chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: experiencing sharp pain in left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 03Mar2021, outcome "not recovered", described as "experiencing sharp pain in left side".  Additional information: Patient was experiencing sharp pain in left side started last night and has come every couple of hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he got sick after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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: ILLNESS (non-serious), outcome "unknown", described as "he got sick after the first dose".  Additional information: The patient was due for the second dose on 17Mar2021 and mentioned he has a scheduled procedure 2 days after the second dose schedule; patient was querying if he can get the second dose or reschedule it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Vaccine positive rechallenge
Clinical narrative: Extremely cold right hand Ocurred after first COVID-19 vaccine and 3rd (booster)
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: Started with my arm being in a lot of pain and spreading through shoulder into neck. Then got dizzy and really tired with a headache. It turned into hot/cold flashes and an inability to regulate my body temperature with whole body aches and  body shakes.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Neck pain, Pain, Pain in extremity, Temperature regulation disorder
Clinical narrative: Started with my arm being in a lot of pain and spreading through shoulder into neck. Then got dizzy and really tired with a headache. It turned into hot/cold flashes and an inability to regulate my body temperature with whole body aches and  body shakes.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Started with my arm being in a lot of pain and spreading through shoulder into neck. Then got dizzy and really tired with a headache. It turned into hot/cold flashes and an inability to regulate my body temperature with whole body aches and  body shakes.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Energy increased, Nasal congestion
Clinical narrative: despite being previously being fully vaccinated  with two doses of the COViD-19 vaccine, he tested positive for COVID; tested positive for COVID; More Energy; feeling congested; he had a slight fever of between 99 and just over 100 degrees; This is a spontaneous report received from a contactable reporter Consumer for a Pfizer sponsored program. The reporter is the patient.  A male patient of unspecified age 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), outcome unknown, described as "despite being previously being fully vaccinated  with two doses of the COViD-19 vaccine, he tested positive for COVID"; COVID-19 (medically significant), outcome unknown, described as "tested positive for COVID"; energy increased (non-serious), outcome unknown; nasal congestion (non-serious), outcome unknown, described as "feeling congested"; pyrexia (non-serious), outcome unknown, described as "he had a slight fever of between 99 and just over 100 degrees". The patient underwent the following laboratory tests and procedures: body temperature: between 99 and 100 degrees, notes: between 99 and just over 100 degrees; sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: despite being previously being fully vaccinated  with two doses of the COViD-19 vaccine, he tested positive for COVID; tested positive for COVID; More Energy; feeling congested; he had a slight fever of between 99 and just over 100 degrees; This is a spontaneous report received from a contactable reporter Consumer for a Pfizer sponsored program. The reporter is the patient.  A male patient of unspecified age 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), outcome unknown, described as "despite being previously being fully vaccinated  with two doses of the COViD-19 vaccine, he tested positive for COVID"; COVID-19 (medically significant), outcome unknown, described as "tested positive for COVID"; energy increased (non-serious), outcome unknown; nasal congestion (non-serious), outcome unknown, described as "feeling congested"; pyrexia (non-serious), outcome unknown, described as "he had a slight fever of between 99 and just over 100 degrees". The patient underwent the following laboratory tests and procedures: body temperature: between 99 and 100 degrees, notes: between 99 and just over 100 degrees; sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Nausea and vomiting . Started 3 days after first dose and became severe after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 13:15 (Lot number: Ew0164) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM. Past drug history included: Clyndamicin, reaction(s): "known allergies: Clyndamicin", notes: known allergies: Clyndamicin. Vaccination history included: Bnt162b2 (COVID vaccine details: , Product: COVID 19, brand: Pfizer, Lot number: ER8732, Lot unknown: False, Administration date: 31Mar2021, Administration time: 01:00 PM, Vaccine location: left arm, Dose number: 1), administration date: 31Mar2021, when the patient was 29 years old, for covid-19 immunisation, reaction(s): "Nausea", "vomiting". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "unknown", described as "Nausea and vomiting . Started 3 days after first dose and became severe after second dose". Therapeutic measures were not taken as a result of condition aggravated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Dysstasia, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Jaw pain; Jaw stiffness; Abdominal pain; lower back pain on left side. Pain started the entire lower back; severe stiffness; Pain when mouth opens; Still in pain when standing, or directly after getting up from sitting or laying down. Cannot stand straight right away; Still mild pain/Still in pain when standing, or directly after getting up from sitting or laying down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 12:00 (Lot number: EW0178) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Batch/lot number: EW0185, Lot unknown: False), when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: PAIN IN JAW (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Jaw pain"; JOINT STIFFNESS (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Jaw stiffness"; ABDOMINAL PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Abdominal pain"; BACK PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "lower back pain on left side. Pain started the entire lower back"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "severe stiffness"; ORAL PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Pain when mouth opens"; DYSSTASIA (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Still in pain when standing, or directly after getting up from sitting or laying down. Cannot stand straight right away"; PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Still mild pain/Still in pain when standing, or directly after getting up from sitting or laying down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in jaw, joint stiffness, abdominal pain, back pain, musculoskeletal stiffness, oral pain, dysstasia, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. No hospitalization Prolonged. No treatment for adverse events. No COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain, Pain in jaw, SARS-CoV-2 test
Clinical narrative: Jaw pain; Jaw stiffness; Abdominal pain; lower back pain on left side. Pain started the entire lower back; severe stiffness; Pain when mouth opens; Still in pain when standing, or directly after getting up from sitting or laying down. Cannot stand straight right away; Still mild pain/Still in pain when standing, or directly after getting up from sitting or laying down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 12:00 (Lot number: EW0178) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Batch/lot number: EW0185, Lot unknown: False), when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: PAIN IN JAW (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Jaw pain"; JOINT STIFFNESS (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Jaw stiffness"; ABDOMINAL PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Abdominal pain"; BACK PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "lower back pain on left side. Pain started the entire lower back"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "severe stiffness"; ORAL PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Pain when mouth opens"; DYSSTASIA (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Still in pain when standing, or directly after getting up from sitting or laying down. Cannot stand straight right away"; PAIN (non-serious) with onset 30May2021 09:00, outcome "not recovered", described as "Still mild pain/Still in pain when standing, or directly after getting up from sitting or laying down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in jaw, joint stiffness, abdominal pain, back pain, musculoskeletal stiffness, oral pain, dysstasia, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. No hospitalization Prolonged. No treatment for adverse events. No COVID prior vaccination. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Drug ineffective
Clinical narrative: stomach pain since starting on the kevzara; Kevzara - medication does not seem to be working; Initial information received on 28-Sep-2021 from other health professional (processed as a non-case) and follow up information regarding an unsolicited valid  non-serious case  was received on 24-Nov-2021 from  patient.  This case involves a 54 years old male patient who experienced stomach pain since starting on the kevzara and kevzara - medication does not seem to be working while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via unknown medical device and SARILUMAB [KEVZARA] via sarilumab pen.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In September 2021, the patient started taking DUPIXENT (DUPILUMAB) with an unknown dosage, strength, formulation, route, frequency, expiration date, batch number and indication and KEVZARA (SARILUMAB) injection with strength 200mg/1.14ml at dose of 200 mg every other week subcutaneous (lot - 1F140A, 31-May-2023) for Rheumatoid arthritis. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. Due to covid-19, batch number and expiration date for dupilumab were not requested.  In SEP-2021 the patient developed a non-serious event "stomach pain since starting on the kevzara" (abdominal pain upper) (latency- same day) following the first dose intake. In 2021 the patient developed a non-serious event "kevzara - medication does not seem to be working" (drug ineffective) (unknown latency) following the first dose intake.  Action taken- unknown for abdominal pain upper; not applicable for drug ineffective.  Corrective treatment- not reported  Outcome: unknown for both the events.   Additional information was received on 24-Nov-2021 from the patient via specialty pharmacy: Case was updated to a valid case from a non-case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I've had worse flue's bugs; Initial information received on 28-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social media via Agency.  This case involves a patient (unknown demographic) who had worse flue's bugs (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's 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 and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had worse flue's bugs (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got my shoot & fighting the flue now , I've had worse flue's bugs."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Condition aggravated, Malaise, Scar
Clinical narrative: sicker than a dog; Initial information was received on 03-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was sicker than a dog (illness) after receiving INFLUENZA VACCINE.  Medical history: patient had the measles at 36 even though he/she had the measles shot when he/she was a little kid. That shit damn near killed the patient. Then at 50 he/she got the Shingles and ended up with scars.  It was unknown if the patient had any concomitant disease or risk factor  The patient's past medical treatment(s), concomitant medications 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 prophylactic vaccination.  On an unknown date the patient was sicker than a dog (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I only ever got inoculated when i was traveling which made me sicker than a dog and I vowed to never take one ever again. Best to build immunity. Taking shots every year only weakens your immunity"  It was unknown if the patient experienced any additional symptoms/events  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome of the event was Unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUA4
Symptoms: Malaise
Clinical narrative: Got real sick for about four days; This spontaneouscase from was retrieved on 30-Nov-2021 from other non-healthcare professional via Agency (reference number: SEQW21-05740) and concerned patient of an unknown age and gender.  The patient's medical history and concomitant medication were unknown.  On unspecified date in 2020, the patient was vaccinated with Fluad Quadrivalent  (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration, anatomical location, dose and indication: not reported). The batch number was not reported.  On unspecified date in 2020, unknown amount of time after receiving Fluad Quadrivalent, the patient got real sick for about four days. The patient stated might as well had the flu.  On an unspecified date in 2020, the patient recovered from the event.   The reporter did not provide a causality assessment.  Company comment: The event of 'sickness' was assessed as unassessable to Fluad Quadrivalent.; Sender's Comments: The event of 'sickness' was assessed as unassessable to Fluad Quadrivalent.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: 12/6/2021 - present (4 days) inpatient admission HCF -  Hospital HISTORY OF PRESENT ILLNESS: Pt is a 89 y.o. male with past medical history of chronic diastolic HFpEF, Afib, restrictive lung disease and recent hospitalization for L1-L2 compression fracture and multiple rib fractures after ground level fall. Patient resides at (PRIVACY) where he recently tested positive for COVID-19 on 12/3. Patient presented to the ED with chief complaint of worsening hypoxia.   Patient was reported to have oxygen saturations in the 80's. He wears 2L oxygen at baseline and reports having a new cough and intermittent SOB. He thinks his symptoms started 1 week ago but is unsure and tested positive on 12/3 for COVID. He is vaccinated with Pfizer although has not received his booster yet. He reportably had monoclonal abx infusion on 12/4. Patient does not recall the infusion and states he received 4 shots for COVID as treatment. He denies having any fever, chills, abdominal pain, vomiting or diarrhea. While in the ED, patient was noted to be in a-fib RVR thus, received cardizem 5mg IV and subsequently became hypotensive.    Upon arrival to the ED, patient was afebrile, tachycardic HR 132bpm, otherwise hemodynamically stable on 4L oxygen. Labs were notable for Na 132, alk phos 145, bilirubin 1.2, wbc 3.29, hgb 9.9, plt 52. CXR showed bilateral pleural effusions slightly decreased in size compared to 11/20/21. No new or worsening opacity. No findings suspicious for overt heart failure. Patient received cardizem 5mg IV subsequently resulting in hypotension. His blood pressure improved with 2L IVF and home midodrine.    Patient will be admitted to HCF for further treatment and evaluation. ASSESSMENT / PLAN:   Iatrogenic hypotension, improving - secondary to IV cardizem - s/p 2L IVF and midodrine - check LA - will hold home lasix and aldactone for now and consider resuming tomorrow - continue BB and midodrine - monitor bp   A-fib RVR- resolved - noted to be recurrent per previous hospitalization - continue BB - tele - keep Mg>2, K>4   COVID-19 infection - vaccinated, did not receive his booster - COVID + 12/3, symptom onset roughly 1 week ago per pt - reported to have had monoclonal abx infusion on 12/4, attempted to call facility to confirm but unable to reach staff - prone positioning daily, tele, continuous pulse ox - trend daily crp, d-dimer - consider monoclonal abx infusion pending discussion with facility    Acute on chronic thrombocytopenia - suspect r/t COVID-19 - monitor cbc   Right arm laceration - wound nurse consult   Chronic diastolic HFpEF - not in acute exacerbation - 9/15/21 ECHO- EF 50-55%, grade 3 diastolic dysfunction, mod AR, mod to severe MR, mod-severe TR - holding lasix and aldactone d/t hypotension, resume when able - continue BB - daily wts, I&O's   Chronic hypoxic respiratory failure Restrictive lung disease Bilateral pleural effusions, stable - stable, baseline 2L oxygen   Deconditioning - lives at facility, own decision maker - PT/OT   DVT prophylaxis: lovenox subq Code status: DNR/DNI Diet: general
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. Patient out of age range for vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: hospitalized for Multiple Pulmonary Embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (hospitalized for Multiple Pulmonary Embolism) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (hospitalized for Multiple Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 24-Oct-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of Blood thinner. At the time of the report, PULMONARY EMBOLISM (hospitalized for Multiple Pulmonary Embolism) outcome was unknown.            Concomitant drugs were not reported.  It was reported that when patient was first admitted to ER they thought it was a heart attack and was given blood thinner Eliquis as treatment.  Company comment: This case concerns a 63-year-old female patient with no medical history reported, who experienced the serious unexpected ADR of pulmonary embolism after second dose of mRNA-1273. The event occurred 6 months after second dose of mRNA-1273. The re-challenge is not applicable since event occurred after second dose and event outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403992 (Patient Link).; Sender's Comments: This case concerns a 63-year-old female patient with no medical history reported, who experienced the serious unexpected ADR of pulmonary embolism after second dose of mRNA-1273. The event occurred 6 months after second dose of mRNA-1273. The re-challenge is not applicable since event occurred after second dose and event outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme prolonged fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Extreme prolonged fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 04-Dec-2021, the patient experienced FATIGUE (Extreme prolonged fatigue). On 09-Dec-2021, FATIGUE (Extreme prolonged fatigue) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medicines were reported. It was reported that, fatigue during day and night, needing rest sleep, unable to accomplish chores, not affecting ADL. No treatment information was provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 2nd dose interrupted by the covid pandemic; This case was reported by a physician via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported this case, who was also a physician. The age at vaccination was not applicable. The patient reported that the 2nd dose of Shingrix was interrupted and delayed by the covid pandemic, which led to social problem . The patient enquired if he/ she could get the 2nd dose now or needed to restart the vaccine series.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via Regulatory Authority and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to shingles vaccine. Additional details were provided as follows: This case was reported for several patients. The age at vaccination was not reported. The reporter stated reporter know a number of people who had gotten shingles after the shingles vaccine. The one thing that seems to be the trigger in these cases was stress. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR222485: same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: This case was reported by a consumer via Regulatory Authority and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for patient's husband. The age at vaccination was not reported. The reporter stated the patient got the Shingles shot and had shingles, his in lower right back area.  The reporter stated had been broke out about a month and at the time of reporting complaining of some pain. The reporter stated the patient got the Shingles shot that's why was not as bad as some. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine didn't work for me/ suspected vaccination failure; vaccine didn't work for me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she shingles vaccine did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: was administered an underdose (<0.5mL); This case was reported by a pharmacist via call center representative and described the occurrence of incorrect dose administered in a male patient who received Herpes zoster (Shingrix) (batch number HM24H, expiry date 25th March 2023) for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Shingrix. On 4th December 2021, unknown after receiving Shingrix, the patient experienced incorrect dose administered. On an unknown date, the outcome of the incorrect dose administered was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The reporter reported that the patient received Shingrix dose less than 0.5mL, which led to incorrect dose administration. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: gave a 16 year old an adult dose of Havrix; gave a 16 year old patient an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 16-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional deails were provided as follows: The age at vaccination was not reported. The patient accidentally received an adult dose of Havrix, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Vaccination site nodule
Clinical narrative: BENIGN SPOT ON BACK; KNOT ON ARM AFTER VACCINE INJECTION SITE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (Janssen series-1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis.  No concomitant medications were reported. It was unknown if patient was enrolled in a Covid-19 vaccine trial. On an unspecified date, the patient had benign spot on back and also knot on the arm that was injection site after taking the vaccination. On an unspecified date, the patient had spot on back which was removed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from benign spot on back, and knot on arm after vaccine injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215901-COVID-19 VACCINE AD26.COV2.S-Benign spot on back . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) 2.5 ml, administered on 07-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 07-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml,, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, involving the same patient is linked to 20211201168. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220152, 20211202199, 20211202193, 20211202161, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211201168, 20211200994, 20211201082, 20211200723, 20211200717, 20211200675, 20211165041, 20211202371, 20211202250, 20211202246, 20211202207, 20211202193, 20211201963, 20211201228, 20211201046, 20211200769, 20211200752, 20211200723, 20211165041, 20211219871 and 20211220155.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: LIFE DESTROYING PAIN/ CHRONIC PAIN (NEW PAIN); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced life destroying pain/ chronic pain (new pain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of life destroying pain or chronic pain/ new pain was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219731, 20211219686, 20211220537, 20211220233, 20211219807, 20211220948 and 20211221158.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: FULL BODY CHILLS; 102 DEG FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced full body chills, and 102 deg fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body chills and 102 deg fever was not reported. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Mobility decreased, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Could not move the left arm after 2nd shot; Swollen deltoid muscle left arm after 2nd shot; Generalized body ache after 2nd shot; Redness at site of injection after 2nd shot; Fever low grade 100.1 F after 2nd shot; This spontaneous case was reported by a physician and describes the occurrence of MOBILITY DECREASED (Could not move the left arm after 2nd shot), VACCINATION SITE SWELLING (Swollen deltoid muscle left arm after 2nd shot), MYALGIA (Generalized body ache after 2nd shot), VACCINATION SITE ERYTHEMA (Redness at site of injection after 2nd shot) and PYREXIA (Fever low grade 100.1 F after 2nd shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MOBILITY DECREASED (Could not move the left arm after 2nd shot), VACCINATION SITE SWELLING (Swollen deltoid muscle left arm after 2nd shot), MYALGIA (Generalized body ache after 2nd shot), VACCINATION SITE ERYTHEMA (Redness at site of injection after 2nd shot) and PYREXIA (Fever low grade 100.1 F after 2nd shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 29-Jan-2021, MOBILITY DECREASED (Could not move the left arm after 2nd shot), VACCINATION SITE SWELLING (Swollen deltoid muscle left arm after 2nd shot), MYALGIA (Generalized body ache after 2nd shot), VACCINATION SITE ERYTHEMA (Redness at site of injection after 2nd shot) and PYREXIA (Fever low grade 100.1 F after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.1 (High) low grade fever 100.1 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  After second shot, patient had a swollen deltoid muscle left arm, could not move the arm, generalized body ache, redness at site of injection and low grade fever 100.1 Fahrenheit. Patient took Tylenol and the reaction went away after 2 days.   This case was linked to MOD-2021-406527, MOD-2021-406569 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Could not move the left arm after 2nd shot; Swollen deltoid muscle left arm after 2nd shot; Generalized body ache after 2nd shot; Redness at site of injection after 2nd shot; Fever low grade 100.1 F after 2nd shot; This spontaneous case was reported by a physician and describes the occurrence of MOBILITY DECREASED (Could not move the left arm after 2nd shot), VACCINATION SITE SWELLING (Swollen deltoid muscle left arm after 2nd shot), MYALGIA (Generalized body ache after 2nd shot), VACCINATION SITE ERYTHEMA (Redness at site of injection after 2nd shot) and PYREXIA (Fever low grade 100.1 F after 2nd shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MOBILITY DECREASED (Could not move the left arm after 2nd shot), VACCINATION SITE SWELLING (Swollen deltoid muscle left arm after 2nd shot), MYALGIA (Generalized body ache after 2nd shot), VACCINATION SITE ERYTHEMA (Redness at site of injection after 2nd shot) and PYREXIA (Fever low grade 100.1 F after 2nd shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 29-Jan-2021, MOBILITY DECREASED (Could not move the left arm after 2nd shot), VACCINATION SITE SWELLING (Swollen deltoid muscle left arm after 2nd shot), MYALGIA (Generalized body ache after 2nd shot), VACCINATION SITE ERYTHEMA (Redness at site of injection after 2nd shot) and PYREXIA (Fever low grade 100.1 F after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.1 (High) low grade fever 100.1 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  After second shot, patient had a swollen deltoid muscle left arm, could not move the arm, generalized body ache, redness at site of injection and low grade fever 100.1 Fahrenheit. Patient took Tylenol and the reaction went away after 2 days.   This case was linked to MOD-2021-406527, MOD-2021-406569 (Patient Link).