Jul2021 (Age at vaccination 28-year-old) as dose 2, single for covid-19 immunisation. The patient did not receive the vaccine administered at military facility. Medical history included ongoing asthma and had since was a child or maybe since she was born. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. Caller, reported on the Pfizer Covid 19 vaccine and who states that she had both shots and has been diagnosed with herpes. She looked online and saw where this could or could not be cause by the vaccine. She would like to know if that was a report side effect or has been reported. She explained that she has been with the same person for the last 5 years.  Healthcare: this was the location the caller got both shots. no phone or email. Caller does not have her card with her, her best friend has it. She does not know when she got the shots or have any product details such as the NDC, Lot, or Expiry. The caller remarks that she has not been able to sleep after getting this news, for the last couple days. She doesn't know the date of the first vaccine but the second was 27Jul2021. The herpes diagnosis was given to her on 05Aug2021. It was explained that she searched online pictures. What happen was she had what looked like a little cut on her vulva, so they just tested that and it came back positive. She had no blister, itching, or burning; nothing like she saw when she searched online for herpes. She had no treatments, she got hasn't gotten blood or urine test at this point. The patient did not had any emergency room/ physician office visit. The patient did not receive treatment for the adverse event. The reporter (health authority) considered the events as non-serious. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. On 05Aug2021, the patient underwent lab tests and procedures which included Genital herpes was resulted as positive. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: vaguely sore arm; This is a spontaneous report from a contactable consumer (patient) reported for self. A 76-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), 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. The patient's medical history and concomitant medications were not reported. The patient experienced vaguely sore arm on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: exhausted all the time/Tired all the time; difficulty walking; This is a spontaneous report from a contactable consumer. A 66-years-old male patient of an un-specified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm (anatomical Location of Administration of Pfizer vaccine considered as suspect) on 29Mar2021 at 13:30 (at the age of 66-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing multiple sclerosis. Patient was going to schedule for rehab due to the reaction patient had. Patient did not put it together at first until the day be-fore yesterday that this could be due to the vaccine. Concomitant medications included carbamazepine (CARBAMAZEPINE) taken for pain medication and fampridine (AMPYRA) (Lot-05399A Expiry- 2023) taken for multiple sclerosis and ever since taking he was 100%, start and stop date were not reported. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection) as dose 1, single on 08Mar2021 (at the age of 66-years-old) for COVID-19 immunization. Patient was on a diet. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations were not available. Additional vaccines administered on same date of the Pfizer suspect reported as none. No prior vaccinations (within 4 weeks). Patient tried to get the Flu shot which gets every year and they would not give it to patient. No adverse events following prior vaccinations. Two weeks later clarified as two to three weeks after getting the second dose of the Pfizer vaccine clarified event that occurred as patient was tired all the time. It was to the point patient could not do anything. Patient could walk around, but not as far. Patient was limited to where he could go. It was never like this before with Multiple Sclerosis. Patient spoke with his MS doctor and the doctor said it could be the vaccine. Up until a month ago even with MS and wearing a leg brace everything was fine. Within a couple of weeks was using a leg brace. Patient was limited to do anything. Patient did not put it together until yesterday that it could be the vaccine. Patient had no problems for a long time. Patient felt normal, then all of a sudden, boom. Adverse event on the COVID-19 Vaccine. Patient had a history of multiple sclerosis and after getting the vaccine patient had been very very tired. Patient has been tired all the time. It was to the point patient could not do anything. patient could walk around, but not as far. Patient was limited to where patient could go. It was never like this before with Multiple Sclerosis. Adverse events did not require a visit Emergency Room/Physician Office. Patient has an appointment scheduled. The outcome of the events were unknown.   The lot number was not provided. Information on lot number has been requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Intervertebral disc protrusion
Clinical narrative: chronic back pain due to a ruptured disc in his back.; chronic back pain due to a ruptured disc in his back.; This is a spontaneous report from a contactable consumer (patient himself) Pfizer-sponsored pro-gram. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 07Jul2021 (age at vaccination: 62-years) as dose 1, single for covid-19 immunisation. Patient had his second Pfizer Covid 19 Vaccine scheduled for 42 days after first dose, on 18Aug2021. Concomitant medications included Oxycodone, which patient took for a medical condition, and if he does not take it, he suffers from pain. He read some information that a person was not supposed to take Tylenol, surrounding the time that the person is getting the vaccine. On an unspecified date, patient experienced chronic back pain due to a ruptured disc in his back. The outcome of event was unknown.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer via Pfizer- sponsored Program. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Aug2021 patient experienced fever after getting the 1st dose of the covid-19 vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye irritation, Movement disorder, Pain in extremity, Tremor
Clinical narrative: his arm is currently sore and he can't move it.; his arm is currently sore and he can't move it.; his eyes are burning and his body is shaking; his eyes are burning and his body is shaking; dizzy; This is a spontaneous report from a Pfizer sponsored program contactable consumer or other non hcp male consumer (patient). A male patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 30Jul2021 as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced his arm is currently sore and he can't move it, his arm is currently sore, and he can't move it, his eyes are burning, and his body is shaking, his eyes are burning, and his body is shaking, dizzy. Treatment received was unknown. Medical information were any medical questions addressed by this program forwarded or referred to medical Information was no. The outcome of the events experienced his arm is currently sore and he can't move, his arm is currently sore, and he can't move it, his eyes are burning, and his body is shaking, his eyes are burning, and his body is shaking, dizzy in 2021 was unknown.  -Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass, Peripheral swelling, Skin discolouration
Clinical narrative: she has a purple bruise and in the middle is a hard ball/ Has like a bruise, purple stain on her arm; she has a purple bruise and in the middle is a hard ball/ Has like a bruise, purple stain on her arm; She has a purple bruise and in the middle is a hard ball; All around the arm there is swelling on the arm; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on an unspecified date in 2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date in 2021 as single dose for covid-19 immunisation and experienced the adverse events Had a bruise for 7 days and it hurt a lot for several days, swelling on the arm and the first time it was only purple and. Patient reported that she stated that she had no side effects from the second vaccine. She stated that she is now after months after getting the vaccine she has a purple bruise and in the middle is a like a little very hard ball on injection arm and swelling on the injection arm on an unspecified date in 2021. She stated that it occurred all of the sudden and she is really scared because the second dose was a long time ago. The case assessed as non-serious by the reporter. The outcome of the events was reported as unknown.   Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: big welt that lasted about a week; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. The patient's concomitant medications were not reported. The historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient experienced big welt that lasted about a week on an unspecified date. Clinical course was reported as consumer calling about the Pfizer COVID-19 vaccine who says she had a friend post on social media asking about the vaccine to talk about side effects, and most people seemed to have none. She says she doesn't know them, but one person wrote after the second shot they had a big welt that lasted about a week, and she doesn't know if this would be a normal side effect or something. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a bubbly rash on the right side mostly on my arm, inside my elbow, wrist, upper thigh, back of calf.; This is a spontaneous report from a contactable Other HCP (patient) reported for herself that: A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Jul2021 12:00 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 23Jun2021 12:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization(Age at vaccination 53 years). The patient past Medical history was not reported. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were 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. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient experienced a bubbly rash on the right side mostly on my arm, inside my elbow, wrist, upper thigh, back of calf on 20Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: Nasal Swab negative on 04Aug2021. No treatment was received. The event outcome was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability
Clinical narrative: all of joints are in pain/bad joint pain; unable to walk or stand up; This is a spontaneous report from a contactable consumer or other non hcp (patient) communicated to Pfizer sponsored program. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 59-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included knees were in pain before receiving the vaccine. The patient concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 59-year-old), as single for covid-19 immunisation. On an unspecified date in 2021, the patient experienced all of joints were in pain/ bad joint pain and unable to walk or stand up. The clinical details of the events as follows: The patient took both doses in Feb2021 and Mar2021, however after a month and a half, she experienced bad joint pain, was unable to walk, or stand up. Before receiving the vaccine, her knees were in pain. She was also taking Meloxicam prior to getting the vaccine. Now all of her joints were in pain. She needed to take it every day instead of before, she would just take it when her knees were in pain and now needed it every day. She wanted to know if there had been any complaints with the same scenario as hers. She just had a general inquiry. She did not want to make any problems. After receiving the vaccine, it was suddenly like in the morning when she woke up, she was fine and after 1 hour, she just started to walk and could not stand up the pain was on both knees. Patient was taking Meloxicam before getting the vaccine only when her knees were hurting her. Now, she has to take it every day. She had an appointment with her doctor on unspecified date on Friday and maybe she would do blood test or give stronger pain medication. She stated she did not want to take Meloxicam every day as she is now. She did not wish to create report. Investigation Assessment was not Provided. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling, pins and needles sensation from their hip to their toes on injection side; This is a spontaneous report from a contactable pharmacist. A 37-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 05Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Aug2021, patient experienced tingling, pins and needles sensation from their hip to their toes on injection side. Pharmacist did not provide specific date or time. No injection site issues noted. Pharmacist verifies that patient has an appointment tomorrow morning with Primary Care Physician and is currently seeing a Chiropractor. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This contactable Pharmacist reported for a male patient. A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 10Aug2021 the patient experienced he developed bumps yesterday. Reporter stated a patient had a reaction to the Pfizer COVID vaccine after receiving the vaccine on Monday, 09Aug2021. Reporter stated he developed bumps yesterday, 10Aug2021 on his injection arm from the elbow to his wrist, but not at the injection site. The red bumps are not itchy nor hurting, but it's just there. Reporter is wondering if this has ever been reported. Escalated as reporter wants to know if there have been specifically any reports of bumps that is not at the injection site but in the injection arm from the elbow to the wrist. Sent reports of allergic reactions and anaphylaxis SRD. Outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain, sore arm after first vaccine; This is a spontaneous report from a contactable other Health Care Professional (Nurse).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date  the patient experienced arm pain, sore arm after first vaccine .The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Headaches went away after receiving the vaccine/his neck muscles are not that tight anymore and he hasn't gotten the headaches; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included high cholesterol, blood pressure high and severe migraine headaches and tension headaches (used to get them every 2-3 days) from an unknown date and unknown if ongoing. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified start date and ongoing and nebivolol hydrochloride (BYSTOLIC) taken for blood pressure high from an unspecified start date (taking for 15 years) and ongoing. Patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Physician stated that he used to get severe headaches for 30 years and since he got the Covid vaccine his headaches have gone away. He stated that he has gotten both doses of the covid vaccine but doesn't remember the dates and stated that the headaches went away right away after getting both doses of the vaccine. He got the 1st dose within the first couple of weeks after it came out because he is a physician. He stated that he had severe migraine headaches and tension headaches and he used to get them every 2-3 days, but since he got the vaccine his neck muscles are not that tight anymore and he hasn't gotten the headaches. States that he has noticed the neck muscles but it's not that much different, it's mostly the headaches that are the biggest difference. He also mentioned that he has been on the concomitant medications for many years and was getting the headaches while taking them. The only thing that has changed recently was that he got the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable other health care professional (Nurse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient only had a sore arm, nothing else. The outcome of event was unknown.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nervousness
Clinical narrative: bad headache; nervous; This is a spontaneous report from a contactable consumer (Patient). A 23-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 23-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC, 2.5mg once a day) taken for anxiety from an unspecified start date and ongoing, has been taking for maybe 8 or 9months. No additional Vaccines Administered on Same Date of the Pfizer Suspect: No prior vaccinations within 4 weeks, no AE(s) following prior vaccinations. On an unspecified date in Apr2021, the patient experienced bad headache, nervous. No treatment received for bad headache. It was reported that with the new variant, his family convinced him to get the second one, which was last Tuesday. Headache after first dose: Was maybe 3 hours later and lasted for 2 days. The patient underwent lab tests and procedures which included blood test: on 2021 Had blood drawn 2 months ago at the doctors, there was nothing serious that came up. The outcome of event (nervous) was unknown, the outcome of event (bad headache) was not recovered.  Information on the lot/batch number has been requested.  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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: The caller is feeling a tingling in the body.; The caller states the tingling is over the legs, felt in the head and arms, little sensations; This is a spontaneous report from a contactable 48-year-old female consumer reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 30Jul2021, it was afternoon, after 17:00 (at the age of 48 years old) as single for covid-19 immunisation. Medical history included Pre-diabetic from 27Jul2021 and ongoing, high blood sugar from 27Jul2021 and ongoing. She had blood work done on 27Jul2021, three days prior to receiving the first dose Pfizer Covid Vaccine. The blood work reported the caller had high blood sugar and was pre-diabetic. There were no concomitant medications. She was a consumer calling to report side effects from the Pfizer Covid 19 Vaccine. On 01Aug2021 patient experienced feeling a tingling in the body. She stated she had one of the unusual side effects and its been like a week and a half ago the she received the first dose Pfizer Covid 19 Vaccine. She was feeling a tingling in the body. She stated the tingling was over the legs, felt in the head and arms, little sensations. She stated this began 01Aug2021, two days after receiving the first dose Pfizer Covid 19 Vaccine. She was still feeling little things but not as much as before. She stated she has only received one dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine. The patient did visit physician office. She stated she did not go to the emergency room and she stated she called her doctor's office. The outcome of events was recovering.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable other health care professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.) as dose 1, single on 10Feb2021 for COVID-19 immunization. Patient was healthy and had not been COVID positive. Patient would like to join a trial for booster doses of these vaccines. On 03Mar2021, the patient experienced sore arm. The outcome of the event was recovered on 04Mar2021.   The lot number was not provided. Information on lot number has been requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches; so tired I can hardly get out of bed.; This is a spontaneous report from a contactable 69-year-old female consumer reported for herself. A 69-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3180) via an unspecified route of administration, administered in Arm Left on 06Aug2021 13:00 as DOSE 1, SINGLE (at the age of 69-year-old) for covid-19 immunisation. Medical history included drug hypersensitivity, ongoing known allergies: Sensitive to myacins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received blood pressure meds acid reflux and thyroid med within 2 weeks of vaccination. On 07Aug2021 at 09:00, patient experienced headaches and felt so tired that she can hardly get out of bed. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jun2021. Patient did not received any treatment for events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash, Rash papular, Speech disorder, Vaccination site rash
Clinical narrative: dizziness; difficulty of talking; rash at the injection site; Rash on her arm/round, dot, like a quarter size rash; rash has a little bump or a minimal bump and that it wasn't that big but not a flat one and that it was like a "red dot."; This is a spontaneous report from a contactable consumer (Husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 03Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jul2021, the patient experienced dizziness, difficulty of talking, on an unspecified date in Jul2021 rash at the injection site, rash on her arm/round, dot, like a quarter size rash, rash has a little bump or a minimal bump and that it wasn't that big but not a flat one and that it was like a red dot. Patient received the first dose of the Pfizer Biontech COVID19 vaccine on 3 Jul 2021. Caller said that his wife experienced dizziness and difficulty of talking that lasted for seconds or a minute or two. Caller mentioned that when he was with her, he did not notice anything. Caller also added that his wife had a rash at the injection site which lasted longer. Caller described the rash as round, dot, like a quarter size rash on the arm. In addition to that, caller said that the rash has a little bump or a minimal bump and that it wasn't that big but not a flat one and that it was like a red dot. Caller stated that it took a couple of weeks to fade out. Caller was asking if his wife can still get the second dose of the Pfizer Biontech COVID19 vaccine since her first dose was on 3 Jul 2021 and has been more than 21 days. The event dizziness and difficulty of talking was recovered on 03Jul2021 and all other events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.