chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Sleep disorder, Vomiting
Clinical narrative: After second dose my arm hurt so much more than first dose; couldn't sleep well; today I've been nauseated; faint-like feeling; threw up twice; I have no appetite; stomach remains swollen; terrible tiredness; I am feeling bad; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: Unknown, time 16:00, Anatomical Location: Arm Left), administration date: 13Feb2021, for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovering", described as "After second dose my arm hurt so much more than first dose"; SLEEP DISORDER (non-serious) with onset 06Mar2021, outcome "recovering", described as "couldn't sleep well"; NAUSEA (non-serious) with onset 06Mar2021, outcome "recovering", described as "today I've been nauseated"; DIZZINESS (non-serious) with onset 06Mar2021, outcome "recovering", described as "faint-like feeling"; VOMITING (non-serious) with onset 06Mar2021, outcome "recovering", described as "threw up twice"; DECREASED APPETITE (non-serious) with onset 06Mar2021, outcome "recovering", described as "I have no appetite"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Mar2021, outcome "recovering", described as "stomach remains swollen"; FATIGUE (non-serious) with onset 06Mar2021, outcome "recovering", described as "terrible tiredness"; FEELING ABNORMAL (non-serious) with onset 06Mar2021, outcome "recovering", described as "I am feeling bad". Therapeutic measures were taken as a result of pain in extremity, sleep disorder, nausea, dizziness, vomiting, decreased appetite, abdominal discomfort, fatigue, feeling abnormal.  Additional information: Patient not had allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Estradiol within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The arm does not get relieve regardless the patient took acetaminophen every 5 hours. The patient stated that the pain makes not caring to do of the patient day, she just wanted to feel better and that this passes away and she worried but her husband says she have to wait to get better. Since the vaccination, the patient not tested for COVID-19. The patient received treatment with Acetaminophen and Alka-Seltzer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound Doppler, X-ray limb
Clinical narrative: Terrible pain in her arm/ only a little bit of arm soreness; 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 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Feb2021 (Lot number: EN5318) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLIC ACID. Vaccination history included: Bnt162b2 (Arm, Left - Administered at about 3:30PM on 18Jan2021(first dose), Lot number-EL8982 , Date of start of reaction/event -18Jan2021, Outcome of reaction/event at the time of last observation-Not Recovered/Not Resolved), administration date: 18Jan2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "arm (left) has been quite sore", "her left armpit area, for about 10 days, was reddened and developed a black and blue like area", "she had a pins and needles feeling develop in her left hand after her first COVID-19 Vaccine, but the pins and needles feeling had subsided". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Feb2021, outcome "recovered", described as "Terrible pain in her arm/ only a little bit of arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had been experiencing terrible pain in her arm since she got the dose of the vaccine. There were no other products and patient history. Reported she was quite healthy. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect. There were not any prior vaccinations (within 4 weeks) and not applicable for adverse event following prior vaccinations. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse event was not provided.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen place where the shot was; Redness where the shot was; pain where the shot was up her arm and neck; pain where the shot was up her arm and neck; feels hot where the shot was; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 10:00 (Batch/Lot number: unknown) at the age of 68 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: VACCINATION SITE SWELLING (non-serious) with onset 06Mar2021, outcome "not recovered", described as "swollen place where the shot was"; VACCINATION SITE ERYTHEMA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Redness where the shot was"; PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious) all with onset 05Mar2021, outcome "not recovered" and all described as "pain where the shot was up her arm and neck"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "not recovered", described as "feels hot where the shot was".  Additional Information: The patient had not received any vaccine within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Muscle spasms
Clinical narrative: flu symptoms; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: INFLUENZA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "flu symptoms"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "muscle spasm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Muscle spasms
Clinical narrative: flu symptoms; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: INFLUENZA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "flu symptoms"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "muscle spasm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6205) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EL9269), administration date: 12Feb2021, when the patient was 74 years old, for covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Tired". Additional Information: The patient had a question that she had her second Pfizer shot last week and she had like no symptoms except maybe being a little tired and she wondered what it indicates. The patient also asked if some people seem to react with a lot of symptoms than others without any, she asked what it meant when the patient have very few symptoms.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Oropharyngeal discomfort
Clinical narrative: feels sick; food won't go down to her throat; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE.), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "feels sick"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "food won't go down to her throat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: he got muffled hearing and hearing radio septum/decreased hearing in the right ear after the 1st dose; Pressure, decreased hearing and ringing in the right ear after the 1st dose; Pressure, decreased hearing and ringing in the right ear after the 1st dose; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) for a Pfizer sponsored program.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2021 16:00 (Lot number: EN6203) as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADIN. The following information was reported: HYPOACUSIS (non-serious) with onset 02Mar2021 06:00, outcome "unknown", described as "he got muffled hearing and hearing radio septum/decreased hearing in the right ear after the 1st dose"; EAR DISCOMFORT (non-serious), TINNITUS (non-serious) all with onset 02Mar2021 06:00, outcome "not recovered" and all described as "Pressure, decreased hearing and ringing in the right ear after the 1st dose". The event "pressure, decreased hearing and ringing in the right ear after the 1st dose" was evaluated at the physician office visit. Additional information: Due to the adverse event the patient was enquiring that whether the patient should take second dose or not. Prior to the vaccination patient was not tested positive for covid. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 78 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administration date unspecified (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included: "Diabetic type-2", start date: Mar1995 (ongoing), notes: Also reported as Diabetic type-2 for 30 years; "Stroke", start date: Jul2017, stop date: Jul2017. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot/Batch number: EL9261, Anatomical location: Arm left), administration date: 30Jan2021, when the patient was 78 years old, single for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other illness at the time. Have never had reaction to any medication of vaccine before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122264 same reporter, patient, suspect product, different event and dose
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Visual impairment
Clinical narrative: headaches; nausea; trouble vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (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: HEADACHE (non-serious), outcome "unknown", described as "headaches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "trouble vision".  No follow-up attempt are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced malaise/felt a little sick, with outcome of unknown. Additional information: The patient seemed fine and thought that it was just mental for him. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain". Therapeutic measures were taken as a result of neck pain. Additional information: Event was reported as follows: The patient got the last dose of the vaccine last 04Feb2021 and can't remember the day of his first dose. The patient took Ibuprofen (for neck pain) 3-4 hours prior to his second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain in upper arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Lot number: EL9265) as dose 2, single and administration date 13Jan2021 (Lot number: EK9231) 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: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain in upper arm".  Additional information: Patient stated that she was an average person. Patient had two doses of Covid vaccine (13Jan2021-first dose, 03Feb- second dose). Unfortunately, she was still experiencing muscle pain in her upper arm up until now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Muscle pain in upper arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Lot number: EL9265) as dose 2, single and administration date 13Jan2021 (Lot number: EK9231) 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: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain in upper arm".  Additional information: Patient stated that she was an average person. Patient had two doses of Covid vaccine (13Jan2021-first dose, 03Feb- second dose). Unfortunately, she was still experiencing muscle pain in her upper arm up until now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Underdose
Clinical narrative: the patient did not receive the full 0.3 mL dose of the Pfizer COVID-19 vaccine; when the nurse, administering the vaccine, withdraw the needle from her daughter's arm, fluid, in which caller believes was the vaccine, leaked from the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 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: UNDERDOSE (non-serious) with onset 10Mar2021, outcome "unknown", described as "the patient did not receive the full 0.3 mL dose of the Pfizer COVID-19 vaccine"; INJECTION SITE EXTRAVASATION (non-serious) with onset 10Mar2021, outcome "unknown", described as "when the nurse, administering the vaccine, withdraw the needle from her daughter's arm, fluid, in which caller believes was the vaccine, leaked from the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness postural, Fall, Fatigue, Pain in extremity
Clinical narrative: Room started spinning like vertigo; Unsteady and very dizzy; Unsteady and very dizzy; Fell; he was extremely tired for both COVID-19 Vaccines; Arm was a little sore after the second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it. The patient's concomitant medications were not reported. Past drug history included: Meclizine for Vertigo, reaction(s): "didn't feel it was helping him", notes: Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it. Vaccination history included: Bnt162b2 (Might have had first injection on 02Feb2021 at 2:30PM), administration date: 02Feb2021, when the patient was 74 years old, for Covid-19 immunisation, reaction(s): "Arm was really, really, severely sore the first time", "he was extremely tired for both COVID-19 Vaccines". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was a little sore after the second dose"; VERTIGO (non-serious), outcome "unknown", described as "Room started spinning like vertigo"; BALANCE DISORDER (non-serious), DIZZINESS POSTURAL (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Unsteady and very dizzy"; FALL (non-serious) with onset Mar2021, outcome "unknown", described as "Fell"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "he was extremely tired for both COVID-19 Vaccines". The events "room started spinning like vertigo", "unsteady and very dizzy" and "unsteady and very dizzy" were evaluated at the physician office visit.  Additional information: It was reported that patient had severe things after the second COVID-19 Vaccine. Arm was a little sore after the second dose. The room started spinning like vertigo. Patient was unsteady and very dizzy. Had to go to doctor's office. Reporter stated the patient was unsteady and he fell. Has never had this before. Patient received second COVID-19 Vaccine on 02Mar2021 around noon. Patient was deathly afraid of the COVID Virus. Patient knows people who had been sick with COVID. was kind of scared and hearing what was going on. Reporter stated that patient was extremely tired for both COVID-19 Vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Room started spinning like vertigo; Unsteady and very dizzy; Unsteady and very dizzy; Fell; he was extremely tired for both COVID-19 Vaccines; Arm was a little sore after the second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it. The patient's concomitant medications were not reported. Past drug history included: Meclizine for Vertigo, reaction(s): "didn't feel it was helping him", notes: Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it. Vaccination history included: Bnt162b2 (Might have had first injection on 02Feb2021 at 2:30PM), administration date: 02Feb2021, when the patient was 74 years old, for Covid-19 immunisation, reaction(s): "Arm was really, really, severely sore the first time", "he was extremely tired for both COVID-19 Vaccines". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was a little sore after the second dose"; VERTIGO (non-serious), outcome "unknown", described as "Room started spinning like vertigo"; BALANCE DISORDER (non-serious), DIZZINESS POSTURAL (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Unsteady and very dizzy"; FALL (non-serious) with onset Mar2021, outcome "unknown", described as "Fell"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "he was extremely tired for both COVID-19 Vaccines". The events "room started spinning like vertigo", "unsteady and very dizzy" and "unsteady and very dizzy" were evaluated at the physician office visit.  Additional information: It was reported that patient had severe things after the second COVID-19 Vaccine. Arm was a little sore after the second dose. The room started spinning like vertigo. Patient was unsteady and very dizzy. Had to go to doctor's office. Reporter stated the patient was unsteady and he fell. Has never had this before. Patient received second COVID-19 Vaccine on 02Mar2021 around noon. Patient was deathly afraid of the COVID Virus. Patient knows people who had been sick with COVID. was kind of scared and hearing what was going on. Reporter stated that patient was extremely tired for both COVID-19 Vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness postural, Fall, Fatigue, Pain in extremity
Clinical narrative: Arm was really, really, severely sore the first time.; Room started spinning like vertigo; Unsteady and very dizzy; Unsteady and very dizzy; Fell; He was extremely tired for both COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 74 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Time :2:30 PM), administration date: 02Feb2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was really, really, severely sore the first time."; VERTIGO (non-serious) with onset Mar2021, outcome "unknown", described as "Room started spinning like vertigo"; BALANCE DISORDER (non-serious), DIZZINESS POSTURAL (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Unsteady and very dizzy"; FALL (non-serious) with onset Mar2021, outcome "unknown", described as "Fell"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "He was extremely tired for both COVID-19 Vaccines".  ADDITIONAL INFORMATION: Consumer reported that patient was unsteady and he fell, he has never had this before. It was reported that patient had vertigo, but doesn't know what this is in regards to the patient and doesn't know if patient experiencing vertigo. Patient was deathly afraid of the COVID Virus.  Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Arm was really, really, severely sore the first time.; Room started spinning like vertigo; Unsteady and very dizzy; Unsteady and very dizzy; Fell; He was extremely tired for both COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 74 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Time :2:30 PM), administration date: 02Feb2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was really, really, severely sore the first time."; VERTIGO (non-serious) with onset Mar2021, outcome "unknown", described as "Room started spinning like vertigo"; BALANCE DISORDER (non-serious), DIZZINESS POSTURAL (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Unsteady and very dizzy"; FALL (non-serious) with onset Mar2021, outcome "unknown", described as "Fell"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "He was extremely tired for both COVID-19 Vaccines".  ADDITIONAL INFORMATION: Consumer reported that patient was unsteady and he fell, he has never had this before. It was reported that patient had vertigo, but doesn't know what this is in regards to the patient and doesn't know if patient experiencing vertigo. Patient was deathly afraid of the COVID Virus.  Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Cramps; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), single for covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "Vomiting"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "Cramps".  Additional information: When probed for the concern consumer stated that he/she was just reporting that he/she had his/her second dose of Pfizer vaccine (captured as Unspecified medication) on Wednesday (March 3rd), and he/she was fine until last night when he/she experienced nausea, vomiting and cramps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Headache
Clinical narrative: Felt like a headache right in the middle of head; Uncomfortableness; Face felt funny on the left side / It felt funny, it was not hurting, it feels kind of something's there, it wasn't numb or anything; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation, reaction: "my arm was sore".  The following information was reported: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered", described as "Face felt funny on the left side / It felt funny, it was not hurting, it feels kind of something's there, it wasn't numb or anything"; HEADACHE (non-serious) with onset 07Mar2021, outcome "recovered", described as "Felt like a headache right in the middle of head"; DISCOMFORT (non-serious) with onset 07Mar2021, outcome "recovered", described as "Uncomfortableness". Therapeutic measures were taken as a result of feeling abnormal, headache, discomfort.  Additional Information: The patient have taken the second shot last Thursday. On the patient's way home, her face felt funny on the left side, it was not hurting, it feels kind of something's there, it wasn't numb or anything but it felt funny. And then, it lasted a few minutes and by the time she got home, she felt it no more. But on Sunday afternoon, she got up and felt like a headache right in the middle of her head and after that she felt the same thing on face and this time, it lasted a little longer, it was just uncomfortableness for about maybe 30 minutes or so and it went away. The patient did not have lab works. The patient stated that she just had aspirin and took one aspirin each time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274396 Same patient and product, different dose and event
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Retching, Tremor
Clinical narrative: Chills; Shaking; Became really hot; Nauseated; Dry heave; Weakened; Elevated body temperature; Tired; Lightheaded/Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6205) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiomyopathy", start date: 2014 (ongoing), notes: Verbatim: Cardiomyopathy; "Defibrillator", start date: 2014 (ongoing), notes: Verbatim: Defibrillator; "Pacemaker", start date: 2014 (ongoing), notes: Verbatim: Pacemaker. Concomitant medication(s) included: CARVEDILOL, start date: 2015; LISINOPRIL, start date: 2015; FISH OIL, start date: 2015; ASPIRIN, start date: 2015. Past drug history included: Statins, notes: Illness/AE: Allergy to statins. The following information was reported: CHILLS (non-serious) with onset 09Mar2021, outcome "recovering", described as "Chills"; TREMOR (non-serious) with onset 09Mar2021, outcome "unknown", described as "Shaking"; FEELING HOT (non-serious) with onset 09Mar2021, outcome "unknown", described as "Became really hot"; NAUSEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Nauseated"; RETCHING (non-serious) with onset 09Mar2021, outcome "unknown", described as "Dry heave"; ASTHENIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Weakened"; BODY TEMPERATURE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "Elevated body temperature"; FATIGUE (non-serious) with onset 09Mar2021, outcome "unknown", described as "Tired"; DIZZINESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "Lightheaded/Dizzy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This consumer had the first dose of the Pfizer-BioNTech COVID-19 Vaccine 08Mar2021. He reported having chills; shaking; then became really hot; nauseated; dry heave; weakened; elevated body temperature; tired; lightheaded; dizzy. He asked for information on these events and recommendations on treating the events. Starting 09Mar2021 around 02:00 had a pretty good bout of major chills and shaking then he became really hot. He did not check his body temperature then. He checked his body temperature today and his has a little elevated body temperature of 99.8 degrees Fahrenheit. He has been nauseated and weakened all morning, had a dry heave about 2 hours before this report. He still gets chills a little bit, but not major with shaking like initially, chills have lessened considerably. He feels a little bit better but was lightheaded, weakened, tired and dizzy.He has had the flu vaccine, shingles vaccine and pneumonia vaccine in the past but that has been a while. Parents are both passed away. One brother does have Diabetes and takes medication for that.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Caller is having Symptoms (feeling sick) and wants to know if she can take 2nd dose tomorrow; 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. Other Case identifier(s): US-PFIZER INC-2021275201.   A female patient 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: MALAISE (non-serious), outcome "unknown", described as "Caller is having Symptoms (feeling sick) and wants to know if she can take 2nd dose tomorrow".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aches and pains; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 (Lot number: EK4176) 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: PAIN (non-serious), outcome "not recovered", described as "aches and pains".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021275370 same patient/event, different vaccine dose number
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Nausea
Clinical narrative: Nausea; Diarrhea; problems with taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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, administration date: 04Feb2021, for COVID-19 immunisation. The following information was reported: DYSGEUSIA (non-serious) with onset 08Mar2021, outcome "unknown", described as "problems with taste"; NAUSEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Diarrhea". Additional Information: Events were described as follows: The patient had some problems with taste starting "last night". He had nausea this morning and diarrhea all day long. The patient was querying on how long the events will last or should he be taking something like Imodium. It was reported that the last one (COVID-19 vaccine) that he got was the one he was having problems with.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: abdominal pain; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: el 3247 on left arm at 10:15 as dose 1, single), administration date: 28Jan2021, when the patient was 67 years old, for Covid-19 immunisation, reaction(s): "Elevated transaminase measurement", "Severe abdominal pain", "abdominal swelling", "chills", "nausea", "vomiting". The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "abdominal pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". The events "abdominal pain", "nausea" and "vomiting" were evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Balance disorder, Dehydration, Pain
Clinical narrative: aches and pains; hard time standing straight, maintaining balance; maybe he was dehydrated; pain in his leg, stated it almost feels like a blood clot/ pain in his right leg; knees were out of whack, there was a pain there and he could not rub it out; knees were out of whack, there was a pain there and he could not rub it out; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 27Jan2021 (Lot number: EL9261) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Batch/Lot number: EK4176), administration date: 06Jan2021, when the patient was 75 years old, for COVID-19 immunisation, reaction: "aches and pains". The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "aches and pains"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "hard time standing straight, maintaining balance"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "maybe he was dehydrated "; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in his leg, stated it almost feels like a blood clot/ pain in his right leg"; ARTHROPATHY (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "knees were out of whack, there was a pain there and he could not rub it out".  Additional information: The clinical course of event was as follows: After the second shot, he had aches and pains, but within a week or two he went from being a 75-year-old active dude to someone who could barely get out of his chair. The patient stated that he was having real bad pains, persisting since he received the second vaccine. If he was driving a car he was fine, but when he was going to get out of the car he almost stumbled out of the car, hard time standing straight, maintaining balance, stated maybe he was dehydrated from the medication and didn't know what it was. He was concerned about a pain in his leg, stated it almost felt like a blood clot, pain in his right leg, knees were out of whack, there was a pain there and he could not rub it out. He did not want it to be a blood clot.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aches and pains; hard time standing straight, maintaining balance; maybe he was dehydrated; pain in his leg, stated it almost feels like a blood clot/ pain in his right leg; knees were out of whack, there was a pain there and he could not rub it out; knees were out of whack, there was a pain there and he could not rub it out; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 27Jan2021 (Lot number: EL9261) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Batch/Lot number: EK4176), administration date: 06Jan2021, when the patient was 75 years old, for COVID-19 immunisation, reaction: "aches and pains". The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "aches and pains"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "hard time standing straight, maintaining balance"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "maybe he was dehydrated "; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in his leg, stated it almost feels like a blood clot/ pain in his right leg"; ARTHROPATHY (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "knees were out of whack, there was a pain there and he could not rub it out".  Additional information: The clinical course of event was as follows: After the second shot, he had aches and pains, but within a week or two he went from being a 75-year-old active dude to someone who could barely get out of his chair. The patient stated that he was having real bad pains, persisting since he received the second vaccine. If he was driving a car he was fine, but when he was going to get out of the car he almost stumbled out of the car, hard time standing straight, maintaining balance, stated maybe he was dehydrated from the medication and didn't know what it was. He was concerned about a pain in his leg, stated it almost felt like a blood clot, pain in his right leg, knees were out of whack, there was a pain there and he could not rub it out. He did not want it to be a blood clot.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased
Clinical narrative: His hemoglobin was low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021263886 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "His hemoglobin was low". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of haemoglobin decreased. Additional information: The events started after 15 days of second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Somnolence, Vaccination site pain
Clinical narrative: Soreness at injection site; headache; drowsiness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Lot number: EL3247) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site"; HEADACHE (non-serious), outcome "unknown", described as "headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "drowsiness".  No follow-up attempts are possible. No further information is expected.