chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Urticaria
Clinical narrative: exposed via breastmilk; hives; This is a spontaneous report received from contactable consumer (mother) reported for baby (patient). A 17-month-old breastfed female patient exposed BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via transmammary on 14Apr2021 (at 17-month-old) at 1st dose, single and on 05May2021 at second dose, single for COVID-19 immunisation. No patient history (medical history, family medical history), other products, and other vaccines within 4 weeks. The patient broke out into hives after caller received each dose of the vaccine. The first time that she noticed the hives was on 18Apr2021. They thought it was a rash but then learned that it was hives. They took the baby to the emergency room on 23Apr2021 but they thought it was unlikely that it was from the vaccine because it's not a live vaccine. They had her do loratadine (CLARITIN toddler chewable) once daily and it worked for 2 days. She stopped taking the Claritin and then the hives would come back. The hives did eventually stop, maybe five days before the second shot. Then the second shot was on 05May2021 and the hives were there the next morning. The baby still had the hives, and the loratadine was helping but it seems like every time she skips a day of loratadine it comes right back. She did ended up seeing a dermatologist for the baby after her second shot. They gave her Baby diphenhydramine hydrochloride (BENADRYL) but it did not work at all. She tried oatmeal baths, and that did not help. The dermatologist said because of the timing it has to be related. Hospital admission was not required for her baby. The only thing caller took directly following her vaccines was the paracetamol (TYLENOL). The hives did not bother the baby at all, they just looked bad. They were warm to the touch, and the baby was warm. They were on her face to just past her knees. They got better only with loratadine. If she misses a day of the loratadine, the next morning they would be bad. They ended up worse under her arms and chest and back - are the worst. The outcome of the events was not resolved.  Communication: PC filed. The caller was provided with company phone number of #, option 3, and hours of operation of Monday through Friday, 8AM to 8PM, Saturday and Sunday 9AM to 3PM for COVID-19 vaccine inquiries, prior to warm transfer. Warm transferred  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547082 same reporter/drug, different patient/event (baby case)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations
Clinical narrative: intermittent palpitations.; tightness in her chest like someone was squeezing her heart; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0168, expiration date unknown) via an unspecified route of administration at arm right on 12May2021 09:00 AM at age of 55-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination and events onset. Medical history included hypertension. Patient had known allergies to Vitamin B shot, anesthesia and flu shot. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient didn't have any other medications (concomitant medication) within 2 weeks of vaccination. After the vaccination, patient had intermittent palpitations. Then about 3 hours later (12May2021 12:00 PM), patient had tightness in her chest like someone was squeezing her heart. Patient had the exact same symptoms after her last flu shot I in 2011. Adverse event start date was 12May2021 at 12:00 PM. The events resulted in emergency room/department or urgent care visit. Patient received prednisone at 40 mg once daily for 3 days as treatment for the events. Outcome of the events was recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient wasn't tested for COVID-19.  Follow-up attempts are needed. Further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: she is little dizzy; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a 13-year-old female patient (reporter's daughter). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0185; expiration date not provided), via an unspecified route of administration on 15May2021 17:00 as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient experienced 'she is little dizzy' on 15Ma2021. Patient's clinical course is as follows: It was reported that the patient was 13-years-old and got Pfizer shot this afternoon about 5 o'clock. Now patient stated 'she is little dizzy'. Reporter stated 'And I don't know is it related to that or not I just wanted to ask'. Reported also mentioned that 'Yes. In certain places you get that at 13'. When concern was paraphrased the reporter stated 'Yes'. When information about department was given, reporter stated, "Are they are there now?". Reporter was informed about Pfizer drug safety role and asked for permission to probe further questions, reporter stated, "Honestly I would like to go to site cause it's 12 o'clock midnight here, it's little late". When probed for lot and expiration, reporter stated, "It's not on the card. Oh 1st dose Pfizer, EW0185". Outcome of the event was unknown.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Malaise, Rash
Clinical narrative: developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt like everything was moving around; weak; Shaking; Chilling; Does not feel ok; half an hour lying down; This is a spontaneous report from a contactable consumer reporting for their daughter (patient). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1  at 12-years-old intramuscular, administered in arm left on 16May2021 (Batch/Lot Number: EW0177) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that within 5 minutes after taking the vaccine on 16May2021, the patient started feeling dizzy, weak and little bit of shaking, chilling. Dizziness was kind of severe dizziness where felt like everything was moving around her. They took her to urgent care center because she does not feel ok after half an hour lying down there. The doctors were there and they gave medications as an injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed (treatment). The patient got the reaction at 1145 am within five minutes feeling dizziness. After 30 minutes waiting were advised to take her to the urgent care. She was prescribed Promethazine 25mg, Ondansetron 4mg, Meclizine 3 times a day for next five days. Reports adverse event (unspecified) still maintains. Then later developed a rash, whole left arm on an unspecified date. Therapeutic measures were taken as a result which included injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed. The outcome of the events was unknown.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt like everything was moving around; weak; Shaking; Chilling; Does not feel ok; half an hour lying down; This is a spontaneous report from a contactable consumer reporting for their daughter (patient). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1  at 12-years-old intramuscular, administered in arm left on 16May2021 (Batch/Lot Number: EW0177) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that within 5 minutes after taking the vaccine on 16May2021, the patient started feeling dizzy, weak and little bit of shaking, chilling. Dizziness was kind of severe dizziness where felt like everything was moving around her. They took her to urgent care center because she does not feel ok after half an hour lying down there. The doctors were there and they gave medications as an injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed (treatment). The patient got the reaction at 1145 am within five minutes feeling dizziness. After 30 minutes waiting were advised to take her to the urgent care. She was prescribed Promethazine 25mg, Ondansetron 4mg, Meclizine 3 times a day for next five days. Reports adverse event (unspecified) still maintains. Then later developed a rash, whole left arm on an unspecified date. Therapeutic measures were taken as a result which included injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: body ache; bad headache; dizziness; This is a spontaneous report from a contactable consumer (patient's father). A 12-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: Not reported), via an unspecified route of administration on 14May2021 around 17:00 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 14May2021 around 5pm and she has got some really bad symptoms right now and don't know what to do. On 15May2021, the following morning she had a bad headache and some dizziness. On an unspecified date, the patient had body ache. The patient received treatment for event bad headache and dizziness with little naproxen. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: left side of cheek close to left bottom lip swollen; lips swelled; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 53-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included allergies: Benzoyl peroxide. The patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 at 04:00 PM (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced lips swelled at 4:00 am on 09May2021, she went to urgent care, took a corticosteroid shot, was put on steroids for a week; finished on 15May2021. On 17May2021, the patient woke up with her left side of her cheek close to her left bottom lip swollen. She was at the hospital now. This case was provided as non-serious by reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The adverse event resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment (steroid shot and medication) received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in May2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Had an episode of Covid and she tested positive and had symptoms; Had an episode of Covid and she tested positive and had symptoms; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got her first dose on 31March2021 and then she had an episode of Covid and she tested positive on an unspecified date and had symptoms on 15Apr2021, and then she got a test yesterday on 15May2021 and tested negative for Covid. Reporter was asking if patient can get the second dose or she have to wait for 90 days. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Investigation
Clinical narrative: positive shingles test; This is a spontaneous report from Pfizer-sponsored program,  received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 14May2021, patient had a positive shingles test. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got my 2nd dose of the Pfizer vaccine on April 7, 2021. I got positive Covid test results both from a rapid and a pcr test 13May and 14May2021; I got my 2nd dose of the Pfizer vaccine on April 7, 2021. I got positive Covid test results both from a rapid and a pcr test 13May and 14May2021; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), the 1ST DOSE, SINGLE on an unspecified date and 2ND DOSE, SINGLE on 07Apr2021 both via an unspecified route of administration (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that "I got my 2nd dose of the Pfizer vaccine on 07Apr2021. I got positive Covid test results both from a rapid and a pcr test 13May and 14May2021. I would like to report my breakthrough case and/or find someone/a study I can report to in hopes to maybe be part of research on Covid in fully vaccinated people. Thank you!" The outcome of the events was unknown.   Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Patient is asking if it's safe to take antibiotics for her infection; This is a spontaneous report from a contactable consumer (patient) via a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer vaccine on 27Apr2021 and the second dose was scheduled on 18May2021 (correct dosing schedule). The patient was asking if it's safe to take antibiotics for her infection. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Insomnia, Vaccination site pain
Clinical narrative: breathing issue, difficulty breathing; headache; tender & soreness in the arm of her injection; trouble sleeping; This is a spontaneous report received from a contactable consumer (reporting on herself).   A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Left on Apr2021, as 2nd dose, single for COVID-19 immunization. The patient medical history and Concomitant medication(s) included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. Patient received her first Pfizer Covid 19 Vaccine on 06May2021. A few hours later she felt a slight headache, tender and soreness in the arm of her injection. The following day she felt short winded and experienced trouble sleeping. She did call EMS out for the breathing issue but was treated at home. She had been working around in the yard. That night she took one Tylenol for her pain. Patient read in the Fact sheet about problems breathing may be related to a serious reaction. Patient asking if she will be okay to take the vaccine since she experienced the breathing issue the following day. While glancing at the fact sheet, she noticed that blood thinners are not allowed after the first dose. She was prescribed a blood thinner after her first dose. She called in to know if it was safe for her to take the second dose while on blood thinners or does she need to stop taking it until her second dose. Clarified and she said that she took the blood thinner after her first dose. She also experienced difficulty breathing the next day and called paramedics to check on her. She wants to know if it will happen again on her second dose. She has been prescribed aspirin 81 mg. She is scheduled to have her second dose on 27May2021. Patinet will receive her second Pfizer Covid 19 Vaccine on 27May2021. Asking if she safe to take the second vaccine. She mentioned that she experienced a headache and minor reactions that went away quickly after the first dose. At night, she had trouble sleeping. She also experienced difficulty breathing the next day and called paramedics to check on her. She wants to know if it will happen again on her second dose. She is scheduled to have her second dose on 27May2021. The outcome of the tender & soreness in the arm of her injection, trouble sleeping, breathing issue and difficulty breathing was unknown and  for event headache was recovered on an unspecified.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: sharp pain in her neck and shoulder; sharp pain in her neck and shoulder; arm was hurting/arm pain; This is a spontaneous report from a contactable consumer (patient's mother) via medical team. A 14-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 14May2021 (at the age of 14-years-old) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sharp pain in her neck and shoulder and her arm was hurting/ arm pain on 17May2021 night. The reporter was concerned because the pain appeared after a few days and not within 24-48 hours. She asked is this could be an indication that the vaccine was placed in the wrong place like not in the muscle. She asked if this is normal or when the patient should have this checked. The reporter stated that her and her husband did not experience any side effects. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; body ache; This is a spontaneous report from a contactable consumer (Patient) via Medical Information team.   A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 18May2021, the patient experienced headache, body ache. Reported serious as no, reported that patient had the first dose of the Pfizer COVID vaccine yesterday. He wants to know if he can take Aspirin, Tylenol or Ibuprofen for the pain. Reported that reporter seriousness for Headache and Body Aches was Unspecified. Reported that patient experienced his headache and body aches began this morning. States he does not want to complete a report he wants to be transferred to health facility. Caller declined to complete report. The outcome of events was not recovered.  Follow up attempt needed. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar event for herself and 3 patients. This is the second of four reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date. The outcome of the event fever was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021564496 Same reporter/drug/event, different patient;US-PFIZER INC-2021565268 Same reporter/drug/event, different patient;US-PFIZER INC-2021566846 same reporter/drug/event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient's mother-in-law). This consumer reported similar event for herself and 3 patients. This is the third of four reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not reported), via an unspecified route of administration on an unspecified date, as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had a fever on an unspecified date after the vaccine. The outcome was unknown for the reported event.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565268 Same reporter/drug/event, different patient;US-PFIZER INC-2021564473 Same reporter/drug/event, different patient;US-PFIZER INC-2021566846 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Little bit of fever; This is a spontaneous report from a contactable consumer (patient's sister-in-law). This consumer reported similar event for herself and 3 patients. This is the fourth of four reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Not reported), via an unspecified route of administration on an unspecified date as unknown dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a little bit of fever after the vaccination, but he was fine after it. The outcome was reported as recovered on an unknown date for the reported event.  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021564473 Same reporter/drug/event, different patient;US-PFIZER INC-2021564496 Same reporter/drug/event, different patient;US-PFIZER INC-2021566846 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID; had COVID; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced had covid and was given Plasma on 11Mar2021. The patient underwent lab tests and procedures which included covid-19: positive. The reporter indicated that her husband was told to wait three months to get the second dose of the vaccine and they were trying to schedule an appointment for the patient to get his second dose. Therapeutic measures were taken as a result of covid. The outcome of event was unknown. Information related to lot/batch number has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: palpitations (210 BPM); Fast heartbeat; This is a spontaneous report from a contactable other hcp. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173, Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in arm right on 07May2021 11:30, single dose for covid-19 immunization. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153, expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 16Apr2021 01:30 PM, single dose for covid-19 immunization. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. The patient underwent lab tests and procedures which included heart rate: 210 on 12May2021 BPM. The patient's medical history was not reported. Concomitant medication that patient received within 2 weeks of vaccination included phentermine (Phentermine) taken for an unspecified indication, start and stop date were not reported; Prilosec (Omeprazole) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B 12) taken for an unspecified indication, start and stop date were not reported.  The patient experienced fast heartbeat and palpitations (210 bpm) and lasted about 10 mins. The patient was shifted to ER on 12May2021 20:30. The event fast heartbeat and palpitations (210 bpm) was found to be medically significant. The patient di not receive treatment.The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events palpitation and Heart rate increased and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: After the second dose, the chest pain has been more persistent.; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGE for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took received her first dose of BNT162B2 on an unspecified date for COVID-19 immunization. After the second dose, the patient experienced the chest pain has been more persistent. After getting the first dose of the vaccine, she had some chest pains that would come and go. After the second dose, the chest pain has been more persistent. Also, with her COPD, in the mornings, she would cough up phlegm. But since getting both doses of the vaccine, she did not cough up anything. She was wondering if there is phlegm there and it was just not coming up. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  Follow up needed, Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: She had swelling and redness that covered almost all of the front part of her upper arm not just at the injection site on her left arm; She had swelling and redness that covered almost all of the front part of her upper arm not just at the injection site on her left arm; Swelling and redness covered front part of arm; Swelling and redness covered front part of arm; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0186; expiry date: unknown), via an unspecified route of administration, administered in the left arm on 11May2021 (at the age of 66 years old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0171), first dose via an unspecified route of administration, administered in left arm on 19Apr2021 as a single dose for COVID-19 immunization and experienced redness and swelling for a few days at the injection site. On 12May2021, the patient developed redness and swelling to the top/front part of her injection arm. She wanted to know if she was ever needed to get a booster dose of this vaccine, will it be ok for her to get it based off this side effect. She had swelling and redness that covered almost all the front part of her upper arm not just at the injection site on her left arm. It was everywhere. It looked like a bad sunburn on one arm. Yesterday, it finally started going down. The redness has gone away. The patient did not have a prescribing doctor. She went to saw the pharmacist after the swelling and redness lasted Wednesday, Thursday, Friday. She just popped in last Friday. She showed up, and the pharmacist's eyes got big like woah. He took a picture of it. She told him it had been there since Wednesday night. He said to call and report it, and to take Ibuprofen and Ice it. She did not take any other medication. She did take the ibuprofen for the swelling. The first shot did turn red at the injection site but not all over her whole arm like the second one. It was red and lasted a couple of days and went away. This one went days and days. It covered almost her whole upper arm. She stated that it finally resolved on 18May2021. The outcome of the events was recovered on 18May2021.  Information about lot/batch number is available. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Extreme Vertigo symptoms for approximately one week with flashes on occasion since; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 66-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0150, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 30Mar2021 (at the age of 66-years-old) as 2nd dose, single for COVID-19 immunization. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 as 1st dose, single for COVID-19 immunization. Patient medical history included type 2 diabetes mellitus and known allergy codeine. Concomitant medications included the patient received within 2 weeks of vaccination was metformin (METFORMIN), losartan (LOSARTAN POTASSIUM), atenolol (ATENOLOL) and estradiol (ESTRADIOL). Prior to vaccination, patient diagnosed with COVID-19 was unknown. Since the vaccination, patient was not tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Facility where the most recent COVID-19 vaccine was administered in public health clinic/administration facility. The patient experienced extreme vertigo symptoms for approximately one week with flashes on occasion since on 22Apr2021 at 05:00. The patient did not received any treatment for event. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Heart rate increased, Tachycardia
Clinical narrative: rapid heart rate; tachycardia; This is a spontaneous report from a non-contactable consumer or other non hcp.A 16-years-old adolescent male patient received bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in right arm on 04May2021 12:00 (at the age of 16years old) as 2nd dose, single for COVID-19 immunization. The patient's Medical history included asthma, ongoing intermittent asthma (only during other upper respiratory illnesses) , respiratory disorder. Allergies were reported as No. The patient previously received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE,lotnumber:EP6955)via unspecified route of administration, In left arm, on 02Apr2021 at 11:15am as first dose, Single for COVID-19 Vaccination.The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, since the vaccination.It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination.The patient's concomitant medications were not reported. On 05May2021 at 19:30 ,the patient experienced rapid heart rate and lasted all day Thursday, subsiding late Thursday night and periodically flaring up on Friday and Saturday. The patient underwent lab tests and procedures which included chest x-ray: clear on, electrocardiogram: mostly regular but confirmed tachycardia on. Therapeutic measures were taken as a result of rapid heart rate (heart rate increased), tachycardia (tachycardia).By Sunday 09May the tachycardia was apparently gone and so far as we can tell has not recurred. The case was reported as non-serious.The outcome for the events were recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: Swollen gland in armpit; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 24Apr2021, (at age of 34-year-old) in left arm as single dose for COVID-19 immunisation. Medical history included asthma and turmeric allergy. Patient did not receive concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 03May2021, at 08:00PM, patient experienced swollen gland in arm pit, flu like symptoms. Events were considered non-serious by the reporter. Patient received second dose of vaccine on 15May2021 at 10:30AM in left arm. It was unknown if the patient received treatment for the events. Outcome of the events were unknown.  Information on the lot/batch number has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: On 05/18/21at 6pm  I started hearing a loud hissing noise in both ears, tinnitus; left ear pain on and off; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8732), via an unspecified route of administration, administered in left arm on 11May2021 (age at the vaccination 59-year-old) as first dose single for covid-19 immunisation. Medical history included migraine and COVID-19. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date vaccine location left arm. On 18May2021 at 6pm patient started hearing a loud hissing noise in both ears, tinnitus, it subsided after about 15 minutes but returned at about 9 pm, it subsided after a few minutes, it has continued to come and go since. Also left ear pain on and off since vaccine. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Vomiting
Clinical narrative: Felt bad; has stomach pain; vomiting; This is a spontaneous report from a contactable consumer (patient's friend) via a medical information team. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16May2021 (at the age of 55-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Caller says they have a friend put on the Pfizer COVID vaccine on Sunday, 16May2021 and since then has felt bad, has stomach pain and vomiting. He wants to know where to take him, whether to the doctor or a hospital. Advised the caller that they should take the patient to the physician as he could get the medical history of the patient and give medical recommendations and rule out possibilities. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Food poisoning, Lymphadenopathy, Nausea
Clinical narrative: food poisoning; swollen lymph nodes in her neck; mild nausea; fever; stomach ache; sore throat; This is a spontaneous report from a contactable consumer (patient reported herself). The report was not related to a study or programme. A 25-years-old female patient received her 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 08Apr2021 at 3:30PM (at the age of 25-years-old), as single dose for covid-19 immunisation. The patient had no medical history, and no concomitant medications were received. No vaccinations were received by the patient within 4 weeks prior to the first administration date of the suspect vaccine. There were no adverse events following prior vaccinations. No 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 are not available). On an unspecified date, 2 weeks after the vaccination (08Apr2021), she got food poisoning. When she had the food poisoning, she had a stomachache and fever. she was also a little bit nauseous. It was reported that as per the patient thinking the food poisoning was not due to the Covid 19 vaccine. On an unspecified date, 3 weeks after the vaccination (08Apr2021), she got swollen lymph nodes in her neck and had a fever and sore throat. On an unspecified date, at the doctor office, she had blood work and an ultrasound of her neck where her lymph nodes were swollen, and for both the results were unspecified. The patient visited physician office, where she was seen by a doctor, who prescribed Penicillin VK 500mg one tablet two times daily for the swollen lymph nodes in her neck and her sore throat. It was a pharmacy bottle. NDC/Lot/Expiry not known. The patient did not visit any emergency room. She has not felt fully recovered until now. The outcome of the events was unknown. The patient wanted to know about the timing of the second dose as it has been 6 weeks since the first dose of the Covid 19 vaccine.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Ultrasound scan
Clinical narrative: food poisoning; swollen lymph nodes in her neck; mild nausea; fever; stomach ache; sore throat; This is a spontaneous report from a contactable consumer (patient reported herself). The report was not related to a study or programme. A 25-years-old female patient received her 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 08Apr2021 at 3:30PM (at the age of 25-years-old), as single dose for covid-19 immunisation. The patient had no medical history, and no concomitant medications were received. No vaccinations were received by the patient within 4 weeks prior to the first administration date of the suspect vaccine. There were no adverse events following prior vaccinations. No 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 are not available). On an unspecified date, 2 weeks after the vaccination (08Apr2021), she got food poisoning. When she had the food poisoning, she had a stomachache and fever. she was also a little bit nauseous. It was reported that as per the patient thinking the food poisoning was not due to the Covid 19 vaccine. On an unspecified date, 3 weeks after the vaccination (08Apr2021), she got swollen lymph nodes in her neck and had a fever and sore throat. On an unspecified date, at the doctor office, she had blood work and an ultrasound of her neck where her lymph nodes were swollen, and for both the results were unspecified. The patient visited physician office, where she was seen by a doctor, who prescribed Penicillin VK 500mg one tablet two times daily for the swollen lymph nodes in her neck and her sore throat. It was a pharmacy bottle. NDC/Lot/Expiry not known. The patient did not visit any emergency room. She has not felt fully recovered until now. The outcome of the events was unknown. The patient wanted to know about the timing of the second dose as it has been 6 weeks since the first dose of the Covid 19 vaccine.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Pain in extremity, Peripheral swelling
Clinical narrative: right arm pain all the way down her arm with swelling on her hand; swelling on her hand; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 14:00 (Batch/Lot Number: EW0183) as 1ST DOSE, SINGLE for covid-19 immunisation administered in Hospital. Medical history included Singles shot (had the shingles shot 5 weeks before the Covid vaccine). Concomitant medication(s) included levothyroxine sodium at once a day; amlodipine besilate at once a day for hypertension; nebivolol hydrochloride (BYSTOLIC) for hypertension. The patient experienced significant right arm pain all the way down her arm, right after vaccine with swelling on her hand on 14May2021, about 6 hours after vaccine. She is very concerned and is asking if she should get the second dose with her 2nd dose due on 9Jun2021. She had blood work at the doctor's office because he said she was bleeding on the inside, making her blood count go low. That was in March. Treatment was received as Tylenol for the events. Outcome of event for swelling on her hand was recovered on an unspecified date and for the other event it was recovering.   Follow-up attempts are possible. further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Dizziness, Influenza like illness
Clinical narrative: Chills; dizzy; aching all over; fever; felt like she had the flu; joint pain that was quite painful all over/had an attack with pains in her shoulders/joint pain attack; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided) via an unspecified route of administration, on 16Feb2021 (at the age of 85-year-old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided) via an unspecified route of administration, on 25Jan2021 (at the age of 85-year-old), as a single dose for COVID-19 immunization. It was reported that the events happened after the second dose of the vaccine. The patient received the second dose of the Pfizer BioNTech COVID 19 vaccine on 16Feb2021. A couple of days after, on 19Feb2021, patient had chills, patient was dizzy, aching all over, had a fever, and it felt like she had the flu. These symptoms resolved within a day, she felt better the next morning when she woke up. A few weeks later, the patient thinks it was 01Mar2021, she began having joint pain that was quite painful all over. The joint pain seems to be worse at night than during the day. Last night the patient had a joint pain attack, it was extreme, the patient wanted to die. It was in the patient's shoulders, knees, and joints. Patient has been prescribed 3 or 4 medications and opioids, none of which have worked.  She took one of the pills last night and 6 hours later, she had an attack with pains in her shoulders, knees and joints. The reporter and patient called 911 but they did not take the patient to the hospital or admit her. The patient took one of her opioids last night- Tramadol HCL 50mg and 6 hours later the joint pain attack happened. The Tramadol did not help the patient's pain, in fact it made it worse. Tramadol HCL 50mg tablet- NDC, lot, expiration date unknown. The medication is in a pharmacy bottle and the print is so small the patient can hardly read it. The patient was following up with her doctor who also prescribed a steroid which she will pick up later today. The reporter and patient completed the VAERS form already on this event. The patient had blood work done yesterday (18May2021), and her doctor said there was no indication of anything wrong with the blood work. Outcome of the events chills, dizzy, aching all over, fever and felt like she had the flu was recovered on 20Feb2021 and joint pain was recovered on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.