chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: Dyskinesia, Muscle twitching, Tension, Tremor
Clinical narrative: Mother reported to PCP that on 2/23/24, 4 days after vaccines, pt began having episodes of full body shaking.  The shaking started with a leg twitch and by the end of the day on 2/23/24 mom describes the episodes as the child would tense up her body and then her whole body would shake or jerk.  The episodes are very brief but can happen multiple times in a row. The episodes became more frequent between 2/23/24-2/27/2024.  Pt was seen in the ER on 2/26/2024 and by PCP facility on 2/27/24.  Mom reports 50 or more episodes since 2/23/2024.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Per employee report, vaccine given 01/19/2024 left deltoid. Soon after vaccination given it began to hurt. Took OTC medications and had some relief but 1-2 days later pain came back and was worse. Has been taking OTC NSAIDs with minimal relief. Indicates that pain is from mid-deltoid area of arm down to mid forearm of left upper extremity. Describes pain as "like a toothache" and that pain "spikes" with use. Holds arm in position like it is in a sling. Denies hives, redness, swelling of the left upper extremity. Injury was not reported until 02/23/2024.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Computerised tomogram, Magnetic resonance imaging, Seizure
Clinical narrative: Seizures, loss of memory
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Patient received Gardasil injection and imminently went pale and felt dizzy about to pass out
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: PATIENT INJECTIONS SITE IS RED AND SLIGHTLY INFLAMMED.  THE REDNESS IS INCREASING IN AREA AT THE INJECTION SITE. NO PAIN. JUST ITCHING
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient called and reported she has a generalized rash to her body.  No report of difficulty breathing.  Patient was instructed to contact her primary care doctor for further evaluation.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Electrocardiogram abnormal, Presyncope, Pruritus, Skin warm, Urticaria
Clinical narrative: On 2/18/2024, Two days after the Boostrix injection, I discovered hives in my abdomen. As the day progressed the hives spread up my torso and down my arms and legs. By the following morning I was covered with hives that were hot to the touch, very itchy and I nearly fainted. I was taken to the Emergency Department and treated with Benadryl and famotidine. When the hives did not subside, I was started on Prednisone and sent home. The hives disappeared and then re-appeared for two more days when the doctor was contacted and I was prescribed Hydroxizine, a stronger anti-histamine.  The hives finally disappeared on 2/21/2024.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cough, Exposure during pregnancy, Flushing, Throat clearing
Clinical narrative: Patient received influenza vaccine today 02/26/2024 around 1:15 pm and about 10 minutes later starting coughing and clearing her throat. She communicated that she was having itching in her throat and felt like it was closing up. She appeared flushed. On examination, she had no uvular or palatal swelling and breath sounds were clear. Several other people were brought into the room for assistance. When her symptoms did not improve over the next 2-3 minutes, 0.3 mg epinepherine pen was administered (1:33 pm) in the left outer thigh by myself for suspected anaphylaxis to the influenza vaccine, and an ambulance was called for transport. Her vitals were normal, she was satting 99% on room air, and no obvious swelling of her face or change in her exam was noted over time.  Oxygen was placed with a mask and her vitals were monitored. About 5 minutes later she reported improvement of her symptoms including sensation of throat swelling and tight breathing. The flushing improved. She still reported some itching in the throat. A second epi injection was not given. EMS arrived after about 10 minutes from the first epi shot and sign out was given. Her vitals remained stable and lung exam without wheezing and good air movement and she was escorted to the hospital.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Patient received influenza vaccine today 02/26/2024 around 1:15 pm and about 10 minutes later starting coughing and clearing her throat. She communicated that she was having itching in her throat and felt like it was closing up. She appeared flushed. On examination, she had no uvular or palatal swelling and breath sounds were clear. Several other people were brought into the room for assistance. When her symptoms did not improve over the next 2-3 minutes, 0.3 mg epinepherine pen was administered (1:33 pm) in the left outer thigh by myself for suspected anaphylaxis to the influenza vaccine, and an ambulance was called for transport. Her vitals were normal, she was satting 99% on room air, and no obvious swelling of her face or change in her exam was noted over time.  Oxygen was placed with a mask and her vitals were monitored. About 5 minutes later she reported improvement of her symptoms including sensation of throat swelling and tight breathing. The flushing improved. She still reported some itching in the throat. A second epi injection was not given. EMS arrived after about 10 minutes from the first epi shot and sign out was given. Her vitals remained stable and lung exam without wheezing and good air movement and she was escorted to the hospital.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Cardiac disorder, Dizziness, Postmenopausal haemorrhage, Uterine dilation and curettage
Clinical narrative: I was told to sit in a chair  near healthcare staff because felt dizzy and though heart felt different. I just wanted to go home and was permitted to do so after observation. When I arrived home I went to bathroom and had frank bleeding ( I was in menopause for a few years) and immediately made an appointment with women's doctor (gynecologist) for the same day. She was also surprised and she mentioned " I should contact the CDC!" -- I kept in contact with her as the frank bleeding continued non- stop every day ( I took iron supplements, etc ) on 5/24/2021 I had to have a surgery at Hospital -- it was a DNC  ( I think, had similar initials ) and afterwards eventually the bleeding stopped.  After Moderna Vaccine 12/3/2021 ( I had to get vaccine because travel out of state) I had pain at my heart for 2 days  --
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient accepted offer for re-vaccination which was completed on 2/27/2024.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Manufacturing product shipping issue
Clinical narrative: Patient received vaccine after 30 day window from being removed from frozen status due to a shipping error from supplier. Patient refused offer for re-vaccination.
Age: 92.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: There was a miscommunication between myself and staff, I am floating and she asked me while watching a RSV video if i Had watched it and I said yes it seems easy. and then she asked me if I was floating and if I can give a shot while she watches a video I said yes I thought she wanted a Flu shot and asked her if she had already got the vaccine ready she said no but both of us did not specify what vaccine. Pt Left the clinic, When I got out she asked me if If i Gave a flu shot to him too and I said yes wasn't that the shot you needed and she said not I already gave him that shot. So we both Gave him a Flu HD. Spoke with supervisor she and advised us to call pt let him know and That he should be fine with two shots, he will be back in a month to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC15
Symptoms: Vomiting
Clinical narrative: Mother states after child was administered immunizations, they went home and she fed child. Per mother, after eating child vomited once. Mother thinks it was related to vaccinations and she brought child today for evaluation. Dr. requesting this to be reported to VAERS.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error, Underdose
Clinical narrative: HIB component of vaccine not given.
Age: 12.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Administration error-child given wrong vaccine
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Patient was to get a RSV Abrysvo vaccine and was given an HPV9 Gardasil vaccine.  MA did not document vaccine in chart before giving the vaccine and noticed afterwards it was an HPV vaccine. Patient had no reaction to vaccine. Provider did go talk to the patient and informed her  of wrong vaccine given. Patient informed and reassured will not hurt baby or mother. Incident report filed. OB patient is G2 P1, 32 weeks at todays visit, EDD is 4/23/2024.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired vaccine during office visit. Refrigeration shelf life had an expiration of 2/23/24 and vaccine was administered on 2/26/24. Mother and provider aware. Advised mother to monitor patient. Mother denies any side effects at this time.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller is a nurse who reports expired MMR II was administered to a patient. Product expired 1/7/2024 and was administered 2/5/2024. Product did not experience temperature excursion through date of administration. Diluent lot and expiration collected; This spontaneous report was received from a nurse, concerning to an unspecified gender patient and age patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-FEB-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml, lot # W017556, expiration date: 07-JAN-2024, albumin status: rHA, administered for prophylaxis (route of administration was not provided) (Expired product administered) ; administered in combination with sterile diluent solution for injection/infusion, lot #W036917, expiration date: 21-SEP-2025, administered for prophylaxis (route of administration was not provided). The reporter also stated that the product did not experienced a temperature excursion through the date of the administration (No adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incomplete course of vaccination, Varicella
Clinical narrative: HCP reported adult patient received one dose of VARIVAX "as a child" but did not receive a second dose.  Caller also states patient had titers drawn that were not reactive.; HCP reported adult patient received one dose of VARIVAX "as a child" but did not receive a second dose.  Caller also states patient had titers drawn that were not reactive.; Varicella; This spontaneous report was received from a pharmacist, referring to an 18-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date (reported as when the patient was a child), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, dose, and route of administration were not provided), but did not receive a second dose (inappropriate schedule of product administration). It was reported that the patient thought she had chicken pox as a child as well (varicella) (it was still unknown whether varicella occurred before or after the vaccination). It was reported that the patient had titers drawn that were not reactive (antibody test negative). At the time of reporting, the outcome of the events of varicella and antibody test negative was unknown.  The causal relationship regarding the events of varicella and antibody test negative to varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.   Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no other AE occurred; first dose of VARIVAX on 12/29/2023 (lot: x021280 expiration: 8/20/2025), and the patient received their second dose of VARIVAX on 1/20/2024; This spontaneous report was received from medical assistant and refers to a 16-year-old patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 29-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #x021280, expiration date: 20-AUG-2025, exact dose, route of administration and anatomical location were not provided) and on 20-JAN-2024, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #x021284, expiration date: 20-AUG-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of vaccine administered). On the same days, the patient was vaccinated with first and second dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (manufacturer unknown) (exact doses, lot #, expiration dates, routes of administration and anatomical locations were not provided) for prophylaxis. Confirmed with caller no other adverse event (AE) occurred (No adverse event). No product quality complaint (PQC).
Age: 53.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: No additional AE; RECOMBIVAX HB was inadvertently administered to a patient when they meant to administer HEPLISAVB.; RECOMBIVAX HB dose administered was the 0.5 mL (5 mcg) Pediatric/Adolescent; This spontaneous report has been received from a nurse, regarding a 53-year-old patient with unknown gender. The patient's concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 21-FEB-2024, the patient was inadvertently vaccinated with the first dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection (1 dose of 0.5 ml (5 mcg) pediatric/adolescent Formulation, lot number X017743 has been verified to be a valid lot number and expiration date was 21-FEB-2026, frequency, anatomical location and route of administration were not reported) when they meant to vaccinated with hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) for prophylaxis (wrong product administered, incorrect dose administered).   The patient had not received any hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) doses prior. The patient has not reported any symptoms. No additional adverse event (AE) (no adverse event).
Age: 71.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: that patient received PREVNAR 20 on 1/26/2024 by PCP and PNEUMOVAX 23 on 2/12/2024 by Rheumatologist.; No adverse effects reported.; This spontaneous report was received from a nurse referring to a 71 year old female patient. The patient's concurrent conditions included immunodeficiency. The patient's medical history and concomitant therapies were not provided.  On 26-JAN-2024, the patient was vaccinated by a primary care physician (PCP) with a dose of pneumococcal vaccine conj 20v (crm197)(PREVNAR 20), Lot#: HG7740, expiration date: 03-APR-2025 (strength, dose, route, and anatomical location were not provided) for prophylaxis.   On 12-FEB-2024, the patient was vaccinated by a rheumatologist with a single dose of pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23) lot # X014729, lot#: X014729 and expiration date: 22-NOV-2024 (strength, dose, route, and anatomical location were not provided) for prophylaxis (Extra dose administered).   It was reported that no product confusion was involved. The rheumatologist was not aware patient had recently received pneumococcal vaccine conj 20v (crm197)(PREVNAR 20). No adverse effects reported.
Age: 29.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: He woke up with arm pain; This spontaneous report was received from a patient, referring to himself, a 29-year-old male patient.   On 17-FEB-2024, the patient was supposed to receive his third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but he was late that time. At the night of 22-FEB-2024, the patient was vaccinated with his third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On 23-FEB-2024, the patient woke up with arm pain. At the time of reporting, the patient had not recovered from the pain. The causal relationship between the pain and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: FLUX, MENB
Symptoms: Pain in extremity
Clinical narrative: Painful arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and Influenza vaccine (unknown arm). On an unknown date, 1 week after receiving Bexsero, the patient experienced pain in arm (Verbatim: Painful arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 19-FEB-2024 This report was submitted via the online direct entry reporting system.  The nurse said that the patient received a Bexsero and Flu shot at the same time in the same arm and had reported pain in arm one week later. It was unknown if the reporter considered the pain in arm to be related to Flu (Influenza) vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Headache, Pain
Clinical narrative: head and body aches; head and body aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 65-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: head and body aches) and general body pain (Verbatim: head and body aches). The outcome of the headache and general body pain were not reported.   It was unknown if the reporter considered the headache and general body pain to be related to Arexvy.     It was unknown if the company considered the headache and general body pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-FEB-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient had head and body aches on day.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; an adult patient received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 56-year-old female patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 19-FEB-2024, the patient received the 2nd dose of Engerix B pediatric. On 19-FEB-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: an adult patient received a pediatric dose of Engerix-B ). 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: 19-FEB-2024 An licensed practical nurse (LPN) called in to report that an adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of child product. The Vaccine Administration Facility was the same as Primary Reporter They provided information about the vaccines, event and patient and consented t receive follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient did not get her second vaccine in the Shingrix series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 20th July 2022 received 1st dose with batch number 39YM7 and expiry date 01 September 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient did not get her second vaccine in the Shingrix series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-FEB-2024 The patient self-reported this case. The patient did not get her second vaccine in the Shingrix series till the time of reporting, which led to an incomplete course of vaccination.  The patient stated her pharmacist did not tell her that she had to get another vaccine.  The reporter did not consent to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: 2 doses of boostrix was given to a patient just a little over 8 hrs apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-JAN-2024, the patient received Boostrix. On 21-JAN-2024, an unknown time after receiving Boostrix, the patient experienced overdose (Verbatim: 2 doses of boostrix was given to a patient just a little over 8 hrs apart). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 19-FEB-2024 The pharmacist reported that 2 doses of Boostrix was given to a patient just a little over 8 hrs apart, which led to overdose. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: third dose after the expiration date; Rotarix third dose administered; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 2295T, expiry date 16-FEB-2024) for prophylaxis.   On 19-FEB-2024, the patient received the 3rd dose of Rotarix lyophilized formulation. On 19-FEB-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: third dose after the expiration date) and extra dose administered (Verbatim: Rotarix third dose administered). The outcome of the expired vaccine used and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-FEB-2024 The reporter reported that on reporting day patient received Rotarix (the vaccine presentation that you need to mix) third dose after the expiration date, which led to extra dose administered and expired vaccine used. The reporter consented to follow-up.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: administration of Arexvy via SC rather than IM.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number h2522, expiry date 19-DEC-2024) for prophylaxis.   On 19-FEB-2024, the patient received the 1st dose of Arexvy (subcutaneous). On 19-FEB-2024, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: administration of Arexvy via SC rather than IM.). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2024 The office manager called in for request information about the administration of Arexvy via subcutaneous (SC) rather than intramuscular (IM), which led to intramuscular formulation administered by other route. They provided information about the patient, vaccine and event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Shingrix in Sep 7th 2018 and today the patient got the second dose.; 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 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 9RC7A, expiry date 21-NOV-2025) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 7th September 2018, with batch 4FS5N and expiry date of 08th March 2021).   On 20-FEB-2024, the patient received the 2nd dose of Shingrix. On 20-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received the first dose of Shingrix in Sep 7th 2018 and today the patient got the second dose.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2024 A pharmacist mentioned that a patient received the first dose of Shingrix in Sep 7th 2018 and today (on the day of reporting) the patient got the second dose, which led to lengthening of vaccination schedule. The health care professional (HCP) asked if an extra dose of Shingrix was required. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: First dose was administered in August 2023 and second dose was received today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L5C22, expiry date 18-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (1st dose received on August 2023).   On 21-FEB-2024, the patient received the 2nd dose of Arexvy. On 21-FEB-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: First dose was administered in August 2023 and second dose was received today). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-Feb-2024 The reporter reported that the patient received a second dose of Arexvy vaccine due to a mishap at the pharmacy.  The first dose was administered in August 2023 and second dose was received on day of reporting. which led to extra dose administered.  The reporter stated that the 2nd dose administered by someone else at the pharmacy. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Fatigue, Headache, Pyrexia
Clinical narrative: she feels tired; headache; fever; brain fog; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-FEB-2024, the patient received the 2nd dose of Shingrix. On 22-FEB-2024, 1 days after receiving Shingrix, the patient experienced tiredness (Verbatim: she feels tired), headache (Verbatim: headache), fever (Verbatim: fever) and brain fog (Verbatim: brain fog). The outcome of the tiredness, headache, fever and brain fog were not resolved.   It was unknown if the reporter considered the tiredness, headache, fever and brain fog to be related to Shingrix.     It was unknown if the company considered the tiredness, headache, fever and brain fog to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 The reporter was the husband of the patient.  He stated that him and his wife both received Shingrix the day before reporting. He mentioned that he felt fine but his wife reported that she felt tired, brain fog , had a headache and fever at the time of reporting. He asked how long symptoms last.  The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid 19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:He has an autoimmune disease vitiligo. Sober for 7 years. Does not smoke cigarettes, but used to over 2.5 years ago.  Previously administered products included for COVID-19 prophylaxis: Moderna and Moderna. Past adverse reactions to the above products included No adverse event with Moderna and Moderna. Concurrent medical conditions included Vitiligo, Abstains from alcohol (Sober for 7 years) and Ex-smoker (Does not smoke cigarettes, but used to over 2.5 years ago.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced COVID-19 (Covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient received booster shot. It has been reported that patient was contracted Omicron in Dec-2021 and patient was diagnosed around December 1st. Patient covid-19 symptoms include migraine, headaches and runny nose and symptom continued for seven days. Patient received treatment medication for a 5-day packet.   This case was linked to MOD-2024-761316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2024: Live follow-up has been appended and reference number updated.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: consistent cough; This spontaneous case was reported by a patient and describes the occurrence of COUGH (consistent cough) in an 80-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (consistent cough). At the time of the report, COUGH (consistent cough) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: Patient stated that he started experiencing a "decreased heartbeat" on the following day, 20Feb2024; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE DECREASED (Patient stated that he started experiencing a "decreased heartbeat" on the following day, 20Feb2024) in a 93-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine, Moderna COVID-19 vaccine (Booster) and Moderna COVID-19 vaccine; for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse event with Flu, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Blood pressure high (currently taking medications for that specific issue. No other additional was provided.).    On 19-Feb-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 20-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEART RATE DECREASED (Patient stated that he started experiencing a "decreased heartbeat" on the following day, 20Feb2024). At the time of the report, HEART RATE DECREASED (Patient stated that he started experiencing a "decreased heartbeat" on the following day, 20Feb2024) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2024, Heart rate: Decreased.         Patient was currently taking medications for high blood pressure. Suspect product dosage text was reported as unknown. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Trigeminal neuralgia
Clinical narrative: Covid-19; Trigeminal neuralgia; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminal neuralgia) and COVID-19 (Covid-19) in a 41-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Epilepsy, SVT, hashimotos, mitral valve regurgitation, aortic leak, COPD, asthma, TMJ, osteoporosis, alopecia areata, Tarlov cyst, azygos fissure, hEDS, fibromyalgia, vaccine allergies=polio & pertussis vaccine allergies Patient was diagnosed with Covid 19.  The patient's past medical history included Azygos fissure, Alopecia areata and Tarlov's cyst. Concurrent medical conditions included Epilepsy, Supraventricular tachycardia, Mitral regurgitation, COPD, Asthma, Osteoporosis, Fibromyalgia, Allergy to vaccine (polio & pertussis vaccine allergies), Hashimoto's disease and TMJ syndrome. Concomitant products included PREGABALIN, LEVETIRACETAM and BACLOFEN for an unknown indication.    On 20-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia). On 23-Feb-2024, the patient experienced COVID-19 (Covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TRIGEMINAL NEURALGIA (Trigeminal neuralgia) had not resolved and COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms/events Patient medical history, concomitant disease, risk factor also included aortic leak and hEDS. There were no lab data/results available.
Age: 0.25
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: Patients parent stated Diarrhea started the day after patient received Rotarix 2/23/24  and has continued up to today 2/27/24. Doctor "encouraged lots of fluids as tolerated" and to "return is symptoms worsen".
Age: 50.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient wasn't 60, but was only 50 years old
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Severe rash(severe itching)
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: - I administered Pentacel (2nd dose)  to the pt. , but when I was going to note it down on the pt's chart, I noticed it had expired on 2/22/24. When preparing the vaccine beforehand, I looked at the expiration date and, in the moment, I misread it, thinking it was still valid.   - I notified the Physician's Assistant who had seen the pt. for a 4 month Well child Check about the incident. He suggested I call someone from the immunization clinic for advice on how to proceed after the incident. I called and was referred. She advised me to notify the parent, and let them know of the incident and that administering an expired vaccine will not be harmful to the child. It would be invalid though, and would mean the child would have to come back for another administration of the pentacel. I would also have to fill up a VAERS form on the CDC website and submit it for records on the CDC site.   -  I called the pt s mother and explained the incident to her. I reassured her that her child would be fine and she said that as long as her child is okay, she ll be okay. I mentioned that he would have to come back for another pentacel administration once we have a fresh stock of it, she acknowledged.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Overdose, Product preparation error, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness/swelling at injection site; redness/swelling at injection site; Irritability; inadvertently given the undiluted whole dose to a baby instead of a diluted Pfizer COVID vaccine 6 months to 4 dose; inadvertently given the undiluted whole dose to a baby instead of a diluted Pfizer COVID vaccine 6 months to 4 dose; This is a spontaneous report received from Nurses and Other HCPs from medical information team, Program ID.  An 8-month-old male patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 15Feb2024 as dose 3, 3 ug single (Lot number: HH3252) at the age of 8 months intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE, manufacturer unknown), for COVID-19 Immunisation. The following information was reported: IRRITABILITY (non-serious) with onset 15Feb2024, outcome "recovered"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 15Feb2024, outcome "unknown" and all described as "inadvertently given the undiluted whole dose to a baby instead of a diluted Pfizer COVID vaccine 6 months to 4 dose"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 15Feb2024, outcome "recovered" and all described as "redness/swelling at injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, irritability. Additional information: It was reported that an 8 month old came in for their third dose of the Covid vaccine and they were inadvertently given the whole vial of the multi-vial that was undiluted instead of the diluted dose. It was the Pfizer Covid vaccine yellow cap for 6 months to 4 years of age formulation. The doctor wanted to call the parents to advise on the side effects or things to look out for. On 22Feb2024, it was reported that the vial was administered without dilution. The error occurred when the product was prepared, and it was not noticed and intercepted before it was supplied to the patient. This is due to inadvertent human error. The expiration date was reported as 10Apr2024.  Follow up (22Feb2024): This is a spontaneous follow-up report received from Other HCPs from medical information team, Program ID. Updated information: reporter information, patient details (age, age at vaccination, height, weight, relevant medical history), suspect product details (vaccination dates, lot number, route of administration), event details (new events Irritability, Vaccination site swelling and Vaccination site erythema).
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Palpitations, Thrombosis
Clinical narrative: he has high blood pressure and is worried about blood clots; he has high blood pressure and is worried about blood clots; palpitations; The initial case was missing the following minimum criteria: [other - info not qualifying for AE reporting  Agency (No adverse event)]. Upon receipt of follow-up information on [21Feb2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "He mentioned he was a constant drinker and just stopped 2 weeks ago" (unspecified if ongoing); "He mentioned he was a constant drinker and just stopped 2 weeks ago" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: had Covid before getting the 1st Pfizer vaccine as well as the boosters. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: THROMBOSIS (medically significant), HYPERTENSION (non-serious), outcome "unknown" and all described as "he has high blood pressure and is worried about blood clots"; PALPITATIONS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Caller mentioned that he almost took the 2024 covid vaccines and he said it did not mention the side effects. He mentioned he was a constant drinker and just stopped 2 weeks ago and wanted to know if he fits for taking the shot. Confirmed he had high blood pressure and had palpitations and worried about blood clots. He also advised he had Covid before getting the 1st Pfizer vaccine as well as the boosters. He said the boosters gave him immunity. Caller would like to know would he get sick from the new variant if he did not get the Comirnaty vaccine. He mentioned he already got the omicron and regular one and he was asking about the Comirnaty.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.  Follow-up (21Feb2024): This is a spontaneous follow-up report received from same Consumer.  Updated information: New events (Thrombosis, Hypertension and Palpitations); Clinical course; Relevant medical history, Historical vaccine added; Product coding updated.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Nurse.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 10:00 as dose 1, single (Lot number: HG4680) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "myeloproliferative disease" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 12Feb2024 to 16Feb2024.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by several factors. However, a contributory role of BNT162b2 omi xbb.1.5 to the events Vaccination failure and Covid-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed COVID;got all COVID Pfizer vaccines; diagnosed COVID;got all COVID Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing), notes: I do have a fatty liver and a cyst on my kidney that's bigger than the kidney; "Cyst on my kidney that's bigger than the kidney" (unspecified if ongoing), notes: I do have a fatty liver and a cyst on my kidney that's bigger than the kidney. There were no concomitant medications. Vaccination history included: Bnt162b2 (She has had her all of her Pfizer COVID vaccine), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Feb2024, outcome "unknown" and all described as "diagnosed COVID;got all COVID Pfizer vaccines". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) High; SARS-CoV-2 test: (23Feb2024) Positive, notes: I tested last night and this morning it was positive for COVID. Yes.". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: She was diagnosed COVID and prescribed Paxlovid. She wanted to know if she could take this medication with her medical conditions.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.