chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive test 14 days after symptom; Positive test 14 days after symptom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 16:45 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 at 16:15 as dose 2, single (Lot number: ER8727), in left arm and on 22Sep2021 at 16:45 as dose 3 (booster), single (Lot number: FF2588) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medication in 2weeks product=asthma steroid; "Ankylosing Spondylitis" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "vesovagal" (unspecified if ongoing); "Known allergies: food" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: wheat" (unspecified if ongoing); "Known allergies: red dye" (unspecified if ongoing); "known allergies: black tea" (unspecified if ongoing); "known allergies: vodka" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: Sep2018, stop date: 10Apr2022; DAYSEE taken for contraception, start date: Jan2010, stop date: 14Apr2022; SUCRALFATE, start date: Dec2019; SYMBICORT taken for asthma, start date: Aug2008, stop date: 18Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Apr2022, outcome "unknown" and all described as "Positive test 14 days after symptom". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Maternal exposure timing unspecified
Clinical narrative: Pregnant PT; flu; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "Pregnant PT"; INFLUENZA (non-serious), outcome "unknown", described as "flu".  Additional information: The patient age is 30-34 years. Pregnant PT reported she received COVID vaccine, and she got her booster in November, and she got her flu back in September.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID twice; got COVID twice; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he caught COVID disease twice.  Clinical Course: 10-17 years. Reports he caught COVID disease twice, has received COVID vaccine, And he don't have a booster, cause he got two shots and got COVID twice. Causality was Not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Recurrence of COVID symptoms, along with positive antigen test; Recurrence of COVID symptoms, along with positive antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: 16Mar2021, stop date: 20Apr2022. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2022 at 12:00, outcome "not recovered" and all described as "Recurrence of COVID symptoms, along with positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Other medication in 2weeks. Anti-viral details included that Product was COVID 19 Treatment, brand Pfizer, treatment start date 20Apr2022, treatment stop date 24Apr2022. Patient had not received any other vaccine in four weeks. Patient had received Paxlovid as a treatment medication. patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: If vaccine received Yes/vaccine brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; If vaccine received Yes/vaccine brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Psoriatic Arthritis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "If vaccine received Yes/vaccine brand=Pfizer / BioNTech /product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: I still have and I am still testing positive; (unspecified date) negative, notes: I tested negative a few days after treatment; (29Apr2022) positive, notes: testing positive 3 days later on 29Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 20Apr2022 to 24Apr2022.  Clinical course: The patient did not receive other medication in 2 weeks of vaccination. He had tested negative a few days after treatment then started testing positive 3 days later Friday evening 29Apr. But it was not until Saturday morning, 30Apr that he started experiencing COVID symptoms again. The patient was treated with Paxlovid from 20Apr2022 to 24Apr2022. He woke up with bad congestion and a cough which he still had, and he was still testing positive.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID twice; got COVID twice; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID twice".  Clinical information: Adverse Event(S)/Product Complaint Details: Age/Date of Birth: 10-17 years. Doctor reports he caught COVID disease twice, has received COVID vaccine and I don't have a booster, cause I got two shots and got COVID twice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 antibody test
Clinical narrative: off label use; Booster; COVID-19; Covid 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer, DOSE 1 to 5), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of off label use, immunisation, drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: shooting pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 at 09:30 as dose 1, single (Lot number: FW0171), in left arm and on 08May2021 at 10:00 as dose 2, single (Lot number: FW0182) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Dust" (unspecified if ongoing); "mold" (unspecified if ongoing); "some trees" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HCTZ; CALCIUM + VIT D. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "shooting pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain.  Additional information: Facility type vaccine was Pharmacy or Drug Store. Patient did not receive any other vaccine other vaccine in four weeks. Patient did not have covid covid prior vaccination. Other medication in two weeks was Multivitamin. Clinical course: It was reported that 3 days after patient first injection, she started to experience a shooting pain on 20Apr2021 in her left arm from injection site to the elbow, noted mostly when swallowed foods. She had second injection 3 weeks after first one. This pain started in her right arm also a few weeks after, but not as regularly. She continues to experience this 1 year later. She has not taken any boosters due to this problem. Her primary care was notified of this but had since left the practice and she is starting over with her partner at the end of May.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=25/Nov/2021; product=COVID 19 Treatment, brand=Paxlovid/vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=25/Nov/2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 19Apr2022, stop date: 29Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=25/Nov/2021". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing full course of Paxlovid Covid symptoms returned 5 days later  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and DRUG INEFFECTIVE, COVID-19 cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Pain
Clinical narrative: body aches so badly; body temperature ran over 100 Degree; Shivering; Headache; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had the COVID three years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (Dose: 3rd (1st booster), Manufacturer: Johnson & Johnson), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches so badly"; PYREXIA (non-serious), outcome "unknown", described as "body temperature ran over 100 Degree"; CHILLS (non-serious), outcome "unknown", described as "Shivering"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had the Pfizer Booster yesterday and had the COVID three years ago, now and  had just a very mild case that lasted for it, so about 4 hours and then the patient lost my taste and smell, with just same sign as the patient had the COVID that was very mild, so yesterday when the patient had Pfizer COVID-19 Vaccine, the patient was feeling fine yesterday and the body aches so badly and body temperature ran over 100 Degree and the patient was Shivering and had headache, so just wanted to know is that listed as possible side effects or should the patient be concerned about my health or not. The reported that it had had COVID and later then it had Booster (COVID Vaccine) and for its second Booster the patient chose not to get the because the patient understood to have Pfizer about 4 months, so it had if it is good to have for mix (vaccination), so the patient chose Pfizer (COVID-19 Vaccine) yesterday. The patient asked to put its check by continue to get the Booster would have the same side effect just to the same pattern or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body aches so badly; body temperature ran over 100 Degree; Shivering; Headache; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had the COVID three years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (Dose: 3rd (1st booster), Manufacturer: Johnson & Johnson), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches so badly"; PYREXIA (non-serious), outcome "unknown", described as "body temperature ran over 100 Degree"; CHILLS (non-serious), outcome "unknown", described as "Shivering"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had the Pfizer Booster yesterday and had the COVID three years ago, now and  had just a very mild case that lasted for it, so about 4 hours and then the patient lost my taste and smell, with just same sign as the patient had the COVID that was very mild, so yesterday when the patient had Pfizer COVID-19 Vaccine, the patient was feeling fine yesterday and the body aches so badly and body temperature ran over 100 Degree and the patient was Shivering and had headache, so just wanted to know is that listed as possible side effects or should the patient be concerned about my health or not. The reported that it had had COVID and later then it had Booster (COVID Vaccine) and for its second Booster the patient chose not to get the because the patient understood to have Pfizer about 4 months, so it had if it is good to have for mix (vaccination), so the patient chose Pfizer (COVID-19 Vaccine) yesterday. The patient asked to put its check by continue to get the Booster would have the same side effect just to the same pattern or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: I just had the sore arm; I can even lift it hardly; I just had the sore arm; I can even lift it hardly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series , manufacture name unknown), for COVID-19 Immunization; Covid-19 vaccine (1st booster dose), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "I just had the sore arm; I can even lift it hardly". Therapeutic measures were taken as a result of pain in extremity, muscular weakness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness postural, Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: difficult breathing; heart pumping going fast; Fever; dizziness; when I stand up, I get dizzy; Weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 Immunization; Bnt162b2 (Dose : 2), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "difficult breathing"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart pumping going fast"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DIZZINESS POSTURAL (non-serious), outcome "unknown", described as "dizziness; when I stand up, I get dizzy"; ASTHENIA (non-serious), outcome "unknown", described as "Weak".  Additional information: The reporter got the booster shot (Pfizer COVID-19) on Friday and was having some symptoms like difficult breathing, heart pumping, going fast, again there as and weak and fever. The reporter does not know if all that was normal or should reporter go to the doctor. The reporter was having dizziness, when stood up, and get dizzy. Regarding lot, the reporter stated the card was in the wallet and wallet was downstairs and reporter told that am not going to do it right now but will call and do it later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Emotional distress, Tinnitus
Clinical narrative: tinnitus that I got shortly after my Pfizer booster and it hasn't go away; I wanted it to go away, it is driving me crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: BNT162b2 (Dose:1, Lot no: EW0153), administration date: 06Apr2021, when the patient was 57-year-old, for Covid-19 Immunization; BNT162b2 (DOSE:2, Lot no: EW0168), administration date: 04May2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "tinnitus that I got shortly after my Pfizer booster and it hasn't go away"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "I wanted it to go away, it is driving me crazy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, emotional distress. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Feeling abnormal, Suspected COVID-19
Clinical narrative: feel worse than COVID did; feel worse than COVID did; it was reported that patient experienced: feel worse than COVID did; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Secondary progressive multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "feel worse than COVID did"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it was reported that patient experienced: feel worse than COVID did".  Additional information: On Apr2021 patient started therapy for Pfizer Biontech covid19 vaccine for on unknown date, it was reported that patient experienced feel worse than covid did   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache, Influenza like illness
Clinical narrative: she got a headache; flu-ish like symptoms; she had a slightly elevated temperature; She states she felt extremely tired and felt like she had a bug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 2, single (Lot number: FF2593) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Caller states she has a history of asthma since a child.; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL taken for seasonal allergy; TUMS [CALCIUM CARBONATE]. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Lot number: 104F83592, Route of Admin: left arm), administration date: 14Oct2021, when the patient was 42-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "recovering", described as "She states she felt extremely tired and felt like she had a bug"; INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2021, outcome "recovering", described as "flu-ish like symptoms"; HEADACHE (non-serious) with onset Nov2021, outcome "recovering", described as "she got a headache"; BODY TEMPERATURE INCREASED (non-serious) with onset Nov2021, outcome "recovering", described as "she had a slightly elevated temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient height was 175 cm and weight was 106.59 kg. Caller stated that she had a history of asthma since a child. She stated that she sees an Allergist once a year and had rescue inhaler. She stated that she had not used the rescue inhaler since last August or September when high pollen and plants die off. She stated that she was the age of 10,11, or 12-years-old when she was diagnosed. No investigations. No prior vaccinations within 4 weeks. No family history relevant to Adverse events. She had no concerns. Stated that she was the only one in her immediate family who has gotten the vaccines. The patient had other conditions and other products. Reporter stated that she called about the Pfizer COVID-19 Vaccine. Reporter stated after her 2nd dose of the COVID-19 vaccine within the 1st 16 hours she got a headache and a fluish like symptoms. She had a slightly elevated temperature but was a low temperature and this took 36-48 hours to feel better. She states she felt extremely tired and felt like she had a bug. Relevant test: none.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Off-label use; COVID 19; Booster; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "hypertension" (unspecified if ongoing), notes: other medical history: hypertension; "hypercholesterol" (unspecified if ongoing), notes: other medical history: hypercholesterol. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy:Codeine", notes: Known allergies: Codeine.  The following information was reported: IMMUNISATION (medically significant) with onset Apr2022, outcome "unknown", described as "Booster"; COVID-19 (medically significant) with onset Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (medically significant), outcome "unknown", described as "Off-label use". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of off label use, immunisation, covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation, Neuralgia
Clinical narrative: Woke up to extreme nerve discomfort, had trouble walking downstairs.  Was considering need to go to ER but took advil which eventually relieved pain/discomfort enough to go back to sleep.  Next day wa; Woke up to extreme nerve discomfort; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Type1 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; VYVANSE. Past drug history included: Known allergies: lorabid, reaction(s): "Known allergies: lorabid". Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2593), administration date: 01Nov2021, when the patient was 24-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 21Apr2021, when the patient was 24-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 22Mar2021, when the patient was 23-year-old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Apr2022, outcome "unknown", described as "Booster"; NEURALGIA (non-serious) with onset 29Apr2022 at 01:00, outcome "recovered" (01May2022), described as "Woke up to extreme nerve discomfort"; GAIT DISTURBANCE (non-serious) with onset 29Apr2022 at 01:00, outcome "recovered" (01May2022), described as "Woke up to extreme nerve discomfort, had trouble walking downstairs.  Was considering need to go to ER but took advil which eventually relieved pain/discomfort enough to go back to sleep.  Next day was". Therapeutic measures were taken as a result of gait disturbance, neuralgia.  Additional Information: The patient was treated with Advil, the patient did not had covid prior to vaccination and was not tested for covid post vaccination. The patient did not receive any other vaccine with four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200650000 similar report from same reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: left arm also got red and was not as bad as this current issue and has resolved but she does not know and there are remnants of a circle there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 at 11:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Folliculitis" (ongoing), notes: Inflammation of hair in skin and has been to dermatologist and has that diagnosed about 2 years ago.; "Shingles" (ongoing), notes: Caller states she was diagnosed with shingles maybe 10-12 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot no: E11284), administration date: 13Jan2021, when the patient was 72-year-old, for covid 19 immunization; BNT162b2 (Dose 2, Lot no: E19263), administration date: 03Feb2021, when the patient was 73-year-old, for covid 19 immunization.  The following information was reported: ERYTHEMA (non-serious) with onset 26Aug2021, outcome "recovered", described as "left arm also got red and was not as bad as this current issue and has resolved but she does not know and there are remnants of a circle there".  Additional information:  States she has a long word and it is folliculitis and it is inflammation of the hair in the skin and got it from who knows what and she has been to a dermatologist and to different dermatologists and has had that diagnosed about 2 years ago. Caller states on her 1st booster of the Pfizer Covid vaccine on 25Aug2021, her left arm also got red and was not as bad as this current issue and has resolved but she does not know and there are remnants of a circle there and this also began the next day after her 1st booster dose. 1st booster dose was given in a park. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Family Medical History Relevant to AE(s). No Relevant Tests.States she does take Valtrex prophylactically when she remembers it because she does not know why she takes it and is a healthy 74-year-old who works out and has pets and tutors in the afternoons.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Muscle fatigue, Near death experience
Clinical narrative: constant feelings that I'm dying; Brain fog; muscle fatigue; fatigue; tinnitus spikes; cold feet and hands; pins and needles in limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation; influenza vaccine (FLU), on 23Feb2022 (Batch/Lot number: unknown), in left arm. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 28Dec2021, when the patient was 21-year-old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Mar2022, outcome "not recovered", described as "Brain fog"; FEELING COLD (non-serious) with onset 01Mar2022, outcome "not recovered", described as "cold feet and hands"; NEAR DEATH EXPERIENCE (medically significant) with onset 01Mar2022, outcome "not recovered", described as "constant feelings that I'm dying"; FATIGUE (non-serious) with onset 01Mar2022, outcome "not recovered"; MUSCLE FATIGUE (non-serious) with onset 01Mar2022, outcome "not recovered"; PARAESTHESIA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "pins and needles in limbs"; TINNITUS (non-serious) with onset 01Mar2022, outcome "not recovered", described as "tinnitus spikes". The events "constant feelings that i'm dying", "brain fog", "muscle fatigue", "fatigue", "tinnitus spikes", "cold feet and hands" and "pins and needles in limbs" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of near death experience, feeling abnormal, muscle fatigue, fatigue, tinnitus, feeling cold, paraesthesia. Began taking Paxlovid within 12 hours of onset of Covid symptoms (fever, aches). Was symptom-free within 18 hours of first treatment. Completed five-day treatment with Paxlovid. Remained symptom-free for seven days after completing treatment, then redeveloped cold symptoms and tested strongly positive again. Cold symptoms subsided within about three days but still testing positive five days after return of symptoms. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: constant feelings that I'm dying; Brain fog; muscle fatigue; fatigue; tinnitus spikes; cold feet and hands; pins and needles in limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation; influenza vaccine (FLU), on 23Feb2022 (Batch/Lot number: unknown), in left arm. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 28Dec2021, when the patient was 21-year-old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Mar2022, outcome "not recovered", described as "Brain fog"; FEELING COLD (non-serious) with onset 01Mar2022, outcome "not recovered", described as "cold feet and hands"; NEAR DEATH EXPERIENCE (medically significant) with onset 01Mar2022, outcome "not recovered", described as "constant feelings that I'm dying"; FATIGUE (non-serious) with onset 01Mar2022, outcome "not recovered"; MUSCLE FATIGUE (non-serious) with onset 01Mar2022, outcome "not recovered"; PARAESTHESIA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "pins and needles in limbs"; TINNITUS (non-serious) with onset 01Mar2022, outcome "not recovered", described as "tinnitus spikes". The events "constant feelings that i'm dying", "brain fog", "muscle fatigue", "fatigue", "tinnitus spikes", "cold feet and hands" and "pins and needles in limbs" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of near death experience, feeling abnormal, muscle fatigue, fatigue, tinnitus, feeling cold, paraesthesia. Began taking Paxlovid within 12 hours of onset of Covid symptoms (fever, aches). Was symptom-free within 18 hours of first treatment. Completed five-day treatment with Paxlovid. Remained symptom-free for seven days after completing treatment, then redeveloped cold symptoms and tested strongly positive again. Cold symptoms subsided within about three days but still testing positive five days after return of symptoms. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Muscle twitching, Nasal discomfort
Clinical narrative: Noticed two or three weeks after receiving the Pfizer Covid 19 Vaccine, muscles in nose are basically twitching, muscles in nose move out of nowhere; Noticed two or three weeks after receiving the Pfizer Covid 19 Vaccine, muscles in nose are basically twitching, muscles in nose move out of nowhere; Noticed two or three weeks after receiving the Pfizer Covid 19 Vaccine, muscles in nose are basically twitching, muscles in nose move out of nowhere; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2022 at 10:00 as dose 2, single (Lot number: FK9729) at the age of 22 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma is not acting up. Caller was born with Asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Lot: FK9729, Time: 1000), administration date: Feb2022, for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious), DYSKINESIA (non-serious), NASAL DISCOMFORT (non-serious) all with onset Mar2022, outcome "not recovered" and all described as "Noticed two or three weeks after receiving the Pfizer Covid 19 Vaccine, muscles in nose are basically twitching, muscles in nose move out of nowhere".  Additional information: The  number was unknown. The patient did not received any other vaccine within 4 week to COVID vaccination. The caller does not have name, address, telephone number or email to provide. The caller has been to doctor in over 7 years.   No follow-up attempts are possible. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Brain injury, Gait disturbance, Speech disorder
Clinical narrative: brain injury; Idiopathic Ataxia; now cannot walk or talk; now cannot walk or talk; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 51 years and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant), outcome "unknown"; ATAXIA (non-serious), outcome "unknown", described as "Idiopathic Ataxia"; GAIT DISTURBANCE (non-serious), SPEECH DISORDER (non-serious), outcome "unknown" and all described as "now cannot walk or talk". Clinical Course: The patient received the two Pfizer vaccines and shortly after spent time in the hospital. Undiagnosed, but diagnosed with a brain injury, with the side effect of Idiopathic Ataxia, at the time of reporting cannot walk or talk. The patient was in good shape.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, brain injury, Ataxia, speech disorder, Gait disturbance cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Joint range of motion decreased, Myocardial infarction, Off label use, Periarthritis
Clinical narrative: MI (myocardial infarction); Severe limitation in my left arm movement; Frozen Shoulder; Booster; off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6199), in left arm, as dose 2, single (Lot number: EP7534), in left arm, as dose 3 (booster), single (Lot number: FC3184), in left arm and as dose 4 (booster), single (Lot number: F129896) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination For the 3rd and 4th vaccinations. The patient had no known allergies. The following information was reported: PERIARTHRITIS (hospitalization, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "Frozen Shoulder"; MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "MI (myocardial infarction)"; JOINT RANGE OF MOTION DECREASED (hospitalization, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "Severe limitation in my left arm movement"; IMMUNISATION (life threatening), outcome "unknown", described as "Booster"; OFF LABEL USE (life threatening), outcome "unknown". The patient was hospitalized for myocardial infarction, joint range of motion decreased, periarthritis (hospitalization duration: 2 day(s)). The events "mi (myocardial infarction)", "severe limitation in my left arm movement" and "frozen shoulder" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of myocardial infarction, joint range of motion decreased, periarthritis.  Clinical course: The patient received all four doses on 23Mar2022. The patient was a healthy individual and experienced a MI (myocardial infarction) 10Nov2021.  Shortly after that she started to experience severe limitation in my left arm movement. Was then diagnosed with Frozen Shoulder. She received blood thinners for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.