chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 23-year-old male patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   On 25-MAR-2024, the patient received the 1st dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug 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: 09-MAY-2024 The reporter reported that for administering a vaccine that was recalled on some GlaxoSmithKline (GSK) because the product was not stored at the recommended temperature. The reporter stated that there was an employee who received the vaccination and asking what are the potential adverse effects would be since they received administration as he received the vaccine prior to the recall notice, which led to incorrect storage of drug. The reporter did not consent to follow up. This US2024059155 case has been linked to the case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024059155:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue
Clinical narrative: wrong technique in device; Reports that nurse put the Luer Lock piece back on the syringe and successfully administered suspect product to a patient; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in device usage process in a patient who received Hib (Hiberix) (batch number 2A95F, expiry date 20-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong technique in device usage process (Verbatim: wrong technique in device), syringe connection issue (Verbatim: Reports that nurse put the Luer Lock piece back on the syringe and successfully administered suspect product to a patient) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the wrong technique in device usage process, syringe connection issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9th May 2024 The reporter stated that the Luer Lock piece of PFS fell off when changing the needle for administration. Defect noticed at preparation step 4 of PI.  It was reported that nurse put the Luer Lock piece back on the syringe and successfully administered suspect product to a patient. Reporter stated full amount of suspect product was administered to patient without injury. No information about the patient was available at the time of reporting. Luer Lock compatible needle was used. Reporter had all components to return including the needle.  No damage noticed on the syringe. Needle was screwed on the luer lock device. The problem was detected when changing the needle for administration. The reporter held the luer lock device in place when attaching the needle. The needle which was used was available. The reporter was not seeking a replacement. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023048013:Same reporter US-GSK-US2023033390:Same reporter US-GSK-US2022180991:Same reporter US-GSK-US2022133254:Same reporter US-GSK-US2022117541:Same reporter US-GSK-US2020173712:Same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Unapproved diluent used/reconstituted with sterile diluent; Unapproved diluent used/reconstituted with sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 29Y9K, expiry date 17-MAY-2026) for prophylaxis.   On 09-MAY-2024, the patient received the 1st dose of Shingrix. On 09-MAY-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Unapproved diluent used/reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Unapproved diluent used/reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-MAY-2024 The medical assistant reported that the patient received a dose of Shingrix vaccine that had been reconstituted with sterile diluent which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case has been linked to the case US2024059169 reported by the same reporter.; Sender's Comments:  US-GSK-US2024059169:Same reporter
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Unapproved diluent used/reconstituted with sterile diluent; received a dose of Shingrix that had been reconstituted with sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 29Y9K, expiry date 17-MAY-2026) for prophylaxis.   On 09-MAY-2024, the patient received the 1st dose of Shingrix. On 09-MAY-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Unapproved diluent used/reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: received a dose of Shingrix that had been reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-MAY-2024 The medical assistant called in to request information about how to proceed after a patient received a dose of Shingrix vaccine that had been reconstituted with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been linked to the case US2024059167 reported by the same reporter.; Sender's Comments:  US-GSK-US2024059167:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in product usage process
Clinical narrative: it could have happened where they didn't change needle; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong technique in drug usage process (Verbatim: need to change out the needle after preparing the vaccine before administering to a patient). The outcome of the wrong technique in drug usage process 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: 09-MAY-2024 The public health nurse reported that the they noticed of an indication on prescribing information of Hiberix vial and prefilled syringe presentation, that they need to change out the needle after preparing the vaccine before administering to a patient but indication on Centers for Disease Control and Prevention and Action Coaltion Immunization Practices recommended that it was not necessary to change the needle. After warm transfer, the reporter mentioned to tier 2 agent that it could have happened where they did not change needle, which led to wrong technique in drug usage process.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received second dose of Arexvy by mistake; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2X7NA, expiry date 23-MAR-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 25-APR-2024, the patient received the 2nd dose of Arexvy. On 25-APR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received second dose of Arexvy by mistake). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 9-May-2024 The physician reported that the patient received second dose of Arexvy by mistake, which led to extra dose administered. The physician reported that the both the shot where the same batch number. The information were provided by GRC agent was asked to health care professional and she did confirm the information were provided. GRC reported that physician said that she forgot that the patient had already one shot on February 2024 and she administered another shot in April 2024. No side effects were reported.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: they were late to get 2nd dose of HepB so we did the Twinrix today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Havrix (received Havrix shot in January). Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 09-MAY-2024, the patient received the 2nd dose of Twinrix. On 09-MAY-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: they were late to get 2nd dose of HepB so we did the Twinrix today). The outcome of the drug dose administration interval too long 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: 09-MAY-2024 A pharmacist called to informed that a patient got a Havrix shot in January, then came back and got the Twinrix in February. The reporter reported that they were late to get 2nd dose of Hepatitis B so they did the Twinrix today at the time of reporting. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in October and 2nd dose 6 months later; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adulto (In October 2023, received first dose).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: first dose in October and 2nd dose 6 months later). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2024 The regional pharmacist reported that the patient received the first dose in October 2023 and 2nd dose 6 months later. The patient received 2nd dose of Engerix B adult, later than the recommended interval, which led to lengthening of vaccinations schedule. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received the first dose of Engerix-B last year in April.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose in April 2021,lot number: axlds and expiration date 7 Dec 2024).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient who received the first dose of Engerix-B last year in April.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 9th May 2024: An HCP called to ask for information about a patient who received the first dose of Engerix-B last year in April 2024. The HCP asked if the series should be re started.  Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. The permission to follow up was not requested during the call.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 3 year old patient was inadvertently administered Kinrix instead of a DTaP; 3 year old patient was inadvertently administered Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 10-MAY-2024, the patient received Kinrix. On 10-MAY-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 3 year old patient was inadvertently administered Kinrix instead of a DTaP) and inappropriate age at vaccine administration (Verbatim: 3 year old patient was inadvertently administered Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2024 The medical assistant reported 3 years old patient was inadvertently administered Kinrix instead of a DTaP which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of Havrix instead of an adult dose; pediatric dose of Havrix instead of an adult dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 81-year-old female patient who received HAV (Havrix pediatric) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   On 10-MAY-2024, the patient received Havrix pediatric. On 10-MAY-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: pediatric dose of Havrix instead of an adult dose) and adult use of a child product (Verbatim: pediatric dose of Havrix instead of an adult dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2024 The pharmacist reported that an adult patient received inadvertently one pediatric dose of Havrix instead of an adult dose which led to Underdose and Adult use of a Child Product. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024059783:Duplicate case
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of havrix instead of an adult dose; pediatric dose of havrix instead of an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old male patient who received HAV (Havrix pediatric) (batch number 23NL, expiry date 16-NOV-2025) for prophylaxis.   On 08-MAY-2024, the patient received Havrix pediatric. On 08-MAY-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: pediatric dose of havrix instead of an adult dose) and adult use of a child product (Verbatim: pediatric dose of havrix instead of an adult dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2024  A nurse called and wanting to know if they can give another pediatric dose to a patient that received, a pediatric dose of havrix instead of an adult dose which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 5 year old patient received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7C7SN, expiry date 16-DEC-2025) for prophylaxis.   On 14-MAY-2024, the patient received the 1st dose of Boostrix. On 14-MAY-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 5 year old patient received a dose of Boostrix ). The outcome of the inappropriate age at vaccine administration 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: 14-MAY-2024 A medical assistant called in to request data about immunogenicity and recommendations on the way to proceed in after a 5 year old patient received a dose of Boostrix as the fifth dose of the Dtap doses, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter Consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000324877.
Age: 18.0
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse gave expired polio vaccine to a patient with no reported adverse event; Initial information received on 08-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old patient of unknown gender who was given expired IPV (VERO) [IPOL] vaccine to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-May-2024, the patient was given expired dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: T1D481M; expiry date: 25-Jul-2022; strength: standard; frequency: once) via unknown route in unknown administration site for Immunisation with no reported 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: 0.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: only got the liquid component of the PENTACEL was given with no reported adverse event; Initial information was received on 15-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 8 months old male patient to whom only the liquid component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was given 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 pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) and rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.  On 13-May-2024, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UK019AA, expiry date: 30-Jun-2025, strength: standard) via intramuscular route in unknown administration site for Immunisation and only got the liquid component of the pentacel was given with no reported adverse event (single component of a two-component 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 and Module of the 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: VARZOS
Symptoms: Herpes zoster, Malaise, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; Sick; pain was so intense; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), sickness (Verbatim: Sick) and pain (Verbatim: pain was so intense). The outcome of the vaccination failure was unknown and the outcome of the shingles, sickness and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, sickness and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, sickness and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 31-DEC-2023  This case was reported by consumer via (social media) interactive digital media. A reporter reported that you should not receive Shingrix if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix. The patient when had shingles, the pain was so intense, now as her friends and family approach their 50th birthday, she tells them don't forget to ask your doctor about the shingles vaccine and also stated if you're 50 years or older, talk to your doctor and schedule your Shingrix vaccine today. The reporter also mentioned that they felt sick after getting the shot. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: HAD A SWOLLEN RIGHT FOOT ON 12/01/21; WENT TO FACILITY (12/03/21) AND FOLLOWED THEIR DIRECTION. FACILITY HAS ALL APPOINTS, OBSERVATIONS, TREATMENTS AND OUTCOMES LISTED ON THEIR SITE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I, nor mother, believe there was any adverse events from vaccine. I am Reporting as on 4/25/2024 I had given Prevnar 20 and Pedvax HIB Both same Lot # etc as on 4/30. So she got 2 doses of each in same site as listed on 4/30. See enclosed records.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dry mouth, Fatigue, Headache
Clinical narrative: cant move limbs, heavy fatigue, headache, dry mouth, sticky tongue,aches and pains in limbs and joints; excessiv pain in lower right back area ( kinda where the liver is).  who?s all at together to make me pretty much immobile. I?m watching to see if it lessens throughout the day.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity, Paraesthesia oral
Clinical narrative: cant move limbs, heavy fatigue, headache, dry mouth, sticky tongue,aches and pains in limbs and joints; excessiv pain in lower right back area ( kinda where the liver is).  who?s all at together to make me pretty much immobile. I?m watching to see if it lessens throughout the day.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Received first shot on Jan 12, 2024 at 8:00 AM and second shot on May 17, 2024 at 8:00 AM.  Both shots resulted in me received severe side effects by 9:00 PM that same night.  I experienced severe headaches, body aches, joint pain in almost every joint in my body, and a fever of 102 for 3 days.  All symptoms resolved by Monday after taking ibuprofen, Tylenol, and Zofran for nausea.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Received first shot on Jan 12, 2024 at 8:00 AM and second shot on May 17, 2024 at 8:00 AM.  Both shots resulted in me received severe side effects by 9:00 PM that same night.  I experienced severe headaches, body aches, joint pain in almost every joint in my body, and a fever of 102 for 3 days.  All symptoms resolved by Monday after taking ibuprofen, Tylenol, and Zofran for nausea.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: The patient received her 2nd Shingrix vaccination on 05/18/2024. She contacted us to report adverse reactions on 05/20/2024. She states that she is having pain, redness, and rash at the injection site. The patient also reports feeling fatigued the day after her vaccine (05/19/24). The patient used Tylenol for the pain on 05/19/24. The pain and fatigue has subsided, but she is still experiencing the redness and the rash. The patient did not report seeking out any additional medical attention.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave Kinrix outside of Age range. No adverse effects noted.  Mother reported no adverse effects.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: STARTING 2 DAYS AFTER INJECTION, PATIENT HAD SEVERE MUSCLE AND JOINT PAIN IN LOWER EXTREMETIES THAT LASTED UP TO 3 WEEKS.  SHE COMPLAINED THAT IT WAS SO BAD THAT SHE HAD TO HAD HELP GETTING OFF THE TOILET.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTION. VACCINE ADMINISTERED WAS INAPPROPRIATE FOR THE AGE OF THE PATIENT.
Age: 56.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacy made a error by giving RSV (Arexvy) vaccine instead of Shingrix.  Patient came back also received 2nd dose of Shingrix.   Spoke to patient  today (5/20/24) and so far patient has so side-effects or any adverse reaction to report.  Patient and his Doctors office have been notified (5/20/204) about the incident.
Age: 13.0
Sex: M
Vaccine: COVID19, HEPA, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given 0.5ml of the Moderna 2023-2024  6mos-11y/o  formulation covid vaccine instead of Spikevax vaccine.  No symptoms reported.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Patient presented complaining of a sore arm nearly 2 months after vaccination. States she has had this continuously since about the day after the injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Crying, Hallucination, visual
Clinical narrative: The day after the Quadracel vaccine was given he woke up crying saying he was seeing spiders. This occurred on May 14th and May 15th.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: Problems my body
Age: 16.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was given to a 16 year old male. Should not have been combo. Should have been Tdap and Polio separate. Proquad was given and should not have been combo. Should have been MMR and Varicella separate.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Blood magnesium, Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count
Clinical narrative: Patient had elevated heart rate around 1am the morning after the vaccination, and then felt an irregular heartbeat. Went to the emergency room around 2am where he was diagnosed with Atrial fibrillation. Treated with metroprolol and recovered to normal heartbeat around 4:30am.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Heart rate irregular, Metabolic function test, Thyroxine free, Troponin
Clinical narrative: Patient had elevated heart rate around 1am the morning after the vaccination, and then felt an irregular heartbeat. Went to the emergency room around 2am where he was diagnosed with Atrial fibrillation. Treated with metroprolol and recovered to normal heartbeat around 4:30am.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Foggy vision
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Death
Clinical narrative: Resident passed away 14 hours after vaccine administration. Vaccine given on 5/17/24 at 1405 resident passed on 5/18/24 at 0430.
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Bone pain, Hypersensitivity, Pain, Pain in extremity
Clinical narrative: Patient had a sore arm, stated that at mid-night that she woke up and pain was radiating up to her collarbone. She called the pharmacy on Sunday morning, and talked the pharmacist. Pharmacist requested that she go to the nearest clinic, and get examined. Patient called pharmacist to inform her that the clinic thought she was having an allergic reaction. Patient did not give us the information to the clinic, or who she saw.
Age: 69.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Anxiety, Chills, Pain, Panic attack, Pyrexia
Clinical narrative: Patient started experiencing chills, fever and body aches the evening after receiving the vaccines. Later on that evening she started to develop anxiety/panic attack symptoms which required treatment with Diazepam for relief. Symptoms mildly improved the following day but are still persisting two days later. The patient gave a call to the pharmacy on Monday morning around 10am to let us know about these symptoms. She has been advised to continue monitoring symptoms and to call us back this afternoon for follow-up
Age: 43.0
Sex: F
Vaccine: COVID19, PNC20, TDAP
Symptoms: Headache, Injection site induration, Injection site swelling, Injection site warmth, Lip swelling
Clinical narrative: Patient reported swelling, warm to the touch, and hard area around injection site. Patient reported headache, hive on arm and hives on body, swelling of tongue and lips. Patient reported taking benardyl.
Age: 43.0
Sex: F
Vaccine: COVID19, PNC20, TDAP
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Patient reported swelling, warm to the touch, and hard area around injection site. Patient reported headache, hive on arm and hives on body, swelling of tongue and lips. Patient reported taking benardyl.
Age: 74.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reported to the pharmacy on 5/17/24 with a red injection site reaction on left arm in the area of the prevnar20 vaccine.  We recommended he place ice on the site and can use benadryl for the swelling.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Fever, chills, body ache (1.5 days);  sore, red lump at injection site that was warm to the touch  (ongoing)
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever, chills, body ache (1.5 days);  sore, red lump at injection site that was warm to the touch  (ongoing)
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: leg was swollen, 2 tone busing - firm swelling on leg. Pt states that it  itches and hurts )
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Back pain, Blood test, Brain fog
Clinical narrative: ONgoing long term side effects from the vaccine.  Pain started the day after the vaccine.   Pain started in low back, shoulder blades, left big toe.  Severe pain for 2 days now continues as random but  intense pain.  Especially down the left leg and low back.  i also Lost sense of smell and taste and wanting to eat.  This has continued.   Fatigue, body heaviness and brain fog, This continues to be a problem to this day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Discomfort, Fatigue, Musculoskeletal pain, Nerve conduction studies
Clinical narrative: ONgoing long term side effects from the vaccine.  Pain started the day after the vaccine.   Pain started in low back, shoulder blades, left big toe.  Severe pain for 2 days now continues as random but  intense pain.  Especially down the left leg and low back.  i also Lost sense of smell and taste and wanting to eat.  This has continued.   Fatigue, body heaviness and brain fog, This continues to be a problem to this day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: ONgoing long term side effects from the vaccine.  Pain started the day after the vaccine.   Pain started in low back, shoulder blades, left big toe.  Severe pain for 2 days now continues as random but  intense pain.  Especially down the left leg and low back.  i also Lost sense of smell and taste and wanting to eat.  This has continued.   Fatigue, body heaviness and brain fog, This continues to be a problem to this day.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure decreased, Dyspnoea, Paraesthesia
Clinical narrative: Pins and needles all over  body  intervals      Low blood pressure    Heavy breathing
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site erythema, Injection site warmth
Clinical narrative: Left Shoulder redness/warmth, headache for two days.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Bumps/breakouts on my arm that did not appear prior to the vaccine
Age: 67.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient hasn't reported any adverse reactions.  We're just reporting since patient had already previously completed the shingrix series and came in to our store to get her "2nd" shot to complete series when really it was the 3rd shot she received. Haven't been able to reach the patient yet but have left a couple voicemails. Dr was made aware and they were unconcerned but would document it.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Autoimmune disorder, Detoxification, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 3/11/2021 PFIZER #2 4/3/2021 THREE DAYS LATER DEVELOPED FEVER INJECTION SITE PAIN THEN LATER MYAGLIAS, POST EXERTIONAL MALAISE, POTS, SMALL FIBER NEUROPATHY, ANA TURNED POSITIVE  DIAGNOSIS COVID-19 VACCINE NEUROIMMUNOLOGICAL AUTOIMMUNE SYNDROME.  TREATED WITH HCQ COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune-mediated neurological disorder, Injection site pain, Laboratory test, Malaise, Myalgia
Clinical narrative: PFIZER #1 3/11/2021 PFIZER #2 4/3/2021 THREE DAYS LATER DEVELOPED FEVER INJECTION SITE PAIN THEN LATER MYAGLIAS, POST EXERTIONAL MALAISE, POTS, SMALL FIBER NEUROPATHY, ANA TURNED POSITIVE  DIAGNOSIS COVID-19 VACCINE NEUROIMMUNOLOGICAL AUTOIMMUNE SYNDROME.  TREATED WITH HCQ COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Pyrexia, Small fibre neuropathy
Clinical narrative: PFIZER #1 3/11/2021 PFIZER #2 4/3/2021 THREE DAYS LATER DEVELOPED FEVER INJECTION SITE PAIN THEN LATER MYAGLIAS, POST EXERTIONAL MALAISE, POTS, SMALL FIBER NEUROPATHY, ANA TURNED POSITIVE  DIAGNOSIS COVID-19 VACCINE NEUROIMMUNOLOGICAL AUTOIMMUNE SYNDROME.  TREATED WITH HCQ COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus
Clinical narrative: Around the 15 minute mark, patient's mother notified staff that patient was having an allergic reaction to her Varicella vaccine. No other vaccines administered today apart from Varivax. Per the patient and mother, itching and redness are noted at site of injection. Patient denies having trouble breathing or any swelling. Sitting comfortably in the lobby, laughing with nurses. Asked mother to wait an additional 10 minutes following the initial 15 mintues to assess for any further reaction. Mom & patient left the clinic before additional 10 minutes was complete. This RN was only able to monitor the patient for a total of 20 minutes while in the clinic.
Age: 8.0
Sex: F
Vaccine: UNK, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: there was no adverse reaction, this vaccine was given as Quadracel at the age of 8 years old instead of giving the Dtap and the IPV separate. No patient harm acquired.
Age: 54.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema multiforme, Herpes simplex test positive, Malaise, Oral discomfort, Oral pain
Clinical narrative: Within a day or two I had fever, malaise, and within 3 days my mouth began to burn, get sore, and it blew up so badly that within the next few weeks I developed Erythema Multiforme in my oral mucosa as well as multiple warts all around my lips, both upper amd lower as well as some areas further outside the lip line.   It took multiple trips to various doctors, and was given prednisone via injection, and oral which did almost nothing.  Magic mouthwash, clindamycin, amoxicillin, Mupirocin,  hydrocortisone, and I also used otc freezing and imoquimid for the warts.  It was the most painful , horrific two months of my life, and I will never get another vaccine so long as I live.
Age: 54.0
Sex: F
Vaccine: HPV9
Symptoms: Oral papilloma, Pyrexia, Skin test negative
Clinical narrative: Within a day or two I had fever, malaise, and within 3 days my mouth began to burn, get sore, and it blew up so badly that within the next few weeks I developed Erythema Multiforme in my oral mucosa as well as multiple warts all around my lips, both upper amd lower as well as some areas further outside the lip line.   It took multiple trips to various doctors, and was given prednisone via injection, and oral which did almost nothing.  Magic mouthwash, clindamycin, amoxicillin, Mupirocin,  hydrocortisone, and I also used otc freezing and imoquimid for the warts.  It was the most painful , horrific two months of my life, and I will never get another vaccine so long as I live.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray normal, Fatigue, General physical condition abnormal, Hypertension
Clinical narrative: Presented to ED at 7:46am  65-year-old gentleman with a history of diverticulitis, chronic liver disease, and prolonged COVID intubation with complicated post COVID course who is presenting from home with fever and generalized fatigue.  After receiving his COVID-vaccine yesterday, patient has developed excessively tired, unable to lift himself out of bed due to overwhelming fatigue.  Tactile fever at home with no shaking chills.  No cough or shortness of breath, though per EMS report noted to be hypoxic on their arrival initially requiring nonrebreather and on 4 L of nasal cannula on arrival here.  No nausea or vomiting.  No leg pain or swelling.  No chest pain or palpitations.  He arrives febrile and mildly hypertensive.  Mild hypoxia requiring 1 L supplemental nasal cannula.  He is generally fatigued appearing but in no acute distress.  He is breathing comfortably with clear lungs, with hypoxia in the low 90s on room air.  Heart is regular.  Abdomen is soft, obese, nontender.  No pedal edema.  Awake, alert, fully oriented and moving all 4 extremities equally.  Clear posterior oropharynx.  In summary, patient's presentation with fever and fatigue with mild hypoxia is concerning for vaccine reaction versus acute infectious process.  Patient feels improved.  Still generally weak however does not want to stay in the hospital.  Will be discharged to the care of his wife.  Will return for worsening symptoms. [PD]
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Laboratory test, Mobility decreased, N-terminal prohormone brain natriuretic peptide increased, Obesity
Clinical narrative: Presented to ED at 7:46am  65-year-old gentleman with a history of diverticulitis, chronic liver disease, and prolonged COVID intubation with complicated post COVID course who is presenting from home with fever and generalized fatigue.  After receiving his COVID-vaccine yesterday, patient has developed excessively tired, unable to lift himself out of bed due to overwhelming fatigue.  Tactile fever at home with no shaking chills.  No cough or shortness of breath, though per EMS report noted to be hypoxic on their arrival initially requiring nonrebreather and on 4 L of nasal cannula on arrival here.  No nausea or vomiting.  No leg pain or swelling.  No chest pain or palpitations.  He arrives febrile and mildly hypertensive.  Mild hypoxia requiring 1 L supplemental nasal cannula.  He is generally fatigued appearing but in no acute distress.  He is breathing comfortably with clear lungs, with hypoxia in the low 90s on room air.  Heart is regular.  Abdomen is soft, obese, nontender.  No pedal edema.  Awake, alert, fully oriented and moving all 4 extremities equally.  Clear posterior oropharynx.  In summary, patient's presentation with fever and fatigue with mild hypoxia is concerning for vaccine reaction versus acute infectious process.  Patient feels improved.  Still generally weak however does not want to stay in the hospital.  Will be discharged to the care of his wife.  Will return for worsening symptoms. [PD]
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Viral test negative, White blood cell count normal
Clinical narrative: Presented to ED at 7:46am  65-year-old gentleman with a history of diverticulitis, chronic liver disease, and prolonged COVID intubation with complicated post COVID course who is presenting from home with fever and generalized fatigue.  After receiving his COVID-vaccine yesterday, patient has developed excessively tired, unable to lift himself out of bed due to overwhelming fatigue.  Tactile fever at home with no shaking chills.  No cough or shortness of breath, though per EMS report noted to be hypoxic on their arrival initially requiring nonrebreather and on 4 L of nasal cannula on arrival here.  No nausea or vomiting.  No leg pain or swelling.  No chest pain or palpitations.  He arrives febrile and mildly hypertensive.  Mild hypoxia requiring 1 L supplemental nasal cannula.  He is generally fatigued appearing but in no acute distress.  He is breathing comfortably with clear lungs, with hypoxia in the low 90s on room air.  Heart is regular.  Abdomen is soft, obese, nontender.  No pedal edema.  Awake, alert, fully oriented and moving all 4 extremities equally.  Clear posterior oropharynx.  In summary, patient's presentation with fever and fatigue with mild hypoxia is concerning for vaccine reaction versus acute infectious process.  Patient feels improved.  Still generally weak however does not want to stay in the hospital.  Will be discharged to the care of his wife.  Will return for worsening symptoms. [PD]
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: Redness, erythematous and warm site, significant pain, fevers, and fatigue.  Diagnosed with cellulitis of left upper extremity.  Treated with BACTRIM DS, doxycycline hyclate, and MEDROL DOSEPACK.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pyrexia
Clinical narrative: Redness, erythematous and warm site, significant pain, fevers, and fatigue.  Diagnosed with cellulitis of left upper extremity.  Treated with BACTRIM DS, doxycycline hyclate, and MEDROL DOSEPACK.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles to face
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received live vaccine Varivax on 1/26/24. Patient received another live vaccine, MMR, on 2/16/24. 21 days after the Varivax. Patient received another MMR on 5/17/24.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Energix- B (pediatric) dose given to 62yo male. Vaccination error.  Patient did not have any side effects or symptoms post immunization.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Abnormal dreams, Chills, Feeling cold, Headache, Nightmare
Clinical narrative: At night, before bed, I had a terrible reaction. I had severe cold chills (couldn't get warm, and shaking) terrible headache (painful intense headache) weird dreams (had strange and scary visions) , sore arm (left arm is sore to the touch) and severe vomiting (I threw up until my stomach was empty).
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Tenderness, Tremor, Vomiting
Clinical narrative: At night, before bed, I had a terrible reaction. I had severe cold chills (couldn't get warm, and shaking) terrible headache (painful intense headache) weird dreams (had strange and scary visions) , sore arm (left arm is sore to the touch) and severe vomiting (I threw up until my stomach was empty).