chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cellulitis; Pain; oxygen saturation decreased; Headache; Chills; Pyrexia; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery in July 2020. Concurrent medical conditions included Type 2 diabetes mellitus, High cholesterol and Hypertension. Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), LOSARTAN, METOPROLOL, VITAMIN D NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia). 10-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen saturation decreased). At the time of the report, CELLULITIS (Cellulitis), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and OXYGEN SATURATION DECREASED (oxygen saturation decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray: clear (Inconclusive) Clear. On 10-Feb-2021, Oxygen saturation: 92% (Low) 92%. On 10-Feb-2021, Pyrexia: 102 degrees (High) 102 degrees. On 10-Feb-2021, SARS-CoV-2 test: no results (Inconclusive) no results and inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was injected on 08-Feb-2021. He began getting headache the afternoon of the 10-Feb-2021 and developed sever night chills by 11.30 pm the night of the 10-Feb-2021, along with fever of 102 degrees, body aches and pain.  He experienced low O2 saturation at 92%. Though possibly unrelated the patient developed cellulitis at incision on left knee which was being treated with unspecified antibiotics. The patient was directed to and seen by urgent care facility. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Memory impairment, Mental impairment, Pain in extremity
Clinical narrative: Mental impairment; Memory impairment; Vision blurred; Pain in extremity; Fatigue; Pyrexia; This case was received via  FDA VAERS (Reference number: 1162631) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MENTAL IMPAIRMENT (Mental impairment) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MENTAL IMPAIRMENT (Mental impairment) (seriousness criterion medically significant), MEMORY IMPAIRMENT (Memory impairment), VISION BLURRED (Vision blurred), PAIN IN EXTREMITY (Pain in extremity), FATIGUE (Fatigue) and PYREXIA (Pyrexia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MENTAL IMPAIRMENT (Mental impairment), MEMORY IMPAIRMENT (Memory impairment), VISION BLURRED (Vision blurred), PAIN IN EXTREMITY (Pain in extremity) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Pyrexia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101.5 (High) fever for 48 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient developed 101.5 fever for 48 hours, third day after the vaccination and patient still experience sore arm, tiredness, weakness, inability to focus, forgetfulness, blurred vision, Exhaustion.   patient took cold showers, and iced her arm  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Mental impairment; Memory impairment; Vision blurred; Pain in extremity; Fatigue; Pyrexia; This case was received via  FDA VAERS (Reference number: 1162631) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MENTAL IMPAIRMENT (Mental impairment) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MENTAL IMPAIRMENT (Mental impairment) (seriousness criterion medically significant), MEMORY IMPAIRMENT (Memory impairment), VISION BLURRED (Vision blurred), PAIN IN EXTREMITY (Pain in extremity), FATIGUE (Fatigue) and PYREXIA (Pyrexia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MENTAL IMPAIRMENT (Mental impairment), MEMORY IMPAIRMENT (Memory impairment), VISION BLURRED (Vision blurred), PAIN IN EXTREMITY (Pain in extremity) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Pyrexia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101.5 (High) fever for 48 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient developed 101.5 fever for 48 hours, third day after the vaccination and patient still experience sore arm, tiredness, weakness, inability to focus, forgetfulness, blurred vision, Exhaustion.   patient took cold showers, and iced her arm  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: was fully vaccinated for herpes zoster in 2020/ suspected vaccination failure; herpes zoster; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included herpes zoster (had in the past, timed frame unknown). Concurrent medical conditions included eosinophilic asthma. Concomitant products included mepolizumab.   In 2020, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine and an unknown time after starting mepolizumab, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient was fully vaccinated for herpes zoster in 2020 and about 3 weeks prior to the report, the patient was presented to the emergency department and diagnosed with herpes zoster. The patient was on Mepolizumab 100 mg SQ every 4 weeks for severe eosinophilic asthma) when recently diagnosed in emergency department. The health care professional had not yet decided if Mepolizumab would be continued. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: First shot Sept 2018 / did not receive the 2nd shingles shot / never got shot #2; Recently got shingles / About 2.5 weeks ago she got a / light case of shingles; About 2.5 weeks ago she got a rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In September 2018, the patient received the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had first dose of shingles and due to confusion between the second shot for shingles and the second shot of the pneumonia vaccine, never received the second shingles vaccine, which led to incomplete course of vaccination. The patient recently experienced Shingles and asked if now he/she could receive 2nd dose of Shingles vaccine. The patient consented to follow up.  Follow up information received from consumer on 28th May 2021: The patient's demographic details were updated. The patient's family had history of Shingles where her mother and sister both had shingles. The patient stated that, she had first dose of Shingrix in 2018 and never received second dose. The patient reported about 2.5 weeks ago of reporting, she had rash which ended up being a light case of shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Got the first shingles vaccine / got a horrible case of shingles; shingles pain / Drives me crazy sometimes; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In December 2018, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows : The age at vaccination was not reported. The patient received the first shingles vaccine and still got a horrible case of shingles in December 2018. At the time of reporting, the patient still dealing with shingles pain. The patient stated it drives the patient crazy sometimes and the patient was taking medications for it. No further information was reported.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Incorrect dose administered, Injection site erythema, Injection site induration
Clinical narrative: Some of the newly trained staff is giving one vial (adjuvant) instead of reconstituting; Still feel a small bump at injection site; Injection site red; Injection heated; Felling tired; Had the chills; Feeling soreness at injection site; Some of the newly trained staff is giving one vial (adjuvant) instead of reconstituting; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, chills and inappropriate reconstitution technique. On 2nd June 2021, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the patient experienced incorrect dose administered. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, tiredness, chills and incorrect dose administered were unknown and the outcome of the injection site induration and inappropriate reconstitution technique were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, tiredness, chills and injection site induration to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient stated that she went to the pharmacy and was told to make sure she gets 2 vials of Shingrix. Pharmacist told patient that some of the newly tarinned staff was giving one vial (adjuvant) instead of reconstituting.  Inquired if Shingrix dose equal to two vials. Also inquired if Shingrix needs to be 2 doses only or if she may need another dose in the future. Patient was concerned but with further questioning, she feels she did get both because she saw the pharmacy reconstituting two vials with different colored caps. She will clarify with pharmacy and call GSK back if needed.  Patient received first dose of shingrix on 01-JUN-2021 in right arm. On same day patient experienced injection site pain, tired, chills. The next day patient experienced a small bump at injection site bump. Reffered her to HCP. Consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120502:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Product preparation issue
Clinical narrative: Some of the newly trained staff is giving one vial (adjuvant) instead of reconstituting; Still feel a small bump at injection site; Injection site red; Injection heated; Felling tired; Had the chills; Feeling soreness at injection site; Some of the newly trained staff is giving one vial (adjuvant) instead of reconstituting; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7GA9, expiry date 11th November 2022) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, chills and inappropriate reconstitution technique. On 2nd June 2021, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the patient experienced incorrect dose administered. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, tiredness, chills and incorrect dose administered were unknown and the outcome of the injection site induration and inappropriate reconstitution technique were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, tiredness, chills and injection site induration to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient. The patient stated that she went to the pharmacy and was told to make sure she gets 2 vials of Shingrix. Pharmacist told patient that some of the newly tarinned staff was giving one vial (adjuvant) instead of reconstituting.  Inquired if Shingrix dose equal to two vials. Also inquired if Shingrix needs to be 2 doses only or if she may need another dose in the future. Patient was concerned but with further questioning, she feels she did get both because she saw the pharmacy reconstituting two vials with different colored caps. She will clarify with pharmacy and call GSK back if needed.  Patient received first dose of shingrix on 01-JUN-2021 in right arm. On same day patient experienced injection site pain, tired, chills. The next day patient experienced a small bump at injection site bump. Reffered her to HCP. Consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120502:Same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19 immunisation, Dyspnoea, Illness, Throat tightness, Wheezing
Clinical narrative: Got very sick after getting the second dose of Shingrix shot; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included influenza, pleurisy, bronchitis and continuous positive airway pressure (Family History) (patient's nephew useed it for unknown breathing condition). Previously administered products included Shingrix (received 1st dose on 28th September 2020) and Fluzone (received on 29th September 2020). Concurrent medical conditions included sciatica. Concomitant products included MMR (MMR vaccine), paracetamol (Tylenol) and vitamins nos (Vitamins).   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and an unknown time after receiving MMR vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient stated that she had taken Tylenol for the last 5 days (pills at night) and she normally tried not to take this conmed. The patient stated that she got very sick after receiving 2nd dose of shingrix vaccine and she did not have any other adverse events with other vaccines. On 1st March 2021 in morning at 10.30 am, the patient got first dose of Pfizer-Biontech COVID 19 vaccine in left deltoid. The patient was not sure whether Lot number was ENV200 or EN6200 as written on the CDC vaccine record. The patient was fine on the day of vaccination but on next day at around 19 pm, the patient chewing up peanuts and did not know but suddenly she could not breathe and was wheezing for air like her throat was closed off. This happened like 10 times and further 10 breath that she could not get air. The patient knew that there can be air trouble, breathing trouble with COVID, but wanted to ask if this could be a side effect of the Pfizer Biontech vaccine. No other information was reported.
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product label confusion
Clinical narrative: Boostrix and Engerix-B have very similar shades of green / could lead to confusing the products; This case was reported by a pharmacist via call center representative and described the occurrence of product label confusion in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced product label confusion. On an unknown date, the outcome of the product label confusion 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 reported. Pharmacist reported that Boostrix and Engerix-B have very similar shades of green, it led to confusing the products, which led to product label confusion. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If it has been 7 months since 1st dose of shingles vaccine can you get the 2nd dose?; This case was reported by a consumer via (Shingrix GSK Chatbot ) 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 7 months ago).   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. The patient received 1st dose 7 months ago and till the time of reporting patient did not receive 2nd dose which led to incomplete course of vaccination. No further information was reported. Follow up was not possible as no contact details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Nausea, Pyrexia, Vomiting
Clinical narrative: Bloody diarrhea; Nausea with vomiting; Nausea with vomiting; Abdominal cramps; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of bloody diarrhea in a male patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   On 6th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2021, less than a day after receiving Shingrix, the patient experienced bloody diarrhea (serious criteria GSK medically significant), nausea, vomiting, abdominal cramp and fever. On an unknown date, the outcome of the bloody diarrhea, nausea, vomiting, abdominal cramp and fever were not recovered/not resolved.   It was unknown if the reporter considered the bloody diarrhea, nausea, vomiting, abdominal cramp and fever to be related to Shingrix.  Additional details were provided as follows: Health care professional called on behalf of patient.  A day before reporting, the patient received 1st dose of Shingrix and on the day of reporting, the side effects experienced were nausea with vomiting, abdominal cramps, fever and bloody diarrhea. Symptoms were started within 24 hours of receiving the vaccine and were not resolved. No patient identifiers were provided for the patient. Call transferred to Medical Information for follow up. Instructed to have patients follow up with their Health care professional. The reporter did not consent to follow-up. This case had been linked with the case US2021122619 (patient's wife), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122619:Same reporter. Wife's case.
Sex: F
Vaccine: HEP
Symptoms: Product preparation issue
Clinical narrative: Administered a pediatric dose of 0.5 ml split from a adult Engerix formulation syringe; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 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.   On 10th May 2021, the patient received Engerix B adult .5 ml and Engerix B Pre-Filled Syringe Device. On 10th May 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. 2 pediatric patients were administered with a pediatric dose of 0.5 ml split from an adult Engerix formulation syringe. One patient was administered the dose on 10th May 2021 and for the other patient details unknown. This led to inappropriate reconstitution technique . Pharmacist unable to provide details on vaccine and patient. Did not consent to follow-up. This case was linked with US2021AMR123242, for same reporter; Sender's Comments:  IT-GLAXOSMITHKLINE-IT2021112529:Deleted US-GLAXOSMITHKLINE-US2021AMR123242:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product preparation issue
Clinical narrative: Administered a pediatric dose of 0.5 ml split from a adult Engerix formulation syringe; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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.   On 10th May 2021, the patient received Engerix B adult .5 ml 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 inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication 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 reported. The pediatric  patient was administered a pediatric dose of 0.5 ml split from an adult Engerix formulation syringe which led to inappropriate preparation of medication. Patient other details were unknown. The reporter consented to follow up. This case has been linked with the case US2021AMR123238 by same reporter.; Sender's Comments:  IT-GLAXOSMITHKLINE-IT2021112533:Deleted US-GLAXOSMITHKLINE-US2021AMR123238:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product packaging confusion
Clinical narrative: Increase / number of mix ups of Adult / and peds / hep B since you changed the look of your boxes; This case was reported by a pharmacist via call center representative and described the occurrence of product packaging confusion in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced product packaging confusion. On an unknown date, the outcome of the product packaging confusion was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, they have notice an increase in the number of mix ups of adult (20mcg) and pediatrics (10mcg) Hepatitis  B since the look of the boxes were changed, which led to product packaging confusion. The pharmacist inquired that if anyone else had reported this or if they would consider different packaging. The information was received via webform. No other information was provided. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: overdue to get her 2nd dose because she had her Covid vaccine/she still has not received the 2nd dose.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th September 2020), COVID 19 vaccine (received 1st dose in January 2021) and COVID 19 vaccine (received 2nd dose in 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. The patient was treated with hydrocortisone (Cortisol). 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 patient received first dose of Shingrix and was overdue to get her second dose because she had her Covid vaccine on January and February of 2021  The Health Care Professional recommended not to get the Shingrix vaccine. The patient reported she got a cortisol shot on March 2021. Till the time of reporting, the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient did not get her 2nd dose of Shingrix vaccine because she wanted to make sure it was safe to get the 2nd dose after the Cortisol injection on March 2021. Medical disclaimer was provided and patient was recommended to consult with health care professional that immunosuppressive therapies may reduce the effectiveness of Shingrix. Not all information is available, lot and expiration date of 1st shot was unknown.
Sex: U
Vaccine: RV1
Symptoms: Medication error, Product preparation issue
Clinical narrative: Have one Rotarix vial with one lot number and a Rotarix syringe with a different lot number; Have one Rotarix vial with one lot number and a Rotarix syringe with a different lot number; This case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Rota (Rotarix lyophilized formulation) (batch number ME43A, expiry date 29th August 2021) and (batch number 77YS5, expiry date 29th April 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced circumstance or information capable of leading to medication error and inappropriate reconstitution technique. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and inappropriate reconstitution technique were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked, could they use Rotarix with two different lot numbers. The reporter stated, they had one Rotarix vial with one lot number and a Rotarix syringe with a different lot number only available which led to inappropriate reconstitution technique and would led to circumstance or information capable of leading to medication error. The reporter did not consent to followup.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: patient had some of the Shingrix vaccine leaked out due to a faulty needle; Inadvertent exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose 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 accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The pharmacist reported that some of the Shingrix vaccine leak due to faulty needle and patient exposed to vaccine, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact.  The reporter was distress and requested agent to provide medical information.  The patient's information, vaccination details or any other details was not collected.  No other information was provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Tinnitus, Vertigo
Clinical narrative: noisy ear; started feeling dizzy; had a five-hour vertigo attack/Since that date she has had seven more vertigo attacks; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meniere's disease (had been inactive for 18 months).   On 12th May 2021 15:14, the patient received the 1st dose of Shingrix (intramuscular). In May 2021, 17 hrs 46 min after receiving Shingrix, the patient experienced dizziness and vertigo. On an unknown date, the patient experienced ear noises. On 13th May 2021, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the dizziness and ear noises were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, vertigo and ear noises to be related to Shingrix.  Additional details were provided as follows:  The case was reported by the patient herself. The patient received the 1st dose of Shingrix at 03:14 PM into the right deltoid.  The next morning on 13th May 2021 at 09:00 AM, the patient started feeling dizzy.  On 13th May 2021 at 06:00 PM, 1 day 2 hours 46 minutes after receiving Shingrix, the patient had a five-hour vertigo attack.  Since then the patient had seven more vertigo attacks and experienced noisy ear and still felt dizzy at the time of reporting. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Infanrix/  given on 03Jun2021/ expired/ on 30May2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-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 3rd June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd June 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:  The patient received the Infanrix vaccine which was expired 4 days prior to the date of vaccination, which led to expired vaccine used.  The reporter declined follow up but did provide the vaccination and patient details.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; developed Shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and 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 and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the In 2019, the patient received both the doses of Shingrix vaccine and the patient now developed Shingles although it was painless. The reporter consented to follow up. No further details provided via web form. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was not reported.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Rash, Varicella
Clinical narrative: chicken pox; rash; pain; nerve pain; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included neuropathy.   On 14th September 2020, the patient received Shingrix. On an unknown date, 4 weeks after receiving Shingrix, the patient experienced chickenpox, rash, pain and nerve pain. The patient was treated with pregabalin and gabapentin. On an unknown date, the outcome of the chickenpox and rash were recovered/resolved and the outcome of the pain and nerve pain were not recovered/not resolved.   The reporter considered the chickenpox, rash, pain and nerve pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported receiving the SHINGRIX vaccine and approximately 4 weeks later got chicken pox and a rash.  Also, stated that about 5 weeks after the vaccination his rash went away.   The patient stated that he had neuropathy in the past and now he had pain and nerve pain that will not go away.   The patient stated he tried taking Pregabalin and Gabapentin but it did not help. The patient consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a vial of powder was left on its own / patient had been given the partial dose; a vial of powder was left on its own / patient had been given the partial dose; 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) (batch number AMVA396A, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 are as follows: The age at vaccination was not applicable for this report. The patient received partial dose of Menevo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. After administering 5 doses of Menveo, the reporter observed that a vial of powder was left on its own. At time of the call, the reporter did not know which patient had been given the partial dose, consequently no patient or vaccine information was specified. The reporter would investigate which patient was given the partial dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didn´t received / second dose / first dose was given 8 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 8 month 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 follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Constipation, Feeling cold, Hypoaesthesia, Memory impairment
Clinical narrative: Numbness around his head that feels like he has a swimming cap on; Caller's thinking / is worse; Caller's / memory is worse; Feels cold; Insane" anxiety; "Insane" anxiety and stress over these adverse events which has not resolved; Has a stiff neck; Had a little bit of a fever; Then was constipated; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number MB7RR, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for fever.   The patient's past medical history included shingles (had severe shingles 5 years ago on the side of the face). Previously administered products included Pfizer covid 19 (received 1st dose before first Shingrix Dose) and Shingles shot (completed shingles shot with agent that was available before Shingrix). Concomitant products included TOZINAMERAN (PFIZER COVID-19 VACCINE (BNT162B2)).   On 27th April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Tylenol at an unknown dose and frequency. On 27th April 2021, less than a day after receiving Shingrix, the patient experienced fever, constipation, abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck. On 29th April 2021, the patient experienced numbness of head. The action taken with Tylenol was unknown. On 29th April 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the constipation was unknown and the outcome of the numbness of head was recovering/resolving and the outcome of the abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck were not recovered/not resolved.   It was unknown if the reporter considered the fever, constipation, numbness of head, abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient had 2 Pfizer COVID 19 doses, last was 1.5 month before Shingrix dose. The patient received Shingrix in left arm. The patient developed a little bit of a fever and took Tylenol then was constipated. After couple days, the patient developed numbness around his head that feels like he had swimming cap on. The patient's thinking and memory was worse and felt cold. After first injection, he had insane anxiety and stress over these adverse events which had not resolved and stiff neck also. The reporter did not consented to follow up. It was unknown if the reporter considered the fever, constipation, numbness of head, abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck to be related to Tylenol.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pyrexia, Stress, Thinking abnormal
Clinical narrative: Numbness around his head that feels like he has a swimming cap on; Caller's thinking / is worse; Caller's / memory is worse; Feels cold; Insane" anxiety; "Insane" anxiety and stress over these adverse events which has not resolved; Has a stiff neck; Had a little bit of a fever; Then was constipated; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number MB7RR, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for fever.   The patient's past medical history included shingles (had severe shingles 5 years ago on the side of the face). Previously administered products included Pfizer covid 19 (received 1st dose before first Shingrix Dose) and Shingles shot (completed shingles shot with agent that was available before Shingrix). Concomitant products included TOZINAMERAN (PFIZER COVID-19 VACCINE (BNT162B2)).   On 27th April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Tylenol at an unknown dose and frequency. On 27th April 2021, less than a day after receiving Shingrix, the patient experienced fever, constipation, abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck. On 29th April 2021, the patient experienced numbness of head. The action taken with Tylenol was unknown. On 29th April 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the constipation was unknown and the outcome of the numbness of head was recovering/resolving and the outcome of the abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck were not recovered/not resolved.   It was unknown if the reporter considered the fever, constipation, numbness of head, abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient had 2 Pfizer COVID 19 doses, last was 1.5 month before Shingrix dose. The patient received Shingrix in left arm. The patient developed a little bit of a fever and took Tylenol then was constipated. After couple days, the patient developed numbness around his head that feels like he had swimming cap on. The patient's thinking and memory was worse and felt cold. After first injection, he had insane anxiety and stress over these adverse events which had not resolved and stiff neck also. The reporter did not consented to follow up. It was unknown if the reporter considered the fever, constipation, numbness of head, abnormal thinking, memory disturbance, feeling cold, anxiety, stress and stiff neck to be related to Tylenol.