chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia, Loss of consciousness, Oxygen saturation
Clinical narrative: Loss of consciousness; Dizziness; Hyperhidrosis; Hypoaesthesia; Pallor; This case was received FDA VAERS (Reference number: 1086426) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema. Concurrent medical conditions included Skin infection (Infection on mid to lower back, possible eczema per patient). Concomitant products included TRIAMCINOLONE for Eczema, CEPHALEXIN [CEFALEXIN] for Skin infection.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), HYPOAESTHESIA (Hypoaesthesia) and PALLOR (Pallor). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), HYPOAESTHESIA (Hypoaesthesia) and PALLOR (Pallor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Oxygen saturation: 99 (normal) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter states that the patient received shot and then blacked out a minute or two later. The reporter called 911, and while on the phone the patient regained consciousness and felt much better.  EMS checked him out and all of his vitals were normal and he could walk upright just fine.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events may be associated with the act of being injected rather than with the vaccine itself.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events may be associated with the act of being injected rather than with the vaccine itself
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Loss of consciousness; Dizziness; Hyperhidrosis; Hypoaesthesia; Pallor; This case was received FDA VAERS (Reference number: 1086426) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema. Concurrent medical conditions included Skin infection (Infection on mid to lower back, possible eczema per patient). Concomitant products included TRIAMCINOLONE for Eczema, CEPHALEXIN [CEFALEXIN] for Skin infection.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), HYPOAESTHESIA (Hypoaesthesia) and PALLOR (Pallor). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), HYPOAESTHESIA (Hypoaesthesia) and PALLOR (Pallor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Oxygen saturation: 99 (normal) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter states that the patient received shot and then blacked out a minute or two later. The reporter called 911, and while on the phone the patient regained consciousness and felt much better.  EMS checked him out and all of his vitals were normal and he could walk upright just fine.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events may be associated with the act of being injected rather than with the vaccine itself.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events may be associated with the act of being injected rather than with the vaccine itself
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Gait disturbance; Pain; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma, Cataracts, Barrett's esophagus, High cholesterol, Kidney stones (High Cholesterol, controlled by medication.) and Carpal tunnel syndrome. Concurrent medical conditions included Rheumatoid arthritis, Osteopenia, GERD and Hypertension (High Blood Pressure, controlled by medication.). Concomitant products included ATORVASTATIN, OMEPRAZOLE and LABETALOL HYDROCHLORIDE (LABETALOL [LABETALOL HYDROCHLORIDE]) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant), GAIT DISTURBANCE (Gait disturbance) and PAIN (Pain). The patient was treated with METHYLPREDNISOLONE for Adverse event, at a dose of UNK dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), GAIT DISTURBANCE (Gait disturbance) and PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 11Mar2021, the day after receiving the first vaccine, it was noted by the patient that they experienced " the worst rheumatoid arthritis (RA) flare" they ever had. The patient stated the morning after was "very painful and that they had to crawl out of their bedroom." The patient reported being unable to walk due to the RA flare.  The following day, presumed 12Mar2021, the patient was back to normal.  For treatment, the patient received a script for methylprednisolone to alleviate the effects.  The patient additionally expressed concern that they were not made aware that this could happen after the vaccine. The patient reported being told by staff at the POD that this was "no different than a usual flu shot." The patient also felt as though they were not being truthfully informed.  Based on the information provided, which includes a temporal association between the reported event and the administration of mRNA-1273 vaccine, a causal association cannot be excluded.; Sender's Comments: Based on the information provided, which includes a temporal association between the reported event and the administration of mRNA-1273 vaccine, a causal association cannot be excluded.
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had my first bout of shingles. I have had 5 bouts since,; This case was reported by a consumer via media and described the occurrence of shingles in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/ herself. The patient took first dose of Shingrix and experienced shingles first bout and had 5 bouts since then. The patient was currently 84 years old. The reporter did not consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Vaccine positive rechallenge
Clinical narrative: am very tired; achy; somewhat nauseated; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, 1 days after receiving Shingrix, the patient experienced tiredness, pain and nausea. On an unknown date, the outcome of the tiredness, pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. Patient had second dose of shingrix and experienced tiredness, achy and nauseated. The patient was seeking advice as what was best for pain and was resting at the time of report. Reporter informed most common side effects with SHINGRIX to the patient. Reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: You get the shingles shot you get a mild case of shingles been there done that/ Suspected vaccination failure; a mild case of shingles been there done that; my arm was sore for over a year and a half; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain in arm. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got a mild case of shingles been there done that and his/her arm was sore for over a year and a half. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after 3 months side effects of vaccination/ Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient got shingles after 3 months side effects of vaccination. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset, and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got 1st vaccine 2 years ago / Will 2ndvaccine now make it effective or do we have to start over?; This case was reported by a consumer via interactive digital media 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 of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The case was reported by the consumer itself. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix two years back. Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient wanted to know, would 2nd vaccine now make it effective or should they start over. The patient consented to follow up. No further information was provided. This case has been linked to US2021AMR113533, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113533:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: I was vaccinated, I am being treated for shingles/ Suspect vaccination Failure; I am being treated for shingles/in my eye; I am being treated for shingles/right side of my head.; So painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated that even though he/she was vaccinated, the patient was being treated for shingles without a rash. The patient had it in the eye and right side of my head at the time of reporting, and it was painful. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got 1st vaccine 2 years ago / Will 2ndvaccine now make it effective or do we have to start over?; This case was reported by a consumer 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 the reporting date).   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 did not received 2nd dose till the time of reporting, which led to incomplete course of vaccination.  The patient wanted to know if the 2nd vaccine would be effective or do we need to start over. This case has been linked with the case US2021AMR113452 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113452:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: had single dose and then could not have second because of COVID; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 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 provided as follows: The age at vaccination was not applicable for this report. The patient had single dose and then could not have second because of COVID. The patient asked if the patient need to start again with first.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Achy reaction to 2d Shingrix / aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 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 pain and headache. On an unknown date, the outcome of the pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain and headache to be related to Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient experienced aches, ague and headache. The patient asked, which painkiller recommended for achy reaction to Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had one dose a year ago can I now take second?; This case was reported by a consumer interactive digital media 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 a year 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 provided as follows The patient self-reported the case. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient asked, could he/she took 2nd dose now.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: received both doses of the Shingrix vaccine in January and since then have had 3 outbreaks / vaccine has made no difference in the recurrrence rate of my outbreaks/Suspected vaccination failure; 3 outbreaks; received both doses of the Shingrix vaccine in January; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (chronic shingles first  occurred in 20's.).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too short. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reporter by the patient herself.  Additional details were provided as follows: The case was reporter by the patient herself. The age at vaccination was not reported. The patient received both doses of Shingrix in January and experienced vaccination failure and shingles. The patient received 2nd dose in less than recommended time frame, which led shortening to vaccination schedule. The patient stated that had 3 outbreaks, after vaccination. The patient inquired how common that was and if there were any data on patients who already had a history of shingles and the recurrence rate when vaccinated. The patient informed that, the vaccine had made no difference in the reoccurrence rate of outbreaks. This case was considered as suspected vaccination failure as details regarding, onset time and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: I have the aches, pain; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were unknown.   It was unknown if the reporter considered the pain and headache to be related to Shingrix.  Additioal details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had aches, pain and headache from the 2nd dose of Shingrix shot, which was received the day before reporting date. The patient inquired was there the preference for ADA, acetaminophen or ibuprofen for pain. The follow up would not be possible as no contact details were available.  GSK note- since it was not clear when the vaccine received by the patient or when the adverse event occurred, worst case approach applied and date before the reporting date considered as vaccination date.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by a consumer via media and described the occurrence of adverse drug reaction in a patient who received Herpes zoster (Shingrix for prophylaxis. The reporter wanted to know what would be best for pain after getting side effects from Shingrix vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Urinary tract infection
Clinical narrative: inappropriate schedule of vaccine; shingles; UTI; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 2nd dose of Shingrix. In September 2019, the patient received the 1st dose of Shingrix. In July 2020, not applicable after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced shingles and urinary tract infection. In September 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the shingles, urinary tract infection and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles and urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received her first dose in September 2019 and developed shingles and a UTI (urinary tract infection) in July 2020. The patient received 2 dose later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: had her first dose on 1/2/2021 and has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 48-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received first dose on 2nd January 2021 with batch number 2573G and expiry date 28th May 2022).   On an unknown date, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received her 1st dose of Engerix B and did not received her 2nd dose yet which led to incomplete course of vaccination. The reporter consented to follow-up. No further details provided.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: reconstituted the menveo powder (men A) with sterile water; reconstituted the menveo powder (men A) 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 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's coworker reconstituted the Menveo powder (Men A) with sterile water and not the diluent provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted to know if the patient needs to come back for revaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received the first dose / in 2018 / has not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date in 2018).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient said that he would get the 2nd dose by now and he knew that he did not have to restart the series per content. No health care professional information given. The reporter did not consent to follow up.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the third dose of Engerix 4 weeks after the second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 10-year-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   Concomitant products included HBV (Engerix B pediatric).   On 13th May 2021, the patient received the 3rd dose of Engerix B pediatric. On 13th May 2021, unknown after receiving Engerix B pediatric, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The patient received 3rd dose earlier than the recommended time frame, which led to shortening of vaccine schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Patient received the 1st dose / on 29Apr2020 and is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 29th April 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. When asked consent for follow-up, the healthcare professional stated he would need to check with patient. The healthcare professional did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Dose 1 was received 02/07/2020 (15 mts ago) never got the 2nd shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th February 2020, 15 months ago from the reporting date).   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 pharmacist reported that the patient was late for 2nd dose and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter would like to confirm if it was ok to move forward. The VAERS details was reported for the 1st dose. The reporter consented to follow-up. No other details of the vaccine was available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose/ June 2018 / the second / his physician said there were no records of it; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in early June 2018).   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 told the reporter that he thought he might had receive the 2nd dose but his physician said there were no records of it. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up. No more information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave the second dose of Shingrix vaccine a month early (28 days after the first dose of Shingrix); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 95JR5, expiry date 5th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine a month early (28 days after the first dose of Shingrix), which led to shortening of vaccination schedule.  The reporter realized it was too early after giving the patient the Shingrix vaccine. No other information was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient's 1st dose was two years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was received 2 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 provided as follows: Age at vaccination was not applicable for this report. The pharmacist asked about delayed Shingrix 2nd dose.  The patient not received 2nd dose of Shigrix till the time of reporting still 2 year after 1st dose, which led to incomplete course of vaccination. The reporter asked if series should be continued or restarted. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3 years ago/never received his second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix 3 years ago from the time 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 provided as follows: The age at vaccination was not applicable for this report. The reporter informed that, the patient received first dose of Shingrix and never received his second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 3 years ago from the time 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 provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix 3 years before and was unable to get second dose, which led to incomplete course of vaccination. No further events was reported. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: down to her hand and sore/ right arm is swollen; right arm  became painful/down to her hand and sore/; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included latex allergy.   On 12th May 2021, the patient received Boostrix. On 20th May 2021, 8 days after receiving Boostrix, the patient experienced extensive swelling of vaccinated limb and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and pain in arm to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix in right arm. The patient's right arm became painful, swollen up all the way down to her hand and sore, but not redness. The patient was still experiencing them and will visit her physician on 26th May 2021. The reporter consented to follow up.  No further clarifications made.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of diluent portion only of Rotarix to a patient.; administration of diluent portion only of Rotarix to a patient.; 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 female patient who received Rota (Rotarix lyophilized formulation) (batch number 952C7, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 24th May 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 24th May 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   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 was administered only diluent portion only of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine. The reported batch number 95F2C7 was not found in sales data sheet, hence was updated to 952C7. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 2018 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got the 1st dose on an unknown date in 2018).   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: Age at vaccination was not applicable for this report. The pharmacist reported that, the patient had not received the 2nd dose yet still 2 years after 1st dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a 57-year-old male (ethnicity and race unspecified) The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total administered on 08-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. On 05-MAY-2021, patient took a clinical laboratory test where it turned up negative antibodies (suspected immunological vaccination failure). On 05-MAY-2021, Laboratory data included: Antibody test (NR: not provided) as negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210536462-covid-19 vaccine ad26.cov2.s-suspected immunological 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
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: FLU LIKE SYMPTOMS; NOT FEELING GOOD; This spontaneous report received from a health care professional concerned a female 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced not feeling good. On 19-MAY-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine  was not applicable. The outcome of the flu like symptoms and not feeling good was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; This spontaneous report received from a patient concerned a 31 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  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body aches. On 17-MAY-2021, the subject experienced shortness of breath. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches on 16-MAY-2021, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: UNKNOWING ADMINISTRATION OF JNJ COVID-19 VACCINE FOLLOWING ONE DOSE OF MODERNA COVID-19 VACCINE DOSE; This spontaneous report received from a pharmacist concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient experienced rash when treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 205A21A,expiry: 23/JUN/2021) dose was not reported, administered on 19-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced unknowing administration of JNJ covid-19 vaccine following one dose of moderna covid-19 vaccine dose. The action taken with covid-19 vaccine  was not applicable. The outcome of unknowing administration of JNJ covid-19 vaccine following one dose of moderna covid-19 vaccine dose was not reported. This report was non-serious.