chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: U
Vaccine: COVID19, DTAPIPV, HEPA, PNC15, VARCEL
Symptoms: Vaccination site pain
Clinical narrative: after vaccine no noticeable side effects besides achy shot site; Initial information received on 14-Mar-2024 regarding an unsolicited valid courtesy non-serious case received from a consumer/non-healthcare professional.  This case involves a 6 years old and unknown gender patient who experienced after vaccine no noticeable side effects besides achy shot site after receiving vaccines vaqta, vaxneuvance, varivax [varicella zoster vaccine live (OKA/MERCK)], Moderna covid-19 vaccine and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2023, the patient received a dose 1 of suspect VAQTA not produced by Sanofi Pasteur (lot XO10374, with unknown strength, dose, form and expiry) via intramuscular route in unknown administration site as Prophylactic vaccination. On 26-Oct-2023, the patient received a dose 5 of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine  Suspension for injection (lot 07656AA, with unknown strength, dose and expiry) via intramuscular route in unknown administration site as Prophylactic vaccination. On 26-Oct-2023, the patient received a dose 1 with dosage 0.5 ml of suspect Moderna covid-19 vaccine injection not produced by Sanofi Pasteur (lot AU5558B, with unknown strength and expiry) via intramuscular route in unknown administration site as COVID-19 prophylaxis. On 26-Oct-2023, the patient received a dose 2 of suspect varicella zoster vaccine live (OKA/MERCK) not produced by Sanofi Pasteur (lot XO11424, with unknown strength, dose, form and expiry) via subcutaneous route in unknown administration site as Prophylactic vaccination. On 26-Oct-2023, the patient received a dose 1 of suspect vaxneuvance not produced by Sanofi Pasteur (lot X020316, with unknown strength, dose, form and expiry) via intramuscular route in unknown administration site as Prophylactic vaccination.  On an unknown date in 2023 the patient developed after vaccine no noticeable side effects besides achy shot site (vaccination site pain) (unknown latency) following the administration of vaqta, vaxneuvance, varivax, Moderna covid-19 vaccine and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Reportedly, For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when it should have been 0.25 ml).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 25.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Off label use
Clinical narrative: use of act-hib to older than 5 yrs with no reported adverse event; Initial information received on 14-Mar-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 years old patient of an unknown gender and it was reported that HIB (PRP/T) vaccine [ACT-HIB] was used in patient older than 5 yrs with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot number; strength; expiry date unknown) was used patient to older than 5 yrs with no reported adverse event (off label use) (latency: same day).  There will be no information regarding batch number in this case.  Reportedly, nurse stated they have a patient who's 25 years old and needs a Hib vaccine and they only have ACT-HIB in their clinic. They wanted to know if they could administer the vaccine. Physician joined the call and stated she saw online it can be given to 25 years 25-year-old patient. Physician decided to administer.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired vaccine with no adverse event; Initial information received on 14-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was inadvertently administered an expired HIB (PRP/T) Vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Mar-2024, the patient received an expired dose of suspect HIB (PRP/T) Vaccine (Expiry: 08-Mar-2024) (lot number, strength and dose not reported) via unknown route in unknown administration site as Immunization with no adverse event (expired product administered) (Latency: same day).   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: 12.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol dose given was from a vial that experienced a temperature excursion beyond extended stability data with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient of IPV (VERO) [IMOVAX POLIO] dose given was from a vial that experienced a temperature excursion beyond extended stability data with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for Prophylactic vaccination; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 13-Mar-2024, the patient received a dose of 0.5 ml of suspect IPV (VERO) lot W1A191M,Expiry date: 16-Feb-2025, strength was unknown via unknown route in left deltoid for Prophylactic vaccination (Immunization) and ipol dose given was from a vial that experienced a temperature excursion beyond extended stability data with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "Reason: Unknown. Max/low temperature reached: 1.5C Duration out of labelled range: 15 hours and 43 minutes Human error? NO Does extended stability data cover the excursion? NO If negative advice, was the product administered to a patient? Caller stated that she doesn't think the punctured IPOL has been administered since the excursion, but would like to know what the next step is if it has. Caller stated that these vaccines were also involved in a previous excursion of 18.1C for 17 hours (punctured IPOL from this excursion was not involved in the previous excursion). "   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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong dose of spikevax/moderna booster was given (Moderna Covid-19, Mrna, Lnp-s, Pf, 25 Mcg/0.25 Ml, 6m-11yr) by this RN on 3/14/24. The vial for moderna 6 months to 11 years with the blue top was put in the bag and bin for the moderna 12+ bin in the VFC fridge by pharmacy. This RN did not double check the vial against the age for the dose given, which is also a blue top.  The patient was supposed to receive the moderna 12+ vaccine at time of visit. No adverse reactions noted when speaking to patient today (3/19/24).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: site pain and treated with ice and bengay
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: dr ordered hpv and tdap was given instead. pt received last tdap 01/23/2024.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient Covid  Vaccination status verified in database as last vaccination date 2022 by Health Department, however after receiving the Moderna vaccination staff noted that the patient have already received  the Moderna 2023-2024 formula vaccination on January 31,2024.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Mouth swelling, Pruritus
Clinical narrative: pt called about 30 minutes after receiving her first hep a/b vaccine and 2nd shingles vaccine and stated she was experiencing itching and swelling (swelling in her mouth), asked if she should take benadryl, we advised her to take benadryl and head to the ER. She called back and said she had decided to just stop by her pcp office instead since she was close by. There they gave her an injection for the swelling and sent in a prescription for hydroxyzine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Fatigue, Headache, Injection site erythema
Clinical narrative: Normal side effects reported such as nausea, headache, lethargy, and tiredness, but I am also confused, and have some memory loss. My injection site is swollen, sore, and has a large, red splotch  even several days later.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lethargy, Nausea
Clinical narrative: Normal side effects reported such as nausea, headache, lethargy, and tiredness, but I am also confused, and have some memory loss. My injection site is swollen, sore, and has a large, red splotch  even several days later.
Age: 67.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity
Clinical narrative: Pain to arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Gave her first shot of Shingrix on 03/08/24, on 03/18/24 she went to ER for symptoms of Bels Palsy, not sure if related.  She said she hasn't seen her PCP since before Covid.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PT CAME IN TO GET THE TDAP. I LOOKED AT SYSTEM AND SAW THAT PT HAS NOT GOTTEN WITHIN 10 YEARS. PT DID SAY SHE WAS PREGNANT. I ASKED IF SHE HAD GOTTEN IT DURING THAT TIME AS IT IS PROTACOL. PT DOES NOT REMEMBER. SHE STATES SHE TRAVELED DURING THE PREGNANCY. I HAD MADE THE ASSUMPTION THAT SHE DID NOT RECEIVE THE SHOT. I GAVE HER THE TDAP BUT THEN I CALLED THE DR. OFFICE AND THEY TOLD ME THAT SHE HAD RECIEVED THE SHOT IN 2021. THE SHOT WAS TOO EARLY. I ADVISED PT TO WATCH OUT FOR ADVERSE SIDE EFFECTS AND REASSURED HER THAT SHE WILL BE FINE AS IT IS AN INACTIVE SHOT.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain injury, Cytokine increased, Immune system disorder, SARS-CoV-2 test
Clinical narrative: Critical seizure condition called Encephalopathy; Immune system over reacted to your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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), administration date: 30Apr2021, for COVID-19 immunization, reaction(s): "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain", "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain". The following information was reported: ENCEPHALOPATHY (medically significant), outcome "unknown", described as "Critical seizure condition called Encephalopathy"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system over reacted to your vaccine".  The patient's (reporter's daughter) immune system overreacted to your vaccine and now suffers from a very critical seizure condition called Encephalopathy. She became ill after her second dose.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Encephalopathy, Immune system disorder
Clinical narrative: Critical seizure condition called Encephalopathy; Immune system over reacted to your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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), administration date: 30Apr2021, for COVID-19 immunization, reaction(s): "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain", "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain". The following information was reported: ENCEPHALOPATHY (medically significant), outcome "unknown", described as "Critical seizure condition called Encephalopathy"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system over reacted to your vaccine".  The patient's (reporter's daughter) immune system overreacted to your vaccine and now suffers from a very critical seizure condition called Encephalopathy. She became ill after her second dose.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Emotional distress, Illness, Pain
Clinical narrative: Critical seizure condition called Encephalopathy; Immune system over reacted to your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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), administration date: 30Apr2021, for COVID-19 immunization, reaction(s): "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain", "Immune system over reacted and continued to make mass production of cytokine cells and attacked her brain". The following information was reported: ENCEPHALOPATHY (medically significant), outcome "unknown", described as "Critical seizure condition called Encephalopathy"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system over reacted to your vaccine".  The patient's (reporter's daughter) immune system overreacted to your vaccine and now suffers from a very critical seizure condition called Encephalopathy. She became ill after her second dose.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Pain, Pyrexia
Clinical narrative: Extreme chills; mild fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Extreme chills), PYREXIA (mild fever) and MYALGIA (body aches) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3033277) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 16-Mar-2024, the patient experienced CHILLS (Extreme chills), PYREXIA (mild fever) and MYALGIA (body aches). At the time of the report, CHILLS (Extreme chills), PYREXIA (mild fever) and MYALGIA (body aches) outcome was unknown.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   Concomitant medication was not reported.  It was unknown if the patient experienced any additional symptoms/events.   Treatment medication was not reported.
Age: 70.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Extreme chills; mild fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Extreme chills), PYREXIA (mild fever) and MYALGIA (body aches) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3033277) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 16-Mar-2024, the patient experienced CHILLS (Extreme chills), PYREXIA (mild fever) and MYALGIA (body aches). At the time of the report, CHILLS (Extreme chills), PYREXIA (mild fever) and MYALGIA (body aches) outcome was unknown.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   Concomitant medication was not reported.  It was unknown if the patient experienced any additional symptoms/events.   Treatment medication was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report T/E. HCP stated VARIVAX was administered during a T/E. T/E was supported for VARIVAX. T/E occurred on 2/19/2024, and it was administered on 2/22/2024. No other information was provided by HCP. No additional AE reported. No PQC re; Information has been received from physician regarding to a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, and concomitant therapies were not reported.  On 19-FEB-2024, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) had a temperature excursion of -13.8 Celsius degrees for a time frame of 31 minutes and -13.6 Celsius degres for 1 hour 56 minutes. On 22-FEB-2024, the patient was vaccinated with an improperly dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1st dose, lot #X012267, expiration date: 30-APR-2025, (strength, and route of administration were not provided) administered for prophylaxis. At the reporting time, the patient had no presented any adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for improperly stored vaccine administration of MMRII to a patient on 26FEB2024. No side effects reported. Operator of device was a Healthcare Professional. No other medical information known. HCP permission to contact obtain; This spontaneous report has been received from a nurse prescriber and refers to a patient of unknown gender and age.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 26-FEB-2024, the patient was vaccinated with improperly storage dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (lot number w029541 which has been verified to be valid, expiration date reported and validated as 15-SEP-2024) as prophylaxis. The administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) were improperly stored (product storage error). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: PNC15
Symptoms: Exposure via eye contact, Exposure via skin contact, Underdose
Clinical narrative: No additional AE reported.; there could have been some product that was not administered to the patient, therefore this AE is being filed for potential missed dose/partial dose; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 13-MAR-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter (ml) injection, at a dose of 0.5 ml in the leg (vaccination scheme, route of administration, lot number and expiration date were not reported) as prophylaxis. It was reported that although the nurse administered a full dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), after removing the needle from the patient's leg, what she believed was the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) product splashed onto her forehead and eye. Since she believed pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) splashed in her eye, there could had been some product that was not administered to the patient (incorrect dose administered). Nurse confirmed product was not broken or damaged prior to or after administration (conflicting information). No additional adverse event (AE) reported.  Lot # is being requested and will be submitted if received.  This is one of two cases received from the same reporter. ; Sender's Comments:  US-009507513-2403USA005106:
Age: 3.0
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB and VAXNEUVANCE; This spontaneous report was received from a nurse practitioner and refers to a 3-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 19-OCT-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes.  On 08-NOV-2023, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025,  and improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), intramuscularly, lot # X019438, expiration date 07-NOV-2025, both vaccines for prophylaxis (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccines storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA004988: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005310: US-009507513-2403USA005309: US-009507513-2403USA005308: US-009507513-2403USA005307: US-009507513-2403USA005306: US-009507513-2403USA005311:
Age: 0.5
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; route/site: intramuscular (ROTATEQ); This spontaneous report was received from a Nurse Practitioner and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 25-OCT-2023, the patient was vaccinated with previously exposed to temperature excursion rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #1933912, expiration date: 21-APR-2024, valid lot number per internal review), administered intramuscularly (Incorrect route of product administration) (for prophylaxis strength was not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection (also reported as VAXELIS), (lot #U7623AA, expiration date: 08-DEC-2025 valid lot number per internal review), administered intramuscularly for prophylaxis (strength was not provided) (Product storage error). No adverse events were reported.   This is one of several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller is a nurse who reports expired PROQUAD was administered to one patient. Product expired 3/6/2024 and was administered on 3/14/2024.; This spontaneous report was received from a Nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 14-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (therapy type: Albumin status rHA), lot # W028568 has been verified to be a valid lot number, expiration date reported and confirmed as 06-MAR-2024, administered for prophylaxis (strength, exact dose, and route of administration were not provided) (Expired product administered), with sterile diluent (BAXTER STERILE DILUENT) (lot number W017640, expiry date was not provided, but upon internal validation was established as 06-NOV-2024) (strength, exact dose, and route of administration were not provided). The reporter confirmed no temperature excursions through date of administration. No adverse event (AE) details available or additional AE reported.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: infant was given 2nd dose of Pediarix on 5-MAR-2024 and the product was expired 3-MAR-2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) (expiry date 03-MAR-2024) for prophylaxis.   On 05-MAR-2024, the patient received the 2nd dose of Pediarix (intramuscular). On 05-MAR-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: infant was given 2nd dose of Pediarix on 5-MAR-2024 and the product was expired 3-MAR-2024). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 07-MAR-2024 The reporter was practice manager reported that an infant (patient) was given her 2nd dose of expired Pediarix vaccine, which led to an expired vaccine used. The reporter did not have a lot number for the product, but did verified the product name and expiry date in the office practice records for the patient. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Intense muscle soreness on the arm of shot, fever lasting 8 hours,  nauseau and headache until nightime. With fluids and OTC painkiller, and a good nights sleep, symptoms were gone on 11/2.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cold sweat, Dizziness, Headache
Clinical narrative: Severe full body muscle pain,  burning pain in all joints, nerve pain in left arm to include forearm and especially left hand which became too stiff to open and close completely, Fever 101 with cold sweats, shivering, headache, nausea and dizziness - nerve pain reducing at 36 hours, joint and muscle pain , headache, low fever 99 continues at a more manageable level 58 hours after the injection.  Nausea appears worse but that may because the pain was too intense to  stand and nausea is worse while standing.  Nerve pain in left forearm and left hand continues despite no previous history of nerve pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Neuralgia, Pyrexia
Clinical narrative: Severe full body muscle pain,  burning pain in all joints, nerve pain in left arm to include forearm and especially left hand which became too stiff to open and close completely, Fever 101 with cold sweats, shivering, headache, nausea and dizziness - nerve pain reducing at 36 hours, joint and muscle pain , headache, low fever 99 continues at a more manageable level 58 hours after the injection.  Nausea appears worse but that may because the pain was too intense to  stand and nausea is worse while standing.  Nerve pain in left forearm and left hand continues despite no previous history of nerve pain.
Age: 0.58
Sex: U
Vaccine: PNC15, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperaturer excursion; This spontaneous report was received from an other health professional and referred to an 8-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 15-NOV-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X019438, expiration date was reported as 07-NOV-2025 (also reported 30-AUG-2025, conflicting information), administered intramuscularly for prophylaxis (strength and anatomical site of administration was not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, expiration date: 23-SEP-2025 (also reported as 30-SEP-2025), administered for prophylaxis (strength, lot #, anatomical site of administration and route of administration were not provided). All vaccines were found experiencing a temperature excursion (TE) (product storage error). Healthcare professional (HCP) requested stability information for vaccine products. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient had shingles twice after vaccination/Suspected vaccination failure; Had shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles twice after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the shots and had twice and shots were way better. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the shot/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after the shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a consumer via interactive digital media. The reporter stated that he/she had shingles when he/she was 22.  Anyway, spoke with a patient who said she and her sister both got shingles after the shot. The reporter was staying away from anything sharp. The reporter stated that hope your husband finally got better. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The case was linked with case US2024AMR033124, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024AMR033124:Same reporter, Case of woman's sister
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired product used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 07-MAR-2024, the patient received the 4th dose of Infanrix. On 07-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired product used). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 07-MAR-2024 The practice manager reported a nurse administered a dose of Infanrix to a patient.  Aterwards, nurse realized the vaccine had already expired. The practice manager stated the patient had no side effects, noted after the vaccine administration.  At the time of reporting, a repeat dose had not been administered.  The vaccine administration facility was the same as primary reporter.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased, Caesarean section, Eclampsia, Exposure during pregnancy, Oedema
Clinical narrative: Due date was 3/8/2024 and vaccine was received 1/21/2024. On 2/2/2024, at 35 weeks pregnant, I suffered a seizure (no prior history of seizures) and was rushed to the hospital. At the time of the seizure, emergency medical services measured my blood pressure at 210/160, and I suffered from extreme swelling/edema. After stabilizing me, doctors performed an emergency C-section, and my baby was delivered 5 weeks prematurely, weighing just over 5 lbs. Prior to the seizure, my blood pressure had been within the normal range before and throughout pregnancy, and my pregnancy had been considered ?low risk.? In light of the seizure, extremely elevated blood pressure, and extreme swelling, my doctor diagnosed my condition as rapid onset pre-eclampsia resulting in eclampsia.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Pre-eclampsia, Premature delivery, Seizure, Swelling
Clinical narrative: Due date was 3/8/2024 and vaccine was received 1/21/2024. On 2/2/2024, at 35 weeks pregnant, I suffered a seizure (no prior history of seizures) and was rushed to the hospital. At the time of the seizure, emergency medical services measured my blood pressure at 210/160, and I suffered from extreme swelling/edema. After stabilizing me, doctors performed an emergency C-section, and my baby was delivered 5 weeks prematurely, weighing just over 5 lbs. Prior to the seizure, my blood pressure had been within the normal range before and throughout pregnancy, and my pregnancy had been considered ?low risk.? In light of the seizure, extremely elevated blood pressure, and extreme swelling, my doctor diagnosed my condition as rapid onset pre-eclampsia resulting in eclampsia.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Some temporary blurred vision that seemed to subside shortly after it started.  I nolonger seem to be experiencing the issue.  Lasted around an hour, maybe less.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given Pedirix that expired date was. 2-17-24.    Notified doctor and we notified the parent and called the Pharmacy.  The Pharmacy stated no harm was done and that we would have to give her another Pedirix.  Patient was well when she left the doctors office and no problems was detected
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Burning sensation, Mobility decreased, Pain in extremity
Clinical narrative: Pain & burning feeling down the left arm to the hand (esp. finger joints) from day of MMR vaccine until present. The pain is 8/10 and restricts finger movements esp. Left 2nd finger.
Age: 1.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered, provider/mom contacted along with GSK. Will repeat vaccine in 30 days D/t recommendations.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Brain fog, Choking, Dysphagia, Dyspnoea
Clinical narrative: 6 DAYS POST 2ND COVID VAX: INABILITY TO SWALLOW, CHEW, MOVE TONGUE, DX: MYASTHENIA GRAVIS, INCURABLE AUTOIMMUNE DISEASE. SUBSEQUENT ADDITIONAL PERSISTENT SYMPTOMS OF DIFFICULTY BREATHING, MUSCLE WEAKNESS THROUGHOUT BODY, CHOKING, WORSENING OF GENERALIZED FATIGUE AND BRAIN FOG.  FIRST DOSE (NOT NOTED ABOVE, PFIZER #1: 3/24/21 Given by facility Pfizer COVID-19 Vaccine. Lot#: ER8732. Dose: 0.3 Left Deltoid, Admin date: 3/24/2021  RESULTED IN: 8 WEEKS OF HEADACHE, EXACERBATION OF GENERALIZED FATIGUE, GASTRO SICKNESS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Mastication disorder, Muscular weakness
Clinical narrative: 6 DAYS POST 2ND COVID VAX: INABILITY TO SWALLOW, CHEW, MOVE TONGUE, DX: MYASTHENIA GRAVIS, INCURABLE AUTOIMMUNE DISEASE. SUBSEQUENT ADDITIONAL PERSISTENT SYMPTOMS OF DIFFICULTY BREATHING, MUSCLE WEAKNESS THROUGHOUT BODY, CHOKING, WORSENING OF GENERALIZED FATIGUE AND BRAIN FOG.  FIRST DOSE (NOT NOTED ABOVE, PFIZER #1: 3/24/21 Given by facility Pfizer COVID-19 Vaccine. Lot#: ER8732. Dose: 0.3 Left Deltoid, Admin date: 3/24/2021  RESULTED IN: 8 WEEKS OF HEADACHE, EXACERBATION OF GENERALIZED FATIGUE, GASTRO SICKNESS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis, Tongue movement disturbance
Clinical narrative: 6 DAYS POST 2ND COVID VAX: INABILITY TO SWALLOW, CHEW, MOVE TONGUE, DX: MYASTHENIA GRAVIS, INCURABLE AUTOIMMUNE DISEASE. SUBSEQUENT ADDITIONAL PERSISTENT SYMPTOMS OF DIFFICULTY BREATHING, MUSCLE WEAKNESS THROUGHOUT BODY, CHOKING, WORSENING OF GENERALIZED FATIGUE AND BRAIN FOG.  FIRST DOSE (NOT NOTED ABOVE, PFIZER #1: 3/24/21 Given by facility Pfizer COVID-19 Vaccine. Lot#: ER8732. Dose: 0.3 Left Deltoid, Admin date: 3/24/2021  RESULTED IN: 8 WEEKS OF HEADACHE, EXACERBATION OF GENERALIZED FATIGUE, GASTRO SICKNESS
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient specifically requested the high dose flu vaccine due to being immunocompromised at age 54. Patient did not have any adverse reactions.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse outcomes noted.  Pt was given a dose on 3/18/24 and per refrigerator expiration date expired on 3/14/24.  Manufacturer expiration was 12/24.  When called for clinical guidance/evidence on effectiveness and recommendation to repeat or not, was told no information has been gathered.  Called Pfizer and spoke with someone
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Vasoconstriction
Clinical narrative: Uncontrollable rigors with significant peripheral vasoconstriction. Rigors had a remarkably large amount of muscle movement. Afebrile,, mild increase pulse (105) and moderately increased systolic BP (160/85). Did not improve with lying down, Tylenol, and covering with blankets. Placement in hot shower improved symptoms so moved to hot bath where symptoms subsided over approximately an hour. Recurred to a lesser degree about 24 h later and again to an even lesser degree 24h after that.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Facial pain, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Day following vaccine parent called to report temp of 102, nausea, weakness, pain in hands and feet.  Pt rested and was feeling better on day 2 and returned to school
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Day following vaccine parent called to report temp of 102, nausea, weakness, pain in hands and feet.  Pt rested and was feeling better on day 2 and returned to school
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: None reported at this time
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Diarrhoea, Feeling of body temperature change
Clinical narrative: It started out like I felt a lumb in my throat by the breast bone, and I continuly clear my throat. That was the beginning, then in the night, I was hot and cold all night. I probably had a fever, but i dont know. I was cold, and actually shivering, and then after that, I had diarrea and joint pain. I was really tired. I went to Urgent Care.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sensation of foreign body, Throat clearing
Clinical narrative: It started out like I felt a lumb in my throat by the breast bone, and I continuly clear my throat. That was the beginning, then in the night, I was hot and cold all night. I probably had a fever, but i dont know. I was cold, and actually shivering, and then after that, I had diarrea and joint pain. I was really tired. I went to Urgent Care.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Pyrexia
Clinical narrative: PATIENT REPORTED DIARRHEA, CHILLS, FEVER AND STOMACH UPSET AFTER VACCINE. SHE STATES THAT THESE SYMPTOMS STARTED ON  DAY 1 OF GETTING VACCINE AND HAS LINGERED FOR OVER 6 PLUS DAYS
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events occurred. I just wanted to self report the error. Heplisav B only indicated in 18 years and up. Patient was 15 at time of administration. I noticed the error when calling to schedule follow up series shots.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-19 Breakthrough Infection
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on inside of legs , stomach, back.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Arthralgia, Asthenia, Fatigue, Liver function test increased
Clinical narrative: Pt reported COVID-like symptoms (weakness, fatigue, N/V, joint aches, but NO fever. Also had pain in abdomen and elevated LFTs.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test, Nausea, Vomiting
Clinical narrative: Pt reported COVID-like symptoms (weakness, fatigue, N/V, joint aches, but NO fever. Also had pain in abdomen and elevated LFTs.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anxiety, COVID-19, Chronic kidney disease, Decubitus ulcer
Clinical narrative: Hospitalization for COVID-19, hyperglycemia, acute kidney injury, anxiety, CKD, pressure ulcer, UTI, urinary retention, Diabetes  on dates 3/6/24 - 3/12/24.  Treated with dexamethasone and vitamin C 500 mg PO BID.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Hyperglycaemia, Urinary retention, Urinary tract infection
Clinical narrative: Hospitalization for COVID-19, hyperglycemia, acute kidney injury, anxiety, CKD, pressure ulcer, UTI, urinary retention, Diabetes  on dates 3/6/24 - 3/12/24.  Treated with dexamethasone and vitamin C 500 mg PO BID.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Brain natriuretic peptide increased, COVID-19 pneumonia, Chronic kidney disease
Clinical narrative: Hospitalization for acute hypoxic respiratory failure/COVID-19 pneumonia, elevated troponin, chronic systolic EF 30-35%, elevated BNP, AKI on CKD stage III, pancytopenia, hypomagnesemia, hyperlipidemia, hypertension on dates 3/10/24- 3/13/24. Treated with dexamethasone, Remdesivir.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic left ventricular failure, Ejection fraction decreased, Hyperlipidaemia, Hypertension, Hypomagnesaemia
Clinical narrative: Hospitalization for acute hypoxic respiratory failure/COVID-19 pneumonia, elevated troponin, chronic systolic EF 30-35%, elevated BNP, AKI on CKD stage III, pancytopenia, hypomagnesemia, hyperlipidemia, hypertension on dates 3/10/24- 3/13/24. Treated with dexamethasone, Remdesivir.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pancytopenia, Troponin increased
Clinical narrative: Hospitalization for acute hypoxic respiratory failure/COVID-19 pneumonia, elevated troponin, chronic systolic EF 30-35%, elevated BNP, AKI on CKD stage III, pancytopenia, hypomagnesemia, hyperlipidemia, hypertension on dates 3/10/24- 3/13/24. Treated with dexamethasone, Remdesivir.
Age: 0.17
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC20
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Mistaken administration of vaccines ordered for 18 month old patient to 2 month old patient
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Asthenia, Cough, Headache, SARS-CoV-2 test
Clinical narrative: Cough, weakness, mild headache
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive home test
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Extra dose administered, Joint swelling
Clinical narrative: Patient received the vaccine twice. Once in 9/22/23 and again in 1/18/24. Patient came back to pharmacy later that month with a swollen knee and bruising in legs.