chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Movement disorder, Neck pain
Clinical narrative: 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 70 year-old female patient received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "immunosuppressed" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE. Past drug history included: Antibiotics, reaction(s): "Reaction", notes: Reaction to an antibiotic 5 years ago.The following information was reported: CHILLS (non-serious) with onset Jan2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown", described as "Headache"; NECK PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "Neckache"; LYMPHADENOPATHY (non-serious) with onset 22Jan2021, outcome "recovered" (23Jan2021), described as "Pain under her arm which she believes was a swollen lymph node"; BURSITIS (non-serious) with onset Jan2021, outcome "recovered" (Feb2021), described as "Hip bursitis"; MOVEMENT DISORDER (non-serious) with onset Jan2021, outcome "unknown", described as "She had difficulty moving in and out of bed". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was concerned and upset that the vaccine may not work for her because she is immunosuppressed. She wants Pfizer to know that this information should be "out there" more and it creates a "false sense of security" in individuals who are on immunosuppressants. Patient was upset that she tested negative for antibodies after the vaccine series. Patient received several weeks of physical therapy after the 1st Pfizer shot. She is on an immunosuppressant drug. Patient began taking immunosuppressant medication BEFORE receiving the Pfizer Covid vaccines. She states she will be going back to her MD for another test to determine if she has immunity against Covid. Caller upset that information about immunosuppressed individuals and the Covid vaccine is not more "out there" for the public to know. She is upset that this population was not included in the clinical trials and is upset that she has been told to proceed with her life as if she wasn't vaccinated. Patient wanted to know if Pfizer will be studying the vaccine with immunosuppressed individuals. Patient stated no one is giving clear warnings that the vaccine may or may not work including her doctor at (withheld). Went for antibody test which came back negative. Doctor told her it does not mean the vaccine did not work but that they do not know how effective it may be. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Presyncope, Vomiting
Clinical narrative: diarrhea; felt "like I wanted to pass out"; vomiting; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 15:00 (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: DIARRHOEA (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "diarrhea"; PRESYNCOPE (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "felt "like I wanted to pass out""; VOMITING (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "vomiting"; DIZZINESS (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 13Apr2021 17:00, outcome "unknown", described as "weakness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Tinnitus
Clinical narrative: ringing in his ears; amplified sound/ hearing; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in his ears"; HYPERACUSIS (non-serious), outcome "unknown", described as "amplified sound/ hearing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Feeling abnormal, Illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I have a cold; I'm sick as a dog; Sore throat; Loosing  my voice; I didn't feel good"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have a cold"; ILLNESS (non-serious), outcome "unknown", described as "I'm sick as a dog"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; DYSPHONIA (non-serious), outcome "unknown", described as "Loosing  my voice"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I didn't feel good"".  Clinical Course: I have a cold, I'm sick as a dog, have a sore throat and loosing  my voice. I can't reach my doctor. How do I cancel the appointment I have today for my second dose and reschedule".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: backache (no fever and no other symptoms); 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 male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 22Apr2021, outcome "unknown", described as "backache (no fever and no other symptoms)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on her foot; 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), administration date 05Apr2021 (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 "pain on her foot". Therapeutic measures were taken as a result of pain in extremity included 2 Tylenols.  Additional information: The caller said that she received the 1st dose on 05APR2021 and she is scheduled to get the 2nd dose today. She is experiencing pain on her foot and she took 2 Tylenols. She would like to know if that is okay.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Head discomfort, Hyperacusis, Lymphadenopathy, Tinnitus
Clinical narrative: my ears started ringing; felt like my head has been under water; extremely sensitive to all loud sounds; extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.; extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 14:00 (Lot number: ER8736) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITINE. The following information was reported: TINNITUS (non-serious) with onset 22Apr2021 22:00, outcome "not recovered", described as "my ears started ringing"; HEAD DISCOMFORT (non-serious) with onset 22Apr2021 22:00, outcome "not recovered", described as "felt like my head has been under water"; HYPERACUSIS (non-serious) with onset 22Apr2021 22:00, outcome "not recovered", described as "extremely sensitive to all loud sounds"; LYMPHADENOPATHY (non-serious), EAR SWELLING (non-serious) all with onset 22Apr2021 22:00, outcome "not recovered" and all described as "extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.". Therapeutic measures were not taken as a result of tinnitus, head discomfort, hyperacusis, lymphadenopathy, ear swelling.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. His ears started ringing and felt like my head had been under water 8 hours after my first Pfizer shot on 22Apr. I am extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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 "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Sjogren's syndrome
Clinical narrative: dry mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Mar2021 09:00 (Lot number: EN6208) at the age of 47 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing), notes: Comments: not given results from dc office. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EL3302, Anatomical sight of injection: Rt Arm, Time: 09:20 AM, Route of administration: Intramascular), administration date: 18Feb2021, for COVID-19 immunization. The following information was reported: DRY MOUTH (non-serious), outcome "recovered", described as "dry mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth.  Additional information: Patient prior vaccination with in 4 weeks was none. Patient treatment drug included Antiviral Valtrex medicine, Dry mouth rinse, toothpaste. AE Term: 1 month.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "cold-like".  Additional information: Caller was a pharmacist who states that a 55 year old female patient received her first dose of the Pfizer BioNTech COVID-19 vaccine 13 days ago and since then has been experiencing "cold-like" symptoms. Caller states that this patient came into to report how she was feeling and caller decided to do a COVID-19 test on her. He would like to know if he could potentially see a positive result on the test because she has received her first dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: feel tingly & kind of numb; feel tingly & kind of numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162B2, administered in arm right, administration date 21Apr2021 11:00 (Lot number: EW0169, Expiration date: Unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Discoid lupus erythematosus (Skin lupus, NOT systemic lupus)" (unspecified if ongoing), notes: Discoid lupus erythematosus (Skin, lupus, NOT systemic lupus). Concomitant medication(s) included: SYNTHROID. Past drug history included: Known allergies: sulfa, reaction(s): "drug allergy", notes: Sulfa. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: mRNA/Pfizer, Lot number: ER8733, Lot unknown: False, Administration date: 23Mar2021, Administration time: 11:00am, Vaccine location: Right arm, Dose number: 1), administration date: 23Mar2021, when the patient was 55 years old, for Covid-19 Immunisation, reaction(s): "feel tingly & kind of numb". The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 22Apr2021 11:15, outcome "recovering" and all described as "feel tingly & kind of numb". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Nausea, Pain
Clinical narrative: which are stronger in the mornings.; body pain; headache; nausea; vomiting; 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 parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "which are stronger in the mornings."; PAIN (non-serious), outcome "recovered", described as "body pain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: He has had body pain, headache, nausea, vomiting. Everything went away, except for the headache and dizziness, which are stronger in the mornings.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: which are stronger in the mornings.; body pain; headache; nausea; vomiting; 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 parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "which are stronger in the mornings."; PAIN (non-serious), outcome "recovered", described as "body pain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: He has had body pain, headache, nausea, vomiting. Everything went away, except for the headache and dizziness, which are stronger in the mornings.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: salty taste in my mouth; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication included: PRILOSEC [OMEPRAZOLE]. The following information was reported: DYSGEUSIA (non-serious) with onset 04Apr2021 11:00, outcome "not recovered", described as "salty taste in my mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: About a week or two after the first vaccination, the patient started having a salty taste in his mouth. The patient was not diagnosed with COVID prior vaccination, was not tested for COVID post vaccination and had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021483024 same patient and drug, different dose and event
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm following his vaccination; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 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 "sore arm following his vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Nausea
Clinical narrative: Experienced tiredness; Nausea; I was catching the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female 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: FATIGUE (non-serious), outcome "unknown", described as "Experienced tiredness"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; INFLUENZA (non-serious), outcome "unknown", described as "I was catching the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A 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 (1st Dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigued".  Additional information: Caller said that her son got the second dose already and her son is feeling very tired and fatigued after his second dose. Caller is asking if her son can take Tylenol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasopharyngitis
Clinical narrative: Caller mentioned that she is "getting over a cold"; the left side of her "face went numb for 10 minutes" but there was no paralysis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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 Apr2021, outcome "unknown", described as "Caller mentioned that she is "getting over a cold""; HYPOAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "the left side of her "face went numb for 10 minutes" but there was no paralysis.  Additional information: Patient reported that 5-6 days later, the left side of her "face went numb for 10 minutes" but there was "no paralysis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain in extremity
Clinical narrative: Sore Rt arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jan2021 (Lot number: EN5318) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Brain Bleed", start date: 20Jan2021 (unspecified if ongoing); "cerebral shunt installed", start date: 1999 (unspecified if ongoing), notes: Admitted to the hospital after C.T. Scan confirmed Brain Bleed , previously installed Cerebral Shunt failed and was replaced. Concomitant medication(s) included: CRESTOR, start date: Dec2020, stop date: Feb2021; PLAVIX, start date: Dec2020, stop date: Feb2021; ASPIRINE, start date: Dec2020, stop date: Feb2021; SPIRONOLACTONE, start date: Dec2020 (ongoing); D3, start date: Oct2020 (ongoing); TURMERIC +, start date: Oct2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Rt arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's concomitant medications included CoQ10 (ongoing), start date Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: The first vaccine took away some of his long-haulers symptoms/It took away his tremors and it took away his fogginess of the brain.; 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 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 76 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: had for a couple years, 2 and a half years maybe; "Covid-19" (unspecified if ongoing), notes: He had Covid once in August and once again in December. Concomitant medication(s) included: OLMESARTAN taken for blood pressure increased; BESILATE D'ATRACURIUM taken for blood pressure increased. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The first vaccine took away some of his long-haulers symptoms/It took away his tremors and it took away his fogginess of the brain.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: patient has been on concomitant medications for a year or year and a half. Investigation Assessment: No. History of all previous immunization with the Pfizer vaccine considered as suspect: none. All vaccines administered on same date with the Pfizer vaccine considered as suspect: none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Family Medical History Relevant to AEs: none  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: I also  have a dull headache on and off during the day; wake  dizzy in the morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Apr2021, outcome "unknown", described as "wake  dizzy in the morning"; HEADACHE (non-serious), outcome "unknown", described as "I also  have a dull headache on and off during the day".  Additional Information: The patient stated that she wake  dizzy in the morning when she first get up and get out of bed. She have had to sit or hold onto something for a bit and it goes away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: my blood pressure has gone up relative to the past reading that I take everyday; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "my blood pressure has gone up relative to the past reading that I take everyday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received his first Pfizer vivid shot on Tuesday and after a couple of days that past his blood pressure has gone up relative to the past reading that I take everyday. Is normal for it to happen and is temporary.  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 discomfort, C-reactive protein increased
Clinical narrative: she is having some "concerns" with her stomach and has been told that her CPR is "higher."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. 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 ([Product = covid-19,Brand = Pfizer, Dose number= 1]), for Covid-19 Immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "she is having some "concerns" with her stomach and has been told that her CPR is "higher."". Relevant laboratory tests and procedures are available in the appropriate section, which included Elevated CRP, results: unknown, on an unspecified date.  Additional information: Caller is a HCP (declined to provide what kind of HCP she is) who received her second dose of the Pfizer BioNTech COVID-19 vaccine and would like to know if there have been any reports of elevated CRP after getting the vaccine. She states that she is having some "concerns" with her stomach and has been told that her CPR is "higher."   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
Clinical narrative: having chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 14Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "stroke", start date: Nov2020 (unspecified if ongoing), notes: She had a stroke as well back in November 2020. Concomitant medication(s) included: ASPIRIN CHILDREN. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "having chills". Additional information: There were no unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: just a slight soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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: PAIN (non-serious), outcome "recovered", described as "just a slight soreness".  Additional Information: After the 1st dose - just a slight soreness that lasted a few hours was all the result of the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: light headed for half day; chills; felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female 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: DIZZINESS (non-serious), outcome "unknown", described as "light headed for half day"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "felt tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever 99.9; 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 70 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Someone such as me with cardiovascular, lung disease" (unspecified if ongoing), notes: Someone such as me with cardiovascular, lung disease; "Someone such as me with cardiovascular, lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "Fever 99.9". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:  It was reported that consumer asking a statement on the need for a booster dose (3rd dose) that was Pfizer investigating the need for a booster dose or not. Received first and second dose of vaccine. Second dose being received on the 03Mar2021. The consumer stated "I have the opportunity to receive third dose. A second dose of the second dose.  I am scheduled for this opportunity Wednesday. Variants outpacing variants at the moment.  Spoke to a pharmacist.  Amount to even less than the Moderna vaccine. Less of a serum of the dosing.  A colleague, Escape the antibodies that vaccine.  My provider. Casual conversation with pharmacist. Even though they were about the same in efficacy. Critically at high risk,  Comorbities. They may say that 90 percentile in terms of percentile.  No guarantee and open to interpretation.  Someone such as me with cardiovascular, lung disease. If I get the flu it could lay me out for weeks, with Prednisone.  My wife crossed over from Cancer. Trying to get as much protection.  Disinfecting gloves with Clorox wipes.  Exquisitely at high risk. Was there going to be unforeseen side effects.  First the starter dose then the hammer dose.  Had very little side effects.  I personally did not have any issues. Periodontal. Fever 99.9 and sore arm. I had an appointment awaiting a decision. At this point its everyone and their dog trying to get an appointment. Endocrinologist. If it ends up killing me."    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Muscle spasms, Muscle twitching
Clinical narrative: She's still experiencing severe muscle fatigue; muscle cramps; twitching; 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 female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (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: MUSCLE FATIGUE (non-serious), outcome "not recovered", described as "She's still experiencing severe muscle fatigue"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "muscle cramps"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "twitching".  Additional information: Reporter had the first dose of Pfizer Covid-19 vaccine 5 days ago (17Apr2021) and she was still experiencing severe muscle fatigue, muscle cramps and twitching. Reporter wanted to know if those were normal side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Fall, Hyperhidrosis
Clinical narrative: fingers are shaking; Patient sliding down in chair, became weak and slumped in chair; became weak; appears pale; sweaty; feeling nauseous; still complained of mild dizziness/Patient states that the fainting feeling comes in waves; Patient appears anxious; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Mar2021 (Lot number: EN6208) at the age of 23 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: EN6200; Administration route: Intramuscular; vaccine location: Left arm]), administration date: 19Feb2021, for COVID-19 immunisation. The following information was reported: TREMOR (non-serious) with onset 10Mar2021, outcome "recovered", described as "fingers are shaking"; FALL (non-serious) with onset 10Mar2021, outcome "recovered", described as "Patient sliding down in chair, became weak and slumped in chair"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "recovered", described as "became weak"; PALLOR (non-serious) with onset 10Mar2021, outcome "recovered", described as "appears pale"; HYPERHIDROSIS (non-serious) with onset 10Mar2021, outcome "recovered", described as "sweaty"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered", described as "feeling nauseous"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovered", described as "still complained of mild dizziness/Patient states that the fainting feeling comes in waves"; ANXIETY (non-serious) with onset 10Mar2021, outcome "recovered", described as "Patient appears anxious". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, fall, asthenia, pallor, hyperhidrosis, nausea, dizziness, anxiety.  Additional information: Patient was offered juice but she declined due to feeling nauseous. 10 minutes later patient was given orange juice and was advised to drink it slowly. Patient states that the fainting feeling comes in waves. After finishing the juice, color came back to her face but still complained of mild dizziness, and denies nausea. Patient appears anxious and fingers are shaking. After some time, patient began to feel better and states her dizziness improved significantly. She was able to walk around and her dizziness did not return. 20 minutes later, all her symptoms subsided; fingers were no longer shaky, and she was no longer pale and sweaty. If Covid prior vaccination and Covid tested post vaccination were unknown. known allergies: None on file.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pallor, Tremor, Vital signs measurement
Clinical narrative: fingers are shaking; Patient sliding down in chair, became weak and slumped in chair; became weak; appears pale; sweaty; feeling nauseous; still complained of mild dizziness/Patient states that the fainting feeling comes in waves; Patient appears anxious; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Mar2021 (Lot number: EN6208) at the age of 23 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: EN6200; Administration route: Intramuscular; vaccine location: Left arm]), administration date: 19Feb2021, for COVID-19 immunisation. The following information was reported: TREMOR (non-serious) with onset 10Mar2021, outcome "recovered", described as "fingers are shaking"; FALL (non-serious) with onset 10Mar2021, outcome "recovered", described as "Patient sliding down in chair, became weak and slumped in chair"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "recovered", described as "became weak"; PALLOR (non-serious) with onset 10Mar2021, outcome "recovered", described as "appears pale"; HYPERHIDROSIS (non-serious) with onset 10Mar2021, outcome "recovered", described as "sweaty"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered", described as "feeling nauseous"; DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovered", described as "still complained of mild dizziness/Patient states that the fainting feeling comes in waves"; ANXIETY (non-serious) with onset 10Mar2021, outcome "recovered", described as "Patient appears anxious". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, fall, asthenia, pallor, hyperhidrosis, nausea, dizziness, anxiety.  Additional information: Patient was offered juice but she declined due to feeling nauseous. 10 minutes later patient was given orange juice and was advised to drink it slowly. Patient states that the fainting feeling comes in waves. After finishing the juice, color came back to her face but still complained of mild dizziness, and denies nausea. Patient appears anxious and fingers are shaking. After some time, patient began to feel better and states her dizziness improved significantly. She was able to walk around and her dizziness did not return. 20 minutes later, all her symptoms subsided; fingers were no longer shaky, and she was no longer pale and sweaty. If Covid prior vaccination and Covid tested post vaccination were unknown. known allergies: None on file.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: MIGRAINE (non-serious), outcome "not recovered", described as "migraine headaches". Additional information: It was reported that the patient experienced migraine headaches since receiving her first injection. These have persisted daily. The patient has received her 2nd dose and was seen by an HCP for these migraine symptoms. It was reported that the event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Ecchymosis, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: felt like someone punched him in the arm; black and blue mark on left arm; This is a spontaneous report received from contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune Condition" (unspecified if ongoing). Concomitant medications included: IMURAN [AZATHIOPRINE] taken for autoimmune disorder (ongoing); PREDNISONE taken for autoimmune disorder. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "recovered" (Mar2021), described as "felt like someone punched him in the arm"; ECCHYMOSIS (non-serious) with onset 2021, outcome "unknown", described as "black and blue mark on left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: About 12 hours after the first shot, he felt like someone punched him in the arm and completely recovered after 4 or 5 days. When he went to get his second dose, he noticed that there was still a black and blue mark on his left arm from where he had the first shot and this was 21 days later, so he decided to get the second shot in his right arm. The patient was on mild immunosuppressants. Yesterday (19Apr2021), the patient had a SARS-COV-2 IgG antibody test. It came back negative with SARS-COV-2 IgG index of 0.02. Antibody interpretation was negative. The patient wanted to know if that was the appropriate test that was run. He asked if the test that they ran would tell him if he had an immune response. He did not want to run around with a false sense of security.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438489 Same patient and drug, different dose and events
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Off label use, Product use issue
Clinical narrative: Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.; Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.; Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 09:45 (Lot number: EW0164) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 23Apr2021, outcome "unknown" and all described as "Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.". Therapeutic measures were not taken as a result of off label use, product use issue, menstrual disorder.  Additional Information: No other vaccine taken in four weeks. Adverse event was Spotting beginning day 2 post vaccination. Patient was breastfeeding 10 month old and had not change in her nursing/pumping schedule and had not been menstruating so this was unusual. No Covid prior vaccination. No Covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021467376 different patient, same drug, same event (split)