chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: spotted after second dose of product; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. It was reported that the reporter wanted to report on a side effect she had after the second vaccine. She said she spotted the next morning after the second vaccine. Two of her coworkers spotted as well. She said women were talking. Reporter wanted to let us know so then we would have data on it. Reporter confirmed it was the Pfizer COVID Vaccine. The outcome of the event was unknown  Information regarding the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021728021 Same reporter/ drug, different patient/ AE;US-PFIZER INC-2021728483 Same reporter/ drug, different patient/ AE
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm sore at the injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0187), via an unspecified route of administration, administered in Arm on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient reported that she received her second dose of Pfizer vaccine two weeks ago and she mentioned that until now from two weeks now her arm was still sore, which was at the injection site. She was just calling because she wanted to know about the side effect. She did not know whether to go through urgent care to have a check out or its just like a normal. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cardiac tamponade, Chills, Dizziness, Dyspnoea
Clinical narrative: Patient presented with large circumferential pericardial effusion with cardiac tamponade; Patient presented with large circumferential pericardial effusion with cardiac tamponade; shortness of breath and lightheadedness for the past few days; shortness of breath and lightheadedness for the past few days; nausea; intermittent fevers and chills/temperature reaching 102 Fahrenheit; intermittent fevers and chills; Vomiting; She Cannot lay backwards; This is a spontaneous report from a non-contactable other HCP. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular administered in Arm Left on 10Jun2021 (age at vaccination: 39-years-old) (Batch/Lot Number: EW0181) as single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took remicade and experienced allergy; bnt162b2, dose 1 intramuscular administered in Arm Left on 20May2021 (Batch/Lot Number: EW0185) for COVID-19 immunization. Age at vaccination was 39 years old. The patient experienced patient presented with large circumferential pericardial effusion with cardiac tamponade, shortness of breath and lightheadedness for the past few days, nausea, intermittent fevers and chills, vomiting, she cannot lay backwards on 15Jun2021 with outcome of recovering, reported as hospitalization, life threatening. Treatment received for the adverse event included Pericardiocentesis. Since the vaccination, patient has not been tested for COVID-19. Clinical course reported as follow: Patient presented with large circumferential pericardial effusion with cardiac tamponade, shortness of breath and lightheadedness for the past few days, that started after she got the second COVID-19 vaccine, Pfizer. She said nausea, vomiting, intermittent fevers and chills, and shortness of breath that have waxed and waned over the past 2 days but immediately got worse today. She could not lay backwards, her symptoms felt better leaning forwards. She was also had fevers and chills, temperature reaching 102 Fahrenheit. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jun2021, Covid19 PCR (Nasal Swab): Negative on 15Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Pericardial effusion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient presented with large circumferential pericardial effusion with cardiac tamponade; Patient presented with large circumferential pericardial effusion with cardiac tamponade; shortness of breath and lightheadedness for the past few days; shortness of breath and lightheadedness for the past few days; nausea; intermittent fevers and chills/temperature reaching 102 Fahrenheit; intermittent fevers and chills; Vomiting; She Cannot lay backwards; This is a spontaneous report from a non-contactable other HCP. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular administered in Arm Left on 10Jun2021 (age at vaccination: 39-years-old) (Batch/Lot Number: EW0181) as single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took remicade and experienced allergy; bnt162b2, dose 1 intramuscular administered in Arm Left on 20May2021 (Batch/Lot Number: EW0185) for COVID-19 immunization. Age at vaccination was 39 years old. The patient experienced patient presented with large circumferential pericardial effusion with cardiac tamponade, shortness of breath and lightheadedness for the past few days, nausea, intermittent fevers and chills, vomiting, she cannot lay backwards on 15Jun2021 with outcome of recovering, reported as hospitalization, life threatening. Treatment received for the adverse event included Pericardiocentesis. Since the vaccination, patient has not been tested for COVID-19. Clinical course reported as follow: Patient presented with large circumferential pericardial effusion with cardiac tamponade, shortness of breath and lightheadedness for the past few days, that started after she got the second COVID-19 vaccine, Pfizer. She said nausea, vomiting, intermittent fevers and chills, and shortness of breath that have waxed and waned over the past 2 days but immediately got worse today. She could not lay backwards, her symptoms felt better leaning forwards. She was also had fevers and chills, temperature reaching 102 Fahrenheit. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jun2021, Covid19 PCR (Nasal Swab): Negative on 15Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient presented with large circumferential pericardial effusion with cardiac tamponade; Patient presented with large circumferential pericardial effusion with cardiac tamponade; shortness of breath and lightheadedness for the past few days; shortness of breath and lightheadedness for the past few days; nausea; intermittent fevers and chills/temperature reaching 102 Fahrenheit; intermittent fevers and chills; Vomiting; She Cannot lay backwards; This is a spontaneous report from a non-contactable other HCP. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular administered in Arm Left on 10Jun2021 (age at vaccination: 39-years-old) (Batch/Lot Number: EW0181) as single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took remicade and experienced allergy; bnt162b2, dose 1 intramuscular administered in Arm Left on 20May2021 (Batch/Lot Number: EW0185) for COVID-19 immunization. Age at vaccination was 39 years old. The patient experienced patient presented with large circumferential pericardial effusion with cardiac tamponade, shortness of breath and lightheadedness for the past few days, nausea, intermittent fevers and chills, vomiting, she cannot lay backwards on 15Jun2021 with outcome of recovering, reported as hospitalization, life threatening. Treatment received for the adverse event included Pericardiocentesis. Since the vaccination, patient has not been tested for COVID-19. Clinical course reported as follow: Patient presented with large circumferential pericardial effusion with cardiac tamponade, shortness of breath and lightheadedness for the past few days, that started after she got the second COVID-19 vaccine, Pfizer. She said nausea, vomiting, intermittent fevers and chills, and shortness of breath that have waxed and waned over the past 2 days but immediately got worse today. She could not lay backwards, her symptoms felt better leaning forwards. She was also had fevers and chills, temperature reaching 102 Fahrenheit. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on 15Jun2021, Covid19 PCR (Nasal Swab): Negative on 15Jun2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Terrible Itching; This is a spontaneous report from a contactable consumer (Neighbour of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration on 16Mar2021, as 2nd dose, single for COVID-19 immunization. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date, as 1st dose, single for COVID-19 immunization. No reaction on previous exposure to drug. The patient medical history and concomitant medications were not reported.  She received 2nd dose of vaccine on 16Mar2021 and had terrible itching. No more information reporter share. Once confirm was it Moderna vaccine. She said sorry It was not Moderna covid vaccine but Pfizer vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Breast pain, Chest discomfort, Chest pain, Chills
Clinical narrative: Heart palpitations; Chest pain; Lightheaded; Weird feeling in both arms; Shakes; Random other pains; Breast pain; Feeling anxious; Depressed; Highly emotional; Chest pain/tightness; Chills; Injection site pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730) via unspecified route of administration in the left arm, on 02Apr2021 at 07:00 PM as a 2nd dose, single for COVID-19 Immunization. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6202) via unspecified route of administration in the left arm, on 12Mar2021 at 07:00 PM as a 1st dose, single for COVID-19 Immunization and experienced 2 weeks after 1st dose, pain in both big toes lasting 5-7days ending with dark purple colour under both big toe nails. The patient was 72-year-old at the time of vaccination. Medical history was not reported. The patient received concomitant medication included unspecified vitamins.The patient had no known allergies. On 17Apr2021 at 08:00 AM (Reported as 2 weeks after 2nd dose), the patient experienced heart palpitations, chest pain, lightheaded, weird feeling in both arms, later chills and shakes. It was reported that for the next 10-14 days, experienced waves of chest pain, injection site pain, random other pains, breast pain, feeling anxious, depressed, highly emotional. A few weeks later, again experienced chest pain/tightness, breast pain, weird feeling in arms, all symptoms can last anywhere from a few minutes, a few hours to a few days at a time, which is still continuing to the present. The patient visited emergency room/ department. The patient did not receive any treatment for the events. 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 and Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed the events as non-serious (serious: no). It was reported that the patient was recovered with lasting effects (Recovered/resolved with sequel).   Device Date : 17Jun2021.  Follow-up attempts are possible. Further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Dizziness, Emotional disorder, Feeling abnormal, Pain
Clinical narrative: Heart palpitations; Chest pain; Lightheaded; Weird feeling in both arms; Shakes; Random other pains; Breast pain; Feeling anxious; Depressed; Highly emotional; Chest pain/tightness; Chills; Injection site pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730) via unspecified route of administration in the left arm, on 02Apr2021 at 07:00 PM as a 2nd dose, single for COVID-19 Immunization. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6202) via unspecified route of administration in the left arm, on 12Mar2021 at 07:00 PM as a 1st dose, single for COVID-19 Immunization and experienced 2 weeks after 1st dose, pain in both big toes lasting 5-7days ending with dark purple colour under both big toe nails. The patient was 72-year-old at the time of vaccination. Medical history was not reported. The patient received concomitant medication included unspecified vitamins.The patient had no known allergies. On 17Apr2021 at 08:00 AM (Reported as 2 weeks after 2nd dose), the patient experienced heart palpitations, chest pain, lightheaded, weird feeling in both arms, later chills and shakes. It was reported that for the next 10-14 days, experienced waves of chest pain, injection site pain, random other pains, breast pain, feeling anxious, depressed, highly emotional. A few weeks later, again experienced chest pain/tightness, breast pain, weird feeling in arms, all symptoms can last anywhere from a few minutes, a few hours to a few days at a time, which is still continuing to the present. The patient visited emergency room/ department. The patient did not receive any treatment for the events. 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 and Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed the events as non-serious (serious: no). It was reported that the patient was recovered with lasting effects (Recovered/resolved with sequel).   Device Date : 17Jun2021.  Follow-up attempts are possible. Further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor, Vaccination site pain
Clinical narrative: Heart palpitations; Chest pain; Lightheaded; Weird feeling in both arms; Shakes; Random other pains; Breast pain; Feeling anxious; Depressed; Highly emotional; Chest pain/tightness; Chills; Injection site pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730) via unspecified route of administration in the left arm, on 02Apr2021 at 07:00 PM as a 2nd dose, single for COVID-19 Immunization. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6202) via unspecified route of administration in the left arm, on 12Mar2021 at 07:00 PM as a 1st dose, single for COVID-19 Immunization and experienced 2 weeks after 1st dose, pain in both big toes lasting 5-7days ending with dark purple colour under both big toe nails. The patient was 72-year-old at the time of vaccination. Medical history was not reported. The patient received concomitant medication included unspecified vitamins.The patient had no known allergies. On 17Apr2021 at 08:00 AM (Reported as 2 weeks after 2nd dose), the patient experienced heart palpitations, chest pain, lightheaded, weird feeling in both arms, later chills and shakes. It was reported that for the next 10-14 days, experienced waves of chest pain, injection site pain, random other pains, breast pain, feeling anxious, depressed, highly emotional. A few weeks later, again experienced chest pain/tightness, breast pain, weird feeling in arms, all symptoms can last anywhere from a few minutes, a few hours to a few days at a time, which is still continuing to the present. The patient visited emergency room/ department. The patient did not receive any treatment for the events. 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 and Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed the events as non-serious (serious: no). It was reported that the patient was recovered with lasting effects (Recovered/resolved with sequel).   Device Date : 17Jun2021.  Follow-up attempts are possible. Further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, in left arm on 16Jun2021 at 09:45 (Batch/Lot number: Not reported) (at the age of 15-years-old) as 2nd dose single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) for seasonal allergy. Patient had no known allergies. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular in left arm in May2021 as 1st dose single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Jun2021 at 23:00, the patient experienced headache, lethargy, aches in large limbs, fever and injection site pain. Patient did not receive treatment for the events. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Headache; fatigue; aches in large limbs; fever; injection site pain-all mild to moderate; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported), via an intramuscular route of administration, administered in left arm on 16Jun2021 at 09:45 (at the age of 12-year-old) as a single dose for covid-19 immunization at clinic. The patient medical history included ongoing seasonal allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for seasonal allergy (received within 2 weeks of vaccination). Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported), via an intramuscular route of administration, administered in left arm on an unspecified date in May2021 as a single dose for covid-19 immunization and did not experienced any reaction. On 16Jun2021 at 23:00, the patient experienced headache, fatigue, aches in large limbs, fever, and injection site pain- all mild to moderate. Patient did not receive any treatment for the events. Events did not result in hospitalization. The outcome of the events was recovered on an unspecified date in Jun2021.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood sodium, Blood sodium decreased, Dizziness
Clinical narrative: dizzy; weak; SODIUM IS LOW; This is a spontaneous report from a contactable consumer based on information received by Pfizer. This case was split from master case 2021711724. This non-serious solicited report was reported on 07Jun2021 by a consumer from a commercial program.  A 72-year-old female patient received BNT162B2 (solution for injection) via unknown route of administration on an unspecified date as unknown dose, single for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included etanercept (ENBREL, Solution for injection in pre-filled pen) for rheumatoid arthritis (had been using sure click autoinjectors for about 10 years). No co-suspect medications were reported. The patient took vaccine on an unknown date. On an unknown date (reported as the next day after vaccine), the patient was very dizzy and weak. The patient underwent lab tests included blood sodium: low on an unspecified date, blood draw came back and showed that her sodium was low. The patient had always been a water drinker and at some point, her healthcare professional advised her to drink less water. It was reported that the patient HCP stated to stop etanercept injection one week before and one week after COVID-19 (Coronavirus disease 2019) vaccine. The clinical outcome of the events was unknown.  Follow up is not required. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (parent). The report received from Pfizer sponsored program.  A male patient of an unspecified age received 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 16Jun2021 as, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 via an unspecified route of administration on unspecified date as, single for covid-19 immunisation. On an unspecified date the patient experienced headache. The outcome of the event was unknown.  Follow up (17Jun2021): This is a follow up spontaneous report received from Pfizer sponsored program COVAX US Support. This Contactable male consumer is reporting for patient (Son) that: suspect details, event details.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (father) reported that a female patient (daughter) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiry date: Unknown), dose 1 via an unspecified route of administration on 16Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that the patient is currently experiencing headache, and asked what over-the counter medication can he give for this? Outcome of the event was unknown.   Follow up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a little fever; This is a spontaneous report from a contactable consumer (patient). This is the first case out of 2 cases. A male patient of an unspecified age received BNT162B2 (Pfizer Covid 19 vaccine, Solution for injection, number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 16Jun2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced fever. Consumer stated, "both had vaccine yesterday, he was feeling okay, a little fever but was good. He wanted to know whether should wait and drink some water or should go to emergency room and was that normal". Limited information was available over the call. Reporter seriousness was unspecified. Outcome of the event was recovered on an unspecified date in Jun2021.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Metamorphopsia, Visual impairment
Clinical narrative: Vision problem; Dizziness; Distorted vision; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's parent) reported for a 14-year-old female patient (reporter's daughter) that: A 14-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration on 12Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her daughter received the first dose on 12Jun2021 after getting the first dose her daughter experience vision problem, dizziness and distorted vision. "Not just the dizziness but she was getting distorted vision also." And the reporter was asking if this is one of the side effects of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain in her leg and now she has swelling in that leg; Severe pain in her leg and now she has swelling in that leg; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother-in-law) of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on an unspecified date (Sunday) as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Jun2021, patient had a severe pain in her leg and in Jun2021, now patient had swelling in that leg. The outcome of both the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 (at the age of 36 years old) (Batch/Lot Number: EW0217) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 (at the age of 36 years old) (Batch/Lot Number: EW0168, Expiry date: 31Aug2021) as single dose for COVID-19 immunisation and experienced no reactions. The patient stated that she got vaccine like yesterday and now on 17Jun2021 experienced headache. She enquired if this is safe to eat the medicine for the headache. No treatment was received in response to adverse event. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Feeling abnormal, Limb discomfort
Clinical narrative: Started breaking out on my chest just one side of my chest; Right side is just in great big sores, it's awful; I got other problems too with my hip and leg; I got other problems too with my hip and leg; It hurts really bad; Have never been so miserable in all my life/I have been through hell about this I really have had never suffered so much in all my life; I have really bad scars left on one side of my chest; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included back problems and blood pressure. Concomitant medications were not reported [She stated that she takes a blood pressure medicine and stated that she have to go through my big bag of medicine]. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. On an unspecified date, the patient started breaking out on her chest just one side of her chest and could not get it away and finally got it under control. Then, her right side was just in great big sores, it was awful and she could not find a doctor to help me and it was really bad. She further stated that she have been through hell about this and really have had never suffered so much in all her life and she could not get anybody to tell what it was, neither take care of it, they had her on different medications and nothing. The patient stated that she just got other problems too with her hip and leg and it hurt really bad and had to take pain pills because of it. She had never been so miserable in all her life. The patient stated that they were just, like one day they might get better but they were just persisting. The patient had really bad scars left on one side of her chest. She went to her family doctor and he gave a cream (Unspecified Medication) and it did not do anything and she went to a dermatologist she did not help her and she went to the ER they did not help her any so she did not know what else to do. Consumer stated regarding start date of event, few days after she took it but she didnt maybe a week after she took it, she was not sure but she had it for so long she thought she was going to rot. The patient underwent lab tests and procedures which included blood test on an unspecified date and results were unknown. Outcome of the events was reported as not recovered.  Information regarding the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain, Scar
Clinical narrative: Started breaking out on my chest just one side of my chest; Right side is just in great big sores, it's awful; I got other problems too with my hip and leg; I got other problems too with my hip and leg; It hurts really bad; Have never been so miserable in all my life/I have been through hell about this I really have had never suffered so much in all my life; I have really bad scars left on one side of my chest; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included back problems and blood pressure. Concomitant medications were not reported [She stated that she takes a blood pressure medicine and stated that she have to go through my big bag of medicine]. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. On an unspecified date, the patient started breaking out on her chest just one side of her chest and could not get it away and finally got it under control. Then, her right side was just in great big sores, it was awful and she could not find a doctor to help me and it was really bad. She further stated that she have been through hell about this and really have had never suffered so much in all her life and she could not get anybody to tell what it was, neither take care of it, they had her on different medications and nothing. The patient stated that she just got other problems too with her hip and leg and it hurt really bad and had to take pain pills because of it. She had never been so miserable in all her life. The patient stated that they were just, like one day they might get better but they were just persisting. The patient had really bad scars left on one side of her chest. She went to her family doctor and he gave a cream (Unspecified Medication) and it did not do anything and she went to a dermatologist she did not help her and she went to the ER they did not help her any so she did not know what else to do. Consumer stated regarding start date of event, few days after she took it but she didnt maybe a week after she took it, she was not sure but she had it for so long she thought she was going to rot. The patient underwent lab tests and procedures which included blood test on an unspecified date and results were unknown. Outcome of the events was reported as not recovered.  Information regarding the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: I have numbness in my leg; I have been tired; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0187, Expiration date: unknown) intramuscular, administered in upper left arm on 26May2021 at 13:00 pm (age at vaccination was 49 years) as 1st dose, single for COVID-19 immunization. Medical history included latex allergy from an unknown date. Concomitant medications included fluticasone propionate (FLONASE) (Nasal spray) taken for hypersensitivity, hydrochlorothiazide, losartan and carvedilol taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Pharmacy store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to know where she could report the symptoms because what she read, the little she read about the symptoms of the vaccine she didn't came across it. So she had got both of the vaccine. On 30May2021, the patient experienced numbness in her leg. She had been tired after she received the vaccine so she wondered with whom she needs to speak with for the side effect. The numbness after the first shot she though it was about on the fourth day. She started feeling the numbness even more it was just kind of in her way. She confirmed Pfizer Covid-19 Vaccine. She was informed about the role of Pfizer drug safety. She stated that her brother actually got his shot the following day after her so the first dose he got on the Thursday and the second dose yesterday and he was fine. He did not experience anything. The outcome of the events was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Hypoaesthesia
Clinical narrative: I have numbness in my leg; I started feeling the numbness even more; I have been tired; This is a spontaneous report from a contactable consumer(patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0217; NDC number, UPC number and expiry date were reported as unknown) via intramuscularly on 16Jun2021 at 18:45 in left arm as a single dose for Covid-19 immunization. Medical history included latex allergy from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE ALLERGY RELIEF); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); losartan (LOSARTAN) and carvedilol (CARVEDILOL) all taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, Formulation: Solution for injection lot number: EW0187) via intramuscularly on 26May2021 at 13:00 in left arm for COVID-19 immunization. The patient did not receive any prior vaccination within 4 weeks. After the second dose the patient she started feeling numbness (today) 17Jun2021 (at 04:00) at work and even more and started feeling the numbness even more its just kind of in her way. The patient was tired after she received the vaccine. She wanted to know where she can report the side effects as she had read about the symptoms of the vaccine which she didn't came across. The patient reported her brother received both the doses of vaccine and he was fine. He did not experience anything. Investigation assessment was not reported. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I got 2 menstrual cycles; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported she got 2 menstrual cycles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Caused me fatigue; This is a spontaneous report from a Pfizer sponsored program received from a contactable female consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on 29May2021 (Batch/Lot number and Expiry date was not reported) as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation and got two menstrual cycles. On an unspecified date in 2021, the patient experienced fatigue. Outcome of the event fatigue was unknown.  Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful/ got a knot her knot there; This is a spontaneous report received from a contactable consumer (Parent) or other non-non health care professional   A 16-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 08Jun2021 as 2nd dose, single for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD. Concomitant medications included methylphenidate hydrochloride (CONCERTA) taken for attention deficit hyperactivity disorder (ADHD), start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  Formulation: Solution for injection, Batch/Lot number was not reported) via a unspecified route of administration (at the age of 16-yesr-old) on 18May2020 as first dose single for COVID-19 immunisation and experienced no reaction on previous exposure to vaccine. it was reported that patient got second dose of vaccine last week on Tuesday, On Jun2021 she got a knot where she got her injection, it was red and burning yesterday on 16Jun2021 and now it has got a hard knot and it is painful on 17Jun2021.  reporter wanted to site where the vaccine was injected it has got a knot like a hard knot there and it was burning and red. No treatment was received for the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Foreign body in throat, Oropharyngeal discomfort, Throat tightness
Clinical narrative: Something is in her throat and was wondering if that was it closing up/some trouble with her throat; Something is in her throat and was wondering if that was it closing up/some trouble with her throat; Something is in her throat and was wondering if that was it closing up/some trouble with her throat; This is a spontaneous report from a contactable consumer (the patient). A 64-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration on 07Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207) on 10Mar2021 for COVID-19 immunisation. On 04Jun2021, the patient experienced something is in her throat and was wondering if that was it closing up/some trouble with her throat. The patient stated the last dose she received was in April and she wanted to know would she be still having side effects because it seems like something was in her throat and was wondering if that was it closing up. She further stated she was having some trouble with her throat and she was wondering if that is a side effect from the Covid. She stated it was the week when (withheld) had all that rain, about 2 weeks ago and she started having trouble with it and its lasted quite some time. The patient stated she scheduled to see her regular primary care doctor next week on a Thursday. The patient stated it was worse the morning when she first called and as the day went on it got better. The outcome of events was resolving.  Information on lot/batch number was available. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Yesterday he started to feel bad; Not feeling well; This is a spontaneous report from a contactable consumer(patient's sister).A 55-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on 14Jun2021(at the age of 55-years-old) as 2nd Dose, Single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on an unspecified date as 1st Dose, Single for COVID-19 immunization. After 2nd dose of vaccination, on 14Jun2021,the patient reported of not feeling well. On 17Jun2021,yesterday he started to feel bad. She would like to know what kind of side effects are to be expected from the vaccine. Seriousness by the reporter was No. The outcome for the events was Unknown.  Information on lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: consumer reported that after first dose, she felt unwell; had headache; body pain during 3 days; This is a spontaneous report from a contactable consumer or other non hcp. The consumer reported about the first dose administered.  A 76-year-old female patient received 1st 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 (Age at vaccination 76-year-old) as dose 1,single for covid-19 immunisation. Medical history included hypersensitivity. The patient's concomitant medication included unspecified profilactic medication. Reporter states during the call patient mentioned she had chronic allergy and prior to first dose administration she took profilactic medication as her physician recommended. On an unspecified date, during the call consumer reported that after first dose, she felt unwell, had headache and body pain during 3 days. She mentioned taking Tylenol for management symptoms subsequently to vaccination. Reporter wanted to know about whether she could change appointment hour for second dose administration. The outcome was resolved on an unspecified date.  Information about lot/batch number has been requested.