chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurts a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurts a lot). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The patient already got vaccinated with shingles vaccine but his/her doctor wanted a second vaccine and his/her arm hurted a lot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fear of disease, Hypersensitivity
Clinical narrative: Allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: Allergic reaction).The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.   It was unknown if the company considered the allergic reaction to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The patient had his/her first shot of shingles a while ago.  The reporter stated that no one told him/her about the second shot of shingles vaccine.  The patient had scared that he/she had shingles but he/she did not. The reporter's doctor said that he/she had an allergic reaction to something.  It was definitely not shingles.  The reporter just got his/her second shingles shot at the time of reporting.  The reporter further stated that he/she wanted to avoid getting shingles. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm / arm pain; general blah feeling; fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of abdominal discomfort (first Covid vaccine bothered for 3 days and made stomach upset and vomiting but then went away).   On an unknown date, the patient received Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm/arm pain), feeling abnormal (Verbatim: general blah feeling) and fatigue (Verbatim: fatigue).  The outcome of the pain in arm and feeling abnormal were recovered/resolved and the outcome of the fatigue was not reported.   It was unknown if the reporter considered the pain in arm, feeling abnormal and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, feeling abnormal and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 and 10-MAR-2023 This case was reported by the patient via interactive digital media. The patient did not had any worst reactions than any other vaccine, and got Shingles shot on the same day received Pneumonia vaccine. The patient had a couple days of just general blah and a sore arm, pretty much same as any other vaccine and expected mild fatigue, mild arm pain, general blah feeling. The patient recently also had a Tetanus booster and those could really make your arm sore. It was unknown if the reporter considered the pain in arm, feeling abnormal and fatigue to be related to Pneumonia vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product use in unapproved indication, Therapeutic response unexpected
Clinical narrative: I will say my last couple bouts were less painful at least.; got vaccines after shingles; I will say my last couple bouts were less painful at least.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles about 10 times). Previously administered products included Antiviral. Concurrent medical conditions included cancer, nerve pain, blistery rash (had the itchy rash of blisters) and pruritus (had the itchy rash of blisters).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I will say my last couple bouts were less painful at least.), product use in unapproved indication (Verbatim: got vaccines after shingles) and unexpected therapeutic effect (Verbatim: I will say my last couple bouts were less painful at least.).  The outcome of the pain was not reported and the outcome of the product use in unapproved indication and unexpected therapeutic effect were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient had it about 10 times and it was excruciating.  The nerve pain was relentless, itchy rash of blisters and it lasted several weeks each time and it was debilitating.  The patient got the vaccine after had Shingles a couple times. The patient say that conditioned last couple bouts were less painful at least.  The patient stated that everyone should get the Shingrix vaccines.  The patient become chronic but it was a bit less painful since the vaccines. The patient had to take antivirals during cancer treatments last year so did not got a breakout.  The patient stated that it was a horrid virus. The patient received Shingrix after having shingles which was less painful after vaccination which led to unexpected therapeutic effect and drug use for unapproved indication. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: just feel tired; Achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: just feel tired) and pain (Verbatim: Achy).  The outcome of the tiredness and pain were not reported.   It was unknown if the reporter considered the tiredness and pain to be related to Shingles vaccine.     It was unknown if the company considered the tiredness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Put off the second one for 3 years; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: Put off the second one for 3 years).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient received two shots, and stated that, he/she put off the second dose for 3 years until she/he was reminded how bad it was to get it. The follow-up could not be possible as no contact details were available. The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that shingles vaccine made him/her just a little sick, but he/she would put up with the sick than actually having the shingles. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Rash was going away; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic drug effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rash.   On 02-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, 2 days after receiving Shingles vaccine, the patient experienced unexpected therapeutic drug effect (Verbatim: Rash was going away). The outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingles vaccine.     It was unknown if the company considered the unexpected therapeutic drug effect to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the first shot and the rash was going away already. He/she was never diagnosed for shingles, but it seemed to be helping anyway only 2 days later. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles twice even one time he/she had the Shingles shot. The physician told to the patient that, he/she would still have the shingles but with the shot, they were not as severe. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Gout, Incomplete course of vaccination
Clinical narrative: gout attack; have to get the next shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of gout attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced gout attack (Verbatim: gout attack) and incomplete course of vaccination (Verbatim: have to get the next shot).  The outcome of the gout attack was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the gout attack to be related to Shingles vaccine.     It was unknown if the company considered the gout attack to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media.  The patient reported that he/she got the first shot and got a small gout attack in April. He/She has to get the next shot thus he/she hoped it would not happen again. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure fluctuation
Clinical narrative: blood pressure all over the place; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blood pressure fluctuation in a male 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 blood pressure fluctuation (Verbatim: blood pressure all over the place).  The outcome of the blood pressure fluctuation was not reported.   It was unknown if the reporter considered the blood pressure fluctuation to be related to Shingles vaccine.     It was unknown if the company considered the blood pressure fluctuation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient's wife via interactive digital media. The patient got the vaccine a few weeks ago and it had his blood pressure all over the place. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The reporter asked about the treatment to the patient as she mentioned after she experienced shingles. The reporter reported that he/she know someone who experienced shingles three weeks after received Shingles vaccine. The reporter stated that he/she know about the vaccine and did not feel led to receive it. He/she recently read about the possible side effects and he/she received flu vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR039687:Same reporter - Hearsay case
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Arm sore; Body not feeling well; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 06-MAR-2023, the patient received Shingles vaccine and TETANUS VACCINE. On 07-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm sore) and feeling unwell (Verbatim: Body not feeling well).  The outcome of the pain in arm and feeling unwell were not reported.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine on Monday and at the same time he/she received a Tetanus vaccine. On next day after received both doses the patient experienced his/her arm was sore and in fact his/her entire body was not feeling well. The patient stated that he/she will receive his/her next shingles vaccine in about two months. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Tetanus vaccine.    Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold
Clinical narrative: Felt cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling cold (Verbatim: Felt cold).  The outcome of the feeling cold was recovered/resolved.   It was unknown if the reporter considered the feeling cold to be related to Shingles vaccine.     It was unknown if the company considered the feeling cold to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received first dose of Shingles vaccine and felt cold for few hours. The patient stated that feeling effect was a good sign the vaccine was working and at 82 years of age there was not much to lose. The patient was nothing experienced after received second dose of shingles vaccine. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Radiation, Chemotherapy and Antibiotics. Concurrent medical conditions included gingival infection, lipoma and anal cancer.   In OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm soreness).  The outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date- 03-MAR-2023 The reporter was the patient.  The patient received the first dose of Shingrix at the end of October 2022 on a Friday and experienced a little arm soreness and the arm soreness went away on Monday.  The reporter gave consent to follow up with HCP (pharmacy).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The reporter called and stated that he never received his second dose of Shingrix. Adverse event was filed.  The reporter stated that he planned to get his second dose as soon as possible.  No healthcare professional information provided but the safety team might reach out to the pharmacy for additional information.  The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Details referred to 1st dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted lyophilized component with 1 percent Xylocaine; Reconstituted lyophilized component with 1 percent Xylocaine and administered the dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L4472) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted lyophilized component with 1 percent Xylocaine) and inappropriate dose of vaccine administered (Verbatim: Reconstituted lyophilized component with 1 percent Xylocaine and administered the dose ). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The licensed practical nurse reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient back in early February 2023. The reporter mentioned for each patient was attempt at first dose of Shingrix. The reporter was unable to provide any vaccine or patient details. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023034623:same reporter US-GSK-US2023034626:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted lyophilized component with Xylocaine; Reconstituted lyophilized component with Xylocaine and administered the doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L4472) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted lyophilized component with Xylocaine) and inappropriate dose of vaccine administered (Verbatim: Reconstituted lyophilized component with Xylocaine and administered the doses). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The licensed practical nurse reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient back in early February 2023. The reporter mentioned for each patient was attempt at first dose of Shingrix. The reporter was unable to provide any vaccine or patient details. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023034624:same reporter US-GSK-US2023034626:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted lyophilized component with 1% Xylocaine; Reconstituted lyophilized component with 1% Xylocaine and administered the doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L4472) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted lyophilized component with 1% Xylocaine) and inappropriate dose of vaccine administered (Verbatim: Reconstituted lyophilized component with 1% Xylocaine and administered the doses).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The licensed practical nurse reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient back in early February 2023. The reporter mentioned for each patient was attempt at first dose of Shingrix. The reporter was unable to provide any vaccine or patient details. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023034623:same reporter US-GSK-US2023034624:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 09Feb2022, 2nd not received; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received st dose on 9th Feb 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 09Feb2022, 2nd not received).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2023 A retired cardiologist called in to report that he received a first dose of Shingrix on 9th Feb 2022 and then he did not receive the second dose. The reporter asked if he could receive the second dose or if he had to start over with vaccination. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.   Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and LOT ER8730) on 22-Aug-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Cancer and Immunocompromised.    On 13-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    Patient past drug history included Shingles.  No concomitant medications were reported.  Patient was going through cancer treatment and unsure of type of cancer. HCP confirms that diagnosis was 1 year ago before receiving COVID-19 vaccines. Patient did not have any allergy.  No treatment information was provided.   This case was linked to MOD-2023-714594 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.   Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and LOT ER8730) on 22-Aug-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Cancer and Immunocompromised.    On 13-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    Patient past drug history included Shingles.  No concomitant medications were reported.  Patient was going through cancer treatment and unsure of type of cancer. HCP confirms that diagnosis was 1 year ago before receiving COVID-19 vaccines. Patient did not have any allergy.  No treatment information was provided.   This case was linked to MOD-2023-714594 (Patient Link).
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product leakage, Underdose
Clinical narrative: due to product leaking and patient not receiving full dose with no adverse event reported; Initial information received  on 13-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who due to product leaking and patient not receiving full dose with no adverse event reported while receiving diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (PREVNAR 13), rotavirus vaccine live reassort oral 5V (Rotateq) and hepatitis B vaccine (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 06-Mar-2023, the patient received a dose 1 at 0.5 mL dose of suspect diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot number: UJ807AAA; expiry date: 08-Oct-2023) via intramuscular route in the left thigh for immunisation.  On 06-Mar-2023, due to product leaking and patient not receiving full dose with no adverse event reported (incorrect dose administered) (latency: same day) following the administration of diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was reported as there is a discrepancy between nurse and parent, nurse reports full administration but the parent reports product leaking and patient not receiving full dose. No details on amount or where the leaking occurred due to full administration reported from staff.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel with an expired diluent was administered to a patient with no reported adverse event; Initial information was received on 15-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 15 months old female patient to whom expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with an expired diluent was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Mar-2023, the patient received a standard expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml total (lot C5816AA, expiry date- 26-FEB-2023) via intramuscular route in the left thigh for Immunization with an expired diluent was administered to a patient with no reported adverse event (expired product administered) (latency- same day). Caller is requesting validity information.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA085728:01533896
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood test normal, Exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnancy from approx. 04/19/22 with EDD of 01/09/2023. No abnormal ultrasounds or blood tests. Baby aspirin as preeclampsia preventative (purely prophylactic). Received primary Pfizer series in 2021 with first booster (Moderna) in November 2021. Moderna booster in august 2022 and Pfizer bivalent in November 2022. Baby boy born on January 14, 2023. No abnormal NSTs before or during labor (weekly monitoring and then continuous during labor). A few minutes later baby heart rate spiked. Diagnosed with SVT with likely WPW.  No family history and not caught in utero despite weekly NST.  Baby put on propranolol. SVT is unexplained and there weren?t other pregnancy complications. Also had a small PDA and PFO with some valve regurgitation at birth
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pregnancy from approx. 04/19/22 with EDD of 01/09/2023. No abnormal ultrasounds or blood tests. Baby aspirin as preeclampsia preventative (purely prophylactic). Received primary Pfizer series in 2021 with first booster (Moderna) in November 2021. Moderna booster in august 2022 and Pfizer bivalent in November 2022. Baby boy born on January 14, 2023. No abnormal NSTs before or during labor (weekly monitoring and then continuous during labor). A few minutes later baby heart rate spiked. Diagnosed with SVT with likely WPW.  No family history and not caught in utero despite weekly NST.  Baby put on propranolol. SVT is unexplained and there weren?t other pregnancy complications. Also had a small PDA and PFO with some valve regurgitation at birth
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot, didn not stop it / Suspected vaccination failure; It is unbearable / getting new episodes; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot, didn not stop it / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: It is unbearable / getting new episodes). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   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: GSK Receipt Date: 06-MAR-2023 This case was reported by the patient via interactive digital media.  The patient stated that he/she had the shingles shot, it did not do anything to stop it (singles). It was unbearable and keep on getting new episodes. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got shot, and got Shingles / Suspected vaccination failure; Got Shingles twice; Lots of pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, and got Shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got Shingles twice) and pain (Verbatim: Lots of pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by the patient via interactive digital media.  The patient stated that he/she had paid 200 dollars for the Shingles shot and got Shingles twice. Lots of pain ensued. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received Bexsero. On 06-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered).  The outcome of the expired vaccine used was not reported.   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: 06-MAR-2023 The reporter was a medical assistant. The reporter reported that they inadvertently administered an expired dose of Bexsero vaccine to the patient in their facility. The reporter wanted to know how to proceed. The reporter did not consent to follow-up. Additional supportive information: The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 05-MAR-2023) for prophylaxis.   On 06-MAR-2023, the patient received Pediarix. On 06-MAR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAR-2023 The reporter was a clinic supervisor. The reporter reported that the patient was inadvertently administered an expired dose of Pediarix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Pediarix vaccine which was already expired, which led to expired vaccine used.
Age: 72.0
Sex: F
Vaccine: YF
Symptoms: Carbohydrate antigen 125 increased, Inflammation
Clinical narrative: the CA125 blood tests shows inflammation and is a marker used to detect cancer and liver disease; currently has slightly elevated CA125 levels.; Initial information received on 15-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 72 years old female patient who had the CA 125 blood tests shows inflammation and is a marker used to detect cancer and liver disease and currently has slightly elevated CA 125 levels. After receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) concomitant(s) and family history were not provided.  At the time of the event, the patient had ongoing Cancer.   In end of December 2022, the patient received unknown dose of suspect yellow fever vaccine -, solution for injection, 9strength: standard, frequency: once) (lot number and expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient had the ca125 blood tests shows inflammation and is a marker used to detect cancer and liver disease (inflammation) and currently has slightly elevated ca125 levels. (carbohydrate antigen 125 increased) (unknown latency) following the administration of yellow fever vaccine.  It was reported as Patient who is a cancer survivor currently has elevated CA125(marker used to detect cancer and liver disease) levels and received YF-VAX in DEC2022. Wanting to know if there is a correlation between and vaccine and her elevated levels. No other symptoms reported Patient Information. she spoke to an infectious disease doctor and he thinks the levels could be a false high and wanting to know if there could be a correlation between the levels and the YF-VAX. Provided caller with information from YF-VAX prescribing information.  Relevant laboratory test results included: Carbohydrate antigen 125 - On an unknown date: [inflammation] Note: CA125 blood tests shows inflammation and is a marker used to detect cancer and liver disease  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Abdominal pain upper, Irritability, Mood altered, Sleep disorder
Clinical narrative: Severe stomach pain and irritability. Change in sleep schedule. Change in mood. This is still ongoing.