chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Investigation, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: severe chest pressure; shortness of breath; This is a spontaneous report from a contactable consumer (patient herself). A 13-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ew0180; Expiration date: unknown) via an unspecified route of administration, administered in Right arm on 05Jun2021 at 13:00 PM as Dose 2,single for COVID-19 immunization. The patient's medical history included behcet's syndrome, crest syndrome antibody, allergy to plants. Concomitant medications included colchicine (COLCHICINE), calcium carbonate, colecalciferol (VITAMIN D 2000), iron (IRON), cetirizine hydrochloride (ZYRTEC ALLER-GY) taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Eq0170; Expiration date: unknown) via an unspecified route of administration, administered in Left arm on 14May2021 at 4:00 PM as Dose 1,Single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. It was reported that, 8 days post vaccination on 13Jun2021 08:00 patient had severe chest pressure and shortness of breath. Previously was significantly athlethic and danced 30-40 hours a week, no she was unable to dance or even walk without feeling like she could not breathe.  ER in  said they have had 2 other cases with similar symptoms 8-10 days post vaccination. Her labs checked out which was okay but she was not breathing normally. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of severe chest pressure and shortness of breath as patient had received mortin, tylenol, steroids and breathing treatments. The patient underwent lab tests and procedures which included SARS-COV-2 test which was negative on 16Jun2021. Since the vaccination, has the patient been tested for COVID-19. The outcome of events was not recovered.  Follow up attempt is excepted. Further information is requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021739775 same reporter/drug/AE, different patient
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, SARS-CoV-2 test
Clinical narrative: severe chest pressure; shortness of breath; This is a spontaneous report from a contactable consumer (patient herself). A 13-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ew0180; Expiration date: unknown) via an unspecified route of administration, administered in Right arm on 05Jun2021 at 13:00 PM as Dose 2,single for COVID-19 immunization. The patient's medical history included behcet's syndrome, crest syndrome antibody, allergy to plants. Concomitant medications included colchicine (COLCHICINE), calcium carbonate, colecalciferol (VITAMIN D 2000), iron (IRON), cetirizine hydrochloride (ZYRTEC ALLER-GY) taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Eq0170; Expiration date: unknown) via an unspecified route of administration, administered in Left arm on 14May2021 at 4:00 PM as Dose 1,Single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. It was reported that, 8 days post vaccination on 13Jun2021 08:00 patient had severe chest pressure and shortness of breath. Previously was significantly athlethic and danced 30-40 hours a week, no she was unable to dance or even walk without feeling like she could not breathe.  ER in  said they have had 2 other cases with similar symptoms 8-10 days post vaccination. Her labs checked out which was okay but she was not breathing normally. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of severe chest pressure and shortness of breath as patient had received mortin, tylenol, steroids and breathing treatments. The patient underwent lab tests and procedures which included SARS-COV-2 test which was negative on 16Jun2021. Since the vaccination, has the patient been tested for COVID-19. The outcome of events was not recovered.  Follow up attempt is excepted. Further information is requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021739775 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Received the first dose of the Pfizer covid 19 vaccine then contracted covid twenty days afterwards; Received the first dose of the Pfizer covid 19 vaccine then contracted covid twenty days afterwards; This is a spontaneous report from a contactable Other Health Professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 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. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of the Pfizer covid 19 vaccine then contracted covid twenty days afterwards. The patient enquired about receiving the second dose of the vaccine since it has been almost two months since his receiving his first dose. The patient was also wondering about receiving other vaccines. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache
Clinical narrative: About one hour after the vaccine he started experiencing intermittent sharp pain down the left side of his hear near the ear; Also had some dizziness present; sharp pains going down the left side of his head; This is a spontaneous report from a contactable consumer (patient reported for himself). The report was not related to a study or programme. An 88-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 18Jun2021 at 11:00AM, as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received his fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single for covid-19 immunisation. On 18Jun2021, about one hour after the vaccine, the patient started experiencing intermittent sharp pain down the left side of his hear near the ear, also had some dizziness present and sharp pains going down the left side of his head. The clinical course of the event as follows: patient stated that he took the second Pfizer Covid shot at 11am in the morning on 18Jun2021. Around one hour after the shot he began to have sharp pains going down the left side of his head that comes and goes. He was reading from the list and it says about having headaches, but what he had are not headaches and reported that they occur every 10 to 15 minutes and it comes down the head and is a little dizzy. The outcome of the events was unknown.   Declines to provide an address but provides an email address. Declines to provide further report details and wants to ask about the side effect.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: Complaints of burning and itching between her elbow and shoulder and then it went across her chest above her breast, onto her neck and into her right upper arm down into elbow; Complaints of burning and itching between her elbow and shoulder and then it went across her chest above her breast, onto her neck and into her right upper arm down into elbow; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included fibromyalgia, allergic to benadryl and migraine (She only tolerates steroids in baby doses, and she does this when she gets a shot for migraines that is going to knock her out). The patient's concomitant medications were not reported. She went to the medical center yesterday to get it. She has a lot of medical allergies. On an unknown date, the patient complaints of burning and itching between her elbow and shoulder and then it went across her chest above her breast, onto her neck and into her right upper arm down into elbow. The patient had taken Meclizine and Tylenol as treatment for the events, and it has calmed down. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches/ Got worse around 30 to 45 minutes; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program and medical information team. A 25-year-old male patient (reporter's son, stated that patient was grown, he was 25) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0151), via an unspecified route of administration in right arm on 18Jun2021 about 12:40 pm (at the age of 25-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included surgery to remove tumors, headaches, problems with his eyes. Had this 5 months ago. Thought he has scar tissue from the surgery. They removed some tumors. They were not cancer or anything like that. He had tubes coming from each side where the fluid drained out. It was scar tissue from that that would heal up. It was swollen there. Concomitant medications included none. Family history included cancer, COPD, diabetes, dementia, and glaucoma. Reporter and patient's father both have cancer, COPD, diabetes. Patient's father has dementia and glaucoma, so they are high risk. It was to protect them, and reporter's grandson was also a high risk. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not administered additional vaccines on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The only reaction was to that contrast stuff they give for an MRI. It was reported that, clarified with reporter that she was calling regarding the Pfizer COVID-19 vaccine. Reporter was calling on behalf of her son who received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 18Jun2021 and reported having some headaches on 18Jun2021. Reporter asked if they could take Tylenol or Ibuprofen. Reporter wanted to verify because she has been told that some medications might "lessen the effect of the vaccine". They also do not have their second dose appointment scheduled. It was reported that, had a slight headache before. He gets headaches and has problems with his eyes. He doesn't wear glasses like he should. He hadn't eaten anything either. It got really bad after the shot. He started really complaining more about 30 to 45 minutes before calling. Got worse around 30 to 45 minutes before the reporter made this call. No investigation assessment. No relevant tests. The adverse event did not require a visit to emergency room and physician office. No treatment medications was received for the adverse event, they were wondering if he could take something. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for COVID 2 weeks post vaccination; She tested positive for COVID 2 weeks post vaccination; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 22Jan2021 as DOSE 1 ,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she tested positive for covid 2 weeks post vaccination on an unspecified date in 2021 ,patient said that She never received her second dose. She was tested positive for COVID 2 weeks post vaccination and she wanted to know whether she can receive the second dose or should she had restart the vaccination response received was vaccination of people with SARS-CoV-2 infection should be differed until the person had recovered from the acute illness suggested that the risk of SARS-CoV-2 reinfection was low in the months after initial infection but might increase with time due to warning immunity patient was tested positive after vaccine, second dose beyond 21 days. CEP 159558. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cough, Deafness, Nasal congestion
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 37-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25May2021 at 11:00 as dose 2, single (at age of 37-years old) for COVID-19 immunization. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously took first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered on an unspecified date as single dose for COVID-19 immunization, and there was no reaction on previous exposure to drug. The patient had drug allergy to omeprazole (PRILOSEC). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 01Jun2021 at 12:00 AM, the patient experienced hearing loss in right ear, right upper stomach pain, fever, chills, cough, and congestion. No treatment was received for all events. The outcome for all events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 37-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25May2021 at 11:00 as dose 2, single (at age of 37-years old) for COVID-19 immunization. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously took first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered on an unspecified date as single dose for COVID-19 immunization, and there was no reaction on previous exposure to drug. The patient had drug allergy to omeprazole (PRILOSEC). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 01Jun2021 at 12:00 AM, the patient experienced hearing loss in right ear, right upper stomach pain, fever, chills, cough, and congestion. No treatment was received for all events. The outcome for all events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Erythema, Flushing, Gingival swelling, Oropharyngeal discomfort
Clinical narrative: Gums started swelling; lips got tingly; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; stretching of her throat; felt dry; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW 0162), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 10:28 (at the age of 47-years-old) as single dose for COVID-19 immunization at doctor's office/urgent care facility. Medical history included seizures, migraines and allergy to Anti-Fungal Medications. Concomitant medication(s) included sumatriptan succinate (IMITREX); calcium; lamotrigine (LAMICTAL), and multivitamin, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Apr2021 at 10:45, reaction started with stretching of her throat and felt dry. She drank some water. At 11:00 gums started swelling and her lips got tingly. Her hands, feet, tongue, and face got red and flushed. She was sent to the ER for observation. Since then she had been on 6 rounds of steroids to try to control the reactions. She had 7 additional reactions within the 9 weeks after the vaccine. She was still on 40 mg of Zyrtec and Pepcid a day to keep down the reaction. She has been to multiple doctors and nobody could figure what the vaccine did to her system. She asked to help her to stop these reactions. Seriousness criteria was reported as Disabling/Incapacitating. Events resulted visit to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Received treatment for the adverse event with Benadryl, Zyrtec, Steroids', and Pepcid. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue erythema
Clinical narrative: Gums started swelling; lips got tingly; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; stretching of her throat; felt dry; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW 0162), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 10:28 (at the age of 47-years-old) as single dose for COVID-19 immunization at doctor's office/urgent care facility. Medical history included seizures, migraines and allergy to Anti-Fungal Medications. Concomitant medication(s) included sumatriptan succinate (IMITREX); calcium; lamotrigine (LAMICTAL), and multivitamin, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Apr2021 at 10:45, reaction started with stretching of her throat and felt dry. She drank some water. At 11:00 gums started swelling and her lips got tingly. Her hands, feet, tongue, and face got red and flushed. She was sent to the ER for observation. Since then she had been on 6 rounds of steroids to try to control the reactions. She had 7 additional reactions within the 9 weeks after the vaccine. She was still on 40 mg of Zyrtec and Pepcid a day to keep down the reaction. She has been to multiple doctors and nobody could figure what the vaccine did to her system. She asked to help her to stop these reactions. Seriousness criteria was reported as Disabling/Incapacitating. Events resulted visit to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Received treatment for the adverse event with Benadryl, Zyrtec, Steroids', and Pepcid. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Dyspnoea, Headache, Pain
Clinical narrative: asthma/hard time breathing; Fever; aches; chills; headache; asthma/hard time breathing; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.   A 12-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate (FLOVENT); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) as needed and Multivitamin. No relevant past drug history. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 17Jun2021 morning the patient had Fever, aches, chills, headache, and asthma/hard time breathing. The outcome for all events was recovered on 19Jun2021.  Follow-up attempts are possible. Further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: asthma/hard time breathing; Fever; aches; chills; headache; asthma/hard time breathing; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.   A 12-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate (FLOVENT); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) as needed and Multivitamin. No relevant past drug history. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 17Jun2021 morning the patient had Fever, aches, chills, headache, and asthma/hard time breathing. The outcome for all events was recovered on 19Jun2021.  Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: she got violently ill; This is a spontaneous report from a Pfizer-sponsored program. A contactable Certified Pharmacy Technician (CPhT) and a 62-year-old female consumer (patient) reported that patent started to receive palbociclib (IBRANCE, tablet) oral on 26May2021 at 15 mg for malignant neoplasm of unspecified site of right female breast and BNT162B2 on an unknown date, as single dose, for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, patient reports, will not be taking medication until after 03Jul2021 and may lower her dosage due to she got violently ill when she got her Covid shot and was taking the Ibrance medication so she was going to hold off on medication. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Laboratory test, Loss of consciousness, Nausea
Clinical narrative: Vasovagal syncope with unconsciousness; Vasovagal syncope with unconsciousness; Ongoing Light headedness; nausea; Headaches; This is a spontaneous report from a contactable consumer. A 45-year-old non pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 09Jun2021 10:00 (at the age of 45-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. 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 historical vaccine includes BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation and did not experience any reaction. On 11Jun2021 19:00, patient experienced vasovagal syncope with unconsciousness, ongoing light headedness, nausea, headaches. The patient underwent lab tests and procedures which included laboratory test: normal on an unknown date in 2021. The events resulted in emergency room visit. No treatment was taken as a result of events. The reporter assessed the events as non-serious. The outcome of the events were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vasovagal syncope with unconsciousness; Vasovagal syncope with unconsciousness; Ongoing Light headedness; nausea; Headaches; This is a spontaneous report from a contactable consumer. A 45-year-old non pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 09Jun2021 10:00 (at the age of 45-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. 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 historical vaccine includes BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation and did not experience any reaction. On 11Jun2021 19:00, patient experienced vasovagal syncope with unconsciousness, ongoing light headedness, nausea, headaches. The patient underwent lab tests and procedures which included laboratory test: normal on an unknown date in 2021. The events resulted in emergency room visit. No treatment was taken as a result of events. The reporter assessed the events as non-serious. The outcome of the events were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac flutter, Cardiac stress test, Electrocardiogram
Clinical narrative: 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 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart flutter, ticking. Reporter was a little bit upset and that was really her question. Patient reported cardiac symptoms after the first COVID-19 vaccine and was seen at the emergency room as directed by primary care physician. She received an EKG, blood work since has gone for a stress test as evaluated by her primary care physician and everything's coming back negative. Heart flutter symptom was more intense throughout day less and less now, so it feels like a flutter and throughout the day. She has also read information from the CDC about myocarditis and pericarditis and wanted to make sure everything she is experiencing was reported. Patient has already reported it a couple of times, the agent do not tell that in MI as they don' list any cardiac side effects of adverse events so she was more curious about the questionnaire that was sent out. It was stated that she was just frustrated, why do she waste her time. The patient underwent lab tests and procedures which included blood test resulted as negative, stress test resulted as negative, EKG resulted as negative on an unspecified date. The outcome of event was recovering. Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone decreased, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: TSH reading of zero; Subacute Thryoiditits Inflamed painful thyroid; elevated t4; Subacute Thryoiditits Inflamed painful thyroid; Subacute Thryoiditits Inflamed painful thyroid; Extreme fatique; headaches; muscle aches; feeling like i have the flu; This is a spontaneous report from a contactable consumer. This 60-year-old female consumer (patient) reported for herself that. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 16:30 (Batch/Lot Number: EW0171) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration in in Arm Left on Apr2021 16:30 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included patient had Subacute thyroidities at age 47. Concomitant medications included progesterone (PROMETRIUM [PROGESTERONE]) and estradiol both taken for an unspecified indication, start and stop date were not reported.  The patient previously took cipr for allergy. It was reported that on 14May2021 patient experienced Subacute Thryoiditits Inflamed painful thyroid, TSH reading of zero (medically significant), elevated t4, Extreme fatigue, headaches, muscle aches, feeling like she have the flu. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient did not test for COVID-19. Outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid pain, Thyroiditis, Thyroiditis subacute, Thyroxine increased
Clinical narrative: TSH reading of zero; Subacute Thryoiditits Inflamed painful thyroid; elevated t4; Subacute Thryoiditits Inflamed painful thyroid; Subacute Thryoiditits Inflamed painful thyroid; Extreme fatique; headaches; muscle aches; feeling like i have the flu; This is a spontaneous report from a contactable consumer. This 60-year-old female consumer (patient) reported for herself that. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 16:30 (Batch/Lot Number: EW0171) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration in in Arm Left on Apr2021 16:30 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included patient had Subacute thyroidities at age 47. Concomitant medications included progesterone (PROMETRIUM [PROGESTERONE]) and estradiol both taken for an unspecified indication, start and stop date were not reported.  The patient previously took cipr for allergy. It was reported that on 14May2021 patient experienced Subacute Thryoiditits Inflamed painful thyroid, TSH reading of zero (medically significant), elevated t4, Extreme fatigue, headaches, muscle aches, feeling like she have the flu. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient did not test for COVID-19. Outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash pruritic
Clinical narrative: itchy rash behind right knee/ delayed rash reaction; mild widespread itching; slight left arm soreness; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:30 (Lot Number: ER8727) at the age of 66-year-old as a single dose for covid-19 immunisation from hospital. Prior to the COVID vaccination the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. The patient was not tested for COVID-19 after the vaccination Medical history included ovarian cancer survivor, allergic asthma (not chronic) allergies to shingrix vaccine and sulfa drugs, all from an unknown date and unknown if ongoing. Concomitant medications included losartan, rosuvastatin, timolol, latanoprost, Alph all taken for an unspecified indication, start and stop date were not reported.  After vaccination, patient waited with emergency medical technician for 30 min with no reaction to 1st dose. On unspecified date in Mar2021 at home, patient had mild widespread itching & slight left arm soreness. On 25Mar2021, 03:30 am patient developed itchy rash behind right knee, which was confirmed as a delayed rash reaction to 1st dose by nurse on 13Apr2021.The outcome of the events was recovered with no treatment received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Nausea; Headache; Joint pain; Fatigue; This is a spontaneous report from a non-contactable consumer received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for covid-19 immunization and no reaction was experienced on previous exposure to vaccine. The patient experienced nausea, headache, joint pain, and fatigue after the second shot. The patient experienced the events for 24 hours and on the following day the symptoms resolved. It was reported that the events took place after use of product. The outcome for the events were recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Nausea, Pain in extremity, Rash
Clinical narrative: felt very sick; small rashes; sore arm; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of an unspecified age reported to 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 14Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt very sick, small rashes, sore arm, nausea. it was reported that patient wanted to know how long the reaction lasts and what medication she can take. She also mentioned that her husband took the first dose but did not have any reactions. The outcomes of all reported events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pruritus, Pyrexia
Clinical narrative: felt very sick; small rashes; sore arm; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of an unspecified age reported to 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 14Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt very sick, small rashes, sore arm, nausea. it was reported that patient wanted to know how long the reaction lasts and what medication she can take. She also mentioned that her husband took the first dose but did not have any reactions. The outcomes of all reported events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8737/Batch was not reported), dose 1 via an unspecified route of administration, administered in arm left 03Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation and experienced muscle pain in upper right arm on 05Apr2021. The reporter stated that patient received the vaccine in left arm on 03apr2021. On 05apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse and contacted her physician. Physician ran multiple blood work, ruled out possibilities and gave me a diagnosis of PMR (polymyalgia rheumatica). Started prednisone 30 msg on 24May21 in decreasing doses. Pain was relieved and she still on the medication. The reporter stated that patient have never experienced such intense pain in her life. Physician attributed her pain to the vaccine. The event polymyalgia rheumatica assessed as serious. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. The reporter stated the events result Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of patient for the events with prednisone 30 msg started on 24May2021. The outcome of the events pain in extremity, condition aggravated was resolving and polymyalgia rheumatica was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Chills, Myalgia, Pain, Pain in extremity
Clinical narrative: A day of chills, body aches, and ibuprofen after the 3rd dose/have a little bit of chills; A day of chills, body aches, and ibuprofen after the 3rd dose; a little bit of muscle ache; arm soreness like he'd gotten a "hard punch in the shoulder."; side effects; he ofered up his arm for a third jab; This is a spontaneous report from a contactable healthcare professional, based on information received by Pfizer, for BNT162B2.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose for covid-19 immunization; first dose of covid-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a day of chills, body aches, and ibuprofen after the 3rd dose and have a little bit of chills, a little bit of muscle ache, arm soreness like he'd gotten a "hard punch in the shoulder", side effects, he ofered up his arm for a third jab. Therapeutic measures were taken as a result of a day of chills, body aches, and ibuprofen after the 3rd dose/have a little bit of chills, a day of chills, body aches, and ibuprofen after the 3rd dose, arm soreness like he'd gotten a "hard punch in the shoulder". The outcome of event was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: A day of chills, body aches, and ibuprofen after the 3rd dose/have a little bit of chills; A day of chills, body aches, and ibuprofen after the 3rd dose; a little bit of muscle ache; arm soreness like he'd gotten a "hard punch in the shoulder."; side effects; he ofered up his arm for a third jab; This is a spontaneous report from a contactable healthcare professional, based on information received by Pfizer, for BNT162B2.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose for covid-19 immunization; first dose of covid-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a day of chills, body aches, and ibuprofen after the 3rd dose and have a little bit of chills, a little bit of muscle ache, arm soreness like he'd gotten a "hard punch in the shoulder", side effects, he ofered up his arm for a third jab. Therapeutic measures were taken as a result of a day of chills, body aches, and ibuprofen after the 3rd dose/have a little bit of chills, a day of chills, body aches, and ibuprofen after the 3rd dose, arm soreness like he'd gotten a "hard punch in the shoulder". The outcome of event was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Laboratory test abnormal, Memory impairment, Neurological symptom
Clinical narrative: Problems with Sleep; can't sleep the required hours; Horrible Extreme Fatigue; had 2 blood tests done and both were abnormal with no answers from the doctors; poisoned by the vaccine; developed a tick in her right eye; neurological problems; last February or March but she could not remember the date; This is a spontaneous report from a Pfizer- COVAX. A contactable 82-year-old female consumer(patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:00-15:00 (did not exactly remember) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that it had been many years since she had taken vaccines. She stated that she got her first dose last February or March but she could not remember the date. She stated that she experienced side effects from the vaccine, and she had problems with sleep, she could not sleep the required hours. Her blood tests, 2 of them, were abnormal. The doctors said that they did not know whether they were abnormal. She had horrible extreme fatigue. She reported that she wasn't going to take the vaccine but every doctor pushed her to take the vaccine and so she took it, and now this company had destroyed her health. She reported that she was 82 and she was in good health. She just heard about the extreme fatigue, she didn't know that was from the vaccine also. She assumed that the vaccine caused her neurological problems. She developed, about month and a half ago, she developed a tick in her right eye and she didn't know what it was from. Her side effects started in the early Spring, probably March. She knew something was different but she didn't put it together with the shot and she didn't think about it. She did not visit emergency room as wasn't smart enough to go to the ER, she never thought it was from the vaccine. She went to doctor with the extreme fatigue and that was how found out about abnormal bloodwork and then she had more blood work done and it was abnormal too. These were things she had never had before. She was not sure if she went to the doctor in March or April. She knew that she had 2 blood tests done and both were abnormal with no answers from the doctors. She had not received her second vaccine. Also, stated that she was poisoned by the vaccine. No treatment taken as nobody knew what to do. She stated that like an idiot, she took it. The outcome of all events were not recovered except the outcome of event short-term memory impairment was unknown.  Follow-up attempts were needed. Further information was expected.