chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: hotspots on random parts of the body that lasted two days; very high temperature which made him delirious; Violent vomiting; very high temperature which made him delirious; bad headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (Pfizer Covid Vaccine Boost34- Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown. , Manufacturer unknown), for Covid-19 Immunization. The following information was reported: DELIRIUM (medically significant), PYREXIA (non-serious), outcome "unknown" and all described as "very high temperature which made him delirious"; VOMITING (non-serious), outcome "unknown", described as "Violent vomiting"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; RASH MACULAR (non-serious), outcome "recovered", described as "hotspots on random parts of the body that lasted two days". The patient underwent the following laboratory tests and procedures: body temperature: very high. No underlying conditions reported by the patient's wife. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: received 3 doses of the Pfizer vaccine; tested positive for Covid; tested positive for Covid; O2 level had decreased to 93%; my pulse rate was 95; difficulty breathing; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: taking immunosuppressive medication. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 3 doses of the Pfizer vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid"; OXYGEN SATURATION DECREASED (non-serious) with onset 12Jan2022, outcome "recovered" (13Jan2022), described as "O2 level had decreased to 93%"; HEART RATE INCREASED (non-serious) with onset 12Jan2022, outcome "recovered" (13Jan2022), described as "my pulse rate was 95"; DYSPNOEA (non-serious) with onset 12Jan2022, outcome "unknown", described as "difficulty breathing". The patient underwent the following laboratory tests and procedures: heart rate: (12Jan2022) 95; (13Jan2022) 62 bpm; oxygen saturation decreased: (12Jan2022) 93 %, notes: decreased; (13Jan2022) 99 %, notes: increased; sars-cov-2 test: (12Jan2022) positive. Therapeutic measures were taken as a result of oxygen saturation decreased; heart rate increased.  Clinical course: Patient was at high risk of developing severe illness for COVID-19 due to an autoimmune disease and taking immunosuppressive medication. Patient had received 3 doses of the Pfizer vaccine but unfortunately tested positive for Covid on 12Jan2022. Within 24 hours, Patient O2 level had decreased to 93%, pulse rate was 95 and patient was having difficulty breathing. Patient was selected and approved to receive Paxlovid on 13Jan2022. He had taken 3 doses and O2 level has increased to 99% and pulse was 62 bpm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Oxygen saturation decreased, SARS-CoV-2 test
Clinical narrative: received 3 doses of the Pfizer vaccine; tested positive for Covid; tested positive for Covid; O2 level had decreased to 93%; my pulse rate was 95; difficulty breathing; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: taking immunosuppressive medication. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 3 doses of the Pfizer vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid"; OXYGEN SATURATION DECREASED (non-serious) with onset 12Jan2022, outcome "recovered" (13Jan2022), described as "O2 level had decreased to 93%"; HEART RATE INCREASED (non-serious) with onset 12Jan2022, outcome "recovered" (13Jan2022), described as "my pulse rate was 95"; DYSPNOEA (non-serious) with onset 12Jan2022, outcome "unknown", described as "difficulty breathing". The patient underwent the following laboratory tests and procedures: heart rate: (12Jan2022) 95; (13Jan2022) 62 bpm; oxygen saturation decreased: (12Jan2022) 93 %, notes: decreased; (13Jan2022) 99 %, notes: increased; sars-cov-2 test: (12Jan2022) positive. Therapeutic measures were taken as a result of oxygen saturation decreased; heart rate increased.  Clinical course: Patient was at high risk of developing severe illness for COVID-19 due to an autoimmune disease and taking immunosuppressive medication. Patient had received 3 doses of the Pfizer vaccine but unfortunately tested positive for Covid on 12Jan2022. Within 24 hours, Patient O2 level had decreased to 93%, pulse rate was 95 and patient was having difficulty breathing. Patient was selected and approved to receive Paxlovid on 13Jan2022. He had taken 3 doses and O2 level has increased to 99% and pulse was 62 bpm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My wife has gotten the vaccine and now she has covid for the second time; My wife has gotten the vaccine and now she has covid for the second time; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My wife has gotten the vaccine and now she has covid for the second time".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: secondary bronchitis infection; COVID symptoms (very mild)/tested positive; COVID symptoms (very mild)/tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovering" and all described as "COVID symptoms (very mild)/tested positive"; BRONCHITIS (non-serious), outcome "unknown", described as "secondary bronchitis infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were taken as a result of bronchitis. Clinical course: The patient has all 3 shots and tested positive on 04Jan2022. COVID symptoms (very mild) started on 27Dec2021. Vaccines worked by experience. The patient got better but then did get secondary bronchitis infection responding with antibiotics (unspecified date). The reporter further described the vaccine as god sent.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid 19 infection; Covid 19 infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 infection".  Clinical course: Patient was a clinical infectious disease pharmacist. Patient was wondering if there were any formal recommendations for how long to wait after Covid 19 infection to receive a booster dose in someone who has already received their primary series. DSU- non-phone case; e-transmitting as potential AE since we unable to confirm if this is regarding an actual patient.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive home ag 17Jan; positive home ag 17Jan; sx of nasal congestion 16Jan; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FF2589) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "positive home ag 17Jan"; NASAL CONGESTION (non-serious) with onset 16Jan2022, outcome "unknown", described as "sx of nasal congestion 16Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive, notes: If COVID tested post vaccination: Yes, COVID test post vaccination: COVID test type post vaccination: Other, COVID test name post vaccination: Home Ag. It was unknown, the patient had other vaccine received in four weeks. It was unknown, If COVID prior vaccination. Patient was tested for covid post vaccination (Home Ag). It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and VACCINATION FAILURE,  COVID-19, NASAL CONGESTION cannot be completely excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4232546-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. 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) all with onset 08Jan2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive; (09Jan2022) positive. The action taken for adalimumab was unknown. Clinical course: Causality for Humira(Adalimumab) The reporter's causality for the event(s) of COVID-19 with Humira(Adalimumab) was no reasonable possibility. Causality 1) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal association between reported events drug ineffective, covid-19 with suspect BNT162B2 is possible.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Paralysis, Product administered to patient of inappropriate age
Clinical narrative: Baby Paralyzed; now unable to move his body, from the neck, down, after taking the shots; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "Baby Paralyzed"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "now unable to move his body, from the neck, down, after taking the shots"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration".Clinical course :The video documents how a healthy, robust child deteriorates in just 13 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR tested positive; PCR tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Dec2020 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "recovered" (15Jan2022) and all described as "PCR tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: I developed symptoms and PCR tested positive. Clinical course: It was reported that, patient was an academic faculty member in a college of medicine. During the pandemic, patient worked in clinic providing patient care 4 days/week without fail. It was stated that, fortunately, patient vaxed in Dec2020, Jan2021, and boosted in Sep2021. On 10Jan2022, had developed symptoms and PCR tested positive. By 15Jan2022, patient's all C19 symptoms had resolved.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Booster; SIRVA; Pain; when she got her booster in the same arm it kind of got worse; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number Unknown), for COVID-19 immunization, reaction(s): "pain", "The vaccine was probably injected in the capsule of the joint", "SIRVA". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious), outcome "not recovered", described as "SIRVA"; PAIN (non-serious), outcome "not recovered", described as "Pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "when she got her booster in the same arm it kind of got worse". The events "sirva" and "pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of shoulder injury related to vaccine administration, pain.  Additional Information: She has been in pain for 11 months. He said his wife is your typical SIRVA case. The vaccine was probably injected in the capsule of the joint. Over the next few days she started having the pain. It got better and when she got her booster in the same arm it kind of got worse. was there any information about decreasing the immune reaction in the tendons. Her pain went up then went down. When she got the booster it went back up significantly. She had 3 steroid shots and a Medrol dose pack. She was working with an orthopedic surgeon and therapy. She was just miserable. He states this was reported several to 6 months ago through the CDC but didn't get a report number. Stated there is no information regarding SIRVA in my resources or the PI. The caller is a pathologist and wants to know if there has been any reports about SIRVA.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I contacted COVID-19; I contacted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Oct2021 (Lot number: ff8859) at the age of 24 years as dose 3 (booster), single, administration date 09Feb2021 (Lot number: EL3247) as dose 2, single and administration date 19Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not administer any other vaccine during last 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jan2022, outcome "recovering" and all described as "I contacted COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Interchange of vaccine products, Pain, Pyrexia
Clinical narrative: Fever 101.2; Severe headache; Severe body aches; Primary immunisation: MODERNA; Booster: BNT162b2; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 at 10:00 (Lot number: unknown) at the age of 37 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Supraventricular tachycardia" (unspecified if ongoing), notes: SVT; "Heart murmur" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Asthma" (unspecified if ongoing) and "Multiple allergies" (unspecified if ongoing), notes: Allergies. Concomitant medications included: LEVOTHYROXINE and BENADRYL. Past drug history included: Flonase, reaction: "Drug allergy", notes: Known allergies: Flonase; Fentanyl, reaction: "Drug allergy", notes: Known allergies: Fentanyl; Singulair, reaction: "Drug allergy", notes: Known allergies: Singulair; Albuterol, reaction: "Drug allergy", notes: Known allergies: Albuterol and Mmr, reaction: "Allergy to vaccine", notes: Known allergies: MMR vaccine. Vaccination history included: Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 20Jan2021, when the patient was 36 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 23Dec2020, when the patient was 36 years old, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Jan2022 at 10:00, outcome "unknown", described as "Primary immunisation: MODERNA; Booster: BNT162b2"; PYREXIA (non-serious) with onset 22Jan2022 at 12:00, outcome "recovering", described as "Fever 101.2"; HEADACHE (non-serious) with onset 22Jan2022 at 12:00, outcome "recovering", described as "Severe headache"; PAIN (non-serious) with onset 22Jan2022 at 12:00, outcome "recovering", described as "Severe body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache and pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Visual impairment
Clinical narrative: Edema in hands that hasnt gone away; Changes in vision; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 41 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medications included: WELLBUTRIN.  The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Edema in hands that hasnt gone away"; VISUAL IMPAIRMENT (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Changes in vision".  Therapeutic measures were not taken as a result of oedema peripheral and visual impairment.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient also received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 41 years as dose 2, single for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got fully vaccinated for the Pfizer covid-19 vaccine in 2021. tested positive for covid-19.; got fully vaccinated for the Pfizer covid-19 vaccine in 2021. tested positive for covid-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got fully vaccinated for the Pfizer covid-19 vaccine in 2021. tested positive for covid-19.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive, notes: she tested positive for covid-19.  Clinical Information: Caller was a consumer who wanted to get her booster dose for the Pfizer COVID-19 vaccine. She got her primary series last year (2021) on June and July. She was diagnosed with COVID-19 this year (2022) and was told to wait at least 90 days to receive her booster dose. Caller wanted to know if this information was correct or when she could receive the booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: a huge flare up after her first covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): US-AMGEN-USASL2022004607.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL taken for psoriatic arthropathy. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "a huge flare up after her first covid vaccine". Subsequently, her health care professional told her to not get the second one. No treatment information was received. The causal relationship between the event psoriatic arthropathy and Enbrel, Single Dose Prefilled Syringe was not provided by the consumer.  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: Rheumatoid arthritis
Clinical narrative: RA symptoms returned and became worse than before taking Enbrel dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Enbrel for Rheumatoid arthritis, reaction(s): "heartburn", notes: Enbrel, Single Dose Prefilled Autoinjector. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 08Jan2022, outcome "not recovered", described as "RA symptoms returned and became worse than before taking Enbrel dose". The patient stated her knees felt swollen and had pain in hands and jaw.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Positive covid results.; Positive covid results.; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 13:00 (Lot number: EW0217) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 09Feb2021 10:00 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 19Jan2021 10:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: red meat" (unspecified if ongoing), notes: Known allergies: red meat. Concomitant medication(s) included: FLU, administration date 06Oct2021. The following information was reported: IMMUNISATION (medically significant) with onset 06Oct2021 13:00, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 09:00, outcome "recovering" and all described as "Positive covid results.". The event "positive covid results." and "positive covid results." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jun2021) negative, notes: Nasal Swab; (23Sep2021) negative, notes: Nasal Swab; (07Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: The patient reported she was aware of symptoms on 05Jan2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Headache, Pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 12Mar2021 (Lot number: EN6204) at the age of 46 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6198, Route of administration: Unspecified, Anatomical site: Right arm), administration date: 19Feb2021, when the patient was 46 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "extreme dizziness"; CONFUSIONAL STATE (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "confusion"; PAIN (non-serious) with onset 13Mar2021 at 08:30, outcome "recovered", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, confusional state and pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient also received bnt162b2 (BNT162B2), administered in right arm, administration date 12Nov2021 (Lot number: 320308) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Microscopy, Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 09Mar2021 (Batch/Lot number: EN6206) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus", start date: 13Mar2021 (ongoing), notes: first visit with PCP regarding ear issue tympanic membrane injection 13Sep2021; "Hypertension", start date: 05Aug2013 (ongoing), notes: treated 13Sep2021 with losartan + an error (sign withheld) 05Jan2021; "Osteoarthritis", start date: 2018 (unspecified if ongoing), notes: hip replacement in 2019; "Hyperlipidemia", start date: 05Aug2021 (ongoing), notes: treated with atorvastatin. Concomitant medication(s) included: ATORVASTATIN taken for hyperlipidaemia, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2013 (ongoing). The following information was reported: TINNITUS (medically significant) with onset 13Mar2021, outcome "not recovered", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (22Sep2021) unremarkable, notes: Unremarkable; microscopy: (13Aug2021) normal, notes: ear canals visibly clear; (05Oct2021) unknown results, notes: Unremarkable. Therapeutic measures were taken as a result of tinnitus. Addition information: Prior vaccination was none. The patient received the third dose of BNT162B2 on 01Oct2021 (Batch/Lot number: FE3592) via intramuscular on deltoid (side not documented) as single dose for COVID-19 immunization. It was reported that: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). The event required the initiation of new medication/other treatment/ procedure.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event
Clinical narrative: administered FLUBLOK to a 13 years old patient with no reported adverse event; Initial information received on 14-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 13 years old male patient who took administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]  with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 13-Jan-2022, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  via intramuscular route in unknown administration site (strength, formulation, lot QFAA2125 and expiry date was unknown) for prophylactic vaccination..  On 13-JAN-2022 the patient developed a non-serious  event "administered flublok to a 13 years old patient with no reported adverse event "(product use issue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered FLUBLOK to a 13 years old patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered flublok to a 13 years old patient with no reported adverse event.  Reporter causality: Related
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: stopped getting the flu when I stopped getting the flu shot; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from the patient.  This case involves an unknown age and unknown gender patient who stopped getting the flu when stopped getting the flu shot while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dosage regimen, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed a non-serious event 'stopped getting the flu when i stopped getting the flu shot' (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The case received from Social media Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I stopped getting the flu when I stopped getting the flu shot."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was drug withdrawn.  It was not reported if the patient received a corrective treatment for the event (stopped getting the flu when I stopped getting the flu shot).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event 'stopped getting the flu when i stopped getting the flu shot'.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: horrible case of the flu; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced horrible case of the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number has been requested.  On an unknown date the patient developed a non-serious horrible case of the flu  (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, Last flu shot gave me a horrible case of the flu so you can keep it thanks.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (horrible case of the flu ).  At time of reporting, the outcome was Unknown for the event horrible case of the flu.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information received on 19-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced allergic reaction while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received INFLUENZA VACCINE produced by unknown manufacturer at an unknown dose (lot number, expiry date, strength, form, frequency not reported) via unknown route in unknown administration site for Flu. On an unknown date the patient developed a non-serious event "allergic reaction" (drug hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I will never get one again. I had an allergic reaction."  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (allergic reaction).  At time of reporting, the outcome was Unknown for the event allergic reaction.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: child unexpectedly moved. Doctor injected only half of the dose (0.25) with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years and 4 months old child  and unknown gender patient (10 kg) who unexpectedly moved. doctor injected only half of the dose (0.25) with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.25 (half dose)  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE injection (strength, frequency, lot U7196AB and expiry date was unknown) via intramuscular route in Left leg for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "child unexpectedly moved. doctor injected only half of the dose (0.25) with no reported adverse event" (incorrect dose administered) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported"Doctor tried to inject Menactra (series U7196AB) into the left leg (intramuscularly), but child unexpectedly moved. Doctor injected only half of the dose (0.25). Please advise, what should we do in this situation? Doctor suggests: enter another half dose (0.25) after 2 weeks. And then give a second dose after 3-6 months. Please, we need your advice."  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (child unexpectedly moved. Doctor injected only half of the dose (0.25) with no reported adverse event).  At time of reporting, the outcome was Unknown for the event child unexpectedly moved. doctor injected only half of the dose (0.25) with no reported adverse event.  Reporter Causality: Related
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered the Adacel (Tdap) prefilled syringe instead of DTaP today with no reported adverse event; Initial information received from United States on 20-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 5 years old male patient who was administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jan-2022, the patient received a  dose (0.5 ml 1X (once) prefilled syringe ) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot: U7187AA, expiry date: 28-Sep-2023 via intramuscular route in unknown administration site for immunization.  On 20-JAN-2022 the patient developed a non-serious administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event (wrong product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported, Pharmacist stated that a male patient, who she believes was 5 years old, was inadvertently administered intramuscularly the Adacel (Tdap) prefilled syringe instead of DTaP today (20 Jan 2022).  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered the Adacel (Tdap) prefilled syringe instead of DTaP today with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: gets the flu every year after flu shot; chills; fever; Initial information received on 20-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who reported gets the flu every year after flu shot, chills and fever while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization. In the context of COVID-19 crisis, the batch no and expiration date were not requested.  On an unknown date the patient developed a non-serious event "gets the flu every year after flu shot" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "chills" (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "fever" (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Caller mentioned a friend's experience with the flu shot".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (gets the flu every year after flu shot, fever, chills).  At time of reporting, the outcome was Unknown for the event gets the flu every year after flu shot, was Unknown for the event fever and was Unknown for the event chills.