chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia
Clinical narrative: Headache; chills; numbness in tips of fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 18:00 as dose 1, single (Lot number: HG2282) at the age of 49 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2023 as unk unk, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "low thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "risk of breast cancer" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; WELLBUTRIN; ATENOLOL; RALOXIFENE; LEVOTHYROXINE. Vaccination history included: Covid 19 vaccine (Dose 1, Single, Manufacture: Unknown), for Covid 19 immunization; Covid 19 vaccine (Dose 2, Single, Manufacture: Unknown), for Covid 19 immunization; Covid 19 vaccine (Dose 3 (Booster), Single, Manufacture: Unknown), for Covid 19 immunization; Covid 19 vaccine (Dose 4(Booster), Single, Manufacture: Unknown), for Covid 19 immunization. The following information was reported: HEADACHE (non-serious) with onset 26Oct2023 at 11:30, outcome "recovering"; CHILLS (non-serious) with onset 26Oct2023 at 11:30, outcome "recovering"; HYPOAESTHESIA (non-serious) with onset 26Oct2023 at 11:30, outcome "recovering", described as "numbness in tips of fingers". Therapeutic measures were not taken as a result of headache, chills, hypoaesthesia. Additional information: Concomitant medication was reported as other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The first time she had COVID, had a headache and it felt like her head was about to explode; The first time she had COVID, had a headache and it felt like her head was about to explode; This is a spontaneous report received from a 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) and as dose 2, 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), COVID-19 (medically significant), outcome "unknown" and all described as "The first time she had COVID, had a headache and it felt like her head was about to explode". Clinical course: Caller stated that during her initial call, she was talking about a home COVID test. The COVID home test had dates on it and she noticed it had expired. Then someone told her it was still good. When she used that home test, the liquid in it was like a slime, so she knew it wasn't good, knew she could just throw that away. She received a bio bottle with papers inside to return the vaccine injectable. She got a card recently saying to return it back. It was clarified it was not any vaccine injectable, she was referring to a COVID home test. She was testing because she had COVID. Then the COVID test was bad so she went to one of the walk in clinics and they tested her, and she found out she did have COVID. She had mild symptoms because of it. She was started on Paxlovid. She never had COVID before. She had 2 COVID-19 Vaccines. The nurse was sick and think it was the nurse who brought COVID. She stated they are the only 3 there and nobody else and the nurse had pneumonia but probably had COVID too. The first time she had COVID, had a headache and it felt like her head was about to explode. Then she had taken another COVID-19 booster, but not right after she had COVID. It was a while after her first time having COVID. When she caught COVID second time, the side effects were better. Had a little cough, nagging cough at night, but they gave her something for that. Because it was 3 days of her symptoms, clarifies that is when they started on her Paxlovid. She stated the Paxlovid did good, she had nothing.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective , COVID-19 cannot be excluded,Linked Report(s) : US-PFIZER INC-202300307923 same patient, different drug/event;US-PFIZER INC-202300308269 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 13Oct2023 to 18Oct2023. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19; After receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "After receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for Covid-19; positive, notes: tested positive again for Covid-19 vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  Clinical course: Caller, a consumer was calling in tested positive for Covid-19 vaccine and took full dose of Paxlovid. 5 days later, symptoms are gone and travelled to another state. Tested positive again for Covid-19 vaccine. Asking if it had anything to do with continuing and how long after taking a full course should be taken for testing negative. The reporter confirmed that after receiving the Pfizer COVID vaccines, the caller tested positive for COVID-19, according to the recording.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Her husband has a rash that runs down his leg and while doing research she saw there was a concern that it could be COVID-19 Vaccine related regarding a previous COVID-19 Vaccine he received.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: moderna covid-19 vaccine (DOSE 1, SINGLE), administration date: 06Feb2021, when the patient was 74-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 2, SINGLE), administration date: 06Mar2021, when the patient was 74-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 27Oct2021, when the patient was 75-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 12Apr2022, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Her husband has a rash that runs down his leg and while doing research she saw there was a concern that it could be COVID-19 Vaccine related regarding a previous COVID-19 Vaccine he received.".  Additional information: Her husband has a rash that runs down his leg and while doing research she saw there was a concern that it could be COVID- 19 Vaccine related regarding a previous COVID-19 Vaccine he received. Rash is on her husband's right leg. Previous COVID-19 Vaccines: Caller states her and her husband had a combination of Moderna and Pfizer. Her husband has had quite a few COVID-19 Vaccines. Moderna COVID-19 Vaccine dates: 06Feb2021 06Mar2021 27Oct2021 12Apr2022. The Moderna vaccines are the only ones listed on his vaccine card. He has had Pfizer COVID-19 Vaccines after 12Apr2022, but they are not listed on the card. They stopped putting them on the vaccine card.   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: 59.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 at 12:00 as dose 1, single (Lot number: MG4629) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild, intermittent asthma" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ancef, reaction(s): "known allergies: Ancef". Vaccination history included: bnt162b2 (vaccine lot number: 10006, vaccine dose number: 5, ), administration date: 12Sep2022, when the patient was 58-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: FP4554, vaccine dose number: 4, ), administration date: 12Apr2022, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: FH8027, vaccine dose number: 3, ), administration date: 22Nov2021, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: ER8736, vaccine dose number: 2), administration date: 26Apr2021, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (vaccine lot number: ER8737, vaccine dose number: 1, ), administration date: 05Apr2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Oct2023, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt with the previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 83-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 and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses".  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-202300348067 Same patient, different vaccine dose number, different AE;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt with the previous doses too; 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.  An 83-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too".  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-202300348067 Same patient, different vaccine dose number, different AE;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt with the previous doses too; 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.  An 83-year-old female patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too".  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-202300348067 Same patient, different vaccine dose number, different AE;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt with the previous doses too; 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.  An 83-year-old female patient received bnt162b2 (BNT162B2), as dose 4 (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: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "anxiety attack", "mild fatigue", "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too".  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-202300348067 Same patient, different vaccine dose number, different AE;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt with the previous doses too; 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.  An 83-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too". 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-202300348067 Same patient, different vaccine dose number, different AE;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Rhinorrhoea
Clinical narrative: Headaches; muscle aches; runny nose; fatigue; body aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 14:45 as dose 1, single (Lot number: HG2282) at the age of 42 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 25Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication included: METFORMIN. Vaccination history included: Covid-19 (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 26Oct2023 at 16:00, outcome "recovering", described as "Headaches"; PAIN (non-serious) with onset 26Oct2023 at 16:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 26Oct2023 at 16:00, outcome "recovering"; MYALGIA (non-serious) with onset 26Oct2023 at 16:00, outcome "recovering", described as "muscle aches"; RHINORRHOEA (non-serious) with onset 26Oct2023 at 16:00, outcome "recovering", described as "runny nose". Therapeutic measures were not taken as a result of headache, myalgia, rhinorrhoea, fatigue, pain.  Additional information: No known allergies. No Covid prior vaccination. No other vaccine in four weeks. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient was given this vaccine ( Kinrix and MMRV)  9/7/2023. Was not recorded in system, therefore when mom brought in patient for vaccinations today, the system report states that she needed this vaccine, when in fact she did not. Our Electronic health record did not cross over information to the data base from the 9/7/2023 visit. When I sat down to enter the data in our EHR, I noted that these vaccines were duplicated today.  These vaccines were given again today as well as the influenza vaccine.  So double doses of the Kinrix and MMRV Proquad were given in a1  month and 24 days time frame.  MD was notified as well as our clinic. Mother was also notified after the incident as well.  Patient received a influenza vaccine as well today.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff muscles
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Below site of injection large red, swollen, hot, painful area on arm.  One week later still showing pink but no other symptoms.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, single, Batch/Lot No: Unknown , Location of injection: Arm Left), administration date: 30Jan2021, when the patient was 67-year-old, for COVID-19 immunization; moderna (Dose 2, single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 27Feb2021, when the patient was 67-year-old, for COVID-19 immunization; moderna (Dose 3 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 29Oct2021, when the patient was 68-year-old, for COVID-19 immunization; moderna (Dose 4 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 01Apr2022, when the patient was 68-year-old, for COVID-19 immunization; moderna bivalent (Dose 5 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 23Sep2022, when the patient was 69-year-old, for COVID-19 immunization; moderna bivalent (Dose 6 (Booster), single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 03Jun2023, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2023) Negative; (26Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Oct2023 to 21Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Lip swelling, Rash
Clinical narrative: Minor rash at left hand (injection arm) and slight swelling on left side of lips. Symptoms last for about 2 hours. No treatment. Just monitoring.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not had any symptoms, but received 2 doses of the flu vaccine, over a month apart
Age: 73.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood glucose increased
Clinical narrative: For 3 days after vaccine, patient experienced high blood sugar levels. No changes in diet or lifestyle. No prior acute illness.
Age: 1.25
Sex: M
Vaccine: COVID19, DTAP, FLU4, HIBV, PNC20
Symptoms: Rash, Urticaria
Clinical narrative: patient got hives and rash on face about five minutes after giving vaccines. pt's vitals were checked and stable, pt was watched for increasing rash and resp distress. rash stayed localized to face and after patient was calm he left.
Age: 12.0
Sex: F
Vaccine: COVID19, FLUN4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Fall, Lip injury
Clinical narrative: Child received vaccination and appeared to be in good health. After vaccination, child stood up. When nurse looked back at the child she was on the ground. The fall resulted in a minor injury, including an abrasion and small cut on the bottom lip. Child was responsive immediately after fall. Able to follow commands, sit and stand. BP 110/60 5 minutes after fall.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Head discomfort, Headache, Nausea, Pyrexia
Clinical narrative: Pt 18w2d.  Headache x3 days - located on right sided of forehead and wraps around to ear. Described as pulsating, throbbing and pressure. Unrelieved by Tylenol. Vertigo and dizziness.   Fever, Nausea and vomiting. Facial rash.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Therapeutic product ineffective, Vertigo, Vomiting
Clinical narrative: Pt 18w2d.  Headache x3 days - located on right sided of forehead and wraps around to ear. Described as pulsating, throbbing and pressure. Unrelieved by Tylenol. Vertigo and dizziness.   Fever, Nausea and vomiting. Facial rash.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Fatigue, Feeling hot, Pain, Pruritus
Clinical narrative: tired at first so I slept.  At 1900 I'm hands and wrist inched.  went to bed about 2100.  Felt hot all night , body aches present and hands continued to itch.  In the morning  noticed erythyma and hives on face , hands and arms.  Then saw entire backcoveted in hives as well as legs, thighs, and abdomen.  No dyspnea.  Received methylprednisolone sodium succinate 62.5 mg/ml inj 125 mg IM left gluteus maximus.  Also started on Prednison x 5 days
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: tired at first so I slept.  At 1900 I'm hands and wrist inched.  went to bed about 2100.  Felt hot all night , body aches present and hands continued to itch.  In the morning  noticed erythyma and hives on face , hands and arms.  Then saw entire backcoveted in hives as well as legs, thighs, and abdomen.  No dyspnea.  Received methylprednisolone sodium succinate 62.5 mg/ml inj 125 mg IM left gluteus maximus.  Also started on Prednison x 5 days
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received an MMR vaccine at another clinic on 9/30/23. Received varicella on 10/9/23 at health department. Varicella given too close to MMR vaccine, making varicella dose invalid. Notified mother of child, let her know when to get additional varicella vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: swelling. redness, pain
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Postictal state, Seizure like phenomena, Syncope
Clinical narrative: Syncope and collapse 1 minute after administration with seizure-like activity lasting 30 seconds. Post-ictal state for 30 minutes.
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Laboratory test
Clinical narrative: around the injection site is itchy red and pink; around the injection site is itchy red and pink; at the site not sore but if you touch it might be a little warm; 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 78-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2023, outcome "unknown" and all described as "around the injection site is itchy red and pink"; VACCINATION SITE WARMTH (non-serious) with onset 2023, outcome "unknown", described as "at the site not sore but if you touch it might be a little warm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that she got the COVID vaccine and around the injection site is itchy red and pink wants to know if this is normal or something to be concerned about. It's about 1/3 quarters to 2 inches in diameter the redness it's kind of pink and itchy at the site not sore but if you touch it might be a little warm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick/feels horrible; 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.  An 86-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 27Oct2023, outcome "unknown", described as "felt sick/feels horrible". Therapeutic measures were taken as a result of malaise.  Additional information: Patient was calling about the Pfizer COVID-19 shot that she just received this morning. Patient reported that as soon as she got home, she felt sick, and she wants to know what she could do about it. The patient also wanted to know how long the symptom may last. Additional Context: Had the Pfizer and was so upset. Clarified had the Pfizer Covid 19 shot this morning and as soon as came home she felt sick. Was 86 years old and stated should not give it to older people unless they know it was going to work. Got Pfizer because a couple of friends got sick from Moderna. Had Pfizer two years ago when first came out and did not get sick. Felt horrible. Took Tylenol. Was really scared. Asked if there is anything she can do and how long this last. She did not know what to do.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 10Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023 at 17:00, outcome "not recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  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: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: 3032282), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 20Oct2023 to 24Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351051 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on Paxlovid treatment on unspecified dates in Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350680 same patient, different drug/event (Paxlovid Case);
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb mass, Pharyngeal mass, SARS-CoV-2 test, Thyroid mass
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on Paxlovid treatment on unspecified dates in Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350680 same patient, different drug/event (Paxlovid Case);
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Soy/legumes" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 01Jan2018, stop date: 29Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 19Oct2023 to 24Oct2023.  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-202300350843 same patient, different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, sngle (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Oct2023 to 23Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350712 same patient, different drug/event;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 16Oct2023 to 20Oct2023.   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-202300350724 same patient, different drug/event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 13:00 as dose 1, single (Lot number: HH7595) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Other medical history: Type 2 diabetes; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Oct2023) Positive, notes: tested positive again; (Oct2023) Negative, notes: This after 2 negative tests; (Oct2023) Negative, notes: This after 2 negative tests. Therapeutic measures were taken as a result of covid-19 treatment included paxlovid from 15Oct2023 to 19Oct2023.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; 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 41-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 19Oct2023 to 23Oct2023 as treatment of COVID-19 and received other medications Extra strength Tylenol with pseudoephedrine from 19Oct2023 to 21Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; 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 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid treatment on unspecified dates.  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-202300350934 same patient, different drug/event (Paxlovid case);
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bronchiectesis" (unspecified if ongoing); "long COVID" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoporosisis" (unspecified if ongoing); "Biaxin/Bactrim/Cipro/Levaquin/Sulfa" (unspecified if ongoing). Concomitant medication(s) included: NITROFURANTOIN, start date: Oct2023, stop date: 14Oct2023. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), administration date: 19Oct2022, for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Oct2023 to 22Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350930 same patient, different drug and AE;