chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Headache, Hepatobiliary scan, Migraine
Clinical narrative: Headache; Migraine; Full body aches; Aching pain in my armpit of my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Oct2021 07:43 (Lot number: FF8841, Expiration Date: 31Mar2022) at the age of 30 years as dose 3 (booster),single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 21Sep2021. Past drug history included: Flu vaccine for Influenza immunization, reaction(s): "Migraine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Left upper arm, Route of administration: Intramuscular, Exp: Apr2021), administration date: 04Feb2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "Migraine", "GI/Digestion Issues"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Left upper arm, Route of administration: Intramuscular, Exp: Apr2021), administration date: 14Jan2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 15Oct2021 05:30, outcome "recovered" (18Oct2021), described as "Migraine"; PAIN (non-serious) with onset 15Oct2021 05:30, outcome "recovered" (17Oct2021), described as "Full body aches"; HEADACHE (non-serious) with onset 18Oct2021, outcome "recovered" (20Oct2021), described as "Headache"; AXILLARY PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "Aching pain in my armpit of my left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, pain, headache, axillary pain. The patient underwent the following laboratory tests and procedures: blood test: unknown results; hepatobiliary scan: unknown results, notes: HIDA scan performed to asses issue; ultrasound scan: unknown results. Therapeutic measures were not taken as a result of migraine, pain, headache, axillary pain.   Additional information: The patient woke up the morning after booster was received with a migraine and full body aches. The patient treated with excedrine migraine as directed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Ultrasound scan
Clinical narrative: Headache; Migraine; Full body aches; Aching pain in my armpit of my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Oct2021 07:43 (Lot number: FF8841, Expiration Date: 31Mar2022) at the age of 30 years as dose 3 (booster),single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 21Sep2021. Past drug history included: Flu vaccine for Influenza immunization, reaction(s): "Migraine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Left upper arm, Route of administration: Intramuscular, Exp: Apr2021), administration date: 04Feb2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "Migraine", "GI/Digestion Issues"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Left upper arm, Route of administration: Intramuscular, Exp: Apr2021), administration date: 14Jan2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 15Oct2021 05:30, outcome "recovered" (18Oct2021), described as "Migraine"; PAIN (non-serious) with onset 15Oct2021 05:30, outcome "recovered" (17Oct2021), described as "Full body aches"; HEADACHE (non-serious) with onset 18Oct2021, outcome "recovered" (20Oct2021), described as "Headache"; AXILLARY PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "Aching pain in my armpit of my left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, pain, headache, axillary pain. The patient underwent the following laboratory tests and procedures: blood test: unknown results; hepatobiliary scan: unknown results, notes: HIDA scan performed to asses issue; ultrasound scan: unknown results. Therapeutic measures were not taken as a result of migraine, pain, headache, axillary pain.   Additional information: The patient woke up the morning after booster was received with a migraine and full body aches. The patient treated with excedrine migraine as directed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional Information: The reporter stated that; he had been having symptoms for 3 months, ever since his first dose of the Pfizer BioNTech Covid-19 vaccine. He did not receive a second dose, stating that if he gets any worse, he will be dead. Has seen a neurologist as well. He reports that he was healthy before this and took no medications, and that he now takes a lot just to get a couple of hours of sleep. He said that you can get a vaccine on any street corner. He got the vaccine, and was severely sick; he lost weight, can't sleep, has ringing in his ears, and has severe pain. He says there were nowhere to get help, and that Pfizer needs to get together with the CDC and FDA to help patients and maybe fix the vaccine. States the doctors need advice; they don't know what to do. Has seen a neurologist as well. He reports that he was healthy before this and took no medications, and that he now takes a lot just to get a couple of hours of sleep. People are getting seriously ill. He says that if you get Covid, they'll give you top notch care. States it was mentally draining, and that this has almost killed him. He talks about a 17 year old football player that was bed-ridden, had heart problems, and was pulled out of school since getting the vaccine. He said the coach took a group of players to get the vaccine, and 3 of them got sick, including the aforementioned player. Caller himself went to the ER twice, and was given morphine the second time with no effect. He just wants Pfizer to take this concern seriously, and asks that it be moved up the ladder and not tossed in the trash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst, SARS-CoV-2 test
Clinical narrative: Cysts in Ovaries; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 13:30 (Lot number: EW0170) at the age of 40 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 Number: 1, Batch/Lot No: EW0176, Location of injection: Left Arm, Vaccine Administration Time: 01:30 PM), administration date: 22Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: OVARIAN CYST (non-serious) with onset 22Jun2021, outcome "unknown", described as "Cysts in Ovaries". The event "cysts in ovaries" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ovarian cyst.  Additional information: Facility where the most recent COVID-19 vaccine was administered at Hospital. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not diagnosed with COVID-19 prior to vaccination. Patient had been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: felt a little tired afterwards; chills; bad headache; ached all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EL9262) at the age of 65 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 (Dose 1, Single, Lot: EL3246, Site: left arm), administration date: 25Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 15Feb2021, outcome "recovered" (15Feb2021), described as "chills"; HEADACHE (non-serious) with onset 15Feb2021, outcome "recovered" (15Feb2021), described as "bad headache"; PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (16Feb2021), described as "ached all over"; FATIGUE (non-serious) with onset 16Feb2021, outcome "unknown", described as "felt a little tired afterwards".  Additional information: The reporter stated when she got the second shot, she had a slight reaction, including chills, bad headache for 2 hours, and ached all over. The next day she felt fine, just a little tired. No investigation assessment was reported.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling on R side of brain/tingling down R arm to leg and along R side of body/ it jumped to L leg and it traveled up the L side of body and thru her left arm followed by numbness; Numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in deltoid right, administration date Jul2021 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Jul2021, outcome "not recovered", described as "Tingling on R side of brain/tingling down R arm to leg and along R side of body/ it jumped to L leg and it traveled up the L side of body and thru her left arm followed by numbness"; HYPOAESTHESIA (non-serious) with onset Jul2021, outcome "unknown", described as "Numbness".  Additional information: within 2 minutes patient had tingling on R side of brain; 25 minutes later had tingling down R arm to leg and along R side of body followed by numbness; then it jumped to L leg and it traveled up the L side of body and thru her left arm followed by numbness; this lasted 15-20 minutes; then her fingers started waking up and then numbness left; the only lingering effect is that monthly before her menstrual period, the tingling on the right side of brain returns for 2 days on and off.  Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Orgasm abnormal, Vulvovaginal swelling
Clinical narrative: Spontaneous Orgasm while sleeping. Really tender down there; Spontaneous Orgasm while sleeping. Really tender down there. Like there is more inflammation down there; kind of hard to urinate also; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 12:00 (Lot number: 3013084) at the age of 42 years as dose 3 (booster), single and administered in arm left, administration date 22Jan2021 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose brand unknown: False, Previous dose Lot number = EJ16905, Previous dose lot unknown: False, Previous dose Administration date= 05Jan2021, Previous dose Dose number= 1, Previous dose vaccine location= Left arm), administration date: 05Jan2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: ORGASM ABNORMAL (non-serious), outcome "unknown", described as "Spontaneous Orgasm while sleeping. Really tender down there"; VULVOVAGINAL SWELLING (non-serious), outcome "not recovered", described as "Spontaneous Orgasm while sleeping. Really tender down there. Like there is more inflammation down there"; DYSURIA (non-serious), outcome "unknown", described as "kind of hard to urinate also". Therapeutic measures were not taken as a result of orgasm abnormal, vulvovaginal swelling, dysuria.  Additional information: The reporter stated that spontaneous orgasm while sleeping really tender down there. Like there is more inflammation down there. It happened after the 2nd shot at night, a couple of hours after the shot. And it happened again after the current booster (3rd shot). It only probably lasts a day. I thought it was just a weird reaction after my 2nd shot. and I was surprised I had the reaction again after my current 3rd shot. I noticed this time it makes it kind of hard to urinate also. Like it is swollen down there. The first reaction eventually went away. The current reaction. I'm still kind of swollen. But I think it will go away like the last time. Facility type vaccine was hospital. Not received the treatment. No Covid prior t the vaccine. Covid test was not performed after vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; 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 85 year-old female patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "deafness" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cortisone injections, notes: cortisone injections. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for COVID-19 immunization; Flu shot, for Immunization, reaction(s): "rash". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "soreness in arm".  Additional information: Reporter states she received her second dose of the Pfizer BioNtech covid 19 vaccine in Mar. States that she received her booster shot yesterday, reports soreness in arm and no other side effects. Reporter reports history of cortisone injections as well as deafness. Reporter Seeking information on the difference between the booster shot and the 3rd shot and the 3 criteria for immunocompromised could be addressed. Reporters son who is very active received his booster shot and experienced side effects of headache and fatigue. Reporter states that she had a side effect of a rash after receiving her flu shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain
Clinical narrative: Cold, but not really chills; Body ache - head to toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: FEELING COLD (non-serious), outcome "unknown", described as "Cold, but not really chills"; PAIN (non-serious), outcome "unknown", described as "Body ache - head to toe".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Diarrhoea, Dysstasia
Clinical narrative: unable to stand for very long and it seems to be worse today than yesterday; diarrhea; feeling very weak; unable to stand for very long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 87 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Sep2021 (Batch/Lot number: unknown) 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: CONDITION AGGRAVATED (non-serious) with onset 19Oct2021, outcome "not recovered", described as "unable to stand for very long and it seems to be worse today than yesterday"; DIARRHOEA (non-serious) with onset 18Oct2021, outcome "unknown", described as "diarrhea"; ASTHENIA (non-serious) with onset 18Oct2021, outcome "unknown", described as "feeling very weak"; DYSSTASIA (non-serious) with onset 18Oct2021, outcome "unknown", described as "unable to stand for very long".  Additional information: Patient started feeling very weak, having diarrhea, unable to stand for very long and it seems to be worse today than yesterday. She received her first dose of the Pfizer COVID-19 Vaccine (Comirnaty) on 28Sep2021 and is scheduled to receive her second dose today but will need to reschedule due to how she was feeling right now.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick in between doses so he missed his 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) 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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got sick in between doses so he missed his 2nd dose".  Additional information: Patient who came in to receive his 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. He said he received his 1st dose sometime around January or February 2021. His supervisor told him that he needs to get two more doses because it has already been 6 months since his 1st dose. He said he got sick in between doses so he missed his 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: I am breaking out with an allergic rash from vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: FF2589) 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: DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "I am breaking out with an allergic rash from vaccine".  Additional Information: It was reported that COVID-19 Vaccine is a Pfizer product and Dates for event I am breaking out with an allergic rash from vaccine was Unspecified to Unspecified. Other Products reported as Yes and dates for Concomitant Products Vitamins are unspecified. Investigation assessments not reported. Consumer stated, "I guess, I am calling, I am not sure. I was given a state number to call and they give me a Pfizer. Basically like I am breaking out with an allergic rash from vaccine." Consumer stated, "I am about to take Benadryl but I have not yet." Consumer also stated, "Can I get a confirmation number or anything to show that I have filed a report".  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Lymph node pain, Lymphadenopathy, Tremor
Clinical narrative: Swollen/painful lymph node continues at time of reporting; approximately 18 hours post inoculation--soreness at lymph node in armpit of left arm began and worsened throughout day.; chills and shaky hands which subsided after about two hours.; chills and shaky hands which subsided after about two hours.; soreness at lymph node in armpit of left arm began and worsened throughout day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Oct2021 12:30 (Lot number: FF8839) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE INACTIVATED, administration date 05Oct2021; PRILOSEC [OMEPRAZOLE]; ALLEGRA. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 24Mar2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3248), administration date: 03Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Oct2021 10:00, outcome "recovering", described as "Swollen/painful lymph node continues at time of reporting"; LYMPH NODE PAIN (non-serious) with onset 18Oct2021 10:00, outcome "recovering", described as "approximately 18 hours post inoculation--soreness at lymph node in armpit of left arm began and worsened throughout day."; CHILLS (non-serious), TREMOR (non-serious) all with onset 18Oct2021 10:00, outcome "recovering" and all described as "chills and shaky hands which subsided after about two hours."; CONDITION AGGRAVATED (non-serious) with onset 18Oct2021 10:00, outcome "recovering", described as "soreness at lymph node in armpit of left arm began and worsened throughout day.". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, chills, tremor, condition aggravated.  Additional information: Most recent COVID-19 vaccine administration facility was Pharmacy or Drug Store. The patient had no known allergies. The patient received birth control pills within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Approximately 18 hours post inoculation--soreness at lymph node in armpit of left arm began and worsened throughout day.24hr post injection-chills and shaky hands which subsided after about two hours. Swollen/painful lymph node continued at time of reporting. The patient was not tested for COVID-19, Since the vaccination. AE did not result in physician/emergency room visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1st dose had bad hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: URTICARIA (non-serious), outcome "recovering", described as "1st dose had bad hives". The event "1st dose had bad hives" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria.  Additional information included: The patient had no covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Took the Pfizer COVID19 vaccine back in April/ "made her feel better"; 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 female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID19 infection", start date: Jan2021 (unspecified if ongoing), notes: Verbatim: COVID19 infection; "long hauler" (unspecified if ongoing), notes: Verbatim: long hauler; "sinuses", start date: 2021 (ongoing), notes: still having problems with her sinuses and smell and taste.; "smell", start date: 2021 (ongoing), notes: still having problems with her sinuses and smell and taste.; "Taste", start date: 2021 (ongoing), notes: still having problems with her sinuses and smell and taste. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "Took the Pfizer COVID19 vaccine back in April/ "made her feel better".  Additional information: Patient had COVID19 infection on January and is still having problems with her sinuses and smell and taste. Patient is considered as long hauler' suffering from long term effects. Patient stated she took the Pfizer COVID19 vaccine back in April which made her feel better', but has not been tested for COVID again. Patient was due for the third dose on 29th of this month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: after the 2nd dose I experienced arm pain, headache and the inability to sleep the first night; headache; inability to sleep the first night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 12:00 (Lot number: EP7534) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for immunisation, administration date 28Sep2021. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 12:00 PM, Lot number: EN6202, Anatomical location: Left arm), administration date: 27Feb2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "after the 2nd dose I experienced arm pain, headache and the inability to sleep the first night"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "inability to sleep the first night". The events "after the 2nd dose i experienced arm pain, headache and the inability to sleep the first night", "headache" and "inability to sleep the first night" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, headache, insomnia.  Additional information: After the 2nd dose patient experienced arm pain, headache and the inability to sleep the first night. All symptoms were gone after 36 hours. No hospitalization prolonged. No relevant medical history and concurrent conditions. No past drug history. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Left ventricular hypertrophy, X-ray
Clinical narrative: left ventricle was swollen; Her BUN, Kidney Cholesterol were elevated.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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 (First dose), when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (Second dose), when the patient was 70 years old, for Covid-19 immunization. The following information was reported: LEFT VENTRICULAR HYPERTROPHY (non-serious), outcome "unknown", described as "left ventricle was swollen"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Her BUN, Kidney Cholesterol were elevated.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller got her Pfizer Covid booster shot weeks ago and took a xray last week. It showed that her left ventricle was swollen. Her BUN, Kidney Cholesterol were elevated. Added that, a year ago everything was fine and she has no heart condition. Asking if Pfizer has reports that it would be permanent. Response included Spoke as per document attached Myocarditis and Pericarditis. The observed risk was higher among males under 40 years of age than among females and older males. The observed risk was highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. Patient was asking where could she find more information regarding what she experiencing. Response included Referred caller to CDC.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Oct 16, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medication not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced vaccination site reaction (arm at the injection site is very red), onset Oct 2021, with outcome of not recovered. Additional information: Patient received the booster dose of the Pfizer COVID-19 vaccine on Saturday afternoon. She noticed her arm at the injection site is very red. It doesn't seem to be getting better. She wondered if there's anything she can do. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong product administered
Clinical narrative: a patient who received the Moderna vaccine in July and supposed to get the second dose and accidentally received Pfizer Covid-19 vaccine in 16October2021; sore injection site left deltoid arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 25 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 15Oct2021 (Lot number: 301458A, Expiration Date: 28Feb2022) at the age of 25 years as dose 2, 0.3 ml single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 13Jul2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Oct2021, outcome "unknown", described as "a patient who received the Moderna vaccine in July and supposed to get the second dose and accidentally received Pfizer Covid-19 vaccine in 16October2021"; VACCINATION SITE PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "sore injection site left deltoid arm". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt "so sick"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (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 1, single), administration date: Mar2021, for Covid-19 Immunisation, reaction(s): "No adverse event". The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "felt "so sick"".  Additional information: Reporter states, she and her husband got their primary series of Pfizer BioNTech Covid-19 Vaccine in Mar2021. She felt fine after the first dose but felt "so sick" after the second dose. She was asking if the booster dose of the Pfizer BioNTech Covid-19 Vaccine is a half dose or a full dose like the first two doses and if now was appropriate timing for the booster dose since her primary series was in March. She was asking if the side effects will be the same for the booster dose as the first two doses.  Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Confusional state, Depression, Diarrhoea
Clinical narrative: I was so sick; headache; body ache; Diarrhea; stomach pain; lung pain; Bone pain; Fever; confussion; Depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 03:48 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "pinched nerve" (ongoing); "Allergies" (unspecified if ongoing); "Covid-19", start date: Jul2021 (not ongoing); "Anxiety attack", start date: 2021 (unspecified if ongoing); "pressure was too much", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I was so sick"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body ache"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; PULMONARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "lung pain"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Bone pain"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "confussion"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "Depression". Therapeutic measures were taken as a result of illness.  Additional information:Patient had delayed my covid due to severe reason one, Patient was having allergies two, she had covid in July which was serious she had to go the emergency room but she discharged herself for lack of proper care because I was unmarried at the time. It took me several weeks to recover and was still not feeling quite myself when she decided on 30Sep2021 to take her vaccine because the pressure was too much, and she was having anxiety attack. The day she took my first shot was great but after next day she was so sick she had medicated. The next day was went worst she had to call my doctor.   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: Headache, Illness, Pain, Pulmonary pain, Pyrexia
Clinical narrative: I was so sick; headache; body ache; Diarrhea; stomach pain; lung pain; Bone pain; Fever; confussion; Depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 03:48 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "pinched nerve" (ongoing); "Allergies" (unspecified if ongoing); "Covid-19", start date: Jul2021 (not ongoing); "Anxiety attack", start date: 2021 (unspecified if ongoing); "pressure was too much", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I was so sick"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body ache"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; PULMONARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "lung pain"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Bone pain"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "confussion"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "Depression". Therapeutic measures were taken as a result of illness.  Additional information:Patient had delayed my covid due to severe reason one, Patient was having allergies two, she had covid in July which was serious she had to go the emergency room but she discharged herself for lack of proper care because I was unmarried at the time. It took me several weeks to recover and was still not feeling quite myself when she decided on 30Sep2021 to take her vaccine because the pressure was too much, and she was having anxiety attack. The day she took my first shot was great but after next day she was so sick she had medicated. The next day was went worst she had to call my doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: After the second dose he had the same pain but worse; This is a spontaneous report received from a contactable reporter(s) nurse  (Other HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "multiple myeloma" (unspecified if ongoing); "a fracture and a tumor in the pelvis" (unspecified if ongoing), notes: He had a fracture and a tumor in the pelvis; "tumor in the pelvis" (unspecified if ongoing), notes: He had a fracture and a tumor in the pelvis. The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "After the second dose he had the same pain but worse".  Additional information: He passed away after receiving the second dose of the Pfizer COVID-19 vaccine. He had multiple myeloma. He had a fracture and a tumor in the pelvis. He has been on chemo treatment and steroids. Patient got the vaccine in the early part of chemotherapy. He received the first vaccine and three weeks later received the second. After the second dose he had the same pain but worse. He had a red arm, sleeping problem and it created a lot of problems where he couldn't walk and needed a walker. He was diagnosed with ischemic bowel disease caused by SRS. He got radiation for the pain and he had ischemic bowel which causes the intestines to not get blood. It started with an inflammation and soon after he died. .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: She has been sick with bad cold; She has been sick with bad cold; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 50 years as dose number unknown, single for covid-19 immunisation; treprostinil diolamin (ORENITRAM), first regimen oral since 23Jan2020 (Batch/Lot number: unknown) and second regimen oral (Lot number: 2101810, Expiration Date: 31Jan2023) at 2.5 mg 3x/day for pulmonary arterial hypertension. Relevant medical history included: "Primary pulmonary arterial hypertension" (unspecified if ongoing), notes: Primary. Concomitant medication(s) included: ADEMPAS; OPSUMIT; DILTIAZEM. The following information was reported: NASOPHARYNGITIS (non-serious), ILLNESS (non-serious), outcome "recovering" and all described as "She has been sick with bad cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: 2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms; 2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 24 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 number=1, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/ provided to reporter at the, time of report completion), for covid-19 immunization, reaction(s): "hives". The following information was reported: URTICARIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Oct2021, outcome "recovering" and all described as "2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms". The event "2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms" and "2nd dose hives were twice as bad had to have medical intervention and only treated the symptoms" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, condition aggravated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.