chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported/ No additional AE/no PQC; HCP calling to report VAQTA was inadvertently administered to a patient today, 1/30/2024, after its labeled expiry date of 12/27/2023.; This spontaneous report has been received from a health care professional and refers to a 60-year-old patient of unknown gender.  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 30-JAN-2024, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (expired product administered), at a dose of 5 milliliter (mL) (lot number W023489 has been determined to be valid for hepatitis a vaccine, inactivated (VAQTA), expiration date reported and validated as 27-DEC-2023), administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided). No adverse events were reported for this patient.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: The nurse grabbed the Proquad instead of MMR so the patient instead got Proquad; The patient got double varicella shot; No addtional AE; This spontaneous report was received from a nurse and refers to a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. concomitant medication included hepatitis a vaccine, inactivated (VAQTA).     On an unspecified date, the patient was supposed to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX); however, the nurse grabbed and administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiration date, route of administration, anatomical location not provided) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) as prophylaxis (wrong product administered), reconstituted with sterile diluent (manufacturer unknown). It was reported that the patient already had the varicella vaccine, so, the patient got double varicella vaccine (on 30-JAN-2024) (extra dose administered). No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: COVID19, HEPA, MMR, PNC15, VARCEL
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: M-M-R II administered on 06-NOV-2023/VARIVAX administered on 19-OCT-2023; low grade fever for 24 hrs after vaccine administration; This spontaneous report was received from a consumer and refers to a 12-month-old male patient. The patient had no chronic/long-standing health conditions, acute illnesses at the time of vaccination and up to one month before, allergies to medications, food, and other products. Concomitant therapies were not reported.   On 19-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 of 2 doses in series, lot # reported and confirmed as: X010536, expiration date was not reported but upon internal validation it was established as: 11-APR-2025, administered subcutaneously (SC), at right thigh (RT)(exact dose was not reported) for prophylaxis; hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 of 2 doses in series, lot # reported and confirmed as: X010374, expiration date was not reported but upon internal validation it was established as: 13-NOV-2024, administered intramuscularly (IM), at right thigh (RT) for prophylaxis (exact dose was not provided); and elasomeran (MODERNA COVID-19 VACCINE) 0.5 ml, lot # reported as: U3914B, administered intramuscularly at left thigh (formulation, expiration date, and indication were not provided). On 06-NOV-2023, the patient was given 0.5 ml elasomeran (MODERNA COVID-19 VACCINE) when it should be 0.25 ml (lot #, expiration date, indication, site and route of administration were not provided). On the same day, he additionally was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe, 4 of 4 doses in series, lot # reported and confirmed as: X020693, expiration date was not reported but upon internal validation it was established as: 18-OCT-2025, administered intramuscularly (IM) at left thigh (LT) for prophylaxis (exact dose was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) subcutaneous injection, 1 of 2 doses in series, lot # reported and confirmed as: X011431, expiration date was not reported but upon internal validation it was confirmed as: 19-APR-2025, administered subcutaneously (SC) at left thigh (LT) for prophylaxis (exact dose was not provided) (inappropriate schedule of product administration).   On an unknown date in November 2023, the patient experienced low-grade fever after vaccine administration (on 06-NOV-2023). After 24 hours, on an unknown date in November 2023, the patient recovered from the event (reported as patient had low-grade fever for 24 hours after vaccine administration).  The causal relationship between the event and suspect vaccines was not provided.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Cellulitis; This spontaneous report was received from a pharmacist via other company via company representative and refers to an adult female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and influenza vaccine (INFLUENZA VACCINE) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced cellulitis with symptoms of redness and swelling that developed in her arm following the vaccination. Final diagnosis was cellulitis. Patient was treated with ceftriaxone. At the reporting time, the outcome of the event was unknown.  The causal relationship between cellulitis and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Female reproductive tract disorder, Neoplasm malignant
Clinical narrative: later was diagnosed with cancer; had gynecological issues; This spontaneous report was received from a nurse prescriber refers to a female, adult patient of unknown exact age (reported as: approximately in her 20's).  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, 0.5 milliliter (lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis.  On an unknown date, the patient experienced female reproductive tract disorder and neoplasm malignant. It was reported that the patient had gynecological issues and later was diagnosed with cancer.   The outcome of neoplasm malignant and female reproductive tract disorder was unknown.   The event of neoplasm malignant was considered to be medically significant.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: first dose was administered on 26-DEC-2014, the second dose was administered on 25-FEB-2015 and third dose was administered on 18-JUL-2019; FBE calling to report AE for patient who received GARDASIL and GARDASIL 9.; third pap smear in JAN2024 that was "abnormal in reference to HPV; on 23JAN2023 the patient had an abnormal pap smear that showed "ASCUS and HPV".; on 23JAN2023 the patient had an abnormal pap smear that showed "ASCUS and HPV".; This spontaneous report was received from Physician and refers to a 25-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-DEC-2014, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).On 26-FEB-2015, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 18-JUL-2019, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Interchange of vaccine product and Inapprorpiate schedule of product administered.  On unknown date in August 2020, the patient had a normal pap smear. On 23-JAN-2023, the patient had an abnormal pap smear that showed Atypical squamous cells of undetermined significance (ASCUS) and Human papilloma virus (HPV). The patient had a third pap smear in unknown date in January 2024 that was abnormal in reference to HPV.At the time of reporting, the outcome of the events was not known.  The causal relationship between all adverse events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Our Pediatric Patient Was Given A Dose Of Heplisav-B; Initial report received on 13-Nov-2023  A licensed practical nurse in the (Privacy) reported that a 13-year-old male patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant mediations at the time of vaccination were not reported. The patient had no known drug allergies.  On 10-Nov-2023, the 13-year-old pediatric patient received a dose of HEPLISAV-B (Lot # 941592, expiration date 31-Aug 2025, and NDC # 435280003-01) intramuscularly in the left deltoid. 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.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Did Not Respond to the Series; Initial report received on 12-Dec-2023  A consumer reported that she, a 50-year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not respond to the series.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On unspecified dates, the patient received the first  and second doses of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported).  On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient had lab testing performed that showed she did not respond to the hepatitis B vaccination series. The patient did not have administration dates or values.   No additional information was reported.    Company Comment: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure due to lack of information on the dosing and serological titer.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure due to lack of information on the dosing and serological titer.
Sex: F
Vaccine: RSV
Symptoms: Chills, Cough, Dyspnoea, Pyrexia, Wheezing
Clinical narrative: shortness of breath; coughing; fever; chills; wheezing post vaccination; This non-serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath), cough (Verbatim: coughing), fever (Verbatim: fever), chills (Verbatim: chills) and wheezing (Verbatim: wheezing post vaccination). The outcome of the shortness of breath, cough, fever, chills and wheezing were not reported.   It was unknown if the reporter considered the shortness of breath, cough, fever, chills and wheezing to be related to Arexvy.     It was unknown if the company considered the shortness of breath, cough, fever, chills and wheezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-FEB-2024 The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis
Clinical narrative: a cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: a cold). The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to Arexvy.     It was unknown if the company considered the cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-FEB-2024 This case was reported by the patient via interactive digital media. The patient stated that hopefully it was a cold and no shortness of breath. The consent for follow-up no not as per process.
Sex: F
Vaccine: RSV
Symptoms: Chills, Cough, Dyspnoea, Pyrexia, Wheezing
Clinical narrative: shortness of breath; coughing; fever; chills; wheezing; This non-serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath), cough (Verbatim: coughing), fever (Verbatim: fever), chills (Verbatim: chills) and wheezing (Verbatim: wheezing). The outcome of the shortness of breath, cough, fever, chills and wheezing were not reported.   It was unknown if the reporter considered the shortness of breath, cough, fever, chills and wheezing to be related to Arexvy.     It was unknown if the company considered the shortness of breath, cough, fever, chills and wheezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-FEB-2024 The reporter reported that a patient experienced shortness of breath, coughing, fever, chills, wheezing post vaccination.  The reporter did not agree to follow up from GlaxoSmithKline. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR018560:Original Case : US2024AMR017093 same reporter, different patient
Sex: U
Vaccine: RSV
Symptoms: Respiratory syncytial virus test positive
Clinical narrative: RSV test positive; This non-serious case was reported by a physician via sales rep and described the occurrence of respiratory syncytial virus serology positive in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 3 days after receiving Arexvy, the patient experienced respiratory syncytial virus serology positive (Verbatim: RSV test positive). The outcome of the respiratory syncytial virus serology positive was not reported.   It was unknown if the reporter considered the respiratory syncytial virus serology positive to be related to Arexvy.     It was unknown if the company considered the respiratory syncytial virus serology positive to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-FEB-2024 The patient tested positive for RSV (Respiratory syncytial virus). The case had been linked to US2024AMR017093, reported by the same reporter, foe a different patient. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2024AMR017093:Original Case : US2024AMR017093 same reporter, different patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the administration of Kinrix as 6th dose of IPV.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M) for prophylaxis.   Previously administered products included Dtpa (received 4 doses of Dtap vaccine on unknown date) and IPV (received 5 doses of IPV vaccine on unknown date).   On 24-JAN-2024, the patient received the 5th dose of Kinrix. On 24-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: the administration of Kinrix as 6th dose of IPV.). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-FEB-2024 The nurse contacted GSK inquiring about Kinrix and what information was available about any information on the administration of Kinrix as the 5th dose of DTaP and 6th dose of IPV.  Partial information about vaccine, patient and event was given.  The patient was mentioned to have arrived, hence the increased amount of IPV vaccines. The Vaccine Administration Facility was the same as Primary Reporter The patient received Kinrix as 6th dose of IPV vaccine, which led to inappropriate schedule of vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling at the injection site; redness at the injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a adult female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Bexsero. In AUG-2023, an unknown time after receiving Bexsero, the patient experienced injection site swelling (Verbatim: swelling at the injection site) and injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site swelling and injection site erythema were resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 02-FEB-2024 A field representative contacted with GSK, reported that a nurse stated a patient received her dose of Bexsero and the patient called the nurse one or two days following the vaccination because she had redness and swelling at the injection site.  The redness and swelling resolved after several days.  Nothing else was reported.  The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 20-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix in 12th August 2023 lot number 797F9 and expiry date 20th December 2025).   On 02-FEB-2024, the patient received the 2nd dose of Twinrix. On 02-FEB-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-FEB-2024 The pharmacist was reported that patient was received 2 doses of Twinrix vaccine. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The vaccine administration facility is the same as primary reporter  The reporter consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: A patient was administered Shingrix reconstituted with sterile water yesterday; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9mb95, expiry date 06-DEC-2025) for prophylaxis.   On 01-FEB-2024, the patient received Shingrix. On 01-FEB-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: A patient was administered Shingrix reconstituted with sterile water yesterday) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-FEB-2024 The certified medical assistant called stating a patient was administered Shingrix reconstituted with sterile water yesterday, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose of Shingrix in January, 2021 and second dose September, 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2021).   In SEP-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the first dose of Shingrix in January, 2021 and second dose September, 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-FEB-2024 The patient self-reported this case. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow-up. The reporter did not wish to provide further personal information.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Immunodeficiency, Influenza, Malaise
Clinical narrative: immunocompromised; shingles; flu; She said she got sick shortly thereafter; This serious case was reported by a consumer via call center representative and described the occurrence of immunocompromised in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a shingles 5 years ago). Concurrent medical conditions included immunocompromised (has a immunocompromised).   On 26-JUL-2023, the patient received the 1st dose of Shingrix. On 26-JUL-2023, immediately after receiving Shingrix, the patient experienced sickness (Verbatim: She said she got sick shortly thereafter). On an unknown date, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and influenza (Verbatim: flu). The outcome of the immunocompromised, shingles, sickness and influenza were resolved.   It was unknown if the reporter considered the immunocompromised, shingles, sickness and influenza to be related to Shingrix.     It was unknown if the company considered the immunocompromised, shingles, sickness and influenza to be related to Shingrix.   Additional Information: GSK receipt date: 05-FEB-2024 The patient self-reported this case. The patient had received Shingrix vaccine and got sick shortly thereafter. The patient was immunocompromised and had shingles and the flu. The reporter reported that the all the symptoms had been resolved. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Arthralgia, Pain in extremity, Skin discolouration, Skin induration
Clinical narrative: Her left arm has intermittent pain; hives on upper chest and face; her hair has been falling out in clumps; hives got hard and turned brown; hives got hard and turned brown; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2023) and Pneumonia vaccine (received in June 2023).   In SEP-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her left arm has intermittent pain), hives (Verbatim: hives on upper chest and face), hair loss (Verbatim: her hair has been falling out in clumps), skin discoloration (Verbatim: hives got hard and turned brown) and skin induration (Verbatim: hives got hard and turned brown). The outcome of the pain in arm, hives, hair loss, skin discoloration and skin induration were not resolved.   It was unknown if the reporter considered the pain in arm, hives, hair loss, skin discoloration and skin induration to be related to Shingrix.   It was unknown if the company considered the pain in arm, hives, hair loss, skin discoloration and skin induration to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2024 The reporter stated she received her 2 doses of Shingrix, dose 1 in June and dose 2 in September 2023.  She stated that she also had the pneumonia shot with one of the doses, she believed the June 2023 dose.  She stated that a few weeks ago she experienced hives on face and upper chest.  She stated that the hives got hard and turned brown.  Her left arm had intermittent pain (like arthritis pain) and that her hair had been falling out in clumps.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Her left arm has intermittent pain; hives on upper chest and face; her hair has been falling out in clumps; hives got hard and turned brown; hives got hard and turned brown; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2023) and Pneumonia vaccine (received in June 2023).   In SEP-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her left arm has intermittent pain), hives (Verbatim: hives on upper chest and face), hair loss (Verbatim: her hair has been falling out in clumps), skin discoloration (Verbatim: hives got hard and turned brown) and skin induration (Verbatim: hives got hard and turned brown). The outcome of the pain in arm, hives, hair loss, skin discoloration and skin induration were not resolved.   It was unknown if the reporter considered the pain in arm, hives, hair loss, skin discoloration and skin induration to be related to Shingrix.   It was unknown if the company considered the pain in arm, hives, hair loss, skin discoloration and skin induration to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2024 The reporter stated she received her 2 doses of Shingrix, dose 1 in June and dose 2 in September 2023.  She stated that she also had the pneumonia shot with one of the doses, she believed the June 2023 dose.  She stated that a few weeks ago she experienced hives on face and upper chest.  She stated that the hives got hard and turned brown.  Her left arm had intermittent pain (like arthritis pain) and that her hair had been falling out in clumps.  The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products
Clinical narrative: the lot number it was not ENGERIX-B  It may be another Hepatitis B such as Recombivax; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a adult female patient who received Hepatitis B vaccine (batch number X021830) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Recombivax) for prophylaxis.   Previously administered products included Hepatitis B (1st dose received on hepatitis B on an unknown date).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine and the 3rd dose of Recombivax. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced interchange of vaccine products (Verbatim: the lot number it was not ENGERIX-B  It may be another Hepatitis B such as Recombivax). The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK receipt date: 05-FEB-2024 The reporter was the patient who was also a pharmacist. The patient stated that she had just got vaccinated for hepatitis B vaccine and she trying to search for the lot number of the hepatitis B vaccine and also she stated that she could not find that it belongs to Engerix-B. The reporter requested to confirm that she got the right vaccine. The lot number provided did not match any vaccine in their system including ENGERIX-B. It was unclear at this time which vaccine she was administered but based on that lot number it was not Engerix-B. The reporter stated that she was calling other Hepatitis B manufacturers to verify the lot number to determine what she was given.   The patient received the first two doses received were GlaxoSmithKline and third dose might had been another Hepatitis B vaccine such as Recombivax, which led to interchange of vaccine products. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult patient received Havrix first dose pediatric formulation; adult patient received Havrix first dose pediatric formulation; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a patient who received HAV (Havrix pediatric) for prophylaxis.   On 22-JAN-2024, the patient received the 1st dose of Havrix pediatric. On 22-JAN-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: adult patient received Havrix first dose pediatric formulation) and adult use of a child product (Verbatim: adult patient received Havrix first dose pediatric formulation). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-FEB-2024 The reporter reported that an adult patient received Havrix dose pediatric formulation, which led to underdose and adult use of a child product. The patient's information was not available at the moment of the call. The reporter did not consent to follow-up.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Overdosage; 6 month old patient received an adult dose of engerix-b; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 6-month-old female patient who received HBV (Engerix B adult) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis.   On 02-FEB-2024, the patient received the 3rd dose of Engerix B adult. On 02-FEB-2024, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: Overdosage) and adult product administered to child (Verbatim: 6 month old patient received an adult dose of engerix-b). The outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 05-FEB-2024 The reporter reported that the patient received an adult dose of Engerix-B inadvertently, which led to overdose and adult product administered to child. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 72 year old male patient accidentally received 2 doses of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GJ3JR, expiry date 10-JUL-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 20-JAN-2024, the patient received the 2nd dose of Arexvy. On 20-JAN-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 72 year old male patient accidentally received 2 doses of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-FEB-2024 The reporter reported that patient accidentally received 2 doses of Arexvy, which led to extra dose administered. The dose 1 was administered on 7th November 2023. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: they had previously gotten the shingles vaccine but still suffered from episodes of shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: they had previously gotten the shingles vaccine but still suffered from episodes of shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: RA Receipt Date: 06-Feb-2024 The reporter requested information about Valtrex and stated that the patient was using it yet they had previously received the shingles vaccine but still suffered from episodes of shingles.  The vaccine administration facility was the same as primary reporter. The reporter declined to gave any more information before ending the call. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cardiac disorder, Injection site pain, Muscle spasms, Peripheral swelling
Clinical narrative: MUSCLE CRAMPING; FEVER; SWELLING OF LEGS; HEART PROBLEMS; I CAN ONLY COMPARE THE PAIN HOURS AFTER THE VACCINE TO CHILD LABOR PAINS; BONE PAIN; This spontaneous report received from a consumer concerned a patient of 31 year old female. Initial information was processed along with the additional information received on 01-FEB-2024 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 26-NOV-2023 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced muscle cramping, fever, swelling of legs, heart problems, i can only compare the pain hours after the vaccine to child labor pains, and bone pain (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramping, fever, swelling of legs, heart problems, i can only compare the pain hours after the vaccine to child labor pains, and bone pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MUSCLE CRAMPING; FEVER; SWELLING OF LEGS; HEART PROBLEMS; I CAN ONLY COMPARE THE PAIN HOURS AFTER THE VACCINE TO CHILD LABOR PAINS; BONE PAIN; This spontaneous report received from a consumer concerned a patient of 31 year old female. Initial information was processed along with the additional information received on 01-FEB-2024 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 26-NOV-2023 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced muscle cramping, fever, swelling of legs, heart problems, i can only compare the pain hours after the vaccine to child labor pains, and bone pain (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramping, fever, swelling of legs, heart problems, i can only compare the pain hours after the vaccine to child labor pains, and bone pain. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Cold) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Melanoma and Mohs micrographic surgery.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that previous vaccines were just Moderna and contained Lidocaine and she was fine , just felt cold straight afterwards.  Treatment information was not provided.   This case was linked to MOD-2024-759947 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: I have started to experience some skin rashes; This spontaneous case was reported by a patient and describes the occurrence of RASH (I have started to experience some skin rashes) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (I have started to experience some skin rashes). At the time of the report, RASH (I have started to experience some skin rashes) outcome was unknown.            No Concomitant medications provided by the reporter. Patient visited emergency room several times. It was recommended to patient a treatment for allergies.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: falling; This spontaneous case was reported by a patient and describes the occurrence of FALL (falling) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Melanoma (Melanoma on face) and Mohs micrographic surgery (Melanoma on face, removed).    On 30-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FALL (falling) (seriousness criterion hospitalization). The patient was hospitalized from 30-Oct-2023 to 31-Oct-2023 due to FALL. On 31-Oct-2023, FALL (falling) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Patient was hospitalized as she kept falling over and could not stand up. She was hospitalized at 11:00 after receiving her vaccine at the pharmacy, kept overnight and released at 20:00. She felt fine afterwards.   No treatment medication was reported.  Company Comment This is an spontaneous case concerning 78-year-old female patient with medical history of Melanoma on face and Mohs micrographic surgery (Melanoma removed). who experienced  the seriousness criteria hospitalization  unexpected event of fall the same day after 3rd. dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2024-759948 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was treated with Paxlovid on 22Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old male patient received BNT162b2 (BNT162B2 NOS), on 17Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid starting on 28Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a physician. A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (PFIZER BIONTECH COVID-19 VACCINE), on 04Sep2023 as dose 5 (booster), single (lot number unknown) at the age of 67 years, in left arm for covid-19 immunisation; COVID-19 vaccine as dose 1, single, as dose 2, single, as dose 3 (booster), single, and as dose 4 (booster), single all for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). Concomitant medication included: CARVEDILOL, start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 29Jan2024 to 02Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 29Jan2024 to 03Feb2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.