chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Peripheral swelling
Clinical narrative: Patient was given the Moderna COVID-19 2024-2025 booster in her home on 5/30/25 by the Health Department as one of our home bound resident's. This was her 6th Moderna COVID-19 vaccine and 2nd given by us with no reactions until after this last dose on 5/30/25. Patient received the vaccine at approximately 12pm on 5/30/25 in her right deltoid. Nursing staff waited approximately 15 min to observe for any adverse effects, none noted. Patient explained that when she woke up at approximately 6am on Saturday 5/31/25 her left leg felt tight and when she looked down it was swollen. She continued that when she looked in the mirror after getting up, they area around her eye brows looked swollen as well. She notified me, RN a nurse at the Health Department on 6/3/25. She experienced no other symptoms and explained that the swelling was going down. She denies shortness or breath or pain. She was instructed to call her physician and explain the above, she understood and agreed. This writer then went out to her house to assess the left leg swelling. Upon assessment her left leg was noted to have slight edema, non pitting, positive pedal pulses, denies pain, no redness or dusky discoloration noted, skin temperature WNL.  Encouraged to keep leg elevated to decrease edema, she understood and agreed.  No further swelling noted around her eye brows. Follow up done on 6/4/25, she feels well again today and has a follow up appointment with her Primary Care Physician on Friday 6/6/25 and report back then.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura, Ophthalmic migraine
Clinical narrative: months after receiving the booster shot of pfizer covid19 vaccine, I started to get migraines associated with auras. this continues to happen ever since. every few weeks I get them. I never have had this happen before receiving the vaccine. The auras last about 30ish minutes and the migraines last the duration of the day.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT INFORMED US THAT HER HAND IS SWOLLEN , SHE WAS VERY LETHERGIC AND HAD FEVER.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dyspnoea, Oropharyngeal pain, Pallor, Productive cough
Clinical narrative: Patient arrived Clinic waiting area via w/c with his wife, c/o sore  throat, cough. Wife states he had a Covid vaccine yesterday at the clinic -States  after the vaccine, started having trouble breathing. States has productive cough  "green" phlegm. Color pale. Wet cough noted.  COVID-19 (PFIZER), MRNA, LNP-S, *  1   06/02/2025.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum discoloured
Clinical narrative: Patient arrived Clinic waiting area via w/c with his wife, c/o sore  throat, cough. Wife states he had a Covid vaccine yesterday at the clinic -States  after the vaccine, started having trouble breathing. States has productive cough  "green" phlegm. Color pale. Wet cough noted.  COVID-19 (PFIZER), MRNA, LNP-S, *  1   06/02/2025.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Flushing
Clinical narrative: Feeling flush, lightheadedness
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The patient reported having leg pain starting  the day after the vaccine was administered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Chief Complaint :   Administered COVID-19 Vaccine Comirnaty in RUA. Noted that this was expired after it was administered. Patient was notified. Left message on voicemail on 5/23/25 at 12:00.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive Hepatitis A vaccine, and correct order was placed. Patient accidentally received Hepatitis B vaccine. .
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: patient came back on 6/4 complaining of redness at injection site with diameter is 12-18 inches long. itchyness at injection site and pain
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Tdap vaccine was administered too high in the left deltoid area (<1 inch from the coracoid process). Pt felt pain with administration of the vaccine that persisted for several weeks and is still present today. Pain didn't improve with conservative management such as application of heat, ice or taking oral NSAIDS. Pt's mobility is full but painful.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired  HepC vaccine given.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The lot expired on 5/30/25. I did not see that as I wrote down the wrong expiration date.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Rash, Rash papular
Clinical narrative: Day 4 after Varicella was given the patient broke out in a full body rash started on legs moved to diaper area moved to chest. Multiple papules. No fever No diarrhea but complaints of fussiness. Benadryl Tylenol and oatmeal baths given.
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient to report 06/02/2025 that  her entire upper left arm has a redness rash down to the elbow
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Child has a syncope episode in office following vaccines. Event occurred within 15 minutes of administration.
Age: 17.0
Sex: M
Vaccine: HEP, MENB, MNQ
Symptoms: Erythema, Urticaria
Clinical narrative: Patient's mom states that around 6:00 pm last night patient presented to her with red hives down entire right arm. His feet were also bright red. (She states that he gets the same reaction of red feet when he is exposed to hazelnuts.) Mom called hospital triage nurse and was advised to give Benadryl. She gave patient benadryl and both hives and red feet improved. No further issues today. She contacted his PCP and they advised him to call and report to us. They will followup with him next week.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site urticaria
Clinical narrative: 6cm hive at the site
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Severe nausea and headache on awakening - especially when exerting, lifting weights
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received Moderna, dose #1 on 4/16/2025.  She came to the office on 5/28/2025 for dose #2 of the primary series. Interim Considerations/CDC.gov, were reviewed prior to administration.  Upon review, it was noted that an unvaccinated person would receive 2 doses, separated by 4 to 8 weeks.  Dose #2 of Moderna was administered, 6 weeks after dose #1.  Upon entering the vaccination dose into vaccination database, it was noted the dose was possibly administered too early.  Upon further review of the CDC Interim Considerations, the 6 months to 4-year-old schedule was used as a reference, not the age 12 to 64 schedule.  Ages 12 to 64, only require 1 dose for an unvaccinated person.  Patient was notified of the error on 5/28/2025.  On 5/29/2025 patient noted to have expected side effects of fever, body aches and sore arm, similar to dose #1.  These symptoms resolved within 3 days.  No additional reports of adverse signs and symptoms.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Hep A adult vaccine was erroneously given instead of Hep A ped/adolescent vaccine. No associated symptoms reported
Age: 1.42
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC15
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a Hep A when patient was not due for it. First dose was administered on 2/17/25, second dose was due 6 months after the first dose ( 8/17/25) but was wrongly administered today 6/04/25 by another MA.
Age: 5.0
Sex: M
Vaccine: MMRV, UNK, UNK, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Gave MMRV and Varicella
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient felt lightheaded and threw up shortly after receiving 3 vaccinations (HPV, tetanus, meningitis).  Patient returned to normal state of health afterwards.
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Back pain, Bone pain, Cyanosis, Decreased appetite
Clinical narrative: Vaccine area is red very tender after 39 minutes of receiving vaccine.  The filling day same redness and tender and swollen Very soar can?t lift my arm. Back of my neck is very tights very soar and very painful if I move my head in any direction. Both shoulder blast are very painful upper back spasms having a hard time moving and walking due to stiff neck and upper back pain All my joints are swollen and very painful to move them the worse pain is my upper back and neck and injection area, no appetite and I have swollen ankles /cankles  my hand and fingertips are cold they are blue purple and swollen my hip bones  hurt when I walk  my entire body is in pain and all my joints.    I came home from work and laying down with my feet elevated to see if my ankles return to normal size.  The back pain still persist  lying in bed.
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Gait disturbance, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine area is red very tender after 39 minutes of receiving vaccine.  The filling day same redness and tender and swollen Very soar can?t lift my arm. Back of my neck is very tights very soar and very painful if I move my head in any direction. Both shoulder blast are very painful upper back spasms having a hard time moving and walking due to stiff neck and upper back pain All my joints are swollen and very painful to move them the worse pain is my upper back and neck and injection area, no appetite and I have swollen ankles /cankles  my hand and fingertips are cold they are blue purple and swollen my hip bones  hurt when I walk  my entire body is in pain and all my joints.    I came home from work and laying down with my feet elevated to see if my ankles return to normal size.  The back pain still persist  lying in bed.
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Joint swelling, Mobility decreased, Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: Vaccine area is red very tender after 39 minutes of receiving vaccine.  The filling day same redness and tender and swollen Very soar can?t lift my arm. Back of my neck is very tights very soar and very painful if I move my head in any direction. Both shoulder blast are very painful upper back spasms having a hard time moving and walking due to stiff neck and upper back pain All my joints are swollen and very painful to move them the worse pain is my upper back and neck and injection area, no appetite and I have swollen ankles /cankles  my hand and fingertips are cold they are blue purple and swollen my hip bones  hurt when I walk  my entire body is in pain and all my joints.    I came home from work and laying down with my feet elevated to see if my ankles return to normal size.  The back pain still persist  lying in bed.
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Vaccine area is red very tender after 39 minutes of receiving vaccine.  The filling day same redness and tender and swollen Very soar can?t lift my arm. Back of my neck is very tights very soar and very painful if I move my head in any direction. Both shoulder blast are very painful upper back spasms having a hard time moving and walking due to stiff neck and upper back pain All my joints are swollen and very painful to move them the worse pain is my upper back and neck and injection area, no appetite and I have swollen ankles /cankles  my hand and fingertips are cold they are blue purple and swollen my hip bones  hurt when I walk  my entire body is in pain and all my joints.    I came home from work and laying down with my feet elevated to see if my ankles return to normal size.  The back pain still persist  lying in bed.
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Visual impairment
Clinical narrative: Mine started behind my eye, my vision was affected; Mine started behind my eye, my vision was affected,; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (Verbatim: Mine started behind my eye, my vision was affected) (serious criteria hospitalization and GSK medically significant) and facial herpes zoster (Verbatim: Mine started behind my eye, my vision was affected,) (serious criteria hospitalization). The patient was treated with gabapentin. The outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster and facial herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date : 27-MAY-2025 This case was reported by a patient via interactive digital media. The patient was on year four with shingles.  The patient started behind his/her eye, his/her vision was affected, side of his/her nose up to his/her scalp back to his/her forehead.  The patient was in the hospital for two days for fear of sepsis.  The patient was taken Gabepentin and a cream for forehead. The patient got the shingles shot but did not go back for the second shot.  The physician said after this long it probably would not go away.; Sender's Comments: Ophthalmic herpes zoster and Herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Some time later developed Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Some time later developed Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date :29-MAY-2025 Nurse reported that patient was fully vaccinated with shingrix vaccines, 2 doses as indicated.  She did not have dates of 1st or 2nd doses given.  Some time later developed shingles.  No additional information was provided regarding events at time of receiving 1st or 2nd dose. Shingles was believed to had developed in January 2025 exact dates not provided when did this happened. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Tingling tongue; numbness in arm; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of tingling tongue in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-MAR-2025, the patient received Shingrix. On 28-MAR-2025, less than a day after receiving Shingrix, the patient experienced tingling tongue (Verbatim: Tingling tongue) and numbness of upper extremities (Verbatim: numbness in arm). The outcome of the tingling tongue and numbness of upper extremities were resolving.   The reporter considered the tingling tongue and numbness of upper extremities to be related to Shingrix.     The company considered the tingling tongue and numbness of upper extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2025 The weight of the patient was reported as 80.29 kgs. Healthcare professional reported that patient had an allergic reaction to Shingrix vaccine. Patient experienced a tingling tongue and numbness in her arm. No other information was provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: burning sensation underneath her left shoulder blade in her back; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tick bite, diabetes, blood pressure high, blood cholesterol increased, indigestion and heartburn. Concomitant products included doxycycline, semaglutide (Ozempic) and potassium.   On 28-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 29-MAY-2025, 1 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation underneath her left shoulder blade in her back). The outcome of the burning sensation was not resolved.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.     It was unknown if the company considered the burning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2025 The patient received first dose of Shingrix in her right arm on 28-MAY-2025, and reported that the next night 29-MAY-2025, she started having a deep, burning sensation underneath her left shoulder blade in her back. The patient reported that this sensation was still there today on 2-JUN-2025, but was not as bad as it was. The patient also reported that she was taking Doxycycline 100MG (Unknown Product Information) by mouth twice a day for a tick bite that was diagnosed on 13-APR-2025, and she started this antibiotic the evening of 29-MAY-2025, after receiving the first dose of Shingrix.
Sex: M
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site was hot; injection site was red; injection site was swollen; injection site was painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel).   On 13-MAR-2025, the patient received Menveo (intramuscular, left arm). On 13-MAR-2025, immediately after receiving Menveo, the patient experienced injection site warmth (Verbatim: injection site was hot), injection site erythema (Verbatim: injection site was red), injection site swelling (Verbatim: injection site was swollen) and injection site pain (Verbatim: injection site was painful). On 16-MAR-2025, the outcome of the injection site warmth, injection site erythema, injection site swelling and injection site pain were resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling and injection site pain to be related to Menveo.     It was unknown if the company considered the injection site warmth, injection site erythema, injection site swelling and injection site pain to be related to Menveo.   Additional Information: GSK Receipt Date: 02-JUN-2025 The patient mother was the reporter.  The patient mother stated that her son, 11 years old, received Menveo vaccine on 13 MAR 2025.  The reporter stated almost immediately a space measuring about 3 by 4 below the injection site was hot, red, swollen and painful which resolved approximately in 3 days.  The reporter also stated when her son received another vaccine containing diphtheria (Daptacel) he had the same type of reaction.  The reporter mentioned this reaction occurred after receiving dose 4 and 5 in the dose vaccination series of Daptacel.  The reporter did have her son examined by his Primary care physician (PCP) and the Primary care physician stated this reaction could be a histamine type reaction.  The reporter also stated that her son is scheduled for an examination with an allergy doctor.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; getting shingles a second time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: getting shingles a second time). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a reporter via interactive digital media. Reporter reported that the vaccine did not prevent his/her mother (patient) from getting it (shingles) a second time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description  time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shots but still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the shots but still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAY-2025 This case was reported by a patient via interactive digital media.  Patient got the shots but still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I did not go back for the second shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sickness. Previously administered products included Shingles vaccine (received first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I did not go back for the second shingles). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 30-MAY-2025 This case was reported by a patient via interactive digital media. The patient did not go back for the second shingles vaccine which led to incomplete course of vaccination. The patient stated that he/she have enough health problems without getting sick again.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: slightly 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: slightly 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: 03-JUN-2025 This case was reported by a patient via interactive digital media. The patient had zero reaction other than slightly sore arm after receiving Shingles vaccine
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: accidentally administered a pediatric dose of Havrix to an adult patient; accidentally administered a pediatric dose of Havrix to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis.   In MAY-2025, the patient received Havrix pediatric. In MAY-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: accidentally administered a pediatric dose of Havrix to an adult patient) and accidental underdose (Verbatim: accidentally administered a pediatric dose of Havrix to an adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable.   Additional Information: GSK Receipt Date: 02-JUN-2025 The pharmacist reported that they accidentally administered a pediatric dose of Havrix to an adult patient, which led to adult use of a child product and accidental underdose
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose/ the 2nd dose was given at 6 months; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose/ the 2nd dose was given at 6 months). The outcome of the drug dose administration interval too long was not applicable.   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: 02-JUN-2025 On 02 June 2025, a GSK Sales Representative contacted Medical Information on behalf of a provider (Internal Medicine) with a query regarding the Twinrix vaccine. They had a question about the dosing and schedule of Twinrix, the normal schedule is 0, 1, 6 months.  The patient got the 1st dose but then the 2nd dose was given at 6 months which led to , which led to lengthening of vaccination schedule.  The reporter enquired if the patient needs one more dose and if so, when it should be administered. The Sales representative and HCP did not have any patient or product details.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 06-NOV-2020).   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: never got the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 02-JUN-2025 The pharmacy intern contacted via chat and reported that the reporter had a patient get the first dose 06th November 2020 and never got the second dose. The reporter asked what do you recommend. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional did not had the vaccine lot number nor the expiration date of the 1st Shingrix dose Also, healthcare professional did not provide consent for Safety team follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix B was administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on an unknown date) and Engerix B (received 2nd dose on an unknown date).   On 30-MAY-2025, the patient received the 3rd dose of Engerix B. On 30-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix B was administration). The outcome of the expired vaccine used was not applicable.   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: 02-JUN-2025 The nurse called to report that the expired dose of Engerix B was administered  to a patient which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter.
Vaccine: COVID19
Symptoms: Biopsy, COVID-19, Rash
Clinical narrative: I took a Moderna 2024 booster, got COVID; Skin rash spreading; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I took a Moderna 2024 booster, got COVID) and RASH (Skin rash spreading) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer BioNTech COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer BioNTech COVID-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I took a Moderna 2024 booster, got COVID) and RASH (Skin rash spreading). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. At the time of the report, COVID-19 (I took a Moderna 2024 booster, got COVID) and RASH (Skin rash spreading) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: Show nothing.         Concomitant medication was not provided.  It was reported that since Covid in 2020 the patient took Pfizer booster prior to Moderna 2024 booster vaccine at Pharmacy and suspects that it may cause rashes.  The patient had done biopsy for rashes, and nothing shown and 4 dermatologists puzzled going on for 5 months.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pain
Clinical narrative: were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043837) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-May-2025, the patient experienced PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort). At the time of the report, PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort) outcome was unknown.            No concomitant medication was reported. Patient and her husband had no issues or problems until they received the 10th COVID-19 vaccines on 24-May-2025. On 25-May-2025, both were unable to sleep without waking up from pain or discomfort every 15-20 minutes.  The pharmacist started injecting the shots into the shoulders. Patient's husband asked him to inject the vaccine in the bicep at the widest point of the arms (into the softest padded area of the upper arm), but he said he had to inject them in the shoulder.  It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Laboratory test
Clinical narrative: the patches of hair lost/when hair loss started, was losing hair all over body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset May2025, outcome "unknown", described as "the patches of hair lost/when hair loss started, was losing hair all over body". The patient underwent the following laboratory tests and procedures: tests: Unknown results, notes: They did all sorts tests. Therapeutic measures were not taken as a result of alopecia.  Clinical course: The patches of hair lost, started a couple weeks ago. Maybe, are just falling out some places, is nothing major. Clarified, when hair loss started, was losing hair all over body. Eyelashes coming back a little bit, everything else, no. Treatment: No, absolutely not, not had he ever intended to. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The event did not require a visit to the Emergency Room or Physician's office. The patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. Patient had no allergies to any previous vaccination, medications, food or other products.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: the patches of hair lost/when hair loss started, was losing hair all over body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset May2025, outcome "unknown", described as "the patches of hair lost/when hair loss started, was losing hair all over body". The patient underwent the following laboratory tests and procedures: tests: Unknown results, notes: They did all sorts tests. Therapeutic measures were not taken as a result of alopecia.  Clinical course: The patches of hair lost, started a couple weeks ago. Maybe, are just falling out some places, is nothing major. Clarified, when hair loss started, was losing hair all over body. Eyelashes coming back a little bit, everything else, no. Treatment: No, absolutely not, not had he ever intended to. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The event did not require a visit to the Emergency Room or Physician's office. The patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. Patient had no allergies to any previous vaccination, medications, food or other products.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body height, COVID-19, Drug ineffective
Clinical narrative: the patches of hair lost/when hair loss started, was losing hair all over body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset May2025, outcome "unknown", described as "the patches of hair lost/when hair loss started, was losing hair all over body". The patient underwent the following laboratory tests and procedures: tests: Unknown results, notes: They did all sorts tests. Therapeutic measures were not taken as a result of alopecia.  Clinical course: The patches of hair lost, started a couple weeks ago. Maybe, are just falling out some places, is nothing major. Clarified, when hair loss started, was losing hair all over body. Eyelashes coming back a little bit, everything else, no. Treatment: No, absolutely not, not had he ever intended to. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The event did not require a visit to the Emergency Room or Physician's office. The patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. Patient had no allergies to any previous vaccination, medications, food or other products.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Laboratory test
Clinical narrative: Next time took it, hair grew again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for Covid-19 immunisation; Comirnaty (DOSE 2, SINGLE), for Covid-19 immunisation; Comirnaty omicron xbb.1.5 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2023, for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2024, outcome "unknown", described as "Next time took it, hair grew again". Additional information: Hair grew back, sometime in fall 2024. Beginning of 2024, went bald, grew back fall, 2024.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Next time took it, hair grew again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for Covid-19 immunisation; Comirnaty (DOSE 2, SINGLE), for Covid-19 immunisation; Comirnaty omicron xbb.1.5 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2023, for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2024, outcome "unknown", described as "Next time took it, hair grew again". Additional information: Hair grew back, sometime in fall 2024. Beginning of 2024, went bald, grew back fall, 2024.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body height, COVID-19, Drug ineffective
Clinical narrative: Next time took it, hair grew again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for Covid-19 immunisation; Comirnaty (DOSE 2, SINGLE), for Covid-19 immunisation; Comirnaty omicron xbb.1.5 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2023, for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2024, outcome "unknown", described as "Next time took it, hair grew again". Additional information: Hair grew back, sometime in fall 2024. Beginning of 2024, went bald, grew back fall, 2024.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;