chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Enuresis, Hypersensitivity, Immediate post-injection reaction, Insomnia, Mood altered
Clinical narrative: My daughter immediately had strong allergic reaction on her hands and arms as well as troubles with sleeping, drastic mood changes, bedwetting which all lasted for about 2-3 weeks
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Tremor, Unresponsive to stimuli
Clinical narrative: Patient came in for 3 vaccines (flu, covid, and tdap) since his is overdue and pt will be around a newborn. Pt states that he gets anxious and lightheaded when receiving vaccines, but is usually fine after a few minutes. Pt received the vaccines, then immediately became unresponsive, staring in front of him. Pt recovered after a minute or so, to the shouting of the pharmacist and tapping of his shoulders. Pt was then very lightheaded and shaking uncontrollably. Pt was given water and rested for about 30 minutes, then recovered and went home. Pt was called twice afterwards (hour after returning home and the next day) and he said that he was feeling better.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, HEP
Symptoms: Circumstance or information capable of leading to medication error, Wrong patient
Clinical narrative: Administration error - vaccines were given to wrong patient due to misidentification error
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Burning sensation, Colitis microscopic, Colonoscopy abnormal
Clinical narrative: Dose: 0.5 mL Route: Intramuscular Site: Left arm Manufacturer: Pfizer-BioNTech Lot#: EN6201 Location:  Referring Provider:  ID: 76 y.o. female with past medical history of hypertension, hyperlipidemia, arthritis present for follow up visit for new complaint of right upper quadrant pain starting mid February. She just had labs with her primary care provider February 16 and the following week noted several episodes of intermittent upper right pain which also radiated to the back. Symptoms seem to occur more at bedtime and does not identify if these were specifically postprandial or any relation to food intake or type. The pain was of a burning quality and the area felt somewhat swollen. It was 5-6 out of 10 in severity she did not note any associated heartburn, nausea, vomiting or other digestive symptoms and her bowel pattern was unchanged. She has Bristol consistency 3-4 bowel movements occurring 3-4 times a day which has been since her COVID shot. She had prior treatment for collagenous colitis but not noting any diarrhea. Weight is stable good intake. No urinary symptoms. The pain actually has resolved in the last week or so and no symptoms at this time.  She saw her primary care provider for low back pain October 23 and was treated with Macrobid for UTI.  Last office visit Dr. 7/21/21: Patient is a 73 y.o. female presenting for follow-up of collagenous colitis. Patient has a history of uncontrollable diarrhea that initially started in February 2021 a few days following her COVID-19 vaccine. Her subsequent colonoscopy on 5/11/21 showed changes on random colon biopsies consistent with collagenous colitis. She was subsequently started on budesonide 3mg TID which she gradually tapered over a six-week period. She has not taken any budesonide over the last three-weeks. She is also no longer on miralax. She notes significant improvement in symptoms with resolved diarrhea. She feels well and denies bowel irregularity, anorexia, abd pain, nausea, vomiting, weight loss, or rectal bleeding. She maintains a relatively healthy diet.   No colon polyps on last 2 colonoscopy 2018 and 2021 and was advised no further screening colonoscopies are needed. S/p CCY 2013  GI Problem list: collagenous colitis
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Dose: 0.5 mL Route: Intramuscular Site: Left arm Manufacturer: Pfizer-BioNTech Lot#: EN6201 Location:  Referring Provider:  ID: 76 y.o. female with past medical history of hypertension, hyperlipidemia, arthritis present for follow up visit for new complaint of right upper quadrant pain starting mid February. She just had labs with her primary care provider February 16 and the following week noted several episodes of intermittent upper right pain which also radiated to the back. Symptoms seem to occur more at bedtime and does not identify if these were specifically postprandial or any relation to food intake or type. The pain was of a burning quality and the area felt somewhat swollen. It was 5-6 out of 10 in severity she did not note any associated heartburn, nausea, vomiting or other digestive symptoms and her bowel pattern was unchanged. She has Bristol consistency 3-4 bowel movements occurring 3-4 times a day which has been since her COVID shot. She had prior treatment for collagenous colitis but not noting any diarrhea. Weight is stable good intake. No urinary symptoms. The pain actually has resolved in the last week or so and no symptoms at this time.  She saw her primary care provider for low back pain October 23 and was treated with Macrobid for UTI.  Last office visit Dr. 7/21/21: Patient is a 73 y.o. female presenting for follow-up of collagenous colitis. Patient has a history of uncontrollable diarrhea that initially started in February 2021 a few days following her COVID-19 vaccine. Her subsequent colonoscopy on 5/11/21 showed changes on random colon biopsies consistent with collagenous colitis. She was subsequently started on budesonide 3mg TID which she gradually tapered over a six-week period. She has not taken any budesonide over the last three-weeks. She is also no longer on miralax. She notes significant improvement in symptoms with resolved diarrhea. She feels well and denies bowel irregularity, anorexia, abd pain, nausea, vomiting, weight loss, or rectal bleeding. She maintains a relatively healthy diet.   No colon polyps on last 2 colonoscopy 2018 and 2021 and was advised no further screening colonoscopies are needed. S/p CCY 2013  GI Problem list: collagenous colitis
Age: 73.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered the 3rd Bexsero dose too early. 3rd Bexsero dose was administered 1/23/25, which should've been administered 4/10/2025
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea at rest, Dyspnoea exertional, Palpitations
Clinical narrative: HPI patient is a 55-year-old male with a known history of hypertension, hyperlipidemia, previous tobacco use, family history of heart disease, who has recently developed intermittent episodes of chest discomfort, palpitations and shortness of breath. The patient describes the chest discomfort as a aching and painful sensation that can occur anytime during either rest or with exertion. The palpitations also occur at a time but more frequently in the evening. Is also noticed dyspnea on exertion and occasional mild shortness of breath at rest. The symptoms have occurred since his COVID-19 vaccination, Moderna vaccine. The patient denies near syncope or syncope. He does have a family history of heart disease. This is prompted him to have a more thorough evaluation.     55-year-old male presents to the emergency department for evaluation of chest pain. The patient describes several days to week of left-sided chest pressure, tightness and heaviness. He describes 2 days of exertional dyspnea and worsening of his pain with exertion. He states that his symptoms started shortly after receiving a COVID-19 vaccine. No fevers, chills, sweats, nauseousness although he had these symptoms at the onset. No vomiting or diarrhea. No rashes or skin changes. No prior history of coronary artery disease or stroke or acute coronary syndrome. Patient does have a history of hypertension, hyperlipidemia and chronic back pain status post 3 surgeries.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MMR-V, Medication Pro-quad, was given in error, lot Y013583, expiration 2/3/2026. The clinic did not receive any reports of reactions.
Age: 78.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Pain in extremity, Tremor
Clinical narrative: Patient was administered the Bexsero booster dose on 2/17/25 and reported a possible reaction to the vaccine. Patient reported having the "shakes and severe pain from his arm and back",
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: PROQUAD - MMR-V medication administered by error.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Injection site pain, Pain in extremity, Rash
Clinical narrative: sore arm, rash, pain at injection site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Condition aggravated, Loss of consciousness, Peripheral swelling, Scab
Clinical narrative: pt says both legs swelled up after getting the first vaccine but after getting the second vaccine both legs swelled up so bad they developed scabs.  After a couple of days the swelling went down. However, her life continue to go down hill. Within a day or so of getting the vaccines she went into heart failure, would black out for a long periods of time. It caused her to have multiple seizures which caused her to knock several teeth. She would try to go to the hospital but was told to stay at home. She thinks it was because of the pandemic. She is not currently seeing a physician and is being asked to sign an behavioral agreement before she can have medical treatment. She was being seen by Dr.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tooth injury
Clinical narrative: pt says both legs swelled up after getting the first vaccine but after getting the second vaccine both legs swelled up so bad they developed scabs.  After a couple of days the swelling went down. However, her life continue to go down hill. Within a day or so of getting the vaccines she went into heart failure, would black out for a long periods of time. It caused her to have multiple seizures which caused her to knock several teeth. She would try to go to the hospital but was told to stay at home. She thinks it was because of the pandemic. She is not currently seeing a physician and is being asked to sign an behavioral agreement before she can have medical treatment. She was being seen by Dr.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Brain fog, Fatigue
Clinical narrative: After he received the vaccine, he immediately had total body aches and pain, brain fog, headaches and he described the pain as having "body cancer." He has never complained of anything like this until the covid vaccine. He has seen multiple doctors from hematology, rheumatology, cardiology, pain management, his primary and a few trips to the emergency room. His bloodwork showed chronic inflammation which was causing him so much pain in his joints and bones that he wasn't able to walk. His brain fog is completely horrible as he forgets things most days and has been living on Tylenol or Advil or whatever is available at the time. He has been unable to work for the past few years due to his illness which means he has no income coming in and has borrowed thousands and thousands of dollars from his family. Chronic inflammation and chronic fatigue is devastating. He stays home most days and nights as he doesn't have any energy to get out of bed. I truly feel he is should be entitled to a compensation as the vaccine was a total sham and he only got it through a scare tactic. We need your help!
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Headache, Immediate post-injection reaction, Impaired work ability, Inflammation
Clinical narrative: After he received the vaccine, he immediately had total body aches and pain, brain fog, headaches and he described the pain as having "body cancer." He has never complained of anything like this until the covid vaccine. He has seen multiple doctors from hematology, rheumatology, cardiology, pain management, his primary and a few trips to the emergency room. His bloodwork showed chronic inflammation which was causing him so much pain in his joints and bones that he wasn't able to walk. His brain fog is completely horrible as he forgets things most days and has been living on Tylenol or Advil or whatever is available at the time. He has been unable to work for the past few years due to his illness which means he has no income coming in and has borrowed thousands and thousands of dollars from his family. Chronic inflammation and chronic fatigue is devastating. He stays home most days and nights as he doesn't have any energy to get out of bed. I truly feel he is should be entitled to a compensation as the vaccine was a total sham and he only got it through a scare tactic. We need your help!
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Memory impairment, Pain
Clinical narrative: After he received the vaccine, he immediately had total body aches and pain, brain fog, headaches and he described the pain as having "body cancer." He has never complained of anything like this until the covid vaccine. He has seen multiple doctors from hematology, rheumatology, cardiology, pain management, his primary and a few trips to the emergency room. His bloodwork showed chronic inflammation which was causing him so much pain in his joints and bones that he wasn't able to walk. His brain fog is completely horrible as he forgets things most days and has been living on Tylenol or Advil or whatever is available at the time. He has been unable to work for the past few years due to his illness which means he has no income coming in and has borrowed thousands and thousands of dollars from his family. Chronic inflammation and chronic fatigue is devastating. He stays home most days and nights as he doesn't have any energy to get out of bed. I truly feel he is should be entitled to a compensation as the vaccine was a total sham and he only got it through a scare tactic. We need your help!
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: itchy red skin rashes and hives on forearms, neck, and lips
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Injection site cellulitis, Injection site rash, Injection site reaction, Limb injury, Nasal congestion
Clinical narrative: Patient returned to clinic on 2/20/25, 13 days after vaccine administration. Presented with open wound & cellulitis to left thigh (15 cm by 25 cm), with yellow edges and pink/red wound. Parents report that patient had rash to both extremities but wound on left thigh developed following vaccine administration. Mother also reports intermittent fever for last week, as high as 102 F, cough, congestion, and runny nose. Mother reports that patient was seen at urgent care where he was prescribed antibiotic ointment for wound and cephalexin.  Patient is positive for fever. Other symptoms include fevers up to 102 degrees, productive cough, sinus and nasal congestion, and runny nose. Patient received wound care during office visit today. Was prescribed vitamin C today and referred to Wound Clinic and Pediatric Dermatology.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Productive cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Sinus congestion
Clinical narrative: Patient returned to clinic on 2/20/25, 13 days after vaccine administration. Presented with open wound & cellulitis to left thigh (15 cm by 25 cm), with yellow edges and pink/red wound. Parents report that patient had rash to both extremities but wound on left thigh developed following vaccine administration. Mother also reports intermittent fever for last week, as high as 102 F, cough, congestion, and runny nose. Mother reports that patient was seen at urgent care where he was prescribed antibiotic ointment for wound and cephalexin.  Patient is positive for fever. Other symptoms include fevers up to 102 degrees, productive cough, sinus and nasal congestion, and runny nose. Patient received wound care during office visit today. Was prescribed vitamin C today and referred to Wound Clinic and Pediatric Dermatology.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Wound
Clinical narrative: Patient returned to clinic on 2/20/25, 13 days after vaccine administration. Presented with open wound & cellulitis to left thigh (15 cm by 25 cm), with yellow edges and pink/red wound. Parents report that patient had rash to both extremities but wound on left thigh developed following vaccine administration. Mother also reports intermittent fever for last week, as high as 102 F, cough, congestion, and runny nose. Mother reports that patient was seen at urgent care where he was prescribed antibiotic ointment for wound and cephalexin.  Patient is positive for fever. Other symptoms include fevers up to 102 degrees, productive cough, sinus and nasal congestion, and runny nose. Patient received wound care during office visit today. Was prescribed vitamin C today and referred to Wound Clinic and Pediatric Dermatology.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna for age 6 months to 11 year given to the patient
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired RECOMBIVAX HB to a patient. Vaccine expired on 09MAR2019 and was administered to a patient on 11MAR2019. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAR-2019, the patient received inadvertent administration of expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, invalid lot P7EE2, expiration date: 09-MAR-2019, administered for prophylaxis (dosage, route of administration, and anatomical location were not provided) (Expired product administered). No additional adverse event was reported.   This is non-valid because the patient is not identifiable.  Follow-up information has been received from the nurse on 05-FEB-2025.  It was confirmed that the patient was a 5-year-old male.  This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2236723. The previous case ID: 2501USA003629. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; a dose of MMR-II expired on 8/13/2016 and was administered on 11/3/2016.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 03-NOV-2016, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (lot#: K011317, expiration date: 13-AUG-2016; dose, strength, and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: has not yet received their third dose; No additional AE; This spontaneous report was received from a Pharmacist and refers to a 25-year-old male patient.   The patient's medical, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.   On an unknown date in April 2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (Dose 1) (strength, dose description, route of administration, lot # and expiration date were not reported). On an unknown date in June 2023, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9)  (GARDASIL®9), (dose 2) (strength, dose description, route of administration, lot # and expiration date were not reported) as prophylaxis, however, the patient has not yet received their third dose (Inappropriate schedule of product administration). No symptoms reported, No additional adverse event.
Age: 2.0
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; Nurse called and reported PROQUAD and VARIVAX were inadvertently concomitantly administered to a patient. Caller stated no patient symptoms have been reported. No additional AE/no PQC reported.; This spontaneous report was received from a Nurse and refers to a 2-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-FEB-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y013347, expiration date: 02-AUG-2026) (1 dose), for an unknown indication and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (lot #Y016876, expiration date: 07-APR-2026), dose number 1, (1 dose), for prophylaxis.  The suspected vaccines were inadvertently concomitantly administered to a patient (accidental overdose). Reported stated no patient symptoms have been reported.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: inappropriate schedule of vaccine; Product administered to patient of inappropriate age; This spontaneous report was received from a lawyer and refers to a 1-month-old female patient who was involved in a litigation process regarding quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (case). All details regarding the patient's medical history, concurrent conditions and concomitant therapies were captured in case.   On 15-MAR-2005, at the age of 1 month, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (product administered to patient of inappropriate age).  On 16-AUG-2005, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (inappropriate schedule of product administration).  On 17-Nov-2005, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis.  This was one of several reports regarding the same patient.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received a Dose of HEPLISAV-B Today, Which Expired on 04-Jan-2025; Initial report received on 22-Jan-2025.  A nurse reported that a 39-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  No medical history or concomitant medications were reported.  On 22-Jan-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 941579, expiration date 04-Jan-2025; NDC number not available) intramuscularly in the left deltoid. The dose of HEPLISAV-B administered had expired on 04-Jan-2025. No side effects were reported.  No other information was available.  Company Comment: The company assessed the event as non-serious; Sender's Comments: The company assessed the event as non-serious
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd Dose 2 1/2 Weeks Early; Initial report received on 31-Jan-2025.   A pharmacist reported that a patient (age, gender, race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization early.   No medical history or concomitant medications were reported.   On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, route, and site not available)].   On an unknown date, 17 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot #, expiration date, route, and site not available).  The patient received the second dose two and a half weeks too early.   No additional information was reported.      Company Comment:The company assessed the event as non-serious; Sender's Comments: The company assessed the event as non-serious
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: First Dose at pharmacy on Dec 20th 2023 and Took a Second Dose at pharmacy on Feb 1, 2025; Initial report received on 03-Feb-2025.  A consumer reported that he received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 20-Dec-2023 and received the second dose on 01-Feb-2025.  No medical history or concomitant medications were reported.  On 20-Dec-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)].  On 01-Feb-2025, 409 days after receiving the first dose of HEPLISAV-B, the patient received dose 2 of  HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). The patient was inquiring if he was fully immunized. No adverse reactions were reported.   The reporter declined to provide further information.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose Recombivax; Initial report received on 03-Feb-2025.  A nurse reported that a female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, then one month later received a dose of RECOMBIVAX.  No medical history or concomitant medications were reported.  On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 944942, expiration date 31-Jan-2027, and NDC number 43528-003-05)] intramuscularly in the right deltoid.  On an unknown date, one month after receiving HEPLISAV-B, the patient received a dose of a hepatitis B vaccine [RECOMBIVAX (lot number and expiration date not reported)].  No side effects were reported.     No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash
Clinical narrative: Second Dose of HEPLISAV-B Not Received; Rash; Red Skin; Initial report received on 05-Feb-2025.    A reporter reported that a 48-year-old female (ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed red skin and rash.      No medical history or concomitant medications were reported.    On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # 43528-002-01, site not available)] intramuscularly.  At the time of reporting, more than a year after receiving the first dose, the patient presented to receive the second dose, but the site would not administer it.   No additional information was reported.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose Heplisav-B, and Second Dose Recombivax; Initial report received on 07-Feb-2025.   A pharmacist reported that a 24-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, then seven months later received a dose of RECOMBIVAX.   No medical history or concomitant medications were reported.     On 11-Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945484, expiration date 20-Apr-2026, NDC # 43528-0003-05, route, and site not available).    In Jan-2025, approximately seven months after having been vaccinated with HEPLISAV-B, the patient received a dose of a hepatitis B vaccine [RECOMBIVAX (lot number and expiration date note reported)]. No side effects were reported.   No other information was available.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Expired product administered, Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Kinrix vaccine administered to infant; Wrong dose Vaccine was given twice; Expired vaccine used; Kinrix vaccine administered to infant; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 12-week-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D / D947X, expiry date 25-JAN-2025) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   On 28-JAN-2025, the patient received Kinrix (intramuscular, right thigh). On 27-NOV-2024, the patient received Kinrix. On 27-NOV-2024, not applicable after receiving Kinrix and an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine administered to infant). On 28-JAN-2025, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine administered to infant), extra dose administered (Verbatim: Wrong dose Vaccine was given twice) and expired vaccine used (Verbatim: Expired vaccine used). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and expired vaccine used 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: 12-FEB-2025  This case was reported by a medical assistant via patient support programs.  The patient received wrong dose. The patient received expired dose of Kinrix, which led to expired vaccine used. No other products were reported.
Vaccine: TDAP, VARZOS
Symptoms: Feeling hot
Clinical narrative: Feel like warm garbage; This non-serious case was reported by a consumer and described the occurrence of feeling of warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for prophylaxis.   On 28-JAN-2025, the patient received Shingrix and Tdap. On 28-JAN-2025, less than a day after receiving Shingrix, the patient experienced feeling of warmth (Verbatim: Feel like warm garbage). The outcome of the feeling of warmth was resolved.   It was unknown if the reporter considered the feeling of warmth to be related to Shingrix.     It was unknown if the company considered the feeling of warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2025 The patient got Shingrix shot and TDAP  on the same day (day of posting) and felt like warm garbage as because beats shingles or tetanus though.
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     It was unknown if the company considered the allergic reaction to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter reported that patient received Shingles vaccine and had an allergic reaction.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: It has been 9 months since my first Shingrix vaccination; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 9 months ago in 2024).   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: It has been 9 months since my first Shingrix vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2025 This case was reported by a patient via interactive digital media. The patient was concerned if it was still advisable to get the second dose now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Still developed respiratory syncytial virus infection; 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included covid-19 (patient had Covid 19 multiple times).   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Still developed respiratory syncytial virus infection). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved.   The reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     The company considered the vaccination failure to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2025 This case was reported by a patient mother via interactive digital media. The patient mother reported that her daughter had received the Respiratory syncytial virus infection vaccination and still developed Respiratory syncytial virus infection. She said it was worse than having covid the times The patient works with disability needs. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Arexvy.
Vaccine: RSV
Symptoms: Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness; upper body muscle aches; slight headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of stiffness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-FEB-2025, the patient received Arexvy. In FEB-2025, an unknown time after receiving Arexvy, the patient experienced stiffness (Verbatim: stiffness), muscle pain (Verbatim: upper body muscle aches) and headache (Verbatim: slight headache). The outcome of the stiffness, muscle pain and headache were not reported.   It was unknown if the reporter considered the stiffness, muscle pain and headache to be related to Arexvy.     It was unknown if the company considered the stiffness, muscle pain and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-FEB-2025 This case was reported by a patient via  interactive digital media. Consumer reported that he/she experience upper body muscle aches, stiffness, slight headache after injection on February 13 2025 The follow-up could not be possible as no contact details were available.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Headache, Pain in extremity, Swelling face
Clinical narrative: new symptom of drooping on left lip has started; patient experienced right arm pain (vaccination was given there); headache; swollen from left eye down to lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number X72D2, expiry date 30-JAN-2027) for prophylaxis.   On 17-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 17-JAN-2025, 12 hrs after receiving Shingrix, the patient experienced pain in arm (Verbatim: patient experienced right arm pain (vaccination was given there)), headache (Verbatim: headache) and facial swelling (Verbatim: swollen from left eye down to lips). On 20-JAN-2025, the patient experienced facial muscle weakness (Verbatim: new symptom of drooping on left lip has started). On 22-JAN-2025, the outcome of the pain in arm and headache were resolved and the outcome of the facial muscle weakness was resolved (duration 2 days). The outcome of the facial swelling was resolved.   It was unknown if the reporter considered the pain in arm, headache, facial swelling and facial muscle weakness to be related to Shingrix.     It was unknown if the company considered the pain in arm, headache, facial swelling and facial muscle weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JAN-2025 Reporter was the patient who received her first Shingrix vaccine on 17th January 2025. Within the first 12 hours patient experienced right arm pain (vaccination was given there), headache, swollen from left eye down to lips.  On the day of reporting 22nd January 2025, right arm pain, swelling from left eye down to lip and headache has subsided, however, on 20th January 2025, new symptom of drooping on left lip has started.  Caller did reach out to the Clinic where she received the vaccine and was told to speak with her healthcare professional.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Havrix vaccine for adults but although she is 18 years old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number 944915) for prophylaxis.   On 17-JAN-2025, the patient received the 1st dose of Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced inappropriate age at vaccine administration (Verbatim: Havrix vaccine for adults but although she is 18 years old). 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: Upon internal review the case was updated on 20-FEB-2025 The Medical Assistant reported that the patient who got the Hepatitis A, Havrix vaccine for adults but although she was 18 years old.  Reporter asked that was that is ok. Patient received adult dose instead of pediatric dose, which ed to in Inappropriate age at vaccine administration. Summary of Changes: General tab, Event tab, product tab and narrative was updated.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: few spots around injection site; arm is hurting at the injection site; muscle aches; not feeling well; arm is painful; arm itching; having a hard time lifting her arm; Injection site bulge; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date).   On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site bulge). In JAN-2025, the patient experienced injection site erythema (Verbatim: few spots around injection site), injection site pain (Verbatim: arm is hurting at the injection site), muscle pain (Verbatim: muscle aches), feeling unwell (Verbatim: not feeling well), pain in arm (Verbatim: arm is painful), itchy upper limbs (Verbatim: arm itching) and injected limb mobility decreased (Verbatim: having a hard time lifting her arm). The outcome of the injection site lump was resolved (duration 2 days) and the outcome of the injection site erythema, injection site pain, pain in arm, itchy upper limbs and injected limb mobility decreased were unknown and the outcome of the muscle pain and feeling unwell were resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that she had her second dose of Shingrix administered on 9-JAN-2025.  Immediately following the injection, the site of injection had a bulge that was present for a couple of days.  Reporter stated after the injection she had muscle aches and was not feeling well.  That symptoms did resolve within a few days.  Two weeks after the injection her arm was painful, itching and her arm was hurting at the injection site. Also stated that she was having a hard time lifting her arm due to the pain when attempting to lift her arm.  She had a few spots around the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pruritus
Clinical narrative: few spots around injection site; arm is hurting at the injection site; muscle aches; not feeling well; arm is painful; arm itching; having a hard time lifting her arm; Injection site bulge; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date).   On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site bulge). In JAN-2025, the patient experienced injection site erythema (Verbatim: few spots around injection site), injection site pain (Verbatim: arm is hurting at the injection site), muscle pain (Verbatim: muscle aches), feeling unwell (Verbatim: not feeling well), pain in arm (Verbatim: arm is painful), itchy upper limbs (Verbatim: arm itching) and injected limb mobility decreased (Verbatim: having a hard time lifting her arm). The outcome of the injection site lump was resolved (duration 2 days) and the outcome of the injection site erythema, injection site pain, pain in arm, itchy upper limbs and injected limb mobility decreased were unknown and the outcome of the muscle pain and feeling unwell were resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site lump, injection site erythema, injection site pain, muscle pain, feeling unwell, pain in arm, itchy upper limbs and injected limb mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that she had her second dose of Shingrix administered on 9-JAN-2025.  Immediately following the injection, the site of injection had a bulge that was present for a couple of days.  Reporter stated after the injection she had muscle aches and was not feeling well.  That symptoms did resolve within a few days.  Two weeks after the injection her arm was painful, itching and her arm was hurting at the injection site. Also stated that she was having a hard time lifting her arm due to the pain when attempting to lift her arm.  She had a few spots around the injection site.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: 25 years old female patient accidentally get the infanrix instead of boostrix; 25 years old female patient accidentally get the infanrix instead of boostrix; female patient accidentally get the infanrix instead of boostrix; 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 25-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received 1st dose of vaccine on an unknown date).   On 24-JAN-2025, the patient received the 1st dose of Infanrix. On an unknown date, the patient received Boostrix. On 24-JAN-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced adult use of a child product (Verbatim: 25 years old female patient accidentally get the infanrix instead of boostrix), accidental underdose (Verbatim: 25 years old female patient accidentally get the infanrix instead of boostrix) and wrong vaccine administered (Verbatim: female patient accidentally get the infanrix instead of boostrix). The outcome of the adult use of a child product, accidental underdose and wrong 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: 27-JAN-2025 The Reporter called to report that they had a 25-year-old female patient who accidentally got the Infanrix instead of the Boostrix, which led to Adult use of a child product, Accidental underdose and Wrong vaccine administered. The patient was supposed to receive the second dose of Boostrix, but instead, she received Infanrix.