chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Limb discomfort, Musculoskeletal discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: feel it now on her neck; Saturday, she had pain in her arm, shoulder, and on her back by her bra strap; back near her bra strap; same pain plus some in her shoulder blade area; discomfort in her arm; This is a spontaneous report from a contactable Other-Health Care Professional. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 10Sep2021 at 18:00 (Lot Number: FF2588) (at the age 39-years-old) as dose 2, single for Covid-19 immunization. Medical history included ongoing fibromyalgia (diagnosed 9 years ago now). Concomitant medication included unspecified medication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left 20Aug2021 (Lot Number: FC3180) (at the age 39-years-old) as dose 1, single for covid-19 immunization and experienced Discomfort.There were no relevant tests. On 10Sep2021, the patient experienced discomfort in her arm, on 11Sep2021, the patient experienced Back pain, Shoulder blade pain and Pain in arm and on 12Sep2021, the patient experienced Neck discomfort. It was reported that patient had the usual arm discomfort Immediately after vaccination . By Saturday 11Sep2021, she had pain in her arm, shoulder, and on her back by her bra strap. By the night, she had all the same pain plus some in her shoulder blade area. The pain has increased to the point of unbearable now. She tried to make a doctor's appointment, but the doctor's office told her to call Pfizer. She didn't have a prescribing doctor. The pain started radiating to the other areas on Saturday 11Sep 2021. The initial discomfort started right after she got the vaccine at 6pm. She pretty much immediately experienced discomfort. She did have discomfort after the first vaccine. She has taken Tylenol arthritis because she has Fibromyalgia, and she typically has pain in this arm. If she were to go to the doctor, she wanted to know if this vaccine can exacerbate fibromyalgia or is it the placement of where she got the injection or how it was administered that is causing the pain she was experiencing. She got the vaccine both times in her left arm. The pain is on the left side. She has had Fibromyalgia. She was diagnosed 9 years ago now. No doctor has agreed to see her. There was no prior vaccinations within 4 weeks. The event did not result in emergency room or physician Office visit. On 13Sep2021 morning, at 5am, she took 2 Tylenol arthritis, and 2 more at 9am to control the pain. Therapeutic measures were taken as result for all events. The patient had not yet recovered from pain in arm and outcome of all other events were unknown.  Follow-up activities are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Herpes zoster, Influenza like illness
Clinical narrative: she felt like she had the flu; chattering teeth; fever; shooting pains; lethargic; sleepy; no appetite; shingle like rash on her neck; This is a spontaneous report from a Pfizer sponsored Program contactable consumer or other non hcp. A 68-years-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 13Feb2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced she felt like she had the flu on an unspecified date with outcome of recovered , chattering teeth on an unspecified date with outcome of recovered , fever on an unspecified date with outcome of recovered , shooting pains on an unspecified date with outcome of recovered , lethargic on an unspecified date with outcome of recovered , sleepy on an unspecified date with outcome of recovered , no appetite on an unspecified date with outcome of recovered , shingle like rash on her neck on an unspecified date with outcome of recovered.  The patient underwent lab tests and procedures which included body temperature: fever   on   fever. Patient stated she was totally coherent during this time. Patient stated it lasted for 3 days and then she was fine. Patient stated she saw her HCP and wanted to know if the history was or the same for the 3rd shot. The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was like or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data. Patient asked is there anything she can do or take to mitigate the reaction and stated her HCP told her to take Tylenol. The outcome of the events was recovered.  The lot number for [BNT162B2] was not Provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia, Somnolence
Clinical narrative: she felt like she had the flu; chattering teeth; fever; shooting pains; lethargic; sleepy; no appetite; shingle like rash on her neck; This is a spontaneous report from a Pfizer sponsored Program contactable consumer or other non hcp. A 68-years-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 13Feb2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced she felt like she had the flu on an unspecified date with outcome of recovered , chattering teeth on an unspecified date with outcome of recovered , fever on an unspecified date with outcome of recovered , shooting pains on an unspecified date with outcome of recovered , lethargic on an unspecified date with outcome of recovered , sleepy on an unspecified date with outcome of recovered , no appetite on an unspecified date with outcome of recovered , shingle like rash on her neck on an unspecified date with outcome of recovered.  The patient underwent lab tests and procedures which included body temperature: fever   on   fever. Patient stated she was totally coherent during this time. Patient stated it lasted for 3 days and then she was fine. Patient stated she saw her HCP and wanted to know if the history was or the same for the 3rd shot. The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was like or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data. Patient asked is there anything she can do or take to mitigate the reaction and stated her HCP told her to take Tylenol. The outcome of the events was recovered.  The lot number for [BNT162B2] was not Provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pustule, Rash, Urticaria
Clinical narrative: All over body rash on forearms, elbows, progressed to back, thighs, abdomen, waist; Welts; Pustules; Itchy; This is a spontaneous report from a contactable nurse. A 71-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via intramuscular route of administration in the left arm on 08Sep2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included leukemia (the patient receiving chemotherapy for leukemia). It was unknown whether the patient had any known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included oral chemotherapy (unspecified) for leukemia from an unknown date and unknown if ongoing. On 10Sep2021, the patient experienced all over body rash, on forearms, elbows, progressed to back, thighs, abdomen, waist. It was reported that, it started as a fine rash and progressed to welts, pustules and was itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the events which included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events all over body rash, on forearms, elbows, progressed to back, thighs, abdomen, waist and it was started as a fine rash and progressed to welts, pustules and itchy was resolving at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Myalgia, Pain, Pyrexia
Clinical narrative: 28 hours after shot High fever; Muscle aches on entire side of body as the shot; Large lump under shot arm; Extremely painful; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 08Sep2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (ESTROGEN) and zolpidem tartrate (AMBIEN) from unknown dates for unknown indications and unknown if ongoing. On 09Sep2021 at 16:00, 28 hours after the shot, the patient experienced high fever, muscle aches on entire side of her body as the shot and a large lump under the shot arm and extremely painful. Therapeutic  measures were not taken for the reported events. Since the vaccination, the patient was not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events 28 hours after the shot high fever, muscle aches on entire side of body as the shot, large lump under the shot arm and extremely painful were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Extra dose administered, Off label use, Peripheral swelling
Clinical narrative: swelling in left leg; burning in her torso and upper arms and upper chest; Caller received her 3rd  Pfizer Covid BT Vaccine, Comirnaty, dose on 03Sep2021; Caller received her 3rd  Pfizer Covid BT Vaccine, Comirnaty, dose on 03Sep2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 03Sep2021 as DOSE 3, SINGLE for covid-19 immunization. Medical history included RA for which Humira injection and Ibuprofen was received. The patient's concomitant medications were not reported. Historical vaccine included first and second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE both for covid-19 immunization. On 03Sep2021, the patient experienced caller received her 3rd Pfizer covid BT vaccine, comirnaty, dose on 03sep2021, on 05Sep2021, the patient experienced burning in her torso and upper arms and upper chest, on 12Sep2021, the patient experienced swelling in left leg. Therapeutic measures were taken as a result of burning in her torso and upper arms and upper chest. No Serious events reported. The outcomes of events (swelling in left leg, Caller received her 3rd Pfizer Covid BT Vaccine, Comirnaty, dose on 03Sep2021) were unknown and the outcome of event (burning in her torso and upper arms and upper chest) was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Grip strength decreased, Malaise, Paraesthesia
Clinical narrative: Felt sick; Arm starting having pin and needle sensation in it; Lost grip and strength in arm and hand/ the feeling is mostly on the under part of right arm, pinky and ring finger on the right side where got the shot and right side of hand; Lost grip and strength in arm and hand; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 06May2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient reported that he got his first shot on 15Apr2021 and was fine then went back for his second shot on 06May2021 and after the second shot on an unknown date in May2021, he felt sick and was sick for a few days and the patient didn't think much about it. Within a week, the patient's arm started having pin and needle sensation in it and he had the same feeling ever since then. The patient lost grip and strength in his arm and hand and the feeling was mostly on the under part of his right arm, pinky and ring finger on the right side where he got the shot and right side of his hand. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt sick, arm starting having pin and needle sensation in it and lost grip and strength in arm and hand/ the feeling is mostly on the under part of right arm, pinky and ring finger on the right side where got the shot and right side of hand was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 20May2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jun2021 at 00:00, the patient had missed menstrual cycle. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed menstrual cycle was unknown at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 10Jun2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Dizziness, Nausea, Photosensitivity reaction
Clinical narrative: Sensitive to light; Loss of balance; Stomach pain; Lightheaded; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Sep2021 at 14:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 12Sep2021 at 18:00, the patient had been sensitive to light, lightheaded, experienced stomach pain and felt nauseous and loss of balance. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sensitive to light, lightheaded, stomach pain, nauseous and loss of balance was not resolved at the time of the report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Feeling abnormal, Heart rate
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history included Mercury poisoning, hot flashes (which she has had for a year or more), arthritis (she says she has arthritis in her neck and since receiving the vaccine feels like she is at the beginning of her physical therapy instead of towards the end) and physiotherapy. The patient concomitant medications were not reported. The patient reported that several adverse reactions after received the first dose of the vaccine 3.5 weeks ago. It was reported that on an unspecified date in 2021, the patient had an elevation in heart rate on and off for two weeks, an increase in blood pressure, aches, pain, brain fog, muscle weakness, and hot flashes, which she has had for a year or more. She also reported not feeling "as strong as I was before the first dose". The patient said she has arthritis in her neck and since receiving the vaccine feels like she is at the beginning of her physical therapy instead of towards the end. She reports not having a local HCP as she recently moved; her previous HCP recommended her not to get the vaccine as she has a history of mercury poisoning. The patient says she does want to be protected, wants to be a team player, and does want to get the second dose but says " I just know I would be in bad shape, I just need more time" (in getting the second dose now) wants more time than to recover from these symptoms so asked how long she can wait to get the second dose. The patient was referred to health care professional. The patient underwent lab tests and procedures which included blood pressure measurement: increase, heart rate: increased on an unspecified date in 2021. The outcome of the events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Muscular weakness, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history included Mercury poisoning, hot flashes (which she has had for a year or more), arthritis (she says she has arthritis in her neck and since receiving the vaccine feels like she is at the beginning of her physical therapy instead of towards the end) and physiotherapy. The patient concomitant medications were not reported. The patient reported that several adverse reactions after received the first dose of the vaccine 3.5 weeks ago. It was reported that on an unspecified date in 2021, the patient had an elevation in heart rate on and off for two weeks, an increase in blood pressure, aches, pain, brain fog, muscle weakness, and hot flashes, which she has had for a year or more. She also reported not feeling "as strong as I was before the first dose". The patient said she has arthritis in her neck and since receiving the vaccine feels like she is at the beginning of her physical therapy instead of towards the end. She reports not having a local HCP as she recently moved; her previous HCP recommended her not to get the vaccine as she has a history of mercury poisoning. The patient says she does want to be protected, wants to be a team player, and does want to get the second dose but says " I just know I would be in bad shape, I just need more time" (in getting the second dose now) wants more time than to recover from these symptoms so asked how long she can wait to get the second dose. The patient was referred to health care professional. The patient underwent lab tests and procedures which included blood pressure measurement: increase, heart rate: increased on an unspecified date in 2021. The outcome of the events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Left armpit (lymph) swelling and pain; Left armpit (lymph) swelling and pain; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on an unknown date in Sep2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Sep2021, the patient experienced left armpit (lymph) swelling and pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left armpit (lymph) swelling and pain were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Erythema, Feeling hot, Nausea
Clinical narrative: Aches; Metallic taste in mouth; Ears red and hot; Ears red and hot; Nausea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 09Sep2021 at 19:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 18Aug2021 at 19:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 10Sep2021 at 15:30, the patient experienced aches, metallic taste in mouth, ears red and hot, nausea and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, metallic taste in mouth, ears red and hot, nausea and chills was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Aches; Metallic taste in mouth; Ears red and hot; Ears red and hot; Nausea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 09Sep2021 at 19:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 18Aug2021 at 19:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 10Sep2021 at 15:30, the patient experienced aches, metallic taste in mouth, ears red and hot, nausea and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, metallic taste in mouth, ears red and hot, nausea and chills was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Fever of 100.1 degrees; Chills; Body aches; General sleepiness; Swelling of the eyelids; Asthmatic wheezing; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Aug2021 at 08:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 15Aug2021 at 03:00, the patient experienced fever of 100.1 degrees, chills, body aches for 24 hours and general sleepiness. On the same day, the patient also experienced swelling of the eyelids, asthmatic wheezing and shortness of breath lasting for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fever of 100.1 degrees, chills, and body aches were resolved on 16Aug2021 at 03:00 (after the duration of 24 hours). The clinical outcome of the event general sleepiness was resolved on an unknown date in 2021; while that of the events swelling of the eyelids, asthmatic wheezing and shortness of breath were resolved on 17Aug2021 at 03:00 (after the duration of 48 hours).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Swelling of eyelid, Wheezing
Clinical narrative: Fever of 100.1 degrees; Chills; Body aches; General sleepiness; Swelling of the eyelids; Asthmatic wheezing; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Aug2021 at 08:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 15Aug2021 at 03:00, the patient experienced fever of 100.1 degrees, chills, body aches for 24 hours and general sleepiness. On the same day, the patient also experienced swelling of the eyelids, asthmatic wheezing and shortness of breath lasting for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fever of 100.1 degrees, chills, and body aches were resolved on 16Aug2021 at 03:00 (after the duration of 24 hours). The clinical outcome of the event general sleepiness was resolved on an unknown date in 2021; while that of the events swelling of the eyelids, asthmatic wheezing and shortness of breath were resolved on 17Aug2021 at 03:00 (after the duration of 48 hours).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Still getting off and on chills; Easily fatigued; Arm is still sore; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Sep2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine.  The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Aug2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 18:00, the patient experienced off and on chills, easily fatigued and his arm was sore. Reportedly, it was then 7 days later he was still getting off and on chills. He was easily fatigued. His arm was still sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue and arm was still sore was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Carcinoid tumour pulmonary, Respiratory failure
Clinical narrative: Hx malignant Carinoid tumor of the Bronchus; Lung-Hx of Respiratory Failure; This is a spontaneous report from a contactable nurse. An 89-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 89-years-old intramuscular, administered in Arm Left on 09Sep2021 11:00 (Lot Number: 301358A) as single dose for covid-19 immunisation.  Medical history included failure to thrive. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication(s) included alprazolam; ondansetron; clarithromycin (CLARITIN); clopidogrel; sennoside a+b (SENNA); albuterol sulfate.  It was reported resident expired 24 hours after COVID vaccination, death causes were hx malignant carinoid tumor of the bronchus, lung-hx of respiratory failure. The adverse event start date and time was reported as 10Sep2021 14:45. No treatment was received. The patient died on 10Sep2021.  An autopsy was not performed.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Carcinoid tumor pulmonary (fatal) Respiratory failure (Fatal) and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Lung-Hx Of Respiratory Failure; Hx malignant Carinoid tumor of the Bronchus
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 13Sep2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Sep2021, the patient experienced sore arm. The event sore arm did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the sore arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was unknown at the time of report.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Tremor
Clinical narrative: Dizzy; Nausea; Headache; Shaking; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 11Sep2021 at 11:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 08Aug2021 at 11:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 11Sep2021 at 11:15, the patient experienced dizzy, nausea, shaking and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, nausea, shaking and headache was not resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from the vaccine; This is a spontaneous report from a non-contactable consumer from a Pfizer sponsored program. An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medication history included and concomitant medication were not reported. On an unspecified date, the patient was died from the vaccine. Caller was a consumer who was interested in receiving the FDA-approved BNT162B2 vaccine and is asking where can she get it. Caller said that in their area, the BNT162B2-labeled vaccine is not available. In addition to that, caller said that her employer wants them to be vaccinated. Caller also expressed her feeling of being uncomfortable in receiving "experimental vaccine" since she does not know what are the side effects and she also mentioned that someone in her family died from the vaccine after the first dose in which that someone never woke up again from sleep and was previously healthy and no medical issues. Caller said that since it is approved already, it should be available and not mislead people in getting the experimental vaccine. Caller said the line kept "breaking up" and could not hear properly. Autopsy was not reported. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died from the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Influenza like illness, Limb discomfort, Migraine
Clinical narrative: Severe flu like symptoms; Body aches; Migraines; severe fatigue; Feeling like my limbs are really heavy; Excessive sleeping; This is a spontaneous report from a contactable other HCP (nurse). A 41-years-old (reported as 40 years) patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 40 years-old) for COVID-19 immunization. Patient medical history included asthma. The patient had taken concomitant medication in two weeks. The patient has known allergies. The patient experienced severe flu like symptoms, body aches, migraines, severe fatigue, feeling like my limbs are really heavy, excessive sleeping on 27Jan2021 04:00. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in Left arm on 06Jan2021 as dose 1, single (at the age of 40 years-old) for COVID-19 immunization. Patient did not receive any other vaccine in four weeks and patient received other medication in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Feb2021. The outcome of the events not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe flu like symptoms; Body aches; Migraines; severe fatigue; Feeling like my limbs are really heavy; Excessive sleeping; This is a spontaneous report from a contactable other HCP (nurse). A 41-years-old (reported as 40 years) patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 40 years-old) for COVID-19 immunization. Patient medical history included asthma. The patient had taken concomitant medication in two weeks. The patient has known allergies. The patient experienced severe flu like symptoms, body aches, migraines, severe fatigue, feeling like my limbs are really heavy, excessive sleeping on 27Jan2021 04:00. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in Left arm on 06Jan2021 as dose 1, single (at the age of 40 years-old) for COVID-19 immunization. Patient did not receive any other vaccine in four weeks and patient received other medication in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Feb2021. The outcome of the events not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amenorrhoea, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: 'My' period has stopped coming; Feel pressure in abdominal area; Body feels different; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via an unspecified route of administration in the left arm on 30Jul2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. On 30Jul2021 at 11:00, after receiving her first injection of Pfizer COVID-19 vaccine, the patient's period had stopped coming. The patient stated that her period had always been regular and on time every month. It was reported that after getting vaccinated the patient's body felt different especially in her abdominal area and felt pressure in that area. The patient further stated that it was too early for her to go through menopause and mentioned that she was not pregnant. The patient was very concerned about the side effect of the vaccine on her hormones and body and stated that, it is now September and has not had her period since July. Therapeutic measures were not taken as a result of the events. On 30Aug2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events period has stopped coming, feel pressure in abdominal area and body feels different was not resolved at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Light headed; Fatigued; Headache; Body ache; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09Sep2021 at 18:00, the patient felt light headed, fatigued and experienced headache, body ache and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ibuprofen. On 13Sep2021, the patient underwent nasal swab test and the result was pending. The clinical outcome of the events light headed, fatigued, headache, body ache and diarrhea was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Light headed; Fatigued; Headache; Body ache; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09Sep2021 at 18:00, the patient felt light headed, fatigued and experienced headache, body ache and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with ibuprofen. On 13Sep2021, the patient underwent nasal swab test and the result was pending. The clinical outcome of the events light headed, fatigued, headache, body ache and diarrhea was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.