chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pituitary tumour, Pruritus, Rash
Clinical narrative: Welts/ hives; Drug dose administration interval too long; Oozing liquid; pain at the injection site; Itching all over body; bumps; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received a shingles vaccine about 6 years ago). Additional patient notes included Pituitary mass 1 millimeter.   On 07-AUG-2024, the patient received the 2nd dose of Shingrix. On 07-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 10-AUG-2024, the patient experienced welts (Verbatim: Welts/ hives). In AUG-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), generalized pruritus (Verbatim: Itching all over body), local swelling (Verbatim: bumps) and skin oozing (Verbatim: Oozing liquid). The outcome of the injection site pain, generalized pruritus, local swelling, welts and skin oozing were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, generalized pruritus, local swelling, welts and skin oozing to be related to Shingrix.     It was unknown if the company considered the injection site pain, generalized pruritus, local swelling, welts and skin oozing to be related to Shingrix.   Additional Information: GSK receipt date: 12-AUG-2024 The patient received a shingles vaccine about 6 years ago, did not knew which vaccine he received 6 years ago.   The patient received another vaccine for shingles and did not have any information to identify vaccine received. The reporter stated he was supposed to get a second shingles vaccine and he was not going back to get the second because of symptoms he experienced.   3 days after getting vaccinated with suspect product welts and bumps appeared all over his body and stated that welts were itching and oozing liquid.   The patient , stated he had pain at the injection site.   The reporter was unwilling to give more information about injection site reaction.   All symptoms were not resolved. The patient had hives all over the body now(at the time of reporting) that had that shot for singles and she told to visit another doctor another doctor was gonna took two months at least to go see him and did not try to go to the emergency today that would take all day. Did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin weeping, Urticaria
Clinical narrative: Welts/ hives; Drug dose administration interval too long; Oozing liquid; pain at the injection site; Itching all over body; bumps; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received a shingles vaccine about 6 years ago). Additional patient notes included Pituitary mass 1 millimeter.   On 07-AUG-2024, the patient received the 2nd dose of Shingrix. On 07-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 10-AUG-2024, the patient experienced welts (Verbatim: Welts/ hives). In AUG-2024, the patient experienced injection site pain (Verbatim: pain at the injection site), generalized pruritus (Verbatim: Itching all over body), local swelling (Verbatim: bumps) and skin oozing (Verbatim: Oozing liquid). The outcome of the injection site pain, generalized pruritus, local swelling, welts and skin oozing were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, generalized pruritus, local swelling, welts and skin oozing to be related to Shingrix.     It was unknown if the company considered the injection site pain, generalized pruritus, local swelling, welts and skin oozing to be related to Shingrix.   Additional Information: GSK receipt date: 12-AUG-2024 The patient received a shingles vaccine about 6 years ago, did not knew which vaccine he received 6 years ago.   The patient received another vaccine for shingles and did not have any information to identify vaccine received. The reporter stated he was supposed to get a second shingles vaccine and he was not going back to get the second because of symptoms he experienced.   3 days after getting vaccinated with suspect product welts and bumps appeared all over his body and stated that welts were itching and oozing liquid.   The patient , stated he had pain at the injection site.   The reporter was unwilling to give more information about injection site reaction.   All symptoms were not resolved. The patient had hives all over the body now(at the time of reporting) that had that shot for singles and she told to visit another doctor another doctor was gonna took two months at least to go see him and did not try to go to the emergency today that would take all day. Did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Serology negative, Therapy non-responder
Clinical narrative: Patient completed the hepatitis B child series in 1994 and gave negative for immunity; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 30-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: Patient completed the hepatitis B child series in 1994 and gave negative for immunity). The outcome of the therapy non-responder was not reported.   Additional Information: GSK Receipt date: 12-AUG-2024 and 16-AUG-2024 A Health Care Professional reported that he/she have a patient who received the childhood series of hepatitis B but did not convert, she never received the hepatitis A vaccines so, she needs to start that and she needs to repeat the hepatitis B. The reporter wanted to know was it ok for her to do the twinrix. Patient completed the hepatitis B child series in 1994 and gave negative for immunity.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Erythema, Pain in extremity, Peripheral swelling, Pulmonary pain
Clinical narrative: Strong sensation in chest; felt a pain in the right lung; Arm redness; Arm soreness; arm hot; arm swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest discomfort in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-AUG-2024, the patient received Arexvy. On 10-AUG-2024, less than a day after receiving Arexvy, the patient experienced chest discomfort (Verbatim: Strong sensation in chest) and pulmonary pain (Verbatim: felt a pain in the right lung). In AUG-2024, the patient experienced erythema of extremities (Verbatim: Arm redness), pain in arm (Verbatim: Arm soreness), extremities hot feeling of (Verbatim: arm hot) and swelling arm (Verbatim: arm swollen). The outcome of the chest discomfort was resolved and the outcome of the erythema of extremities, pain in arm, extremities hot feeling of and swelling arm were not resolved and the outcome of the pulmonary pain was unknown.   It was unknown if the reporter considered the chest discomfort, erythema of extremities, pain in arm, extremities hot feeling of, swelling arm and pulmonary pain to be related to Arexvy.     It was unknown if the company considered the chest discomfort, erythema of extremities, pain in arm, extremities hot feeling of, swelling arm and pulmonary pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-AUG-2024 The patient self-reported this case. The patient informed about Arexvy vaccine which was administered that when it was first injected she had a real sudden strong sensation in the middle of her chest very transient that lasted about 2 seconds and it was gone. The arm she had gotten with different vaccines but it had gotten really sore and red and hot and swollen and today (on the day of reporting) Monday the arm was still the same. She was not used to getting that from a vaccine and was not concerned about that. Several hours later that evening she kind of felt a pain in the right lung sort of in the bottom and intensified a little bit with breathing and it was not like she got a cough or anything like that it was just a pain in the lung. The reporter consent to follow up.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Skin warm
Clinical narrative: Strong sensation in chest; felt a pain in the right lung; Arm redness; Arm soreness; arm hot; arm swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest discomfort in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-AUG-2024, the patient received Arexvy. On 10-AUG-2024, less than a day after receiving Arexvy, the patient experienced chest discomfort (Verbatim: Strong sensation in chest) and pulmonary pain (Verbatim: felt a pain in the right lung). In AUG-2024, the patient experienced erythema of extremities (Verbatim: Arm redness), pain in arm (Verbatim: Arm soreness), extremities hot feeling of (Verbatim: arm hot) and swelling arm (Verbatim: arm swollen). The outcome of the chest discomfort was resolved and the outcome of the erythema of extremities, pain in arm, extremities hot feeling of and swelling arm were not resolved and the outcome of the pulmonary pain was unknown.   It was unknown if the reporter considered the chest discomfort, erythema of extremities, pain in arm, extremities hot feeling of, swelling arm and pulmonary pain to be related to Arexvy.     It was unknown if the company considered the chest discomfort, erythema of extremities, pain in arm, extremities hot feeling of, swelling arm and pulmonary pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-AUG-2024 The patient self-reported this case. The patient informed about Arexvy vaccine which was administered that when it was first injected she had a real sudden strong sensation in the middle of her chest very transient that lasted about 2 seconds and it was gone. The arm she had gotten with different vaccines but it had gotten really sore and red and hot and swollen and today (on the day of reporting) Monday the arm was still the same. She was not used to getting that from a vaccine and was not concerned about that. Several hours later that evening she kind of felt a pain in the right lung sort of in the bottom and intensified a little bit with breathing and it was not like she got a cough or anything like that it was just a pain in the lung. The reporter consent to follow up.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong age/accidentally administered a dose of Kinrix to a 10 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Concomitant products included VAXELIS.   On 07-AUG-2024, the patient received the 1st dose of Kinrix. On 07-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age/accidentally administered a dose of Kinrix to a 10 month 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: 13-AUG-2024 The medical assistant explained they accidentally administered a dose of Kinrix to a 10-month-old patient, which led to an inappropriate age at vaccine administration. A previous dose of Vaxelis was administered on 30-MAY-2024. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 12-AUG-2024, the patient received the 2nd dose of Shingrix. On 13-AUG-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever). In AUG-2024, the patient experienced shivering (Verbatim: Shivering). The patient was treated with ibuprofen. The outcome of the shivering was unknown and the outcome of the fever was resolving.   It was unknown if the reporter considered the shivering and fever to be related to Shingrix.     It was unknown if the company considered the shivering and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 13-AUG-2024 The patient self-reported. She received second dose of Shingrix on Monday 12 August 2024, that night the patient began to experience shivering, and at 3 AM on 13 August 2024, experienced fever.  The patient took her temperature this morning and it was 102 degrees F.  The patient had taken Ibuprofen for the fever which reduces her temperature to 100-101 degrees F.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B, Hepatitis B antibody abnormal, Vaccination failure
Clinical narrative: Suspected vaccination failure; now caring for a family member that has been diagnosed with hepatitis b,; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and hepatitis b (Verbatim: now caring for a family member that has been diagnosed with hepatitis b,) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the hepatitis b was not reported.   It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.     The company considered the vaccination failure to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The company considered the hepatitis b to be unrelated to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.   Additional Information: GSK Receipt Date: 14-AUG-2024 The pharmacist reported that, he had a customer stated they received all three doses of hep. b series in 1996. They were caring for a family member that had been diagnosed with hepatitis b, and so the customer was wondering if she could and should receive the series again.  The pharmacist reported that, the customer not had titers checked, but did mention that the patient (her sister) had titers checked and they were low.  The patient also had the series in the 1990s.  The pharmacist did not had records available, so he was unsure which hepatitis b series the customer and the patient (her sister) received, the dates, or any patient specific information. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Hepatitis B vaccine (Dose 1, 2 and 3). Hepatitis B is an unlisted event which is considered unrelated to GSK Hepatitis B vaccine (Dose 1, 2 and 3).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: blistering; Suspected vaccination failure; Consumer states he out a shingles outbreak in March 2024; had pain for 2 to 3 days; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed with shingles on left lower trunk in 2001, case was very severe with a lengthy duration). Concomitant products included upadacitinib (Rinvoq).   In MAY-2018, the patient received the 2nd dose of Shingrix. In MAR-2018, the patient received the 1st dose of Shingrix. In MAR-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Consumer states he out a shingles outbreak in March 2024). On an unknown date, the patient experienced pain (Verbatim: had pain for 2 to 3 days) and blister (Verbatim: blistering). The outcome of the vaccination failure was not reported and the outcome of the shingles and blister were resolved and the outcome of the pain was resolved (duration 3 days).   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister 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, pain and blister to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2024 The patient self-reported this case. The patient stated in 2018, when he was 64 years old he had both series of Shingrix vaccine administered and he had out a shingles outbreak in March 2024 (lack of effect).  The patient stated that this bout of shingles was in the same location as the previous outbreak (left lower trunk) and the shingles lasted for 5 or 6 weeks before resolving and was less in severity and in duration compared to his first outbreak.   He was prescribed a medication called Rinvoq. The patient had pain for 2 to 3 days and blistering (unspecific amount of time). This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was 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 Shingrix Dose 2.
Sex: U
Vaccine: COVID19, RAB, COVID19, RAB
Symptoms: Brain injury
Clinical narrative: brain injury; This spontaneous case was reported by a patient and describes the occurrence of BRAIN INJURY (brain injury) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN INJURY (brain injury) (seriousness criterion medically significant). At the time of the report, BRAIN INJURY (brain injury) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  Patient received two shots that included one was  rabavert rabies vaccine and other one was booster of Moderna-covid-19 vaccine. Company comment: This is a regulatory authority case concerning a patient of an unknown age and gender with no medical history provided who experienced the unexpected serious (due to medically significant) event of brain injury on unknown day. Patient received two shots that included one was  rabavert rabies vaccine and other one was booster of Moderna-covid-19 vaccine that occurred on unknown date. At the time of the report the event was not resolved.The event is assessed as not related due to lack of information about patient`s medical history, preceding factors and temporal association with the vaccine. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.  Patient had both the shots and patient interpreted that may cause the brain injury.  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19, RAB, COVID19, RAB
Symptoms: Brain injury, Motor dysfunction, Nervous system disorder
Clinical narrative: brain injury; This spontaneous case was reported by a patient and describes the occurrence of BRAIN INJURY (brain injury) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN INJURY (brain injury) (seriousness criterion medically significant). At the time of the report, BRAIN INJURY (brain injury) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  Patient received two shots that included one was  rabavert rabies vaccine and other one was booster of Moderna-covid-19 vaccine. Company comment: This is a regulatory authority case concerning a patient of an unknown age and gender with no medical history provided who experienced the unexpected serious (due to medically significant) event of brain injury on unknown day. Patient received two shots that included one was  rabavert rabies vaccine and other one was booster of Moderna-covid-19 vaccine that occurred on unknown date. At the time of the report the event was not resolved.The event is assessed as not related due to lack of information about patient`s medical history, preceding factors and temporal association with the vaccine. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.  Patient had both the shots and patient interpreted that may cause the brain injury.  No treatment medications provided by the reporter.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: irritable bowel syndrome; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (irritable bowel syndrome) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2020,  after starting , the patient experienced IRRITABLE BOWEL SYNDROME (irritable bowel syndrome). At the time of the report, IRRITABLE BOWEL SYNDROME (irritable bowel syndrome) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Patient stated he had been dealing with Lyme disease as well as irritable bowel syndrome. Also stated that, they want to classify it as Lyme disease, but they hadn't gotten that far yet but just based on his own research, he stated he was diagnosed with irritable bowel syndrome very recently. He has not been diagnosed with Lyme disease but stated he has been doing his own research about where irritable bowel disease took there and that it causes Lyme disease. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Influenza like illness, Pain
Clinical narrative: woke up at morning with discomfort; everything was hurting; She felt like a flu for a little while; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (woke up at morning with discomfort), PAIN (everything was hurting) and INFLUENZA LIKE ILLNESS (She felt like a flu for a little while) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Aug-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Aug-2024, the patient experienced DISCOMFORT (woke up at morning with discomfort), PAIN (everything was hurting) and INFLUENZA LIKE ILLNESS (She felt like a flu for a little while). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Flu like symptoms, at an unspecified dose and frequency. In August 2024, DISCOMFORT (woke up at morning with discomfort), PAIN (everything was hurting) and INFLUENZA LIKE ILLNESS (She felt like a flu for a little while) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient stated it was not really like unexpected. No concomitant medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd August 2023, batch number 274YD, expiry date 15th September 2025).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-AUG-2024 Pharmacist called to report a patient received the first dose of Shingrix in August 2023 and has not received the second dose yet. Reporter mentioned this same situation where patients move from out of state and have received only one dose of Shingrix more than 6 months ago happens lot for her. No further details shared. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Peripheral swelling, Vaccination site pain
Clinical narrative: shortness of breath; her arm was swollen; developed an allergic reaction; vaccine site gets like really bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: JL0446) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative cancer" (ongoing). Concomitant medication(s) included: ARIMIDEX taken for neoplasm malignant. Past drug history included: Polysorbate, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, EWO150), administration date: 08Apr2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "arm got swollen", "shortness of breath", "developed an allergic reaction", "vaccine site gets like really bad"; BNT162b2 (DOSE 2, SINGLE, EW0169), administration date: 26Apr2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "arm got swollen", "shortness of breath", "developed an allergic reaction", "vaccine site gets like really bad"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, EW0186), administration date: 18Aug2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "arm got swollen", "shortness of breath", "developed an allergic reaction", "vaccine site gets like really bad"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, FJ5682), administration date: 07Feb2022, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "arm got swollen", "shortness of breath", "developed an allergic reaction", "vaccine site gets like really bad". The following information was reported: DYSPNOEA (non-serious), outcome "recovered", described as "shortness of breath"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "her arm was swollen"; HYPERSENSITIVITY (non-serious), outcome "recovered", described as "developed an allergic reaction"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "vaccine site gets like really bad". Therapeutic measures were taken as a result of dyspnoea.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240658 Same patient, different vaccine dose and same events.;US-PFIZER INC-202400240660 Same patient, different vaccine dose and same events.;US-PFIZER INC-202400240659 Same patient, different vaccine dose and events.;US-PFIZER INC-202400240656 Same patient, different vaccine dose and events.;US-PFIZER INC-202400240657 Same patient, different vaccine dose and same events.;
Sex: U
Vaccine: UNK
Symptoms: Glaucoma
Clinical narrative: patient then have had glaucoma. Possible drug interaction with Covid-19 vaccine and Xalatan; patient then have had glaucoma. Possible drug interaction with Covid-19 vaccine and Xalatan; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; latanoprost (XALATAN). The patient's relevant medical history and concomitant medications were not reported. The patient informed that the Covid vaccine was so helpful with her during the Covid and was scared to take the covid shots yet have been convinced after a week. The patient then have had glaucoma. Possible drug interaction with Covid-19 vaccine and Xalatan. The action taken for latanoprost was unknown. The outcome of the events was unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Peripheral swelling, Vaccination site pain
Clinical narrative: shortness of breath; vaccine site gets like really bad; her arm was swollen; developed an allergic reaction; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0169) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative cancer" (ongoing). Concomitant medication(s) included: ARIMIDEX taken for tumour ulceration (ongoing). Past drug history included: Polysorbate, reaction(s): "Drug hypersensitivity", notes: I was allergic to Polysorbate. Vaccination history included: BNT162b2 (Dose 1, single, Manufacture unknown, EWO150), administration date: 08Apr2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "shortness of breath". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccine site gets like really bad"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arm was swollen"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "developed an allergic reaction".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240124 Same patient, different vaccine dose and same events.;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Peripheral swelling, Vaccination site pain
Clinical narrative: shortness of breath; arm got swollen; developed an allergic reaction; vaccine site gets like really bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative cancer" (ongoing). Concomitant medication(s) included: ARIMIDEX taken for tumour ulceration (ongoing). Past drug history included: Polysorbate, reaction(s): "allergic to Polysorbate". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, EWO150), administration date: 08Apr2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "shortness of breath"; BNT162b2 (DOSE 2, SINGLE, EW0169), administration date: 26Apr2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "arm got swollen"; BNT162b2 (DOSE 2, SINGLE, EW0169), administration date: 26Apr2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "shortness of breath", "developed an allergic reaction", "vaccine site gets like really bad". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm got swollen"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "developed an allergic reaction"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccine site gets like really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240124 Same patient, different vaccine dose and same events.;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Malaise, Peripheral swelling
Clinical narrative: shortness of breath; her arm was swollen; developed an allergic reaction; the last one was the worse because shortly after getting the injection, I barely made it to the restroom; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Dec2023 as dose 1, single (Lot number: JL0446) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative cancer" (unspecified if ongoing), notes: Ulcerative cancer, it was active cancer then. Concomitant medication(s) included: ARIMIDEX taken for neoplasm malignant. Vaccination history included: BNTb162 (Dose 1, Lot: EWO150), administration date: 08Apr2021, for COVID-19 immunization, reaction(s): "shortness of breath"; BNT162b2 (Dose 2, Lot: EW0169), administration date: 26Apr2021, for COVID-19 immunization, reaction(s): "shortness of breath"; BNT162b2 (Dose 3, Lot: EW0186), administration date: 18Aug2021, for COVID-19 immunization, reaction(s): "shortness of breath"; BNT162b2 (Dose 4, Lot FJ5682), administration date: 07Feb2022, for COVID-19 immunization, reaction(s): "shortness of breath", "allergies"; BNT162b2 (Dose 5, Lot: JL0446), administration date: 27Oct2022, for COVID-19 immunization, reaction(s): "shortness of breath", "developed an allergic reaction", "her arm was swollen". The following information was reported: DYSPNOEA (medically significant), outcome "unknown", described as "shortness of breath"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her arm was swollen"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "developed an allergic reaction"; MALAISE (non-serious), outcome "unknown", described as "the last one was the worse because shortly after getting the injection, I barely made it to the restroom". Therapeutic measures were taken as a result of dyspnoea. Clinical course: the last vaccination was the worst, as shortly after receiving the injection, she barely made it to the restroom.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240124 Same patient, different vaccine dose and same events.;
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Deafness, Vertigo
Clinical narrative: lost 90% of hearing in right ear; balance was approximately 30 percent prior to the Pfizer shots; had a second vertigo attack; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old patient received BNT162b2 (BNT162B2), on 08May2022 as dose 4 (booster), single (Lot number: F54989) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Lot#: 015M20A), administration date: 16Feb2021, when the patient was 77-year-old, for Covid-19 Immunisation; moderna (Dose 2, Lot#: 048A21A), administration date: 19Mar2021, when the patient was 78-year-old, for Covid-19 Immunisation; BNT162b2 (Dose 3 (Booster), Lot#: 3015S8A), administration date: 08Nov2021, when the patient was 78-year-old, for Covid-19 Immunisation, reaction(s): "extreme vertigo". The following information was reported: VERTIGO (non-serious) with onset 2022, 30 days after the suspect product(s) administration, outcome "unknown", described as "had a second vertigo attack"; DEAFNESS (medically significant), outcome "not recovered", described as "lost 90% of hearing in right ear"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance was approximately 30 percent prior to the Pfizer shots". The events "lost 90% of hearing in right ear", "had a second vertigo attack" and "balance was approximately 30 percent prior to the pfizer shots" required physician office visit. At the age of 76, prior to 2021, patient played 5-6 rounds of golf weekly carried an 8.5 golf index and swam nearly daily. Now play golf after the Covid shots one to two times a week. Directed by physician and taking guidance from The Centers for Disease Control and Prevention (CDC), patient took following Covid-19 shots, and experienced the following: After taking the Pfizer shot on 08May2022, patient lost 90 percent of hearing in right ear and had a second vertigo attack 30 days after the shot. To this day patient's hearing had not corrected and patient's balance was approximately 30 percent prior to the Pfizer shots. Patient had followed up with primary care physician and several other physicians and specialists with no positive results. Patient live with loss of hearing and balance issues, and swim several times a week replacing golf with swimming.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400108976 same patient, different event, different dose of vaccine;
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Nausea, Vomiting
Clinical narrative: death; shortness of breath; Nausea; vomiting; Safety information originally reported under manufacturer case 202200798478  has been nullified and re-entered under this new manufacturer report number 202400241010.  This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "acute kidneyfailure" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: prior vaccination. The patient took concomitant medications. Past drug history included: Tramadol, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: NAUSEA (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered"; DEATH (death, medically significant) with onset 04Jun2022 at 17:30, outcome "fatal"; DYSPNOEA (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered", described as "shortness of breath"; VOMITING (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered". The events "death", "shortness of breath", "nausea" and "vomiting" required emergency room visit. Therapeutic measures were not taken as a result of death, dyspnoea, nausea, vomiting. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Covid was not tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (07Jul2022): Follow-up attempts are completed. No further information is expected.  Follow-up (21Aug2024): This is a follow-up report to notify that the case 202200798478 and 202400241010 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400241010.  Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: death
Sex: U
Vaccine: HEPA, PNC20
Symptoms: Pain, Screaming
Clinical narrative: Patient yelled loudly because of the amount of pain; This is a spontaneous report received from a Nurse from a sales representative.  A 12-month-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; hepatitis a vaccine (HEPATITIS A VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Patient yelled loudly because of the amount of pain". It was unknown if therapeutic measures were taken as a result of pain. Additional information: The patient also received chickenpox vaccine on the same day. It was unknown if the patient receives any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nephropathy
Clinical narrative: kidney desease; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 28Mar2022 as dose number unknown, 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: NEPHROPATHY (non-serious), outcome "unknown", described as "kidney desease".  Additional information: On 28Mar2022, the patient took the Pfizer Covid-19 vaccine and as a result, shortly thereafter, developed kidney disease. Prior to the vaccination, the patient stated that was healthy and did not have kidney disease.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Glaucoma
Clinical narrative: Drug ineffective; COVID-19; glaucoma; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; GLAUCOMA (medically significant), outcome "unknown". Clinical course: Reporter mentioned that the Covid vaccine was so helpful with her during the Covid and was scared to take the covid shots yet had been convinced after a week. Reporter then has had glaucoma.  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-202400240591 same patient, different drugs/event;
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: extreme vertigo; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Lot# 015M20A), administration date: 16Feb2021, when the patient was 77-year-old, for COVID-19 immunization; moderna (Dose 2, Lot# 048A21A), administration date: 19Mar2021, when the patient was 78-year-old, for COVID-19 immunization. The following information was reported: VERTIGO (hospitalization) with onset 04Dec2021, outcome "unknown", described as "extreme vertigo". The patient was hospitalized for vertigo (start date: 04Dec2021, discharge date: 06Dec2021, hospitalization duration: 3 day(s)). The event "extreme vertigo" required physician office visit. Clinical course: At the age of 76, prior to 2021, patient played 5-6 rounds of golf weekly carried an 8.5 golf index and swam nearly daily. And now play golf after the Covid shots one to two times a week. Directed by physician and taking guidance from The Centers for Disease Control and Prevention (CDC), patient took following Covid-19 shots, and experienced the following: After taking the Pfizer booster shot on 08Nov2021, patient was hospitalized 27 days later for three days with extreme vertigo.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400240749 same patient, different event, different dose of vaccine;
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Really sick on that trip; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: ILLNESS (non-serious), outcome "unknown", described as "Really sick on that trip". Additional information: the patient received the vaccine in the fall of 2023. The patient went on a family trip and got really sick on that trip.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Ordered and administered Hep A (Havrix) instead of Hep B at 2 months of age. No symptoms or abnormalities noted in pt by parents. Found out about vaccine error at 4 month visit on 8/21/24