chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, SARS-CoV-2 test, Throat tightness
Clinical narrative: Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; This is a spontaneous report from a contactable consumer. This 30-year-old female consumer (patient). A 30-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date: unknown), via unspecified route, administered in arm right on 16Jul2021 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history includes Penicillin allergy and covid-19. Concomitant medications include vitamin e, cyanocobalamin (VITAMIN B-12), folic acid, omeprazole (PROTONIX). No other vaccines received 4 weeks prior to vaccination. Prior to vaccination patient was diagnosed with covid and since the vaccination the patient has been tested for covid. On 16Jul2021 12 :45 AM, after the vaccination, the patient throat started to feel "funny" her mouth and throat had a tingling sensation and a metallic taste in her mouth. Within 5 minutes her throat began to feel tight. It progressively got tighter. she went straight to the ER. her blood pressure was 160/95 and heart rate was 150. her throat did not close all the way off thankfully but closed enough for her to not be able to swallow. Patient received steroid pack and steroid shot as treatment for the observed events. The patient underwent lab tests and procedures on 16Jul2021 which include Blood pressure 160/95, heart rate 150 and SARS-CoV-2 test which showed a negative result. The outcome of the events are recovering.  No follow-up attempts possible. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient then got COVID-19 and never got the 2nd dose; The patient then got COVID-19 and never got the 2nd dose; This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age received bnt162b2 (BNT162B2, BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing did go through immunotherapy. The patient's concomitant medications were not reported. On an unspecified date patient experienced the patient then got covid-19 and never got the 2nd dose with, Caller states that she has a patient who was "involved in home health back in Jan and received the 1st dose of the Pfizer COVID-19 Vaccine. The patient then got COVID-19 and never got the 2nd dose. The caller wants to know if the patient can get her 2nd dose or if they need to restart the series over. Caller would also like to know if there are any contraindications for the patient getting the 2nd dose of the Pfizer COVID-19 Vaccine after having had immunotherapy treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for all events was unknown.   Follow-up(19Jul2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient that:  Caller declined to proceed with report stating she doesn't have all of her information and she will let her son know that they can report and requested transfer to regulatory authority. Full report details not obtained.   Information on the lot/batch number has been requested.; Sender's Comments: The reported event Covid 19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Inflammatory marker increased, Inflammatory marker test
Clinical narrative: Guillian Barre syndrome; High inflammatory markers; This is a spontaneous report from a non-contactable consumer or other non-HCP. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Events took place after use of product. On an unspecified date in 2021, the patient experienced high inflammatory markers, suspected Guillian Barre syndrome. The symptoms began around 40 days after vaccine, he had reported to Pfizer and another regulatory authority. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity
Clinical narrative: Affected my arm; My elbow and around elbow too, it seems like when I grip my fist together, it hurts there and if I lift something, grips my fist and pull up, it hurts; It seems like my joint or like straight out to it, it hurts; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EWO185), via an unspecified route of administration, administered on 30Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via unspecified route of administration, administered on unspecified date as dose 1, single for COVID-19 immunisation and experienced ache. It was reported that on an unspecified date in Jul2021, the patient had a vaccine shot, the second one, patient affected arm, elbow and around elbow too, it seems like when patient grip fist together, it hurts there and if lift something, grips patient fist and pull up, it hurts and it has been three weeks that is why (sentence incomplete). Patient looked online and it says it is for couple of days, it is not couple of days, it is three weeks. Patient just wanted to know what (sentence incomplete). On an unspecified date in 2021, it seems like joint or like straight out to it, it hurts, it's a kind of (sentence incomplete), it was not worse, but it was not better, it was just the same amount." Patient stated as, "I have got EWO185, I don't know if it is O or 0, let me read it again, it is EW and then I think it is 0185 or it is O, I am not sure if it is O or 0." and just wanted to know about the side effect why it was not going away. The outcome of event was not recovered.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Autoimmune disorder
Clinical narrative: Caller said his son suffered an autoimmune response; This is a spontaneous report from a contactable consumer (Mother) reported for patient (son). A 13-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 14May2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The reporter said that after receiving one dose and got tested for antibody, the result was negative. She wanted to know if that was normal and if it happened and wanted to know if her son was protected while testing negative for the antibody. She called on behalf of her son who received the 1st dose of the Pfizer Biontech COVID19 vaccine on 14May2021 and was supposed to receive the 2nd dose on 08Jun2021, but missed it due to hospitalization. She said her son suffered an autoimmune response 2 days after. Her son also tested negative for the antibody after first dose. She wanted recommendation on getting the 2nd dose of the vaccine beyond the 21-day window. The event led to hospitalization. The patient underwent lab tests and procedures which included antibody test: negative on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Headache, Vision blurred
Clinical narrative: vision being off; blurred vision; slight headache; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm left on 20Jul2021 at 12:20 PM (Lot Number: EW0186) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure (abnormal). Concomitant medications included atenolol with five years for blood pressure (abnormal), amlodipine besilate with five years for blood pressure (abnormal). On 20Jul2021, patient had vision was kind of off, slight headache. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 20Jul2021 at around 12:20pm. She started having blurred vision and slight headache at around 1:15-1:30. She would like to know if anyone else has reported these side effects. Patient stated that she will not get her second dose of the vaccine. Patient never got shots, never got the flu shot. Patient was fine in there but when she started looking at her phone, reading the email, her vision was kind of off. It was blurry a little bit. She had a slight headache. She didn't see that as a side effect. She didn't know if anyone else has had this reaction to the shot or not. Patient got the vaccine about 12:20PM. She had to wait 15 minutes so she got out of there about 12:50. She looked at her phone so maybe her vision being off and the headache started about 1:15PM or 1:30PM. It affected her when she looks at something she needs to read. Sees far fine. She had a headache and can tell when reading the article they gave her or her phone. She can't see that clear. Patient did not feel like she was having a medical emergency where she would need to call or go to the emergency room. Events did not require a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). Outcome of the event blurred vision was unknown, while of the other events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oedema peripheral, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: Developed shortness of breathe; Right leg edema; Hospitalized with heavy burden bilateral PE; 3 blood clots in right leg; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 16:00 (58-years-old at the time of vaccination), (Batch/Lot Number: EK9231) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension (HTN) hyperlipidaemia (HLD), gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. Patient had known allergies to Penicillin (PCN), Sulfa, honey dew, Boniva. Concomitant medication included rosuvastatin calcium (CRESTOR), loratadine (CLARITINE) omeprazole (PRILOSEC [OMEPRAZOLE]), hctz (HCTZ), docusate sodium (COLACE) and calcium taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Dec2020 16:15 (Batch/Lot Number: EL0140) as DOSE 1, SINGLE for covid-19 immunization. On 04Feb2021 14:00, the patient experienced developed shortness of breath and right leg edema. 3 weeks after 2nd vaccine. Hospitalized with heavy burden bilateral PE and 3 blood clots in right leg. The events was serious (medically significant). The patient was hospitalized for 5days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021. Patient received treatment for the events as Eliquis many tests. The clinical outcome of the events was recovering at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Lymphoma
Clinical narrative: CLL lymphoma; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she was vaccinated with the Pfizer (COVID) vaccine, had the 2 vaccines, had CLL lymphoma, had been tested twice by Oncologist and had negative antibodies. And Oncologist would like patient to take a third vaccine. Patient asked if there was any way patient can get that vaccine. No other additional information was provided. The patient underwent lab tests and procedures which included antibody test: negative on unspecified date. Clinical outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blood disorder, Dizziness, Gastrointestinal disorder
Clinical narrative: pain in stomach after the second dose; Her hemoglobin was 7. Normal for women is 12-13./ One result for her hemoglobin was 7.1 then it was up to 7.9.; She had Xrays and an Ultrasound. Those indicated she had a hiatal hernia.; She still is having blood problems.; She also had an upper GI; The pain was higher up and went from side to side and would go around to the back.; The pain was higher up and went from side to side and would go around to the back.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; slept the whole day after getting the second dose; This is a spontaneous report from a contactable consumer. This 68-Year-Old female consumer reported for herself that received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on Left arm anatomical location on 10Jun2021. (at the age 68-year-old) as a dose 2, single for covid-19 immunisation. Patient historical vaccine included received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on left arm anatomical location on 20May2021 as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included PAROXETINE HYDROCHLORIDE (Paxil) 20mg daily at night start from Sep2012 which was ongoing. After second dose of Pfizer vaccine patient experienced slept the whole day after getting the second dose on 11Jun2021 and pain in stomach on 13Jun2021 patient hospitalized due to pain in stomach from 23Jun2021 to 25Jun2021. Patients' hemoglobin range was decreased from unknown date which was 7 Normal for women is 12-13. / One result for her hemoglobin was 7.1 then it was up to 7.9. Patient was very close to having a transfusion. She had Xray's and an Ultrasound those indicated she had a hiatal hernia. She still was having blood problems. Patient continued to feel sluggish and dizzy after te second dose and had stomach pain. The pain was higher up and went from side to side and would go around to the back. Patient had an upper GI gastrointestinal disorder start from unspecified date. On 23Jun2021 patient underwent lab test hemoglobin which result was 7 and 7.1 and in JUL2021 again tested hemoglobin result was 7.9 range normal for women is 12-13. Patient done second test which was ultrasound and Xray which result was hiatal hernia. The outcome of the events pain in stomach was recovered in june2021, slept whole days was recovered on 12JUN2021. And outcome for another events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Hiatus hernia, Pain, Sluggishness
Clinical narrative: pain in stomach after the second dose; Her hemoglobin was 7. Normal for women is 12-13./ One result for her hemoglobin was 7.1 then it was up to 7.9.; She had Xrays and an Ultrasound. Those indicated she had a hiatal hernia.; She still is having blood problems.; She also had an upper GI; The pain was higher up and went from side to side and would go around to the back.; The pain was higher up and went from side to side and would go around to the back.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; slept the whole day after getting the second dose; This is a spontaneous report from a contactable consumer. This 68-Year-Old female consumer reported for herself that received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on Left arm anatomical location on 10Jun2021. (at the age 68-year-old) as a dose 2, single for covid-19 immunisation. Patient historical vaccine included received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on left arm anatomical location on 20May2021 as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included PAROXETINE HYDROCHLORIDE (Paxil) 20mg daily at night start from Sep2012 which was ongoing. After second dose of Pfizer vaccine patient experienced slept the whole day after getting the second dose on 11Jun2021 and pain in stomach on 13Jun2021 patient hospitalized due to pain in stomach from 23Jun2021 to 25Jun2021. Patients' hemoglobin range was decreased from unknown date which was 7 Normal for women is 12-13. / One result for her hemoglobin was 7.1 then it was up to 7.9. Patient was very close to having a transfusion. She had Xray's and an Ultrasound those indicated she had a hiatal hernia. She still was having blood problems. Patient continued to feel sluggish and dizzy after te second dose and had stomach pain. The pain was higher up and went from side to side and would go around to the back. Patient had an upper GI gastrointestinal disorder start from unspecified date. On 23Jun2021 patient underwent lab test hemoglobin which result was 7 and 7.1 and in JUL2021 again tested hemoglobin result was 7.9 range normal for women is 12-13. Patient done second test which was ultrasound and Xray which result was hiatal hernia. The outcome of the events pain in stomach was recovered in june2021, slept whole days was recovered on 12JUN2021. And outcome for another events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Ultrasound scan, X-ray, X-ray with contrast upper gastrointestinal tract
Clinical narrative: pain in stomach after the second dose; Her hemoglobin was 7. Normal for women is 12-13./ One result for her hemoglobin was 7.1 then it was up to 7.9.; She had Xrays and an Ultrasound. Those indicated she had a hiatal hernia.; She still is having blood problems.; She also had an upper GI; The pain was higher up and went from side to side and would go around to the back.; The pain was higher up and went from side to side and would go around to the back.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; slept the whole day after getting the second dose; This is a spontaneous report from a contactable consumer. This 68-Year-Old female consumer reported for herself that received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on Left arm anatomical location on 10Jun2021. (at the age 68-year-old) as a dose 2, single for covid-19 immunisation. Patient historical vaccine included received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on left arm anatomical location on 20May2021 as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included PAROXETINE HYDROCHLORIDE (Paxil) 20mg daily at night start from Sep2012 which was ongoing. After second dose of Pfizer vaccine patient experienced slept the whole day after getting the second dose on 11Jun2021 and pain in stomach on 13Jun2021 patient hospitalized due to pain in stomach from 23Jun2021 to 25Jun2021. Patients' hemoglobin range was decreased from unknown date which was 7 Normal for women is 12-13. / One result for her hemoglobin was 7.1 then it was up to 7.9. Patient was very close to having a transfusion. She had Xray's and an Ultrasound those indicated she had a hiatal hernia. She still was having blood problems. Patient continued to feel sluggish and dizzy after te second dose and had stomach pain. The pain was higher up and went from side to side and would go around to the back. Patient had an upper GI gastrointestinal disorder start from unspecified date. On 23Jun2021 patient underwent lab test hemoglobin which result was 7 and 7.1 and in JUL2021 again tested hemoglobin result was 7.9 range normal for women is 12-13. Patient done second test which was ultrasound and Xray which result was hiatal hernia. The outcome of the events pain in stomach was recovered in june2021, slept whole days was recovered on 12JUN2021. And outcome for another events was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Breast swelling, Drug effect less than expected, Rash
Clinical narrative: Entire torso and knees consumed with an intense rash; Little bump under my breast; Not progressing as i hoped/doctor expected that my skin should have cleared by now; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 2021, as dose 1, single for COVID-19 immunisation; and received dupilumab (DUPIXENT, Solution for injection, Lot Number: Unknown), via subcutaneous route of administration from 27May2021 to an unspecified date, as dose 1, single for atopic dermatitis. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, following the first intake of BNT162b2 and dupilumab, the patient's entire torso and knees consumed with an intense rash, little bump under my breast. The rashes were not progressing as she had hoped. The doctor expected that her skin should have cleared by now. Dupilumab was continued. The event rash assessed as serious. It was not reported if the patient received a corrective treatment for the events. The clinical outcome of the events entire torso and knees consumed with an intense rash and little bump under my breast was not resolved. The clinical outcome of the event not progressing as i hoped/doctor expected that my skin should have cleared by now, was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Vaccination site scar
Clinical narrative: Vaccinated with BioNTech, with doses 4 weeks apart, and then a third time with Moderna 8; After all doses: slight dent in the injection site; This is a spontaneous report from a Non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose and received second dose via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient also received third dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via intramuscular route from Jun2021 (Batch/Lot number was not reported), as single dose for COVID-19 immunisation. Medical history included hypochondriac and thrombosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient states that he was vaccinated two times with BioNTech, with doses 4 weeks apart, and then a third time with Moderna, 8 weeks later. The patient is now being offered a fourth dose 6 weeks after. The patient states they (the vaccination centres) don't know that he has previously been vaccinated. After all doses on an unknown date in 2021, patient had slight dent in the injection site. The event was considered as non-serious. Patient reports hearing discussions in the media about getting a third vaccination to boost the vaccination. The patient would make the effort to receive the fourth vaccination if advised to do so. The patient heard that the antibody count could be increased by 5 or 10 times if a third dose is received. The patient has also just read that BioNTech is more efficient with a larger time between doses. The patient says they want to be vaccinated again because they are a bit of a hypochondriac and have a medical history of a risk of thrombosis and want to avoid even having a slight case of Covid. The patient has the following questions: Are there studies for receiving multiple doses of vaccines? Is it worth it to receive the fourth vaccination dose from Moderna? Would It make sense to test the antibody numbers let this decide whether a fourth vaccination is necessary? It would be interesting to see the antibody levels in a young person that has been vaccinated so many times. When the patient was directed to contact their HCP, they stated that they were trying to avoid this as they knew their HCP would not be happy with them being vaccinated so many times. The outcome of the event slight dent in the injection site was recovered after 2-3 days on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Inappropriate schedule of product administration, Nausea, Off label use
Clinical narrative: 100.3 fever; body aches; nausea; cold sweats, woke up in middle of night completely soaking wet; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; This is a spontaneous report from a contactable consumer (patient). This 40-year-old male consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 19Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 05Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 prior vaccination. No known allergies. There were no concomitant medications. Facility type for vaccine was pharmacy or drug store. No other vaccine administered in four weeks. No other medications in two weeks was provided. Patient was not tested Covid post vaccination. On 20Jul2021 at 14:00, patient experienced 100.3 fever, body aches, nausea, cold sweats, woke up in middle of night completely soaking wet. No treatment received for AE. The outcome of all events were recovering.   Information about batch/lot number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 100.3 fever; body aches; nausea; cold sweats, woke up in middle of night completely soaking wet; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; This is a spontaneous report from a contactable consumer (patient). This 40-year-old male consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 19Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 05Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 prior vaccination. No known allergies. There were no concomitant medications. Facility type for vaccine was pharmacy or drug store. No other vaccine administered in four weeks. No other medications in two weeks was provided. Patient was not tested Covid post vaccination. On 20Jul2021 at 14:00, patient experienced 100.3 fever, body aches, nausea, cold sweats, woke up in middle of night completely soaking wet. No treatment received for AE. The outcome of all events were recovering.   Information about batch/lot number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: body ache; I got very high fever; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 15Apr2021 07:30 (lot number: EP6955; expiry date: unknown) at the age of 40-years-old, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955; expiry date: unknown) in the right arm, as dose 1 single, at 12:30 PM, for COVID-19 immunisation. Patient is a vegan. The patient was not diagnosed with COVID prior vaccination. Facility type vaccine was reported as "Other". The patient did not receive other vaccines in four weeks; and did not receive other medications in two weeks. On 15Apr2021, after getting second dose of Pfizer, immediately after 15 minutes (07:45), patient experienced headache. After 12 hours of vaccine (at 19:30), the patient got a very high fever and body ache which remained for 4-5 days. After that, fever and body pain were gone but headache remained after 3 months. The patient did not receive treatment for the events. Outcome of the events body ache and fever was recovered on unspecified date in Apr2021. Outcome of the event headache was not recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Hearing loss; Unilateral tinnitus; This is a spontaneous report from a contactable consumer (reporting for himself). A 22-year-old male patient received bnt162b2 (Lot Number: EP 7533), via an unspecified route of administration, administered in left arm on 11Apr2021 13:30 (at the age of 22-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Apr2021 12:00, the patient experienced unilateral tinnitus and hearing loss. The events resulted in disability or permanent damage.  Therapeutic measures were taken as a result of the events included prednisone 60mg 2-week taper. No covid prior vaccination nor covid tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Tinnitus
Clinical narrative: Started with a headache; pulsatile tinnitus; arm and legs would suddenly twitch; This is a spontaneous report from a contactable consumer reported for a female patient who experienced same symptoms as her daughter. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced symptoms started with a headache, pulsatile tinnitus (as which also her daughter as experienced) which in your ear you could hear your heartbeat constantly for 2-3 weeks and when subsided went down to her face, her sinus to her neck and her left arm that then tingle. Which is now down to her legs, just her touching her legs would hurt and that her arm and legs would suddenly twitch. The clinical outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: one of her coworkers had a very red face that benadryl helped; This is a spontaneous report from a contactable consumer. A patient (co-worker) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reported one of her co-workers had a very red face that Benadryl helped on an unspecified date. Therapeutic measures were taken as a result of one of her co-workers had a very red face that Benadryl helped. The outcome of event was unknown.  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity
Clinical narrative: Problems with his throwing shoulder on the right arm, moderate pain in the right shoulder; His son is having pain on his throwing arm or the right arm; Problems with his throwing shoulder on the right arm; This is a spontaneous report from a contactable consumer (patient's father). A 16-year-old male patient (reporter's son) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: was not reported, Expiry Date: was not reported) via an unspecified route of administration in left shoulder on an unspecified date on 11:30 as Dose 2 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date (Batch/Lot Number: was not reported, Expiration Date: was not reported) for covid-19 immunization. Reporter stated after 2 days of vaccination, patient having pain on his throwing arm or the right arm. He did mention that his son plays baseball. He wasn't feeling 100%, but nothing like that. He has pain in the shoulder when trying to throw and it's still bothering him. Reporter stated that he wanted to see if there are any reports; his son who is 16, nearly 17 years old received the Pfizer COVID 19 vaccine in his left shoulder. Reports the next morning, his son is having problems with his throwing shoulder on the right arm and moderate pain in the right shoulder. The outcome of all events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Caller is asking if she can apply topical rubbing alcohol to injection site. She states with injections it can "minimize swelling and pain". Received first dose today.; Caller is asking if she can apply topical rubbing alcohol to injection site.  She states with injections it can "minimize swelling and pain". Received first dose today.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she could apply topical rubbing alcohol to injection site. She stated with injections it could minimize swelling and pain. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Pain, Pyrexia
Clinical narrative: persistent cough. The cough got worse after getting the second dose.; fever; weakness; aching; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 23Jun2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0196, Expiration date: Unknown), via an unspecified route in the left arm on 15Jul2021 (age at vaccination: 65-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jun2021, patient experienced persistent cough, fever, weakness and aching after getting both doses. The cough got worse after getting the second dose. She wanted to know how long will this last and was asking for treatment recommendations. Patient said she already called up her doctor and they gave him cough medicine which was only masking the problem. She said that this has nothing to do with her health as this is vaccine related. The clinical outcome of the persistent cough got worsened, fever and achiness lasted for about 3 days and weakness lasted for a week.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Insomnia, Pain in extremity, Restless legs syndrome
Clinical narrative: Couldn't sleep for one night.; restless legs syndrome; Sore arm; This is a spontaneous report from a contactable consumer(patient). A 15-year-old male patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0198), via an Intramuscular route of administration on 30Jun2021 at 18:00(at the age of 15-year-old male) into left arm as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jun 2021, the patient Couldn't sleep for one-night, restless legs syndrome, Sore arm. It was reported that Pfizer COVID 19 vaccine- mother is calling on behalf of her 15-year-old son who received the second dose of the vaccine yesterday.  She states he has had no reaction or side effects from the second dose, and he says, "he feels fine like he never got the vaccine. After the first dose, she says he had a sore arm and restless legs syndrome overnight but that has resolved. For me I do have a reaction because I get an arm soreness after the first dose and a headache and a higher temperature than normal after the second dose. Caller is a 51-year-old female. Caller received the Pfizer COVID 19 vaccine as well. First dose: 22Feb2021 LOT #EN6200, second dose: 15March2021 Lot #EN6205.she has additional questions about her own side effects however she is at work and doesn't feel comfortable talking about it at this time. She stated she would call back later. Stated it is possible for people to have no side effects after either dose of the vaccine. Stated to caller we would be unable to determine if he received the vaccine or if it was prepared appropriately. Referred caller back to the vaccination provider. Reports her son just took the second dose yesterday and then he felt fine and did not even have a arm sore. She is asking did he really get the vaccine? Caller adds the first one he had kind of like an arm sore for one day but otherwise he was fine. Then four days later at night-time, he got like restless leg syndrome; he had to keep moving his leg to get comfortable and couldn't sleep for one night. That was the first time he had that. She did take him to the doctor, but the doctor said it might be low iron but the blood test for iron was fine. They still don't know what caused the problem. He is completely recovered from that now. (name) she expected with a young boy that there might be more problems; and she kept him home just in case; but he felt totally fine like he never had the vaccine. he can move his arm all around everywhere without difficulty. The patient was not visited to Emergency Room for the event. The patient was visited to Physician Office for restless leg. The patient did not receive any vaccine four weeks Prior Vaccinations. The patient underwent lab tests and procedures which included blood iron with normal result on an unspecified date 2021.The outcome of the events was recovered In Jun2021.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Tiredness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 38-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167), via an intramuscular route of administration (at the age of 38-years), administered in arm right on 28Apr2021 19:20  as dose 2, single for COVID-19 immunization. The patient medical history included family history as Mother and Maternal Mother with Diabetes type 2 and none from an unknown date and unknown if ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731), via an intramuscular route of administration (at the age of 38-years), administered in arm right on 07Apr2021 20:00 as dose 1, single for COVID-19 immunization and experienced headache and tiredness. The concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache and tiredness. Patient stated that it felt more intense in the second dose in both I felt both I felt good after the second day of the vaccination. The treatment was not received for the event. The clinical outcome of the event was reported as recovered on an unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Patient took 2nd covid shot thursday running fever and has a headache; Patient took 2nd covid shot thursday running fever and has a headache; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of Covid Shot on an unspecified date, as single dose for COVID-19 immunization. The pharmacist reported that the patient took 2nd COVID shot and on an unspecified date (on Thursday) running fever and has a headache, so MD advised to hold off on shot until fever goes down. Potentially next day. Pharmacist advised that they have not heard of any known DDI'S or adverse events associated with Dupixent and COVID vaccines. No additional information was provided and stated that If require additional information, please contact the reporter directly. The outcome of the events was unknown.  Follow-up attempts are needed; Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: small flare up of hives; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. On an unspecified date, after second dose of vaccine, patient had a small flare up of hives. This was not confirmed if it was caused by vaccine or not. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia
Clinical narrative: Numbness in the hands and legs; High heart rate; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself.  A male patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE NUMBER UNKOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced numbness in the hands and legs and High heart rate. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.