chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tryptase, Urticaria
Clinical narrative: After the first dose she developed a rash on her torso; hives; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 13Jan2021 (Lot number: EL3249) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Verbatim: Eczema, Diagnosed since she was a child. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "After the first dose she developed a rash on her torso"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hives". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received second and third dose of Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chloasma, Headache, Heavy menstrual bleeding
Clinical narrative: unhealthy spike in blood pressure; headache; started menstrual period that was unusually heavy; periods of flush/hot flashes; melasma on face appeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Sep2021 17:00 (Lot number: FC3182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 21Sep2021, outcome "recovered", described as "unhealthy spike in blood pressure"; HEADACHE (non-serious) with onset 21Sep2021, outcome "unknown", described as "headache"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 21Sep2021, outcome "unknown", described as "started menstrual period that was unusually heavy"; HOT FLUSH (non-serious) with onset 21Sep2021, outcome "unknown", described as "periods of flush/hot flashes"; CHLOASMA (non-serious) with onset 21Sep2021, outcome "unknown", described as "melasma on face appeared". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, headache, heavy menstrual bleeding, hot flush, chloasma.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that, the patient was not diagnosed with Covid-19 prior to vaccination and had not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: unhealthy spike in blood pressure; headache; started menstrual period that was unusually heavy; periods of flush/hot flashes; melasma on face appeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Sep2021 17:00 (Lot number: FC3182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 21Sep2021, outcome "recovered", described as "unhealthy spike in blood pressure"; HEADACHE (non-serious) with onset 21Sep2021, outcome "unknown", described as "headache"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 21Sep2021, outcome "unknown", described as "started menstrual period that was unusually heavy"; HOT FLUSH (non-serious) with onset 21Sep2021, outcome "unknown", described as "periods of flush/hot flashes"; CHLOASMA (non-serious) with onset 21Sep2021, outcome "unknown", described as "melasma on face appeared". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure increased, headache, heavy menstrual bleeding, hot flush, chloasma.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that, the patient was not diagnosed with Covid-19 prior to vaccination and had not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: headache; foggy feeling; fever 100.2; sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Oct2021 12:00 (Lot number: EW0217) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METFORMIN; HCTZ; OZEMPIC. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=EM9810,, prev dose administrator_route=Intramuscular,, prev dose administration_time=08:30 AM, prev dose dose number=1,, prev dose vaccine location=Leftarm), administration date: 05Feb2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=EN6205,prev dose administrator_route=Intramuscular,, prev dose administration_time=09:00 AM, prev dose dose number=2,, prev dose vaccine location=Leftarm), administration date: 26Feb2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "headache"; FEELING ABNORMAL (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "foggy feeling"; PYREXIA (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "fever 100.2"; PAIN IN EXTREMITY (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "sore arm"; FATIGUE (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, feeling abnormal, pyrexia, pain in extremity, fatigue.  Additional information: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; foggy feeling; fever 100.2; sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Oct2021 12:00 (Lot number: EW0217) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METFORMIN; HCTZ; OZEMPIC. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=EM9810,, prev dose administrator_route=Intramuscular,, prev dose administration_time=08:30 AM, prev dose dose number=1,, prev dose vaccine location=Leftarm), administration date: 05Feb2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=EN6205,prev dose administrator_route=Intramuscular,, prev dose administration_time=09:00 AM, prev dose dose number=2,, prev dose vaccine location=Leftarm), administration date: 26Feb2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "headache"; FEELING ABNORMAL (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "foggy feeling"; PYREXIA (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "fever 100.2"; PAIN IN EXTREMITY (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "sore arm"; FATIGUE (non-serious) with onset 03Oct2021 21:00, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, feeling abnormal, pyrexia, pain in extremity, fatigue.  Additional information: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia, Pruritus
Clinical narrative: itchiness around my chest and back then random areas on my body; feel like bugs were crawling on me; more of a tingle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Lot number: FC3184) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "itchiness around my chest and back then random areas on my body"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "feel like bugs were crawling on me"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "more of a tingle". Therapeutic measures were not taken as a result of pruritus, feeling abnormal, paraesthesia.  Additional information: The patient did not have repeating node relevant medical history and concurrent conditions. There was not reported name of the drug and reaction was allergy. Active Drug substance names: Covid-19. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fevers; chills; body aches; headache after 12-14 hours of vaccine which lasted 36hours total; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jan2021 12:00 (Lot number: EL0142) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "depression" (unspecified if ongoing); "b12 deficiency" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, administration date 27Sep2021; ZOLOFT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 17:30 PM), administration date: 21Dec2020, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "fevers"; CHILLS (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "chills"; PAIN (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "body aches"; HEADACHE (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "headache after 12-14 hours of vaccine which lasted 36hours total". Therapeutic measures were taken as a result of pain. Additional Information: Patient received 3rd dose (booster) on 01Oct2021 at 12:30 PM on the right arm (lot No. EW0169). for booster on 02Oct2021 at 12:00 PM Patient had developed lymphadenopathy, swelling and pain at right axilla. Neck stiffness as well - still 48 hours post vaccine. Patient was not recovered and treatment received as otc ibuprofen. In the Public Health Clinic/Administration facility most recent COVID-19 vaccine was administered. On 27Sep2021 patient received Influenza vaccines on Right arm within 4 weeks prior to the COVID vaccine. patient received Zoloft within 2 weeks of vaccination. Prior to vaccination Patient wasn't diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No Known Allergies. Ethnicity and Race information is available.  Follow-up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 61-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3184), at the age of 61, on Oct 1, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed a rash (patient broke-out in a rash all over her body), onset Oct 2, 2021, with outcome of unknown. No therapeutic measures taken as a result of rash. Additional information: Patient stated, "I received the Pfizer the day before yesterday. I am a having a reaction. I am breaking-out in a rash all over my body. I was not taking any treatment, but I was going to go to the emergency room." No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Lip swelling, Pain
Clinical narrative: Woke up with my upper lip swollen and I do have dermal filler in that lip; body aches/pains; flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Sep2021 (Lot number: 30155BA) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 30Sep2021, outcome "unknown", described as "body aches/pains"; INFLUENZA (non-serious) with onset 30Sep2021, outcome "unknown", described as "flu"; LIP SWELLING (non-serious) with onset 02Oct2021, outcome "unknown", described as "Woke up with my upper lip swollen and I do have dermal filler in that lip".  Additional Context:Consumer stated, had a Pfizer booster on Friday night, all day, mean on Thursday night, all day yesterday had the body aches, 'flu', pains and everything (further not clarified) that had with the other two shots. However, got up at 3 o'clock this morning and upper lip (Voice breaking) icing it,did have dermal fillers in that lip, woke up with upper lip swollen and did had dermal filler in that lip, so of course googled it and that was a reaction to the other, Moderna, but couldn't find anything that was a reaction to the Pfizer. So went to the urgent care, they sent me to back to withheld where  got it and withheld said go back to urgent care and call Pfizer. So, had calling Pfizer, had  you heard this before, what was going on.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Pain at the injection site; fever; chills; entire body hurt. I couldn't even lay down, or touch/rub any part of my body. Any surface of my body that touched something was very painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 17:00 (Lot number: FC3184) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Rice" (unspecified if ongoing); "Allergies: dairy" (unspecified if ongoing); "Allergies: gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergies: Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, prev dose lot number=FC3184, prev dose administration time=05:30 PM, prev dose vaccine location=Left arm), administration date: 01Sep2021, when the patient was 48 years old, for COVID-19 immunization. It was also reported that patient did not received any other vaccine within 4 weeks prior to the Covid vaccine. Patient was not diagnosed with Covid 19 prior to the vaccination and after the vaccination. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Sep2021 13:00, outcome "recovered" (Sep2021), described as "Pain at the injection site"; PYREXIA (non-serious) with onset 23Sep2021 13:00, outcome "recovered" (Sep2021), described as "fever"; CHILLS (non-serious) with onset 23Sep2021 13:00, outcome "recovered" (Sep2021), described as "chills"; PAIN (non-serious) with onset 23Sep2021 13:00, outcome "recovered" (Sep2021), described as "entire body hurt. I couldn't even lay down, or touch/rub any part of my body. Any surface of my body that touched something was very painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, pain.   Addition information: 20 hours later after 2nd dose, she got a fever, chills and her entire body hurt. She couldn't even lay down, or touch/rub any part of her body. Any surface of her body that touched something was very painful. Lasted about 40 hours.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Headache, Illness
Clinical narrative: low grade fever; diarrhea; headache; achy; fatigued; runny nose; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "low grade fever"; DIARRHOEA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 08Aug2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "fatigued"; RHINORRHOEA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "runny nose"; ILLNESS (non-serious) with onset 08Aug2021, outcome "not recovered", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The attached report concerning your product, PFIZER/ BIONTECH VACCINE, is being forwarded to you on behalf of Moderna in compliance with the FDA regarding post-marketing adverse event reporting dated March 1992 and posted 1998, Section VI (i).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: low grade fever; diarrhea; headache; achy; fatigued; runny nose; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "low grade fever"; DIARRHOEA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 08Aug2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "fatigued"; RHINORRHOEA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "runny nose"; ILLNESS (non-serious) with onset 08Aug2021, outcome "not recovered", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The attached report concerning your product, PFIZER/ BIONTECH VACCINE, is being forwarded to you on behalf of Moderna in compliance with the FDA regarding post-marketing adverse event reporting dated March 1992 and posted 1998, Section VI (i).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Movement disorder, Palpitations
Clinical narrative: Today I just feel bad; I have pain in my hip and back; I have pain in my hip and back; I had like heart palpitation; I was trembling; I couldn''t lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension; AMLODIPINE; LISINOPRIL.  The following information was reported: PALPITATIONS (non-serious) with onset 01Oct2021, outcome "unknown", described as "I had like heart palpitation"; TREMOR (non-serious) with onset 01Oct2021, outcome "unknown", described as "I was trembling"; MOVEMENT DISORDER (non-serious) with onset 01Oct2021, outcome "unknown", described as "I couldn''t lay down"; FEELING ABNORMAL (non-serious) with onset 02Oct2021, outcome "unknown", described as "Today I just feel bad"; BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 02Oct2021, outcome "unknown" and all described as "I have pain in my hip and back". Therapeutic measures were taken as a result of palpitations, tremor, movement disorder, feeling abnormal, back pain, arthralgia.  Additional Context: Concern: Consumer stated, she was just concern about side effect she was having last night she was trembling like (voice not clear) together and she had like heart palpitation that's what she call it. She couldn't lay down. She had to you know kind of sit and then up and today she just feel bad and she have pain in my hip and back and she was wondering was that side effect from, she got her on 15Sep2021. she got my COVID Pfizer (Covid-19 Vaccine), 15Sep. Treatment: Consumer stated, she only took a painkiller. Acetaminophen. Dose: Consumer stated, she just took one, 500 milligrams.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Today I just feel bad; I have pain in my hip and back; I have pain in my hip and back; I had like heart palpitation; I was trembling; I couldn''t lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension; AMLODIPINE; LISINOPRIL.  The following information was reported: PALPITATIONS (non-serious) with onset 01Oct2021, outcome "unknown", described as "I had like heart palpitation"; TREMOR (non-serious) with onset 01Oct2021, outcome "unknown", described as "I was trembling"; MOVEMENT DISORDER (non-serious) with onset 01Oct2021, outcome "unknown", described as "I couldn''t lay down"; FEELING ABNORMAL (non-serious) with onset 02Oct2021, outcome "unknown", described as "Today I just feel bad"; BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 02Oct2021, outcome "unknown" and all described as "I have pain in my hip and back". Therapeutic measures were taken as a result of palpitations, tremor, movement disorder, feeling abnormal, back pain, arthralgia.  Additional Context: Concern: Consumer stated, she was just concern about side effect she was having last night she was trembling like (voice not clear) together and she had like heart palpitation that's what she call it. She couldn't lay down. She had to you know kind of sit and then up and today she just feel bad and she have pain in my hip and back and she was wondering was that side effect from, she got her on 15Sep2021. she got my COVID Pfizer (Covid-19 Vaccine), 15Sep. Treatment: Consumer stated, she only took a painkiller. Acetaminophen. Dose: Consumer stated, she just took one, 500 milligrams.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Electrocardiogram, Investigation, Skin test
Clinical narrative: After the second dose she got hives on her face and arms.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Feb2021 (Lot number: EL9265, Batch number: FCBOH) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Had eczema since she was a child; "sensitive skin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, LOT: EL3249, Time: early afternoon, Had a rash after three days with the first dose., Batch: FCBOH, arm), administration date: 13Jan2021, when the patient was 73 years old, for COVID-19 Immunization, reaction(s): "rash on her torso", "hives".  The following information was reported: URTICARIA (non-serious) with onset Feb2021, outcome "unknown", described as "After the second dose she got hives on her face and arms.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Family Medical History Relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tryptase, Urticaria
Clinical narrative: After the second dose she got hives on her face and arms.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Feb2021 (Lot number: EL9265, Batch number: FCBOH) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Had eczema since she was a child; "sensitive skin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, LOT: EL3249, Time: early afternoon, Had a rash after three days with the first dose., Batch: FCBOH, arm), administration date: 13Jan2021, when the patient was 73 years old, for COVID-19 Immunization, reaction(s): "rash on her torso", "hives".  The following information was reported: URTICARIA (non-serious) with onset Feb2021, outcome "unknown", described as "After the second dose she got hives on her face and arms.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Family Medical History Relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: fever; chills; fatigue; a general feeling that I had been hit by a truck for 24-36 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 Number: 1), for COVID-19 immunization, reaction(s): "little sore around the injection site". The following information was reported: PYREXIA (non-serious), outcome "recovered" (2021), described as "fever"; CHILLS (non-serious), outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious), outcome "recovered" (2021), described as "fatigue"; FEELING ABNORMAL (non-serious), outcome "recovered" (2021), described as "a general feeling that I had been hit by a truck for 24-36 hours".  Additional information: I had been hit by a truck for 24-36 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Musculoskeletal stiffness, Swelling
Clinical narrative: developed lymphadenopathy; swelling and pain at right axilla; swelling and pain at right axilla; Neck stiffness as well - still 48 hours post vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 12:30 (Lot number: EW0169) at the age of 38 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Psoriasis, depression, b12 deficiency" (unspecified if ongoing); "Psoriasis, depression, b12 deficiency" (unspecified if ongoing); "Psoriasis, depression, b12 deficiency" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, administration date 27Sep2021; ZOLOFT. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 11Jan2021, for Covid-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 21Dec2020, for Covid-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Oct2021, outcome "not recovered", described as "developed lymphadenopathy"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 02Oct2021, outcome "not recovered" and all described as "swelling and pain at right axilla"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Neck stiffness as well - still 48 hours post vaccine". Therapeutic measures were taken as a result of lymphadenopathy, swelling, axillary pain, musculoskeletal stiffness.  Additional information: patient received within 2 weeks of vaccination :Zoloft. Prior to vaccination, patient was not diagnosed with COVID-19.  Since the vaccination, patient had not been tested for COVID-19. Device Date and device timestamp was on 04Oct2021. The patient did not reported any allergies.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dry throat, Facial pain, Feeling abnormal, Headache
Clinical narrative: My Face is swollen; pain in my face; numbness in my face; running nose; sore throat; dry throat; headaches; foggy episodes; chest congestion pain; chest congestion pain; arm severe pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 10:30 (Lot number: 301258A) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "Allergy". The following information was reported: SWELLING FACE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "My Face is swollen"; FACIAL PAIN (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "pain in my face"; HYPOAESTHESIA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "numbness in my face"; RHINORRHOEA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "running nose"; OROPHARYNGEAL PAIN (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "sore throat"; DRY THROAT (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "dry throat"; HEADACHE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "foggy episodes"; RESPIRATORY TRACT CONGESTION (non-serious), CHEST PAIN (non-serious) all with onset 29Sep2021 20:00, outcome "not recovered" and all described as "chest congestion pain"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "arm severe pain". Therapeutic measures were not taken as a result of swelling face, facial pain, hypoaesthesia, rhinorrhoea, oropharyngeal pain, dry throat, headache, feeling abnormal, respiratory tract congestion, chest pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oropharyngeal pain, Pain in extremity, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: My Face is swollen; pain in my face; numbness in my face; running nose; sore throat; dry throat; headaches; foggy episodes; chest congestion pain; chest congestion pain; arm severe pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 10:30 (Lot number: 301258A) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "Allergy". The following information was reported: SWELLING FACE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "My Face is swollen"; FACIAL PAIN (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "pain in my face"; HYPOAESTHESIA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "numbness in my face"; RHINORRHOEA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "running nose"; OROPHARYNGEAL PAIN (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "sore throat"; DRY THROAT (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "dry throat"; HEADACHE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "foggy episodes"; RESPIRATORY TRACT CONGESTION (non-serious), CHEST PAIN (non-serious) all with onset 29Sep2021 20:00, outcome "not recovered" and all described as "chest congestion pain"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "arm severe pain". Therapeutic measures were not taken as a result of swelling face, facial pain, hypoaesthesia, rhinorrhoea, oropharyngeal pain, dry throat, headache, feeling abnormal, respiratory tract congestion, chest pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: My Face is swollen; pain in my face; numbness in my face; running nose; sore throat; dry throat; headaches; foggy episodes; chest congestion pain; chest congestion pain; arm severe pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 10:30 (Lot number: 301258A) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrum, reaction(s): "Allergy". The following information was reported: SWELLING FACE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "My Face is swollen"; FACIAL PAIN (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "pain in my face"; HYPOAESTHESIA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "numbness in my face"; RHINORRHOEA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "running nose"; OROPHARYNGEAL PAIN (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "sore throat"; DRY THROAT (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "dry throat"; HEADACHE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "foggy episodes"; RESPIRATORY TRACT CONGESTION (non-serious), CHEST PAIN (non-serious) all with onset 29Sep2021 20:00, outcome "not recovered" and all described as "chest congestion pain"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "arm severe pain". Therapeutic measures were not taken as a result of swelling face, facial pain, hypoaesthesia, rhinorrhoea, oropharyngeal pain, dry throat, headache, feeling abnormal, respiratory tract congestion, chest pain, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Rash developed all over my body; very itchy; Spot rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Lot number: EW0173) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing). Concomitant medication(s) included: METFORMIN; CREON; JARDIANCE; GLIMEPIRIDE. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot No: EW0162, Location of injection: Arm Left), administration date: 13Apr2021, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 10May2021, outcome "not recovered", described as "Rash developed all over my body"; PRURITUS (non-serious) with onset 10May2021, outcome "not recovered", described as "very itchy"; RASH MACULAR (non-serious) with onset 10May2021, outcome "not recovered", described as "Spot rash". The events "rash developed all over my body", "very itchy" and "spot rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus, rash macular.  Additional information: It was reported that the rash developed all over his body. Spot rash, very itchy. It continues to form. The dermatologist prescribed something to help that costs a lot and at best only seems to pause the effect. The patient received treatment (Enstilar topical application) for the events. He claims other patients who received Pfizer shot reported the same. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever; swelling at injection with redness to elbow for a week; swelling at injection with redness to elbow for a week; extreme joint pain; severe headache; Missed worked for both shots; This is a spontaneous report received from a 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 02Dec2020 (Lot number: EL0140) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; VACCINATION SITE SWELLING (non-serious), ERYTHEMA (non-serious), outcome "recovered" and all described as "swelling at injection with redness to elbow for a week"; ARTHRALGIA (non-serious), outcome "recovered", described as "extreme joint pain"; HEADACHE (non-serious), outcome "recovered", described as "severe headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "Missed worked for both shots". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site swelling, erythema, arthralgia, headache, loss of personal independence in daily activities.  Additional information: The patient received  dose 2 on 06Jan2021, lot number EK9231, administrator route reported was intramuscular on left arm. No other vaccine received in four weeks. All adverse reactions were felt except myocarditis. Fever, swelling at injection with redness to elbow for a week, extreme joint pain, severe headache, all for 2 days before subsiding. Missed worked for both shots. No treatment received for adverse event. No covid prior vaccination. Patient tested positive for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site swelling
Clinical narrative: Fever; swelling at injection with redness to elbow for a week; swelling at injection with redness to elbow for a week; extreme joint pain; severe headache; Missed worked for both shots; This is a spontaneous report received from a 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 02Dec2020 (Lot number: EL0140) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; VACCINATION SITE SWELLING (non-serious), ERYTHEMA (non-serious), outcome "recovered" and all described as "swelling at injection with redness to elbow for a week"; ARTHRALGIA (non-serious), outcome "recovered", described as "extreme joint pain"; HEADACHE (non-serious), outcome "recovered", described as "severe headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "Missed worked for both shots". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site swelling, erythema, arthralgia, headache, loss of personal independence in daily activities.  Additional information: The patient received  dose 2 on 06Jan2021, lot number EK9231, administrator route reported was intramuscular on left arm. No other vaccine received in four weeks. All adverse reactions were felt except myocarditis. Fever, swelling at injection with redness to elbow for a week, extreme joint pain, severe headache, all for 2 days before subsiding. Missed worked for both shots. No treatment received for adverse event. No covid prior vaccination. Patient tested positive for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pain, Pyrexia
Clinical narrative: fever; Flu like symptoms; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2021 (Lot number: EK9231) at the age of 62 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 of the Pfizer Covid Vaccine:  Given on 15Dec2020; Lot Number: EH9899.), administration date: 15Dec2020, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Jan2021, outcome "recovered" (07Jan2021), described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Jan2021, outcome "recovered" (07Jan2021), described as "Flu like symptoms"; PAIN (non-serious) with onset 06Jan2021, outcome "recovered" (07Jan2021), described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.