chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patients receiving a 3rd or 4th dose of Shingrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patients receiving a 3rd or 4th dose of Shingrix.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 15-AUG-2024 A pharmacist reported to obtain safety information on patients receiving a 3rd or 4th dose of Shingrix which led to extra dose administered. Reporter mentioned that they had restarted Shingrix series after a late 2nd dose but mentioned that no patient information or other details were available, just mentioned it had happened'.  The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: soreness at injection site; redness at injection site; swelling at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 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: soreness at injection site), injection site erythema (Verbatim: redness at injection site) and injection site swelling (Verbatim: swelling at injection site). The outcome of the injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-AUG-2024 Customer reported experiencing swelling, redness, and soreness at the injection site after receiving the Shingrix vaccine. Patient date of birth, gender, and initials were not available.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Engerix-B to a patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   On 16-AUG-2024, the patient received Engerix B. On 16-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Engerix-B to a patient.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-AUG-2024 The nurse reported the administration of an expired dose of Engerix-B to a patient which led to expired vaccine used.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: we administered the Engerix-B, hepatitis B vaccine and it was given to a patient that is 38 years old but we gave the 0-19 years old, the 0.5 mL; administered the Engerix-B pediatric vaccine and it was given to a patient that is 38 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 39-year-old female patient who received HBV (Engerix B pediatric) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis.   On 16-AUG-2024, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 16-AUG-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: we administered the Engerix-B, hepatitis B vaccine and it was given to a patient that is 38 years old but we gave the 0-19 years old, the 0.5 mL) and underdose (Verbatim: administered the Engerix-B pediatric vaccine and it was given to a patient that is 38 years old). The outcome of the adult use of a child product was unknown and the outcome of the underdose was not reported.   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: 16-AUG-2024 The nurse reported that they administered the Engerix-B pediatric vaccine which was 0.5 ml and it was given to an adult patient, which led to adult use of a child product and underdose. The reporter was asking to see if they could go ahead and give her a second 0.5 ml.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Skipped the 3rd dose, and now are back for a booster; the accelerated schedule for Twinrix, and got the "1st dose September 11, 2019. 2nd dose September 23rd, 2019.; 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 female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 23-SEP-2019, the patient received the 2nd dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 23-SEP-2019, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: the accelerated schedule for Twinrix, and got the "1st dose September 11, 2019. 2nd dose September 23rd, 2019.). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Skipped the 3rd dose, and now are back for a booster). The outcome of the drug dose administration interval too long was unknown and the outcome of the incomplete course of vaccination was not reported.   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: 16-AUG-2024 The pharmacist reported that the patient was under the accelerated schedule for Twinrix and got the 1st dose. The patient received 2nd dose longer than the recommended interval which led to lengthening of vaccination schedule.  The patient skipped the 3rd dose and he was back for a booster at the time of reporting. The pharmacist reported that according to the vaccination record of the patient, the first two doses were administered in another facility than where reporter was calling from.  Till the time of reporting the patient did not receive 3rd dose which led to incomplete course of vaccination. This case was linked with US2024102700, reported by the same reporter.; Sender's Comments:  US-GSK-US2024102700:male patient case
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Skipped the 3rd dose; 1st dose September 11, 2019. 2nd dose September 23rd, 2019; 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 male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 23-SEP-2019, the patient received the 2nd dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 23-SEP-2019, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose September 11, 2019. 2nd dose September 23rd, 2019). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Skipped the 3rd dose). The outcome of the drug dose administration interval too long was unknown and the outcome of the incomplete course of vaccination was not reported.   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: 16-AUG-2024 The pharmacist reported that a male was under the accelerated schedule for Twinrix, and got the 1st dose. The patient received 2nd dose longer than the recommended interval which led to lengthening of vaccination schedule.  The patient skipped the 3rd dose, and he was back for a booster at the time of reporting. The pharmacist reported that according to the vaccination record of the patient, the first two doses were administered in another facility than where reporter was calling from.  Till the time of reporting the patient did not receive 3rd dose which led to incomplete course of vaccination. This case was linked with US2024102698, reported by the same reporter.; Sender's Comments:  US-GSK-US2024102698:Female patient case
Sex: U
Vaccine: TDAP
Symptoms: Device leakage, Incorrect dose administered
Clinical narrative: it started to leak out, so obviously as soon as I saw that I stopped to give it to the patient"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: it started to leak out, so obviously as soon as I saw that I stopped to give it to the patient"). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-AUG-2024 The pharmacist reported that he/she was just administering the Boostrix vaccine to the patient and the connection between the needle and the syringe was not good and so it started to leak out, so obviously as soon as pharmacist saw than they stopped to give it to the patient, which led to incomplete dose administered.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Needle issue, Underdose
Clinical narrative: report while administering boostrix needle leaked; hardly any vaccine was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 79-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16-AUG-2024, the patient received Boostrix. On 16-AUG-2024, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: hardly any vaccine was given). On an unknown date, the patient experienced syringe leak (Verbatim: report while administering boostrix needle leaked). The outcome of the accidental underdose was unknown and the outcome of the syringe leak was not reported.   It was unknown if the reporter considered the syringe leak to be related to Boostrix.     It was unknown if the company considered the syringe leak to be related to Boostrix.   Additional Information: GSK Receipt Date: 16-AUG-2024 The pharmacist reported that while administering boostrix needle leaked and hardly any vaccine was given which led to accidental underdose.  The pharmacist stated the leak came from the part between the needle and syringe and multiple times confirmed it was not a quality issue.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: injection arm sore and pain/ pain on the other arm; pain on neck/tender around the neck; Pain get scale to 9/ pain moved injected arm to the neck and to the other arm; Inflamed around the neck; neck is so sored that patient can barely move; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number MS245, expiry date 16-JUN-2026) for prophylaxis.   On 09-AUG-2024, the patient received the 1st dose of Shingrix. In AUG-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: injection arm sore and pain/ pain on the other arm), neck pain (Verbatim: pain on neck/tender around the neck), radiating pain (Verbatim: Pain get scale to 9/ pain moved injected arm to the neck and to the other arm), inflammation (Verbatim: Inflamed around the neck) and mobility decreased (Verbatim: neck is so sored that patient can barely move). The outcome of the pain in arm, neck pain, radiating pain, inflammation and mobility decreased were not resolved.   It was unknown if the reporter considered the pain in arm, neck pain, radiating pain, inflammation and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm, neck pain, radiating pain, inflammation and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-AUG-2024 The patient experienced injection arm sore and pain.  The pain moved from the injected arm to the neck and to the other arm and it was still painful.  Pain gets scale to 9. Patient stated that was able to do daily normal activities. The patient has inflamed and tender around the neck. The neck was so sored that patient can barely move.  It's been a week from reporting date.  The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: injection arm sore and pain/ pain on the other arm; pain on neck/tender around the neck; Pain get scale to 9/ pain moved injected arm to the neck and to the other arm; Inflamed around the neck; neck is so sored that patient can barely move; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number MS245, expiry date 16-JUN-2026) for prophylaxis.   On 09-AUG-2024, the patient received the 1st dose of Shingrix. In AUG-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: injection arm sore and pain/ pain on the other arm), neck pain (Verbatim: pain on neck/tender around the neck), radiating pain (Verbatim: Pain get scale to 9/ pain moved injected arm to the neck and to the other arm), inflammation (Verbatim: Inflamed around the neck) and mobility decreased (Verbatim: neck is so sored that patient can barely move). The outcome of the pain in arm, neck pain, radiating pain, inflammation and mobility decreased were not resolved.   It was unknown if the reporter considered the pain in arm, neck pain, radiating pain, inflammation and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm, neck pain, radiating pain, inflammation and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-AUG-2024 The patient experienced injection arm sore and pain.  The pain moved from the injected arm to the neck and to the other arm and it was still painful.  Pain gets scale to 9. Patient stated that was able to do daily normal activities. The patient has inflamed and tender around the neck. The neck was so sored that patient can barely move.  It's been a week from reporting date.  The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Inadvertent Administration of Engerix-B pediatric dose to an adult patient; Inadvertent Administration of Engerix-B pediatric dose to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 21-year-old female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Inadvertent Administration of Engerix-B pediatric dose to an adult patient) and underdose (Verbatim: Inadvertent Administration of Engerix-B pediatric dose to an adult patient). The outcome of the adult use of a child product and underdose 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: 16-AUG-2024 Registered Nurse mentioned that they administered an Engerix-B pediatric dose (up to nineteen years old dose) to an adult female patient (twenty one year old) which led to adult use of a child product and underdose. She wanted to know which advise they have to follow. Registered Nurse did not provide further detail about patient demographics (she only provided proactively age and gender), also she did not provide any vaccination/vaccine detail. Finally, she reactively does not consent Safety Department follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection, Vaccination failure
Clinical narrative: suspected vaccination failure; patient is experiencing break through shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: patient is experiencing break through shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 19-AUG-2024 An HCP reported the following he/she was wondering if any other additional Shingrix vaccination are recommended outside of the normal 2 dose schedule if a patient was experiencing break through shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix was administered to a 5-year-old patient; Shingrix was administered to a 5-year-old patient, intended vaccine to be administered was varicella.; 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 5-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2024, the patient received Shingrix. In JUN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix was administered to a 5-year-old patient) and wrong vaccine administered (Verbatim: Shingrix was administered to a 5-year-old patient, intended vaccine to be administered was varicella.). The outcome of the inappropriate age at vaccine administration was unknown and the outcome of the wrong vaccine administered was not reported.   Additional Information: GSK Receipt Date: 19-AUG-2024 The nurse called and reported that the Shingrix was administered to the patient of an inappropriate age and intended vaccine to be administered was varicella, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consent to follow-up via email.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug ineffective, Herpes zoster, Illness, Ophthalmic herpes zoster, Pain
Clinical narrative: It was in my eyes but not very deep; lot of pain; Suspected vaccination Failure (Lack of Effect); contracted the shingles on my scalp; very sick; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-OCT-2019, the patient received the 2nd dose of Shingrix. In JUL-2019, the patient received the 1st dose of Shingrix. In JAN-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure (Lack of Effect)) (serious criteria GSK medically significant) and shingles (Verbatim: contracted the shingles on my scalp). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It was in my eyes but not very deep) (serious criteria GSK medically significant), sickness (Verbatim: very sick) and pain (Verbatim: lot of pain). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported and the outcome of the sickness was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, sickness and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, sickness and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 19-AUG-2024 The reporter called and reported that had the Shingrix vaccinations and had contracted the shingles on the scalp. The reporter wanted to know if it was possible to get another one or two, since did not wanted to go through that again.  The patient was very sick for about 2 months.  The patient had shingles only on my scalp but it didn't go in the eyes or the ears, it was very close.  It was in the eyes but not very deep but was in a lot of pain and did not want to had that again. This case was considered as suspected vaccination failure as details laboratory test confirming shingles were unknown at the time of reporting. Consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: It was in my eyes but not very deep; lot of pain; Suspected vaccination Failure (Lack of Effect); contracted the shingles on my scalp; very sick; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-OCT-2019, the patient received the 2nd dose of Shingrix. In JUL-2019, the patient received the 1st dose of Shingrix. In JAN-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure (Lack of Effect)) (serious criteria GSK medically significant) and shingles (Verbatim: contracted the shingles on my scalp). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It was in my eyes but not very deep) (serious criteria GSK medically significant), sickness (Verbatim: very sick) and pain (Verbatim: lot of pain). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported and the outcome of the sickness was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, sickness and pain to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, sickness and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 19-AUG-2024 The reporter called and reported that had the Shingrix vaccinations and had contracted the shingles on the scalp. The reporter wanted to know if it was possible to get another one or two, since did not wanted to go through that again.  The patient was very sick for about 2 months.  The patient had shingles only on my scalp but it didn't go in the eyes or the ears, it was very close.  It was in the eyes but not very deep but was in a lot of pain and did not want to had that again. This case was considered as suspected vaccination failure as details laboratory test confirming shingles were unknown at the time of reporting. Consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Cough; Decreased appetite; Dyspnoea; RESPIRATORY TRACT CONGESTION; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Decreased appetite), DYSPNOEA (Dyspnoea), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunization.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included Sulfonamide allergy (SULFA ANTIBIOTICS). Concomitant products included BACLOFEN, LOSARTAN POTASSIUM, PRAVASTATIN SODIUM, CYANOCOBALAMIN, RIVAROXABAN (XARELTO), ACETAMINOPHEN and MONTELUKAST for an unknown indication.    On 22-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Jun-2024, the patient experienced COUGH (Cough) (seriousness criterion hospitalization), DECREASED APPETITE (Decreased appetite) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, COUGH (Cough), DECREASED APPETITE (Decreased appetite), DYSPNOEA (Dyspnoea), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: Normal. On an unknown date, Influenza virus test: Negative. On an unknown date, Respiratory syncytial virus test: Negative. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered COUGH (Cough), DECREASED APPETITE (Decreased appetite), DYSPNOEA (Dyspnoea), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) and HEADACHE (Headache) to be related.    No treatment medication was reported.  Company Comment: This spontaneous case concerns an 74-year-old female patient, with medical history of Congestive heart failure, who experienced the unexpected serious (due to hospitalization) events of cough, decreased appetite, dyspnoea, respiratory tract congestion and headache which occurred two days after receiving  a dose of SPIKEVAX 2023-2024 vaccine, which was an unknown dose of COVID-19 vaccination schedule. It was reported that she underwent Chest X-ray, Influenza virus test, Respiratory syncytial virus test and SARS-CoV-2 test all with  Negative results.The outcome of the event was reported as unknown. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine  is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Respiratory syncytial virus test, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Cough; Decreased appetite; Dyspnoea; RESPIRATORY TRACT CONGESTION; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Decreased appetite), DYSPNOEA (Dyspnoea), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunization.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included Sulfonamide allergy (SULFA ANTIBIOTICS). Concomitant products included BACLOFEN, LOSARTAN POTASSIUM, PRAVASTATIN SODIUM, CYANOCOBALAMIN, RIVAROXABAN (XARELTO), ACETAMINOPHEN and MONTELUKAST for an unknown indication.    On 22-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Jun-2024, the patient experienced COUGH (Cough) (seriousness criterion hospitalization), DECREASED APPETITE (Decreased appetite) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, COUGH (Cough), DECREASED APPETITE (Decreased appetite), DYSPNOEA (Dyspnoea), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: Normal. On an unknown date, Influenza virus test: Negative. On an unknown date, Respiratory syncytial virus test: Negative. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered COUGH (Cough), DECREASED APPETITE (Decreased appetite), DYSPNOEA (Dyspnoea), RESPIRATORY TRACT CONGESTION (RESPIRATORY TRACT CONGESTION) and HEADACHE (Headache) to be related.    No treatment medication was reported.  Company Comment: This spontaneous case concerns an 74-year-old female patient, with medical history of Congestive heart failure, who experienced the unexpected serious (due to hospitalization) events of cough, decreased appetite, dyspnoea, respiratory tract congestion and headache which occurred two days after receiving  a dose of SPIKEVAX 2023-2024 vaccine, which was an unknown dose of COVID-19 vaccination schedule. It was reported that she underwent Chest X-ray, Influenza virus test, Respiratory syncytial virus test and SARS-CoV-2 test all with  Negative results.The outcome of the event was reported as unknown. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine  is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Glioblastoma multiforme
Clinical narrative: stroke; GBM brain cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and GLIOBLASTOMA MULTIFORME (GBM brain cancer) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria medically significant and life threatening) and GLIOBLASTOMA MULTIFORME (GBM brain cancer) (seriousness criteria medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and GLIOBLASTOMA MULTIFORME (GBM brain cancer) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter. No treatment medications provided by the reporter. Company comment-This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant and life threatening) unexpected AESI cerebrovascular accident and the event glioblastoma multiforme on an unknown date after a dose of SPIKEVAX NOS vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported patient had a stroke immediately after patient got Moderna shot. A few months later patient was diagnosed with glioblastoma multiforme brain cancer. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2024: Live non-significant information received in which new reference number was added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Peripheral swelling, Vaccination site reaction
Clinical narrative: shortness of breath; her arm got swollen; vaccine site gets like really bad; allergies/developed an allergic reaction after getting the COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative cancer" (unspecified if ongoing). Concomitant medication(s) included: ARIMIDEX taken for neoplasm malignant. Past drug history included: Poly 'ethylene', reaction(s): "allergic to poly 'ethylene'". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: EWO150), administration date: 08Apr2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "shortness of breath", "vaccine site gets like really bad", "her arm was swollen", "developed an allergic reaction after getting the COVID-19 vaccine"; BNT162b2 (DOSE 2, SINGLE, lot number: EW0169), administration date: 26Apr2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "shortness of breath", "vaccine site gets like really bad", "her arm was swollen", "developed an allergic reaction after getting the COVID-19 vaccine"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, lot number: EW0186), administration date: 18Aug2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "shortness of breath", "vaccine site gets like really bad", "arm got swollen", "developed an allergic reaction after getting the COVID-19 vaccine". The following information was reported: ALLERGY TO VACCINE (non-serious) with onset Mar2022, outcome "unknown", described as "allergies/developed an allergic reaction after getting the COVID-19 vaccine"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arm got swollen"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "vaccine site gets like really bad". The events "shortness of breath", "allergies/developed an allergic reaction after getting the covid-19 vaccine", "her arm got swollen" and "vaccine site gets like really bad" required physician office visit. Additional information: Patient mentioned that she developed an allergic reaction after getting the COVID-19 vaccine. So her arm got swollen. Patient had a many vaccines and every time she got it, she had been a shortness of breath and then the vaccine site got like really bad. Patient went to the doctor. That's how bad it was. Because she went right away because she was scared because she couldn't breathe and her arm was all swollen.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240124 Same patient, different vaccine dose and events.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP.  A male patient 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, lot number unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 2, lot number unknown), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), lot number unknown), for Covid-19 Immunization; Bnt162b2 omi (DOSE 4 (BOOSTER), lot number unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she and her husband tested positive for COVID.  Clinical course: Caller's husband tested positive for Covid and he went to the hospital and prescribed Paxlovid but cannot pick up the medication and he was told to call Pfizer to get medications. Caller also said he already had 5 doses of the vaccine and doesn't know if her husband needed some more. Resolution: Submitted two precautionary AEs. The caller is wondering why she needs to get more medication.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400109583 same reporter/product/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Her blood pressure went up to 195-90/it occurred with all 3 vaccines; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000051875.  A 68-year-old female patient 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: "Idiopathic urticaria" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Food related allergies" (unspecified if ongoing); "Airborne allergies" (unspecified if ongoing); "Hives" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 23Feb2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "her blood pressure went up to 195-90/it occurred with all 3 vaccines"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "her blood pressure went up to 195-90/it occurred with all 3 vaccines". The following information was reported: BLOOD PRESSURE INCREASED (medically significant), outcome "recovering", described as "Her blood pressure went up to 195-90/it occurred with all 3 vaccines". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: went up to 195-90; finally came down to 110 or 120/80, notes: took her blood pressure 3 or 4 times; normally 110 over 60 or 70. Clinical course: On unknown date, it was reported that patient experienced: when she received the COVID vaccines first one on 23Feb2021, her blood pressure went up to 195-90 and it is normally 110 over 60 or 70, and it occurred with all 3 vaccines. The patient stated that they wanted to take her to the hospital after the vaccine but the paramedics at the vaccine site took her blood pressure 3 or 4 times and it finally came down to 110 or 120/80. Patient's concurrent condition included: was not reported. Patient's concomitant medication included: was not reported.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400241874 same patient/product, different dose/event;US-PFIZER INC-PV202400109710 same patient/product, different dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: her blood pressure went up to 195-90/it occurred with all 3 vaccines; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000051875.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic urticaria" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Food related allergies" (unspecified if ongoing); "Airborne allergies" (unspecified if ongoing); "Hives" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Feb2021, outcome "recovering", described as "her blood pressure went up to 195-90/it occurred with all 3 vaccines". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (23Feb2021) 110 or 120/80, notes: paramedics at the vaccine site took her blood pressure 3 or 4 times and it finally came down to 110 or 120/80; (23Feb2021) 195-90, notes: her blood pressure went up to 195-90 and it is normally 110 over 60 or 70. Clinical Course: Patient's concurrent condition was not reported. On 23Feb2021, patient started therapy with Pfizer BioNTech Covid-19 vaccine for active immunization against Covid-19 disease. On unknown date, it was reported that patient experienced: when she received the COVID vaccines first one on 23Feb2021, her blood pressure went up to 195-90 and it is normally 110 over 60 or 70, and it occurred with all 3 vaccines. The patient stated that they wanted to take her to the hospital after the vaccine but the paramedics at the vaccine site took her blood pressure 3 or 4 times and it finally came down to 110 or 120/80.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400241874 same reporter/patient/event, different dose;US-PFIZER INC-202400241875 same reporter/patient/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: Patient started experiencing neurological effects within 10 days of getting the vaccine.; This is a spontaneous report received from a Nurse from a sales representative.  A 42-year-old male patient 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 and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "not recovered", described as "Patient started experiencing neurological effects within 10 days of getting the vaccine." Batch/lot number is not provided, and it cannot be obtained.  Additional information: It was unknown if patient received other vaccine on same date, other vaccine in four weeks, other medications in two weeks.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefaclor, reaction(s): "Known allergies: Cefaclor". Vaccination history included: Janssen (DOSE 1, SINGLE), administration date: Apr2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2 (BOOSTER), SINGLE), administration date: Oct2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2022, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2024 at 17:00, outcome "recovered" (15Aug2024) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2024) negative, notes: at 7:00 am; (09Aug2024) positive, notes: at 5:00 pm; (15Aug2024) negative; (17Aug2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Aug2024 to14Aug2024. Clinical course: Initial Covid symptoms began midday 08Aug. Covid antigen test negative 09Aug 7:00am. Covid antigen test positive 09Aug 5:00pm. Took full prescribed course of Paxlovid (300mg/100mg dose packs 2x daily, 5 days) from 09Aug evening through 14Aug morning. Symptoms improved significantly on 10Aug, and antigen tested negative 15Aug and 17Aug.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.