chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Lymphadenopathy, Pain in extremity
Clinical narrative: flu; swollen lymph node; headache; sore 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 female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "unknown", described as "sore arm"; INFLUENZA (non-serious) with onset 13Mar2021, outcome "unknown", described as "flu"; LYMPHADENOPATHY (non-serious) with onset 13Mar2021, outcome "unknown", described as "swollen lymph node"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "headache".  Additional information: Reporter stated that she had her first Pfizer Covid vaccine shot last Thursday (11Mar2021) and experienced some side effects. Thursday-Friday she had a sore arm, Saturday she experienced flu, swollen lymph node and headache. Asking if she is contagious with these side effects as would want to go out tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms
Clinical narrative: Leg cramps; Toes are open like someone who has arthritis, it is very weird.; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 13:00 (Lot number: EN6208) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Leg cramps"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "Toes are open like someone who has arthritis, it is very weird.". Therapeutic measures were taken as a result of muscle spasms, feeling abnormal.  Additional information: The patient jumped on her legs and moved it around and drank lots of water. The patient had not received any other vaccines within 4 weeks and had no events prior vaccination. The patient had no additional vaccines administered on same date of COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache
Clinical narrative: felt chills; moderate headache; This is a spontaneous report received from a contactable consumer who is a Pfizer colleague. The reporter is the patient.  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 15Mar2021 13:15 (Lot number: EL3247) at the age of 56 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: LEVOTHYROXINE. Past drug history included: Erythromycin, reaction: "known allergies: childhood erythromycin allergy". Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EL3247), administration date: 22Feb2021 10:15, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 12:00, outcome "recovered" (2021), described as "felt chills"; HEADACHE (non-serious) with onset 16Mar2021 12:00, outcome "recovered" (2021), described as "moderate headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache.  Additional information: The patient had no other vaccines in four weeks prior to vaccination. He was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. He also stated that he checked his temperature but had no fever. The patient took ibuprofen 400 mg one time as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness; 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: PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pain in extremity, Vaccination site pain
Clinical narrative: sore arms after the 1st shot; some soreness at the injection site for a couple of days after the injection; 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 86 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Jan2021 14:45 (Lot number: EL9261, Expiration Date: 31May2021) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms after the 1st shot"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "some soreness at the injection site for a couple of days after the injection". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The vaccine was administered at the left deltoid (reported as Left shoulder). The patient had no prior vaccinations within 4 weeks. The patient reported that he experienced sore arms after the 1st shot and got no absolute reactions after the 2nd shot. He's had just an uneasy feeling all along on what level immunity should he has had he gotten the 2 shots properly. The patient was querying what was the quantitative test to determine level of antibodies of Pfizer covid-19 vaccine during the clinical trial.    No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: enlarged lymph nodes; felt achy; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 15:15 (Lot number: EI9262) at the age of 48 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (07Feb2021), described as "enlarged lymph nodes"; PAIN (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (07Feb2021), described as "felt achy"; PAIN IN EXTREMITY (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (06Feb2021), described as "sore arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Mar2021) negative. Therapeutic measures were not taken as a result of lymphadenopathy, pain, pain in extremity.  Additional information: Facility type vaccine was in hospital. The patient did not receive any other vaccine in four weeks. The patient had not covid prior vaccination. The patient had covid tested post vaccination.   No follow-up attempts are possible. No further information is expected
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness, starting 3-4 hours after injection and lasting several hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Mar2021 10:00 (Lot number: EP6955) at the age of 50 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION; TRI-SPRINTEC; ZOLOFT. The following information was reported: FATIGUE (non-serious) with onset 16Mar2021, outcome "recovered" (Mar2021), described as "Tiredness, starting 3-4 hours after injection and lasting several hours.". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient had no known allergies. The patient did not receive other vaccine in four weeks. The vaccine was given in a workplace clinic.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, SARS-CoV-2 test
Clinical narrative: 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.An 86 year-old female patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Batch/Lot number: unknown) at the age of 86 years as dose 1, single and administration date 25Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: BALANCE DISORDER (non-serious) with onset 04Feb2021, outcome "not recovered", described as "abrupt change in stability in her legs/unsteadiness in participant's legs/leg muscles are not as stable"; GAIT DISTURBANCE (non-serious) with onset 04Feb2021, outcome "not recovered", described as "wobbliness". Relevant laboratory tests and procedures are available in the appropriate section.Additional information: The patient reported that she walks a lot and is a solid walker. She does not use walkers or canes. She spoke with a very qualified Physical Therapist and was told sometimes her body, even though the Pfizer vaccine is good for her, the body says wait a minute. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Echocardiogram, Electrocardiogram, Pain in extremity
Clinical narrative: soreness in her arm/Pain top part of thighs; pain in the lower abdomen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:15 (Lot number: EN6199) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2016 (ongoing); "High Blood pressure", start date: 2000 (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: 2016 (ongoing); DILTIAZEM HCL taken for hypertension, start date: 2000 (ongoing); OLMESARTAN taken for hypertension, start date: 2017 (ongoing). The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 11Mar2021, outcome "not recovered", described as "pain in the lower abdomen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in her arm/Pain top part of thighs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain lower.  Additional information: Patient did not received any other Pfizer vaccine on the same date of BNt162b2 administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that 1 week ago, she had her shot and she experienced soreness in her arm but on Thursday (11Mar2021) she began having pain in her lower abdomen and it had continued to hurt. She asked if this was a complaint that anyone else was giving. She can barely get up. She didn't have this pain until she had the vaccine. She thought that the pain would go away. When she laid down, the pain got bad. Last night the pain was horrific. She took Ibuprofen and it took the edge off. The pain does not go completely away. The pain was worse when she laid on her sides. It was driving her nuts. Taking Ibuprofen helped her to be able to do things. The pain was in the lower abdomen and top part of thighs. She has not seen her physician for this. She had a previously scheduled appointment with her cardiologist and had an Echo and EKG. Events did not result to physician office and emergency room visit.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity
Clinical narrative: Moderately sore arm; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 09:15 (Lot number: EL3247) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Mar2021 21:00, outcome "recovered" (Mar2021), described as "Moderately sore arm"; NIGHT SWEATS (non-serious) with onset 16Mar2021 21:00, outcome "recovered" (Mar2021), described as "night sweats". Therapeutic measures were not taken as a result of pain in extremity, night sweats. Additional information: The patient had no known allergies. Other medications in two weeks included multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Muscle spasms, Nausea, Pain
Clinical narrative: nauseated; chills; Runny nose; aches; spasms; symptoms just like the flu; lost a little bit of weight; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 07Mar2021 (Lot number: EL3248) at the age of 75 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "nauseated"; CHILLS (non-serious) with onset 14Mar2021, outcome "unknown", described as "chills"; RHINORRHOEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "Runny nose"; PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "aches"; MUSCLE SPASMS (non-serious) with onset 14Mar2021, outcome "unknown", described as "spasms"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Mar2021, outcome "unknown", described as "symptoms just like the flu"; WEIGHT DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "lost a little bit of weight". The events "nauseated", "chills", "runny nose", "aches", "spasms", "symptoms just like the flu" and "lost a little bit of weight" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Weight, Weight decreased
Clinical narrative: nauseated; chills; Runny nose; aches; spasms; symptoms just like the flu; lost a little bit of weight; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 07Mar2021 (Lot number: EL3248) at the age of 75 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "nauseated"; CHILLS (non-serious) with onset 14Mar2021, outcome "unknown", described as "chills"; RHINORRHOEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "Runny nose"; PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "aches"; MUSCLE SPASMS (non-serious) with onset 14Mar2021, outcome "unknown", described as "spasms"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Mar2021, outcome "unknown", described as "symptoms just like the flu"; WEIGHT DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "lost a little bit of weight". The events "nauseated", "chills", "runny nose", "aches", "spasms", "symptoms just like the flu" and "lost a little bit of weight" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: headaches; migraine; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6203) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing), notes: diagnosed about 5-10 years ago; "Congestive heart failure", start date: 2003 (unspecified if ongoing), notes: diagnosed in 2003 and hospitalized for a month. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "migraine"; NAUSEA (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "nausea"; HEADACHE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "headaches".  Additional information: It was reported that patient had the first dose of the shot on 05Mar2021 and stated later on that day and the next day had a severe migraine with nausea and was resolved by 07Mar2021. Patient then stated that for two days she did not have anything, and then she started having intermittent headaches on 11Mar2021 and since then. She stated they were not as bad as the migraine but they come and go. Patient wanted to know if these headaches could still be related to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Decreased appetite, Dry mouth
Clinical narrative: bad fatigue/ tiredness; pounding headache; chills/ the shakes; sweats/ hot sweats; cold sweats; aches and pains; dry mouth; her energy level is even worse to where she can hardly get up to go to the bathroom.; Muscle pain; swelling of the arm where she got the injection; not feeling well and not herself/ I have been very sick with the first dose; not feeling well and not herself; loss of appetite; 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 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; ATORVASTATIN taken for blood cholesterol abnormal; SYMBICORT taken for asthma. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "bad fatigue/ tiredness"; HEADACHE (non-serious), outcome "not recovered", described as "pounding headache"; CHILLS (non-serious), outcome "recovering", described as "chills/ the shakes"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "sweats/ hot sweats"; COLD SWEAT (non-serious), outcome "recovering", described as "cold sweats"; PAIN (non-serious), outcome "recovering", described as "aches and pains"; DRY MOUTH (non-serious), outcome "not recovered", described as "dry mouth"; ASTHENIA (non-serious), outcome "unknown", described as "her energy level is even worse to where she can hardly get up to go to the bathroom."; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling of the arm where she got the injection"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well and not herself/ I have been very sick with the first dose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well and not herself"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite".  Additional Information: The patient reported that the first three days were really bad with fatigue, headache, chills, sweats, aches and pains. The reporter mentioned that being 74 year old, her energy level was not great to begin with. She asked how long will her symptoms last because it was 5 days already and she was still not feeling well. The patient did not want to get the second dose because she have been very sick with the first dose. The reporter asked if it was safe for her to get the second dose because she does not want to go through these (the events) again. Second dose was scheduled for 03Apr2021. The patient was advised to get in touch with her primary doctor to see what he has to say about it.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Malaise
Clinical narrative: bad fatigue/ tiredness; pounding headache; chills/ the shakes; sweats/ hot sweats; cold sweats; aches and pains; dry mouth; her energy level is even worse to where she can hardly get up to go to the bathroom.; Muscle pain; swelling of the arm where she got the injection; not feeling well and not herself/ I have been very sick with the first dose; not feeling well and not herself; loss of appetite; 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 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; ATORVASTATIN taken for blood cholesterol abnormal; SYMBICORT taken for asthma. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "bad fatigue/ tiredness"; HEADACHE (non-serious), outcome "not recovered", described as "pounding headache"; CHILLS (non-serious), outcome "recovering", described as "chills/ the shakes"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "sweats/ hot sweats"; COLD SWEAT (non-serious), outcome "recovering", described as "cold sweats"; PAIN (non-serious), outcome "recovering", described as "aches and pains"; DRY MOUTH (non-serious), outcome "not recovered", described as "dry mouth"; ASTHENIA (non-serious), outcome "unknown", described as "her energy level is even worse to where she can hardly get up to go to the bathroom."; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling of the arm where she got the injection"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well and not herself/ I have been very sick with the first dose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well and not herself"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite".  Additional Information: The patient reported that the first three days were really bad with fatigue, headache, chills, sweats, aches and pains. The reporter mentioned that being 74 year old, her energy level was not great to begin with. She asked how long will her symptoms last because it was 5 days already and she was still not feeling well. The patient did not want to get the second dose because she have been very sick with the first dose. The reporter asked if it was safe for her to get the second dose because she does not want to go through these (the events) again. Second dose was scheduled for 03Apr2021. The patient was advised to get in touch with her primary doctor to see what he has to say about it.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site swelling
Clinical narrative: bad fatigue/ tiredness; pounding headache; chills/ the shakes; sweats/ hot sweats; cold sweats; aches and pains; dry mouth; her energy level is even worse to where she can hardly get up to go to the bathroom.; Muscle pain; swelling of the arm where she got the injection; not feeling well and not herself/ I have been very sick with the first dose; not feeling well and not herself; loss of appetite; 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 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; ATORVASTATIN taken for blood cholesterol abnormal; SYMBICORT taken for asthma. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "bad fatigue/ tiredness"; HEADACHE (non-serious), outcome "not recovered", described as "pounding headache"; CHILLS (non-serious), outcome "recovering", described as "chills/ the shakes"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "sweats/ hot sweats"; COLD SWEAT (non-serious), outcome "recovering", described as "cold sweats"; PAIN (non-serious), outcome "recovering", described as "aches and pains"; DRY MOUTH (non-serious), outcome "not recovered", described as "dry mouth"; ASTHENIA (non-serious), outcome "unknown", described as "her energy level is even worse to where she can hardly get up to go to the bathroom."; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling of the arm where she got the injection"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well and not herself/ I have been very sick with the first dose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well and not herself"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite".  Additional Information: The patient reported that the first three days were really bad with fatigue, headache, chills, sweats, aches and pains. The reporter mentioned that being 74 year old, her energy level was not great to begin with. She asked how long will her symptoms last because it was 5 days already and she was still not feeling well. The patient did not want to get the second dose because she have been very sick with the first dose. The reporter asked if it was safe for her to get the second dose because she does not want to go through these (the events) again. Second dose was scheduled for 03Apr2021. The patient was advised to get in touch with her primary doctor to see what he has to say about it.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea/when he blows wind it is watery; 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 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:30 (Lot number: EN7534) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 17Mar2021 05:30, outcome "not recovered", described as "Diarrhea/when he blows wind it is watery". Additional information: Patient had no Family Medical History Relevant to the adverse events. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks and no adverse events following prior vaccinations. The patient was querying if the event has anything to do with the vaccine. The patient had will have have his second dose on 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart pounding/ pounding heartbeat/ heart was palpitating; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (age reported as over 65; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Jan2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 23Jan2021, outcome "recovered" (2021), described as "heart pounding/ pounding heartbeat/ heart was palpitating". Additional information: The event was reported to occur 10 or 11 hours after vaccination at night.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headaches; nausea; 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 female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (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 (First dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "headaches"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea". Additional information: She was having a very uncomfortable experience after the second dose of the vaccine and she still suffers these side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An adult female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MEDROL [METHYLPREDNISOLONE], start date: 17Mar2021. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "body aches". Additional information: It was reported that the patient age was between 28-32 who still had body aches. Patient received steroid Medrol dose pack for 6 days. The patient is concerned regarding the steroid and the second dose is in a few days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Feeling abnormal, Headache
Clinical narrative: felt dizzy; seemed like a night sweat/whole body broke out into a sweat; abdominal pain/stomach hurts a little bit; about 50% of the time she will have to go to the bathroom and have diarrhea; Hot flashes; mild headache; feels weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 09:30 (Lot number: EN6205) at the age of 47 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "anxiety" (ongoing); "contraception" (ongoing); "Allergic to all kinds of Penicillins" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE HCL taken for anxiety, start date: Nov2019 (ongoing); JUNEL FE taken for contraception, start date: Mar2020 (ongoing). Past drug history included: Amoxicillin, start date: Jan2021, reaction(s): "rash", notes: had a reaction in early Jan2021; treated with a steroid, Prednisone; Amoxicillin, start date: Jan2021, reaction(s): "hives"; Prednisone, start date: Jan2021, for Rash; Prednisone, start date: Jan2021, for Hives. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovering", described as "felt dizzy"; NIGHT SWEATS (non-serious) with onset 16Mar2021, outcome "recovering", described as "seemed like a night sweat/whole body broke out into a sweat"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Mar2021, outcome "not recovered", described as "abdominal pain/stomach hurts a little bit"; DIARRHOEA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "about 50% of the time she will have to go to the bathroom and have diarrhea"; HOT FLUSH (non-serious) with onset 16Mar2021, outcome "recovering", described as "Hot flashes"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "mild headache"; FEELING ABNORMAL (non-serious) with onset 16Mar2021, outcome "unknown", described as "feels weird". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after vaccination, past 5pm of 16Mar2021, the patient felt dizzy, had hot flashes and her whole body broke out into a sweat. Hot flash would come on and then she would get dizzy. She stated that it happened through the night about every 2 hours. The events last for about a minute and she just feels weird afterward. The last time this happened was about 17Mar2021 09:30, stated that it was not as strong and confirmed she had diarrhea. The patient went to bed with a mild headache and she did not have it when she woke up in the middle of the night. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Night sweats
Clinical narrative: felt dizzy; seemed like a night sweat/whole body broke out into a sweat; abdominal pain/stomach hurts a little bit; about 50% of the time she will have to go to the bathroom and have diarrhea; Hot flashes; mild headache; feels weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 09:30 (Lot number: EN6205) at the age of 47 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "anxiety" (ongoing); "contraception" (ongoing); "Allergic to all kinds of Penicillins" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE HCL taken for anxiety, start date: Nov2019 (ongoing); JUNEL FE taken for contraception, start date: Mar2020 (ongoing). Past drug history included: Amoxicillin, start date: Jan2021, reaction(s): "rash", notes: had a reaction in early Jan2021; treated with a steroid, Prednisone; Amoxicillin, start date: Jan2021, reaction(s): "hives"; Prednisone, start date: Jan2021, for Rash; Prednisone, start date: Jan2021, for Hives. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021, outcome "recovering", described as "felt dizzy"; NIGHT SWEATS (non-serious) with onset 16Mar2021, outcome "recovering", described as "seemed like a night sweat/whole body broke out into a sweat"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Mar2021, outcome "not recovered", described as "abdominal pain/stomach hurts a little bit"; DIARRHOEA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "about 50% of the time she will have to go to the bathroom and have diarrhea"; HOT FLUSH (non-serious) with onset 16Mar2021, outcome "recovering", described as "Hot flashes"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovered" (16Mar2021), described as "mild headache"; FEELING ABNORMAL (non-serious) with onset 16Mar2021, outcome "unknown", described as "feels weird". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after vaccination, past 5pm of 16Mar2021, the patient felt dizzy, had hot flashes and her whole body broke out into a sweat. Hot flash would come on and then she would get dizzy. She stated that it happened through the night about every 2 hours. The events last for about a minute and she just feels weird afterward. The last time this happened was about 17Mar2021 09:30, stated that it was not as strong and confirmed she had diarrhea. The patient went to bed with a mild headache and she did not have it when she woke up in the middle of the night. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: her arm sore; pain in the injections site; could barely move her arm; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "unknown", described as "her arm sore"; VACCINATION SITE PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "pain in the injections site"; MOBILITY DECREASED (non-serious) with onset 17Mar2021, outcome "unknown", described as "could barely move her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I was very very dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 83-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 14:10 (Lot number: EL9265) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitamin D low" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "water pill" (unspecified if ongoing); "Heart" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA taken for chronic obstructive pulmonary disease (ongoing); FLECAINIDE taken for cardiac disorder (ongoing); METOPROLOL taken for cardiac disorder (ongoing); ATORVASTATIN taken for blood pressure abnormal (ongoing); LOSARTAN (ongoing); POTASSIUM (ongoing); FUROSEMIDE (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d deficiency (ongoing). Vaccination history included: Bnt162b2 (first dose, left arm at 14:30), administration date: 19Jan2021, for Covid-19 Immunisation. The following information was reported: DIZZINESS (non-serious) with onset 03Mar2021, outcome "not recovered", described as "I was very very dizzy". Additional information: The patient reported that about two weeks ago, first noticed dizziness and then experienced it again today (as of reporting). Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: nausea/ slightly nauseous; chills; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 10Mar2021 (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: CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "chills"; NAUSEA (non-serious) with onset 15Mar2021, outcome "recovering", described as "nausea/ slightly nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling drunk, Headache, Nausea
Clinical narrative: Dizziness/ dizziness when moving the head too fast like something was turning; Headache; loss of balance everytime when walking, turning, and moving the head up, down or quickyly (need to walk slowly); Nausea; felt like drunk; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 15Mar2021 10:00 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (ongoing); "high cholesterol" (ongoing); "slightly low blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 16Mar2021 07:00, outcome "not recovered", described as "Dizziness/ dizziness when moving the head too fast like something was turning"; HEADACHE (non-serious) with onset 16Mar2021 07:00, outcome "recovering", described as "Headache"; BALANCE DISORDER (non-serious) with onset 16Mar2021 07:00, outcome "not recovered", described as "loss of balance everytime when walking, turning, and moving the head up, down or quickyly (need to walk slowly)"; NAUSEA (non-serious) with onset 16Mar2021 07:00, outcome "not recovered", described as "Nausea"; FEELING DRUNK (non-serious) with onset 16Mar2021 07:00, outcome "not recovered", described as "felt like drunk". Additional information: The patient was concomitant taking unspecified medications for high cholesterol. The patient also received unspecified allergy shot on 10Mar2021. The patient has no relevant family medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: asking if okay to take aspirin for pain after first dose; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 17Mar2021, this case now contains all required information to be considered valid.  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 63 year-old male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pollen allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "asking if okay to take aspirin for pain after first dose". Therapeutic measures were taken as a result of pain.  Additional Information: The patient has allergies and was wondering if taking "allergy" and aspirin medication would be safe. The reporter then clarified allergy was pollen and aspirin for pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.