chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: PNC21, PNC21
Symptoms: Fatigue, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: heavy fatigue; painful raised welt approx 2 x 4 inches centered on left deltoid injection site with 1 inch diameter rash; painful raised welt approx 2 x 4 inches centered on left deltoid injection site; This spontaneous report was received from a Patient on 02-Jul-2025 concerning his/herself of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-Jul-2025, the patient was vaccinated with a Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y019158, expiration date: 20-May-2026) (1 time), administered by Intramuscular route in the left deltoid for prophylaxis. On 02-Jul-2025, the patient experienced heavy fatigue, painful raised welt approximately 2 x 4 inches (Vaccination site urticaria, Vaccination site pain) centered on left deltoid injection site with 1 inch diameter rash on upper edge of armpit.   The patient recovered from the events approximately on 07-Jul-2025, reported as lasted for lasted for 4-5 days. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site rash, Skin warm
Clinical narrative: injection site reaction over L deltoid - 8 cm erythema, warmth, pruritis, pain
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: injection site reaction over L deltoid - 8 cm erythema, warmth, pruritis, pain
Age: 74.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Immediate post-injection reaction, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: The caller stated that right away, her arm hurt at the injection site.; the pharmacist will not be giving her any more doses of CAPVAXIVE because they believe she has an allergy to one of the ingredients; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; This spontaneous report was received from a 74-year-old female patient and referred to herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z004302, expiration date: 04-Sep-2026) for prophylaxis.  On 04-Jul-2025, right away, her arm hurt at the injection site. By 06-Jul-2025, her left arm was itchy, swollen, and red. The patient stated that her left arm was red from the injection site down to her elbow and that her left arm was"double the size" of her right arm.The patient stated that the pharmacist would not be giving her any more doses of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) because they believe she had an allergy to one of the ingredients.  At the reporting time, the patient had not recovered from all the events.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as withdrawn.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. The causal relationship between Allergy to vaccine and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was default to be related.
Age: 74.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chills, Erythema, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: The caller stated that right away, her arm hurt at the injection site.; the pharmacist will not be giving her any more doses of CAPVAXIVE because they believe she has an allergy to one of the ingredients; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; This spontaneous report was received from a 74-year-old female patient and referred to herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z004302, expiration date: 04-Sep-2026) for prophylaxis.  On 04-Jul-2025, right away, her arm hurt at the injection site. By 06-Jul-2025, her left arm was itchy, swollen, and red. The patient stated that her left arm was red from the injection site down to her elbow and that her left arm was"double the size" of her right arm.The patient stated that the pharmacist would not be giving her any more doses of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) because they believe she had an allergy to one of the ingredients.  At the reporting time, the patient had not recovered from all the events.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as withdrawn.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. The causal relationship between Allergy to vaccine and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was default to be related.
Age: 74.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site pruritus, Injection site swelling, Paraesthesia, Sleep disorder
Clinical narrative: The caller stated that right away, her arm hurt at the injection site.; the pharmacist will not be giving her any more doses of CAPVAXIVE because they believe she has an allergy to one of the ingredients; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; The caller stated that by 07/06/2025, her left arm  was itchy, swollen, and red.; This spontaneous report was received from a 74-year-old female patient and referred to herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z004302, expiration date: 04-Sep-2026) for prophylaxis.  On 04-Jul-2025, right away, her arm hurt at the injection site. By 06-Jul-2025, her left arm was itchy, swollen, and red. The patient stated that her left arm was red from the injection site down to her elbow and that her left arm was"double the size" of her right arm.The patient stated that the pharmacist would not be giving her any more doses of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) because they believe she had an allergy to one of the ingredients.  At the reporting time, the patient had not recovered from all the events.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as withdrawn.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. The causal relationship between Allergy to vaccine and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was default to be related.
Age: 74.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Immediate post-injection reaction, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Whole upper arm was swollen and red. It was itchy too.she felts chills and tingling in left hand-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Patient came in on 7/8/25 around 2:30pm to pick up prescription. At that time she came in spoke to the pharmacists present to discuss the side effects. We immediately recommended that she takes benadryl. She was not experiencing any chills any more.Just swelling  and itching around the left upper arm. She will call her primary and make appt.She had also contacted the manufacter to ask about side effect and she was directed to contact her local pharmacy to report the issue. No bruising though.
Age: 74.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chills, Erythema, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Whole upper arm was swollen and red. It was itchy too.she felts chills and tingling in left hand-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Patient came in on 7/8/25 around 2:30pm to pick up prescription. At that time she came in spoke to the pharmacists present to discuss the side effects. We immediately recommended that she takes benadryl. She was not experiencing any chills any more.Just swelling  and itching around the left upper arm. She will call her primary and make appt.She had also contacted the manufacter to ask about side effect and she was directed to contact her local pharmacy to report the issue. No bruising though.
Age: 74.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site pruritus, Injection site swelling, Paraesthesia, Sleep disorder
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Whole upper arm was swollen and red. It was itchy too.she felts chills and tingling in left hand-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Patient came in on 7/8/25 around 2:30pm to pick up prescription. At that time she came in spoke to the pharmacists present to discuss the side effects. We immediately recommended that she takes benadryl. She was not experiencing any chills any more.Just swelling  and itching around the left upper arm. She will call her primary and make appt.She had also contacted the manufacter to ask about side effect and she was directed to contact her local pharmacy to report the issue. No bruising though.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in 2019) and Shingrix (Received 2nd dose of Shingrix vaccine in 2019).   On 14-JUL-2025, the patient received the 3rd dose of Shingrix (left deltoid). On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 14-JUL-2025 The patient had already received both doses of the Shingrix vaccine in 2019 and mistakenly got the vaccine again today which led to extra dose administered.
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Wrong product administered
Clinical narrative: swelling/pain at sites; swelling/pain at sites; asked if the vaccine he had in the syringe was Novavax. He nodded "yes."/was told I was given Pfizer.; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Feb2025 as dose 1 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization series complete), for covid-19 immunization, reaction(s): "hypersensitivity". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 22Feb2025, outcome "unknown", described as "asked if the vaccine he had in the syringe was Novavax. He nodded "yes."/was told I was given Pfizer."; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling/pain at sites".  Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G22GH, expiry date 01-JUL-2025) for prophylaxis.   On 13-JUL-2025, the patient received Arexvy (intramuscular, left arm). On 13-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: expired vaccine administered). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 14-JUL-2025 The pharmacist calling on behalf patient stated that they administered a dose of Arexvy to the patient day before reporting and the vaccine expired which led to, expired vaccine used. The reporter stated she did file a report of the incident in VAERS.
Age: 16.0
Sex: M
Vaccine: MENB, MENB, MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Double dose on same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ZK9P4) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number EK7DG) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 23-JUN-2025, the patient received Bexsero, Menveo, Bexsero and Menveo. On 23-JUN-2025, an unknown time after receiving Bexsero, Menveo, Bexsero and Menveo, the patient experienced accidental overdose (Verbatim: Double dose on same day). The outcome of the accidental overdose 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: 09-JUL-2025 and 11-JUL-2025 The reporter had a patient that, on the date of the visit, inadvertently received the Menveo 1 vial, they received 2 doses on the same day. They also received the Bexsero. So, on that day, they received a double, 2 of each on the same day. The healthcare professional informed that on the same day on 23rd June 2025 the patient received 2 doses of Menveo (1 vial) and 2 doses of Bexsero, in total, the patient received 4 doses which led to accidental overdose.
Age: 37.0
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; Second dose on 3/31/2025, and Third dose administered today, 6/25/2025; This spontaneous report was received from a Pharmacist and refers to a 37-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   The patient received 3 dose series of vaccination with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection  dose 1 on 26-FEB-2025 (dose, lot#, expiration date, route and site of vaccination were not provided), dose 2 on 31-MAR-2025 (dose, lot#, expiration date, route and site of vaccination were not provided), and dose 3 on 25-JUN-2025 (inappropriate schedule of vaccine administered) (lot #Y014059, expiration date: 01-Nov-2026), 0.5 mL (route and site of administration were not provide).  No additional adverse event was reported.
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Skin papilloma
Clinical narrative: They had a 9 year old patient who had severe warts on his entire body, they explained it as the worst they had seen. After being vaccinated with 3 doses of GARDASIL 9 his symptoms resolved completely.; This spontaneous report was received from a nurse and refers to a 9-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 1, administered by unknown route (indication, expiration date, and lot # were not reported). On an unknown date, the patient was administered Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 2, administered by unknown route (indication, expiration date, and lot # were not reported). On an unknown date, the patient was administered Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 3, administered by unknown route (indication, expiration date, and lot # were not reported).  On an unspecified date, after being vaccinated with 3 doses of the suspect vaccine, the patient's severe warts on his entire body (described as "the worst they had seen") resolved completely (Therapeutic response unexpected). At the reporting time, the outcome of event was not known.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not applicable.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no symptomatic adverse events; Inbound call from nurse calling to report administration of expired GARDASIL-9 to a patient on 18-MAR-2025.  Caller states that they discovered that the dose was administered expired after the patient came in recently for the next dose.  Confirmed no; This spontaneous report was received from a nurse and refers to a 22-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 18-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #X019862, expiration date: 14-Feb-2025) (0.5 ml / once), for prophylaxis, administration of expired vaccine (expired product administered). The nurse reported that it was discovered that the dose was administered expired after the patient came in recently for the next dose. Confirmed no symptomatic adverse events (no adverse event).
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Extra Dose Administered; Gave HEPLISAV-B Series Two Doses 28 Days Apart, Rechecked Titer and He is Non-Reactive; Initial report received on 07-Jul-2025.  A nurse reported that a 33-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a titer lab test which showed that he is non-reactive.  No concomitant medications or medical history was reported.    On 07-Apr-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 945660 and expiration date 31-Jan-2027; NDC number not available) intramuscularly in the left deltoid.  On 12-May-2025, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number 945664 and expiration date 31-Jan-2027; NDC number not available) intramuscularly in the left deltoid.   On 24-Jun-2025, 44 days after receiving the second dose of HEPLISAV-B, the patient had a qualitative hepatitis B surface antibody titer test performed. The test result showed non-reactive (not immune to hepatitis B virus infection).   On 09-Jul-2025, 59 days after receiving the second dose of HEPLISAV-B, the patient received dose 3 of a hepatitis B vaccine HEPLISAV-B (lot number 946060 and expiration date 05-May-2027; NDC number not available) intramuscularly in the left deltoid.   No additional information was reported.    Company Comment: The company assessed the events as non-serious. The event of vaccination failure was considered not immunologically confirmed based on the dosing schedule.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was considered not immunologically confirmed based on the dosing schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash/ general rash on chest; This non-serious case was reported by a other health professional via sales rep and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: developed a rash/ general rash on chest). The outcome of the rash was resolved.   The reporter considered the rash to be related to Shingrix.     The company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2025 The physician assistant that they had a patient who developed a rash after the 1st dose of Shingrix injection and was general rash on chest that lasted a few weeks.
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: rsv's infections/suspected vaccination failure; rsv's infections; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: rsv's infections/suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: rsv's infections). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2025 This case was reported by a consumer via interactive digital media. After the RSV shot, he/she had stopped taking any vaccines. That's how bad rsv's infections were to his/her body that he/she had to check in emergency room and it was happened first time in his/her life. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming 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 RSV vaccine.
Vaccine: VARZOS
Symptoms: Dehydration, Malaise, Pyrexia, Vomiting
Clinical narrative: running a fever; I had my first shot and I was so sick for 4-5 days; throwing up dehydrated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fever (Verbatim: running a fever), sickness (Verbatim: I had my first shot and I was so sick for 4-5 days) and dehydration (Verbatim: throwing up dehydrated). The outcome of the fever and dehydration were not reported and the outcome of the sickness was resolved.   It was unknown if the reporter considered the fever, sickness and dehydration to be related to Shingrix.     It was unknown if the company considered the fever, sickness and dehydration to be related to Shingrix.   Additional Information: GSK Receipt Date: -8-JUL-2025 This case was reported by a patient via interactive digital media. The had my first shot and was so sick for 4-5 days.  The smell of food made sick.  The patient was throwing up dehydrated, running a fever.  It all started within 3 hours after had the shot, patient refuse the second shot because friends of mine that had the shots got really sick off of the second one. This case is linked with US2025AMR088832, reported by same reporter.; Sender's Comments:  US-GSK-US2025AMR088832:friend case
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Paraesthesia, Peripheral swelling
Clinical narrative: raised injection site; red area (a few square inches) at injection site; hot to touch the injection site; she is still tired; swollen fingers/ arm; tingling fingers; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: raised injection site), injection site erythema (Verbatim: red area (a few square inches) at injection site), injection site warmth (Verbatim: hot to touch the injection site), tiredness (Verbatim: she is still tired), peripheral swelling (Verbatim: swollen fingers/ arm) and tingling of extremity (Verbatim: tingling fingers). The outcome of the injection site swelling, injection site erythema, injection site warmth and peripheral swelling were resolving and the outcome of the tiredness was not resolved and the outcome of the tingling of extremity was resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, tiredness, peripheral swelling and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site warmth, tiredness, peripheral swelling and tingling of extremity to be related to Shingrix.   Additional Information: GSK receipt date: 08-JUL-2025 The subject was the reporter, a physician, and the patient. She was a personal friend who shared that she received Shingrix the day before. In the arm where she received the injection, she had a raised, red area (a few square inches) that it was hot to the touch. She noted her fingers were swollen and tingling due to the swelling in that same arm. She had put cool compresses on the area which have helped. She had not taken any medication for this yet but planned to take Tylenol before bed. The reporter followed up with her this morning and she said the swelling was down, finger tingling was gone. She noted that she was still tired (which she did not mention originally). Overall, she said she was improved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix + Adjuvant administration only; Incorrect dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 2HJ99, expiry date 04-APR-2027) for prophylaxis.   On 07-JUL-2025, the patient received Shingrix. On 07-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix + Adjuvant administration only) and inappropriate dose of vaccine administered (Verbatim: Incorrect dose administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 07-JUL-2025 Nurse reported that a patient received the Adjuvant portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix Third dose given; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date) and Shingrix (received second dose of Shingrix on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix Third dose given). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 09-JUL-2025 The healthcare professional mentioned that a patient received two doses of Shingrix and the by mistake a third dose was administered which led to extra dose administered. No further details were provided.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Havrix today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix 720) (batch number 943Y2, expiry date 05-MAY-2025) for prophylaxis.   On 11-JUL-2025, the patient received Havrix 720. On 11-JUL-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: received an expired dose of Havrix today). 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: 11-JUL-2025 A Registered Nurse reported a two year old received an expired dose of Havrix today which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) in 2022 at an unspecified dose and frequency. In 2022, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects.   This case was linked to MOD-2025-788129 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7164B and AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis.   On 30-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects.   This case was linked to MOD-2025-788129 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site reaction
Clinical narrative: little injection site reaction limited to a localized area in the arm; Covid infection in 14-Feb-2024 and has experienced very mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) and COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis.   On 02-Dec-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 27-Apr-2024, received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2024, the patient experienced COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms). On an unknown date, the patient experienced INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved and COVID-19 (Covid infection in 14-Feb-2024 and has experienced very mild symptoms) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. Patient had a Covid infection in 14-Feb-2024 and had experienced very mild symptoms.  It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects.   This case was linked to MOD-2025-788129 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis.    On 15-Sep-2024, the patient received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, PAIN (By the 9th dose of vaccine taken she hardly had any side effects, just some soreness.) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. By the 9th dose of vaccine taken, she hardly had any side effects, just some soreness with no fever or aches.  It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects.   This case was linked to MOD-2025-788129 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: flu like feeling; little injection site reaction limited to a localized area in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 007B21A and 076C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (diagnosed with multiple sclerosis 30 years ago or even more) and Hemochromatosis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like feeling) and INJECTION SITE REACTION (little injection site reaction limited to a localized area in the arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had the usual side effects after taking Moderna covid vaccines throughout the years, these symptoms were, fever, chills, little injection site reaction limited to a localized area in the arm, flu like feeling, aches and it all usually lasted about 36 hours. Every shot was less reactive than the one before. It was unknown if the patient experienced any additional symptoms/events. She took Tylenol to ease the side effects.   This case was linked to US-MODERNATX, INC.-MOD-2025-788167 (E2B Linked Report). This case was linked to MOD-2025-788134, MOD-2025-788137, MOD-2025-788138, MOD-2025-788141 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-788167:Husband's  case
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Other Vaccines:  VaccineTypeBrand: heplisav; Manufacturer: dynavax tech; LotNumber: 946064; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 06/28/2025
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Injection site bruising, Injection site erythema, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: arm/finger numbness/tingling especially in wrist-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: numbness/tingling arm/hand/wrist
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Palpitations
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: fast heart beat/ palpitations-Mild, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: glaxosmithkline; LotNumber: h4279; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: UNKNOWN
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Chest discomfort, Chest pain, Eye swelling, Mouth swelling, Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: pt developed symptoms 15 min after injection, he rushed to ER and was given benadryl and medrol dose pack. Symptoms has subside after medication
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: pt developed symptoms 15 min after injection, he rushed to ER and was given benadryl and medrol dose pack. Symptoms has subside after medication
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site pain, Loss of consciousness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: AFTER VACCINE ADMNISTRATION, PATIENT BECAME LIGHT HEADED DIZZY, PASSED OUT 5-10 SECONDS, SHAKING, THEN BECAME ALERT. THEN, SWEATY, FLUSH, PALE. NO FALLS, BLOOD PRESSUE ~10 MINS AFTER EVEN 104/72 PULSE 80, ~25 MINS AFTER 124/80
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pallor, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: AFTER VACCINE ADMNISTRATION, PATIENT BECAME LIGHT HEADED DIZZY, PASSED OUT 5-10 SECONDS, SHAKING, THEN BECAME ALERT. THEN, SWEATY, FLUSH, PALE. NO FALLS, BLOOD PRESSUE ~10 MINS AFTER EVEN 104/72 PULSE 80, ~25 MINS AFTER 124/80
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Fatigue, Injection site pain, Lethargy, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Weakness-Severe, Additional Details: pt came after a month complaining she has take pain management course probably some kind of injection and was in mergency for few days, Other Vaccines:  VaccineTypeBrand: shingles; Manufacturer: glaxosmith; LotNumber: 3273h; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: md3414; Route: im; BodySite: right; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Weakness-Severe, Additional Details: pt came after a month complaining she has take pain management course probably some kind of injection and was in mergency for few days, Other Vaccines:  VaccineTypeBrand: shingles; Manufacturer: glaxosmith; LotNumber: 3273h; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: md3414; Route: im; BodySite: right; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Reported bloody nose-Medium, Systemic: Headache-Medium, Additional Details: Patient came to pharmacy in-person on 07/08/25 and reported that she had these side effects after receiving the vaccine on 06/24/25.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient visited doctor after pain/swelling/redness in injection site did not subside. Doctor mentioned that the injection appeared to be given too low on the arm. Redness and swelling are better, but patient is still experiencing pain.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Systemic: tachycardia-Mild, Systemic: Tachycardia-Mild
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient reported event via email.  Patient unable to be reached by phone after multiple attempts.