chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; body and joint pain; Fatigue; body and joint pain; headache; fever; pain at injection site; chills; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EW0217 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation in Pharmacy or Drug Store. Medical history included COVID-19. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. The patient experienced fatigue, body and joint pain, headache, fever, pain at injection site, chills, swollen lymph nodes, breasts enlarged and swollen as well as tender on 10Jun2021 04:00. Reporter considered the events as non-serious. The patient underwent lab tests and procedures which included COVID-19 antigen test via nasal swab: negative on 07Jul2021. Patient visited Doctor or other healthcare professional office/clinic visit due to the events. Patient did not receive any treatment for the events. The outcome for the events was not recovered. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number ER8730 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Jun2021 13:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; body and joint pain; Fatigue; body and joint pain; headache; fever; pain at injection site; chills; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EW0217 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation in Pharmacy or Drug Store. Medical history included COVID-19. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. The patient experienced fatigue, body and joint pain, headache, fever, pain at injection site, chills, swollen lymph nodes, breasts enlarged and swollen as well as tender on 10Jun2021 04:00. Reporter considered the events as non-serious. The patient underwent lab tests and procedures which included COVID-19 antigen test via nasal swab: negative on 07Jul2021. Patient visited Doctor or other healthcare professional office/clinic visit due to the events. Patient did not receive any treatment for the events. The outcome for the events was not recovered. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number ER8730 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Jun2021 13:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Haemorrhage, Headache, Hypoaesthesia
Clinical narrative: bleed heavily with large blood clots; bleed heavily with large blood clots; chest pains; headache; hives on my neck; very sick; 2min after receiving, my throat started burning but never closed; numbness; rib pain; extremely fatigued; I recently am having some weird vision things happening; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01Jul2021 at 15:00 pm (age at the vaccination was 39 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included Ehlers Danlos. The patient did not have any known allergies. Concomitant medication the patient received within two weeks of vaccination included Amphetamine aspartate, amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jul2021, 2 mins after receiving the vaccine, the patient's throat started burning but never closed and she took antihistamines and went to work. 48 hours later a headache started and hives on her neck, a few hours later she became very sick. The next morning she woke up to hives all over her legs and chest pains she began to bleed heavily with large blood clots. A few days later she felt better but weeks have gone by and she was still getting hives, numbness, rib pain, she hemorrhaged for eight days and that started again yesterday. She was extremely fatigued and still had hives coming and going. She was recently having some weird vision things happening. Obviously she had an immediate allergic reaction to something but now the vaccine was not meshing well with her body and symptom. She did have ehlers danlos syndrome and she realized there was just no real studies for ED patients and the vaccine. She was just hoping to let someone know what was going on. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with EKG, epi pen, allergist appt, opt out of 2nd dose. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Musculoskeletal chest pain, Throat irritation, Thrombosis, Urticaria
Clinical narrative: bleed heavily with large blood clots; bleed heavily with large blood clots; chest pains; headache; hives on my neck; very sick; 2min after receiving, my throat started burning but never closed; numbness; rib pain; extremely fatigued; I recently am having some weird vision things happening; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01Jul2021 at 15:00 pm (age at the vaccination was 39 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included Ehlers Danlos. The patient did not have any known allergies. Concomitant medication the patient received within two weeks of vaccination included Amphetamine aspartate, amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jul2021, 2 mins after receiving the vaccine, the patient's throat started burning but never closed and she took antihistamines and went to work. 48 hours later a headache started and hives on her neck, a few hours later she became very sick. The next morning she woke up to hives all over her legs and chest pains she began to bleed heavily with large blood clots. A few days later she felt better but weeks have gone by and she was still getting hives, numbness, rib pain, she hemorrhaged for eight days and that started again yesterday. She was extremely fatigued and still had hives coming and going. She was recently having some weird vision things happening. Obviously she had an immediate allergic reaction to something but now the vaccine was not meshing well with her body and symptom. She did have ehlers danlos syndrome and she realized there was just no real studies for ED patients and the vaccine. She was just hoping to let someone know what was going on. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with EKG, epi pen, allergist appt, opt out of 2nd dose. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: bleed heavily with large blood clots; bleed heavily with large blood clots; chest pains; headache; hives on my neck; very sick; 2min after receiving, my throat started burning but never closed; numbness; rib pain; extremely fatigued; I recently am having some weird vision things happening; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01Jul2021 at 15:00 pm (age at the vaccination was 39 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included Ehlers Danlos. The patient did not have any known allergies. Concomitant medication the patient received within two weeks of vaccination included Amphetamine aspartate, amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jul2021, 2 mins after receiving the vaccine, the patient's throat started burning but never closed and she took antihistamines and went to work. 48 hours later a headache started and hives on her neck, a few hours later she became very sick. The next morning she woke up to hives all over her legs and chest pains she began to bleed heavily with large blood clots. A few days later she felt better but weeks have gone by and she was still getting hives, numbness, rib pain, she hemorrhaged for eight days and that started again yesterday. She was extremely fatigued and still had hives coming and going. She was recently having some weird vision things happening. Obviously she had an immediate allergic reaction to something but now the vaccine was not meshing well with her body and symptom. She did have ehlers danlos syndrome and she realized there was just no real studies for ED patients and the vaccine. She was just hoping to let someone know what was going on. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with EKG, epi pen, allergist appt, opt out of 2nd dose. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling on her left arm.; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses and had tingling on her left arm. She was going to see her doctor on 16Jul2021 however, she wanted to know if tingling was temporary or she should be concerned. Medical questions were addressed by the program forwarded/referred to medical information. The outcome of the event was unknown.  Information on the Batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Folliculitis
Clinical narrative: Folliculitis; This is a spontaneous report based on information received by a contactable consumer or other non hcp.    A 38-years-old female patient received BNT 162b2 (COVID-19 VACCINE, Solution for injection, Lot No number 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 was not reported. The patient's concomitant medications were not reported.  The patient experienced folliculitis on an unspecified date. As you may be aware, the FDA Guidelines for Post marketing Reporting of Adverse Drug Reactions (Docket No. 85D-0249) dated March 1992 (Part VI, I), require that reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant. Additionally, per 21 CFR 314.80, Post-marketing Reporting of Adverse Drug Experiences, updated 01Apr2016, the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section. We are, therefore, forwarding the information below relating to your product which was obtained by one of our employees during the normal course of business. Outcome of the event was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report from a Regulatory Authority. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 20Jun2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received the first dose of the Pfizer Covid-19 vaccine on 20Jun2021 and was scheduled to get the second dose on 12Jul2021 but did not push through because she developed flu-like symptoms. (Withheld) would like to know if his wife can make another appointment for getting the second dose or if she can just walk-in at the pharmacy. Patient mentioned he needed a interpreter. On an unspecified date in 2021, the patient experienced flu-like symptoms. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Neoplasm malignant
Clinical narrative: Caller states that the woman in the study had brain hemorrhaging and a cancerous growth, after the vaccine.; Caller states that the woman in the study had brain hemorrhaging and a cancerous growth, after the vaccine.; This is a spontaneous report from a Pfizer-sponsored program Support reported by a contactable consumer or other non-health care professional. A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that cardiologist gave him a study which reported a woman, who had the vaccine, died on the operating table, after her brain was haemorrhaging and they found a cancerous growth. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/ Batch number have been requested.; Reported Cause(s) of Death: after her brain was hemorrhaging; and they found a cancerous growth
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 5 or 6 inch big bruise on my right arm and then it coming back every week again and going. They are smaller but darker like a black; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) dose 1 via an unspecified route of administration on 27Apr2021 as single dose for COVID-19 immunisation. The patient experienced 5 or 6 inch big bruise on my right arm and then it coming back every week again and going. they were smaller but darker like a black on an unspecified date 2021. Patient stated they had the shot, COVID vaccine on the 27Apr2021 and the second one was on 18May2021 and they gave us the shot we had 5 or 6 big bruise on patient arm, they are smaller but darker like a black hollow and patient had little concerned because it happened to no one else and why it is happening. Patient was unwilling to complete the report. Patient informed about the role of Pfizer Drug Safety and Medical Information Department for the concern and was provided with the contact for Pfizer Medical Information and was informed that the department is open from Monday to Friday, from 8 am to 8 pm and 9 am to 3 pm on Saturday and Sunday as per EST. When asked for permission for further probing, consumer stated No, not right now I am in the rush. Hence, limited information available over the call. Thus, product details (LOT, NDC, UPC and expiry date) could not be probed. The outcome of the reported event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: She is having an extreme pain joint and muscle pain; She is having an extreme pain joint and muscle pain; This is a spontaneous report from a contactable consumer (Husband). A female patient (Wife) of an unspecified age received second dose of bnt162b2 (PFIZER COVID-19 VACCINE: solution for injection; Lot number: 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 first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On an unspecified date, Reporter Stated, I am calling on behalf of my wife she had her second dose of Pfizer vaccine and she is having an extreme pain joint and muscle pain and I was wondering what is okay for her to take to help her relieve that or anything at all (Unspecified Medication). The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Lymphadenopathy
Clinical narrative: lymph nodes in armpit pain; armpit pain; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 19Apr2021 (Batch/Lot number: not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced lymph nodes in armpit pain. Patient reported that today (at the time of reporting, 17Jul2021 patient was still with lymph nodes in the armpit. Patient visited the doctor, and the patient underwent the blood test which came back clear. Patient mentioned that it was a lot of time already and it was not going away. The outcome of events was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: feel bad; Her hip, knees, arms hurt; Her hip, knees, arms hurt; hardly walk; dizziness; vomiting; has no strength; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 at night, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jul2021, 1 day after the administration of first dose of vaccine, the patient felt bad and continued even at the time of reporting. On an unspecified date in Jul2021, after the administration of first dose of vaccine, the patient's hip, knees, and arms hurt. Patient had no strength and can hardly walk. Patient enquired whether this was normal. Patient also mentioned that, about 8 days ago she had a lot of dizziness and vomiting. Patient enquired whether she should get the second dose. The clinical outcome of the event feel bad was not resolved, and the clinical outcome of all other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: feel bad; Her hip, knees, arms hurt; Her hip, knees, arms hurt; hardly walk; dizziness; vomiting; has no strength; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 at night, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jul2021, 1 day after the administration of first dose of vaccine, the patient felt bad and continued even at the time of reporting. On an unspecified date in Jul2021, after the administration of first dose of vaccine, the patient's hip, knees, and arms hurt. Patient had no strength and can hardly walk. Patient enquired whether this was normal. Patient also mentioned that, about 8 days ago she had a lot of dizziness and vomiting. Patient enquired whether she should get the second dose. The clinical outcome of the event feel bad was not resolved, and the clinical outcome of all other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; tenderness at injection site; fatigue; headache; This is a spontaneous report from a contactable consumer (patient) received via a sales representative.   A 12-year-old female patient received second dose of BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. The patient experienced sore arm, tenderness at injection site, fatigue and headache, 20 hours after receiving her second Covid-19 vaccine dose.  It was reported that events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Feeling abnormal, Thrombosis, Ultrasound abdomen
Clinical narrative: Has multiple blood clots; He had been feeling different for about a week since he got the second shot.; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in upper right arm on 19Jun2021 at 12:00 (at the age of 24 years) as dose 2, single for covid-19 immunisation. The patient had no medical history and family medical history relevant to adverse events. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number was not reported) via an unspecified route of administration, in left arm on 29May2021 as dose 1, single for covid-19 immunisation. Patient had no additional vaccines administered on same date of the pfizer suspect and no prior vaccinations within 4 weeks. The reporter wanted to inform that the patient had a bad reaction to the Pfizer vaccine. On an unspecified date in 2021 patient experienced had multiple blood clots, he had been feeling different for about a week since he got the second shot. The patient was hospitalized for has multiple blood clots from 15Jul2021 to still in hospital. The blood clots were persisting and was not dissolving. On 18Jul2021 patient underwent lab tests which included CT scans, ultrasounds abdomen, and blood work waiting on results. Therapeutic measures were taken as a result of has multiple blood clots (thrombosis) includes treatment with IV Heparin. The outcome for event multiple blood clots was not recovered, and for feeling different for about a week it was unknown.  Information about Lot/Batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Dizziness, Fatigue, Feeling of body temperature change
Clinical narrative: tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation.  Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Peripheral swelling, Skin exfoliation, Skin lesion
Clinical narrative: tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation.  Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Vaccination site pain
Clinical narrative: pain at the injection site in his right arm.; nausea; upset stomach; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Right on 18Jul2021 10:30 (at the age of 68 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included 2 stents in the heart , blood disorder, cerebral disorder. Concomitant medications included donepezil hcl 10mg has been on the medication probably 6 months from 18Jul2021 for the brain; clopidogrel 75mg once a day as blood thinner has been taking forever. The patient received pneumonia shot 11 days ago. Reporter stated that her 68-year-old husband received his first dose of the Pfizer Covid-19 vaccine on 18Jul2021 and started having complaints of nausea, upset stomach from afternoon until evening on 18Jul2021 15 to 20 minutes after the shot. Is not experiencing this anymore. It lasted from the afternoon to the evening, then it stopped. Today, he started having pain at the injection site in the right arm this morning and is not so bad. Reporter was unsure if she has reported husband's AE and wanted to know if these complaints are normal and have been reported before after receiving the Pfizer Covid-19 vaccine. No treatment was received for the adverse events. No additional vaccines were administered on Same Date of the Pfizer Suspect. The adverse events did not require visit to emergency room nor physician office. The outcome of the events nausea and upset stomach was recovered on an unspecified date in 2021 and pain at the injection site was not recovered.  Information about the Lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Headache, Pyrexia
Clinical narrative: fever; stomach pain/his stomach hurts; stomach burning; he experienced a bad headache/head hurt really bad; This is a spontaneous report from a contactable consumer or other non hcp (Daughter) reporting for father (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date are unknown), via an unspecified route of administration on 15Jul2021 between 16:00-18:00 at the age of 55-years-old as dose 2, single for COVID-19 immunisation. Patient's medical history including any illness at time of vaccination and concurrent conditions included ongoing High Blood Pressure and ongoing Cholesterol from unspecified date. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as dose 1, single for COVID-19 immunisation. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations within 4 weeks were none. AE(s) following prior vaccinations were none. Family medical history relevant to AE(s) was none. Relevant tests were none. Patient age at time of vaccination was 55 years. On 15Jul2021, the patient experienced headache, head hurt really bad, stomach hurts and burns and on 18Jul2021, experienced fever. Caller was a caregiver calling on behalf of her 55-year-old father. The caller reports that he received his second dose of the Pfizer BIONTECH COVID-19 vaccine on 15Jul2021. Afterwards he experienced a bad headache and a fever, those symptoms have since resolved. He was now experiencing stomach pain, stomach burning and diarrhea. The case was reported as non-serious. The patient took received Tylenol as treatment for headaches and pyrexia. The outcome of event headache was recovered on 15Jul2021 and fever was recovered on 18Jul2021 while other events were not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt a little bad on the day patient had his 2nd Covid-19 vaccine; This is a spontaneous report from a non-contactable consumer (patient) received by Pfizer from Novartis. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization . The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization. The patient felt a little bad on the day he had his 2nd covid-19 vaccine (on an unspecified date). The outcome of the event was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: had temperature of 100; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported had temperature of 100 on an unspecified date. Patient had second vaccine and then had temperature of 100. Wanted to know how to bring temperature down. Patient disconnected before reading Isi. The patient underwent lab tests and procedures which included body temperature: 100. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Now the muscle in her arm still hurts when she rotates it 360 degrees; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm on 31Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 11Mar2021 for covid-19 immunisation. On an unspecified date caller states she had to request her second dose be in her opposite arm of the first dose because it was still sore from the first dose, and now the muscle in her arm still hurts when she rotates it 360 degrees. Caller states it also hurts when she extends her arm backwards. Caller asks if other people have had this or should she go see a doctor. Caller also asks which HCP she should go to. Caller states so it looks to me that either I go to my doctor and pay my own bills or I hire a lawyer and have you guys pay for it. So, Pfizer is basically offering no follow up for patients in terms of maybe looking themselves and assessing my arm them-selves, nothing. You, Pfizer will not have your doctors look at my arm. So, this legal department could reimburse me for my expenditure. So, the possibility of going to an office owned by Pfizer where there are doctors working with Pfizer checking my arm out themselves, by Pfizer isn't an option. Either I go to my doctor and submit a claim for reimbursement or that's it. Pfizer will not check my arm and they do not have doctors to see my arm or evaluate my arm or suggest any course of action as a result of taking the vaccine in that arm is that correct? I do want to share that this conversation is also recorded on my end on my side, and I will be taking this further thank you so much. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: low grade fever; Shakiness; This is a spontaneous report from a non-contactable consumer (Patient's mother) received from the Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 16Jul2021, as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported.  The patient experienced low grade fever and shakiness on Jul2021. The reporter would like to know if it is okay for patient to take Tylenol. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes outbreak 72 hours after second dose; This is a spontaneous report from a contactable consumer or other non hcp (patient reporting for herself). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 16Jul2021 at 16:00 as dose 2, single dose for covid-19 immunization (at the age of 46-years-old). Medical history included ovarian cyst and fibroids from an unknown date and unknown if ongoing and patient had known allergies of gluten, MSG (monosodium glutamate) and quinoa. Concomitant medication(s) included clonazepam (KLONOPIN) taken for an unspecified indication and start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19. Since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor's office/urgent care. It was reported that the patient experienced herpes outbreak 72 hours after second dose of vaccine on 19Jul2021 at 17:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received the treatment for the event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: numbness in her body; Dizziness; Blurred vision; difficulty sleeping since taking the pfizer covid vaccine; has to take breaks if she goes for a walk; numbness has been giving her a lot of pain and is getting worse; she cannot drive or work; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 59-year-old female patient second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on May2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Apr2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization and the patient reported that she received first dose of pfizer covid vaccine on either April 12th or 13th, after 18 days starting on 30Apr2021, caller reports symptoms like numbness (started on right side, spread to left side including her fingers) and numbness all over body including tongue. The patient stated that after she received her 2nd dose on either May 2 or 3rd, she developed numbness in her body. A few days after the 2nd dose, she reports dizziness and blurred vision. She went to the emergency department had a CT scan, but they didn't find anything. She was prescribed Meclizine. After she took the medication, the dizziness and blurred vision resolved however, she still had ongoing numbness in her body, and it has spread to her back. On 13Jul2021, she saw a neurologist; was given some vitamins, B2, magnesium, Q 10. On the 16Jul2021, she had another MRI test which results unknown. She could not drive or work and has to take breaks if she went for a walk. She reported numbness has been for 2 months and 20 days. She also stated numbness has been giving her a lot of pain and was getting worse. She was concerned that it will continue to get worse. Also reported she has had difficulty sleeping since taking the pfizer covid vaccine and needs to take a sleeping pill and asking for reason she was having numbness (i.e. was it related to vaccine) and also asking for treatment advice. Outcome of the event dizziness and blurred vision was recovered on an unspecified date in 2021. Outcome of the events she cannot drive or work and has to take breaks if she goes for a walk was unknown and for all other events, it was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging, Pain, Vision blurred
Clinical narrative: numbness in her body; Dizziness; Blurred vision; difficulty sleeping since taking the pfizer covid vaccine; has to take breaks if she goes for a walk; numbness has been giving her a lot of pain and is getting worse; she cannot drive or work; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 59-year-old female patient second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on May2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Apr2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization and the patient reported that she received first dose of pfizer covid vaccine on either April 12th or 13th, after 18 days starting on 30Apr2021, caller reports symptoms like numbness (started on right side, spread to left side including her fingers) and numbness all over body including tongue. The patient stated that after she received her 2nd dose on either May 2 or 3rd, she developed numbness in her body. A few days after the 2nd dose, she reports dizziness and blurred vision. She went to the emergency department had a CT scan, but they didn't find anything. She was prescribed Meclizine. After she took the medication, the dizziness and blurred vision resolved however, she still had ongoing numbness in her body, and it has spread to her back. On 13Jul2021, she saw a neurologist; was given some vitamins, B2, magnesium, Q 10. On the 16Jul2021, she had another MRI test which results unknown. She could not drive or work and has to take breaks if she went for a walk. She reported numbness has been for 2 months and 20 days. She also stated numbness has been giving her a lot of pain and was getting worse. She was concerned that it will continue to get worse. Also reported she has had difficulty sleeping since taking the pfizer covid vaccine and needs to take a sleeping pill and asking for reason she was having numbness (i.e. was it related to vaccine) and also asking for treatment advice. Outcome of the event dizziness and blurred vision was recovered on an unspecified date in 2021. Outcome of the events she cannot drive or work and has to take breaks if she goes for a walk was unknown and for all other events, it was not recovered.  Information on the lot/batch number has been requested.