chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Tired; Headache; Place where he got the shot was hurting too; it was painful; This is a spontaneous report received from a consumer.  A 60-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Tired". The following information was reported: HEADACHE (non-serious) with onset 06Oct2024, outcome "recovering"; FATIGUE (non-serious) with onset 06Oct2024, outcome "not recovered", described as "Tired"; VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "unknown", described as "Place where he got the shot was hurting too; it was painful". Therapeutic measures were taken as a result of fatigue, headache, vaccination site pain.  Additional Information: For other medications, the patient does take but does not know the amount though. The patient had over the course of the last several years, he had all of his COVID-19 shots from Pfizer. The patient had a Pfizer vaccine on Sunday (06Oct2024), and he had been feeling very tired. On his first vaccine a couple years ago (unspecified) when he had his Pfizer COVID-19 Vaccine (patient had no vaccine 4-week prior), he was also very tired, but he had not been tired in other ones. This time, he was tired again and he was wondering how long the company thinks that may last. The place where he got the shot was hurting too, it was painful, and he had headaches with the first day which is not as much today. But the patient was still very tired. As treatment, the patient just took ibuprofen.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400272977 Same patient and product; different dose and event;
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Back pain, Nervousness, Pain, Pain in extremity
Clinical narrative: Within 5 minutes or less from the injections I walked about 50 yards then started having intense lower back pain that traveled down my spine, legs and right arm. I also developed a bad headache. It was a sharp pain, like an intense spasm. I could no longer walk and dropped to the floor in a ball. About 10 minutes passed and I was able to use my grocery cart to stand and very slowly starting walking back to the pharmacist. I made it about 1/3 of the way and had to stop at a bench. I waited about 25 minutes and started getting some relief from the pain/spasms and I was left with shortness of breath, very shaky and I felt like I has experienced some kind of intense adrenaline rush. I made it back to the pharmacist and reported the reaction.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Back pain, Dyspnoea, Headache, Pain, Syncope
Clinical narrative: Within 5 minutes or less from the injections I walked about 50 yards then started having intense lower back pain that traveled down my spine, legs and right arm. I also developed a bad headache. It was a sharp pain, like an intense spasm. I could no longer walk and dropped to the floor in a ball. About 10 minutes passed and I was able to use my grocery cart to stand and very slowly starting walking back to the pharmacist. I made it about 1/3 of the way and had to stop at a bench. I waited about 25 minutes and started getting some relief from the pain/spasms and I was left with shortness of breath, very shaky and I felt like I has experienced some kind of intense adrenaline rush. I made it back to the pharmacist and reported the reaction.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLU3
Symptoms: Tremor
Clinical narrative: Within 5 minutes or less from the injections I walked about 50 yards then started having intense lower back pain that traveled down my spine, legs and right arm. I also developed a bad headache. It was a sharp pain, like an intense spasm. I could no longer walk and dropped to the floor in a ball. About 10 minutes passed and I was able to use my grocery cart to stand and very slowly starting walking back to the pharmacist. I made it about 1/3 of the way and had to stop at a bench. I waited about 25 minutes and started getting some relief from the pain/spasms and I was left with shortness of breath, very shaky and I felt like I has experienced some kind of intense adrenaline rush. I made it back to the pharmacist and reported the reaction.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Lichen planus
Clinical narrative: lichen planus
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray, Erythema, Fine motor skill dysfunction, Skin swelling, Viral test
Clinical narrative: 2 hours after shot  face and body started turning red and puffy for 2 days, had to administer Benadryl to lower symptoms. every 3 weeks have to go to hospital for a steroid shot and breathing treatments. also loss of motor skills noted
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenitis
Clinical narrative: lymph gland in the neck.; This spontaneous report was received from a nurse via a company representative regarding her 11-year-old daughter (female). The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.   On 31-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided).  On 02-AUG-2024 (reported as two days after), the patient developed a  lymph gland in the neck (Lymphadenitis). At the time of reporting, the outcome of the event had not been reported.    The causal relationship between lymphadenitis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Lot# is being requested and would be provided upon received.
Sex: M
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Was Knocked Out Not Feeling Well For 4 Hours; Initial report received on 19-Sep-2024.  A consumer reported that he, a male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and it "knocked him out," like not feeling well for 4 hours.  No medical history or concomitant medications were reported.  The patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, and NDC #, route, and site not reported)].   On the same day, the patient stated that it "knocked him out."   He stated, "like he did not feel well for 4 hours."   No other information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently administered a 2nd dose of Arexvy; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (1st dose received on 31st October 2023).   On 27-SEP-2024, the patient received Arexvy. On 27-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient inadvertently administered a 2nd dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 Healthcare professional stated patient inadvertently administered a 2nd dose of Arexvy which led to extra dose administered. Email stated they had given a patient her RSV vaccine on Friday but did not realize she already had received one last year on. She was an 89 year old female who was in good health, active, and no chronic health conditions that  aware of.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Havrix adult was administered to 4yr old; Havrix adult was administered to 4yr old; This non-serious case was reported by a other health professional and described the occurrence of adult product administered to child in a 4-year-old male patient who received HAV (Havrix adult) (batch number 4T93R) for prophylaxis.   On 01-OCT-2024, the patient received Havrix adult 1 ml. On 01-OCT-2024, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Havrix adult was administered to 4yr old) and overdose (Verbatim: Havrix adult was administered to 4yr old). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 Havrix adult was administered to 4yr old which led to adult product administered to child and overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Ophthalmic herpes zoster; 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and ophthalmic herpes zoster (Verbatim: Ophthalmic herpes zoster) (serious criteria GSK medically significant). The outcome of the vaccination failure, shingles and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date : 06-OCT-2024 Reporter reported that he/she had vaccine and had shingles 3 times twice in eye. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: wrong route of administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 54-year-old female patient who received MMR (Priorix) (batch number 53F2A, expiry date 01-NOV-2024) for prophylaxis.   On 21-AUG-2024, the patient received the 2nd dose of Priorix (intramuscular). On 21-AUG-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: wrong route of administration). The outcome of the subcutaneous injection formulation administered by other route 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: 03-OCT-2024 Vaccine was supposed to be administered subcutaneous, but was administered intramuscular instead which led to subcutaneous injection formulation administered by other route.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra Dose; This non-serious case was reported by a pharmacist 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 K3CX7, expiry date 12-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (1st dose received on 21st November 2023, lot number KZ4H9, expiry date 2nd march 2025).   On 26-SEP-2024, the patient received the 2nd dose of Arexvy. On 26-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2024 Pharmacist reported she administered a dose of Arexvy to a 72 year old female patient on 26 September 2024 without realizing the patient had already received a dose of Arexvy on 21 November 2023 which led to extra dose administered.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose of Havrix 5 months after receiving the 1st one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received the 2nd dose of Havrix 5 months after receiving the 1st one).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: received the 2nd dose of Havrix 5 months after receiving the 1st one). The outcome of the drug dose administration interval too short 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: 30-SEP-2024 A pharmacist called to inform that a 5 year old patient received the 2nd dose of Havrix 5 months after receiving the 1st one (did not specify dates). Pharmacist was looking for guidance, as the patient was required to have the Hepatitis A vaccination for school. The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received the first dose of Twinrix in 2018 and never got another dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received the first dose of Twinrix in 2018 and never got another dose). The outcome of the incomplete course of vaccination 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: 30-SEP-2024 Nurse Practitioner reported a patient received the first dose of Twinrix in 2018 and never got another dose. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: intending to receive Flulaval have received Tdap inadvertently; look alike and could be mistaken for each other at a glance; This non-serious case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 26-SEP-2024, the patient received Boostrix. On 26-SEP-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: intending to receive Flulaval have received Tdap inadvertently) and look alike packaging (Verbatim: look alike and could be mistaken for each other at a glance). The outcome of the wrong vaccine administered and look alike packaging were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2024 The reporter wanted to reach out to inform about the safety concern that had been escalated in the past few days where a mix up of Flulaval and Tdap occurring. There had been two events where individuals intending to receive Flulaval had received Tdap inadvertently, which led to wrong vaccine administered. When comparing the similarity of the products, it was very evident they were vey much alike and could be mistaken for each other at a lance, which led to look alike packaging. The reporter said that could please escalate this concern, that would be wonderful as this problem may persist throughout flu season.; Sender's Comments:  US-GSK-US2024AMR120693:Original Case : US2024AMR120690
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number T92HK, expiry date 10-AUG-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 28-SEP-2024, the patient received the 2nd dose of Shingrix. On 28-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: early 2nd dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2024 A pharmacist reported that a patient got the second dose of Shingrix 5 days after the first dose. First dose was given on Sep 23rd 2024 and the second dose on Sep 28th2024. Both doses have the same lot number and expiration date. The pharmacist asked for safety data and recommendations on this situation.  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose not received yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20th March 2024, lot number 32TE3, expiry date 10th June 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: second dose not received yet). The outcome of the incomplete course of vaccination 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: 30-SEP-2024 Pharmacy Student explained that a patient got their first dose of Twinrix back on March 20th 2024 and now they wanted to get a second dose but caller looked at the Prescribing Information that according to the normal schedule the second dose needs to be administered 1 month later. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: They used sterile saline instead of the included adjuvant to reconstitute the vaccine; They used sterile saline instead of the included adjuvant to reconstitute the vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: They used sterile saline instead of the included adjuvant to reconstitute the vaccine) and inappropriate dose of vaccine administered (Verbatim: They used sterile saline instead of the included adjuvant to reconstitute the vaccine). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 The GSK Field Sales Professional reported that he received information from the provider's office that an adverse event had occurred with their Menveo vial plus vial preparation. They used sterile saline instead of the included adjuvant to reconstitute the vaccine which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. No further information is available from the Field Sales Professional.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Havrix adult dose to pediatric patient; Havrix adult dose to pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 05-SEP-2024, the patient received the 1st dose of Havrix adult. On 05-SEP-2024, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Havrix adult dose to pediatric patient) and overdose (Verbatim: Havrix adult dose to pediatric patient). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 Office manager reported that adult dose was given as a first dose of Havrix to a pediatric patient. Office manager also stated the parent did not notify them of the child having any adverse events which led to adult product administered to child and overdose.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: use normal saline diluent instead of the adjuvant suspension; use normal saline diluent instead of the adjuvant suspension; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: use normal saline diluent instead of the adjuvant suspension) and inappropriate dose of vaccine administered (Verbatim: use normal saline diluent instead of the adjuvant suspension). The outcome of the wrong solution used in drug reconstitution was unchanged and the outcome of the inappropriate dose of vaccine administered was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2024 A Advanced Practice Registered Nurse started a chat and informed that CMA used normal saline diluent instead of the adjuvant suspension which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case is linked with US2024121565, same reporter different patient.; Sender's Comments:  US-GSK-US2024121565:male patient
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: reconstituted the Arexvy lyophilized component with sterile saline solution; reconstituted the Arexvy lyophilized component with sterile saline solution; 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 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2KJ34, expiry date 03-JUL-2025) for prophylaxis.   On 01-OCT-2024, the patient received Arexvy. On 01-OCT-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted the Arexvy lyophilized component with sterile saline solution) and inappropriate dose of vaccine administered (Verbatim: reconstituted the Arexvy lyophilized component with sterile saline solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAY-2024 The healthcare professional reported that she reconstituted the Arexvy lyophilized component with sterile saline solution which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. This dose was given to a patient on Oct 1st 2024. The healthcare professional asked if patient had to be re vaccinated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant got vaccine with no reported adverse event; Initial information received on 19-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 38 years old female  pregnant patient who got influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date is 14-Nov-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 19-Sep-2024, the pregnant patient received unknown dose (dose 1) of suspect influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection (lot UT8423JA; strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination with no reported adverse event (exposure during pregnancy) (latency: same day). Relevant prenatal testing after exposure was not reported.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: opened Ipol were out of range for 30 minutes and reached 8.28C and administered to a patient  with no reported Adverse Event; Initial information received on 27-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is link cluster case US-SA-2024SA282315.  This case involves an opened IPV (VERO) [IPOL] were out of range for 30 minutes and reached 8.28c and administered to a 5 years old female patient 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, the patient administered unknown dose of suspect opened IPV (VERO), Suspension for injection, (lot W1A191M; Expiration Date : 16-FEB-2025) via unknown route in unknown administration site for Prophylactic vaccination which was out of range for 30 minutes and reached 8.28c with no reported adverse event (poor quality product administered) (unknown latency).  Caller stated that the products were involved in two separate excursions. Caller stated the first excursion occurred on 13Jul2024 while they were doing inventory; products were out of range for 30 minutes and reached 8.28C.Caller stated that the second excursion occurred through 20Jul2024 to 23Jul2024 due to unknown cause; products were out of range for 47 hours and 30 minutes and reached 1.47C.    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.; Sender's Comments:  US-SA-2024SA282315:02219685
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Computerised tomogram, High frequency ablation, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: GIVEN IN MY LEFT UPPER ARM, IT DIDN'T FEEL LIKE THE FIRST ONE I TOOK ON 03/22/2021 THIS ONE HAD A BURNING SENSATION AND MY ARM WENT NUMB AFTER GETTING IT. I COULDN'T USE MY ARM THE ENTRE DAY, IT WAS SWOLLEN AND HURTING I WENT TO THE EMERGENCY ROOM BECAUSE IT WOULDN'T STOP HURTING AND THEY TOLD ME I WAS HAVING THE FLU OR SOMETHING AND THAT WASN'T TRUE I HAD A FEVER BUT THE SIGHT BECAME RED AND HARD AND I WAS UNABLE TO LIFT MY ARM OR TURN MY HEAD AND IT JUST KEPT GETTING WORSE UNTIL I HAD TO FINALLY GO SEE THE PCP AND THEN I SAW NUEROSURGEON, THEN PAIN MANAGEMENT WHO DID NERVE BLOCK NERVE BURN SENT ME FOR PHYSICAL THERAPY BY THEN THE TENDONS WAS OFF THE BONE IN MY SHOULDER. I HAD TO HAVE SURGERY TO REPAIR IT  ON 09/8/2022 THEY ATTACHED THE TENDON BACK TO THE BONE WITH SCREWS. I AM STILL UNABLE TO LIFT MY LEFT ARM HALFWAY ABOVE MY HEAD
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Magnetic resonance imaging, Mobility decreased, Nerve block
Clinical narrative: GIVEN IN MY LEFT UPPER ARM, IT DIDN'T FEEL LIKE THE FIRST ONE I TOOK ON 03/22/2021 THIS ONE HAD A BURNING SENSATION AND MY ARM WENT NUMB AFTER GETTING IT. I COULDN'T USE MY ARM THE ENTRE DAY, IT WAS SWOLLEN AND HURTING I WENT TO THE EMERGENCY ROOM BECAUSE IT WOULDN'T STOP HURTING AND THEY TOLD ME I WAS HAVING THE FLU OR SOMETHING AND THAT WASN'T TRUE I HAD A FEVER BUT THE SIGHT BECAME RED AND HARD AND I WAS UNABLE TO LIFT MY ARM OR TURN MY HEAD AND IT JUST KEPT GETTING WORSE UNTIL I HAD TO FINALLY GO SEE THE PCP AND THEN I SAW NUEROSURGEON, THEN PAIN MANAGEMENT WHO DID NERVE BLOCK NERVE BURN SENT ME FOR PHYSICAL THERAPY BY THEN THE TENDONS WAS OFF THE BONE IN MY SHOULDER. I HAD TO HAVE SURGERY TO REPAIR IT  ON 09/8/2022 THEY ATTACHED THE TENDON BACK TO THE BONE WITH SCREWS. I AM STILL UNABLE TO LIFT MY LEFT ARM HALFWAY ABOVE MY HEAD
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rotator cuff repair, Tendon injury
Clinical narrative: GIVEN IN MY LEFT UPPER ARM, IT DIDN'T FEEL LIKE THE FIRST ONE I TOOK ON 03/22/2021 THIS ONE HAD A BURNING SENSATION AND MY ARM WENT NUMB AFTER GETTING IT. I COULDN'T USE MY ARM THE ENTRE DAY, IT WAS SWOLLEN AND HURTING I WENT TO THE EMERGENCY ROOM BECAUSE IT WOULDN'T STOP HURTING AND THEY TOLD ME I WAS HAVING THE FLU OR SOMETHING AND THAT WASN'T TRUE I HAD A FEVER BUT THE SIGHT BECAME RED AND HARD AND I WAS UNABLE TO LIFT MY ARM OR TURN MY HEAD AND IT JUST KEPT GETTING WORSE UNTIL I HAD TO FINALLY GO SEE THE PCP AND THEN I SAW NUEROSURGEON, THEN PAIN MANAGEMENT WHO DID NERVE BLOCK NERVE BURN SENT ME FOR PHYSICAL THERAPY BY THEN THE TENDONS WAS OFF THE BONE IN MY SHOULDER. I HAD TO HAVE SURGERY TO REPAIR IT  ON 09/8/2022 THEY ATTACHED THE TENDON BACK TO THE BONE WITH SCREWS. I AM STILL UNABLE TO LIFT MY LEFT ARM HALFWAY ABOVE MY HEAD
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tenoplasty, Ultrasound Doppler
Clinical narrative: GIVEN IN MY LEFT UPPER ARM, IT DIDN'T FEEL LIKE THE FIRST ONE I TOOK ON 03/22/2021 THIS ONE HAD A BURNING SENSATION AND MY ARM WENT NUMB AFTER GETTING IT. I COULDN'T USE MY ARM THE ENTRE DAY, IT WAS SWOLLEN AND HURTING I WENT TO THE EMERGENCY ROOM BECAUSE IT WOULDN'T STOP HURTING AND THEY TOLD ME I WAS HAVING THE FLU OR SOMETHING AND THAT WASN'T TRUE I HAD A FEVER BUT THE SIGHT BECAME RED AND HARD AND I WAS UNABLE TO LIFT MY ARM OR TURN MY HEAD AND IT JUST KEPT GETTING WORSE UNTIL I HAD TO FINALLY GO SEE THE PCP AND THEN I SAW NUEROSURGEON, THEN PAIN MANAGEMENT WHO DID NERVE BLOCK NERVE BURN SENT ME FOR PHYSICAL THERAPY BY THEN THE TENDONS WAS OFF THE BONE IN MY SHOULDER. I HAD TO HAVE SURGERY TO REPAIR IT  ON 09/8/2022 THEY ATTACHED THE TENDON BACK TO THE BONE WITH SCREWS. I AM STILL UNABLE TO LIFT MY LEFT ARM HALFWAY ABOVE MY HEAD
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: About 24 hours post vaccine, my Apple Watch alerted me to a high heart rate. I was sitting down, had a 102 fever, and my heart rate tracked from 130-136 for about 30 minutes. It stayed above 119 for a few hours.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome
Clinical narrative: My daughter had the Pfizer covid vaccine and her life has not been the same since. Has POTS and many other side effects. Many heat related effects as well. Changed her whole life. Is there any help for her to get her life back? This affects her on a daily basis from driving to doing daily tasks and activities.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Injected with Moderna covid vaccine at pharmacy. That evening experienced headache, body aches and pain, chills. By morning chills gone but headache remained. I am male in very good health with only exception mild high blood pressure and hypothyroidism.
Sex: U
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: Describe Event, Problem, or Product Use Error: Lot LN6739 Exp. 2026/01 SN: 382808587818. This is for covid vaccine ages 6m to < 5 yr. According to staff, they opened our box of pfizer vaccine from being sealed and began to draw up dose out of vial. When staff member went to scan the dose, the dose flagged as expired on MAR. Upon review of vial, it was noted that the 2023-24 formulation was present with expiration date of 2024/07. Again, this was taken out of a brand new, unopened box of 2024-25 vaccines. The lot number and exp on the vial did not match the lot number and exp on the box. The nurse states she then crosschecked all the other vials within the container and confirmed that no other doses where incorrect. I can confirm that the bin in which the dose is stored is brand new, as we recently transferred to our new standardization bins. To my knowledge, we did NOT have any remaining 2023-2024 doses left within clinic elsewhere. Information on misfit vial-Lot: HH3252 Exp 2024/07
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Influenza, Malaise
Clinical narrative: The shingles shot made me sicker than the Covid Shot. I was sick with flu symptoms for 2 weeks. Had shortness of breath and massive headaches.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient reports getting a flu shot on a friday in med-September and the next day went to the ER with a fever of 103F and a stiff neck. Findings showed no known cause so patient checked herself out and went home to lie down. She drank water and her fever went away after about an hour and her stiff neck was better the next day.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUX, TDAP
Symptoms: Unevaluable event
Clinical narrative: I was just vaccinated at pharmacy again. I've been vaccinated there multiple times. I have a recommendation. I recommend showing patients the vaccine before injecting them so they can at least confirm it's the correct type. I think my doctor has the best practice - they have patients sign to confirm both the vaccine type and lot. The pharmacy was very busy, and I got three different vaccines. It would be very easy for anyone to make a mistake. Confirmation like this is common in doctor's offices and in medical laboratories. Failure to confirm as has always happened in my experience at pharmacy is very likely to lead to errors. Also, the person who gave me this shot swabbed a 6 square inch area on my arm with the alcohol. I'm sure it's only necessary to have a small part where the needle will go in. He swabbed such a large area, I have no confidence he happened to hit the small spot where the needle went in.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Received Comirnaty COVID 24-25 Covid 19 Vaccine (Pfizer-Biontech) Injection NDC: 00069-2432-10. After receiving above vaccine in afternoon, by evening, I had major chills, fever, headache, muscle pain, tiredness, mild nausea. Symptoms resolved next day.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received Comirnaty COVID 24-25 Covid 19 Vaccine (Pfizer-Biontech) Injection NDC: 00069-2432-10. After receiving above vaccine in afternoon, by evening, I had major chills, fever, headache, muscle pain, tiredness, mild nausea. Symptoms resolved next day.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Mouth swelling, Nausea, Sinus congestion, Swelling face
Clinical narrative: -nausea first day. Next morning - swollen face, mouth, tongue, sinuses swollen; bottom of mouth - took benadryl - waited 45min - took second dose of benadryl - swelling lessened - migraine persisted - motrin 400mg taken - took more benadryl next morning for some sinus sweling - all resolved
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: -nausea first day. Next morning - swollen face, mouth, tongue, sinuses swollen; bottom of mouth - took benadryl - waited 45min - took second dose of benadryl - swelling lessened - migraine persisted - motrin 400mg taken - took more benadryl next morning for some sinus sweling - all resolved
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling to left upper arm around injection site. Patient advised by provider to treat with Ibuprofen, Zyrtec, & apply ice.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness
Clinical narrative: Pt felt weak + faint, had pt sit down pt was alert and answered all questions correctly. Paramedics took vitals (all normal). Mom denied transport to hospital. Pt was doing fine when he came in again
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Pain and motion limitation upper lateral part of shoulder since day after injection
Age: 5.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient received incorrect dose it was a SARSCOV2 Pfizer 6m-4 years. 0.3 mcg
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: In July '21 self palpate right breast mass
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Bell's palsy on September 20, 2024
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuralgia, Pain, Trigeminal neuralgia
Clinical narrative: Extreme facial nerve pain. Unusually focused on nerves around the right eye. Never experienced this before with any TN issue. Unable to open right eye without severe nerve pain.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Painful respiration
Clinical narrative: pt states when she breath it hurts. She can't take deep breaths. She went to UC on 10/13/24. she had a chest xray.  The xray was negative. Her temp was 100. She was not prescribed any medicine. They referred he to follow up with a primary care doctor if she didn't recover.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicte dose of the Fluad vaccine. Patients initial dose was 08/31/2024
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: RN (writer) accidentally administered a 2024-2025 Formulation of the COVID-19 Booster (Moderna Spikevax) intended for ages 12+ and up, to the patient who is currently 10 years, 11 months and weighs 84 lb (38.1 kg). RN administered the vaccine during an office visit on Wednesday, October 9th & did not realize the mistake until the following day when signing/reviewing the log-book for another patient and immediately notified supervisor team, filed an internal incident report, and was also guided to fill out this report. Further notified PCP and ordering provider seeing the patient of the mistake and awaiting guidance on preference to relay this information to pt/family. The difference is the amount given: 0.25 mL for ages 6 months - 11 years, and 0.5 mL for ages 12 years and up, including adults.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Rash
Clinical narrative: I had a big painful rash on my left arm at the injection site.  It is currently still there after 3 days. It is very warm to the touch.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 6 year old child was administered Quadracel for the third dose of DTAP and third dose of Polio. Quadracel/Kinrix are only licensed to be utilized as the fifth dose of DTAP and the fourth or fifth dose of Polio for ages 4-6 years old. Because minimum intervals were met, the dose is considered valid per immunization program nurse and recommendations.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reports the influenza vaccine was given in the subcutaneous tissue adjacent to the deltoid in the left arm. She reported feeling fluid pocket in the left arm with some pain (3/10). She stated she took Tylenol that afternoon and one this am. Denied need to be seen by provider - just wanted to report it. Nurse noted slightly warm 8 mm circle to left arm lower and to the right of deltoid space; without noting any fluid in this tissue space.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: The patient experienced tingling in her hand and arm almost immediately, however she was fully recovered the following day. The patient herself is a nurse and acknowledged the placement was correctly administered in her deltoid (not too high or low).
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On 10/1/2024 PHN administered Vaxelis to a 5 y/o child.  On 10/1/2024 facility consulted with Dr. since Vaxelis is only approved to be administered to children 6 weeks through 4 years of Age.   Per Dr. the dose is considered valid, and the child does not need to be revaccinate. Nurse will review policy regarding use of Vaxelis.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Injury associated with device
Clinical narrative: Needlestick injury / exposure
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3, HEP, HEPA, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child received 2 doses of the flu vaccine. After event occured, patient remained in office additional 30 minutes. No signs or symptoms observed or reported. Patient instructed to report any signs or symptoms to Health Unit or ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dtap/IPV quadracel was given as 3rd dose and can only be used for 5th dose of Dtap and 4th or 5th dose of IPV.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal discomfort, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: pt had soreness at the injections site. Later that night she had upset stomach. She had normal bowels. She had problems sleeping that night. She was not well next morning. She continues to have upset stomach being nauseated. She has not had any medical treatment at this time.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a third dose of Shingrix when they were not indicated for a third dose. He has not had an adverse reaction.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: Patient reported heat, redness, and a hard bump under the skin near where the COVID vaccine was placed. She said it started a few hours after the vaccine and was worse the next morning upon waking.
Age: 83.0
Sex: M
Vaccine: PNC20
Symptoms: Abdominal discomfort, Faeces soft, Injection site pain, Myalgia, Pain
Clinical narrative: pt states he developed soreness at the injection site. He had mild symptoms that were expected. By 10/13/24 he had body and muscle aches. He developed upset stomach and soft stool. He has no fever. He has never felt this way after being vaccinated.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Full blood count normal, Metabolic function test normal, Pyrexia, Respiratory viral panel, Urine analysis normal
Clinical narrative: Fever within 24 hours of vaccine administration, then next day, following fever resolution, parent noted possible seizure like activity, generalized tonic-clonic with possible emergence of focality at the left upper extremity, lasting 10-15 seconds.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient is experiencing a localized injection site reaction to her left deltoid. Site is slightly warm to the touch, red and inflammed and swollen to the touch. Patient doesn't report any itching or trouble breathing. and the swelling has not grown since this morning 10/14/24. Patient didn't report any pain to the area other than standard arm soreness. Pharmacist recommended using tylenol routinely over the next 24 hours to help with the inflammatory response and we follow up with provider in 48 hours to see if the swelling has gone down.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Temporomandibular pain and dysfunction syndrome
Clinical narrative: Temporomandibular joint disorder (TMJD): pain in right jaw/side of face especially when biting or opening mouth.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient did not experience any adverse effects from receiving a second dose of Prevnar 20 six months after receiving an initial dose of Prevnar 20.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, warm, and itchy spot. Raised. Did not progress to need medical attention.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, C-reactive protein, Contusion, Dehydration, Differential white blood cell count
Clinical narrative: Diagnosis of Henoch-Schonlein purpura (HSP). Purple bruising and rash all over her body- focused mostly on lower extremeties. INTENSE pain all over her body; inability to walk; missing of school following the diagnsis ( Currently on WEEK 2) ER VISIT. Still experiencing intense pain after finishing course of Keflex 250MG/5ML; Prednisolone 15MG/5ML; still taking Oxycodone 5ML/5ML solution in addition to Tylenol. we are in second week of pain and HSP symptoms