chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: terrible arm; 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).  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "terrible arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; 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), administration date 04Mar2021 (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: MALAISE (non-serious) with onset 25Mar2021, outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site discomfort
Clinical narrative: red dot on my arm and did feel something there; red dot on my arm and did feel something there; This is a spontaneous report received from a non-contactable reporter(Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown" and all described as "red dot on my arm and did feel something there".  Additional information: Caller received her first dose this morning, the injection according to her only lasted half a second and she didn't feel anything. She was querying if that normal. She was not sure if got the vaccine but she has seen a red dot on her arm and did felt something there.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Feels so much better/his breathing is better and he is stronger/feels "younger than springtime."; 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 88 year-old male 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 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "Feels so much better/his breathing is better and he is stronger/feels "younger than springtime."  Additional information: The patient stated he received his second dose of the Pfizer BioNTech COVID-19 vaccine and "feels so much better." He stated that his breathing is better, and he is stronger. He feels "younger than springtime." Caller would like to know why the vaccine has made him feel this way.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bowel movement irregularity, Chills, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: Slight sore arm; slight headache; some GI issues; generally don't feel good; unusual bowel movements; chills; feels like a fever, but no fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Slight sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headache"; GASTROINTESTINAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "some GI issues"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "generally don't feel good"; BOWEL MOVEMENT IRREGULARITY (non-serious) with onset Mar2021, outcome "unknown", described as "unusual bowel movements"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "feels like a fever, but no fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received her second dose of the Pfizer-BioNTech Covid19 vaccine on 22Mar2021. She states that had a slight sore arm and a slight headache for a short time afterword, then she felt fine. Then as the week went on, she started with some GI issues, generally don't feel good, unusual bowel movements, chills, feels like a fever, but no fever. She stated that she kept on thinking she had a fever, and she took her temperature and she don't have a fever. She just wanted to know if this is all normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Slight sore arm; slight headache; some GI issues; generally don't feel good; unusual bowel movements; chills; feels like a fever, but no fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Slight sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headache"; GASTROINTESTINAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "some GI issues"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "generally don't feel good"; BOWEL MOVEMENT IRREGULARITY (non-serious) with onset Mar2021, outcome "unknown", described as "unusual bowel movements"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "feels like a fever, but no fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received her second dose of the Pfizer-BioNTech Covid19 vaccine on 22Mar2021. She states that had a slight sore arm and a slight headache for a short time afterword, then she felt fine. Then as the week went on, she started with some GI issues, generally don't feel good, unusual bowel movements, chills, feels like a fever, but no fever. She stated that she kept on thinking she had a fever, and she took her temperature and she don't have a fever. She just wanted to know if this is all normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: I became really happy and had great amounts of energy for several days after my first dose of Pfizer.; I became really happy and had great amounts of energy for several days after my first dose of Pfizer.; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 65 years (as reported) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sciatica" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE; ESZOPICLONE; RISPERIDONE; TRAZODONE. Past drug history included: Droperidol, reaction(s): "Drug allergy"; Cogentin, reaction(s): "Drug allergy"; Seroquel, reaction(s): "Drug allergy"; Frova, reaction(s): "Drug allergy". The following information was reported: ENERGY INCREASED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious) all with onset Mar2021, outcome "recovered" (Mar2021) and all described as "I became really happy and had great amounts of energy for several days after my first dose of Pfizer.". Therapeutic measures were not taken as a result of energy increased, therapeutic response unexpected.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date (Mar2021), the patient became really happy and had great amounts of energy for several days after first dose vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head colds; 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. The patient reported for himself and his wife. This is first of two reports.  A male patient received bnt162b2 (BNT162B2), 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: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "head colds".  Additional information: Age of patient: 80, unit unknown. Product: Pfizer-Biontech Covid-19 Vaccine. The patient and his wife had their 1st Pfizer vaccine dose on 10Mar2021, and the next vaccine dose is due tomorrow. The patient stated he and his wife had head colds, no fever. The patient asked if they should reschedule their 2nd dose and if it is ok to have a cold when they get the vaccine.  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-2021361868 Same reporter/vaccine/events, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gait inability, Vertigo
Clinical narrative: experienced extreme vertigo; could not walk straight; intermittent fogginess; dizziness; 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 49 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 11:30 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mrna, reaction(s): "Sore arm"; Diphtheria, reaction(s): "Sore arm"; Pertussis, reaction(s): "Sore arm". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "experienced extreme vertigo"; GAIT INABILITY (non-serious), outcome "unknown", described as "could not walk straight"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "intermittent fogginess"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: Caller mentioned that she received the 1st dose of the Pfizer Covid19 Vaccine last Saturday 11:30am and had no problems all throughout Saturday whatsoever. On Sunday morning, when she woke up, she experienced extreme vertigo and could not walk straight. Till this day, she would still have periods of vertigo, intermittent fogginess and dizziness. She mentioned that she feels like her head in is in a blender while walking around, this was an awful experience, and she would not want to live like this. She mentioned that she received a similar received a mRNA Diphtheria, Pertussis vaccine and had no problems but a sore arm. She would not have problems with Flu shots and MMR vaccine. She mentioned that everyone she knows that received the vaccine over 55 years old, including her 71-year-old mother had no problem with it. She mentioned that she has seen people talking about vertigo as a side effect in Drug Reactions website but the CDC does not report it as a side effect. She is asking if this has been reported and for what to do with it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Ear discomfort, Hypoacusis, Pain in extremity, Paraesthesia
Clinical narrative: Pins and needles from her feet; Pins and needles from her arms; My ear started burning inside like right ear; Almost hearing change like basically by 75% I couldn't hear much; I couldn't think straight, there was no concentration, no attention; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: ER2613) at the age of 35 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 18Mar2021, outcome "unknown", described as "Pins and needles from her feet"; PARAESTHESIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Pins and needles from her arms"; EAR DISCOMFORT (non-serious) with onset 18Mar2021, outcome "unknown", described as "My ear started burning inside like right ear"; HYPOACUSIS (non-serious) with onset 18Mar2021, outcome "unknown", described as "Almost hearing change like basically by 75% I couldn't hear much"; DISTURBANCE IN ATTENTION (non-serious) with onset 18Mar2021, outcome "unknown", described as "I couldn't think straight, there was no concentration, no attention".  Additional Information: Consumer stated, "I think I am having some side effects of the vaccine (Covid vaccine). I had the vaccine on 18Mar I think last Thursday and right after the vaccine in some minutes I was super dizzy, almost hearing change like basically by 75% I couldn't hear much and it lasted for 15-20 minutes and then I felt a bit better but then two days I couldn't think straight, there was no concentration, no attention like it was just like I was really dunk kind and then after it was like buzzing in the ear the first day and was like high pitch sound in the quiet room. Like in three days I started feeling needle and pins in my feet and leg, they are starting to move up and now and now its hands and arms and its day nine and I still have these symptoms and yesterday my ear started burning inside like right ear. I don't know how to explain it but the question is how long do these symptoms last, are they temporary, permanent or its the immune response or its there like some kind of reaction going on with my immune system that started whatever nerve reaction. What is happening and what do I do about it and same is it even a good idea to go get the second shot if I am having these reaction to the first one.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: poison ivy on face; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 14Mar2021 (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: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "poison ivy on face". Therapeutic measures were taken as a result of dermatitis contact. Additional Information: The patient's age was reported to be 41 (unit unknown). The patient received first dose of Pfizer BioNTech Covid vaccine on 14Mar2021. She was supposed to receive second dose on Sunday but developed poison ivy on face and had to start a 6-day prednisone taper yesterday. She was to take 30mg for two days, then 20mg for two days, then 10 mg for 2 days. She wanted to know if she is okay to still receive the second dose Sunday or she should delay it. Her PCP was very conservative and told her she wasn't sure. When she spoke to her pharmacist, she said it was a low dose amount of steroid for a short duration but was not sure either.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Tremor
Clinical narrative: Chills; Shaking; Muscle spasm; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Feb2021, stop date: Feb2021, notes: She had COVID-19 in February around Valentine's day until the end of Feb2021. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovering", described as "Chills"; TREMOR (non-serious) with onset Mar2021, outcome "recovering", described as "Shaking"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "recovering", described as "Muscle spasm". Therapeutic measures were taken as a result of chills, tremor, muscle spasms.  Additional Information: After the patient got the vaccine, she had chills and shaking like muscle spams. She treated it with ibuprofen and it helped.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: has a scratchy sore throat; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (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: THROAT IRRITATION (non-serious), outcome "unknown", described as "has a scratchy sore throat". Additional Information: The patient was wondering if this was due to the vaccine or coincidentally showing symptoms of the virus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Pain in extremity
Clinical narrative: loss of appetite; pain in arm; nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient in her 40's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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), for Covid-19 Immunisation. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 17:45 (Batch/Lot number: unknown) at the age of 45 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: DIZZINESS (non-serious) with onset 30Mar2021 05:00, outcome "not recovered", described as "dizzy". Therapeutic measures were not taken as a result of dizziness.  Additional information: No other vaccine in four weeks. The patient received Vitamins within 2 weeks of vaccination. The patient reported that in the morning of 30Mar2021 at 5 AM when the patient tried to leave bed, he got dizzy. He has been like this all day when he looks up. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her shot; it hurt really bad; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her shot; it hurt really bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 59 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE) (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), outcome "unknown", described as "Arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm has been sore ever since; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 78-year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EN9581) at the age of 78 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 (Lot Number: Not provided)), for COVID-19 Immunization, reaction(s): "Did not have a problem". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Feb2021, outcome "not recovered", described as "Arm has been sore ever since".  Additional Information: The patient got the second dose of the Pfizer COVID vaccine on 10Feb2021 and her arm had been sore ever since. She did not have a problem with the first dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure to go up; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure to go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was querying if it was normal for her blood pressure to go up after getting the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not provided), for COVID-19 immunisation. The patient experienced pain in extremity/peripheral swelling/arm is swollen just a little/little pain in that arm/the other arm strangely a little pain/arm is very, very sore, with outcome of unknown. Additional Information: Yesterday (unspecified date) about 1 o'clock, patient had the second shot of the vaccine. After the first shot, patient did not feel pain, and experienced nothing. For the second shot, they got little pain in that arm and the other arm strangely also had a little pain. The person who admitted the patient at the time of the shot, mentioned what to take, but patient thought of not needing to take anything because there was no problem with the first shot. Since the second shot, their arm was very, very sore. Also, it's swollen just a little. Patient wanted to know what type of treatment to get. The person advised Benadryl (diphenhydramine), Tylenol (acetaminophen) or Advil (ibuprofen) but ignored it because the patient was basing it on the first experience. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Gastric disorder, Muscle spasms, Vomiting
Clinical narrative: Diarrhea really bad; Uncontrollably, terribly vomiting /he was violently throwing up; Chills; Muscle spasm; stomach bug; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 08:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Diarrhea really bad"; VOMITING (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Uncontrollably, terribly vomiting /he was violently throwing up"; CHILLS (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Chills"; MUSCLE SPASMS (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "Muscle spasm"; GASTRIC DISORDER (non-serious) with onset 24Mar2021 18:00, outcome "unknown", described as "stomach bug".  Additional information: Reporter stated that her husband got his first dose (Unspecified medication) yesterday morning at 8:45 and then at about 6 o'clock last night, he had diarrhea really bad and then it ended up like uncontrollably, terribly vomiting and then had chills. They were not even chills, like more of muscle spasms. She doesn't know if he was having a reaction or there was a stomach bug going around and he may have had the stomach bug. She was trying to figure out if like violently throwing up is one of the symptoms or just throwing up. Like he was violently throwing up then he had to run to the bathroom with diarrhea. Reporter stated that she was just trying to figure out if he had a severe reaction and should not get the second one or maybe there was a stomach bug going around their area and maybe it was just, he happened to get the shot that morning and then had the stomach bug as well. Reporter further stated that he had muscle spasms too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Fatigue, Vaccination site pain
Clinical narrative: fatigue; He has elevated cholesterol; Pain at site of jab; This is a spontaneous report received from contactable reporter (Consumer) from a sales representative. The reporter is the patient.  A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 54 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: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "Pain at site of jab"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "He has elevated cholesterol". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had his first COVID Vaccine this morning 27Mar2021 and experienced pain at sight of jab and fatigue. The patient was reported to be 230 (units not provided) and 5 ft. 10 in. The patient was not taking any prescription medicines but was taking multivitamins. He has elevated cholesterol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Arm sore where she got her first dose; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6199) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (ongoing); "Thyroid problem" (ongoing); "High blood pressure" (ongoing). Concomitant medications included: METFORMIN taken for glucose tolerance impaired (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); LOSARTAN taken for hypertension (ongoing); LOTENSIN [CAPTOPRIL] taken for hypertension (ongoing); TYLENOL taken for pyrexia, start date: 03Mar2021, stop date: 03Mar2021. Vaccination history included: Flu vaccine (She had flu shot before. On the first day, she had mild flu like symptoms but they went away the next day and she felt good. She got the flu vaccine last year, so it wasn't even close.), administration date: 2020, reaction: "Mild flu-like symptoms". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Arm sore where she got her first dose".  Additional Information: The patient received COVID-19 vaccine since she had prediabetes and wanted to make sure that she was covered because of underlying conditions. She made an appointment to see her doctor today at 1:00 PM (date unspecified). When she had her first dose, she did not have a lot of symptoms, just fatigue and her arm where she got the vaccine was very sore. She didn't take her medications the day of the vaccine and didn't eat anything either for both doses. She hydrated very much before. She checked with her primary doctor to see if it was advisable to take the vaccine and he said it was no problem. On the first day of the COVID vaccine, she took acetaminophen (TYLENOL) thinking in case she got a fever, she should take it then her daughter said taking it makes it less effective. She thought oh great, she didn't know that. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room or physician office. The patient did not receive prior vaccinations within 4 weeks. The patient had no family medical history relevant to adverse events and had no relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335699 Same patient and drug; Different dose and events
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: fatigue/tiredness; headache; chills; dizziness/dizzy; nausea; feeling unwell; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parksinson's" (unspecified if ongoing), notes: takes Parkinson's medication that she had and took it before the shot. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "fatigue/tiredness"; HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "nausea"; MALAISE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "feeling unwell"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of fatigue, headache, chills, dizziness, nausea, malaise, asthenia.  Additional information: It was reported that events were all ongoing. Headache, chills, nausea, feeling unwell and dizzy all worsened. Reporter was concerned about having the second one on 31Mar2021 and if the patient should take it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: fatigue/tiredness; headache; chills; dizziness/dizzy; nausea; feeling unwell; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parksinson's" (unspecified if ongoing), notes: takes Parkinson's medication that she had and took it before the shot. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "fatigue/tiredness"; HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "nausea"; MALAISE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "feeling unwell"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of fatigue, headache, chills, dizziness, nausea, malaise, asthenia.  Additional information: It was reported that events were all ongoing. Headache, chills, nausea, feeling unwell and dizzy all worsened. Reporter was concerned about having the second one on 31Mar2021 and if the patient should take it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fall, Nervousness, X-ray
Clinical narrative: Still nervous; fall last night; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  An 80 year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 27Feb2021 15:35 (Lot number: EN6200) at the age of 80 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: FALL (non-serious) with onset 25Mar2021, outcome "unknown", described as "fall last night"; NERVOUSNESS (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Still nervous". The event "fall last night" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient has not taken any other products. The patient had a nasty fall last night and she is still nervous about it today. She had the shot in Feb2021 but she doesn't remember the exact date. She has recently moved and doesn't have access to a lot of records. She is waiting to go today but she needs to know if we have a record of when she got the first shot. It was supposed to be three weeks but she thinks it is longer. She fell last night face first over the rug on the hardwood floor and went to ER but she was not admitted. They did x-rays and blood work but they said she was fine. The granddaughter took the phone and provided her grandmother received the first dose of the Pfizer COVID 19 vaccine on 27Feb2021 at 1535PM in the right arm. They are going at 1230 today to get then next dose. The patient has no history of all previous immunization with the COVID-19 Vaccine and has no additional vaccines administered on same date of the COVID-19 Vaccine. The event fall required emergency room visit but did not require hospital admission. The other event did not require physician office visit. The patient has no prior vaccinations within 4 weeks and has no medical history including any illness at time of vaccination. The patient has no family history.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: soreness at the side of her neck; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "soreness at the side of her neck". Therapeutic measures were taken as a result of neck pain.  Additional information: Caller received the Pfizer Covid-19 vaccine first dose this morning, 26Mar2021 and she experienced soreness at the side of her neck. Her 2nd dose will be on 16Apr2021. She wanted to know if Advil will work as well after taking Tylenol..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Soreness; Had little pain the same day, mainly in her arm; Chills / Shivering; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 13:00 (Lot number: EN6199) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (The patient did not provide name, manufacturer, national drug code (NDC), lot, expiry date or dose.), reaction: "Little Dizziness". The following information was reported: PAIN (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "Soreness"; PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "Had little pain the same day, mainly in her arm"; CHILLS (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "Chills / Shivering".  Additional Information: The main reason that the patient received COVID-19 vaccine was to reduce the risk of getting the COVID-19 virus and there were other reasons also. The patient stated that her experience with the vaccine was not bad. She had soreness and a little pain with the first dose. She got chills later in the evening (05Mar2021) for a brief time and that was it. She got her first vaccine on 05Mar2021 and the soreness started shortly after receiving it around 13:00 and had a little pain the same day, mainly in her arm. Chills started the same day later in the evening (05Mar2021) and that was strange. She started shivering and supposed it was chills but they didn't last very long. The patient stated that all were already completely resolved. She was sore the next day or not the next morning but she believed that they all resolved within 24-28 hours. She stated that the pains here and there were for different reasons. She had vaccines way back in junior high and she felt like she was going to pass out. She thought that they gave her three different things, one might had been measles mumps rubella, and it may had been two vaccines and one oral thing. She had spots before her eyes and felt like she might pass out and they had her put her head between her knees and did not think she passed out. She did not have names, manufacturer, NDC, lot, expiry date or doses to provide. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency or physician office. The patient did not receive prior vaccinations within 4 weeks.The patient did not have relevant tests done.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremors with First Vaccine; This is a spontaneous report received from contactable reporter (Consumer).  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 12:50 (Lot number: EN6199) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: the patient had Covid with severe symptoms in Mar2020. The patient's concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 05Mar2021, outcome "recovered" (08Mar2021), described as "Tremors with First Vaccine". Additional Information: The reported stated that tremors should be added to the side effects because the patient had them after his first vaccine also. The patient has no additional vaccines administered on same date of the COVID-19 Vaccine. The events did not require emergency room or physician office visit. The patient has no prior vaccinations within 4 weeks and has no adverse events following prior vaccination. As reported, the patient has no Medical History (including any illness at time of vaccination). The patient has no family medical history relevant to the adverse events and has no relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021352988 same patient, different drug dose and different event.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: slight headache; sore arm; This is a spontaneous report received from a contactable reporter (Nurse).  A 89 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 89 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "slight headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Additional Information: Nurse stated that the patient is in a long term care facility and was checked and there were no other indications. Nurse stated that events will resolved in 2-3 days, no fever or no other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.