chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Extra dose administered; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Extra dose administered). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 29-FEB-2024 This case was reported the patient via interactive digital media. The patient got all three vaccines and never had shingles before, now(at the time of reporting) had them over 20 times.  The patient had on medication to prevent shingles now and still got it. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient received vaccine three times, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 29-FEB-2024 This case was reported by the consumer via interactive digital media. The reporter was so confused because that so many people were saying they got shingles even though they had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case is linked with US2024AMR030254, by same reporter.; Sender's Comments:  US-GSK-US2024AMR030254:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Varicella
Clinical narrative: both of the arms turned red; super itchy; broke out in hives on the left side torso; got the chicken pox blisters on the palms of hands; blisters on the palms of the hands; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced erythema of extremities (Verbatim: both of the arms turned red), itchy upper limbs (Verbatim: super itchy), hives (Verbatim: broke out in hives on the left side torso), chickenpox (Verbatim: got the chicken pox blisters on the palms of hands) and blister (Verbatim: blisters on the palms of the hands). The outcome of the erythema of extremities, itchy upper limbs, hives, chickenpox and blister were not reported.   It was unknown if the reporter considered the erythema of extremities, itchy upper limbs, hives, chickenpox and blister to be related to Shingles vaccine.     It was unknown if the company considered the erythema of extremities, itchy upper limbs, hives, chickenpox and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had a bad reaction to the Shingles vaccine. Both arms turned red and were super itchy. The patient broke out in hives on the left side torso and got the chicken pox blisters on the palms of his/her hands.  The physician said he/she was one in 10,000 that reacted like that to the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: feel like crap). The outcome of the feeling abnormal was resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.   It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-FEB-2024 This case was reported by a patient via interactive digital media. The patient hated the shot as it made him/her felt like crap for a couple of days but patient would do it again because that was nothing compared to the pain and nerve damage possible with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I only had a sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: I only had a sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 This case was reported by a patient via interactive digital media. The patient had a sore arm and stated hopefully 2nd one would not be too bad.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: had administered few Shingrix vaccines to few patients yesterday, on Feb 25th 2024 and one of the patient only received the diluent only; inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-FEB-2024, the patient received Shingrix. On 25-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: had administered few Shingrix vaccines to few patients yesterday, on Feb 25th 2024 and one of the patient only received the diluent only) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 26-FEB-2024 The pharmacist reported that she had administered a few Shingrix vaccines to several patients. The reporter reported that one of the patients only received the diluent, but it was uncertain which one among them. which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to the follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Product supply issue
Clinical narrative: They don't have Twinrix in stock; This non-serious case was reported by a nurse via call center representative and described the occurrence of product supply issue in a 47-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2005) and Twinrix (received 2nd dose in 2005).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced product supply issue (Verbatim: They don't have Twinrix in stock). The outcome of the product supply issue 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: 26-FEB-2024 A registered nurse (RN) stated that a patient received 2 doses of Twinrix back in 2005 (states that she was not certain that it was actually Twinrix), but did not receive the 3rd one. They did not had Twinrix in stock but had Engerix-B and asked, could they administer this instead. It did not appear that the Engerix-B had been administered yet (till the time of reporting). The patient received the 2 doses of Twinrix at another facility.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site urticaria, Pain, Pyrexia, Rash
Clinical narrative: R arm 3 hard dime size welts beneath injection site; one welt on butt; fever; achy; felt miserable; small prickly rash on arm, abdomen and legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer.   On 04-JAN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JAN-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), pain (Verbatim: achy) and feeling miserable (Verbatim: felt miserable). On 05-JAN-2024, the patient experienced injection site wheal (Verbatim: R arm 3 hard dime size welts beneath injection site) and welts (Verbatim: one welt on butt). In JAN-2024, the patient experienced rash (Verbatim: small prickly rash on arm, abdomen and legs). The outcome of the injection site wheal and welts were not resolved and the outcome of the fever, pain and feeling miserable were resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.     It was unknown if the company considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The patient received second dose of Shingrix vaccine and in evening she had a fever, achy and felt miserable. She stated that the next evening she felt 3 dime sized hard bums on her right arm below the injection site, and one on her butt. The patient also reported that the days later a small prickly rash appeared on her arms, abdomen and legs.  She saw her health care professional who ordered an ultra sound and now needs a biopsy.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: R arm 3 hard dime size welts beneath injection site; one welt on butt; fever; achy; felt miserable; small prickly rash on arm, abdomen and legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer.   On 04-JAN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JAN-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), pain (Verbatim: achy) and feeling miserable (Verbatim: felt miserable). On 05-JAN-2024, the patient experienced injection site wheal (Verbatim: R arm 3 hard dime size welts beneath injection site) and welts (Verbatim: one welt on butt). In JAN-2024, the patient experienced rash (Verbatim: small prickly rash on arm, abdomen and legs). The outcome of the injection site wheal and welts were not resolved and the outcome of the fever, pain and feeling miserable were resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.     It was unknown if the company considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The patient received second dose of Shingrix vaccine and in evening she had a fever, achy and felt miserable. She stated that the next evening she felt 3 dime sized hard bums on her right arm below the injection site, and one on her butt. The patient also reported that the days later a small prickly rash appeared on her arms, abdomen and legs.  She saw her health care professional who ordered an ultra sound and now needs a biopsy.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Injection site nodule, Metastatic renal cell carcinoma
Clinical narrative: R arm 3 hard dime size welts beneath injection site; one welt on butt; fever; achy; felt miserable; small prickly rash on arm, abdomen and legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer.   On 04-JAN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JAN-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), pain (Verbatim: achy) and feeling miserable (Verbatim: felt miserable). On 05-JAN-2024, the patient experienced injection site wheal (Verbatim: R arm 3 hard dime size welts beneath injection site) and welts (Verbatim: one welt on butt). In JAN-2024, the patient experienced rash (Verbatim: small prickly rash on arm, abdomen and legs). The outcome of the injection site wheal and welts were not resolved and the outcome of the fever, pain and feeling miserable were resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.     It was unknown if the company considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The patient received second dose of Shingrix vaccine and in evening she had a fever, achy and felt miserable. She stated that the next evening she felt 3 dime sized hard bums on her right arm below the injection site, and one on her butt. The patient also reported that the days later a small prickly rash appeared on her arms, abdomen and legs.  She saw her health care professional who ordered an ultra sound and now needs a biopsy.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Condition aggravated, Injection site erythema, Injection site haematoma, Injection site rash
Clinical narrative: R arm 3 hard dime size welts beneath injection site; one welt on butt; fever; achy; felt miserable; small prickly rash on arm, abdomen and legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer.   On 04-JAN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JAN-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), pain (Verbatim: achy) and feeling miserable (Verbatim: felt miserable). On 05-JAN-2024, the patient experienced injection site wheal (Verbatim: R arm 3 hard dime size welts beneath injection site) and welts (Verbatim: one welt on butt). In JAN-2024, the patient experienced rash (Verbatim: small prickly rash on arm, abdomen and legs). The outcome of the injection site wheal and welts were not resolved and the outcome of the fever, pain and feeling miserable were resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.     It was unknown if the company considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The patient received second dose of Shingrix vaccine and in evening she had a fever, achy and felt miserable. She stated that the next evening she felt 3 dime sized hard bums on her right arm below the injection site, and one on her butt. The patient also reported that the days later a small prickly rash appeared on her arms, abdomen and legs.  She saw her health care professional who ordered an ultra sound and now needs a biopsy.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site reaction, Metastasis, Renal cancer metastatic, Swelling, Ultrasound scan abnormal
Clinical narrative: R arm 3 hard dime size welts beneath injection site; one welt on butt; fever; achy; felt miserable; small prickly rash on arm, abdomen and legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer.   On 04-JAN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JAN-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), pain (Verbatim: achy) and feeling miserable (Verbatim: felt miserable). On 05-JAN-2024, the patient experienced injection site wheal (Verbatim: R arm 3 hard dime size welts beneath injection site) and welts (Verbatim: one welt on butt). In JAN-2024, the patient experienced rash (Verbatim: small prickly rash on arm, abdomen and legs). The outcome of the injection site wheal and welts were not resolved and the outcome of the fever, pain and feeling miserable were resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.     It was unknown if the company considered the injection site wheal, fever, pain, feeling miserable, welts and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 The patient received second dose of Shingrix vaccine and in evening she had a fever, achy and felt miserable. She stated that the next evening she felt 3 dime sized hard bums on her right arm below the injection site, and one on her butt. The patient also reported that the days later a small prickly rash appeared on her arms, abdomen and legs.  She saw her health care professional who ordered an ultra sound and now needs a biopsy.  The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd dose; Early 2nd dose prescribed by MD; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 2P5E9, expiry date 18-APR-2026) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 26-FEB-2024, the patient received the 2nd dose of Shingrix. On 26-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose) and off label use (Verbatim: Early 2nd dose prescribed by MD). The outcome of the drug dose administration interval too short and off label use were unknown.   Additional Information: GSK Receipt date: 26-FEB-2024 The pharmacist reported that, the patient received 1st dose of Shingrix on 15th February 2024. The patient showed up on 26th February 2024 asking for the 2nd dose to be administered as the physician told the patient to do so which led to off label use and shortening of vaccination schedule. According to the reporter the patient ended up having another vaccine. The vaccine administration was the same as primary reporter. The reporter consented to follow up.
Age: 9.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix-administered to 9 years old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 473YA) for prophylaxis.   On 25-MAY-2023, the patient received Pediarix. On 25-MAY-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix-administered to 9 years old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2024 The registered nurse reported that the patient 9 years of age received Pediarix vaccine by mistake, which led to an inappropriate age at vaccine administration.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second Shingrix dose after only 20 days from the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Z9N3, expiry date 26-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 25-SEP-2023, the patient received the 2nd dose of Shingrix. On 25-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: second Shingrix dose after only 20 days from the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The patient received 1st dose on 05-SEP-2023 with batch number YZ9F7 and expiry date 08-JUL-2024. The pharmacist reported that the patient received his second Shingrix dose after only 20 days from the first dose, which led to shortening of vaccinations schedule. At the time of reporting, a repeat dose has not been administered.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Inflammatory bowel disease, Serology negative, Therapy non-responder
Clinical narrative: serology non-reactive/negative following series completion; IBD diagnosis; 3rd dose on 19th February 2010; On 2nd December 2009 received 2nd dose; This serious case was reported by a pharmacist via call center representative and described the occurrence of inflammatory bowel disease in a 14-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 19-FEB-2010, the patient received the 3rd dose of Engerix B. On 02-DEC-2009, the patient received the 2nd dose of Engerix B. On 11-SEP-2009, the patient received the 1st dose of Engerix B. On 02-DEC-2009, not applicable after receiving Engerix B and Engerix B, an unknown time after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: On 2nd December 2009 received 2nd dose). On 19-FEB-2010, the patient experienced drug dose administration interval too short (Verbatim: 3rd dose on 19th February 2010). On 25-FEB-2024, the patient experienced inflammatory bowel disease (Verbatim: IBD diagnosis) (serious criteria GSK medically significant). On an unknown date, the patient experienced therapy non-responder (Verbatim: serology non-reactive/negative following series completion). The outcome of the inflammatory bowel disease was not reported and the outcome of the therapy non-responder, drug dose administration interval too short and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the inflammatory bowel disease to be related to Engerix B, Engerix B and Engerix B.     It was unknown if the company considered the inflammatory bowel disease to be related to Engerix B, Engerix B and Engerix B.   Additional Information: GSK Receipt date: 29-FEB-2024 The reporter reported that the patient had a diagnosis that likely put him in immunocompromised category. Patient diagnosed with Inflammatory bowel disease. Patient would be stating remicade but had not yet begun. The patient previously received full childhood vaccine of Engerix-B, but recent serology came back as non-reactive or negative. 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. The patient received 2nd dose of Engerix-B, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema
Clinical narrative: I have noticed the appearance of rashes on my chest, face, and stomach, and to my concern, these symptoms seem to be increasing.; I have observed the development of a red patch around the injection site on my arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (I have noticed the appearance of rashes on my chest, face, and stomach, and to my concern, these symptoms seem to be increasing.) and VACCINATION SITE ERYTHEMA (I have observed the development of a red patch around the injection site on my arm) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (I have noticed the appearance of rashes on my chest, face, and stomach, and to my concern, these symptoms seem to be increasing.) and VACCINATION SITE ERYTHEMA (I have observed the development of a red patch around the injection site on my arm). At the time of the report, RASH (I have noticed the appearance of rashes on my chest, face, and stomach, and to my concern, these symptoms seem to be increasing.) and VACCINATION SITE ERYTHEMA (I have observed the development of a red patch around the injection site on my arm) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: pain at the injection site; developed stomach ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site) and stomach pain (Verbatim: developed stomach ache). The outcome of the injection site pain and stomach pain were unknown.   It was unknown if the reporter considered the injection site pain and stomach pain to be related to Shingrix.     It was unknown if the company considered the injection site pain and stomach pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 The patient self-reported this case. The customer (patient) reported she developed stomach ache and pain at the injection site after received the Shingrix vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain at injection site; redness size of a coin; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-FEB-2024, the patient received the 1st dose of Shingrix (left arm). In FEB-2024, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site) and erythema (Verbatim: redness size of a coin). The outcome of the injection site pain and erythema were not resolved.   It was unknown if the reporter considered the injection site pain and erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 The reporter stated that patient received her dose of Shingrix last Friday (from the date of reporting) and she was still experiencing redness (size of a coin) and pain at injection site (left arm).
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: heart racing; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of heart racing in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number TF3A9, expiry date 08-OCT-2024) for prophylaxis.   In SEP-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced heart racing (Verbatim: heart racing). The outcome of the heart racing was unknown.   It was unknown if the reporter considered the heart racing to be related to Shingrix.     It was unknown if the company considered the heart racing to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 Pharmacist reported a dose of Shingrix was administered to a patient and she presented heart racing. No exact vaccination date reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: shakes; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shakes), CHILLS (Chills) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose-1, Batch no.- EN6199) on 17-Mar-2021, Pfizer (Dose-1, Batch no.- EN6199) on 17-Mar-2021, Pfizer (Dose-1, Batch no.- EN6199) on 17-Mar-2021, Pfizer (Dose-2, Batch no.- EN6208) on 07-Apr-2021, Pfizer (Dose-2, Batch no.- EN6208) on 07-Apr-2021, Pfizer (Dose-2 and Batch no.- EN6208) on 07-Apr-2021. Past adverse reactions to the above products included Chills with Pfizer and Pfizer; Headache with Pfizer and Pfizer; and Shaking with Pfizer and Pfizer. Concurrent medical conditions included Sulfonamide allergy (sulfa product) and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism, UBIDECARENONE (COQ10 [UBIDECARENONE]) and VITAMINS NOS for an unknown indication.    On 28-Nov-2021 at 4:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shakes), CHILLS (Chills) and HEADACHE (headache). At the time of the report, TREMOR (shakes), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.            Other ongoing concomitant medications were Pure Osteo balance (3 capsules, daily), Thorne Super EPA (2 capsules daily). Patient never diagnosed with COVID-19. The event did not cause the patient to seek medical care. There was no other potential cause.  No treatment medications provided by the reporter.   This case was linked to MOD-2024-756968, MOD-2024-762674 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tremor
Clinical narrative: shakes; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shakes), CHILLS (Chills) and HEADACHE (headache) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose: 1, Batch no.- EN6199) on 17-Mar-2021, Pfizer (Dose: 1, Batch no.- EN6199) on 17-Mar-2021, Pfizer (Dose: 1, Batch no.- EN6199) on 17-Mar-2021, Pfizer (Dose: 2, Batch no.- EN6208) on 07-Apr-2021, Pfizer (Dose: 2, Batch no.- EN6208) on 07-Apr-2021, Pfizer (Dose: 2 and Batch no.- EN6208) on 07-Apr-2021. Past adverse reactions to the above products included Chills with Pfizer and Pfizer; Headache with Pfizer and Pfizer; and Shaking with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Sulfa Products) and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism, UBIDECARENONE (COQ10 [UBIDECARENONE]) and VITAMINS NOS for an unknown indication.    On 15-Sep-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shakes), CHILLS (Chills) and HEADACHE (headache). At the time of the report, TREMOR (shakes), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.            Other ongoing concomitant medications were Pure Osteo balance (3 capsules, daily), Thorne Super EPA (2 capsules daily).  On 28-NOV-2021, the patient received Moderna vaccine dose: 3 at 4:40 pm. Patient never diagnosed with COVID-19.  The event did not cause the patient to seek medical care.  There was no other potential cause.  Patient experienced chills, shakes and headache with every COVID vaccine.   No treatment medication was reported.   This case was linked to MOD-2024-756968, MOD-2024-762670 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Coma
Clinical narrative: Suffered a major stroke/suffered paralysis; Patient entered coma; This spontaneous case was reported by an attorney and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a major stroke/suffered paralysis) and COMA (Patient entered coma) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a major stroke/suffered paralysis) (seriousness criteria hospitalization and medically significant) and COMA (Patient entered coma) (seriousness criteria hospitalization and medically significant). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a major stroke/suffered paralysis) and COMA (Patient entered coma) was resolving.        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.   No concomitant medication was reported. In 2024, as of now the patient being at home and doing rehabilitation because she suffered paralysis.  Company comment-This is a spontaneous case concerning a female patient of unknown age with no relevant medical history reported, who experienced the unexpected and serious (hospitalization and medically significant) events cerebrovascular accident (AESI) and coma 2 days after a dose of mRNA-1273 vaccine, given as a first dose of COVID vaccine schedule, was administered. It was reported patient was hospitalized when the symptoms started 2 days after vaccination, and not only suffered a major stroke but also entered coma. The current status of the patient is at home and doing rehabilitation because she suffers paralysis. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes, Other medical history: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective, treatment included paxlovid from 14Feb2024 to 19Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Augmentin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Feb2024 to 01Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion Location of injection: Arm Left, Dose: 4), administration date: Nov2022, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Dose: 3), administration date: Dec2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Dose: 2), administration date: Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Dose: 1), administration date: Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 22Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2024) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: I had a heart attack right after I had my first COVID shot; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The patient also took other concomitant therapy. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "I had a heart attack right after I had my first COVID shot".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood test, Body temperature, Chills, Nausea
Clinical narrative: I had a heart attack right after I had my first COVID shot; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The patient also took other concomitant therapy. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "I had a heart attack right after I had my first COVID shot".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Pain, Pyrexia, Renal failure, SARS-CoV-2 test
Clinical narrative: I had a heart attack right after I had my first COVID shot; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The patient also took other concomitant therapy. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "I had a heart attack right after I had my first COVID shot".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sluggishness, Tremor
Clinical narrative: I had a heart attack right after I had my first COVID shot; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them. I have a defibrillator" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The patient also took other concomitant therapy. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "I had a heart attack right after I had my first COVID shot".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: died of a heart attack; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "died of a heart attack". It was unknown if therapeutic measures were taken as a result of myocardial infarction. The patient date of death was unknown. Reported cause of death: "died of a heart attack". It was not reported if an autopsy was performed.  Clinical course: Reporter stated that her child, 37, died of a heart attack after taking a COVID booster. She did not state the brand or manufacture of the product. No other details were provided  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. ; Reported Cause(s) of Death: died of a heart attack