chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site induration
Clinical narrative: Injection site is hard; It is bigger than it should have been, it's just like a little hard ball in there; it's warm to the touch; it itches all around the edges; This is a spontaneous report from a contactable consumer (patient). A unknown age patient of unspecified gender received bnt162b2 (COMIRNATY, Solution for injection, Lot Number EL3249 was reported), via an unspecified route of administration on 12FEB 2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took Historical Vaccine BNT162B2 (COMIRNATY, Solution for injection, Lot Number unknown), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced Injection site is hard, and it was bigger than it should have been, it's just like a little hard ball in there; it's warm to the touch; it itches all around the edges. Reporter wanted to know if the injection go to my 'anatomy' or it just go into my arm, you know into the muscles of my arm. It's quite big and it's just about the second one but it is a size of a very small ball and around the edges it is very itchy, it itches all around the edges. So, reporter (patient) was wondering if this is something should be concerned about. The clinical outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a noncontactable other HCP (patient). A 28-year-old (non-pregnant) female received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN5318), at the vaccination age of 28, via an unspecified route of administration, left arm, on Jan 15, 2021, at 13:00, single dose, for COVID-19 immunization. The patient has a medical history of acne, eczema, anxiety and ADHD (attention deficit hyperactivity disorder). Concomitant medications included spironolactone 150 mg, sertraline hydrochloride 200mg and Adzenys XR 18.8 mg. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and tested for COVID post vaccination. On Jan 15, 2021, patient experienced itchy rash (similar to hives but more mild), with only a few spots on arms and torso. Patient first noticed night of first vaccine around 11 pm or so. Unsure if related. Lasted about 2-3 days. The patient did not receive any treatment for the events. Patient underwent lab test and procedure, which included SARS-CoV-2 test: Negative on Jan 15, 2021 and SARS-CoV-2 test: Negative on Jan 29, 2021. Outcome of the event: recovered Jan 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Peripheral swelling
Clinical narrative: Allergic reaction to the covid vaccine...arm was swollen; Allergic reaction to the covid vaccine...arm was swollen; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporter similar events for 2 patients (Wife and himself). This is 1st of 2 reports. This male consumer (Patient) reported that:  A male 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 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced allergic reaction to the covid vaccine, arm was swollen. Patient was asked for the confirmation of appointment for a second dose due tomorrow, asking if the facility would cancel due to the bad weather. The clinical outcome of events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207649 Same reporter/drug/AE, different patient
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Little rashes over my body like on the wrist and my legs.; lot of itching; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left arm by the shoulder) on 30Jan2021 (age at vaccination was 76 years) as dose 1, single for COVID-19 immunization. The patient's medical history included cholesterol and blood pressure both were controlled. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced little rashes over his body like on the wrist and his legs and lot of itching. The patient stated that he did not really know the start date of rashes. Maybe 5 days after the shot. The patient experienced them because they didn't go away. It was one on the wrist, one on the leg and one on the arm and it was not all over his body. It has lot of itching on his skin specifically. The patient asked if that was one of the side effects. The patient received treatment with over the counter anti-itch cream. The outcome of the events was not resolving.   Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Disturbance in attention, Insomnia, Nausea
Clinical narrative: inability to concentrate; Injection site soreness; sore shoulder; sore finger knuckles; insomnia; nausea; vomiting; confusion; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 46-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included known allergies to sulfa medications. Concomitant medications in two weeks were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ16850), via an unspecified route of administration on 21Jan2021 at 11:00 AM (at the age of 46-year-old), as single dose in left arm for COVID-19 immunization. Patient did not receive any other vaccine in four weeks after COVID vaccine. On 15Feb2021 at 22:00, 11 hours after second dose of vaccine, the patient experienced injection site soreness, sore shoulder, sore finger knuckles, insomnia, nausea, vomiting, confusion, and inability to concentrate. Patient did not receive treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was resolving.    Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vomiting
Clinical narrative: inability to concentrate; Injection site soreness; sore shoulder; sore finger knuckles; insomnia; nausea; vomiting; confusion; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 46-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included known allergies to sulfa medications. Concomitant medications in two weeks were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ16850), via an unspecified route of administration on 21Jan2021 at 11:00 AM (at the age of 46-year-old), as single dose in left arm for COVID-19 immunization. Patient did not receive any other vaccine in four weeks after COVID vaccine. On 15Feb2021 at 22:00, 11 hours after second dose of vaccine, the patient experienced injection site soreness, sore shoulder, sore finger knuckles, insomnia, nausea, vomiting, confusion, and inability to concentrate. Patient did not receive treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was resolving.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Lymphadenopathy, Pyrexia, Vaccination site erythema
Clinical narrative: pain in armpit of injected arm; Injection site pain; injection site pain, significant swelling (walnut sized lump), and redness; injection site pain, significant swelling (walnut sized lump), and redness; Fever; chills; significant lymph node enlargement; This is a spontaneous report from a non-contactable consumer (patient). A 42-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247) via an unspecified route of administration in left arm 16Feb2021 for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medication were not reported. She did not receive other vaccine in four weeks. She had no Covid prior vaccination and not tested Covid post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247) via unspecified route of administration in left arm 26Jan2021 for COVID-19 immunisation at workplace clinic. The patient experienced injection site pain, significant swelling (walnut sized lump), and redness, fever, chills and significant lymph node enlargement, pain in armpit of injected arm on 17Feb2021. She did not receive treatment for adverse events. The outcome events was recovering.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: pain in armpit of injected arm; Injection site pain; injection site pain, significant swelling (walnut sized lump), and redness; injection site pain, significant swelling (walnut sized lump), and redness; Fever; chills; significant lymph node enlargement; This is a spontaneous report from a non-contactable consumer (patient). A 42-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247) via an unspecified route of administration in left arm 16Feb2021 for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medication were not reported. She did not receive other vaccine in four weeks. She had no Covid prior vaccination and not tested Covid post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247) via unspecified route of administration in left arm 26Jan2021 for COVID-19 immunisation at workplace clinic. The patient experienced injection site pain, significant swelling (walnut sized lump), and redness, fever, chills and significant lymph node enlargement, pain in armpit of injected arm on 17Feb2021. She did not receive treatment for adverse events. The outcome events was recovering.  No follow-up attempts were possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Illness, Pain in extremity
Clinical narrative: Upset stomach; Sick a little bit; Headache; Chills; Slight fever; Arm really hurts; arm sore; This is a spontaneous report from a contactable Consumer (patient, self-reported). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9266 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient had second vaccine and really want to talk but don't know whom to call. The patient had it yesterday and it was at (city and state name). at the (Institute name) and it was Pfizer. Now the patient had been sick a little bit from it, like headache, chills, little upset stomach, and a real slight fever on an unspecified date and asked was that normal. The patient stated, the patient's arm really hurts, the first vaccine it didn't. As the consumer was unwilling to share any further information, reporter type was unknown and limited information was available over the call. Consumer further stated, the patient had a headache and mean I am just not, they told me its the same vaccine as the first one. The patient asked why did it hurt when they gave it to me the and why was my arm sore and why am I sick. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Upset stomach; Sick a little bit; Headache; Chills; Slight fever; Arm really hurts; arm sore; This is a spontaneous report from a contactable Consumer (patient, self-reported). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9266 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient had second vaccine and really want to talk but don't know whom to call. The patient had it yesterday and it was at (city and state name). at the (Institute name) and it was Pfizer. Now the patient had been sick a little bit from it, like headache, chills, little upset stomach, and a real slight fever on an unspecified date and asked was that normal. The patient stated, the patient's arm really hurts, the first vaccine it didn't. As the consumer was unwilling to share any further information, reporter type was unknown and limited information was available over the call. Consumer further stated, the patient had a headache and mean I am just not, they told me its the same vaccine as the first one. The patient asked why did it hurt when they gave it to me the and why was my arm sore and why am I sick. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Swelling
Clinical narrative: Received my second shot of the vaccine and my armpit is swollen; It is just one armpit, the side that I got the shot on; Stiff neck; Pain in my neck and it ran down my arm; Pain in my neck and it ran down my arm; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Formulation: Solution for injection Lot Number: EL9266, Expiration Date: 31May2021), via an unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunisation. The patient Medical history included none. There were no concomitant medications. On an unknown date, the patient had swelling in the armpit and it happened probably within like 10 to 15 minutes after she got the vaccine and it was only one not on both armpits it was just one armpit. On an unspecified date, the patient had pain in her neck and it ran down her arm and experienced stiff neck. The patient wanted to know if she could take Motrin that will make this swelling go away. The patient was asking how long it would last or what she can do about it. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Swelling
Clinical narrative: Received my second shot of the vaccine and my armpit is swollen; Pain in my neck and it ran down my arm; Stiff neck; Pain in my neck and it ran down my arm; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation and co-suspect reported as Ibuprofen (MOTRIN [IBUPROFEN]), route of administration, start and stop date, (Batch/lot number and dose were not reported). The patient medical history and concomitant medications were not reported. The patient had swelling in the armpit and it happened probably within like 10 to 15 minutes after she got the vaccine and it was only one not on both armpits it was just one armpit. On an unspecified date, the patient had pain in her neck and it ran down her arm and experienced stiff neck. The patient want to know if she can take Motrin that will make this swelling go away. The patient was asking how long it will last or what she can do about it. The clinical outcome for events was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea last 3 days; This is a spontaneous report from a contactable consumer or other non hcp (patient himself).  A 86-years-old male patient 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, administered in Arm Left on 30Jan2021 11:00 as dose 1, single and he received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EL3249) via an unspecified route of administration, administered in Arm Left on 20Feb2021 11:00 (at the age of 86-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure, blood cholesterol increased and COPD from an unknown date and unknown if ongoing. Concomitant medications included lisinopril, omeprazole, sertraline and simvastatin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was lisinopril, omeprazole, sertraline, and simvastatin. Prior and since the vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. On an unspecified date the patient experienced diarrhea last 3 days. Seriousness criteria-resulting in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect reported as no. No treatment received for the adverse event. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Diarrhea for over 48 hours; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (age at vaccination 48-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, heart disease, sleep apnea. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included lisinopril; hydrochlorothiazide; metoprolol, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 01Feb2021 13:00 (age at vaccination 48-year-old) as single dose for COVID-19 immunization. The patient experienced diarrhoea for over 48 hours since 22Feb2021 16:00. The patient did not receive any treatment for the adverse event. The reporter assessed the event as non-serious. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Covid test post vaccination (Nasal Swab): negative on 23Feb2021. Outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Myalgia
Clinical narrative: woke up with Chill in the middle of the night; being very hot; moderate nausea and fatigue; moderate nausea and fatigue; significant soreness at the injection site; server headache; muscle pain through both legs, particularly through the lower legs; This is a spontaneous report from a non-contactable consumer, the patient. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in arm left on 23Feb2021 10:30 as dose 2 single (at the age of 38-years-old) for covid-19 immunization. The medical history reported as none. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunization. On 24Feb2021 02:00 AM, the patient woke up with chill in the middle of the night, that was followed by being very hot. Patient experienced moderate nausea and fatigue. There was significant soreness at the injection site and experienced a server headache and muscle pain through both legs, particularly through the lower legs. The patient did not have allergies to medications, food or other products. 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 and not received any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed this case as non-serious. The outcome of the events was recovered.  No follow-up attempts were possible. No further information was expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: woke up with Chill in the middle of the night; being very hot; moderate nausea and fatigue; moderate nausea and fatigue; significant soreness at the injection site; server headache; muscle pain through both legs, particularly through the lower legs; This is a spontaneous report from a non-contactable consumer, the patient. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in arm left on 23Feb2021 10:30 as dose 2 single (at the age of 38-years-old) for covid-19 immunization. The medical history reported as none. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunization. On 24Feb2021 02:00 AM, the patient woke up with chill in the middle of the night, that was followed by being very hot. Patient experienced moderate nausea and fatigue. There was significant soreness at the injection site and experienced a server headache and muscle pain through both legs, particularly through the lower legs. The patient did not have allergies to medications, food or other products. 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 and not received any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed this case as non-serious. The outcome of the events was recovered.  No follow-up attempts were possible. No further information was expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: starting to run a fever; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration on 17Feb2021 as single for covid-19 immunisation (age at the vaccination 75 years old). The patient's medical history and concomitant medications were not reported. She had the second vaccine (clarified as Pfizer Covid Vaccine) yesterday. On 18Feb2021, the patient starting to run a fever. she stated that she really need to call the other number asked for help. She need to go. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. No treatment was received. Outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes under right arm are swollen and painful; Lymph nodes under right arm are swollen and painful; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 12:00 as DOSE 2 (Age at vaccination: 70 Years), SINGLE for covid-19 immunisation. Medical history included myocardial infarction from 2009 (Heart Attach 12 years ago-healthy now). No allergies to medications, food, or other products. Concomitant medications included atorvastatin (ATORVASTATIN), lisinopril (LISINOPRIL), metoprolol (METOPROLOL) and Entebia. The patient received dose 1 of bnt162b2 on 27JAN2021 at 12:00 PM for covid-19 immunisation (lot_number: EN6201, vaccine location: Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced lymph nodes under right arm are swollen and painful on 18Feb2021 at 08:00. No treatment was received for the adverse events. Outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the right shoulder muscle where I was injected; This is a spontaneous report from a contactable 51-year-old male consumer reported for himself. A 51-year-old male patient received second dose of bnt162b2 (Pfizer BioNtech COVID 19 vaccine, Solution for injection, Lot number: EL3247) via an unspecified route in the right arm on 24Feb2021 at 14:00 (age at vaccination: 51-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer BioNtech COVID 19 vaccine, Solution for injection, Lot number: EL3247) via an unspecified route in the right arm on 03Feb2021 at 13:45 (age at vaccination: 51-year-old), as a single dose for covid-19 immunization. No allergies to medications, food, or other products were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 24Feb2021 at 14:30, patient experienced soreness in the right shoulder muscle where he was injected. Patient did not receive any treatment for the event. The clinical outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Feeling cold, Pyrexia
Clinical narrative: Caller is a consumer who received her second dose of Pfizer-Biontech Covid19 vaccine, yesterday and woke up with a high fever between 101.5 degree F-102 degree F; She is feeling pretty miserable; she was freezing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9267; expiration date: unknown) via an unspecified route of administration in left arm on 24Feb2021 at 15:45 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Hypothyroidism, Cholesterol, Palpitations. Concomitant medication included Rosuvastatin Calcium taken for cholesterol, Metoprolol Succinate taken for palpitations, levothyroxine sodium (SYNTHROID) taken for Hypothyroidism, Women's Multivitamin, Biotin, ergocalciferol (VITAMIN D), Omega 3 all started on an unspecified date. Prior Vaccinations (within 4 weeks) first dose of COVID19 Vaccine was none. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9263; expiration date: unknown) via an unspecified route of administration in left arm on 03Feb2021 (at the 65-year-old) as single dose for COVID-19 immunization. On 25Feb2021, at around 03:00 the patient woke up with a high fever between 101.5 degree F-102 degree F, she was feeling pretty miserable. She didn't take her temperature at that time, but she was freezing. Patient asked if she can take Tylenol. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Asthma seems to be acting up.; fever; fatigue; chills; had a sore arm.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch / lot number: unknown) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. On 16Feb2021, the patient had a sore arm. On 17Feb2021, experienced fatigue, chills, fever. On an unspecified date had asthma seems to be acting up. She was wondering if she will have worse symptoms with the second dose. Outcome of the events was unknown.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pain
Clinical narrative: Coughing; chills; aches; This is a spontaneous report from a non-contactable other hcp (patient). A 25-years-old male patient received BTN162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9767), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not received any other vaccine in four weeks. On 18Feb2021, at 12:00, the patient experienced coughing, chills and aches. Patient did not receive any treatment to the events. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Headache, Pain in extremity, Physical examination
Clinical narrative: Big pressure feeling with back and chest pain; Big pressure feeling with back and chest pain; Clarified headache was very slight; sore arm; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 85-years-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 85-year-old) for covid-19 immunisation. Medical history included Sleep apnea, insomnia, Flu shot (Arm was sore just a little bit more than the Flu shot or shingles shot. Was nothing to be concerned about. Caller did not provide lot/Exp for Shingles shot or Flu shot.) from an unknown date and unknown if ongoing and ongoing to sleep (patient taking Concomitant Products Trazodone (Verbatim): to sleep). Concomitant medications included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and trazodone taken to sleep. The patient had a sore arm (Only in injection arm, which was the right arm), which she expected. Tuesday night and this morning, she had just a slight headache with a lot of back and chest pain at the same time. It felt like a big pressure each time. Within half an hour it went away each time. A month before the COVID-19 Vaccine, she had her shingles vaccine. Doesn't think it has anything to do with the spacing between vaccines. Had shingles shot and COVID-19 Vaccine in different arms. Arm was sore just a little bit more than the Flu shot or shingles shot. Was nothing to be concerned about. By the next day she didn't feel her arm soreness. Clarified headache was very slight and occurred at the same time she felt that big pressure, patient was not someone who gets headaches. Big pressure feeling with back and chest pain had occurred on 16Feb2021 and 19Feb2021. Each time it subsided within half an hour. Second COVID-19 Vaccine would be on 06Mar2021. The patient underwent lab tests and procedures which included physical examination: everything was good including her heart on unknown date in Jan2021. The outcome of events sore arm recovered on 14Feb2021 and for other events reported as recovered on 19Feb2021.  Information for Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Nausea
Clinical narrative: Big pressure feeling with back and chest pain; Big pressure feeling with back and chest pain; Clarified headache was very slight; sore arm; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 85-years-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 85-year-old) for covid-19 immunisation. Medical history included Sleep apnea, insomnia, Flu shot (Arm was sore just a little bit more than the Flu shot or shingles shot. Was nothing to be concerned about. Caller did not provide lot/Exp for Shingles shot or Flu shot.) from an unknown date and unknown if ongoing and ongoing to sleep (patient taking Concomitant Products Trazodone (Verbatim): to sleep). Concomitant medications included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and trazodone taken to sleep. The patient had a sore arm (Only in injection arm, which was the right arm), which she expected. Tuesday night and this morning, she had just a slight headache with a lot of back and chest pain at the same time. It felt like a big pressure each time. Within half an hour it went away each time. A month before the COVID-19 Vaccine, she had her shingles vaccine. Doesn't think it has anything to do with the spacing between vaccines. Had shingles shot and COVID-19 Vaccine in different arms. Arm was sore just a little bit more than the Flu shot or shingles shot. Was nothing to be concerned about. By the next day she didn't feel her arm soreness. Clarified headache was very slight and occurred at the same time she felt that big pressure, patient was not someone who gets headaches. Big pressure feeling with back and chest pain had occurred on 16Feb2021 and 19Feb2021. Each time it subsided within half an hour. Second COVID-19 Vaccine would be on 06Mar2021. The patient underwent lab tests and procedures which included physical examination: everything was good including her heart on unknown date in Jan2021. The outcome of events sore arm recovered on 14Feb2021 and for other events reported as recovered on 19Feb2021.  Information for Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included. It was reported that, after administration of the 2nd dose patient experienced headache on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Joint swelling
Clinical narrative: joint swelling/pain; joint swelling/pain; mild fever (99.4-99.9); Chills; Nausea; Headaches; Body aches; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 42-year-old male patient received bnt162b2 (BNT162B2, formulation; solution for injection), via an unspecified route of administration on 19Feb2021 10:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 42-year-old) for covid-19 immunisation. Medical history included high blood pressure, sleep apnea and Known allergies: Gluten, some melons from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate taken for an unspecified indication, start and stop date were not reported (received within two weeks of vaccination). The patient had not received any other vaccine within 4 weeks. The patient experienced mild fever (99.4-99.9), chills, nausea, headaches and body aches on 19Feb2021 at 19:00. The patient experienced joint swelling/pain on 22Feb2021 (on day 4). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID since the vaccination. No treatment received for events. The patient underwent lab tests and procedures which included body temperature: 99.4-99.9 on 19Feb2021. The outcome of events reported as recovered in Feb 2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: joint swelling/pain; joint swelling/pain; mild fever (99.4-99.9); Chills; Nausea; Headaches; Body aches; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 42-year-old male patient received bnt162b2 (BNT162B2, formulation; solution for injection), via an unspecified route of administration on 19Feb2021 10:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 42-year-old) for covid-19 immunisation. Medical history included high blood pressure, sleep apnea and Known allergies: Gluten, some melons from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate taken for an unspecified indication, start and stop date were not reported (received within two weeks of vaccination). The patient had not received any other vaccine within 4 weeks. The patient experienced mild fever (99.4-99.9), chills, nausea, headaches and body aches on 19Feb2021 at 19:00. The patient experienced joint swelling/pain on 22Feb2021 (on day 4). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID since the vaccination. No treatment received for events. The patient underwent lab tests and procedures which included body temperature: 99.4-99.9 on 19Feb2021. The outcome of events reported as recovered in Feb 2021.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever; Weakness; This is a spontaneous report from a contactable physician (Patient). A 24-year-old male patient received first dose of BNT162B2 (PRIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration, administered in Arm Left on 24Feb2021 09:00 (at the age of 24-year-old) as single dose for covid-19 immunisation. Medical history included covid-19. There were no concomitant medications. Patient did not receive any other vaccine within four weeks of COVID vaccine and he did not receive any other medication within two weeks. Patient was not tested for COVID-19 since vaccination. On 25Feb2021 at 10:15 AM, the patient experienced fever and weakness. Therapeutic measures were taken as a result of fever and weakness. The outcome of events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Salivary gland disorder
Clinical narrative: he is experiencing a fever which he suspects is due to a blocked saliva gland.; he is experiencing a fever which he suspects is due to a blocked saliva gland.; This is a spontaneous report received from a non-contactable consumer via a Pfizer-sponsored program.A male patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,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.The patient stated that he was experiencing a fever which he suspects is due to a blocked saliva gland on an unspecified date.The outcome of the events was unknown.Patient wanted to know if that would be a problem for receiving the second dose.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: fever; tiredness; chills; sweating; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient (Age: 74 Unit: Unspecified) 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 22Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid from 14Jan2021 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fever, tiredness, chills, sweating. Patient received treatment for reported events with prescribed 2 baby aspirin in the morning and 2 in the evening every day. It was reported that patient wanted to know how long these side effects lasted and wanted to know if he can continue with aspirin as treatment. The outcomes of reported events were unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: a rapid heartbeat for 1 minute and a half approximately then this symptom subsided; This is a spontaneous report from a contactable consumer via medical information team. A 67-year-old female patient received bnt162b2 (Pfizer-Bionetch, COVID-19 vaccine, Solution for injection, Batch/Lot Number: EN6201 and expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 (age at vaccination 67-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation.The patient medical history included asthma ongoing, digestive disorder ongoing , anxiety ongoing, had allergy. Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) taken for asthma, oxazepam taken for anxiety, cimetidine (TAGAMET [CIMETIDINE]) taken for digestive disorder. The patient previously took FLU vaccine. It was reported that patient experience with the first Covid shot she took it on Feb 19, at hospital and they were aware that she had allergy so they took very good care but after received the injection and they tell you to go out and sit for little because they have some papers to prepare and give, while sitting there did notice my heart rate begin to increase, I had a fast heartbeat but it only lasted I say about a minute or minute and a half then it subsided, but what happened was she felt like it's nothing to report but after I get home maybe should told them have a fast heart and they had a room for those who have allergy, sat for half hour, was fine, maybe thought, better report it, called my primary care physician and she said you have to report it to your provider that gave you the shot, didn't the call the hospital or anything and other than that fine but it was unusual. she had flu vaccine and shingles and all I never experience that but this one she experienced a fast heart rate for a minute or so and I think sat there and it did subsides and I felt that it may be wasn't anything so I thought I better give you call and ask you should I take my second vaccine I need some professional information on what to do. No treatment was received for the event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer or other non health care professional. This consumer reported for a male patient.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was 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. It was reported that, reporter husband and herself received the 2nd dose of the Pfizer covid vaccine yesterday. Today (on 19Feb2021) they both developed a fever, one ranged from 99-100 F and the other ranged 100.4-100.5 F. As per the documentation received form the facility they received the vaccine, they were advised to call their doctor if they had a fever, loss of taste, etc as they may need to take a covid test. But as for other symptoms, they make take pain medication. The patient underwent lab tests and procedures which included fever: 100.4-100.5 fahrenheit (100.4-100.5 F) on 19Feb2021. The reporter assessed the seriousness as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021184160 similar report from same reporter