chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: received Hiberix diluent alone; received Hiberix diluent alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old patient who received Hib (Hiberix) (batch number M7422, expiry date 15-JUN-2027) for prophylaxis.   On 09-MAY-2024, the patient received Hiberix. On 09-MAY-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: received Hiberix diluent alone) and inappropriate dose of vaccine administered (Verbatim: received Hiberix diluent alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The nurse stated that the patient received Hiberix diluent alone from 2 different locations, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.   This was 1 of 7 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024061908:INTIAL CASE US-GSK-US2024AMR063489:Same reporter / different patient US-GSK-US2024AMR063487:Same reporter / different patient US-GSK-US2024AMR063486:Same reporter / different patient US-GSK-US2024AMR063484:Same reporter / different patient US-GSK-US2024AMR063489:Same reporter / different patient US-GSK-US2024AMR063479:Same reporter / different patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 27-MAY-2024  This case was reported by patient via interactive digital media. The patient reported that he/she got his/her 1st shot, no problem other than a sore arm.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error, Underdose
Clinical narrative: only diluent administered; only diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa657a, expiry date 30-SEP-2023) for prophylaxis.   On 04-MAR-2022, the patient received the 1st dose of Menveo. On 04-MAR-2022, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2024 The reporter stated that in regards to a vaccine when the patient was 11 years old the only thing was that only saline(later confirmed in call its diluent of Menveo) of the Menveo vaccine was given which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked that did she should get the booster now or how it has to be done. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received another series this year 24 april; received another series this year 14th Feb; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 2F9C5, expiry date 18-APR-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 03-OCT-2019 with batch number M9P52) and Shingrix (received 2nd dose on 02-DEC-2019 with batch number 47XJ3).   On 24-APR-2024, the patient received the 4th dose of Shingrix. On 14-FEB-2024, the patient received the 3rd dose of Shingrix. On 14-FEB-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received another series this year 14th Feb). On 24-APR-2024, the patient experienced extra dose administered (Verbatim: received another series this year 24 april). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2024. Pharmacist reports 83 year old patient received Shingrix series in 2019 at a different pharmacy chain, and then received another series this year at his pharmacy which led to extra dose administered. The vaccine administration facility was the same as primary reporter. Reporter gave permission for follow-up.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: administered the diluent portion to a 12 month old patient; administered the diluent portion to a 12 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-month-old female patient who received MMR (Priorix) (batch number 43G92, expiry date 01-MAY-2025) for prophylaxis.   On 23-MAY-2024, the patient received the 1st dose of Priorix. On 23-MAY-2024, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: administered the diluent portion to a 12 month old patient) and inappropriate dose of vaccine administered (Verbatim: administered the diluent portion to a 12 month old patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2024 Registered Nurse explained that on May 23rd 2024 she forgot to reconstitute Priorix and only administered the diluent portion to a 12 month old patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: 7 DAYS POST VACCINE, CONSUMER REPORTED TO HAVE HEART ATTACK; 7 DAYS POST VACCINE, CONSUMER REPORTED TO HAVE 2 STROKES; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-MAY-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  Consumer stated 7 days post administration of thecovid-19 vaccine ad26.cov2.s, he suffered a heart attack (dose series1), 2 strokes (dose series1) and had stents placed as a result of heart attack and now he was having great difficulty obtaining life insurance.  Per consumer he had placed a request with the organization but stated it remains in pending status. Consumer provided pharmacy he received vaccine and HCP information, agent only spoke with consumer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 7 days post vaccine, consumer reported to have heart attack and 7 days post vaccine, consumer reported to have 2 strokes was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;  Myocardial infarction and Cerebrovascular accident; The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myocarditis, Pericardial effusion, Pericarditis
Clinical narrative: PERICARDITIS; MYOCARDITIS; PERICARDIAL EFFUSION; EXTREME FATIGUE FOR ABOUT 8 MONTHS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 95 pounds, and height was 64 inches. No past medical history or concurrent conditions were reported. The patient experienced bruising on fingers/ bruise more easily, extreme fatigue for 3 months and strange blood vessels in fingers (dose series 1) when treated with covid-19 vaccine nrvv ad26 (JNJ 78436735) for covid-19 prophylaxis. The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. On DEC-2021, the patient experienced pericarditis, myocarditis, pericardial effusion, and extreme fatigue for about 8 months (dose series 2). Reporter stated "Well, they (medical team) sent me to you. You know, I've talked to my cardiologist after getting pericarditis (dose series 2) after getting the Johnson & Johnson (vaccine). You know, I am looking for the statistics and Novavax must have those statistics! I took 2 J&J (Covid-19 vaccines). Patient took the 1st dose in JUN-2021 and the 2nd dose in DEC-2021. After the 1st dose she was extremely fatigued for about 3 months. After the 2nd dose, the patient was extremely fatigued for about 8 months(dose series 2) and she developed palpitations and other heart irregularities. She went to the cardiologist and she discovered she had pericardial effusion (dose series 2). She told him that she had the vaccine (J&J) and she thought that was the probable cause. She think it may have been related to having myocarditis (dose series 2), she don't know. If she had that, to cause the fatigue and then if she just got the fluid in the pericardium. The effusion has not healed in 2 years." Caller was referred to the vaccine manufacturer to report the Non-Company AE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pericarditis, myocarditis, extreme fatigue for about 8 months and pericardial effusion was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211118676 (dose series 1 case).; Sender's Comments: V0: Myocarditis, Pericarditis: The events are labelled, hence assessed as potentially related  Pericardial effusion: The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Dysmenorrhoea, Post-acute COVID-19 syndrome
Clinical narrative: she hadn't had her period for 2 years since she had received her Moderna COVID-19 vaccine; cramps yesterday but added it's weird because when she didn't get her period; long covid; This spontaneous case was reported by a patient and describes the occurrence of AMENORRHOEA (she hadn't had her period for 2 years since she had received her Moderna COVID-19 vaccine), DYSMENORRHOEA (cramps yesterday but added it's weird because when she didn't get her period) and POST-ACUTE COVID-19 SYNDROME (long covid) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (allergic to Lisinopril).   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced POST-ACUTE COVID-19 SYNDROME (long covid). On 27-May-2024, the patient experienced DYSMENORRHOEA (cramps yesterday but added it's weird because when she didn't get her period). On an unknown date, the patient experienced AMENORRHOEA (she hadn't had her period for 2 years since she had received her Moderna COVID-19 vaccine). On 27-May-2024, AMENORRHOEA (she hadn't had her period for 2 years since she had received her Moderna COVID-19 vaccine) had resolved. At the time of the report, DYSMENORRHOEA (cramps yesterday but added it's weird because when she didn't get her period) and POST-ACUTE COVID-19 SYNDROME (long covid) had resolved.            No concomitant medication was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. She also stated that she did not call her HCP because she felt like it was a normal period despite having the cramps that were out of this world but it was over - she had the cramps previous day but added it was weird because when she didn't get her period, she used to get cramps like she was going to have her period and then previous day she had her period came back. Patient did not remember the exact date of when she had received the Moderna shots which she received in 2 doses earlier. she had the COVID-19 diagnosis, she stated that she had gotten it in December of 2021 and then remembered she might have gotten the COVID-19 vaccines in June or August and September of 2021. Patient added that she had only two doses of the COVID-19 vaccine because of the side effects and she ended up getting COVID which was a long COVID for three months as stated. She stated that the vaccines finally worn off because she had taken the shot but she got pissed off because she ended up catching COVID. No treatment medication was reported.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Scar
Clinical narrative: I was tested for VZV antibody in July 2019, and was told I needed to get varicella vaccine. This is the test result: Absence of detectable antibodies indicates lack of specific immune response to vaccine or previous exposure to VZV infection. Such patients are considered  to be non-immune and are therefore susceptible to primary infection.          I took the varicella vaccine on 8/29/2019. I then got shingles starting in late May and diagnosed on 6/2/2024. If the 2019 test result showed I had no previous exposure to chickenpox and I immediately received vaccination, how could I have dormant chickenpox virus in my body? The only plausible explanation is that the varicella vaccine introduced the virus into my system, and caused unnecessary suffering and skin scarring.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Headache and achy joints
Sex: F
Vaccine: PPV
Symptoms: Audiogram abnormal, Deafness, Deafness bilateral, Deafness permanent, Extra dose administered
Clinical narrative: Pneumococcal vaccine pneumovax received twice 07/21/2016 and 08/04/2016 Caused 20% permanent loss of hearing And 40% high frequency sound hearing loss
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Customer called and reported that VARIVAX was administered following a temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 13-MAY-2024, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W018824, expiration date: 14-JUN-2024, administered by health professional for prophylaxis (strength, dose, and route of administration were not provided) (product storage error). The vaccine was exposed to 32 degrees Fahrenheit (F) for 18 hours on an unknown date. There was no previous temperature excursion.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report was received from medical assistant and refers to an 1-year-old of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, valid lot #X026789 with expiration date: 14-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) which was inappropriately stored in temperature of 19.8 F for 20 hours and 15 minutes (product storage error). No previous temperature excursions were noted.  No adverse effects were reported (no adverse event).; Sender's Comments:  US-009507513-2405USA007600: US-009507513-2405USA007924:2405USA007912
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: not adverse event; Medical assistant called and reported that a dose of GARDASIL 9 was inadvertently administered to a 6 month old. Caller stated no patient symptoms have been reported. Caller mentioned she is also filing a VAERS report. No additional information provi; This spontaneous report was received from medical assistant and refers to a 6-month-old patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-MAY-2024, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1967338, expiration date: 26-JAN-2026) for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No symptoms have been reported (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient given pediatric dose; Adult patient given pediatric dose; This non-serious case was reported by a other health professional and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2024) for prophylaxis.   On 15-MAY-2024, the patient received the 1st dose of Engerix B pediatric. On 15-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient given pediatric dose) and adult use of a child product (Verbatim: Adult patient given pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-MAY-2024 The adult patient was given pediatric dose which led to underdose and adult use of a child product.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidentally got a third dose today on 22-05-2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in NOV-2023) and Shingrix (received 2nd dose in JAN-2024). Additional patient notes included Patient had no medical history.   On 22-MAY-2024, the patient received the 3rd dose of Shingrix. On 22-MAY-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: accidentally got a third dose today on 22-05-2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2024 The patient self-reported this case. The patient accidentally got the third dose of Shingrix vaccine, which led to extra dose administered. The reporter consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Erythema, Myalgia
Clinical narrative: still feeling muscle pain and redness; still feeling muscle pain and redness; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   In APR-2024, the patient received Arexvy and Abrysvo. On an unknown date, less than 2 months after receiving Arexvy, the patient experienced erythema (Verbatim: still feeling muscle pain and redness) and muscle pain (Verbatim: still feeling muscle pain and redness). The outcome of the erythema and muscle pain were not resolved.   It was unknown if the reporter considered the erythema and muscle pain to be related to Arexvy.     It was unknown if the company considered the erythema and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-MAY-2024 The reporter stated that he/she knew an patient who got one of these RSV vaccines (Abrysvo or Arexvy) 6 weeks ago and less than 2 months after the vaccination (Abrysvo or Arexvy), was still feeling muscle pain and redness after 6 weeks. After spoke to found out the pharmacist had these two products and did not know if the patient knows which one got 6 weeks ago.  The patient had gone to primary care doctor in that 6 week period and all said was to put ice on them.  Surprisingly the doctor did not cared what got injected into this person. Some of the people said to that should go see an orthopedist, might be the needle broke into bone, so had that appointment.  The reporter asked that did this seem bizarre, ice did not solve the problem, orthopedist will take an x-ray to see if the needle cracked bone In the meantime was going to try to find out if can go back to the place got the injection to see which one received. The GlaxoSmithKline representative explained that Pfizer's was actually the Abrysvo and Arexvy was the GlaxoSmithKline product.  The caller asked how far this penetrates when it was injected and pressed for what he/she had seen in his/her own clinical experience. It was unknown if the reporter considered the erythema and muscle pain to be related to Abrysvo.
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Crying, Eye disorder, Eye pain
Clinical narrative: pain in the eye/it hurts all around and if she blinks hard, her eyeballs hurt; weeping and sensitivity of the eye; sensitivity of the eye; pink eye; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of eye pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included uveitis. Concurrent medical conditions included psoriatic arthritis. Concomitant products included tofacitinib citrate (Xeljanz Xr).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced eye pain (Verbatim: pain in the eye/it hurts all around and if she blinks hard, her eyeballs hurt), crying (Verbatim: weeping and sensitivity of the eye), eye disorder (Verbatim: sensitivity of the eye) and pinkeye (Verbatim: pink eye). The outcome of the eye pain, crying, eye disorder and pinkeye were not reported.   It was unknown if the reporter considered the eye pain, crying, eye disorder and pinkeye to be related to Shingles vaccine.     It was unknown if the company considered the eye pain, crying, eye disorder and pinkeye to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-MAY-2024  The patient self-reported She wanted to know if it can cause pain in the eye, weeping and sensitivity of the eye two days after getting the shingles vaccine.  She saw an optometrist and he said it was pink eye but her eye isn't pink and it's not oozing yellow, it kind of feels like when she had uveitis but not quite the same.  It feels like she got punched in the eye, it hurts all around and if she blinks hard, her eyeballs hurt.  She was going back to her primary doctor to see if she can get a referral to an ophthalmologist.
Age: 64.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 64 years patient received Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 64-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included attention deficit hyperactivity disorder and chronic pain. Concurrent medical conditions included immunocompromised. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 17-FEB-2024, the patient received the 1st dose of Bexsero. On 17-FEB-2024, an unknown time after receiving Bexsero and an unknown time after receiving SHINGRIX and TWINRIX, the patient experienced inappropriate age at vaccine administration (Verbatim: 64 years patient received Bexsero). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 24-MAY-2024  A patient received Bexsero vaccine along with Shingrix and Twinrix. The pharmacist who administered vaccine advanced against 3 vaccines at once and patient stated that she wanted to get them over with. The patient had 2nd dose Bexsero scheduled for April but did not show for appointment, this was when the reporter called manufacturer about age for vaccine. A patient received Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Muscular weakness, Pyrexia
Clinical narrative: he could not get out of bed; soreness (injection site); redness (injection site)/ red mark where he got his injection; Fever; Muscle weakness/He also states it is hard to close his left hand compared to his right; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 16-MAY-2024, the patient received Arexvy (left arm). In MAY-2024, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: soreness (injection site)), injection site erythema (Verbatim: redness (injection site)/ red mark where he got his injection), fever (Verbatim: Fever) and muscle weakness (Verbatim: Muscle weakness/He also states it is hard to close his left hand compared to his right). On 17-MAY-2024, the patient experienced bedridden (Verbatim: he could not get out of bed). The outcome of the injection site pain, injection site erythema, fever and muscle weakness were unknown and the outcome of the bedridden was not reported.   It was unknown if the reporter considered the injection site pain, injection site erythema, fever, muscle weakness and bedridden to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site erythema, fever, muscle weakness and bedridden to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-MAY-2024 This case was self-reported by the patient. The patient was received a dose of Arexvy vaccine last Thursday (from the date of reporting). He stated that he developed fever of 100.6 F Fahrenheit (when his normal temperature was 96.7).  On Friday and Saturday (1 and 2 days after receiving vaccine), he could not get out of bed.  He also had a red mark and soreness where he got his injection. He also stated it was hard to close his left hand compared to his right. The reporter did not consent to follow up.
Age: 3.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received a 4th dose; received 3rd dose longer than interval of time period; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 5-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 32m5g, expiry date 14-SEP-2025) for prophylaxis.   Previously administered products included Engerix b (received first dose of Engerix B on 31st May 2018) and Engerix b (received second dose of Engerix B on 3rd July2018).   On 17-SEP-2021, the patient received the 3rd dose of Engerix B. On 21-MAY-2024, the patient received the 4th dose of Engerix B. On 17-SEP-2021, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received 3rd dose longer than interval of time period). On 21-MAY-2024, the patient experienced extra dose administered (Verbatim: received a 4th dose). The outcome of the drug dose administration interval too long 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: 21-MAY-2024 The reporter reported that the one of the patient received the Engerix B vaccine, and their state immunization registry were not able to pull it up at the time of visit, but on their records it showed that patient received 2 hepatitis B vaccine, so they gave today on 21st May 2024. But now the IT got the state registry fixed and it showed that patient already got the 3rd dose, and this was a 4th dose which led to Extra dose administered. And patient received the 3rd dose longer than the recommended interval which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 33 year old patient was administered a pediatric dose of Engerix-B yesterday; 33 year old patient was administered a pediatric dose of Engerix-B yesterday; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 33-year-old female patient who received HBV (Engerix B Junior) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 22-MAY-2024, the patient received Engerix B Junior. On 22-MAY-2024, an unknown time after receiving Engerix B Junior, the patient experienced adult use of a child product (Verbatim: 33 year old patient was administered a pediatric dose of Engerix-B yesterday) and underdose (Verbatim: 33 year old patient was administered a pediatric dose of Engerix-B yesterday). The outcome of the adult use of a child product and underdose 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: 23-MAY-2024 The other health professional (Office manager) reported that, a 33 year old patient was administered a pediatric dose of Engerix-B day before reporting which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not get it in 6 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in NOV-2021).   On an unknown date, the patient did not received 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 it in 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2024 The reporter had a patient who received Shingrix first dose and usually the 2nd dose was from to 2 to 6 months, but this patient did not get it in 6 months. Now it was more than 2 years and they had question that can he get the 2nd dose now or he must start over for the 1st dose. While they asked to the caller if he agree to do a follow up with safety team, the caller said that he only needs the information related to the question but never said no or yes. Also, caller reported the date of the 1st dose as November 2021, on the report they set it as 01Nov2021 due to the system does not allow only month and year. However, they did not get the specific day. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. This case is linked with US2024064969 for same reporter.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received MMR (Priorix) (batch number CB979, expiry date 13-MAY-2024) for prophylaxis.   On 23-MAY-2024, the patient received the 1st dose of Priorix. On 23-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-MAY-2024 The medical assistant called in to report that an expired dose of Priorix had accidently given to a patient, which led to expired vaccine used. They solicited medical information, which was provided. The  reporter consented to follow up.
Age: 6.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 year old patient to have received Twinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Hepatitis a vaccine (received on unknown date), Hepatitis b vaccine (1st dose received on an unknown date), Hepatitis b vaccine (2nd dose received on an unknown date) and Hepatitis b vaccine (3rd dose received on an unknown date).   In MAY-2024, the patient received Twinrix 1 ml. In MAY-2024, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 year old patient to have received Twinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2024. The nurse reported that a family practice primary care clinic had a 6 year old, patient and in her medical history says that she was given Twinrix vaccine and so reporter wanted to make sure that it was safe for that 6 year old patient to received Twinrix vaccine. The healthcare professional said that patient received 1.0 ml dose, that reporter was not aware that patient was immunocompromised. This was the first-time patient received Twinrix. The patient received Twinrix vaccine below than the recommended age limit, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the second dose a year later; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got the second dose a year later). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 24-MAY-2024 The Pharmacist reported that a patient got the first dose of Shingrix about one year ago and got the second dose a year later. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. Had no details to provide about the patient and no vaccine lot or expiration date information. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Arm  numbness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4n9pf, expiry date 12-DEC-2025) for prophylaxis.   On 24-MAY-2024, the patient received the 1st dose of Shingrix (left arm). On 24-MAY-2024, 40 min after receiving Shingrix, the patient experienced numbness of upper extremities (Verbatim: Arm  numbness). The outcome of the numbness of upper extremities was unknown.   It was unknown if the reporter considered the numbness of upper extremities to be related to Shingrix.     It was unknown if the company considered the numbness of upper extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2024 The pharmacist reported that the patient received her 1st dose of Shingrix vaccine on the day of reporting. 40 minutes after the vaccination she experienced (left) arm numbness.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: recivied Infanrix vaccine instead of the Boostrix vaccine; 25 year old recieved a shot of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 25-year-old female patient who received DTPa (Infanrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 28-MAY-2024, the patient received Infanrix. On 28-MAY-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: recivied Infanrix vaccine instead of the Boostrix vaccine) and inappropriate age at vaccine administration (Verbatim: 25 year old recieved a shot of Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-MAY-2024. Healthcare professional gave a 25 years old patient the Infanrix vaccine instead of the Boostrix vaccine which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expire product to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered an expire product to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAY-2024 The reporter administered an expire product to a patient which led to expired vaccine used. Already spoke with the patient about a patient safety report, our facility was wondering if there was any way to extend expiration date or a timeline went to give the new first dose since it was invalidated in our system. No additional details available. Unknown if follow up was available as no mailing address provided but email address was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3031280) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Anatomical site of injection: Arm Batch/Lot number: EP7534) on 26-Mar-2021, Pfizer / BioNTech (Anatomical site of injection: Arm Batch/Lot number: EW0162) on 17-Apr-2021, Pfizer / BioNTech (Anatomical site of injection: Arm Batch/Lot number: FH8027) on 22-Nov-2021, Pfizer / BioNTech (Anatomical site of injection: Arm Batch/Lot number: GH9693) on 23-Sep-2022, Pfizer / BioNTech (Location of injection: Arm Left) on 10-Oct-2022 and Flu Vaccine (Anatomical site of injection: Arm Fall 2021 - 2023). Past adverse reactions to the above products included No adverse effect with Flu Vaccine, Pfizer / BioNTech, Pfizer / BioNTech, Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Hashimoto's disease since 2009, Allergy NOS, Leukopenia (Low white blood cell count after covid vaccine.) since November 2021 and Irregular menstrual cycle (Irregular menstrual cycle after covid vaccine. Patient period had started early after booster dose April 2021.) since April 2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jul-2009 to an unknown date for Hypothyroidism.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Jan-2024 to 20-Jan-2024 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.            It was reported that the patient did not received any treatment. Patient was taking blood test and seeing hematologist to monitor low white blood cell count. Patient had several doctor visits for irregular menstrual cycle.  Given that the Moderna product was not reported as a suspect product, and there is no other attribution to the Moderna product in this report from the other manufacturer, the Moderna product is not considered to be a suspect product in this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2024: Significant follow up received. Classification of tracking only and no patient identifier was deleted. Updated gender and medical history. Suspect product was recoded, Paxlovid was updated as a treatment medication. Deleted the event menstruation irregular and updated narrative.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have headaches daily; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (I have headaches daily) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 024C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (I have headaches daily). At the time of the report, HEADACHE (I have headaches daily) outcome was unknown.      No concomitant medications were reported. Patient reported that, prior to covid vaccine it was very rare for patient to have headaches. Two years later after covid vaccination patient had headache daily. Headache was not severe but do make it difficult to concentrate when trying to work.  Headache intensifies when patient did rigorous exercise.  Treatment medications were not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: sore throat; congestion; Yellow skin similar to jaundice; dizziness; nausea; vomiting; fatigue; headache; chills; body aches; sore injection site; fever; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness) and NAUSEA (nausea) in a 22-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 208H23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 29-May-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore injection site) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congestion), YELLOW SKIN (Yellow skin similar to jaundice), DIZZINESS (dizziness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore injection site) and PYREXIA (fever) was resolving.            Concomitant medication not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medication not reported.