chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Asthenia, Discomfort, Hypopnoea, Injected limb mobility decreased
Clinical narrative: Began to react to shot the first night about 3am (9/21, Thursday).  Had swelling and tenderness of axillary lymph nodes and breasts on both sides of body.  Had shallow breathing due to the swelling and pain.  Ended up in a recliner, due to discomfort.  Very uncomfortable and unable to sleep.  Thursday in am, had increased tenderness and swelling which also involved both arms.  Left arm-  being unable to lift left arm above shoulder height.   Took Tylenol extra strength.   Next day Friday, both hips were also extremely sore and painful... I took a flexeril and extra strength Tylenol.  Continued flexural and Tylenol Saturday, Sunday, Monday and Tuesday 9/26/23.   The extreme discomfort, swelling and painful lymph nodes  seem to be gone.  Now just weak, but no pain or swelling.      From Thursday 9/21  through Monday 9/25/23 I spent most of time on bedrest.   No respiratory symptoms.   covid home tests x 2 were negative.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Peripheral swelling, SARS-CoV-2 test negative
Clinical narrative: Began to react to shot the first night about 3am (9/21, Thursday).  Had swelling and tenderness of axillary lymph nodes and breasts on both sides of body.  Had shallow breathing due to the swelling and pain.  Ended up in a recliner, due to discomfort.  Very uncomfortable and unable to sleep.  Thursday in am, had increased tenderness and swelling which also involved both arms.  Left arm-  being unable to lift left arm above shoulder height.   Took Tylenol extra strength.   Next day Friday, both hips were also extremely sore and painful... I took a flexeril and extra strength Tylenol.  Continued flexural and Tylenol Saturday, Sunday, Monday and Tuesday 9/26/23.   The extreme discomfort, swelling and painful lymph nodes  seem to be gone.  Now just weak, but no pain or swelling.      From Thursday 9/21  through Monday 9/25/23 I spent most of time on bedrest.   No respiratory symptoms.   covid home tests x 2 were negative.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Sleep disorder, Tenderness
Clinical narrative: Began to react to shot the first night about 3am (9/21, Thursday).  Had swelling and tenderness of axillary lymph nodes and breasts on both sides of body.  Had shallow breathing due to the swelling and pain.  Ended up in a recliner, due to discomfort.  Very uncomfortable and unable to sleep.  Thursday in am, had increased tenderness and swelling which also involved both arms.  Left arm-  being unable to lift left arm above shoulder height.   Took Tylenol extra strength.   Next day Friday, both hips were also extremely sore and painful... I took a flexeril and extra strength Tylenol.  Continued flexural and Tylenol Saturday, Sunday, Monday and Tuesday 9/26/23.   The extreme discomfort, swelling and painful lymph nodes  seem to be gone.  Now just weak, but no pain or swelling.      From Thursday 9/21  through Monday 9/25/23 I spent most of time on bedrest.   No respiratory symptoms.   covid home tests x 2 were negative.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Chills, Dysphonia, Fatigue, Headache
Clinical narrative: Hoarseness, chest pain, severe headache, mild nausea, chills,mild fever, muscle weakness, fatigue, mild shaking.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Muscular weakness, Nausea, Pyrexia, Tremor
Clinical narrative: Hoarseness, chest pain, severe headache, mild nausea, chills,mild fever, muscle weakness, fatigue, mild shaking.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Contusion
Clinical narrative: PATIENT DESCRIBES BRUISING IN THE ARM.PATIENT DESCRIBES BRUISING AS NEVER SEEN BEFORE
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calls to report PNEUMOVAX 23 lot#u035117  8/18/2023 administered after expiration date.   See AE case 02467053   No further AE.  No PQC  MIR request case 02467042.; Medical assistant calls to report PNEUMOVAX 23 lot#u035117  8/18/2023 administered after expiration date.   See AE case 02467053   No further AE.  No PQC  MIR request case 02467042.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #u035117, expiration date: 18-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 07-SEP-2023, medical assistant called to report pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered after expiration date. See adverse event (AE) case 02467053.  No further AE. No product quality complain (PQC). Request case 02467042.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: HCP calling to report an infant spit up after receiving first dose of ROTATEQ.  HCP reports the mother had just fed the infant and burped them, and this occurred right after administration of ROTATEQ.; accidental underdose; This spontaneous report was received from a registered nurse and refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), first dose, orally (lot #, expiration date, dose and frequency were not reported) for prophylaxis.      On an unknown date, after receiving the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), the patient spit up. The reporter mentioned that the mother had just fed the infant and burped them, and this occurred right after administration of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).   At the reporting time, the outcome of the event infantile spitting up was not reported.The reporter did not provide a causality assessment between the event and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse event; Caller reported VARIVAX was administered to a 4 month old.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report as received from a certified medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031813, expiration date 05-OCT-2024, dose of 0.5 milliliter, subcutaneously in the right thigh, for prophylaxis.No additional adverse events were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Physician reported that a patient developed generalized rashes after receiving the first dose of VARIVAX.   The physician stated that the rashes were resolved and the patient doesn't have the rashes anymore.   No additional AEs were reported. No fur; This spontaneous report was received from a physician and refers to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, strength, dose of administration, anatomical location was not provided) as vaccination.  On an unknown date, after receiving the vaccine, the patient experienced generalized rashes which on unspecified date, were resolved. At the reporting time, the patient did not developed the rashes anymore.  Causality assessment between the rash and varicella virus vaccine live (oka/merck)(VARIVAX) was not reported.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Syringe issue, Vaccination site discharge
Clinical narrative: When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not; When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not; When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 41-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Sep2023 as dose number unknown, single (Lot number: HH7595) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCHARGE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), SYRINGE ISSUE (non-serious) all with onset Sep2023, outcome "unknown" and all described as "When they are trying to give the medication to the patient and pulling the syringe out the medication is leaking. Caller would like to know if the patient received the proper amount of dose or not".   Additional information: The pharmacist called and stated that they are giving the new COVID-19 vaccine (BNT162B2) to the patient. When they are trying to give the medication, and pulled the syringe out, the medication was leaking. The pharmacist would like to know if the patient received the proper amount of dose or not. Further stated that when they tried to administer the vaccine, it was leaking out. The pharmacist wanted to know if the patient should receive another dose.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: In the past, always got reaction from all Pfizer Covid shots she has had/ With every single one of them, was sick for a few days; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 21Sep2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (004756). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "recovered", described as "In the past, always got reaction from all Pfizer Covid shots she has had/ With every single one of them, was sick for a few days". Additional information: Patient was calling about Comirnaty 2023-2024 formula for 12 years and up (Lot number: HG4629). She was concerned whether she got valid dose of vaccine because, she did not have reaction. She was wondering whether she was given prefilled syringe, with no medication in it. In the past, she always got reaction from all Pfizer Covid shots she has had. With every single one of them, she was sick for a few days. This time, she had no reaction at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Influenza, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; has the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 2, single (Lot number: EL9266) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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: INFLUENZA (non-serious) with onset 2023, outcome "not recovered", described as "has the flu"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Sep2023, outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2023) Positive, notes: home test; (29Aug2023) Negative, notes: home test; (20Sep2023) Positive, notes: Rapid test at home.  Clinical course: the patient contracted Covid 19Aug2023 and she was still having symptoms of Covid or she has the flu. It's been a month now. She was supposed to get the Pfizer Covid 19 vaccine on Tuesday 26Sep2023.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CKD (Chronic kidney disease) stage 3" (unspecified if ongoing); "Left bundle branch block" (unspecified if ongoing); "hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Penicillin, reaction(s): "Known allergies: penicillin". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Sep2023 to 18Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308043 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Parosmia, SARS-CoV-2 test
Clinical narrative: Lost my taste; After receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis C back", start date: 2011 (unspecified if ongoing), notes: hepatitis C back in 2011. Concomitant medication(s) included: OXYCODONE; LYRICA; OMEPRAZOLE; ESTRACE; ALBUTEROL HFA; ATROVENT; FLEXERIL [CEFIXIME]; OXYBUTYNIN; MOBIC; AMBIEN. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "Lost my taste"; PAROSMIA (non-serious), outcome "unknown", described as "After receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ageusia.  Additional information: Patient stated, back in 2011, patient had hepatitis C back in 2011 (History). When all first started giving out the COVID shot and that when patient took first shot because she should take it in two phases of first shot. The first shot patient took and lost her taste, and she could smell stuff strong and when she got tested for COVID she did not have COVID. It was asked if any vaccine prior to 4 weeks of vaccination, consumer stated, no, she never took any type of COVID vaccine before that. Consumer stated, treatment for loss of taste, no medicine. Just her basic medicine patient was taking.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308269 same patient, LOE case;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lost my taste; After receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis C back", start date: 2011 (unspecified if ongoing), notes: hepatitis C back in 2011. Concomitant medication(s) included: OXYCODONE; LYRICA; OMEPRAZOLE; ESTRACE; ALBUTEROL HFA; ATROVENT; FLEXERIL [CEFIXIME]; OXYBUTYNIN; MOBIC; AMBIEN. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "Lost my taste"; PAROSMIA (non-serious), outcome "unknown", described as "After receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ageusia.  Additional information: Patient stated, back in 2011, patient had hepatitis C back in 2011 (History). When all first started giving out the COVID shot and that when patient took first shot because she should take it in two phases of first shot. The first shot patient took and lost her taste, and she could smell stuff strong and when she got tested for COVID she did not have COVID. It was asked if any vaccine prior to 4 weeks of vaccination, consumer stated, no, she never took any type of COVID vaccine before that. Consumer stated, treatment for loss of taste, no medicine. Just her basic medicine patient was taking.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308269 same patient, LOE case;
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: lost my taste; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatis C", start date: 2011 (unspecified if ongoing), notes: hepatis C back in 2011 (History). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, The first shot I took I lost my taste), for Covid-19 immunization, reaction(s): "I lost my taste". The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "lost my taste". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The first shot she took she lost her taste, and she could smell stuff strong and when she got tested for COVID she did not have COVID. Then when she took the second shot the same thing happened and again, she did not have COVID, but it was just something that she told the nurse that gave the shot, and she says she was never done like that before. So, she thought of share, reported because the all of that in actual time for anything different but she said you could not be you got to have corona. You must have COVID if you do smell and she said no, she don't have it and she was tested, and she did not have that (further not clarified).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory disease
Clinical narrative: Chronic lung condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Jun2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CHRONIC RESPIRATORY DISEASE (non-serious), outcome "unknown", described as "Chronic lung condition".  Additional information: The reporter was just wanted to know if and when she will be able to get the new Comirnaty vaccines. She said that patient and her husband both received the COVID booster in June of this year on to be exact June 8th of this year and they are just enquiring about a timeframe or when they can receive the new Comirnaty vaccine. Patient had a chronic lung condition. She has taken all of the COVID vaccination booster so far, the last one she had was 08Jun2023. Her husband is 96 and the same goes for him. He does not have the same health issues that Patient do. The question is, are we now both due for the new vaccine booster that is out or do we wait.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, SARS-CoV-2 test
Clinical narrative: Allergic reaction only to covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jan2022 as dose 2 (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, lot number unknown), administration date: Dec2021, when the patient was 11 years old, for covid-19 immunization, reaction(s): "Allergic reaction only to covid vaccine - previously reported". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergic reaction only to covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309430 same reporter/patient, different dose number/events;
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, SARS-CoV-2 test
Clinical narrative: Allergic reaction only to covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer (dose 2, lot number unknown), administration date: Jan2022, when the patient was 11 years old, for COVID-19 immunization; Pfizer (dose 1, lot number unknown), administration date: Dec2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergic reaction only to covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309430 same reporter/patient, different dose number/event;
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node in my neck seems swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Sep2023, outcome "unknown", described as "Lymph node in my neck seems swollen". Additional information: the patient stated "I got the new Covid Vaccine last Thursday and I just wanted to check because yesterday, I had it done in my left arm so my left lymph node seems swollen" and specified that "Not my left arm in my neck like my lymph node in my neck seems swollen. That happened 6 days after I got the shot."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose number unknown, single (Lot number: HG4629) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 20Sep2023, outcome "recovering"; PYREXIA (non-serious) with onset 20Sep2023, outcome "recovering", described as "Fever". Therapeutic measures were taken as a result of dizziness, pyrexia.  Additional information: following vaccination, the patient was feeling dizziness and with fever, took acetaminophen (TYLENOL).
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: My left eye hurt like crazy for 2 weeks; I broke out with a rash over the injection site; I broke out with a rash over the injection site. It was red and itchy; I broke out with a rash over the injection site. It was red and itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: Nov2022, for COVID-19 immunisation. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Jun2023, outcome "unknown", described as "I broke out with a rash over the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jun2023, outcome "unknown", VACCINATION SITE PRURITUS (non-serious) with onset Jun2023, outcome "recovered" (2023) and all described as "I broke out with a rash over the injection site. It was red and itchy"; EYE PAIN (non-serious) with onset Jun2023, outcome "unknown", described as "My left eye hurt like crazy for 2 weeks". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pruritus.  Additional Information: Patient left eye hurt like crazy for 2 weeks after and broke out with a rash over the injection site. It was red and itchy. Patient used Betamethasone for 4 days and the rash stopped itching.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK
Symptoms: Illness
Clinical narrative: I got completely sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: ILLNESS (non-serious), outcome "unknown", described as "I got completely sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN ARM, PAIN, REDNESS, ARM REALLY "HOT"
Age: 62.0
Sex: M
Vaccine: FLUA4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administered wrong dose - patient is 62 y.o. and less than the recommended age for Fluad.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain, Swelling
Clinical narrative: bruising , swelling , pain,
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lip swelling, Rash maculo-papular
Clinical narrative: Onset of pruritic maculopapular rash 2 days after receipt of vaccine.  Seen  the following day at which time also reported sensation of mild lip swelling.  Added 2nd antihistamine to medications along w/ PO steroid.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Pediatric patient briefly fainted for about 5-10 minutes after receiving vaccine. He regained consciousness immediately within a few minutes.  Patient was breathing.  Patient was seated in a chair and allowed to rest. EMT was called. Per mom  boy has low BP and may have reacted to vaccine anxiety.  The boy was given water to drink and a sugar sachet. EMT left after seeing the boy in stable condition. Mom gave him apple juice and a cookie.  After about 1/2 hour once the boy  felt completely normal , mom and the boy left.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received a flu shot instead of the new Covid-19 booster that he made an appointment for. No adverse reaction occurred on the day of vaccination.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Hypertension, Myalgia
Clinical narrative: PATIENTS BLOOD PRESSURE WENT VERY HIGH, SHE GOT DIZZY AND HAD MUSCLE PAIN IN THE NECK AND IN THE BACK
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Wrong product administered
Clinical narrative: Fever, chills  Wrong vaccine - should have received Flublok
Age: 74.0
Sex: F
Vaccine: DTAP
Symptoms: Condition aggravated, Hypersensitivity, Paraesthesia
Clinical narrative: Allergies. Such as when I?m exposed to  regular allergic products plus feeling of pin sticks.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Confusional state, Disorientation, Fatigue
Clinical narrative: Fever reached 102.6 on and off for several hours.  Confusion, loss of memory, disorientation. Extreme fatigue, joint pain.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever reached 102.6 on and off for several hours.  Confusion, loss of memory, disorientation. Extreme fatigue, joint pain.
Age: 70.0
Sex: F
Vaccine: TYP
Symptoms: Muscle spasms, Nausea
Clinical narrative: Nausea, severe cramps in both legs and arms
Age: 0.42
Sex: M
Vaccine: PNC13, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was accidentally given a 3rd dose of Rotarix. He had no adverse reactions and no treatment was needed.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Computerised tomogram, Cranioplasty, Decompressive craniectomy
Clinical narrative: Brain clots which lead to hemorhage on the left side of the brain.  Immediate right side paralysis.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hemiplegia, Hydrocephalus, Magnetic resonance imaging, Thrombectomy, Transfusion
Clinical narrative: Brain clots which lead to hemorhage on the left side of the brain.  Immediate right side paralysis.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ventricular drainage, Ventriculo-peritoneal shunt, Wound treatment, X-ray
Clinical narrative: Brain clots which lead to hemorhage on the left side of the brain.  Immediate right side paralysis.
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC13, DTPPVHBHPB, HIBV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Vaxelis was administered instead of DTaP (infanrix); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2609152-1. The original narrative from the sender is as follows:  It was reported that Vaxelis was administered instead of DTaP (Infantrix).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Vaxelis was administered instead of DTaP (infanrix)". Due to the nature of the event the causal relationship between Vaxelis and the events, "Vaxelis was administered instead of DTaP (infanrix)" is not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Erythema, Influenza A virus test, Influenza B virus test, Irritability
Clinical narrative: Redness mild facial swelling; Redness mild facial swelling; runny nose; congestion, runny nose; fussiness; diarrhea; vomiting seen in ed on 1/20/2023; low grade fever; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2610038-1. The original narrative from the sender is as follows:  The patient experienced redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting and was seen in the ER (emergency room) on 20-JAN-2023. The patient was given Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride), and was tolerating Pedialyte. The patient had no further vomiting, the redness and swelling of the face improved, and was given Tylenol (paracetamol) shortly before discharged from the ED (emergency department) to home.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting". Due to the nature of the event the causal relationship between Vaxelis and the events, " Rapid influenza A test, Rapid influenza B test, RSV (Respiratory syncytial virus) test, and SARS-COV-2 test negative" is not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Respiratory syncytial virus test, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Redness mild facial swelling; Redness mild facial swelling; runny nose; congestion, runny nose; fussiness; diarrhea; vomiting seen in ed on 1/20/2023; low grade fever; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2610038-1. The original narrative from the sender is as follows:  The patient experienced redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting and was seen in the ER (emergency room) on 20-JAN-2023. The patient was given Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride), and was tolerating Pedialyte. The patient had no further vomiting, the redness and swelling of the face improved, and was given Tylenol (paracetamol) shortly before discharged from the ED (emergency department) to home.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting". Due to the nature of the event the causal relationship between Vaxelis and the events, " Rapid influenza A test, Rapid influenza B test, RSV (Respiratory syncytial virus) test, and SARS-COV-2 test negative" is not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Swelling face, Vomiting
Clinical narrative: Redness mild facial swelling; Redness mild facial swelling; runny nose; congestion, runny nose; fussiness; diarrhea; vomiting seen in ed on 1/20/2023; low grade fever; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2610038-1. The original narrative from the sender is as follows:  The patient experienced redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting and was seen in the ER (emergency room) on 20-JAN-2023. The patient was given Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride), and was tolerating Pedialyte. The patient had no further vomiting, the redness and swelling of the face improved, and was given Tylenol (paracetamol) shortly before discharged from the ED (emergency department) to home.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting". Due to the nature of the event the causal relationship between Vaxelis and the events, " Rapid influenza A test, Rapid influenza B test, RSV (Respiratory syncytial virus) test, and SARS-COV-2 test negative" is not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Erythema, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Irritability
Clinical narrative: Redness mild facial swelling; Redness mild facial swelling; runny nose; congestion, runny nose; fussiness; diarrhea; vomiting seen in ed on 1/20/2023; low grade fever; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2610038-1. The original narrative from the sender is as follows:  The patient experienced redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting and was seen in the ER (emergency room) on 20-JAN-2023. The patient was given Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride), and was tolerating Pedialyte. The patient had no further vomiting, the redness and swelling of the face improved, and was given Tylenol (paracetamol) shortly before discharged from the ED (emergency department) to home.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting". Due to the nature of the event the causal relationship between Vaxelis and the events, " Rapid influenza A test, Rapid influenza B test, RSV (Respiratory syncytial virus) test, and SARS-COV-2 test negative" is not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Redness mild facial swelling; Redness mild facial swelling; runny nose; congestion, runny nose; fussiness; diarrhea; vomiting seen in ed on 1/20/2023; low grade fever; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; Lab data: rapid influenza A, B, RSV, COVID; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2610038-1. The original narrative from the sender is as follows:  The patient experienced redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting and was seen in the ER (emergency room) on 20-JAN-2023. The patient was given Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride), and was tolerating Pedialyte. The patient had no further vomiting, the redness and swelling of the face improved, and was given Tylenol (paracetamol) shortly before discharged from the ED (emergency department) to home.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "redness, mild facial swelling, fussiness, low grade fever, congestion, runny nose, and vomiting". Due to the nature of the event the causal relationship between Vaxelis and the events, " Rapid influenza A test, Rapid influenza B test, RSV (Respiratory syncytial virus) test, and SARS-COV-2 test negative" is not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Fever, localized redness on the thigh where vaccines were given, fussiness; Fever, localized redness on the thigh where vaccines were given, fussiness; Fever, localized redness on the thigh where vaccines were given, fussiness; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2611990-1. The original narrative from the sender is the following:  "Fever, localized redness on the thigh where vaccines were given, fussiness".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " Fever, localized redness on the thigh where vaccines were given, fussiness".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Irritability, Pyrexia, Vaccination site erythema
Clinical narrative: Fever, localized redness on the thigh where vaccines were given, fussiness; Fever, localized redness on the thigh where vaccines were given, fussiness; Fever, localized redness on the thigh where vaccines were given, fussiness; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2611990-1. The original narrative from the sender is the following:  "Fever, localized redness on the thigh where vaccines were given, fussiness".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " Fever, localized redness on the thigh where vaccines were given, fussiness".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, UNK, DTPPVHBHPB, UNK
Symptoms: Erythema, Oedema peripheral
Clinical narrative: After administration of vaccines, patient turned extremely red, leg edema; After administration of vaccines, patient turned extremely red, leg edema; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2613851-1. The original narrative from the sender is as follows:  After administration of vaccines, a four-month-old neonate turned extremely red, leg edema.  Due to the nature of the event the causal relationship between Vaxelis and the events, "After administration of vaccines, patient turned extremely red, leg edema" is related.  No further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth at the injection site; Swelling, redness, warmth at the injection site; Swelling, redness, warmth at the injection site; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2614536-1. The original narrative from the sender is as follows:  The patient experienced swelling, redness, warmth at the injection site.  The reporter did not provide and assessment of the causal relationship between Vaxelis and the events, "The patient experienced swelling, redness, warmth at the injection site".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Blood lactic acid, Brain natriuretic peptide normal, Full blood count abnormal, Mean cell volume normal, Platelet count increased
Clinical narrative: Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2618090-1. The original narrative from the sender is as follows:  On 17-Apr-2023, after vaccination with Vaxelis on 14-Apr-2023, a four-month-old neonate experienced seizure like activity-full body shaking upon feeding afternoon bottle (had eaten half of the bottle, or (about 1.5-2 ounces). Afterward the neonate fell asleep for about twenty minutes. The neonate was reported to be in normal state of health upon waking up. He was brought in and had an evaluation in the ER (emergency room) about one hour after the event. At that time, he had a normal physical exam. Lab results were reported as CBC (complete blood count): wnl (within normal limits), Plt (Platelets): 550, MCV (mean corpuscle volume): 50, BMP (basic metabolic panel): wnl (within normal limits), and lactic acid: 2.2.  Due to the nature of the event the causal relationship between Vaxelis and the event, "Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.)" was assessed as related, whereas, the events, "blood lactic acid", "brain natriuretic peptide normal", "full blood count abnormal", "mean cell volume normal", "platelet count increased" were considered not applicable.   No further information is expected.