chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm very sore and tender; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult 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).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, 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.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. Patient experienced arm very sore and tender after 2nd shot. The patient stated that it was better than getting shingles. The follow up would not possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104395:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: you still can get Shingles after having the shot because I did!; you still can get Shingles after having the shot because I did!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Vaccination failure
Clinical narrative: I've had the vaccine, too. But I have had the shingles since; I've had the vaccine, too. But I have had the shingles since. A very mild case; Pain; Numbness / Still having numbness; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and numbness. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles and numbness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and numbness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received shingles vaccine and experienced shingles, pain, numbness and a mild case with no blisters. The reporter mentioned that, patient still had numbness. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an adult 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 and experienced sore arm, refer case US2021AMR104393).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, 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.  Additional details were provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication. The patient received 2 shots and experienced sore arm, which was way better than shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104393:
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Vaccination failure
Clinical narrative: Shingles / into eye; Double dose vaccine / he got it / One year later he got shingles so bad / covered from hairline, accross eyebrow, eyelid and into the eye; Scabs have healed; Still has nerve damage with daily attacks; Still has nerve damage with daily attacks; Double dose vaccine / he got it / One year later he got shingles so bad / suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had twice, pretty bad each time). Previously administered products included Shingles vaccine (one dose vaccine received on an unknown date) and Acyclovir (took for years because the one dose vaccine would not work for him and was told he did not need acyclovir and to stop taking it).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 9th May 2020, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and neurological symptom. On 9th May 2021, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, scab and nerve damage. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and scab were recovered/resolved and the outcome of the nerve damage and neurological symptom were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, scab, nerve damage and neurological symptom to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. In 2019, the patient received the both doses of Shingles vaccine (double dose vaccine). One year later (the day before Mother's Day 2020), the patient got shingles so bad he was covered from hairline, across eyebrow, eyelid and into eye. The reporter stated that even though the scabs had healed the patient still had nerve damage with daily attacks and was lucky that his eye has healed with no significant damage. The reporter mentioned that during treatment they had learned that there were lots of people like this patient. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104433, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104433:Same reporter. Master case: "lots of people"
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've had both shots. I had shingles a few years ago, but a mild case! / suspected vaccination failure; had shingles a few years ago, but a mild case!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated he/she had both Shingles shots and had shingles a few years ago but was mild case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Scab
Clinical narrative: suspected vaccination failure; Shingles / into eye; Double dose vaccine / got it / One year later got shingles / lots of people like him; So bad / lots of people like him; Scabs have healed / lots of people like him; Still has nerve damage with daily attacks / lots of people like him; This case was reported by a consumer and described the occurrence of suspected vaccination failure in an unknown number of adult patients 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, feeling bad, scab and nerve damage. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was selected as adult as per vaccine indication. It was reported that lots of patients got shingles so bad he and covered from hairline, across eyebrow, eyelid and into eye. The patient also experienced scabs and nerve damage. This case was considered as suspected vaccination failure as detail regarding time to onset and laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104425, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104425:Same reporter. Husband's case. US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles / into eye; Double dose vaccine / got it / One year later got shingles / lots of people like him; So bad / lots of people like him; Scabs have healed / lots of people like him; Still has nerve damage with daily attacks / lots of people like him; This case was reported by a consumer and described the occurrence of suspected vaccination failure in an unknown number of adult patients 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, feeling bad, scab and nerve damage. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was selected as adult as per vaccine indication. It was reported that lots of patients got shingles so bad he and covered from hairline, across eyebrow, eyelid and into eye. The patient also experienced scabs and nerve damage. This case was considered as suspected vaccination failure as detail regarding time to onset and laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104425, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104425:Same reporter. Husband's case. US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Varicella
Clinical narrative: Chicken pox; Got my shingles shot 2 years ago / very painful; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced chickenpox and pain. On an unknown date, the outcome of the chickenpox and pain were unknown.   It was unknown if the reporter considered the chickenpox and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 1st dose of Shingles vaccine 2 years ago and experienced pain and chickenpox really bad as a child. The patient was glad that he/she had got it. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had a Shingles shot (the first one) and I got the Shingles / was vaccinated / got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult 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, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccines and experienced shingles. The follow-up would not possible as no contact details were available
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Chills, Fatigue
Clinical narrative: Began shivering; Upset stomach; Tiredness; Increased blood pressure / usually 110/65 and this morning it has been 147/75 and 145/75 respectively; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th May 2021, 5 days after receiving Shingrix, the patient experienced shivering, upset stomach, tiredness and increased blood pressure. On 12th May 2021, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the upset stomach, tiredness and increased blood pressure were not recovered/not resolved.   The reporter considered the shivering, upset stomach, tiredness and increased blood pressure to be possibly related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received Shingrix on the right arm. The patient began experiencing side effects that might be related to the Shingrix vaccine.  On 11th May 2021, the patient began shivering that lasted for about 12 hours and then resolved. On the same day, the patient had an upset stomach, tiredness and increased blood pressure that had not resolved till the time of reporting. The patient's blood pressure was usually 110/65 and on 11th May 2021 and on the morning of the reporting date, it had been 147/75 and 145/75 respectively. The patient was going to see his Health care provider on the reporting date. The reporter consented to follow-up via email but did not give permission to contact health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Insomnia, Pruritus, Skin reaction, Sleep disorder
Clinical narrative: Skin reaction; itching; general discomfort; Inability to sleep; welts; This case was reported by a pharmacist via call center representative and described the occurrence of skin reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, 10 days after receiving Shingrix, the patient experienced skin reaction, pruritus, discomfort, sleeplessness and welts. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the skin reaction, pruritus, discomfort, sleeplessness and welts were recovering/resolving.   It was unknown if the reporter considered the skin reaction, pruritus, discomfort, sleeplessness and welts to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Reported stated patient received first dose of Shingrix and experienced an all over skin reaction. Reported stated patient experienced itching, welts, general discomfort, and inability to sleep associated with the all over skin reaction. Reported stated patient has attempted to treat the skin reaction with Benadryl and prednisone. Reporter stated they would ask patient to call in to provide information and additional details. Reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Skin reaction; itching; general discomfort; Inability to sleep; welts; This case was reported by a pharmacist via call center representative and described the occurrence of skin reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, 10 days after receiving Shingrix, the patient experienced skin reaction, pruritus, discomfort, sleeplessness and welts. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the skin reaction, pruritus, discomfort, sleeplessness and welts were recovering/resolving.   It was unknown if the reporter considered the skin reaction, pruritus, discomfort, sleeplessness and welts to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Reported stated patient received first dose of Shingrix and experienced an all over skin reaction. Reported stated patient experienced itching, welts, general discomfort, and inability to sleep associated with the all over skin reaction. Reported stated patient has attempted to treat the skin reaction with Benadryl and prednisone. Reporter stated they would ask patient to call in to provide information and additional details. Reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was given on 24Dec2019 and second dose 20Apr2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received first dose on 24th December 2019,  batch number 227FL, expiry date: 26th November 2021).   On 20th April 2021, the patient received the 2nd dose of Shingrix. On 20th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: Patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Reporter consented to follow up.
Age: 20.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: is now past due for dose three of the Twinrix series; received dose two late; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 21-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 22nd November 2019).   On 8th September 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th September 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not applicable for 3rd dose of Twinrix. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The HCP (health care professional) did not provide lot number and expiration date for dose 1 or dose 2. The reporter consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient is late for the second dose / first dose was administrated on July 14 2020 / The patient only received the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 30-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 14th July 2020, batch number- 3C422, expiration date-17th April 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. No adverse events were reported. The reporter consented to follow up.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Oral discomfort, Paraesthesia
Clinical narrative: tingling in the hands; burning metallic taste in his mouth; burning metallic taste in his mouth; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 42-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Concomitant products included ibuprofen (Motrin).   On 7th May 2021, the patient received the 1st dose of Engerix B adult (intramuscular). In May 2021, less than a week after receiving Engerix B adult, the patient experienced tingling of extremity, taste metallic and burning oral sensation. On an unknown date, the outcome of the tingling of extremity, taste metallic and burning oral sensation were not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity, taste metallic and burning oral sensation to be related to Engerix B adult.  Additional details were provided as follows: The patient received 1st dose of Engerix B vaccine and started feeling a burning metallic taste in his mouth and tingling in his hands. The reporter gave medical disclaimer and referred to healthcare professional. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered an extra dose (Third dose) of Shingrix / patient received the first dose on 10/30/2020 and the second dose on 1/22/21; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th October 2020) and Shingrix (received 2nd dose on 22nd January 2021).   On 13th May 2021, the patient received the 3rd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist administered an extra dose (Third dose) of Shingrix to the patient. The pharmacist thought they were administering the second dose but patient already received 1st and 2nd dose. The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Powder component of Menveo with a Non-GSK supplied diluent; Powder component of Menveo with a Non-GSK supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received powder component of Menveo with a Non-GSK supplied diluent, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administred. No adverse event was reported. No patient identifier, no lot number, no expiiration date and no vaccination date was provided. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received / second dose of Shingrix 37 days later than the 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the second dose of Shingrix 37 days after the first dose, less than the recommended interval, which led to shortening of vaccination schedule. No further details were provided at the time of call. No lot number or expiration date was available as vaccine was administered in different facility from where the call was made. No Information on batch number or expiration date was available as it was administered in a different facility. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired / Menveo dose / powder was the expired component of vaccine not the diluent; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA266A, expiry date 31st March 2021) for prophylaxis.   On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 14th May 2021, the patient was inadvertently administered Menveo, which was expired on 31st March 2021. The reporter stated that, lyophilized powder was the expired component of vaccine not the diluent. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 10Nov2019. Second had not been administered at time of the call.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 10th November 2019, batch number JC55P and expiry date 15th November 2021.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive his 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: first dose of Shingrix over 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date 2 years ago, prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix,  which led to incomplete course of vaccination. The reporter asked if 2nd dose should be administered or needs to restart the series. The reporter was unable to provide the vaccine details (date of administration, lot number and expiration date). The reporter did not consent to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early second dose / First dose was given on 22Jan2021 and second dose on 22Feb2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd February 2021, the patient received the 2nd dose of Shingrix. On 22nd February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received second Shingrix vaccine less than the recommended interval, which led to shortening of vaccination schedule. The reporter only had the lot number and birth year of patient. No further information reported. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Pain in extremity
Clinical narrative: STROKE; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and diabetes type 2.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 04-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, the patient had sore arm. On 28-MAR-2021, the patient's right peripheral vision was gone and went to emergency room and diagnosed with stroke. The patient got hospitalized. At hospital, alteplase was administered as the treatment medication for stroke. Patient was discharged on 02-APR-2021. The magnetic resonance imaging (MRI) has shown small spot (stroke confirmed) while Computerized axial tomography scan (CAT) scan did not show the stroke. The patient was hospitalized for 5 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 02-APR-2021 and the outcome of sore arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;20210518127-covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Dyspnoea, Magnetic resonance imaging
Clinical narrative: STROKE; SHORT WINDED; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg around 10 year ago, and concurrent conditions included high blood pressure, social drinker, hole in heart from birth, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on left arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel bisulfate, colecalciferol, escitalopram, finasteride, gabapentin, hydroxychloroquine sulfate, levothyroxine, lisinopril, thioctic acid, ticagrelor and verapamil hydrochloride were drug used for unknown indication.  On 12-APR-2021, the patient experienced headaches, which lasted 1 week. On 18-APR-2021, the patient had CT scan (computerized tomography) result was not reported. Patient was sent home for tension headache. On same day,  patient had also experienced no energy. On 19-APR-2021, the patient was Hospitalized for MRI (Magnetic resonance imaging) which showed patient had stroke within 5 days and also had plaque around the brain. Patient was started on Plavix and aspirin. On 21-APR-2021, the patient discharged from hospital. On same date, the patient went to cardiologist to have monitor placed where patient had another stroke and patient was readmitted to the hospital. patient was taken off Plavix and started on Lisinopril and placed on heart monitor. On 23-APR-2021, the patient was discharged from hospital. Patient was hospitalized for 5 days. On APR-2021 patient had experienced down hill, short winded and voice was gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and had not recovered from short winded. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210518146-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Mean platelet volume, Mean platelet volume increased
Clinical narrative: MPV IS HIGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Mean platelet volume (NR: not provided) Normal. On 08-APR-2021, the subject experienced mpv is high. Laboratory data included: Mean platelet volume (NR: not provided) High. The action taken with covid-19 vaccine  was not applicable. The outcome of mpv is high was not reported. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: HEART PAIN; LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced heart pain, and leg pain. The action taken with covid-19 vaccine  was not applicable. The outcome of the heart pain and leg pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Asthenia, Breast neoplasm, Dizziness, Dysstasia
Clinical narrative: ROCKHARD TUMORS IN BREAST; CONGESTION; CANNOT STAND UP; DIZZINESS; SHAKING; SWELLING OF FEET; CANNOT EAT MUCH; SICK; CANNOT WALK; VOMITING; FALL; LEGS HURT; NO STRENGTH; TROUBLE HOLDING THINGS; HEADACHE; TIRED; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient stated that she had breast cancer before and undergone chemo radiation last year. she stated that her left breast is missing. She was on chemo radiation per three week. The patient stated that she had been through two rotator cuff surgeries with joints replacement and metal screws in 2011 and her concurrent conditions included non alcoholic, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced congestion, she was unable to stand and shaking up, she felt dizziness and fall. The patient also experienced swelling of her feet, she was not eating much and feeling sick, with difficulty in walking and was vomiting. She was not doing good as she noticed large rock-hard tumors had popped up in her breast after covid shot, her legs were crumbled, she had no strength and experienced trouble in holding things even had headache, felt tired and nauseous. The patient stated that she don't drive she don't use caffeine, her limb was crippled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot stand up, dizziness, shaking, swelling of feet, legs hurt, headache, congestion, tired, cannot eat much, sick, nausea, no strength, trouble holding things, cannot walk, vomiting, rock-hard tumors in breast and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521006- Covid-19 vaccine ad26.cov2.s-Rock hard tumors in breast. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Gait inability, Headache, Illness
Clinical narrative: ROCKHARD TUMORS IN BREAST; CONGESTION; CANNOT STAND UP; DIZZINESS; SHAKING; SWELLING OF FEET; CANNOT EAT MUCH; SICK; CANNOT WALK; VOMITING; FALL; LEGS HURT; NO STRENGTH; TROUBLE HOLDING THINGS; HEADACHE; TIRED; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient stated that she had breast cancer before and undergone chemo radiation last year. she stated that her left breast is missing. She was on chemo radiation per three week. The patient stated that she had been through two rotator cuff surgeries with joints replacement and metal screws in 2011 and her concurrent conditions included non alcoholic, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced congestion, she was unable to stand and shaking up, she felt dizziness and fall. The patient also experienced swelling of her feet, she was not eating much and feeling sick, with difficulty in walking and was vomiting. She was not doing good as she noticed large rock-hard tumors had popped up in her breast after covid shot, her legs were crumbled, she had no strength and experienced trouble in holding things even had headache, felt tired and nauseous. The patient stated that she don't drive she don't use caffeine, her limb was crippled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot stand up, dizziness, shaking, swelling of feet, legs hurt, headache, congestion, tired, cannot eat much, sick, nausea, no strength, trouble holding things, cannot walk, vomiting, rock-hard tumors in breast and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521006- Covid-19 vaccine ad26.cov2.s-Rock hard tumors in breast. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY