chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Fall, Mobility decreased
Clinical narrative: big bruise on her face; had bad joint problems since my pfizer covid vaccine. It's hard to bend and move; had bad joint problems since my pfizer covid vaccine. It's hard to bend and move; Patient fell; This is a spontaneous report from a contactable consumer (patient's neighbour). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 75-year-old) as 1st dose, single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications included none. Family medical history relevant to events was unknown. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if patient received additional vaccines administered on same date of the Pfizer suspect. On an unspecified date, the reporter stated that patient had joint pain since her Pfizer covid shot. The patient had bad joint problems since pfizer covid vaccine. It's hard to bend and move. The patient fell and was hospitalized. After patient fell down, she had to go to the hospital. The patient falling down, was part of the reason for patient's joint pain. Patient fell and could not get up, and they had to call 911. The reporter thinks it was Feb2021 whenever patient fell down in parking lot. After falling, patient had to go to the hospital. The reporter could not help patient move because of her own shoulder pain after receiving the Pfizer covid vaccine. Reporter explained that to patient, and patient stated she has had joint pain after the covid vaccine too, and that she still has joint pain ever since she fell. Reporter thinks patient fell about two months ago. Reporter does not know dates that patient received either dose of the covid vaccine. Reporter confirms that patient received both doses of the Pfizer covid vaccine. The reporter does not know if patient fell after the first dose, or second dose of the Pfizer covid vaccine. Reporter believes that patient was admitted to the hospital. The patient had a big bruise on her face. The reporter does not know dates of hospitalization. The patient told reporter that she fell and had to go to the hospital. Reporter knows that it was after patient got the covid vaccine. Reporter does not know if it was right after patient received the covid vaccine, or later. Events resulted in emergency room visit. The relevant tests included none. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021642670 Same reporter / drug, different patient;US-PFIZER INC-2021641551 Same reporter/ drug,different patient
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172, Expiration date: unknown) via intramuscular route, administered in Arm Left on 23May2021 around 13-13:30 (at the age of 46-years) as single dose for covid-19 immunization. The patient had no relevant medical history (Further clarified). The patient was not receiving any medications. The patient did not receive other vaccinations within 4 weeks prior to the first administration of the suspect vaccine. The patient's concomitant medications were not reported. Height and weight reported as 5 foot 136 and confirmed height as 130 pounds (further clarified; captured 136 cm as height and 130 pounds as weight). On an unspecified date in 2021, the patient experienced shingles. The clinical course included: on 23May2021, the patient received Pfizer vaccine and believed there was a correlation between the vaccine and the patient was totally trying to blank. She had a received a side effect and was totally blanking it out. She was on medication for it right now. That she had to do was chicken pox (Not further clarified hence not captured in tab) it was called, she doesn't know why she was blanking at. Yes, it was shingles. So, she went to urgent care like five day succeed, five days after and so she had shingles for which she was on medication for and the doctor who told to believe that there was a correlation and so she wants to know what the recommendation is as far as the receiving the second vaccination. When probed for the second shot, she stated, she was not due to take that until the 13th. The patient received treatment with Valaciclovir for shingles. The patient underwent lab tests and procedures which included blood work on yesterday (01Jun2021)- results unknown (Further not clarified). The outcome of the event was unknown.  Follow attempt needed; Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Dizziness, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: Passing out multiple times; Heart stopping for 11seconds; Lightheaded; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 01:15 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient past medical history included high blood pressure, borderline diabetes, penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID. On an unspecified date in Apr2021, the patient experienced lightheaded and passing out multiple times and heart stopping for 11seconds and visited emergency room. Patient was hospitalized for 3 days. Eventually needing a pacemaker. Reported seriousness criteria: Life threatening and Hospitalization. The patient was not diagnosed with COVID-19 prior to vaccination and tested for Covid-19. The patient lab test includes sars-cov-2 test: negative on 27May2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone densitometry, Musculoskeletal discomfort, Somnolence
Clinical narrative: sore shoulder; Shoulder discomfort (Musculoskeletal discomfort); sleepy; This is a spontaneous report from non-contactable consumer via two different programs. A 77-year-old female consumer reported that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) dose 2 via an unspecified route of administration on 08Apr2021 (at the age of 77-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. On 02Apr2021, female patient initiated Tymlos (abaloparatide) 80mcg daily subcutaneous injection, Lot# unknown, for the treatment of osteoporosis.Medical history included , intervertebral disc protrusion from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified) , nerve compression from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified). Surgery from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified), tooth injury from an unknown date and unknown if ongoing. verbatim: Teeth were clear after one year of therapy.  The patient's concomitant medications were not reported. Historical drugs included Fosamax (alendronate sodium) and Forteo (teriparatide). Relevant surgical, social, or substance-usage history was not provided Relevant concomitant medications were not provided. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced dizziness (start/stop date 02Apr2021, duration just a few minutes also reported as less than an hour), product use omission (did not use Tymlos on 08Apr2021) (start/stop date 08Apr2021), and intentional product misuse (took two doses of Tymlos on the same day) (start/stop date 09Apr2021). No treatment was reported. 09Apr2021, patient experienced sleepy and shoulder discomfort (musculoskeletal discomfort). On an unspecified date, patient had sore shoulder. Diagnostic tests included a bone mineral analysis; per patient, results were 3.6 (units not reported). The action taken with Tymlos was dose not changed. The outcome of events was unknown.  Additional information has been requested.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: She said she cannot feel her face at all; She had numbness in her face and her arm; cannot feel her face at all;  left side her face she felt numbness; This is a spontaneous report received from a contactable Pharmacist. A 39-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration, in upper left arm, on 12May2021, as a first dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She said she did not take Prior vaccine within 4 weeks. She does not have any health condition and did not take any like medication. On 12May2021, Pharmacist stated, "So, she reported that she had numbness in her face and her arm after the first vaccine for about two hours. She said she cannot feel her face at all she got her shot on the left side upper arm and then also just left side her face she felt numbness." Pharmacist stated, I do not have lab data information. Pharmacist stated, "I do not know where she got her first vaccine, I do not have any of her first vaccine information because she did not get from us." Reporter seriousness for she had numbness in her face and her arm; cannot feel her face at all; left side her face she felt numbness was reported as unspecified. Outcome of the event numbness in her face and her arm was reported as recovered on n unknown date and outcome of the event cannot feel her face at all was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His arm extremely sore; This is a spontaneous report from a contactable pharmacist. A adult male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation in pharmacy or drug store. Medical history included covid-19 about a year ago and cardiac operation. Concomitant medications included allopurinol, amitriptyline, bumetanide, carvedilol, colchicine, diazepam, glimepiride, lisinopril, loratadine, meloxicam, metformin, methotrexate, metolazone, omeprazole, oxycodone, semaglutide (OZEMPIC), pregabalin, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), plecanatide (TRULANCE), ergocalciferol (VIT D), ursodiol and docusate sodium (STOOL SOFTENER). On an unspecified date, the patient's arm was extremely sore. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hyperhidrosis, Illness, Sensory disturbance, Tremor
Clinical narrative: doesn't feel right leg or left arm; cramps in her stomach; Shaking; Sweating; throwing up; feeling really sick; This is a spontaneous report from a contactable consumer (patients sister). A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number, expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jun2021 at like around 12:30 or 1:00 pm (as reported) as single dose for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. No additional vaccines were administered on the same date of COVID-19 vaccine. The patient medical history and concomitant medications were not reported. Family medical history relevant to AEs was none. Patient was not taking any other products. Patient did not had prior vaccination within 4 weeks. On 02Jun2021 reporter stated that her 14 year old sister got vaccinated yesterday and when she woke up she felt really sick. On 02Jun2021, at 09:00 the patient experienced cramps in her stomach, shaking, sweating, throwing up and has gotten worse. On 02Jun2021, patient reported she felt like she did not feel one of her legs and one of her arms. Clarified that it is the right leg and the left arm. Started about an hour and a half later than the other symptoms, so was around 10:30 this morning and had gotten worse. Patient did not visit emergency room or physician office. No treatment was received for the events cramps in her stomach, shaking, sweating, throwing up, felt like she did not feel one of her legs and one of her arms. When they passed through the place to get the vaccine, they said to get it just in case, for the next school year. Investigation assessment and relevant tests was reported as no. The outcome of events cramps in her stomach, shaking, sweating, throwing up, doesn't feel right leg or left arm was not recovered and the outcome of other event was unknown.    Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: doesn't feel right leg or left arm; cramps in her stomach; Shaking; Sweating; throwing up; feeling really sick; This is a spontaneous report from a contactable consumer (patients sister). A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number, expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jun2021 at like around 12:30 or 1:00 pm (as reported) as single dose for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. No additional vaccines were administered on the same date of COVID-19 vaccine. The patient medical history and concomitant medications were not reported. Family medical history relevant to AEs was none. Patient was not taking any other products. Patient did not had prior vaccination within 4 weeks. On 02Jun2021 reporter stated that her 14 year old sister got vaccinated yesterday and when she woke up she felt really sick. On 02Jun2021, at 09:00 the patient experienced cramps in her stomach, shaking, sweating, throwing up and has gotten worse. On 02Jun2021, patient reported she felt like she did not feel one of her legs and one of her arms. Clarified that it is the right leg and the left arm. Started about an hour and a half later than the other symptoms, so was around 10:30 this morning and had gotten worse. Patient did not visit emergency room or physician office. No treatment was received for the events cramps in her stomach, shaking, sweating, throwing up, felt like she did not feel one of her legs and one of her arms. When they passed through the place to get the vaccine, they said to get it just in case, for the next school year. Investigation assessment and relevant tests was reported as no. The outcome of events cramps in her stomach, shaking, sweating, throwing up, doesn't feel right leg or left arm was not recovered and the outcome of other event was unknown.    Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: non tender, 1-2 inch node supraclavicular, non-tender node above his clavicle after his second dose; This is a spontaneous report from contactable physician from a Pfizer sponsored program.  A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown) via unspecified route of administration in left arm on 26May2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown) via unspecified route of administration on an unspecified date, as 1st dose, single for COVID-19 immunization. On an unspecified date in 2021, the patient developed a non-tender, 1-2 inch node supraclavicular, not painful, non-tender node above his clavicle after his second dose. Reporter wanted to know if it's a common occurrence. Caller stated if this was a common side effect then this information should be publicly provided when getting injection. Caller enquired if this situation was a common occurrence with his age. The outcome of event was unknown.  Information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021641345 same reporter, product and AE, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Migraine, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report form the contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, NDC number and Expiry Date: Unknown) via an unspecified route of administration in left arm on 16Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included autoimmune disorder (diagnosed 35 years ago) and has not been experiencing any symptoms from that just some very minor symptoms very recently. Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Patient had previously received first dose of vaccine (Lot no: EP7534) on 26Mar2021 and had left arm swelling (injection arm) and pain, along with migraines and fatigue which resolved after a week. Immediately the same day as the 2nd dose of the vaccine, the patient had pain in her left (injection) arm/hurting and restricted movement in her left arm. On an unspecified date (after the second dose), patient was extremely tired, very fatigued and had migraines along with pain and swelling in her left (injection) arm. The pain in her arm continued for about 6 weeks. Patient did not remember what got better and what got worse and forgot about it, but the pain never went away. The swelling got better but was not as bad. No treatment was received for the events. Events did not require visit to emergency room or physician office. The outcome of events pain in her left (injection) arm was swelling and hurting and restricted movement in this arm was not resolved while for other events fatigue and migraine was unknown.  Additional information has been requested.; Sender's Comments: Agent, caller is a consumer that reported her side effects after receipt of both doses of Pfizer COVID vaccine, however her question is if she can get further clarification if possible, regarding if she should go have quantitative antibody testing that will tell her if she is protected or not? caller was warm transferred by Agent and caller stated "I got information that I did not understand", caller asked: "How do I know if my second dose worked if I had this side effects?. E-transmitted duplicate AE, caller did not provide additional AE details Response: Responded per documents attached and referred for discussion. Offered to send PRD by email, but caller declined and stated her HCP will have that information. Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller stated from prior INT: "I got information that I did not understand" Caller stated she also did not understand information provided by Agent during this follow-up INT. Response: Referred back to her HCP for specific recommendations and medical advice regarding antibody testing, and offered to email the PRD from response provided in prior Request and Interaction, but caller declined and stated her HCP will have that information.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Still breaking out with psorias; This is a spontaneous report from a contactable consumer, the patient and nurse. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 52-year-old) as 2nd dose, single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ, Manufacturer: PFIZER LABS; Formulation: oral solution), oral from an unspecified date (Batch/Lot number was not reported; Expiration Date: 30Jun2023) to an unspecified date, at 5 mg, twice a day for arthropathic psoriasis. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced morphine (0.5mg/ml P-F) and had drug allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date for covid-19 immunisation. The patient stated she's has been fully vaccine for COVID 19, and still breaking out with psoriasis, meds haven't cleared it up yet. MD aware. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Off label use, Product use issue
Clinical narrative: Patient is currently breastfeeding; Patient is currently breastfeeding; Nodules to left cheek and glabella; This is a spontaneous report from a contactable healthcare professional. A 41-year-old breast feeding female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 30Apr2021 (at the age of 41-year-old), as 2nd dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's past medications included restylane Lyft and restylane L. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 09Apr2021, as single dose for COVID-19 immunization. On 13May2021, 13 days after the second shot, the patient developed nodules to left cheek and glabella. Nodules were palpable but not visible. The treatment medications included Clindamycin and Medrol dose pack. The clinical outcome of the event nodules to left cheek and glabella was not resolved. The clinical outcome of all other events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021647606 Same reporter, different events
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Pain
Clinical narrative: I noticed that my thigh my right thigh about the size of my hand; when I stood up I could feel the pressure like there was some blockage and it hurt to walk; I noticed that my thigh my right thigh about the size of my hand; when I stood up I could feel the pressure like there was some blockage and it hurt to walk; It would get better and it hasn't got any better and it's getting red everyday it's getting darker red; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 56-years-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer BioNtech Covid-19 Vaccine), via an unspecified route of administration, administered in left arm on 18May2021 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included headache. Concomitant medications included ibuprofen (220mg) taken for headache. On 29May2021, the patient experienced i noticed that my thigh my right thigh about the size of my hand; when i stood up i could feel the pressure like there was some blockage and it hurt to walk and it would get better and it hasn't got any better and it's getting red everyday it's getting darker red. Clinical course of the event was reported as I was calling two weeks ago in one day, on 18May2021 I got my first Pfizer BioNtech shot vaccination shot and Saturday morning I noticed that my thigh my right thigh about the size of my hand I had something going on like, when I stood up I could feel the pressure like there was some blockage and it hurt to walk but as I kept walking it was slowly the pain would kind of subside, but I took some aspirin and anyway I waited several days to see if it would get better and it hasn't got any better and it's getting red everyday it's getting darker red, I don't have a health insurance I don't know if it's related to the shot or not but I was just wondering if it's anyway I would go to ER and if somebody could cover the costs that's why I was calling about. The patient took aspirin (200 mg) tablets two each and took two of those on Sunday took like three dosage. The patient further reported that the events have not improved, persisting. At the type of reporting, the outcome of the events i noticed that my thigh my right thigh about the size of my hand; when i stood up i could feel the pressure like there was some blockage and it hurt to walk and it would get better and it hasn't got any better and it's getting red everyday it's getting darker red was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Heart rate increased, Peripheral swelling
Clinical narrative: it was reported that patient experienced: Severe swelling in feet and leg; rapid heartbeat; extreme exhaustion; flare-ups all over body; This is a spontaneous report from Drug Safety and consumer (patient): A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included tocilizumab (ACTEMRA). On 01May2021, it was reported that patient experienced: severe swelling in feet and legs, rapid heartbeat, extreme exhaustion, flare-ups all over body. The outcome of the reported events was unknown.  No further information was reported.Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Actually this is a positive event but did not know how to report a positive event. I had two warts in my right hand...probably more than 10 years. I burned them about 8 years ago but they soon came back; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:15 as single dose for COVID-19 immunization. Medical history included blood cholesterol increased, skin papilloma, I had two warts in my right hand, probably more than 10 years. I burned them about 8 years ago, but they soon came back. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included atorvastatin (ATORVASTATIN) taken for an unspecified indication. The patient previously took azitromicin and experienced drug hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the COVID. It was reported that, actually that was a positive event but did not know how to report a positive event. Patient had two warts in her right hand probably more than 10 years. She burned them about 8 years ago, but they soon came back (28Apr2021). She took the first vaccine and one disappeared and the second one started to fade. She took the second vaccine and two weeks later both were totally gone. She had not done anything different in her life other than this vaccine and had those warts for many years. She could not find any other explanation that the vaccine. The patient had not received any treatment for adverse event. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: swollen eye; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 02Jun2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jun2021, the patient woke up with swollen eye. Something similar had never happened to him and he wants to know if it is something reported with the vaccine. Referred to his physician for treatment recommendation. The outcome of the event was unknown.  Information about lot/batch no has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: had a red patch that was hot around the site; The muscles in her entire right arm are very sore and says that it's painful; had a red patch that was hot around the site; red patch on my arm was just red and hot and hard; The muscles in her entire right arm are very sore and says that it's painful; This is a spontaneous report received from contactable consumer (patient). An 80-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: Unknown), via an unspecified route of administration, administered in upper right arm on 25Feb2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis, Deaf (I am on a 'casting' call phone because I am deaf) and the patient also took Penicillin (I was three years old saved my life). The patient's concomitant medications were not reported. The patient stated that she took lot of medications (unspecified) she had a set of "tremor", it was a long list. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown) in left arm on 04Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient had infusion of Simponi on 04Feb2021 the same day she took first dose of vaccine. No other vaccine was administered prior to first dose of COVID vaccine. It was reported that the patient experienced a side effect after getting the second dose of the Pfizer-BioNTech COVID-19 Vaccine on an unspecified date in 2021. Originally, she had a red patch that was hot around the site in the hand for about two weeks. The muscles in her entire right arm are very sore and said that it's painful when she reached. The entire arm was painful and uncomfortable, and it was getting worse. On an unspecified date in 2021, the patient was recovered from the event "red patch on my arm was just red and hot and hard" and outcome was unknown for the event "the muscles in her entire right arm are very sore and says that it's painful"  Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose fluctuation, Blood pressure fluctuation, Blood pressure measurement, Drug hypersensitivity
Clinical narrative: experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; This is a spontaneous report from a contactable consumer (wife) via medical information team. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunization. Medical history and concomitant were not reported. It was reported that on 17Feb2021 that her husband experienced reaction 2-3 minutes after the vaccine, went to emergency room, now is allergic to all kind of food and medicine and blood pressure and Blood glucose goes up and down. Caller stated she know other people have reported this and also stated that husband's life is changed, can't get back to normal. She wanted to know about this. He had seen multiple doctors, and no one knows what was happened. She wanted to know about any information about doctors or support groups who can treat these symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Food allergy, Hypersensitivity
Clinical narrative: experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; experienced reaction 2-3 minutes after the vaccine. He went to ER, been to ER every other day, now is allergic to all kind of food and medicine. His blood pressure and Blood glucose goes up and down; This is a spontaneous report from a contactable consumer (wife) via medical information team. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunization. Medical history and concomitant were not reported. It was reported that on 17Feb2021 that her husband experienced reaction 2-3 minutes after the vaccine, went to emergency room, now is allergic to all kind of food and medicine and blood pressure and Blood glucose goes up and down. Caller stated she know other people have reported this and also stated that husband's life is changed, can't get back to normal. She wanted to know about this. He had seen multiple doctors, and no one knows what was happened. She wanted to know about any information about doctors or support groups who can treat these symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: his stomach is hurting bad; received the Pfizer Covid vaccine on 29May2021 and subsequently tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient's wife). A 45 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: Unknown), via an unspecified route of administration on 27May2021, as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29May2021, the patient experienced fever and it kept going up to 102, 103, 104 and that went on for two days. Treatment medications included Tylenol and Motrin, but nothing could lower the temperature. Patient was taken to Emergency room, where he was tested positive for COVID on 01Jun2021, therefore he returned home and stayed isolated for 14 days. In the Emergency room, patient was treated with an IV. On 03Jun2021, 7 days after the first shot of vaccine, the patient's stomach was hurting badly. Reporter enquired whether this was the effect of the vaccine shot. The patient underwent lab tests and procedures which included body temperature: going up to 102, 103, 104 on unknown dates in May2021, and SARS-CoV-2 test: positive on 01Jun2021. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested. Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Her daughter's throat started to close; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 55-year-old female patient. (This report is for the first dose)  A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 02Apr2021 (At 55-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.   The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 03Jun2021 and experienced adverse events.   Reporter stated that on 02Ap2021, 5 hours later after receiving the first dose her daughter's throat started to close. Immediately called 911 but 911 mentioned that they she doesn't need an EpiPen. Was not advised to go to the ER. The outcome of the events was unknown.    Follow up information needed, Information related to lot/batch no. has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Vaccination site pain
Clinical narrative: Her head is killing her/ Headache; Headache and woke up with migraine; Arm was very sore; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in left arm on 01Jun2021 17:15 (at the age of 56-year-old) single dose for COVID-19 immunisation at Pharmacy. The patient medical history was none. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were none. It was reported that her head was killing her. Asked what can she take for it. Headache at 18:45 and woke up with migraine on 01Jun2021. Arm was very sore on . Got it two days ago and immediately got a headache within an hour and a half or so. That night headache lasted all night and she went to bed Woke up in morning and still had nagging headache. Headache came and went all day. Would get worse and then go away. Last night headache started getting really bad. Went to bed early. Woke up this morning with a migraine. Arm very sore confirmed in the injection arm, upper left arm. Had a little soreness on 01Jun2021. On 02Jun2021 was more sore. 03Jun2021 it's the same. The patient did not visit emergency room or physician office. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had arm pain that was sore to touch but it went away.; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 08May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after the first dose of the vaccine they put a band aid on her arm due to her being on a blood thinner and she waited the fifteen minutes and she had arm pain that was sore to touch but it went away on an unknown date in May2021. She got the pain in her arm. This lasted about 2-3 days and when she touched her arm, it was still sore. The pain is gone but it was sore when she touched her arm, it went away after the first dose. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hair texture abnormal, Hypoaesthesia oral, Pain in extremity, Pruritus
Clinical narrative: Sore arm; I also had numbness on the left side of my lower lip, upper lip and left nostril; itchiness on the back of my head and a little bit of itchiness on my arm; Dying of the hair; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 20May2021 as 1st dose, single dose for covid-19 immunization. The medical history and concomitant medications were not reported. On an unspecified date after the vaccination the patient experienced a sore arm and she put ice on it. She also had numbness, like when you go to the dentist, on the left side of my lower lip, upper lip and left nostril. She also had itchiness on the back of head and a little bit of itchiness on arm. Most of the itchiness was on the back of her head though. The patient was not sure if there was something with her permanent or dying of the hair and the vaccine that may have caused the itching. The patient was scheduled second dose on 10Jun2021. She enquired about if she could have her second dose. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site haemorrhage
Clinical narrative: redness; soreness; quite a bit or 2 to 3 drops of still wet, coagulated blood; This is a spontaneous report from a contactable consumer (patient) or other non HCP  A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route of administration, on 02jun2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history included ITP (Idiopathic thrombocytopenic purpura). concomitant medications were not reported. On 03jun2021, 1 day after the vaccination, the patient experienced quite a bit or 2 to 3 drops of still wet, coagulated blood after removing bandage (after wiping it away, her arm wasn't actively bleeding), redness and soreness. She enquired regarding explaining the medical conditions including bleeding disorder or blood thinners to vaccination provider which was mentioned in the fact sheet. In response to her history of Idiopathic thrombocytopenic purpura she was informed that When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections or choose alternative routes because of the risk for hematoma formation after injections. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Fatigue
Clinical narrative: Feeling weak; Tired; This is a spontaneous received report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173, Pfizer NTEC), via an unspecified route of administration on 06May2021 in arm left in the morning at unknown time after 09:00 as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included minerals nos, vitamins nos (CENTRUM A TO ZINC) taken for supplementation therapy, start and stop date were not reported. The patient previously took first dose of BNT162B2 (Lot: EW0153) on 07Apr2020 at around 10:00 the Left arm for COVID-19 immunisation. Patient reports experienced feeling weak on 08May2021 and tired since then on May2021.  She wants to know if we have reports of the tiredness lasting this long, as she said most people she knows only reported 3 days of fatigue. She stated she had seen her HCP yesterday. The patient who called to report feeling weak after the second dose of the Pfizer Covid Vaccine. Event was still ongoing. Onset date approximate initially she felt good on 06May2021, but by 08May2021 she had onset of feeling weak time of onset unknown 09May2021 she felt weaker. She still was feeling weak and reported outcome as persistent, about the same. She was administered a B12 shot yesterday in the doctor's office and thought she would feel good, but today she still feels the same, feeling weak. B12 shot: Lot/NDC/Expiry: Unknown, product administered in the doctor's office. She went to her doctor who referred her to Pfizer. She asked if there have been any other reports of feeling weak after the Pfizer Covid Vaccine and why she had no problems with the first dose of Pfizer Covid Vaccine, but feeling weak after the second Pfizer Covid Vaccine. Dosage previously discontinued/treatment completed. Patient took Pfizer Covid Vaccine because everybody else got it. Second dose completed prescribed therapy. The patient underwent lab tests and procedures which included blood test: unknown on 02Jun2021. Therapeutic measures were taken as a result of feeling weak. The outcome of the event feeling weak was reported not recovered and the event tired was reported as unknown.  Description of Product Complaint: Consumer was the patient who called to report adverse event of feeling weak after Pfizer Covid Vaccine. During report mentioned that she was administered a B12 shot yesterday in the doctor's office and thought she would feel good, but today she still feels the same, feeling weak. B12 shot: Lot/NDC/Expiry: Unknown, product administered in the doctor's office.