chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: after a below freezing temperature excursion; Inappropriate age at vaccine administration; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 28th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the inappropriate age at vaccine administration and incorrect storage of drug 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 physician reported that, 4 years old patient was administrated with Boostrix after a below freezing temperature excursion, which led to inappropriate age at vaccine administration and incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by same reporter for different patients. There was discrepancy in suspect reported in narrative as Boostrix and in structured field as Kinrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea, Pain, Salivary hypersecretion
Clinical narrative: achy; tired; nauseated/  felt like throwing up; dizzy; watery mouth; This case was reported by a physician via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 24th July 2021, 1 days after receiving Shingrix, the patient experienced pain, tiredness, nausea, dizziness and salivation. The patient was treated with ondansetron (Zofran). On an unknown date, the outcome of the pain, tiredness, nausea, dizziness and salivation were unknown.   It was unknown if the reporter considered the pain, tiredness, nausea, dizziness and salivation to be related to Shingrix.  Additional details were provided as follows: The physician reported that the patient received a dose of Shingrix and 1 day after the vaccination patient experienced feeling achy,tired,nauseated,dizzy,watery mouth and felt like throwing up. The physician prescribed Zofran as measure. The Physician said a patient was waiting and did not answer any more questions. The case was linked with US2020153384 and US2019104391 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153384:Same reporter US-GLAXOSMITHKLINE-US2019104391:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 25Sept2018 / has not received 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 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th September 2018 with batch number C7B9P and expiry date 27th February 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 follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: got the first dose / November 2020 / has not gotten the second dose; developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2021, 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/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 details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported for the first dose and was not applicable for the second dose. The patient stated that he got the first dose of Shingrix and developed shingles. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: cannot lift that arm; pain in her left arm; This case was reported by a other health professional via call center representative and described the occurrence of injected limb mobility decreased in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxab2az, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 28th July 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injected limb mobility decreased and pain in arm. The action taken with Bexsero Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 provide are as follows: The case was reported by Medical assistance. The reporter reported that patient was administered with Bexsero in left arm and started feeling pain in her left arm and could not lift that arm. All the symptoms were in the arm that the vaccine was administered. The patient still present the symptoms, at the time of reporting. The reporter consented to follow-up.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old male patient who received HAV (Havrix 720 Junior) (batch number yr532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAV (Havrix 720 Junior).   On 2nd August 2021, the patient received the 2nd dose of Havrix 720 Junior (intramuscular) and Havrix Pre-Filled Syringe Device. On 2nd August 2021, unknown after receiving Havrix 720 Junior and Havrix Pre-Filled Syringe Device and an unknown time after receiving Havrix 720 Junior, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The nurse reported that the patient received the 1st dose and the 2nd dose in the left arm and the 2nd dose was administered before recommended interval, which led to shortening of vaccination schedule. No further details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: on 7/31/2020 with 1 dose / due to COVID  second dose was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (first dose of shingrix received on 31st July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: Age at vaccination not applicabe for this report. Due to covid pandemic situation, second dose of shingrix was not administered to the patient yet. The reporter consented to follow up. The VARES details pertains to 1st dose of Shingrix.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: his rash got worse and spread to other spots/other areas of his body; This case was reported by a consumer and described the occurrence of rash aggravated in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, 1 day after receiving Shingrix, the patient experienced rash aggravated. The patient was treated with prednisone. On an unknown date, the outcome of the rash aggravated was not recovered/not resolved.   It was unknown if the reporter considered the rash aggravated to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient was at his doctor's office that day being seen for a rash on his waist that he thought was poison ivy. The rash was in just one spot. The doctor advised him to use an over-the-counter cream. The patient asked if he could get the Shingrix shot that day The doctor agreed to give him the shot in left deltoid. The next day patients rash was worse and spread to other spots and other area of body after administration of shingrix vaccine. The doctor prescribed him prednisone 5 mg tab. He was instructed to take 40 mg 8 tablets the first day, 30 mg 6 tablets then second day. The patient was on prednisone taper for about 7 to days. The doctor told him he could discontinue the prednisone if his rash resolves. Did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered  only the liquid component of the Menveo; administered  only the liquid component of the Menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA521A, expiry date 30th April 2022) for prophylaxis.   On 30th July 2021, the patient received Menveo. On 30th July 2021, unknown after receiving Menveo, 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 as follows: The patient was inadvertently administered only the liquid component of the Menveo resulting in the administration of liquid component of MenACWY without lyopholized A component of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. At the time of the report the patient had not reported any issues.  The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered on 12/Jul/2021/expiration date of 05/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired Bexsero vaccine. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient received Infanrix insted of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided as follows: The medical assistant reported that a 11-years-old patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: received Boostrix on 5-29-2020 and accidently received another / today 8-3-2021; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (a dose received on 29th May 2020).   On 3rd August 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient accidently received another Boostrix vaccine in an unknown arm on the day of reporting, which led to extra dose administered. No other details were known. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: arm was sore; painful; This case was reported by a consumer and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had a case of shingles during the decade of the 1990's). Previously administered products included Zostavax with an associated reaction of herpes zoster (believed that she had Zostavax vaccine on an unknown date ,after that episode of shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient stated that, she had received the 1st dose of Shingrix more than 6 months ago and her arm was sore. The patient had not received the 2nd dose of Shingrix because the 1st dose was painful. The patient stated that, her arm was sore for around 1 to 1 and 1 and half weeks. Not all information was available. The lot and expiration date were not available.  The patient did not provide consent to follow up with health care professional.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 43 year old patient received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number 94B7F, expiry date 25th May 2022) for prophylaxis.   On 3rd August 2021, the patient received the 1st dose of Shingrix. On 3rd August 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The nurse reported that 43 year old patient received Shingrix and confirmed that the patient did not present any risk of zoster due to immunodeficiency or inmunosupression caused by known disease or therapy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: dose / was administered without reconstitution with the powder portion; dose / was administered without reconstitution with the powder portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th July 2021, the patient received Menveo. On 30th July 2021, unknown after receiving Menveo, 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 provide are as follows: The case was reported by medical assistant. The age at vaccination was not reported. The reporter realized during inventory that one dose of Menveo was administered without reconstitution with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The administration of Menveo occurred to 3 different patients on Friday and was not identified which one of them had received the incomplete vaccine. No patient's identifiers, lot numbers or expiration dates were provided.  The health care professional informed would call us back in case patient was identified. The reporter consented to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1 dose / on 08/5/2020 / had not yet received the second dose of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 5th August 2020 from batch number 4F472, expiry date 6th November 2022).   On an unknown date, the patient received the 2nd 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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 8.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Pediarix to an 8y/o; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided as follows: The health care professional reported that a 8 years old patient was administered Pediarix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received /a dose of Infanrix that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa (Infanrix) (batch number j947T, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 2nd Aug 2021, the patient was administered Infanrix, which was expired on 30th May 2021. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administrated with Infanrix instead of Boostrix; 11 years old /administrated with Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number d2kx9, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 provided were as follows: Nurse reported that a 11 year old patient was administrated with Infanrix instead of Boostrix which led to Wrong vaccine administered and Inappropriate age at vaccine administration . No adverse event was reported. Reporter consented to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under treatment with Solaris received / Menveo 3 years before this report; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details provided were as follows: Patient's age was not reported but patient could be 77 or 78 years old. Pharmacist reported that the patient was under treatment with Solaris received a dose of Menveo 3 years ago which led to inappropriate age at vaccine administration. As an oversight, this was recognized by Medical information agent after the Health care professional/Medical information interaction ended. No more information was available. The Health care professional neither agreed or declined Follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Product use in unapproved indication
Clinical narrative: abdominal pain; received the Shingrix Vaccine while having active Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced abdominal pain and drug use for unapproved indication. On an unknown date, the outcome of the abdominal pain and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and started to have abdominal pain. The patient received the Shingrix vaccine while having active shingles, which led to drug use for unapproved indication. No further information available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Product administered at inappropriate site
Clinical narrative: administered above the deltoid region of upper arm / which caused pain; administered above the deltoid region of upper arm; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient received first shot of Shingrix and patient believed the vaccine was administered above the deltoid region of upper arm (possible vaccine administered at Inappropriate Site) which caused pain and led to vaccine administered at inappropriate site. The patient stated that, she was due for her second dose of Shingrix vaccine. The reporter was asking questions to collect information from the patient to submit adverse event to safety but the patient kept denying to answer the questions indirectly by saying okay, that all I needed or okay, well thank you for the information.reporter tried twice to obtain required information to file adverse event. The reporter could not collect patient's full address, phone number, and an email address. also, could not collect  health care professional contact information, date of birth, lot number, expiry date date, dose, date of administration, left/right arm, date of the first dose of Shingrix, how soon did the symptom (pain) start after the shot, and if the symptom has been resolved. The patient did provide consent to follow-up and also did not provide any contact information of health care professional.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: have not received their 2nd dose due to COVID; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (first dose of shingrix received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The pharmacist stated that the patients who received the first dose of Shingrix, but did not received second dose due to covid. Inquired for can the dose be administered now. Age at vaccination was not reported. Consented follow up. No exact amounts of patients nor demographics was available at the time of call.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose /11th November, 2020; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received on 11th November 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 male patient received his first dose of Shingrix and She'd like to know how to proceed ,and patient did not received second dose yet which led to incomplete course of vaccination. No vaccine information was provided at the time of the call. No further events were reported at the time of the call. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 13-December-2020 / planning / second dose this weekend; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5 ml) received intramuscularly on 13th December 2020 at the pharmacy).   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 case was reported by patient's spouse. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, but was planning to receive 2nd dose this weekend, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up. This case had been linked with US2021166467, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021166467:Same reporter. Spouse's case.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 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 (received 1st dose 2 years ago from 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, the patient did not receive 2nd dose, which led to incomplete course of vaccination and the reporter asked information for such situation. The reporter did not have patient information and stated that this was asked by a physician in their hospital. The reporter consented to follow up via email.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Administrated / vaccine / reconstituted with sterile water; Administrated / vaccine / reconstituted with sterile water; 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 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 4th August 2021, the patient received Menveo. On 4th August 2021, 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 information was provided as follows: The reporter was a medical assistant.  The patient received Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No adverse event was reported. No lot number and expiration date were provided. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: SLEEPLESS NIGHTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included cetostearyl alcohol/glycerol for drug used for unknown indication. On an unspecified date, the subject experienced sleepless nights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleepless nights was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned an adult 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: 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 suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000188117; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Condition aggravated, Inflammation, Prostatic specific antigen
Clinical narrative: INFLAMMATION; MILD TIGHTNESS IN THE CHEST; LEFT SHOULDER AND ELBOW LIT UP, INJURED ARM (LEFT ARM) FLARED UP, ARM LOCKED AFTER VACCINATION; 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 past medical history included arm injury, got close-lined on shoulder, and concurrent conditions included type 1 diabetes, high cholesterol, and cow-milk lactic acid allergy, and other pre-existing medical conditions included the patient had no unknown drug allegies. he was on blood thinners.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for type 1 diabetes. On 27-MAR-2021, the subject experienced left shoulder and elbow lit up, injured arm (left arm) flared up, arm locked after vaccination. On APR-2021, the subject experienced mild tightness in the chest. Treatment medications included: cortisone. On an unspecified date, the subject experienced inflammation. Laboratory data (dates unspecified) included: PSA test (NR: not provided) Results unspecified. Additional treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left shoulder and elbow lit up, injured arm (left arm) flared up, arm locked after vaccination, mild tightness in the chest and inflammation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from company representative, via social media (a media news article) concerned multiple (4) patients of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. All of them were fully vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced covid-19 infection (Suspected Covid-19 Infection and Suspected clinical vaccination failure), and were hospitalized (date unspecified). Number of days hospitalized and discharge dates were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 Infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210801922-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. 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: SPECIAL SITUATIONS 20210801922-Covid-19 vaccine ad26.cov2.s-Suspected Covid-19 Infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Influenza like illness, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer (patient's wife) concerned a 43-year-old male. The patient's height, and weight were not reported. The patient did not have any underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination on right arm.  No concomitant medications were reported.  On 20-MAR-2021, 8 hours after the shot, the patient experienced flu-like symptoms. On 30-JUL-2021, the patient had Antibody test which showed Immunoglobulin G (IgG) was negative and immunological vaccine failure was confirmed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760356. This report was associated with product quality complaint: 90000188476.; Sender's Comments: V0: 20210802749- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccine failure. 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: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombosis
Clinical narrative: DVT; BLOOD CLOT; This solicited report received from a lawyer, concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administrated for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, 3 weeks after vaccination, the patient developed a blood clot and DVT (deep vein thrombosis). Treatment medications (dates unspecified) included: Xarelto (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the DVT and blood clot was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and DVT, and blood clot was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: UNKNOWN) dose was not reported, administered on 25-MAY-2021 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 low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and headache was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cough, Pain, Pain in extremity, Parosmia
Clinical narrative: WEIRD SENSE OF SMELL; WEIRD SENSE OF TASTE; RUNNY NOSE; COUGH; SORENESS ON THE LEFT ARM; BURNING PAIN ON THE LEFT ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (152/80), and chronic obstructive pulmonary disease (copd). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the subject experienced burning pain on the left arm. On 03-AUG-2021, the subject experienced weird sense of smell. On 03-AUG-2021, the subject experienced weird sense of taste. On 03-AUG-2021, the subject experienced runny nose. On 03-AUG-2021, the subject experienced cough. On 03-AUG-2021, the subject experienced soreness on the left arm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 152/80 (High). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning pain on the left arm on 03-AUG-2021, and had not recovered from soreness on the left arm, weird sense of smell, weird sense of taste, runny nose, and cough. This report was non-serious.