chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Skin discomfort
Clinical narrative: skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes; It burns/on the sides of the mouth and the lips they just burns; Dry skin; I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been; it's dry, on the sides of the mouth and the lips; Itchy; Redness/It's all over my neck. It just everywhere"; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been) and LIP DRY (it's dry, on the sides of the mouth and the lips) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013421A and 012A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive and was hospitalized 8 days) in August 2020 and Lumpectomy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been), LIP DRY (it's dry, on the sides of the mouth and the lips), PRURITUS (Itchy) and ERYTHEMA (Redness/It's all over my neck. It just everywhere"). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK, qid 7 days. At the time of the report, SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been), LIP DRY (it's dry, on the sides of the mouth and the lips), PRURITUS (Itchy) and ERYTHEMA (Redness/It's all over my neck. It just everywhere") had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Laboratory details: Biopsy done but results were not provided
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; Drug ineffective; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DULAGLUTIDE (TRULICITY), Regular insulin, ISOPHANE INSULIN (NPH INSULIN) and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment product was not provided by the reporter  This is a case of Drug ineffective, lack of efficacy, with both doses given and COVID-19 diagnosed several months later. Based on current available information and the temporal association between product and the start date of the COVID-19 diagnosis a causal relationship is possible for the event of Drug ineffective.   This case was linked to MOD-2021-294145 (Patient Link).; Sender's Comments: This is a case of Drug ineffective, lack of efficacy, with both doses given and COVID-19 diagnosed several months later. Based on current available information and the temporal association between product and the start date of the COVID-19 diagnosis a causal relationship is possible for the event of Drug ineffective.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Insomnia, Platelet count, Platelet count increased
Clinical narrative: Developed COVID-19; Elevated platelet counts (300 to 530); Trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)) and COVID-19 (Developed COVID-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1232366) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.    Concurrent medical conditions included Dry skin. Concomitant products included OMEPRAZOLE, DIAZEPAM and HYDROXYZINE for an unknown indication.   In June 2021, the patient RUXOLITINIB PHOSPHATE (JAKAFI) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) dosage was changed to 5 milligram twice a day. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram once a day. In July 2021, the patient experienced PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)) (seriousness criterion hospitalization). On 18-Jul-2021, the patient experienced COVID-19 (Developed COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was hospitalized on sometime in July 2021 due to PLATELET COUNT INCREASED. At the time of the report, PLATELET COUNT INCREASED (Elevated platelet counts (300 to 530)), COVID-19 (Developed COVID-19) and INSOMNIA (Trouble sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Platelet count: 530 (High) High. On an unknown date, Platelet count: 300 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited the emergency room 3 time due to elevated platelet count. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medication RUXOLITINIB was considered as cosuspect.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medication RUXOLITINIB was considered as cosuspect.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pneumonia bacterial, Vaccination complication, Vaccination site pain
Clinical narrative: bacterial pneumonia; felt a little ill; felt tired the next day; had a sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL (bacterial pneumonia) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA BACTERIAL (bacterial pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt a little ill), FATIGUE (felt tired the next day) and VACCINATION SITE PAIN (had a sore arm for a day). The patient was hospitalized from sometime in May 2021 to sometime in May 2021 due to PNEUMONIA BACTERIAL. At the time of the report, PNEUMONIA BACTERIAL (bacterial pneumonia), VACCINATION COMPLICATION (felt a little ill) and FATIGUE (felt tired the next day) outcome was unknown and VACCINATION SITE PAIN (had a sore arm for a day) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Patient was hospitalized for 4.5 days around the end of May for bacterial pneumonia with no other side effects or symptoms.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected due to decline on follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected due to decline on follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Magnetic resonance imaging, VIth nerve paralysis
Clinical narrative: Sixth nerve eye palsy; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VITH NERVE PARALYSIS (Sixth nerve eye palsy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Cataract operation (Consumer had a cataract surgery about 6 years ago.) in 2015. Concurrent medical conditions included Diabetes and Blood pressure.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VITH NERVE PARALYSIS (Sixth nerve eye palsy) (seriousness criterion medically significant) and DIPLOPIA (Double vision). At the time of the report, VITH NERVE PARALYSIS (Sixth nerve eye palsy) and DIPLOPIA (Double vision) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Consumer stated her A1C stays below7.. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Consumer was scheduled for MRI to rule out for brain tumor. Consumer was diagnosed with sixth nerve eye palsy.         Consumer was call to report possible adverse events and with a MI inquiry.  Consumer stated she experienced adverse event after 1st dose of the vaccine but still got her 2nd dose. Consumer stated her adverse event is still ongoing and has not subsided. On 03Mar2021 consumer experienced double vision while driving. Consumer contacted her HCP who scheduled MRI and additional eyes tests. Consumer's HCP suggested that the condition may be caused by diabetes and give it time to selfheal. Consumer stated that she was healthy prior to vaccination.  Consumer was not prescribed medication(s) for the condition.   Consumer does not take any medicaion except for blood pressure and diabetes. Treatment information was not provided.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's med hx of HTN and DM are confounding factors that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's med hx of HTN and DM are confounding factors that may play a possible contributory role.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Intentional dose omission, VIth nerve paralysis
Clinical narrative: sixth nerve palsy to the face; face was paralyzed / drooping face; Intentional dose omission; This spontaneous case was reported by a consumer and describes the occurrence of VITH NERVE PARALYSIS (sixth nerve palsy to the face) and FACIAL PARALYSIS (face was paralyzed / drooping face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITH NERVE PARALYSIS (sixth nerve palsy to the face) (seriousness criterion medically significant), FACIAL PARALYSIS (face was paralyzed / drooping face) (seriousness criterion medically significant) and INTENTIONAL DOSE OMISSION (Intentional dose omission). At the time of the report, VITH NERVE PARALYSIS (sixth nerve palsy to the face), FACIAL PARALYSIS (face was paralyzed / drooping face) and INTENTIONAL DOSE OMISSION (Intentional dose omission) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.  It was reported that few days after the vaccination subject experienced  sixth nerve palsy on face, her face was paralyzed and face was drooping down, Subject chosen not  to get the second dose No Concomitant medicines were provided No Treatment medicines were provided.  company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Loss of consciousness, Malaise, Tremor
Clinical narrative: blacked out/lost consciousness; started shaking and couldn't hit the keys; felt sick like she had the flu; felt sick like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out/lost consciousness), TREMOR (started shaking and couldn't hit the keys), MALAISE (felt sick like she had the flu) and INFLUENZA (felt sick like she had the flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out/lost consciousness) (seriousness criterion medically significant), TREMOR (started shaking and couldn't hit the keys) (seriousness criterion medically significant), MALAISE (felt sick like she had the flu) (seriousness criterion medically significant) and INFLUENZA (felt sick like she had the flu) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out/lost consciousness), TREMOR (started shaking and couldn't hit the keys), MALAISE (felt sick like she had the flu) and INFLUENZA (felt sick like she had the flu) outcome was unknown.            No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: This case concerns a 75-year-old female with serious unexpected events of loss of consciousness, tremor, malaise, and influenza. Event latency within hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-295447 (Patient Link).; Sender's Comments: This case concerns a 75-year-old female with serious unexpected events of loss of consciousness, tremor, malaise, and influenza. Event latency within hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death, Dermatosis
Clinical narrative: died; Dermatosis; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (died) (seriousness criteria death and medically significant) and DERMATOSIS (Dermatosis). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DERMATOSIS (Dermatosis) outcome was unknown.      Concomitant medication and treatment drug were not reported.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: a month ago got a breakthrough COVID-19 infection; Lack of efficacy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant informations were reported. No Treatment informations were reported.; Sender's Comments: This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between this event is assessed as not applicable. Causality for the event drug ineffective is assessed as possible.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Gait disturbance, Illness, Vision blurred
Clinical narrative: I was sick for 3 months/ sick; Dizzy; blurred vision; double vision; I could not walk; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick for 3 months/ sick), DIZZINESS (Dizzy), VISION BLURRED (blurred vision), DIPLOPIA (double vision) and GAIT DISTURBANCE (I could not walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included Aspirin for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (I was sick for 3 months/ sick), DIZZINESS (Dizzy), VISION BLURRED (blurred vision), DIPLOPIA (double vision) and GAIT DISTURBANCE (I could not walk). At the time of the report, ILLNESS (I was sick for 3 months/ sick), DIZZINESS (Dizzy), VISION BLURRED (blurred vision), DIPLOPIA (double vision) and GAIT DISTURBANCE (I could not walk) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No treatment information was provided.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Heart inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Heart inflammation) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Heart inflammation) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.  Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Illness, Pain, Pain in extremity
Clinical narrative: started getting sick; she had pain before on her leg but with the first shot it intensified; she had pain before on her leg but with the first shot it intensified/Pain; back pain; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included ongoing pain in extremity (she had pain before on her leg but with the first shot it intensified). The patient's concomitant medications were not reported. The patient experienced started getting sick , she had pain before on her leg but with the first shot it intensified, she had pain before on her leg but with the first shot it intensified/pain, back pain on an unspecified date. it was reported during report 1 about herself this caller reported information about her sister who she reported also had the Pfizer shot. Caller mentioned that her sister had the Pfizer Shot and had side effects. She would have to ask her sister who started getting sick but that was to be expected and then got better the next day. She was the only one except for this one sister who she thinks was having a side effect. Caller was the only one having side effects within she would say 2 weeks. Her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she was still having the front. So then when she got the second shot she told the nurse her pain had increased and she said now it was getting pretty, she was been putting ice and stuff like that she got her shots really early, this was like months later. The outcome for all events was recovering.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she got the second shot she told the nurse her pain has increased; This is a spontaneous report from a contactable consumer. This consumer reported for a female pa-tient (sister) that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspeci-fied route of administration on an unspecified date as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included, back pain from an unknown date and unknown if ongoing. It was reported that her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she's still having the front. The patient's concomitant medications were not re-ported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. Post dose 1 she started having a pain. It was reported that, the patient got the second shot she told the nurse her pain has increased on an unspecified date. Reporter stated she was calling regarding the Pfizer shot, the first one, the Covid 19 vaccine. During report 1 about herself this reporter reported information about her sister who she reported also had the Pfizer shot. Reporter mentioned that her sister had the Pfizer Shot and had side effects. She would have to ask her sister who started getting sick but that was to be expected and then got better the next day. She was the only one except for this one sister who she thought was having a side effect. Reporter was the only one having side effects within she would say 2 weeks. Her sister started having a pain, she had pain before on her leg but with the first shot it intensified. Then it got mild so she though it was related to her back pain and whatever. They took care of the back but she was still having the front. So then when she got the second shot she told the nurse her pain has increased and she said now it was getting pretty, she had been putting ice and stuff like that she got her shots really early, this was like months later. Therapeutic measures were taken as a result of the event. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Nausea, Pain
Clinical narrative: stomach cramps; nausea; vomiting; diarrhea; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.  A 32-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection), via an unspecified route of administration on 19Jul2021 10:30 (Batch/Lot Number: ew0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Other medications in two weeks: Birth control, prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. Patient stated that she had experienced nausea, vomiting and diarrhea since approximately 6 hours post vaccination. I also experienced chills, body aches and stomach cramps. The outcome of the events were recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: stomach cramps; nausea; vomiting; diarrhea; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.  A 32-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection), via an unspecified route of administration on 19Jul2021 10:30 (Batch/Lot Number: ew0217) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Other medications in two weeks: Birth control, prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. Patient stated that she had experienced nausea, vomiting and diarrhea since approximately 6 hours post vaccination. I also experienced chills, body aches and stomach cramps. The outcome of the events were recovering.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Photophobia
Clinical narrative: Headache; sensitivity to light; experience of nausea and dizziness and I still get that feeling now; experience of nausea and dizziness and I still get that feeling now; This is a spontaneous report from a Contactable consumer (patient, self-reporting). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN0181 and expiration date was not reported), dose 1 via an unspecified route of administration on 23Jun2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. On June 23rd Patient took the first Pfizer COVID Vaccine now that week patient was fine but the week of 4Jul2021 and started getting strong headache some sensitivity to light and some experience of nausea and dizziness and still get that feeling now. Patient was supposed to have the 2nd vaccine last week but belated twice (Missed dose) because patient still feel those things, so do not know whether that's common after the first week. The outcome of the event was not recovered.  Follow-up (27Aug2021): Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951226 similar report from same reporter
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: I had chest pain; my left arm went numb; Pain is always there. Sometimes I feel it in my arm; I get short of breath; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153, Expiration date: not reported, Age at vaccination: 43-year-old) via an unspecified route of administration in right arm on 08Apr2021 04:00 PM as single dose for COVID-19 immunization. The patient medical history included seasonal allergies. Concomitant medications included Zyrtec D, Mucinex DM and Flonase. On 21Jul2021, patient experienced chest pain, numbness of extremities, pain, short of breath. Lab test included EKG, blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment as antibiotics received for events. No other vaccine was administered in four weeks. Covid was not present prior vaccination. Patient had no known allergies. The outcome of events was recovered on an unknown date with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Hypoaesthesia, Pain, Pulmonary function test
Clinical narrative: I had chest pain; my left arm went numb; Pain is always there. Sometimes I feel it in my arm; I get short of breath; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153, Expiration date: not reported, Age at vaccination: 43-year-old) via an unspecified route of administration in right arm on 08Apr2021 04:00 PM as single dose for COVID-19 immunization. The patient medical history included seasonal allergies. Concomitant medications included Zyrtec D, Mucinex DM and Flonase. On 21Jul2021, patient experienced chest pain, numbness of extremities, pain, short of breath. Lab test included EKG, blood work in the ER checking for Heart attack, Echo and stress test, CT of my chest, PFT and 6 min walk for my lungs. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment as antibiotics received for events. No other vaccine was administered in four weeks. Covid was not present prior vaccination. Patient had no known allergies. The outcome of events was recovered on an unknown date with sequel.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Vomiting
Clinical narrative: Gabapentin (captured as suspects) they gave me, that made me sick and vomit; Gabapentin (captured as suspects) they gave me, that made me sick and vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration on 03May2021 (at the age 57-year-old) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation; gabapentin (Formulation: Unknown), via unspecified route of administration, from unspecified date, unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient stated 'gabapentin (captured as suspects) they gave me, that made me sick and vomit' on an unspecified date. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Nasal congestion, Pyrexia
Clinical narrative: Fever for 4days so far (073121) from date of shot; chest burning sensation; congestion; chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot Number: EW0173) via an unspecified route of administration, administered in right arm on 28Jul2021 14:30 (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included meningococcal vaccine a/c/y/w and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 26Jul2021. On 28Jul2021 23:00, the patient experienced running fever for 4days so far (073121) from date of shot, chest burning sensation, congestion, chills and fatigue and treatment received for the events were unknown. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Ocular hyperaemia
Clinical narrative: I feel like Dizzy; My both eyes are like a little bit red; This is a spontaneous report from a contactable consumer (Patient).   A patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I feel like Dizzy and My both eyes are like a little bit red. It was reported that when probed for the concern, consumer stated, he got his first Covid Vaccine yesterday and today he didn't know if it was the part of it or not but he felt like dizzy and his both eyes were like a little bit red. Outcome of all the events was unknown.   Information on lot number/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Spot where I had the shot is very swollen and red; Spot where I had the shot is very swollen and red; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: FA7484), via an unspecified route of administration on an unspecified date, dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had the vaccine on Saturday. The patient reported that the spot where he/she had the shot was very swollen and red but noticed it was magnetic. The patient put a quarter or penny or whatever on that spot it stays there until he/she removed it. The patient was asking what was magnetic in that shot. The clinical outcome for events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: experiencing pain; numbness on right side of shoulder and then going down now the area is expanding; This is a spontaneous report from a contactable consumer (Patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date: was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered in Deltoid Left on an unspecified date as dose 1, single for COVID-19 immunization and experienced slight fever. The patient experienced experiencing pain, and numbness on right side of shoulder and then going down now the area is expanding on an unspecified date. Consumer stated, he have a problem and it seemed as if it is not only his but he have the vaccine but, he thought this effect will go away and it never went away and first shot he had because he took the Pfizer, the first one on left shoulder and 2nd one was on the second shoulder, he mean on right shoulder and initially he did get any experience any side effect other than just slight fever but now he experiencing pain that never went away, it's just increasing, and increasing, and numbness on right side of shoulder and then going down now the area is expanding and he tried to do some exercises and his wife experiencing the same thing and even other friends that also receive the same vaccine on the same day are also complaining the same thing. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994049 same reporter/ drug, different AE/ patient;US-PFIZER INC-202100994048 same reporter/ AE/ drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date. The patient experienced tiredness on an unspecified date. The patient stated she has received both doses of the Pfizer BioNtech covid 19 vaccine series and the only side effect was tiredness. Patient was now seeking information regarding the 3rd booster dose of the vaccine. Response was given from CONS-Booster Dose (US) (v1.0) as well as press release from 08Jul2021 (website link). The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: She is experiencing tiredness; Caller states his wife is lightheaded/dizzy and weak; Caller states his wife is lightheaded, dizzy and weak; This is a spontaneous report from a contactable consumer (patient's husband) reported for Patient. A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, NDC number and Expiry Date: Not Provided) via an unspecified route of administration on 09Aug2021 at 14:05 as dose 2, single for COVID-19 immunization (vaccinated at the age of 90-years). The patient medical history and Concomitant medications were not provided. The reporter stated that his wife (patient) was lightheaded, dizzy and weak on 09Aug2021. The reporter questioned what the patient should do, he further stated that if Pfizer gives the shots, they should know what to do about the side effects and his wife, was not given information sheet, after her vaccine, about the common side effects, he wanted to have information if her side effects had been reported. The outcome of all the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pruritus, Urticaria
Clinical narrative: Have a regular pain that's feels like someone punched in the arm like my muscle hurts over it; Neck started itching; Whole entire neck was just itching terrible and all night I was itching; Covered in hives; Still covered in hives like they didn't go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso; Have a regular pain that's feels like someone punched in the arm like my muscle hurts over it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: not reported), via an unspecified route of administration, administered in right arm in Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 in May2021 (a confirm case). The concomitant medications for patient were not reported. It was reported that the patient had COVID back in May a confirm case and then was told by the doctor to get the vaccine (Unspecified vaccine) anyway and she told the patient to get it at Saturday, so the patient went and got first dose. The patient got vaccinated yesterday morning on right arm, it was maybe like 10 O'clock or 11 O'clock something like that. It was Saturday whenever it was 8th or 7th the patient did not know. And it was reported that "I got it in my right arm and probably about 9 O'clock at night my neck started", On an unspecified date in Aug2021, the patient reported to "have a regular pain that's feels like someone punched in the arm like my muscle hurts over it", but according to patient that was not the big deal but about 9 at night "neck started itching; whole entire neck was just itching terrible and all night I was itching". The patient thought maybe the patient was getting bitten by mosquito or something but then the patient went to bed. Then the patient woke up in morning and the patient was "covered in hives; still covered in hives like they didn't go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso". The patient reported that the patient did not get hives. So, that was not, the only thing the patient did different was to take the vaccine and the patient was covered in hives and it was 8 O'clock at night and the patient was still completely covered on torso. The patient did not want to take Benadryl or something and just wanted to know why the patient having hives. The patient did not want to take the second one if the patient getting the hives. The patient did not want to get any mail. Further probing could not be done as the consumer was unwilling to share any further information at that point of time. Hence limited information available over the call. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Muscle aches; Arm feels like it was punched, after first vaccine; Bad headache, after first vaccine; Slept for 3 hours, after first vaccine; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 58-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Aug2021 (at the age of 58-year-old) as dose 1, single for COVID-19 vaccination. Medical history included fibromyalgia, migraines, headache and muscle aches (muscle aches as well from the fibromyalgia). Concomitant medications were not reported. Historical vaccine included Influenza vaccine and usually got a headache. The patient got the first dose on 09Aug2021 (reported as today) and her second dose already scheduled. On 09Aug2021, the patient experienced arm feels like it was punched, muscle aches and a bad headache, after the vaccine. She came home from getting the vaccine and slept for 3 hours. She was not saying any of that was from the vaccine. The patient would like to know if a person had to quarantine after getting the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.