chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Treatment for Asthma and Congestion; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "Preservative Sulfites" (unspecified if ongoing), notes: known allergies Preservative Sulfites, metabisulfites; "known allergies: NSAIDs" (unspecified if ongoing), notes: known allergies: NSAIDs; "Congestion" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: aspirin; Saccharin, reaction(s): "known allergies: saccharin", notes: known allergies: saccharin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. The patient received Paxlovid on 29Dec2022 to 02Jan2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches / headache never went away it increased so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headaches / headache never went away it increased so bad ". The event "headaches / headache never went away it increased so bad " required emergency room visit.  Course of events: Caller states when it first came out she got the Pfizer covid vaccine shot and says she is current up to now. Caller states when she first got the shot all the normal things happened, headaches and everything but her headache never went away it increased so bad that she went to the ER. She had no health problems and the ER didn't say why she had the headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metabolic disorder, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: nauseous; started vomiting still vomiting today, twice a day.; "potabolism" to go down.; tingling started off in hands in feet; my fact mouth gums tongue tingling.; my fact mouth gums tongue tingling.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunisation, reaction(s): "headache". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; VOMITING (non-serious), outcome "not recovered", described as "started vomiting still vomiting today, twice a day."; METABOLIC DISORDER (non-serious), outcome "unknown", described as ""potabolism" to go down."; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling started off in hands in feet"; PARAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious), outcome "not recovered" and all described as "my fact mouth gums tongue tingling.". Relevant laboratory tests and procedures are available in the appropriate section.  Course of events: When she got the other shot couple of days after she was nauseous and started vomiting still vomiting today (16Jan2023), twice a day. Caller states this has caused her "potabolism" to go down. And after this last shot, now tingling started off in hands in feet, now its her fact mouth gums tongue tingling. Caller states she went to hospital, she has had an MRI and they cant figure out why this is happening.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nauseous; started vomiting still vomiting today, twice a day.; "potabolism" to go down.; tingling started off in hands in feet; my fact mouth gums tongue tingling.; my fact mouth gums tongue tingling.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunisation, reaction(s): "headache". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; VOMITING (non-serious), outcome "not recovered", described as "started vomiting still vomiting today, twice a day."; METABOLIC DISORDER (non-serious), outcome "unknown", described as ""potabolism" to go down."; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling started off in hands in feet"; PARAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious), outcome "not recovered" and all described as "my fact mouth gums tongue tingling.". Relevant laboratory tests and procedures are available in the appropriate section.  Course of events: When she got the other shot couple of days after she was nauseous and started vomiting still vomiting today (16Jan2023), twice a day. Caller states this has caused her "potabolism" to go down. And after this last shot, now tingling started off in hands in feet, now its her fact mouth gums tongue tingling. Caller states she went to hospital, she has had an MRI and they cant figure out why this is happening.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous T-cell lymphoma, Investigation, Non-Hodgkin's lymphoma
Clinical narrative: Non Hodgkins Lymohoma post Pizer vaccine/non-Hodgkin's lymphoma which infected the skin "mycosis fungoides"; non-Hodgkin's lymphoma which infected the skin "mycosis fungoides"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 2, single (Lot number: EL8982) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Raynauds" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; TOPIRAMATE taken for migraine. Vaccination history included: BNT162b2 (Batch/lot number: EL0142   , Dose 1), administration date: 15Jan2021, when the patient was 55-year-old, for covid-19 immunization. The following information was reported: NON-HODGKIN'S LYMPHOMA (medically significant), outcome "unknown", described as "Non Hodgkins Lymohoma post Pizer vaccine/non-Hodgkin's lymphoma which infected the skin "mycosis fungoides""; CUTANEOUS T-CELL LYMPHOMA (medically significant), outcome "unknown", described as "non-Hodgkin's lymphoma which infected the skin "mycosis fungoides"". The patient underwent the following laboratory tests and procedures: Lab test: Unknown results. Therapeutic measures were taken as a result of non-hodgkin's lymphoma, cutaneous t-cell lymphoma.  Additional information: Consumer stated, "I received an email after I reported some symptoms post COVID vaccination and they emailed me back saying that they would like to speak to me directly and they gave me a reference#." When asked if have any questions regarding the Side effects: Consumer stated, "I only have one. I have Non-Hodgkin's Lymphoma now, It's a Mycosis Fungoides. There are only 6 cases per million reported. I want to know if there are other reported cases post COVID vaccination." Prior Vaccinations (within 4 weeks): Consumer stated, "No." Consumer further stated, "I am now on a chemotherapy ointment. It is called Valchlor. It is a topical ointment. That is for my Mycosis Fungoides, the Non-Hodgkin's Lymphoma. Consumer stated, "I am in treatment now. The last prescription (Valchlor) that I told you, that is the treatment that I am in now. Prior to the chemotherapy ointment, I was using Triamcinolone Acetonide ointment. Those are the two treatments that I am currently using for my Non-Hodgkin's Lymphoma. I am using both."
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; The initial case was missing the following minimum criteria: Unspecified Product. Upon receipt of follow-up information on (13Jan2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Course of events: Patient was losing her hair by the fistfuls. It kept clogging the bathtub drain. She did see a dermatologist that told her that the 4 vaccines she received was a major problem. Her physician recommended a special shampoo and conditioner which she cannot purchase because it is $66.00. Patient asked for help through this. It was traumatizing. She was very scared and unhappy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: hair loss; The initial case was missing the following minimum criteria: Unspecified Product. Upon receipt of follow-up information on (13Jan2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Course of events: Patient was losing her hair by the fistfuls. It kept clogging the bathtub drain. She did see a dermatologist that told her that the 4 vaccines she received was a major problem. Her physician recommended a special shampoo and conditioner which she cannot purchase because it is $66.00. Patient asked for help through this. It was traumatizing. She was very scared and unhappy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Retinal detachment
Clinical narrative: Detached retina; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETINAL DETACHMENT (medically significant), outcome "unknown", described as "Detached retina". Therapeutic measures were taken as a result of retinal detachment. Clinical course: on 05Jan, patient had emergency surgery for a detached retina. Patient had no other injury or medical indicator, it happened suddenly. Patient have had the Pfizer vaccine for COVID. Patient just wanted to report in case this is data that the company is collecting of a common theme.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: UNK
Symptoms: Illness, Post-acute COVID-19 syndrome
Clinical narrative: Long term COVID vaccine illnesses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Long term COVID vaccine illnesses".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Supraventricular tachycardia
Clinical narrative: I developed supra ventricular tachycardia with underlying atrial fibrillation; I developed supra ventricular tachycardia with underlying atrial fibrillation; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), SUPRAVENTRICULAR TACHYCARDIA (non-serious) all with onset Sep2021, outcome "unknown" and all described as "I developed supra ventricular tachycardia with underlying atrial fibrillation".  Clinical course: The patient registered nurse for 5 years. There was no heart disease on patients mother or fathers side of the family. The patient received covid vaccine in Aug2021. Roughly a month later developed supra ventricular tachycardia with underlying atrial fibrillation.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information the reported serious event Atrial fibrillation is more likely an intercurrent or due to underlying medical condition.However the contributory role of the suspect product BNT162b2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Brain oedema, Drug reaction with eosinophilia and systemic symptoms, Investigation
Clinical narrative: Dress syndrome; brain swelling; amnesia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Lot number: EL9267) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EL9262), administration date: 31Jan2021, when the patient was 79-year-old, for Covid-19 immunization. The patient did not receive any prior vaccinations within 4 weeks. The following information was reported: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (medically significant) with onset 26Jul2021, outcome "unknown", described as "Dress syndrome"; AMNESIA (non-serious) with onset 26Jul2021, outcome "unknown"; BRAIN OEDEMA (medically significant) with onset 26Jul2021, outcome "unknown", described as "brain swelling". The patient underwent the following laboratory tests and procedures: Multiple tests: (26Jul2021) Unknown results, notes: Dress syndrome, brain swelling, amnesia, rehab. Clinical course: Specific relevant test for thromboembolic events thrombocytopenia: None. The patient did not receive Paxlovid.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Influenza, Malaise
Clinical narrative: the flu shot caused me to be very sick with the flu for two weeks; nowsick for the fourth day after taking the latest Covid booster; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional via Social Media.  This case involves an unknown age and unknown gender patient who received the flu shot that caused to be very sick with the flu for two weeks and now sick for the fourth day after taking the latest covid booster after receiving vaccines COVID-19 vaccine and influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation- not reported) via unknown route in unknown administration site for prophylactic vaccination and also received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number, expiry date, strength, formulation- not reported) via unknown route in unknown administration site for covid-19 immunization.  On an unknown date the patient developed a non-serious event, the flu shot caused me to be very sick with the flu for two weeks (influenza) and nowsick for the fourth day after taking the latest covid booster (malaise) (unknown latency) following the administration of influenza vaccine and COVID-19 vaccine.  It is unknown if there were lab data/results available  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old patient was given PENTACEL because she was behind with her vaccinations with No adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 5 years old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] because she was behind with her vaccinations with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]).  On 03-Jan-2023, the 5 years old patient received total 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: U7198AA, expiry date: 28-Jan-2023) via intramuscular route in the right arm for Immunization (Immunisation) because she was behind with her vaccinations with no adverse event (product administered to patient of inappropriate age) (latency: same day)   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event 5 year old patient was given pentacel because she was behind with her vaccinations with no 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient was meant to receive Pediarix and a standalone HIB vaccine, but PENTACEL was given in error with no reported adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 months old male patient who experienced patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix).  On 11-Jan-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of  0.5ml  lot UJ664AAA at expiry date of 4-May-2023  via intramuscular route in left leg Immunization.  On 11-Jan-2023 the patient developed a non-serious event of patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error with no reported adverse event (wrong product administered) (latency : same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was meant to receive Pediarix and a standalone HIB vaccine, but Pentacel was given in error with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was meant to receive pediarix and a standalone hib vaccine, but pentacel was given in error 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.
Age: 69.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: HCP states that they accidentally gave a patient act-hib in which the diluent that came with it was expired, with no reported adverse event; Initial information received on 12-Jan-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old male patient whose hcp states that they accidentally gave a patient act-hib in which the diluent that came with it was expired, with no reported adverse event after receiving vaccine haemophilus type B (HIB) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (CRM197) (MENVEO) for Immunisation.  On 28-Nov-2022, the patient received a standard 0.5 ml dose of suspect haemophilus type B (HIB) vaccine Powder and solvent for solution for injection (lot UJ603AA, expiry date: 29-Oct-2022)  via intramuscular route in the deltoid nos not specified as immunization.  On 28-NOV-2022 the patient developed hcp states that they accidentally gave a patient act-hib in which the diluent that came with it was expired, with no reported adverse event (expired product administered) on same day  The HCP asks if the dose is valid and if they should revaccinate the patient    Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: did not give the ACT-HIB portion of the vaccine with no reported AE; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who was not given the act-hib portion of the vaccine with no reported ae after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Jan-2023, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine  (Suspension for injection) at a dose of 0.5 ml  via unknown route in unknown administration site for Immunization (strength, batch number and expiry date: unknown). Batch/lot number requested  On 05-Jan-2023 the patient was not given the act-hib portion of the vaccine with no reported ae (product preparation error) (latency same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event did not give the act-hib portion of the vaccine with no reported ae.   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: F
Vaccine: MNQ
Symptoms: Human chorionic gonadotropin negative, Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: patient received a MENQUADFI while an HCG test was negative. Several days later the patient had a positive pregnancy test with no reported adverse event; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age female pregnant patient who was exposed to vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] while her hcg test was negative. several days later the patient had a positive pregnancy test with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received a MENQUADFI while an HCG test was negative. Several days later the patient had a positive pregnancy test with no reported adverse event occurred at unknown gestation period<<the gestation period at onset and gestation period at exposure data needs to be populated, if available>>  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's previous pregnancy/ies were not provided.   On an unknown date, the pregnant patient whose hcg test was negative. several days later the patient had a positive pregnancy test with no reported adverse event (maternal exposure before pregnancy) had received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, expiry date: not reported) with unknown strength, frequency, route, anatomical location for immunization.  <<Relevant prenatal testing after exposure included >> Relevant laboratory test results included: Human chorionic gonadotropin negative - On an unknown date:  [HCG test was negative] Pregnancy test - On an unknown date:  [positive pregnancy test]  Action taken: not applicable.  Outcome : Unknown. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy skin abnormal, Cancer surgery, Cyst, Electrodesiccation, Keratoacanthoma
Clinical narrative: Steady growth of cyst-like area on side of face, first noticed by patient (reporting) early/mid-November, 2022 (about a month after receiving vaccination) seen by dermatologist 1/12/23 (5-week delay due to difficulty in getting an appointment). Dermatologist diagnosed as Keratoacanthoma of cheek, from his notes on MyChart:  ?ordered DESTRUCTION MALIGNANT LESION 0.6-1 cm (Face)? by excision and electrodesiccation. Size of tumor was 0.9 cm in his notes. Currently the wound is healing without any adverse symptoms.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Skin lesion, Squamous cell carcinoma of skin, Wound healing normal
Clinical narrative: Steady growth of cyst-like area on side of face, first noticed by patient (reporting) early/mid-November, 2022 (about a month after receiving vaccination) seen by dermatologist 1/12/23 (5-week delay due to difficulty in getting an appointment). Dermatologist diagnosed as Keratoacanthoma of cheek, from his notes on MyChart:  ?ordered DESTRUCTION MALIGNANT LESION 0.6-1 cm (Face)? by excision and electrodesiccation. Size of tumor was 0.9 cm in his notes. Currently the wound is healing without any adverse symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Hallucination, Pain, Seizure
Clinical narrative: Severe generalized pain, convulsions, spastic involuntary movement, halluciantions x4 days
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Rash macular, Visual field defect
Clinical narrative: Left side peripheral vision become wavy and spotted over with light blotches. Happened the night of the injection so far. Lost sense of taste in eating food for 5 days after injection.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Urticaria
Clinical narrative: Hives for3months straight non stop....then 5 strokes at end of hives
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Headache, Immunisation reaction
Clinical narrative: Covid arm, large red patch 2?x 2?, swelling, hot, sore arm, fever, chills, sore body, headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Covid arm, large red patch 2?x 2?, swelling, hot, sore arm, fever, chills, sore body, headache
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 YO was given kinrix; Kinrix was given instead of DTap; Kinrix was given instead of DTap/ received kinrix as 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTap-IPV (had received 3 doses of DTap-IPV on an unknown date).   On 9th January 2023, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered 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 Information: GSK receipt date: 9-Jan-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received a dose Kinrix as 4th dose instead of DTap vaccine at an inappropriate age, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Administered IV instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 47-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 7th January 2023, the patient received Boostrix (intravenous). On 7th January 2023, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter did not have lot number or expiration date at time of interaction. The reporter did not confirm that it was the vital formulation. The reporter consented to follow-up via postal. Additional supportive information: The patient received a dose of Boostrix via intravenous instead of intramuscular, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 09-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ILLNESS (We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient received three shots with Pfizer. No treatment medicine were reported.   Reporter did not allow further contact
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 3 years ago, 2nd received now; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix approximately 3 years ago right before covid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient just got Shingrix again but was not sure if this considered his/her second dose. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Body temperature increased, COVID-19, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Very sore throat, headache, body and muscle aches, congestion. Fatigue after a couple days - that subsided but lasted the longest - 2 weeks I would say. Then we tested positive again. Second time I had a little congestion, a minor headache. Nothing serious.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Very sore throat, headache, body and muscle aches, congestion. Fatigue after a couple days - that subsided but lasted the longest - 2 weeks I would say. Then we tested positive again. Second time I had a little congestion, a minor headache. Nothing serious.
Age: 38.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Mobility decreased, Pain
Clinical narrative: Had full body aches the night after getting the vaccine that improved with Tylenol. Then they returned midday the next day so I laid down to rest and took Tylenol but after an hour or so found that I couldn?t lift my neck or get out of bed without extreme pains. The pain has improved in the nearly two weeks since but is still there and was not much helped by a massage.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dry skin, Erythema, Musculoskeletal discomfort, Neuralgia
Clinical narrative: AM's after the SARS-CoV-2 vaccination noticed feeling of discomfort at Right Lower back on the skin & husband saw rash - red & rough skin & later developed vesicles - fluid filled at (R) low back - lots of pain & pain involved sciatic nerve - electric shock pains down (R) leg x 8 weeks
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Sciatica
Clinical narrative: AM's after the SARS-CoV-2 vaccination noticed feeling of discomfort at Right Lower back on the skin & husband saw rash - red & rough skin & later developed vesicles - fluid filled at (R) low back - lots of pain & pain involved sciatic nerve - electric shock pains down (R) leg x 8 weeks
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Heart rate increased, Nodal arrhythmia, Supraventricular tachycardia
Clinical narrative: AVRT Supraventricular Tachycardia, currently controlled at the rate of 1 episode per month with the use of telmisartan.   Prior to telmisartan therapy, SVT episodes were increasingly occuring up to the rate of 3 episodes per week.  Episodes are controlled effectively with valsalva maneuver.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: patient called 1.14.23 to report her injection site reaction. It had formed a clear large bubble with redness and swelling. Advised patient to return to Clinic for further evaluation, but she states it was already mostly resolved.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Infection, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient experienced rash, followed with burning pain sensation. went to ED for follow up and they diagnosed as infection. rash is located on right upper arm posterior away from the injection site which is upper arm right deltoid. rash has continued to enlarge over past 2 days to 3 inch by 4 inch circular welt/rash on back of upper arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pain, Paraesthesia, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient experienced rash, followed with burning pain sensation. went to ED for follow up and they diagnosed as infection. rash is located on right upper arm posterior away from the injection site which is upper arm right deltoid. rash has continued to enlarge over past 2 days to 3 inch by 4 inch circular welt/rash on back of upper arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient experienced rash, followed with burning pain sensation. went to ED for follow up and they diagnosed as infection. rash is located on right upper arm posterior away from the injection site which is upper arm right deltoid. rash has continued to enlarge over past 2 days to 3 inch by 4 inch circular welt/rash on back of upper arm.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: I sustained a punctate right occipital stroke in a cortical location confirmed by MRI on brain. I suffered Left side numbness and left eye blindness for around 2 hrs and continued partial loss of left eyesight for several days.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Head injury, Skin laceration, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted soon after giving the vaccine, fell face forward and hit his head and had laceration on his forehead, was sent to the ER for further management.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: round red circular rash, left deltoid, patient said warm to touch,pain at injection site
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Systemic: pain/swelling in hand on same side as injection site-Medium
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Loss of consciousness, Pallor
Clinical narrative: Administered HPV vaccine in Left Deltoid.  Left the room to grab discharge paperwork. About 30 seconds later, parents started yelling and screaming that patient passed out. Patient found to be pale and passed out on table. Awoke within 5 seconds of RN coming into room. Vitals taken and pt was found to be stable. Pt was a little confused but was completely oriented within one minute. Juice and a snack were given and then patient was discharged with parents in stable condition.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Hemiplegia
Clinical narrative: Debilitating stroke 11/1/22, ongoing hemiplegia