chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days 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: 17-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that a year before the pandemic his or her physician was vigorously pressuring him or her to get the shingles vaccine. The reporter stated that in 2021 his or her coworker who was 20 years younger than him or her experienced shingles right after received Shingles vaccine as did many other recently vaccinated peoples. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Mild flu-like symptoms; Lot of tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Mild flu-like symptoms) and tiredness (Verbatim: Lot of tiredness). The outcome of the influenza-like symptoms and tiredness were resolved.   It was unknown if the reporter considered the influenza-like symptoms and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that, glad to say he/she got the vaccine. the first, no big deal. The second one gave her/ him mild flu-like symptoms and a lot of tiredness for a few days but he/she will prefer that over shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the shingles 3 weeks after got shot; 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: Got the shingles 3 weeks after got shot). 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: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles 3 weeks after she/he got her/his shot The patient stated never again,no more shots for him/her. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had them on my right upper leg and hip).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved (duration 3 days).   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: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had them on her/his right upper leg and hip. It was bad but patient make sure not to scratch.  The patient got the shot and only had a sore arm for 3 days. The follow-up could not be possible as no contact details were available.
Sex: M
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 male 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, several days 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: 18-MAR-2023 This case was reported by a patient wife via interactive digital media. The reporter reported that her husband was fully vaccinated with Shingles vaccine  The reporter stated that the patient experienced Shingles shortly after received second dose of Shingles vaccine. The reporter stated that it was damned if you receive the shingles vaccine damned if you did not receive the shingles vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051880   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both vaccines the first one didn't affect patient no other way but a sore arm. The second vaccine hit his/her with everything from sore arm to dizziness, and feeling so sick to my stomach.  But patient glad to have gotten them. The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR051880, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR051880:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; Dizziness; Feeling so sick to my stomach; Second vaccine hit me with everything; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2023AMR051879).   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 pain in arm (Verbatim: Sore arm), dizziness (Verbatim: Dizziness), stomach discomfort (Verbatim: Feeling so sick to my stomach) and feeling abnormal (Verbatim: Second vaccine hit me with everything). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm, dizziness, stomach discomfort and feeling abnormal were not reported.   It was unknown if the reporter considered the pain in arm, dizziness, stomach discomfort and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, dizziness, stomach discomfort and feeling abnormal to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051879   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both vaccines the first one didn't affect patient no other way but a sore arm. The second vaccine hit his/her with everything from sore arm to dizziness, and feeling so sick to my stomach.  But patient glad to have gotten them. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR051879:Same patient
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness; Injection site redness; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2X7, expiry date 29-JUL-2023) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Shingrix. On 30-MAR-2023, 2 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site soreness) and injection site erythema (Verbatim: Injection site redness). The outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt date:30-MAR-2023. The public health nurse reported that a patient experienced injection site soreness and redness after the first dose of Shingrix was administered 28-MAR-2023. The symptoms started two days later.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt date: 30-MAR-2023. The reporter was the patient.  She mentioned she received Shingrix and had pain at the injection site that lasted a few days. Nothing else was reported. The reporter did not consent to follow-up. The case was linked with case US2023048019, reported by same reporter.; Sender's Comments:  US-GSK-US2023048019:same reporter
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: injected an expired vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 7-year-old patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 01-APR-2023, the patient received Havrix. On 01-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: injected an expired vaccine). 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: 01-APR-2023 The adverse event was left via voicemail. Pharmacist did not provide date of birth, address, lot number, or expiration date of product. Registered Pharmacist provided the expiration and slight details and their contact for follow-up. It was reported that they had expired Havrix vaccine that was injected into a child. It was Havrix, NDC 58160-0825-52. They needed the directive if they should repeat the shot or wait for a while for a 7-year-old, or it was still a good enough product to count.  Pharmacist provided the patient and vaccine details. The reporter did not consent to follow-up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; 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 69-year-old male patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix (first dose was received on 12th October 2022).   On 27-MAR-2023, the patient received the 2nd dose of Twinrix. On 27-MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). 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: 03-APR-2023 The reporter consented to follow up via fax. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 01-APR-2023) for prophylaxis.   On 03-APR-2023, the patient received Boostrix. On 03-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The reporter consented to follow up. Healthcare professional gave consent for safety team follow up. The patient received a Boostrix vaccine which was already expired, which led to expired vaccine used.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Lightheadedness and dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, several weeks after receiving Shingrix, the patient experienced dizziness (Verbatim: Lightheadedness and dizziness). The outcome of the dizziness was resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK Receipt date: 03-Jan-2023. Patient received Shingrix about a month ago (does not remember exact date). Patient stated a few weeks later he noticed he has lightheadedness and dizziness since then.  He had an appointment with his HCP in a few days and will report to HCP.  The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 30-MAR-2023, the patient received Havrix. On 30-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date:03-APR-2023. Pharmacist reporting having administered an expired dose of Havrix. Adverse event contained all reported information. HCP gave consent for safety team follow up. Patient received an expired dose, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2020, 2nd dose in 2023; 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 59-year-old male patient who received Herpes zoster (Shingrix) (batch number fa277, expiry date 24-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received first dose in October 2020).   On 25-MAR-2023, the patient received the 2nd dose of Shingrix. On 25-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2020, 2nd dose in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 4-Apr-2023 The pharmacist asked that should restart the vaccine series. The reporter was in a hurry and just mentioned that lot number and was unable to confirm. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 513HB, expiry date 20-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received first dose on 13th December 2021).   On 04-APR-2023, the patient received the 2nd dose of Shingrix. On 04-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received a late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 4-Apr-2023 The medical assistant provided information about vaccine, patient and consented to receive follow-up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in Jan2022, 2nd in 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 13th Jan 2022).   On 05-JAN-2023, the patient received the 2nd dose of Shingrix. On 05-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in Jan2022, 2nd in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 4-Apr-2023 The nurse did not want the information stored in their database but agreed to follow-up by safety. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-JAN-2023, 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: Sore arm). The outcome of the pain in arm was 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: 04-APR-2023 The patient herself reported this case.   The patient stated that she had her dose of Shingrix administered and she had a sore arm for a couple days. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). The outcome of the incorrect storage of drug 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: 4-Apr-2023 The nurse reported that a patient received Boostrix on an unknown data after it was exposed to temperatures between 10 and 16 degrees celsius for an extended period of time which exceeds one week.  A pharmacist reportedly called about this, but it was not known if the adverse event was already reported.  Centers for disease control and prevention (CDC) said to revaccinate.  Caller declined for providing additional information. Did not consent to follow-up. The patient received a dose of Boostrix after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Some side effects, diagnosed GBS; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Some side effects, diagnosed GBS) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-APR-2023 The reporter was the field representative. The reporter reported that the patient received first dose of Shingrix and noticed some side effects (unknown side effects) after the vaccination but did not report them. Upon returning to the clinic for her second vaccination, it was reported that the patient demonstrated symptoms of Guillain-Barre syndrome. The patient was hospitalized immediately (date was unknown). Upon hospitalization the diagnosis of Guillain-Barre syndrome was confirmed. No further information was known.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Drug dechallenge positive, Head discomfort, Headache, Lymphadenopathy, Mobility decreased
Clinical narrative: 2 seizures; Severe headache; Swollen glands; Weakness in left arm; Pins and needles sensation in the left arm; Blurred vision; Ringing in both ears; Pain; Unable to turn their head/ Head immobility; Inability to move left arm/ Arm immobility; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a female patient who received Herpes zoster (Shingrix) (batch number 5SC3X) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced seizure (Verbatim: 2 seizures) (serious criteria GSK medically significant), headache (Verbatim: Severe headache), swollen glands (Verbatim: Swollen glands), weakness of arms (Verbatim: Weakness in left arm), pins and needles (Verbatim: Pins and needles sensation in the left arm), blurred vision (Verbatim: Blurred vision), ringing in ears (Verbatim: Ringing in both ears), pain (Verbatim: Pain), head discomfort (Verbatim: Unable to turn their head/ Head immobility) and mobility decreased (Verbatim: Inability to move left arm/ Arm immobility). Shingrix was discontinued (Dechallenge was positive). The outcome of the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, pain, head discomfort and mobility decreased were resolved and the outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, ringing in ears, pain, head discomfort and mobility decreased to be related to Shingrix.     It was unknown if the company considered the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, ringing in ears, pain, head discomfort and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date:04-Apr-2023 The patient was the reporter. The reporter reported experiencing numerous adverse reactions, after dose of Shingrix. The reporter was experiencing a severe headache, two seizures, swollen glands, inability to move left arm and weakness in left arm. The reporter also had pins and needles sensation in the left arm. The reporter was unable to turn head for a period of time and had blurred vision.  The reporter also had ringing in both ears.  The reporter said all symptoms resolved between 3 weeks to 2 months after first dose, with the exception of the ringing in the ears. The health care professional (HCP) advised not to receive second dose of Shingrix. The reporter did not consent to follow up. This case had been linked with US2023049707 reported by the same reporter.; Sender's Comments:  US-GSK-US2023049707:Same report, other patient
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain, Paraesthesia, Seizure, Tinnitus
Clinical narrative: 2 seizures; Severe headache; Swollen glands; Weakness in left arm; Pins and needles sensation in the left arm; Blurred vision; Ringing in both ears; Pain; Unable to turn their head/ Head immobility; Inability to move left arm/ Arm immobility; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a female patient who received Herpes zoster (Shingrix) (batch number 5SC3X) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced seizure (Verbatim: 2 seizures) (serious criteria GSK medically significant), headache (Verbatim: Severe headache), swollen glands (Verbatim: Swollen glands), weakness of arms (Verbatim: Weakness in left arm), pins and needles (Verbatim: Pins and needles sensation in the left arm), blurred vision (Verbatim: Blurred vision), ringing in ears (Verbatim: Ringing in both ears), pain (Verbatim: Pain), head discomfort (Verbatim: Unable to turn their head/ Head immobility) and mobility decreased (Verbatim: Inability to move left arm/ Arm immobility). Shingrix was discontinued (Dechallenge was positive). The outcome of the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, pain, head discomfort and mobility decreased were resolved and the outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, ringing in ears, pain, head discomfort and mobility decreased to be related to Shingrix.     It was unknown if the company considered the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, ringing in ears, pain, head discomfort and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date:04-Apr-2023 The patient was the reporter. The reporter reported experiencing numerous adverse reactions, after dose of Shingrix. The reporter was experiencing a severe headache, two seizures, swollen glands, inability to move left arm and weakness in left arm. The reporter also had pins and needles sensation in the left arm. The reporter was unable to turn head for a period of time and had blurred vision.  The reporter also had ringing in both ears.  The reporter said all symptoms resolved between 3 weeks to 2 months after first dose, with the exception of the ringing in the ears. The health care professional (HCP) advised not to receive second dose of Shingrix. The reporter did not consent to follow up. This case had been linked with US2023049707 reported by the same reporter.; Sender's Comments:  US-GSK-US2023049707:Same report, other patient
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: 2 seizures; Severe headache; Swollen glands; Weakness in left arm; Pins and needles sensation in the left arm; Blurred vision; Ringing in both ears; Pain; Unable to turn their head/ Head immobility; Inability to move left arm/ Arm immobility; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a female patient who received Herpes zoster (Shingrix) (batch number 5SC3X) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced seizure (Verbatim: 2 seizures) (serious criteria GSK medically significant), headache (Verbatim: Severe headache), swollen glands (Verbatim: Swollen glands), weakness of arms (Verbatim: Weakness in left arm), pins and needles (Verbatim: Pins and needles sensation in the left arm), blurred vision (Verbatim: Blurred vision), ringing in ears (Verbatim: Ringing in both ears), pain (Verbatim: Pain), head discomfort (Verbatim: Unable to turn their head/ Head immobility) and mobility decreased (Verbatim: Inability to move left arm/ Arm immobility). Shingrix was discontinued (Dechallenge was positive). The outcome of the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, pain, head discomfort and mobility decreased were resolved and the outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, ringing in ears, pain, head discomfort and mobility decreased to be related to Shingrix.     It was unknown if the company considered the seizure, headache, swollen glands, weakness of arms, pins and needles, blurred vision, ringing in ears, pain, head discomfort and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date:04-Apr-2023 The patient was the reporter. The reporter reported experiencing numerous adverse reactions, after dose of Shingrix. The reporter was experiencing a severe headache, two seizures, swollen glands, inability to move left arm and weakness in left arm. The reporter also had pins and needles sensation in the left arm. The reporter was unable to turn head for a period of time and had blurred vision.  The reporter also had ringing in both ears.  The reporter said all symptoms resolved between 3 weeks to 2 months after first dose, with the exception of the ringing in the ears. The health care professional (HCP) advised not to receive second dose of Shingrix. The reporter did not consent to follow up. This case had been linked with US2023049707 reported by the same reporter.; Sender's Comments:  US-GSK-US2023049707:Same report, other patient
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Adjuvant not mixed with Antigen; Only adjuvant administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number MY2Y2, expiry date 08-JUL-2024) for prophylaxis.   On 05-APR-2023, the patient received the 1st dose of Shingrix. On 05-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant not mixed with Antigen) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-APR-2023 The pharmacist reported that a patient received Shingrix first dose without the lyophilized antigen component. The reporter consented to follow-up by email. The patient received Shingrix without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 13Mar2023, 2nd on 03Apr2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number TY2TY, expiry date 09-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 03-APR-2023, the patient received the 2nd dose of Shingrix. On 03-APR-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: 1st dose on 13Mar2023, 2nd on 03Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   Concurrent medical conditions included hypothyroidism, autism and depression.   On 06-APR-2023, the patient received Havrix. On 06-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix 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-APR-2023 The nurse reported that an expired dose of Havrix was administered to a patient. The reporter consented to follow up via email. The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Rash
Clinical narrative: PUFF BALL ON THE COLLAR BONE ON THE LEFT SIDE; ARM WAS SORE; RED SPOTS CAME WITHIN A WEEK OR TEN DAYS/THEN THESE LITTLE DOTS ALL OVER THE ARM/SIZE OF A PEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced arm was sore, and red spots came within a week or ten days/then these little dots all over the arm/size of a pea. On an unspecified date, the patient experienced puff ball on the collar bone on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was sore, red spots came within a week or ten days/then these little dots all over the arm/size of a pea and puff ball on the collar bone on the left side was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood iron, COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 tested postive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 tested postive) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22H) for COVID-19 prophylaxis.     The patient's past medical history included Blood disorder NOS (Blood thin). Concurrent medical conditions included Allergy to nuts (Allergy to cashewnuts), Allergy to nuts (Allergy to pistachio nuts), Pollen allergy (Allergy to seasonal pollen), Blood pressure abnormal, Enlarged prostate and Iron deficiency (Low iron). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] from 2007 to March 2022 for Blood disorder NOS, LISINOPRIL from 2007 to an unknown date for Blood pressure abnormal, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) from 2005 to an unknown date for Enlarged prostate, IRON from 2010 to an unknown date for Iron deficiency.    On 01-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced COVID-19 (COVID-19 tested postive). At the time of the report, COVID-19 (COVID-19 tested postive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2022, SARS-CoV-2 test: (Positive) At home rapid test. On an unknown date, Blood iron: Low.         The height of the patient was reported as 6 inches.  No treatment medication were provided.   This case was linked to MOD-2023-716553 (Patient Link).
Age: 70.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: AE due to comingling of Moderna and Pfizer dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (AE due to comingling of Moderna and Pfizer dose) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 031A21A and 030M20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (AE due to comingling of Moderna and Pfizer dose). At the time of the report, IMMUNISATION REACTION (AE due to comingling of Moderna and Pfizer dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported.  It was reported that patient received Pfizer bivalent.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2023: Live Follow-up appended significant- event vaccination adverse reaction added.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pericardial effusion, Tachycardia
Clinical narrative: Tachycardia; Caller says it makes her uncomfortable because it is an experimental drug.; Pericardial effusion; This spontaneous case was reported by a patient and describes the occurrence of PERICARDIAL EFFUSION (Pericardial effusion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 068H21A and 010A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no known allergies. They were tested for pollen but it was not confirmed.  Concurrent medical conditions included Hashimoto's disease, Turner's syndrome, Hypothyroidism and Heart disease congenital (Visit cardiologist every 1 to 2 years.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PERICARDIAL EFFUSION (Pericardial effusion) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and FEELING ABNORMAL (Caller says it makes her uncomfortable because it is an experimental drug.). At the time of the report, PERICARDIAL EFFUSION (Pericardial effusion), TACHYCARDIA (Tachycardia) and FEELING ABNORMAL (Caller says it makes her uncomfortable because it is an experimental drug.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TACHYCARDIA (Tachycardia) to be related. No further causality assessments were provided for PERICARDIAL EFFUSION (Pericardial effusion) and FEELING ABNORMAL (Caller says it makes her uncomfortable because it is an experimental drug.).    Concomitant medication was not provided.  It was reported that the patient had apprehensions because of patient's medical history. Patient had been visiting the doctor for past 34 years. Treatment information was not provided.  Company comment: This spontaneous case concerns a 34-year-old female patient with underlying Hashimoto's disease, congenital heart disease who experienced the unexpected serious (medically significant) event of Pleural effusion which occurred unknown days after receiving second dose of mRNA-1273 vaccine. She also experienced tachycardia on an unknown date. Investigation and treatment details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event
Clinical narrative: patient was asking about what happens if the Moderna Covid-19 was given after the expiration date; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was asking about what happens if the Moderna Covid-19 was given after the expiration date), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age 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 EXPIRED PRODUCT ADMINISTERED (patient was asking about what happens if the Moderna Covid-19 was given after the expiration date), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was asking about what happens if the Moderna Covid-19 was given after the expiration date), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient was asking about what happens if the Moderna Covid-19 was given after the expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact