chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: is late for the 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose on 8th February 2021) and Engerix B (received second dose on 9th March 2021).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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. The pharmacist reported that a patient received the first and second dose of Engerix and was late for the 3rd dose. Till the time of reporting, the patient did not receive the third dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with US2021174366, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174366:same reporter
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva396a, expiry date 31st August 2021) for prophylaxis.   On 3rd September 2021, the patient received the 1st dose of Menveo. On 3rd September 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 are as follows: The case was reported by Medical assistant. The patient received a expired dose of Menveo was expired on 31st August 2021, which led to expired vaccine used. The reporter consented to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Peripheral swelling, Swelling
Clinical narrative: right armpit is swollen.; Nausea; Achy; Tired; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2021, 10 hrs after receiving Shingrix, the patient experienced nausea, pain and tiredness. On 9th September 2021, the patient experienced local swelling. On an unknown date, the outcome of the nausea, pain and tiredness were recovered/resolved and the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the nausea, pain, tiredness and local swelling to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The patient received Shingrix vaccine in right arm and she felt nausea, achy and tired about 10 hours later, then by the next morning those symptoms subsided. The patient stated that 2 days after dose her right armpit is swollen. The reporter consented to follow up. This case has been linked with case US2021192877, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192877:same reporter
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: receiving on 09/02/21 only the adjuvant component of Shingrix; receiving on 09/02/21 only the adjuvant component of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number BM27F, expiry date unknown) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The health care professional reported that male patient receivied only the adjuvant component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. Reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third accidentally given; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in June 2018) and Shingrix (received 2nd dose of Shingrix in December 2018).   On 8th September 2021, the patient received the 3rd dose of Shingrix. On 8th September 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 provided were as follows: Age at vaccination was not reported. A third dose of Shingrix was accidentally given to a patient at the pharmacy which led to extra dose administered. Reporter consented to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Nightmare
Clinical narrative: hallucinations; bad dreams; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2021, the patient received the 1st dose of Shingrix. In July 2021, 12 hrs after receiving Shingrix, the patient experienced hallucination (serious criteria GSK medically significant) and bad dreams. On an unknown date, the outcome of the hallucination and bad dreams were unknown.   It was unknown if the reporter considered the hallucination and bad dreams to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix and she experienced after 12 hours hallucinations and very bad dreams. The reporter did not had lot number and expiration date. The reporter consented to follow-up by phone.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose in 2019 , now planning get second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2019, 0.5mL left deltoid intramuscularly, batch number: EE924 Expiry date: 16th October 2020).   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. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The patient now planning to get the second dose. The patient did not have an exact date when the first dose was given. The reporter gave a consent to reach her for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019 did not receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (might have received the 1st dose in 2019).   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 reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported a patient did not received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination.  Reporter had no other details or even if there was a patient.  The reporter consented to follow up via email.
Age: 0.08
Sex: U
Vaccine: TDAP
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluant was given; only the diluant was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 1-month-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis.   On 27th August 2021, the patient received Boostrix. On 27th August 2021, unknown after receiving Boostrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The reporter stated that only the diluant was given for a Boostrix vaccine to a child, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The health care professional office gave permission to contact them. This case was linked with US2021192895, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192895:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 27P85, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (the patient received the first 2 doses of shingrix about 2 years ago).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 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 age at vaccination was not reported. The pharmacist reported that the patient received 3 doses of Shingrix, third dose was administered this year, which led to extra dose administered. No reactions reported. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Pain, Rash papular, Urticaria
Clinical narrative: hive marks in back area; Round and raise marks/ had 8 to 9 large marks ½ inch wide/ 2 or 3 large marks at least 2 inches wide; marks were stinging; This case was reported by a consumer via call center representative and described the occurrence of hives in a 20-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number G05NG, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced hives, raised rash and stinging. On an unknown date, the outcome of the hives, raised rash and stinging were unknown.   It was unknown if the reporter considered the hives, raised rash and stinging to be related to Boostrix.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received Boostrix vaccine in the right arm and experienced few hive marks in the back area, the marks were round and raise the patient had 8 to 9 large marks ½ inch wide and the marks were stinging. The reporter did not consent to follow up
Sex: U
Vaccine: TDAP
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was given the diluant only; was given the diluant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a child patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 27th August 2021, the patient received Boostrix. On 27th August 2021, unknown after receiving Boostrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that only the diluent was given for a Boostrix vaccine to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The health care professional office gave permission to contact them. This case was linked with US2021192892, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192892:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not had a 2nd dose yet.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th December 2019).   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. The physician  reported that he had a patient who received their first dose of Shingrix and has not had a 2nd dose till the time of reporting, which led to incomplete course of vaccination.  The reporter asked if the patient need to restart the series. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th November 2019).   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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu shot (getting (yearly) flu).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported the case for herself. The patient experienced flu-like symptoms for a couple days. The side effects were expected and left after a day or so. The reporter did not specify if side effects occurred after dose 1 or dose 2 or both. The reporter did not consent to follow-up. For 2nd dose, refer case US2021AMR193160, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192911:same reporter US-GLAXOSMITHKLINE-US2021AMR193164:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu shot (gets yearly).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The case was reported by patient's wife. The patient experienced flu-like symptoms for a couple days. The side effects were expected and left after a day or so. The reporter did not specify if side effects occurred after dose 1 or dose 2 or both. The reporter stated that she was certain that her husband does not want GlaxoSmithKline to contact his doctor. The reporter did not consent to follow-up. For 2nd dose, refer case US2021AMR193164, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192908:same reporter US-GLAXOSMITHKLINE-US2021AMR193160:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Headache, Herpes zoster, Vaccination failure
Clinical narrative: both doses in 2019, now shingles / suspected vaccination failure; Shingles; burning sensation; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, fatigue and headache. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, fatigue and headache to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient received both doses of Shingrix in 2019. The patient currently experienced a Shingles outbreak. The patient also experienced fatigue, headache, and a burning sensation (did not specify part of body where sensation is occurring). All symptoms were ongoing. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the adjuvant; Administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2021, the patient received Shingrix. On 9th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not reported but patient was older than 50 years old. Pharmacist reported that a nurse from the facility he works at, administered only the adjuvant AS01B from a Shingrix vaccine to a patient, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up. The case was linked with case US2021192917 and US2021192920 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192917:Same reporter. US-GLAXOSMITHKLINE-US2021192920:Same reporter.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2 doses in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 40-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 10th September 2021, the patient received the 2nd dose of Boostrix. On 10th September 2021, unknown after receiving Boostrix, 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 information was provided as follows: Registered pharmacist reported that a patient received 2 doses of Boostrix within 3 months, which led to drug dose administration interval too short. Reporter had provided limited information. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Gait inability
Clinical narrative: dizziness; could not walk; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included allergy (allergic to PEG) and penicillin allergy.   On 20th June 2020, the patient received Boostrix (intramuscular) .5 ml. On an unknown date, less than 2 years after receiving Boostrix, the patient experienced dizziness and unable to walk. The patient was treated with dramamine (nos) (Dramamine). On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the unable to walk was unknown.   It was unknown if the reporter considered the dizziness and unable to walk to be related to Boostrix.  Additional details were provided as follows: The patient received a dose of Boostrix and experienced dizziness. She was not sure how long after the vaccine she began dizziness.  She had several episodes of dizziness that had lasted from one to three days.  One episode of dizziness was so severe that she could not walk confidently.  She still had episodes of dizziness occasionally.  She took Dramamine for the dizziness which was unresolved. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to get the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of series received two to three years ago from the date of 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 reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that a patient forgot to get the 2nd dose of Shingrix which led to incomplete course of vaccination.   Pharmacist was not the administering provider of the vaccine and did not had lot number or expiration date details for 1st dose. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 2020 and second on 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7F94C, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th September 2020).   On 29th May 2021, the patient received the 2nd dose of Shingrix. On 29th May 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: Pharmacist reported that, a patient received the 2nd dose of Shingrix later than recommended schedule which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported for the first dose and not applicable for the second dose. The patient received the first dose and experienced an episode of shingles. Till the time of reporting, the patient did not receive the second dose, which led to  incomplete course of vaccination. The reporter wanted to know when could get 2nd dose. Lot number and expiration date of 1st dose of Shingrix was asked but health care professional confirmed she did not had that information. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Head cold.; he did on feel well; This case was reported by a consumer via call center representative and described the occurrence of head cold in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular). In August 2021, 2 days after receiving Shingrix, the patient experienced head cold and malaise. On an unknown date, the outcome of the head cold and malaise were recovered/resolved.   It was unknown if the reporter considered the head cold and malaise to be related to Shingrix.  Additional information was provided as follows: The patient had the vaccine about two weeks ago from the day of reporting. Two days post vaccination the patient did on feel well and developed a head cold. The reporter consented to follow up. This case was linked to case US2021193290 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193290:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site warmth, Rash papular
Clinical narrative: inflammation at injection site; bumpy, itchy rash/ a reddish, irregular, raised hive-like appearance; bumpy, itchy rash/ a reddish, irregular, raised hive-like appearance; Chills; Shakes; experienced redness and warmth at the injection site.; experienced redness and warmth at the injection site.; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2021, the patient received the 1st dose of Shingrix. On 2nd July 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, chills and tremor. On 5th July 2021, the patient experienced erythropapular rash and hives. On an unknown date, the patient experienced injection site inflammation. On 13th July 2021, the outcome of the erythropapular rash and hives were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site inflammation, chills and tremor were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site inflammation, chills, tremor, erythropapular rash and hives to be related to Shingrix.  Additional information was provided as follows: The patient experienced redness and warmth at the injection site and chills, shakes that night, on the day dose was received.  On an unknown date, less than a week after vaccination the patient also had inflammation at injection site. On 5th July 2021, 3 days after vaccination the patient developed a bumpy, itchy rash which was along lower abdomen and upper breasts and had a reddish, irregular, raised hive-like appearance with visible border.  Till the time of reporting the patient had not received second dose of Shingrix. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Urticaria
Clinical narrative: inflammation at injection site; bumpy, itchy rash/ a reddish, irregular, raised hive-like appearance; bumpy, itchy rash/ a reddish, irregular, raised hive-like appearance; Chills; Shakes; experienced redness and warmth at the injection site.; experienced redness and warmth at the injection site.; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2021, the patient received the 1st dose of Shingrix. On 2nd July 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, chills and tremor. On 5th July 2021, the patient experienced erythropapular rash and hives. On an unknown date, the patient experienced injection site inflammation. On 13th July 2021, the outcome of the erythropapular rash and hives were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site inflammation, chills and tremor were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site inflammation, chills, tremor, erythropapular rash and hives to be related to Shingrix.  Additional information was provided as follows: The patient experienced redness and warmth at the injection site and chills, shakes that night, on the day dose was received.  On an unknown date, less than a week after vaccination the patient also had inflammation at injection site. On 5th July 2021, 3 days after vaccination the patient developed a bumpy, itchy rash which was along lower abdomen and upper breasts and had a reddish, irregular, raised hive-like appearance with visible border.  Till the time of reporting the patient had not received second dose of Shingrix. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 23rd November 2020 in left arm by intramuscular route, batch number AG7M9 expiry date 6th May 2022).   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 reported as follows: The age at vaccination was not applicable for this report. Medical assistant reported a patient had not received 2nd dose till the time of reporting which led to incomplete course of vaccination.  The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from the date of reporting, the reporter did not know the exact date).   On 5th July 2021, the patient received the 2nd dose of Shingrix. On 5th July 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: Pharmacist reported that a patient who received 2nd dose of Shingrix later than recommended schedule which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of injection site swelling (and redness at the injection site every year to the flu shot, for tolerance refer case US2021AMR194127) and Covid shot with an associated reaction of adverse reaction (had reaction (no details provided) to 2nd dose which was received in 2021).   On 20th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th September 2020, less than an hour after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The patient had redness and swelling at the injection site that resolved in 2 weeks. The patient had both doses of COVID19 vaccines in 2021 and she had a strong reaction (no details provided) to the second dose of COVID19 vaccine. The reporter consented to follow up. This case is linked to case US2021AMR194127 reported by the same reporter for the same patient (Flu vaccine).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR194127:Same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: didn´t received full dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 10th September 2021, the patient received Shingrix. On 10th September 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional information was provided as follows: The patient did not receive a full dose of Shingrix as the needle lose some volume while the vaccine was being administered, which led to incomplete dose administered. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 19th February 2020, batch number 54YKVAK0VP,expiryy date 22th March 2020).   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 reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported a patient had not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix today inadvertently; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2019) and Shingrix (2nd dose received in December 2019).   On 10th September 2021, the patient received the 3rd dose of Shingrix. On 10th September 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 reported as follows: Pharmacist reported that a patient experienced a 3rd dose of Shingrix inadvertently on the day of reporting which led to extra dose administered. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Diagnosed with non-Hodgkin's lymphoma; Night sweats; Unexplained weight loss; Excruciating pain in left arm from lymph node; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced NIGHT SWEATS (Night sweats), WEIGHT DECREASED (Unexplained weight loss), LYMPH NODE PAIN (Excruciating pain in left arm from lymph node) and FATIGUE (Fatigue). On 07-Sep-2021, the patient experienced NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma) (seriousness criterion medically significant). At the time of the report, NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma), NIGHT SWEATS (Night sweats), WEIGHT DECREASED (Unexplained weight loss), LYMPH NODE PAIN (Excruciating pain in left arm from lymph node) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, White blood cell count: 32000 (abnormal) White blood cells: 32000.         No concomitant medication were reported.  No treatment information was reported.  Company comment- This case concerns a  61-year-old, male patient with no relevant medical history, who experienced the unexpected events of Non Hodgkin's lymphoma, night sweats, weight decreased and lymph node pain and expected event of Fatigue. The events of night sweats, weight decreased, fatigue and lymph node pain occurred approximately three days after the second dose of Moderna COVID-19 Vaccine, while diagnosis of Non Hodgkin's lymphoma was made three months after second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.   This case was linked to MOD-2021-245684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Followed up received on 7-SEP-2021 that contains updated event as Non-Hodgkin's lymphoma. Case upgraded to serious.; Sender's Comments: This case concerns a  61-year-old, male patient with no relevant medical history, who experienced the unexpected events of Non Hodgkin's lymphoma, night sweats, weight decreased and lymph node pain and expected event of Fatigue. The events of night sweats, weight decreased, fatigue and lymph node pain occurred approximately three days after the second dose of Moderna COVID-19 Vaccine, while diagnosis of Non Hodgkin's lymphoma was made three months after second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pancreatitis
Clinical narrative: In April, he went for CT scan and found out that his pancreas were enlarged; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (In April, he went for CT scan and found out that his pancreas were enlarged) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PANCREATITIS (In April, he went for CT scan and found out that his pancreas were enlarged) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in May 2021 due to PANCREATITIS. At the time of the report, PANCREATITIS (In April, he went for CT scan and found out that his pancreas were enlarged) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: found out that his pancreas were enlarged (abnormal) found out that his pancreas were enlarged.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication medications included blood thinner and blood pressure medication (unspecified).  In April the patient went for CT scan and found out that pancreas were enlarged. He was hospitalized in may and again on 16-Aug-2021. He has stent in the pancreas.  Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.  Treatment medication included steroids, stent.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Nerve injury
Clinical narrative: NERVE DAMAGE; FALLOUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune issue lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that the vaccine ruined the patient's life. The patient was 5 months in and still dealing with the fallout. The patient had unspecified surgery 3 weeks ago to fix nerve damage, which was partially successful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nerve damage, and had not recovered from the fallout. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210915702-COVID-19 VACCINE AD26.COV2.S- Nerve damage. This event is considered not related. The event has an unknown/unclear 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: UNDERLYING DISEASE
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced administration of vaccine expired due to temperature excursion. On 21-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine expired due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915852, 20210916228, 20210916312, 20210916300, 20210916455, 20210913164, 20210915646, 20210916553, 20210916401, 20210916658, 20210916910, 20210916415, 20210916697, 20210916965, 20210917160, 20210915623, 20210916808, 20210916465, 20210915661, 20210917074, 20210916129, 20210916520, 20210916715, 20210916811, 20210916849, 20210916959, 20210917163, 20210916907, 20210916768, 20210917515, 20210917226, 20210917500, 20210916584, 20210918425, 20210915719, 20210916498 and 20210917603.