chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 10:00 (Lot number: ER8732) at the age of 49 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Allergies: pcn" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "severe adhesive allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6207, prev dose lot unknown=False, prev dose dose number=1, prev dose vaccine location=Right arm), administration date: 12Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Headache", "Fatigue". The following information was reported: PYREXIA (non-serious), outcome "recovering", described as "Fever"; HEADACHE (non-serious), outcome "recovering", described as "headache"; FATIGUE (non-serious), outcome "recovering", described as "fatigue". The events "fever", "headache" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, fatigue.  Additional Context: Fever over 104, not able to reduce with medication below 101, severe joint pain through back and hips, headache, chills, brain "zaps", Extreme fatigue. All symptoms Lasting over 24 hrs. After 24 hrs, severe joint pain remains. First dose had a headache and fatigue for a few hrs. 2nd dose fever, headache, fatigue for 6-8 hrs. 3rd dose makes me never want to get a 4th if recommended.  Follow-Up (13Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Rash erythematous, SARS-CoV-2 test
Clinical narrative: full body red rash; full body red rash; slight shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Dec2020 (Lot number: EL1284) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy-carrot" (unspecified if ongoing); "Known allergy-penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies : morphine". The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH (non-serious), outcome "unknown" and all described as "full body red rash"; DYSPNOEA (non-serious), outcome "unknown", described as "slight shortness of breath". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced full body red rash with slight shortness of breath on first dose, when I got the 2nd dose a month later, he took 1000mg Tylenol, and 50 mg Benadryl 1 hour prior to vaccine and still ended up with body rash and shortness of breath. both time this was with in less than 5 minutes of getting the Pfizer vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Depression, Fatigue, Feeling abnormal
Clinical narrative: fatigue; headache; muscle and joint pain; muscle and joint pain; memory impairment; brain fog; depression; anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0217) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "known allergies; Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: pfizer, prev dose brand unknown: False, prev dose lot number: EW0187, prev dose lot unknown: False, prev dose administration date: 21May2021, prev dose dose number: 1), administration date: 21May2021, for COVID-19 IMMUNIZATION. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "muscle and joint pain"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory impairment"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; DEPRESSION (non-serious), outcome "not recovered", described as "depression"; ANXIETY (non-serious), outcome "not recovered", described as "anxiety". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, headache, myalgia, arthralgia, memory impairment, feeling abnormal, depression, anxiety.  Clinical course: 2nd shot fatigue, headache, muscle and joint pain, memory impairment, brain fog, depression, anxiety within 24 hours and has continued for 6 months.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: Yes. Other medical history: Blood pressure, weight. Language: EN. Reporting type: AE. If other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Memory impairment, Myalgia, SARS-CoV-2 test
Clinical narrative: fatigue; headache; muscle and joint pain; muscle and joint pain; memory impairment; brain fog; depression; anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (Lot number: EW0217) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "known allergies; Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: pfizer, prev dose brand unknown: False, prev dose lot number: EW0187, prev dose lot unknown: False, prev dose administration date: 21May2021, prev dose dose number: 1), administration date: 21May2021, for COVID-19 IMMUNIZATION. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "muscle and joint pain"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory impairment"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; DEPRESSION (non-serious), outcome "not recovered", described as "depression"; ANXIETY (non-serious), outcome "not recovered", described as "anxiety". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, headache, myalgia, arthralgia, memory impairment, feeling abnormal, depression, anxiety.  Clinical course: 2nd shot fatigue, headache, muscle and joint pain, memory impairment, brain fog, depression, anxiety within 24 hours and has continued for 6 months.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: Yes. Other medical history: Blood pressure, weight. Language: EN. Reporting type: AE. If other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear disorder, Ear pain, Eating disorder, Movement disorder
Clinical narrative: TMJ dysfuntion; intense pain when trying to eat etc; I woke up with intense pain on my right side TMJ; limited movement; pain in the ear; popping sound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 17:00 (Lot number: 330368D) as dose 1 , single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAPROXEN. The following information was reported: TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "TMJ dysfuntion"; EATING DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "intense pain when trying to eat etc"; ARTHRALGIA (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "I woke up with intense pain on my right side TMJ"; MOVEMENT DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "limited movement"; EAR PAIN (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "pain in the ear"; EAR DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "popping sound". Therapeutic measures were not taken as a result of temporomandibular joint syndrome, eating disorder, arthralgia, movement disorder, ear pain, ear disorder.  Additional information: The patient was not diagnosed with COVID-19 prior and since the vaccine. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Temporomandibular joint syndrome
Clinical narrative: TMJ dysfuntion; intense pain when trying to eat etc; I woke up with intense pain on my right side TMJ; limited movement; pain in the ear; popping sound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 17:00 (Lot number: 330368D) as dose 1 , single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAPROXEN. The following information was reported: TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "TMJ dysfuntion"; EATING DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "intense pain when trying to eat etc"; ARTHRALGIA (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "I woke up with intense pain on my right side TMJ"; MOVEMENT DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "limited movement"; EAR PAIN (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "pain in the ear"; EAR DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "popping sound". Therapeutic measures were not taken as a result of temporomandibular joint syndrome, eating disorder, arthralgia, movement disorder, ear pain, ear disorder.  Additional information: The patient was not diagnosed with COVID-19 prior and since the vaccine. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 12Jan2021 (Lot number: EL3246) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot Number: EL1284), administration date: 23Dec2020, when the patient was 40 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021), described as "Fever".  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: mild Shingles outbreak  on right leg 1  month following first 2 vaccines and 2 months following the 3 rd vaccine.  There is no history of shingles outbreak in the past until receipt of this vaccine.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 (Lot number: El8982) at the age of 49 years as dose 2, single and intramuscular, administered in arm left, administration date 31Dec2020 (Lot number: Ek5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "Migraines" (unspecified if ongoing), notes: Other medical history: migraines; "Cervical Disc Disease" (unspecified if ongoing), notes: Other medical history: cervical disc disease; "Chronic Muscle Spasm" (unspecified if ongoing), notes: Other medical history: chronic Muscle spasm. The patient's concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset Jan2021, outcome "not recovered", described as "mild Shingles outbreak  on right leg 1 month following first 2 vaccines and 2 months following the 3 rd vaccine. There is no history of shingles outbreak in the past until receipt of this vaccine.". The event "mild shingles outbreak on right leg 1  month following first 2 vaccines and 2 months following the 3 rd vaccine. there is no history of shingles outbreak in the past until receipt of this vaccine." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster.The patient did not receive any other vaccine in four weeks.The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain
Clinical narrative: chest pain; felt uneasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jul2021 (Lot number: EW0202) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 02Jul2021, outcome "recovered" (Jul2021), described as "chest pain"; ANXIETY (non-serious) with onset 02Jul2021, outcome "recovered" (Jul2021), described as "felt uneasy".  Additional information: Caller stated he has just spoken with agent and reported his adverse event from receiving the first and second dose of the Pfizer COVID 19 vaccine in Jul2021. Caller reported that he wanted to report a concern and reaction and get some information on the Pfizer recommendations for the booster dose of the Covid-19 vaccine. He had the first administration on 02Jul2021, and the second dose was on 23Jul2021. On 02Jul2021, for a day or so after receiving the dose, he had mild chest pain and felt uneasy. He did not monitor his vitals other than that. What was recommended by Pfizer concerning this information? He was required to get the booster for enrolment for the next semester. Is it contraindicated for him to get the booster dose? Caller said that he recovered from all the symptoms that he had previously. He said that his symptoms resolved about 2 days after receiving the vaccines. Additional Vaccines Administered on same date of the Pfizer suspect none. Patient did not require any emergency room and physician office for adverse event. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: none. Adverse following prior vaccinations: None.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Palpitations
Clinical narrative: flushing; light headed; heart racing; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EW0150) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "muscular dystrophy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; CLONAZEPAM; DULOXETINE [DULOXETINE HYDROCHLORIDE]; VARENICLINE; BACLOFEN; TIZANIDINE. The following information was reported: FLUSHING (non-serious) with onset 07Apr2021, outcome "recovered", described as "flushing"; DIZZINESS (non-serious) with onset 07Apr2021, outcome "recovered", described as "light headed"; PALPITATIONS (non-serious) with onset 07Apr2021, outcome "recovered", described as "heart racing"; PALPITATIONS (non-serious) with onset 07Apr2021, outcome "recovered", described as "heart palpitations". Therapeutic measures were not taken as a result of flushing, dizziness, palpitations, palpitations.  Additional information: Caller is a female consumer who states she had a reaction with both doses of the Pfizer Covid 19 vaccine. It was thought at the time that it was a phycological reaction to the injection. When receiving the second dose she informed the nurse of her previous reaction and they stated it was probably a reaction to the needle but patient reports not having a problem with needles. She relays that almost immediately after the injection the same symptoms began as well as she described it to when you have a CT scan with iodine and you feel flushed and warm. She states that she nurse said she was red. She waited at the doctor for 1 hour after injection. Reaction lasted about 45 minutes. Her nurse practitioner did not recommend that she get any further doses. The doctor stated that since they did not have baseline vitals prior to the injections to compare her post injection vitals to that they cannot made the decision on if she should or should not receive a booster dose after these reactions. Her neurologist does not recommend her to receive a booster dose. On 28Apr2021 second dose confirmed. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alzheimer" (unspecified if ongoing), notes: his illness of Alzheimer. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash".  Additional information: It was reported that, caller mentioned her husband got as clarified the Pfizer Covid shot and he got a rash. Caller initially said she is not even going to report what happened to her husband. She then went on to explain her husband got a rash and they feel its from the shot. However, the doctors do not think so. They think its from his illness of Alzheimer. Caller does not believe this as she has never heard this happening with Alzheimers.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, SARS-CoV-2 test
Clinical narrative: They both have developed a strange dermatitis that has lasted for months/ her son's are on the crook of his elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 (Lot number: EW0173) at the age of 16 years as dose 2, single and administered in arm left, administration date 28Apr2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ringworm" (unspecified if ongoing), notes: He actually has had ringworm prior because he is a wrestler and he thought that it was also ringworm.; "Seasonal spring allergies" (unspecified if ongoing), notes: diagnosed when he was 3 years old. There were no concomitant medications. The following information was reported: DERMATITIS (non-serious) with onset Dec2021, outcome "not recovered", described as "They both have developed a strange dermatitis that has lasted for months/ her son's are on the crook of his elbow". The event "they both have developed a strange dermatitis that has lasted for months/ her son's are on the crook of his elbow" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dermatitis.  Additional information: The patient's wife first stated she was calling about both the pediatric and adult dose of the Pfizer COVID vaccine and later stated that both her husband and son, who was 16 at the time, both would have received the adult dose, she assumed. They are at a point where they are thinking her husband and son are having reactions to it. Maybe a month or two later, her husband started having a strange dermatitis on his hands, which has now been treated by several different doctors and continued to get worse. Son has a similar issue with it on his arm. Maybe it could be in relation to their vaccines. Neither had very much of a reaction with either dose. This report is to capture information for her son. It is unknown patient received any other vaccines within four weeks prior to the first administration date of the suspect vaccine. Patient's Medical History including any illness at time of vaccination is Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity Illness.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chest pain, Disturbance in attention, Malaise
Clinical narrative: disoriented; chest pain; after the second dose he felt very ill for a few days/felt uneasy/felt severely unwell; his blood pressure was dropping down to 90s/60s when it usually runs around 120/80; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 34-year-old male patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Lot number: EY0584) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 02Jul2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "Chest pain". The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "after the second dose he felt very ill for a few days/felt uneasy/felt severely unwell"; BLOOD PRESSURE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his blood pressure was dropping down to 90s/60s when it usually runs around 120/80"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "disoriented". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Muscular dystrophy
Clinical narrative: flushing; warm; light headed; heart racing; heart palpitations; nurse said she was red; muscular dystrophy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: ER8736) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BACLOFEN; CLONAZEPAM; DULOXETINE DR; LEVOTHYROXINE; TIZANIDINE; VARENICLINE. Vaccination history included: Bnt162b2 (Dose 1, LOT#, Consumer stated, "The first one is EW0150), administration date: 07Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: FLUSHING (non-serious), outcome "recovered", described as "flushing"; FEELING HOT (non-serious), outcome "recovered", described as "warm"; DIZZINESS (non-serious), outcome "recovered", described as "light headed"; PALPITATIONS (non-serious), outcome "recovered", described as "heart racing"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitations"; ERYTHEMA (non-serious), outcome "recovered", described as "nurse said she was red"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown", described as "muscular dystrophy". Therapeutic measures were not taken as a result of flushing, feeling hot, dizziness, palpitations, palpitations, erythema, muscular dystrophy. Additional information: Caller is a female consumer who states she had a reaction with both doses of the Pfizer Covid 19 vaccine. With the first dose she experienced after 5-10 minutes flushing, light headed, heart racing, and heart palpitations. It was thought at the time that it was a phycological reaction to the injection. When receiving the second dose she informed the nurse of her previous reaction and they stated it was probably a reaction to the needle but patient reports not having a problem with needles. She relays that almost immediately after the injection the same symptoms began as well as she described it to when you have a CT scan with iodine and you feel flushed and warm. She states that she nurse said she was red. She waited at the doctor for 1 hour after injection. Reaction lasted about 45 minutes. Her nurse practitioner did not recommend that she get any further doses. The doctor stated that since they did not have baseline vitals prior to the injections to compare her post injection vitals to that they cannot made the decision on if she should or should not receive a booster dose after these reactions. She would like to know if these are common reactions and if she should receive a booster dose after these reactions with the initial series?  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: flushing; warm; light headed; heart racing; heart palpitations; nurse said she was red; muscular dystrophy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: ER8736) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BACLOFEN; CLONAZEPAM; DULOXETINE DR; LEVOTHYROXINE; TIZANIDINE; VARENICLINE. Vaccination history included: Bnt162b2 (Dose 1, LOT#, Consumer stated, "The first one is EW0150), administration date: 07Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: FLUSHING (non-serious), outcome "recovered", described as "flushing"; FEELING HOT (non-serious), outcome "recovered", described as "warm"; DIZZINESS (non-serious), outcome "recovered", described as "light headed"; PALPITATIONS (non-serious), outcome "recovered", described as "heart racing"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitations"; ERYTHEMA (non-serious), outcome "recovered", described as "nurse said she was red"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown", described as "muscular dystrophy". Therapeutic measures were not taken as a result of flushing, feeling hot, dizziness, palpitations, palpitations, erythema, muscular dystrophy. Additional information: Caller is a female consumer who states she had a reaction with both doses of the Pfizer Covid 19 vaccine. With the first dose she experienced after 5-10 minutes flushing, light headed, heart racing, and heart palpitations. It was thought at the time that it was a phycological reaction to the injection. When receiving the second dose she informed the nurse of her previous reaction and they stated it was probably a reaction to the needle but patient reports not having a problem with needles. She relays that almost immediately after the injection the same symptoms began as well as she described it to when you have a CT scan with iodine and you feel flushed and warm. She states that she nurse said she was red. She waited at the doctor for 1 hour after injection. Reaction lasted about 45 minutes. Her nurse practitioner did not recommend that she get any further doses. The doctor stated that since they did not have baseline vitals prior to the injections to compare her post injection vitals to that they cannot made the decision on if she should or should not receive a booster dose after these reactions. She would like to know if these are common reactions and if she should receive a booster dose after these reactions with the initial series?  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Headache, Pyrexia
Clinical narrative: Dizzy; headache; abdominal pain; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 15:00 (Lot number: 330368D) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "Dizzy"; HEADACHE (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "headache"; ABDOMINAL PAIN (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "abdominal pain"; PYREXIA (non-serious) with onset 04Jan2022 06:00, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of dizziness, headache, abdominal pain, pyrexia.  Additional Information: There was no Seriousness criteria-Results in death, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered was facility. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Throat irritation, Urticaria
Clinical narrative: broke out into generalized hives covering my whole body; lips were swollen and tingly; lips were swollen and tingly; throat felt itchy; small welts; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: fj8762) at the age of 28 years as dose 2, single and administration date 16Nov2021 02:30 (Lot number: fg3527) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XULANE. Vaccination history included: Flu vaccine, administration date: 02Nov2021, when the patient was 28 years old, for Flu vaccination.  The following information was reported: URTICARIA (non-serious) with onset 16Nov2021 04:30, outcome "not recovered", described as "broke out into generalized hives covering my whole body"; LIP SWELLING (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 16Nov2021 04:30, outcome "not recovered" and all described as "lips were swollen and tingly"; THROAT IRRITATION (non-serious) with onset 16Nov2021 04:30, outcome "not recovered", described as "throat felt itchy"; URTICARIA (non-serious) with onset 16Nov2021 04:30, outcome "not recovered", described as "small welts". The events "broke out into generalized hives covering my whole body", "lips were swollen and tingly", "lips were swollen and tingly", "throat felt itchy" and "small welts" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, lip swelling, paraesthesia oral, throat irritation, urticaria.  Additional information: After 1st vaccine, two hours later broke out into generalized hives covering my whole body and my lips were swollen and tingly, and throat felt itchy. went to urgent care and got treated there. improved with small welts coming up every couple days, then ten days after second vaccine had same reaction happen and not itchiness and welts have not completely gone away with treatment and I am almost a month out from second vaccine. Patient has received other vaccine within 4 weeks of receiving COVID-19 vaccine. Its unknown if patient had COVID-19 prior to vaccination. Patient had not been tested for COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus, Skin lesion
Clinical narrative: a raised lesion appeared near injection site/Raised skin lesions appeared all over my legs, arms and torso; Lichen Planus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 11:45 (Lot number: EN6205) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE; LOSARTAN. The following information was reported: SKIN LESION (non-serious) with onset 18Mar2021 15:00, outcome "recovering", described as "a raised lesion appeared near injection site/Raised skin lesions appeared all over my legs, arms and torso"; LICHEN PLANUS (non-serious) with onset 18Mar2021 15:00, outcome "recovering", described as "Lichen Planus". The events "a raised lesion appeared near injection site/raised skin lesions appeared all over my legs, arms and torso" and "lichen planus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin lesion, lichen planus.  Additional information:The patient was not diagnosed with COVID-19,Prior to vaccination. The patient had not been tested for COVID-19,Since the vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Product: COVID 19 Brand: Pfizer ;Brand unknown: False;Lot number: ER8727,Lot unknown: False;Administration date: 07Apr2021;Administration time: 02:00 PM;Dose number: 2 Vaccine Location: Left arm  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: Ongoing cough; could and flu Like symptoms; excessive fatigue; loss of appetite; irritability; loss of energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2021 15:00 (Lot number: FK5618) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5618, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 02Dec2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "Ongoing cough"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "could and flu Like symptoms"; FATIGUE (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "excessive fatigue"; DECREASED APPETITE (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "loss of appetite"; IRRITABILITY (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "irritability"; ASTHENIA (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "loss of energy". The events "ongoing cough", "could and flu like symptoms", "excessive fatigue", "loss of appetite", "irritability" and "loss of energy" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, influenza like illness, fatigue, decreased appetite, irritability, asthenia.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Reported Event: Ongoing cough, could and flu Like symptoms, excessive fatigue, loss of appetite, irritability, loss of energy. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, SARS-CoV-2 test
Clinical narrative: Ongoing cough; could and flu Like symptoms; excessive fatigue; loss of appetite; irritability; loss of energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2021 15:00 (Lot number: FK5618) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5618, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 02Dec2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "Ongoing cough"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "could and flu Like symptoms"; FATIGUE (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "excessive fatigue"; DECREASED APPETITE (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "loss of appetite"; IRRITABILITY (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "irritability"; ASTHENIA (non-serious) with onset 24Dec2021 21:00, outcome "not recovered", described as "loss of energy". The events "ongoing cough", "could and flu like symptoms", "excessive fatigue", "loss of appetite", "irritability" and "loss of energy" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, influenza like illness, fatigue, decreased appetite, irritability, asthenia.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Reported Event: Ongoing cough, could and flu Like symptoms, excessive fatigue, loss of appetite, irritability, loss of energy. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable other HCP. A 6-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK5618), at the age of 6, in right arm, on Jan 6, 2022, at 14:15, single dose, for COVID-19 immunization. Medical history and concomitant medication not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK5618), at the age of 5, in right arm, Dec 2021, single dose, for COVID-19 immunization. The patient experienced pyrexia (fever) and dizziness, onset Jan 7, 2022, at 03:00, with outcome of not recovered. Therapeutic measures were not taken as a result of pyrexia and dizziness. Additional information: No other vaccine in four weeks and no other medications in two weeks. No COVID-19 prior vaccination. No COVID-19 post vaccination. No follow-up attempts possible. No further information expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A 7-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FL0007, expiration date: Mar 7, 2022), at the age of 7, in left arm, on Jan 5, 2022, single dose, for COVID-19 immunisation. Medical history included egg allergy (not ongoing), notes: patient allergic to eggs a long time ago. Patient eats eggs now with no problems. Concomitant medications not reported. The patient developed urticaria (got hives one day later), onset Jan 6, 2022, with outcome of recovered (Jan 2022). Therapeutic measures were taken as a result of urticaria. Additional information: The patient's mom contacted the doctor who had her to use Benadryl and topical hydrocortisone. The hives resolved with these and no other treatments. The mother of the patient mentioned the doctor said if the hives did not resolve within 72 hours to seek further medical attention. In less than 72 hours, patient fully recovered. The mother denied knowledge of any other medications, medical conditions, labs, testing or treatments relevant to these events. NDC number of COVID-19  vaccine for ages 5 to 11: 59267105501. No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: She suffered from headaches prior to the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8735) at the age of 67 years as dose 2, single and administration date 10Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU.  The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "She suffered from headaches prior to the booster".  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: Second vaccine: rash break out between his knees and ankles on both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Feb2021 12:58 (Lot number: EL9262, Expiration Date: 03Feb2021) at the age of 76 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease", start date: Jun2011 (ongoing), notes: Diagnosed 6-7 years ago; "BPH", start date: Sep2014 (ongoing); "ASCAD", start date: May2005 (ongoing); "Hyperchol", start date: May2005 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3 ML SINGLE , Dosage text :30mcg/0.3mL, left arm, Time: 14:53, Anatomical Site of injection: Deltoid Left, Route of administration: Intramuscular, Batch/Lot Number: EK4176), administration date: 13Jan2021, when the patient was 76 years old, for COVID-19 immunization, reaction(s): "rash". The following information was reported: RASH (non-serious) with onset 09Feb2021, outcome "recovered", described as "Second vaccine: rash break out between his knees and ankles on both legs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling in regards to the Corona Vaccine.The caller explains the withheld hospital told him to give Pfizer a call and report what he  asked them about. Caller states he got the first shot in January and second one on 03Feb2021. Six days after the second shot in February, he had a rash break out between his knees and ankles on both legs. The rash did not itch and never bothered him at all. He never had a rash of any kind like that in his life. He didn't know whether it was from the vaccine or it was just a coincidence or what. He states the rash went away within 4 or 5 weeks, it never once bothered him. Caller mentions the Lot number for the second dose has even smaller print than the first one. He states he guess eyeglass companies make them use small print. He confirms the expiration date was the same date he received the vaccine, 03Feb2021.   No follow-up attempts are possible. No further information is expected.