chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Pain at the injection site; Myalgia; Shivering; Fever; Upset stomach; Fatigue; 1st dose in 2019, 2nd dose on 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 as 0.5 mg/ml dose in unknown deltoid via intramuscular route).   On 25-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 25-APR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site), myalgia (Verbatim: Myalgia), shivering (Verbatim: Shivering), fever (Verbatim: Fever), upset stomach (Verbatim: Upset stomach), fatigue (Verbatim: Fatigue) and drug dose administration interval too long (Verbatim: 1st dose in 2019, 2nd dose on 2023). The outcome of the injection site pain, myalgia, shivering, fever, upset stomach and fatigue were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, myalgia, shivering, fever, upset stomach and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, myalgia, shivering, fever, upset stomach and fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 26-APR-2023 This case was reported by patient's wife. The patient's wife reported that her husband received his first Shingrix vaccine four years ago.  The patient received his second Shingrix vaccine one day before reporting and started symptoms last night which included pain at the injection site, myalgia, shivering, fever, upset stomach, and fatigue. The reporter stated that symptoms had not resolved this morning. The reporter was not willing to share mailing address, but did gave email. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pain at the injection site; Myalgia; Shivering; Fever; Upset stomach; Fatigue; 1st dose in 2019, 2nd dose on 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 as 0.5 mg/ml dose in unknown deltoid via intramuscular route).   On 25-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 25-APR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site), myalgia (Verbatim: Myalgia), shivering (Verbatim: Shivering), fever (Verbatim: Fever), upset stomach (Verbatim: Upset stomach), fatigue (Verbatim: Fatigue) and drug dose administration interval too long (Verbatim: 1st dose in 2019, 2nd dose on 2023). The outcome of the injection site pain, myalgia, shivering, fever, upset stomach and fatigue were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, myalgia, shivering, fever, upset stomach and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, myalgia, shivering, fever, upset stomach and fatigue to be related to Shingrix.   Additional Information: GSK Receipt date: 26-APR-2023 This case was reported by patient's wife. The patient's wife reported that her husband received his first Shingrix vaccine four years ago.  The patient received his second Shingrix vaccine one day before reporting and started symptoms last night which included pain at the injection site, myalgia, shivering, fever, upset stomach, and fatigue. The reporter stated that symptoms had not resolved this morning. The reporter was not willing to share mailing address, but did gave email. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Nov 1 2022, 2nd dose Jan 18th 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 39-year-old male patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 18-JAN-2023, the patient received the 2nd dose of Engerix B. On 18-JAN-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Nov 1 2022, 2nd dose Jan 18th 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter reported that a patient received a 2nd dose of Engerix-B later than the recommended interval. No 3rd dose given till the time of reporting. The reporter consented to follow up.  The patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness of arm; swelling of arm; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 min after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: redness of arm) and swelling arm (Verbatim: swelling of arm). The outcome of the erythema of extremities and swelling arm were resolved (duration 5 days).   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was a GlaxoSmithKline representative who was reporting on behalf of an HCP (doctor). He reported that the patient experienced swelling and redness of the arm right above the elbow for 4 to 5 days.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose: 2019; 2nd dose: 26-APR-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix sometime in 2019).   On 26-APR-2023, the patient received the 2nd dose of Shingrix. On 26-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: 2019; 2nd dose: 26-APR-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 26-APR-2023 The patient was over 50 years. The patient received the first dose at the patient's doctor's office. The pharmacist did not had the patient's date of birth and date details regarding first dose. The pharmacist did not had lot or expiry date of the second dose as the vial had been thrown away. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Dilutent injected without mixing; Dilutent injected without mixing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   On 26-APR-2023, the patient received the 1st dose of Shingrix. On 26-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Dilutent injected without mixing) and inappropriate dose of vaccine administered (Verbatim: Dilutent injected without mixing). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 26-APR-2023 The registered pharmacist asked what was the recommendation if only the Shingrix diluent was injected without being mixed with the powder. The reporter confirmed that only the Shingrix adjuvant was administered to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received only Shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 YO receive Kinrix; the patient was supposed to receive Tdap not Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.  Previously administered products included DTaP and IPV (caught up with their DTaP and IPV series prior to receiving Kinrix).  On 25-APR-2023, the patient received Kinrix. On 25-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 YO receive Kinrix) and wrong vaccine administered (Verbatim: the patient was supposed to receive Tdap not Kinrix). The outcome of the inappropriate age at vaccine administration and wrong 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 Information: GSK Receipt Date: 26-APR-2023 and 27-APR-2023 A healthcare professional called to inform that, a patient accidentally received a dose of Kinrix. Upon callback to Healthcare Professional (HCP) to review the medical information, it was determined that the patient was supposed to receive Tdap not Kinrix. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. The 11 year old patient was given Kinrix instead of Tdap vaccine which had led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given days before 6 months; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given days before 6 months). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The nurse called in to ask for the definition of 6 months between doses of Havrix. After reviewing recommendations for calculating intervals between doses the healthcare professional realized that the second dose of Havrix was administered a few days before the minimum 6 months interval described in the Product information.  The reporter asked if the dose given was counted as valid. The reporter mentioned that several patients were involved in this situation. However, the reporter did not provided patients information nor data about the vaccine administered (Lot number, expiry date, date of administration).  The reporter consented to follow up. The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Ringing in ears, like a buzzing sound; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   On 21-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 23-APR-2023, 2 days after receiving Shingrix, the patient experienced ringing in ears (Verbatim: Ringing in ears, like a buzzing sound). The outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.     It was unknown if the company considered the ringing in ears to be related to Shingrix.   Additional Information: GSK receipt date: 27-Apr-2023 The reporter was a pharmacist calling on behalf of a patient. The patient received his 1st dose of Shingrix last Friday from reporting and reported that the patient came to the pharmacy yesterday, on 26-APR-2023 complaining that he started ringing in his ears like a buzzing sound on Sunday, 23-APR-2023.  The ringing had not stopped till the time of reporting, when reporter last spoke to the patient. Consent to follow up with healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3 Shingrix doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 429MK, expiry date 28-MAY-2024) for prophylaxis.   On 21-FEB-2023, the patient received the 3rd dose of Shingrix. On 21-FEB-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received 3 Shingrix doses). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 27-APR-2023 The reporter wanted to know that what should patient watch for if given three doses of Shigrix and not two.  The reporter did consent to follow up. The vaccine administration facility was same as primary reporter. The reporter also confirmed that the patient received 3rd dose of Shingrix. The reporter had only the gender information as the vaccine was administered at another facility. The reporter did consent to follow up via email. The patient received extra dose of Shigrix in error, which led to extra dose administered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Hypotension
Clinical narrative: Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------ I95.9 HYPOTENSION 7/30/2021 HYPOTENSION J96.00 ACUTE RESPIRATORY FAILURE 8/12/2021 HYPOTENSION I95.9 HYPOTENSION 7/30/2021 WEAKNESS J96.00 ACUTE RESPIRATORY FAILURE 8/12/2021 WEAKNESS
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebral artery occlusion, Cerebrovascular accident, Hypotension, Ischaemia
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  HYPOTENSION 12/23/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 UTI (URINARY TRACT INFECTION)  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 UTI (URINARY TRACT INFECTION)  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 UTI (URINARY TRACT INFECTION)  HYPOTENSION 12/23/2021 UTI (URINARY TRACT INFECTION)  ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  HYPOTENSION 12/23/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  HYPOTENSION 12/23/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Lacunar stroke, Urinary tract infection
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  HYPOTENSION 12/23/2021 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY  ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 UTI (URINARY TRACT INFECTION)  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 UTI (URINARY TRACT INFECTION)  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 UTI (URINARY TRACT INFECTION)  HYPOTENSION 12/23/2021 UTI (URINARY TRACT INFECTION)  ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  HYPOTENSION 12/23/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 5/3/2021 ATRIAL FIBRILLATION, UNSPECIFIED  HYPOTENSION 12/23/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administered after BUD
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administered after BUD.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2013, 2nd MArch 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.  Previously administered products included Twinrix (1st dose was received as Twinrix pre-filled syringe in 2013).  In MAR-2023, the patient received the 2nd dose of Twinrix. In MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 2013, 2nd MArch 2023). The outcome of the drug dose administration interval too long 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 Information: GSK Receipt Date: 27-APR-2023 Pharmacist reported that, a patient had received their first dose of Twinrix in 2013 and their second dose in March of 2023. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up via mail. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast conserving surgery, Intraductal proliferative breast lesion, Mammogram abnormal, Radiotherapy
Clinical narrative: I went in for my annual mammogram on 10/24/2022. I was called back for additional imaging on 10/28/2022. An area of abnormal cells was detected in the right breast. I underwent a biopsy on 10/31/2022. I was then diagnosed with ductal carcinoma in situ at stage 0. On 11/18/2022, I underwent a lumpectomy of the right breast. From 1/12/2023 through 2/8/2023, I underwent 20 sessions of radiation treatment. As of 4/3/2023, I am now on a course of tamoxifen.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms Administered after BUD
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptoms or signs. administered after BUD
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administered after BUD
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered after BUD No symptoms
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered after BUD. No symptoms
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: ADMINISTERED AFTER BUD NO SYMPTOMS
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Mesenteric vein thrombosis
Clinical narrative: Patient developed mesenteric venous thrombosis involving superior mesenteric vein and inferior mesenteric vein
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Mesenteric vein thrombosis
Clinical narrative: Superior mesenteric venous thrombosis and inferior mesenteric venous thrombosis.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal distension, Abdominal pain, Computerised tomogram abdomen abnormal, Diverticulitis, Gastrointestinal injury
Clinical narrative: On 02/14/2023, I noticed I had bloating and pain on my left side of my abdomen. About 2 or 3 days it was not going away so I went to the urgent care, and they sent me to emergency room to make sure I did not need surgery. On 02/16/2023, they did a CAT scan exam, there was a micro abrasion in the intestine.  They admitted me to the hospital from 02/16/2023 to 02/18/2023 and I was put on an IV and was given antibiotics. Then I was determined that I had diverticulitis. The treatment was to continue the antibiotic in a pill form, and I was put on a low fiber diet at first. Within a week or two, I had to go on a high fiber diet.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Medical diet
Clinical narrative: On 02/14/2023, I noticed I had bloating and pain on my left side of my abdomen. About 2 or 3 days it was not going away so I went to the urgent care, and they sent me to emergency room to make sure I did not need surgery. On 02/16/2023, they did a CAT scan exam, there was a micro abrasion in the intestine.  They admitted me to the hospital from 02/16/2023 to 02/18/2023 and I was put on an IV and was given antibiotics. Then I was determined that I had diverticulitis. The treatment was to continue the antibiotic in a pill form, and I was put on a low fiber diet at first. Within a week or two, I had to go on a high fiber diet.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 14th September 2022 with lot number 299J9 and expiry date 01st July 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Apr-2023 The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (expiry date 31-JUL-2022) for prophylaxis.   On 25-APR-2023, the patient received Engerix B. On 25-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-APR-2023 As per reporter lot number was not available.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up for safety team. The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 31Aug2022, 2nd never; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 31st August 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 31Aug2022, 2nd never). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-APR-2023 The reporter stated he never followed up to get his second dose. He planned to get his second dose as soon as possible. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-May-2023 Pharmacist reported on 1st May 2023 that patient received the first dose of Shingrix in October 2021 and the 2nd dose had not been administered yet. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 9/12/2018, missed 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 12-SEP-2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 9/12/2018, missed 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-May-2023 The reporter was the pharmacist who stated that the patient received first dose of Shingrix on 12th September 2018 and missed second dose.  No other information provided. The reporter consented to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number ZA3H9, expiry date 30-JUN-2023) for prophylaxis.   On 11-APR-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 01-MAY-2023 The medical assistant reported that a patient received a Flulaval QIV that was exposed to a below temperature excursion of negative 40 degree Fahrenheit.  The healthcare professional (HCP) provided adverse event (AE) details but did not reported which season of the vaccine was. The reporter consented to follow up. The patient received a Flulaval QIV that was exposed to a below temperature excursion of negative 40 degree F, which led to incorrect storage of drug.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Got Kinrix instead of Daptacel; Kinrix was dose #4 of DTaP and IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 01-MAY-2023, the patient received Kinrix. On 01-MAY-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Got Kinrix instead of Daptacel) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was dose #4 of DTaP and IPV). The outcome of the wrong vaccine administered and inappropriate schedule 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 Information: GSK receipt date: 01-MAY-2023 The medical assistant reported that a patient received a dose of Kinrix instead of Daptacel inadvertently.  This was dose 4 of DTaP and IPV.  The reporter consented to follow up via email. The patient received Kinrix (4th dose)  instead of Daptacel, which led to wrong vaccine administered and inappropriate schedule of vaccine administered.
Age: 2.17
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given Quadracel and she is 2yo. Patient has not suffered any ill effects
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given a booster shot from a multi-dose vial that had been opened 26 hours ago (exceeding the 12 hour time frame from first puncture). Pt has no adverse s/sx at time of call.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Patient experienced arm pain the day after her vaccination. Two days later she had redness on her arm around the injection site. She said it was warm to the touch and hurt. Patient said the next day the redness got bigger and was still warm to the touch. It was around 5 inches in length. Patient went to doctor and they stated it was an infection and patient was prescribed antibiotics.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash pruritic
Clinical narrative: patient developed a itchy rash on the back of his hands which then spread to his legs and back
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site on left thigh is red, swollen and hot to the touch. Was advice to watch for now, apply cold towel compresses, give Tylenol as needed.  Call us back immediately if symptoms worsen or do not get better. Will schedule a doctor visit.
Sex: U
Vaccine: COVID19-2
Symptoms: Death, Pain, Pain in extremity
Clinical narrative: Patients husband called Monday morning. The couple got the vaccine together on Thursday and were experiencing sore arms and legs. His wife woke up late Sunday night in pain. The husband called 911 and he stated that she passed away within a matter of 5 minutes.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PATIENT REPORTED EXPERIENCING TINNITUS ("HUMMING IN THE EARS") FOR BOTH EARS. WENT TO SEE HE ENT MD AND WAS INFORMED THAT PATIENT MIGHT BE EXPERIENCING THIS AS A SIDE EFFECT OF COVID VACCINES. PT RECEIVED LAST PFIZER VACCINE ON 07/25/22. REPORTED TO HAVE STARTED EXPERIENCING TINNITUS AROUND 11/2022,  SAW THE HE ENT DOCTOR AROUND 12/2022. PATIENT CLAIMED SHE HAS NEVER EXPERIENCED THIS REACTION WITH ANY OF HER PREVIOUS COVID SHOTS.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Persistent left upper arm pain at site of injection for almost 2 months. Decreased ROM of left shoulder. Patient without fever, chills, erythema or edema at site of injection.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Scab
Clinical narrative: Patient came in the pharmacy today to report that she had soreness, bruising, and scabbing from her Shingrix vaccine that she received on 4/17/2023. She stated the reaction lasted about 1 week and the scabbing got better after applying moisturizer to the area.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 04/30/23
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: vasovagal syncope
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine on a date beyond the BUD. BUD was 12/21/2022, the vaccine date administered was 02/01/2023
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: No adverse reactions within a month of receiving the April 2022 booster. In addition, I did not have any adverse reaction to the original COVID-19 immunization, nor to any of the other booster vaccines.    On December 24, 2022, I began feeling bad with a low-grade fever (under 100 degrees F). I also had a sore throat. About 5:00PM, I used an at-home test I had available; that test showed positive for COVID.   On December 25, 2022, I went to an available outpatient clinic. I was seen by a Nurse-Practioner. She administered another COVID test, which also returned a positive result. She said I had very mild symptoms. Because of the mild symptoms plus the fact I was using Rosuvistatin, she said I was not a candidate for Paxlovid. I used over the counter medications and all of my symptoms were clear by 27DEC2022.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was given from a bottle that had been opened more than 12 hours.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, UNK, UNK, UNK
Symptoms: Biopsy bone marrow, Blood smear test, Blood test abnormal, Infusion, Neutrophil count decreased
Clinical narrative: Provider told me my platelet count was low and to stop donating platelets (July/2021) Annual Physical blood work showed platelets, WBC and neutraphils were below normal range (Dec /2021)  Referal to Hemotologist Hemotogist observed for 9 months. Blood work continued to be below normal range for platelets, WBC and neutraphils.  No treatments were administerd. Annual Physical blood work showed platelets, WBC and neutraphils still below normal range. 2nd hemotologist was referred. (11/2022) Under Dr. care, one iron infusion treatment (3/13/2023 &  3/16/2023).  Bone marrow biopsy for suspect pancytopenia (procedure done on 4/27/2023).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, UNK, UNK, UNK
Symptoms: Platelet count decreased, White blood cell count decreased
Clinical narrative: Provider told me my platelet count was low and to stop donating platelets (July/2021) Annual Physical blood work showed platelets, WBC and neutraphils were below normal range (Dec /2021)  Referal to Hemotologist Hemotogist observed for 9 months. Blood work continued to be below normal range for platelets, WBC and neutraphils.  No treatments were administerd. Annual Physical blood work showed platelets, WBC and neutraphils still below normal range. 2nd hemotologist was referred. (11/2022) Under Dr. care, one iron infusion treatment (3/13/2023 &  3/16/2023).  Bone marrow biopsy for suspect pancytopenia (procedure done on 4/27/2023).
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine after it's BUD from storage in the refrigerator.  BUD was 12/21/22, Given 12/29/22, called and alerted patient. patient is fine and appreciates reach out.. Does not want to pursue getting another booster.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Arthralgia, Disturbance in attention, Dizziness, Feeling hot, Headache
Clinical narrative: I felt extreme dizziness after getting Pfizer shot #1, I had to sit down at the pharmacy I got it at, because I had overheated after getting the shot. The next two days, managers were helping me, because I was starting to go blank and forget what I was saying or focusing on far more than usual. On June 30, after dose #2, I suddenly started feeling extreme weakness in the left arm, and the weakness traveled to my right arm. I was at work and sitting down on a comfy seat. I felt nerve pain shooting up the back of my arms, through my shoulder and head, up and down my legs, and my vision went blank, and I kept blinking so I could see again. Once I got home from work, I lost feeling in my hands for roughly 30 minutes.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Hypoaesthesia, Memory impairment, Muscular weakness, Neuralgia, Pain
Clinical narrative: I felt extreme dizziness after getting Pfizer shot #1, I had to sit down at the pharmacy I got it at, because I had overheated after getting the shot. The next two days, managers were helping me, because I was starting to go blank and forget what I was saying or focusing on far more than usual. On June 30, after dose #2, I suddenly started feeling extreme weakness in the left arm, and the weakness traveled to my right arm. I was at work and sitting down on a comfy seat. I felt nerve pain shooting up the back of my arms, through my shoulder and head, up and down my legs, and my vision went blank, and I kept blinking so I could see again. Once I got home from work, I lost feeling in my hands for roughly 30 minutes.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Pain in extremity, Visual impairment, X-ray
Clinical narrative: I felt extreme dizziness after getting Pfizer shot #1, I had to sit down at the pharmacy I got it at, because I had overheated after getting the shot. The next two days, managers were helping me, because I was starting to go blank and forget what I was saying or focusing on far more than usual. On June 30, after dose #2, I suddenly started feeling extreme weakness in the left arm, and the weakness traveled to my right arm. I was at work and sitting down on a comfy seat. I felt nerve pain shooting up the back of my arms, through my shoulder and head, up and down my legs, and my vision went blank, and I kept blinking so I could see again. Once I got home from work, I lost feeling in my hands for roughly 30 minutes.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Illness, Impaired work ability, Influenza virus test, Insomnia
Clinical narrative: I had a hard time sleeping, nose was running, so I stayed home from work. On the third day I woke up with an extremely sore throat, and I went to the doctor, and he tested me and told me that I had COVID.  He prescribed LAGEVRIO (MOLNUPIRAVIR) 200 MG. I started taking it and within 3-4 days felt much better. I still quarantined at home for 10 days after the onset of my illness.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a hard time sleeping, nose was running, so I stayed home from work. On the third day I woke up with an extremely sore throat, and I went to the doctor, and he tested me and told me that I had COVID.  He prescribed LAGEVRIO (MOLNUPIRAVIR) 200 MG. I started taking it and within 3-4 days felt much better. I still quarantined at home for 10 days after the onset of my illness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: tired, sore, aching, stiff legs
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: arm sorness
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Product administered at inappropriate site, Underdose
Clinical narrative: Incorrectly administered 0.1 ml of MMR vaccine IM on the Left Deltoid. Stopped immediately once known that wrong site was used.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site mass, Injection site rash, Pyrexia, Somnolence, Vomiting
Clinical narrative: FEVER VOMITTING, DROWSINESS FOR 2-3 DAYS, LOCALIZED RASH AND LUMPS (NOT HIVE LOOKING) AROUND BOTH INJECTED VACCINES ADMINISTERED ON LEFT ARM DELTOID FOR 2 - 3 DAYS
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache, Immediate post-injection reaction
Clinical narrative: Extreme pain while shot being administered from my shoulder to my finger tips, the same pain as the Flu vaccine. Immediately I felt dizzy after the shot was administered. After leaving the store, walking to the car, I started feeling short of breath and nauseous from being so dizzy. Since I had just had the Flu vaccine in December and the symptoms mimicked that my husband immediately drove me to the local Hospital. Enroute to the hospital I became itchy all over my neck, arms, and torso. I was immediately brought into a treatment area where the nurses started an IV and the doctor, Dr., came in the room and immediately advised to give me Benadryl and steroids via IV. After some time the itchiness/hives had subsided a little bit but I developed a headache. After being monitored by staff in the ER, I was later released with 3 prescriptions for:   Benadryl, steroids, and an epipen.  The arm pain continued for approximately two weeks after receiving the vaccine.  I followed up with my primary after the allergic reaction.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Extreme pain while shot being administered from my shoulder to my finger tips, the same pain as the Flu vaccine. Immediately I felt dizzy after the shot was administered. After leaving the store, walking to the car, I started feeling short of breath and nauseous from being so dizzy. Since I had just had the Flu vaccine in December and the symptoms mimicked that my husband immediately drove me to the local Hospital. Enroute to the hospital I became itchy all over my neck, arms, and torso. I was immediately brought into a treatment area where the nurses started an IV and the doctor, Dr., came in the room and immediately advised to give me Benadryl and steroids via IV. After some time the itchiness/hives had subsided a little bit but I developed a headache. After being monitored by staff in the ER, I was later released with 3 prescriptions for:   Benadryl, steroids, and an epipen.  The arm pain continued for approximately two weeks after receiving the vaccine.  I followed up with my primary after the allergic reaction.
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Rash
Clinical narrative: Broke out in rash on left arm
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Condition aggravated, Impaired gastric emptying, Inflammation, Inflammatory marker increased
Clinical narrative: New onset of gastroparesis and flare of her RA; Inflammation with high inflammatory markers il-6 and hs-crp
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interleukin level increased, Laboratory test abnormal, Rheumatoid arthritis
Clinical narrative: New onset of gastroparesis and flare of her RA; Inflammation with high inflammatory markers il-6 and hs-crp
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt came in for Covid-Bivalent Booster was given regular Covid Vaccine in error
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Left Arm: 8cm in size, red in color (localized) at injection site. Warmth, erythema, swelling and tenderness and no fluctuance.  Treated with Bactrim DS 800 mg-160mg twice daily
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for the updated Bivalent covid booster. Was mistakenly given the regular Covid vaccine instead of the Bivalent
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE ADDENDUM NOTE 10/24/22 : OCCURRED 10/18/22 PATIENT REQUESTED FIRST DOSE OF COVID VACCINE AND WAS INADVERTENTLY GIVEN A BOOSTER DOSE BY LPN NO COMPLAINTS OFFERED BY THE PATIENT NO TREATMENT ADVISED.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: None noted I gave monovalent adult Pfizer as a booster dose instead of the bivalent adult Pfizer vaccine. There was no harm to the patient. Action: All healthcare providers received training on the bivalent booster vaccine. Monovalent and bivalent vaccines are labeled in the storage unit. The job aid and infographics are posted.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Pruritus, Rash
Clinical narrative: Rash to both arms & neck c/o itching.