chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: diarrhea; little pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "little pain at the injection site"; DIARRHOEA (non-serious) with onset 04Mar2021, outcome "recovered" (04Mar2021), described as "diarrhea".  Additional information: The patient was querying if these were typical side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia
Clinical narrative: body aches; really bad headache; her head feels prickly on her forehead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "really bad headache"; PARAESTHESIA (non-serious), outcome "unknown", described as "her head feels prickly on her forehead".  Additional Information: The patient wanted to know if the side effects were normal. The patient also has questions in regard to the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills .; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Mar2021, outcome "unknown", described as "chills ."; PAIN (non-serious) with onset 04Mar2021, outcome "unknown", described as "body ache".  Additional information: The patient was querying if Tylenol can be taken for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she is not feeling well".  Additional information: It was reported that patient will be getting the 2nd dose of the vaccine tomorrow and she will be having a chemotherapy next week. The patient also wanted to know if she will continue to get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 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), for Covid-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: He is been throwing up, he has been vomiting/vomiting in every half an hour or every hour; Nauseous; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 13:00 (Lot number: EN6205) 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: NAUSEA (non-serious) with onset 04Mar2021 18:00, outcome "unknown", described as "Nauseous"; VOMITING (non-serious) with onset 04Mar2021 21:00, outcome "unknown", described as "He is been throwing up, he has been vomiting/vomiting in every half an hour or every hour".  Additional information: he is like vomiting in every half an hour or every hour.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinusitis" (unspecified if ongoing), notes: always had allergies before, he probably had allergies before, because he has sinusitis, uses Flonase; "allergies" (unspecified if ongoing), notes: always had allergies before, he probably had allergies before, because he has sinusitis, uses Flonase. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021266075 same reporter/drug/event; different patient
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little sore on the injection site; 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 54-year-old female patient received bnt162b2 (Pfizer Covid-19 Vaccine), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "little sore on the injection site". Additional information: The patient wanted to reschedule her second dose. She had her first dose last 04Mar. She had a little sore on the injection site after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), administration date 23May2020 (Batch/Lot number: unknown) at the age of 57 years as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "Migraines". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: This case involves a 70-years old and unknown gender patient who had colds (nasopharyngitis), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment, vaccination, concomitant medication 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 colds (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the event nasopharyngitis. Information on the batch number to be requested.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 08-Dec-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Everytime I get the Flu shot I get the Flu ! I don't get the Flu shot I don't get the Flu I haven't even had a Cold in over 5 years ! All I did was change my diet I eat more veggies then meat Now!"  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 any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: died; Initial information was received on 10-Dec-2021 regarding an unsolicited valid Social Media serious case received from a Consumer via social media.  This case involves an adult female patient (unknown age) who died (death) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(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, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  It is unknown if the patient experienced any additional symptoms/events.  Laboratory data and corrective treatment prior to death were not reported.  At the time of reporting, cause of death was not reported, it was unknown if autopsy was done.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from Facebook involves an adult female patient (unknown age) who died, after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Died
Sex: U
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: This case is linked to case 2021SA377054 (CLUSTER). This case involves two patient (unknown age and gender) who experienced dizzy (Dizziness) while receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE). On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient experienced dizzy (Dizziness) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. It was reported "Rep reports that Nurse Practitioner has informed him of 3 patients who experienced adverse events when receiving MENQUADFI vaccine. She stated that 2 patients who received the MENQUADFI concomitantly with the HPV vaccine complained of dizziness. One additional patient, no concomitant vaccines mentioned, "almost fell on the floor". Description was vague, but sales rep states that fainting or almost fainting was implied". Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome of event was unknown. There will be no information available on batch number for this case. Based on information previously received, case classification and case validity in narrative has been amended.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: This case involves a 4-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 6 days earlier than due date (inappropriate schedule of product administration). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 06-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (injection, lot number: UJ494AA and expiry date: 09-Jul-2021) via an intramuscular route at an unknown administration site. On 28-Oct-2021 she also received a 0.5 mL dose of the same vaccine (injection, lot number: UJ494AA and expiry date: 09-Jul-2021) via a subcutaneous route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day). It was reported "Caller states that a patient received a dose of PENTACEL 6 days earlier than they were due, and would like to know what they should do next?" At the time of reporting, no adverse event was reported. 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 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: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Medication error, Product preparation issue
Clinical narrative: ACTHIB being reconstituted with sterile water with no adverse event; Initial information received on 07-Dec-2021 regarding an unsolicited valid  non-serious case from nurse via regulatory agency (under reference number 00888121).  This case involves a 7 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] that was being reconstituted with sterile water (product preparation issue) .  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); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  On 03-Dec-2021, the patient received a third 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ587AA and expiry date: 17-Sep-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  It was reported " (Registered Nurse) RN calling in regards to ACTHIB being reconstituted with sterile water. Caller would like advise to know how to proceed after product was administered to a patient."  At time of reporting, no adverse event was reported.  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: 77.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 77-year-old male patient who was accidently given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Off label use). The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included ECULIZUMAB (SOLIRIS). On 21-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6920AA and expiry date: 15-Apr-2022) (Frequency once) via intramuscular route in the left arm for prophylactic vaccination. It was reported "The clinic reported that a dose of MENACTRA was accidently given to a 77-year-old male but with further research it was discovered the consumer was prescribed the MENACTRA due to being prescribed an upcoming therapy that needed the vaccination. The clinic reported that the consumer is needing to have a series of 2-doses of Menactra due to starting the therapy Soliris (eculizumab); that the MENACTRA was prescribed to be given 8-weeks apart; that the Nephrologist prescribed the Menactra and the Soliris (eculizumab); that the Soliris (eculizumab) will be performed with the nephrologist; that the clinic reached out to the nephrologist and confirmed the need for the MENACTRA; and that the consumer is now planning to get the second dose at his pharmacy". It was a case of actual medication error due to Off label use in unapproved age group (same day latency). At the time of report no adverse event was reported.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: vaccine sprayed out between the needle and the syringe with no reported adverse event; the plastic hub attached to the syringe where the needle screws on is loose and spins, no AE; vaccine sprayed out between the needle and the syringe and into the face of the patient with no reported adverse event; Initial information was received on 07-Dec-2021 regarding an unsolicited valid non-serious case from a nurse via physician.  This case involves patient (demographics unknown) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] which sprayed out between the needle and the syringe and into the face of the patient as a result of the plastic hub attached to the syringe where the needle screws on was loose and spined (underdose, needle issue and exposure via skin contact).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7384LA, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose, needle issue and exposure via skin contact (latency same day).  It was reported "A medical assistant was administering this vaccine and the vaccine sprayed out between the needle and the syringe. When I looked over the needle and syringe, I noticed the plastic hub attached to the syringe where the needle screws on is loose and spins. My thoughts are when our MA tightened the needle onto the syringe the hub spun and did not allow the needle to be tightened properly. I did check the other syringes in this same box and the plastic hubs do not twist, they are fixed into place. Nurse (RN) reports that FLUZONE QIV NP syringe was used on a patient and that the hub was loose on the product and when the MA went to administer the product the fluid sprayed out between the needle and the syringe and into the face of the patient"  No adverse event was reported.  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 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: 0.08
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: a dose of ACTHIB was reconstituted with sterile water and administered to a patient, with no AE; Initial information received on 09-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Agency number: 00891537.  This case involves a 1 months old male patient who was administered  a dose of acthib was reconstituted with sterile water after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE for Immunisation.  On 07-Dec-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number: UJ587AA and expiry date: 17-SEP-2022) via intramuscular route in unknown administration site for prophylactic vaccination.   It was case of an actual medication error due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event was reported.   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: 1.0
Sex: F
Vaccine: DTAP, HIBV, TD
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally gave a TENIVAC vaccination to a 16 month old patient/ no AE; rash on the right cheek; accidentally gave a TENIVAC vaccination to a 16 month old patient instead of their fourth dose of DAPTACEL; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency (under the reference: 00891947).  This case involves a 1-year-old female patient who had rash on the right cheek (rash), accidentally gave a DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of their fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered, Product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB).  On 09-Dec-2021, the patient received a O.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [frequency once, strength: standard, lot C5779AA, expiry date: 02-Oct-2022] via intramuscular route in the left vastus lateralis for prophylactic vaccination.  On 09-Dec-2021, the patient developed a non-serious rash on the right cheek (rash) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Caller states that a new employee accidentally gave a TENIVAC vaccination to a 16-month-old patient in the office on 09-Dec-2021 instead of their fourth dose of DAPTACEL. Caller states that the patient has returned to the clinic due to a rash on the right cheek and was given Benadryl 1mk/kg to treat this. Caller states that she has reported this incident to safety online."  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  No laboratory data reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash.  At time of reporting, the outcome was unknown for the events.  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: U
Vaccine: UNK, YF
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired Sodium Chloride Injection Diluent given with yellow fever with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from other health professional via regulatory agency (Reference number- 00892353) and transmitted to Sanofi on 10-Dec-2021.  This case involves a patient (unknown demographic) receiving expired sodium chloride injection diluent given YELLOW FEVER VACCINE - US [YF-VAX] and while treated with SODIUM CHLORIDE (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US [lot U6427AA, expiry date 30-sep-2021] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient started taking SODIUM CHLORIDE [lot number and expiry date not reported] via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "expired Sodium Chloride Injection Diluent given with yellow fever." does pt need to be re- vaccinated?  At time of reporting, no adverse event reported.  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: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tinnitus
Clinical narrative: Tinnitus (both ears worse in left ear); This spontaneous case from the was retrieved on 16-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1833078-1), reported by other healthcare professional and concerned a 66-year-old, female patient.  The patient's concurrent conditions included asthma, hypertension and allergiy to sulfonamides, nonsteroidal anti-inflammatory drugs (NSAIDs), nitrofurans, azithromycin and verapamil. The patient 's concomitant medications included bisoprolol, Breo ellipta (fluticasone furoate, vilanterol trifenatate), senior multivitamin (vitamins NOS), magnesium oxide and B12 (cyanocobalamin), all used for unreported indications.  On 26-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported). The batch number reported was 312869.  On the same day the patient was also vaccinated with a non-company co-suspect Covid-19 Moderna vaccine (elasomeran; route of administration: intramuscular, anatomical location: left arm, dose: reported as '3' and indication: not reported). The batch number was 088D21A.   On 31-Oct-2021, in the evening, five days after receiving Fluad Quadrivalent and Covid-19 vaccine Moderna , the patient experienced tinnitus.  At the time of initial reporting, the patient had not recovered from the event. Tinnitus was worsening in both ears and it was worse in left ear.  The reporter did not provide a causality assessment.  The event was assessed as non-serious.  Company comment: A patient was vaccinated with the suspect product Fluad Quadrivalent and non-company co-suspect Covid-19 Moderna vaccine. Five days after vaccination the patient developed tinnitus. Causality is confounded by concurrent administration of co-suspect vaccine. Causality is additionally confounded by therapy with concomitant drug bisoprolol. Based on plausible time relationship, causality is assessed as possibly related. Sender's Comments: A patient was vaccinated with the suspect product Fluad Quadrivalent and non-company co-suspect Covid-19 Moderna vaccine. Five days after vaccination the patient developed tinnitus. Causality is confounded by concurrent administration of co-suspect vaccine. Causality is additionally confounded by therapy with concomitant drug bisoprolol. Based on plausible time relationship, causality is assessed as possibly related.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure cluster
Clinical narrative: Seen in ED for seizure cluster approx 30min after receiving Moderna vaccine
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Chills, fatigue, soreness at injection site
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Swelling
Clinical narrative: swollen under left arm pit. today  swollen  on left side of chest.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Crying, Impaired work ability, Intermenstrual bleeding, Mood swings
Clinical narrative: Shortly after receiving my second dose of Moderna I continued birth control as normal, which is my usual and only ?medication?  On the 27th of November 2021 I began breakthrough bleeding like I never have before.  It has not stopped.  I am still bleeding, consistently, not heavy.  I made absolutely no connection to the vaccine until today when I realized that was the only thing that could?ve contributed and I have a friend who went through something similar.  I have never had such adverse mood swings, as I am bleeding through my birth control on a daily basis. It is affecting my ability to work my job due to uncontrollable crying due to emotional instability, something I have never encountered before.   I have yet to see a gyno and scheduled an appointment in order to confirm this.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achiness for half of a day; he felt tiredness; This spontaneous case was reported by another health care professional and describes the occurrence of PAIN (achiness for half of a day) and FATIGUE (he felt tiredness) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A. and 026L20A.) for COVID-19 vaccination.     Concurrent medical conditions included Joint injury (Joint injuries). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (achiness for half of a day). 03-Feb-2021, the patient experienced FATIGUE (he felt tiredness). On 04-Feb-2021, PAIN (achiness for half of a day) and FATIGUE (he felt tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In concomitant medications GNC Joint supplement was also reported. No treatment details were reported.  Company Comment - This case concerns a 39 year old male patient with concurrent medical condition of joint injury, who experienced the non-serious unexpected event of pain and the expected event fatigue. The events occurred on the same day after receiving the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Patient's concurrent condition of joint injury remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-402807 (Patient Link).; Sender's Comments: This case concerns a 39 year old male patient with concurrent medical condition of joint injury, who experienced the non-serious unexpected event of pain and the expected event fatigue. The events occurred on the same day after receiving the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Patient's concurrent condition of joint injury remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Vaccination complication
Clinical narrative: felt rugged; body aches; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt rugged), MYALGIA (body aches), HEADACHE (headache) and ARTHRALGIA (joint pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION COMPLICATION (felt rugged), MYALGIA (body aches), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, VACCINATION COMPLICATION (felt rugged), MYALGIA (body aches), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication was provided The patient didn't had any side effects after receiving first vaccine.  On 28-Mar-2021, the Patient felt more rugged. No treatment received by the patient   This case was linked to MOD-2021-414003 (Patient Link).
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation 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 burning sensation and tingling sensation. On an unknown date, the outcome of the burning sensation and tingling sensation were unknown.   It was unknown if the reporter considered the burning sensation and tingling sensation to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles on an unknown date and experienced burning and tingling sensation of neck and face. Consent to follow up was not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Crying, Herpes zoster, Nerve block, Nervous system disorder, Suicidal ideation
Clinical narrative: The vaccine had zero effect, shingles/suspected vaccination failure; snivelling suicidal baby; shingles; performed a nerve block; This case was reported by a consumer via interactive digital media 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), suicidal ideation (serious criteria GSK medically significant), shingles and nervous system disorder. On an unknown date, the outcome of the vaccination failure, suicidal ideation and shingles were unknown and the outcome of the nervous system disorder was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, suicidal ideation, shingles and nervous system disorder to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that toughest no nonsense man he/she ever met, was turned into a sniveling suicidal baby by a few weeks of shingles. The reporter stated that patient begged them to take him out into the woods with his favorite shotgun.  The reporter contacted a family friend who whisked him to a physician who performed a nerve block.  The patient was back to his old self, a week later. The reporter stated that Shingles vaccine had zero effect but the nerve block worked. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: The vaccine had zero effect, shingles/suspected vaccination failure; snivelling suicidal baby; shingles; performed a nerve block; This case was reported by a consumer via interactive digital media 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), suicidal ideation (serious criteria GSK medically significant), shingles and nervous system disorder. On an unknown date, the outcome of the vaccination failure, suicidal ideation and shingles were unknown and the outcome of the nervous system disorder was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, suicidal ideation, shingles and nervous system disorder to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that toughest no nonsense man he/she ever met, was turned into a sniveling suicidal baby by a few weeks of shingles. The reporter stated that patient begged them to take him out into the woods with his favorite shotgun.  The reporter contacted a family friend who whisked him to a physician who performed a nerve block.  The patient was back to his old self, a week later. The reporter stated that Shingles vaccine had zero effect but the nerve block worked. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Accidental overdose
Clinical narrative: received Pediarix and Engerix-B pediatric dose at the same time; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received HBV (Engerix B) (batch number 95SN2, expiry date 1st January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 8th April 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2021, the patient received Engerix B 10 mcg, Engerix B Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On 8th December 2021, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Pediarix and Engerix B pediatric dose at the same time yesterday, which led to accidental overdose. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Boostrix and Kinrix; 5 y/o patient received Boostrix; 5 y/o patient received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   On 8th December 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix. On 8th December 2021, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix, the patient experienced overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and wrong 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 details were provided as follows: The age at vaccination was not reported. Medical assistant reported that the patient inadvertently received Boostrix while also receiving Kinrix, which led to overdose, inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE; SICK; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was sick, tested positive for coronavirus disease 19 (Covid-19) virus test and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, covid-19 test positive and sick was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000206372.; Sender's Comments: V0: 20211220917-Covid-19 vaccine ad26.cov2.s - covid-19 test positive. 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). 20211220917-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS