chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) contracted COVID.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter stated his wife received every vaccine that she was eligible to receive. She was blood type O. She contracted COVID. She did receive Moderna COVID19 vaccines. He knows other people who got COVID because they lost their sense of smell and taste. He stated the flu did not do that, but COVID was attack that part in the body. He believed that his wife would have been worse had she not been vaccinated with Moderna's vaccines.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: she has experienced a soreness whenever she lays down on her left arm/shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (she has experienced a soreness whenever she lays down on her left arm/shoulder) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced ARTHRALGIA (she has experienced a soreness whenever she lays down on her left arm/shoulder). At the time of the report, ARTHRALGIA (she has experienced a soreness whenever she lays down on her left arm/shoulder) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  She had received 5 doses of the Moderna COVID-19 vaccines on: 3-MAR-2021 with lot number 038K20A, On 31-MAR-2021, lot number 023M20A, On 26-NOV-2021, lot number 058H21A, On 2-MAY-2022, lot number 056M21A.  On 20-SEP-2022, lot number AS7148B After receiving the injection of the Moderna vaccine on 2MAY2022 she had experienced a soreness whenever she lays down on her left arm/shoulder. Other times if she' sleeping it hurts so bad that it wakes her up.  No vaccines 4 weeks prior to COVID-19 vaccines. No medications or treatments provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: tested positive for Covid this week; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid this week) in a 62-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 000000) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure high (High blood). Previously administered products included for Product used for unknown indication: COVID-19 vaccine (1st dose) in January 2021, COVID-19 vaccine (2nd dose) in February 2021, COVID-19 vaccine (3rd dose) in November 2021, COVID-19 vaccine (4th dose) in July 2022, PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5) (5th dose) on 15-Oct-2022, COVID-19 vaccine (6th dose - late Mar-2023) in March 2023 and Albiterol. Past adverse reactions to the above products included No adverse event with Albiterol, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, PFIZER BIONTECH COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/5). Concurrent medical conditions included Asthma.  On 26-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 03-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (tested positive for Covid this week). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 04-Oct-2023 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid this week) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2023, Body temperature: Eleveated temperature at 99.5. On 03-Oct-2023, SARS-CoV-2 test: Positive and Negative. On 04-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received new vaccine last Tuesday, 26-Sep-2023, and tested positive for Covid this week. He stated that he was not blaming the vaccine for this and in fact he was pro vaccine. He asked if this negates the effect of the vaccine since he had the disease very close to the time, he got the vaccine.  On 02-Oct-2023, the patient started having symptoms of scratchy throat and elevated temperature at 99.5 and took a home test on 03-Oct-2023 which turned positive. He went to an Urgent Care where they took a "quick test" and a PCR. The quick test turned negative, and he was still awaiting for the results of the PCR. He again did a home test on Wednesday, 04-Oct-2023 which was still positive. He was taking Paxlovid, and he states that his symptoms are negligible, and he is attributing it to the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-744329 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744329:Mother's case, Same reporter
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Skin is red, tender, and warm to the touch at the injection site; Skin is red, tender, and warm to the touch at the injection site; Skin is red, tender, and warm to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Skin is red, tender, and warm to the touch at the injection site), VACCINATION SITE PAIN (Skin is red, tender, and warm to the touch at the injection site) and VACCINATION SITE WARMTH (Skin is red, tender, and warm to the touch at the injection site) in a 27-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) in 2022.    On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced VACCINATION SITE ERYTHEMA (Skin is red, tender, and warm to the touch at the injection site), VACCINATION SITE PAIN (Skin is red, tender, and warm to the touch at the injection site) and VACCINATION SITE WARMTH (Skin is red, tender, and warm to the touch at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Skin is red, tender, and warm to the touch at the injection site), VACCINATION SITE PAIN (Skin is red, tender, and warm to the touch at the injection site) and VACCINATION SITE WARMTH (Skin is red, tender, and warm to the touch at the injection site) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Patient skin was red, tender, and warm to the touch at the injection site and was Painful to the touch.  It was unknown if the patient had experienced any additional symptoms/events.  The patient had no medical history, concomitant disease or risk factor. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Sex: M
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: side effects experiencing after receiving the new Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects experiencing after receiving the new Moderna COVID-19 vaccine) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects experiencing after receiving the new Moderna COVID-19 vaccine). At the time of the report, ADVERSE DRUG REACTION (side effects experiencing after receiving the new Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact.
Sex: U
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: have no feeling down my left arm at all and it's getting weaker; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (have no feeling down my left arm at all and it's getting weaker) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced HYPOAESTHESIA (have no feeling down my left arm at all and it's getting weaker). At the time of the report, HYPOAESTHESIA (have no feeling down my left arm at all and it's getting weaker) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2023: Live follow-up received on 08-Oct-23: reference numbers were added.
Sex: U
Vaccine: UNK
Symptoms: Fatigue, Pyrexia, Urticaria
Clinical narrative: Hives from shoulder to elbow for 6 days; Fatigue; Fever; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives from shoulder to elbow for 6 days), FATIGUE (Fatigue) and PYREXIA (Fever) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives from shoulder to elbow for 6 days), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, URTICARIA (Hives from shoulder to elbow for 6 days), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Left injection site arm hurts; slight fever; sore left arm/arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm/arm hurts), PYREXIA (slight fever) and VACCINATION SITE PAIN (Left injection site arm hurts) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021424A, 939905, 010A21A and 3032264) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore left arm/arm hurts). In March 2021, the patient experienced PYREXIA (slight fever). In November 2021, the patient experienced VACCINATION SITE PAIN (Left injection site arm hurts). At the time of the report, PAIN IN EXTREMITY (sore left arm/arm hurts), PYREXIA (slight fever) and VACCINATION SITE PAIN (Left injection site arm hurts) outcome was unknown.            Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744784 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744784:Bivalent Case
Sex: U
Vaccine: COVID19
Symptoms: Muscle atrophy, Pericarditis, Vocal cord disorder
Clinical narrative: Pericarditis; Damaged his vocal chords; Muscle wastage; This serious initial spontaneous safety report was received by Novavax on 06-OCT-2023 from a consumer, via social media monitoring.  A male of an unspecified age and race was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  The individual was reported as "healthy and well prior." No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced pericarditis (PT: Pericarditis) (Serious: Medically Significant), he damaged his vocal chords (PT: Vocal cord disorder), and he developed muscle wastage (PT: Muscle atrophy).  At the time of reporting, the event outcome of Pericarditis, Vocal cord disorder, and Muscle atrophy was unknown.  Lot number was not provided in the report.; Sender's Comments: This male of an unspecified age experienced: Pericarditis, Muscle atrophy and Vocal cord disorder after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Pericarditis was assessed as serious. The events Muscle atrophy and Vocal cord disorder were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Sex: M
Vaccine: HEP
Symptoms: Alopecia, Blister, Blood bilirubin increased, Decreased appetite, Dehydration
Clinical narrative: ,turned white and swollen at time of injection follwed by Rash All Over ,Pain ,Blitstering opening sores ,puss ,Dehydration,loss of consciousness,weight loss,face ,contact intching. And pain swelling on side of injections site.loss of appetite,Jaundice.loss of hair swelling at injection site. Eczematous condition,Extreme hospitalizations visits ,triamcinalone,hydrocortisone etc  High bilirubin Bililite
Sex: M
Vaccine: HEP
Symptoms: Eczema, Hyperbilirubinaemia, Injection site swelling, Jaundice, Loss of consciousness
Clinical narrative: ,turned white and swollen at time of injection follwed by Rash All Over ,Pain ,Blitstering opening sores ,puss ,Dehydration,loss of consciousness,weight loss,face ,contact intching. And pain swelling on side of injections site.loss of appetite,Jaundice.loss of hair swelling at injection site. Eczematous condition,Extreme hospitalizations visits ,triamcinalone,hydrocortisone etc  High bilirubin Bililite
Sex: M
Vaccine: HEP
Symptoms: Pain, Pallor, Phototherapy, Pruritus, Pustule
Clinical narrative: ,turned white and swollen at time of injection follwed by Rash All Over ,Pain ,Blitstering opening sores ,puss ,Dehydration,loss of consciousness,weight loss,face ,contact intching. And pain swelling on side of injections site.loss of appetite,Jaundice.loss of hair swelling at injection site. Eczematous condition,Extreme hospitalizations visits ,triamcinalone,hydrocortisone etc  High bilirubin Bililite
Sex: M
Vaccine: HEP
Symptoms: Rash, Swelling, Weight decreased, Wound
Clinical narrative: ,turned white and swollen at time of injection follwed by Rash All Over ,Pain ,Blitstering opening sores ,puss ,Dehydration,loss of consciousness,weight loss,face ,contact intching. And pain swelling on side of injections site.loss of appetite,Jaundice.loss of hair swelling at injection site. Eczematous condition,Extreme hospitalizations visits ,triamcinalone,hydrocortisone etc  High bilirubin Bililite
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pfizer Covid-19 vaccine (5yrs-11yrs) given to 13 yr old instead of Comirnaty Covid vaccine (12+ yrs). Reported event to Pfizer, was told to repeat vaccination 8 weeks from last dose to ensure full immunity.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Fever >101F, chills,  joint pain, severe head ache
Age: 7.0
Sex: M
Vaccine: DTAP, FLUA4
Symptoms: Induration, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 101.5 fever, nausea,  significant bilateral arm pain. Both deltoid areas severely hot to touch, very swollen to the point of being firm, and very painful to touch.
Age: 7.0
Sex: M
Vaccine: DTAP, FLUA4
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: 101.5 fever, nausea,  significant bilateral arm pain. Both deltoid areas severely hot to touch, very swollen to the point of being firm, and very painful to touch.
Age: 7.0
Sex: M
Vaccine: DTAP, FLUA4
Symptoms: Tenderness
Clinical narrative: 101.5 fever, nausea,  significant bilateral arm pain. Both deltoid areas severely hot to touch, very swollen to the point of being firm, and very painful to touch.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: expiration of vaccine:2/4/2026 first day: soreness, red around injection site  Second thru 9/22/23: Red area became the size of 10 inches down my arm & 6 inches around my arm, very red, hot, sore. This area was very swollen like a giant red angry lump on my arm, almost looked like the vaccine ran down my arm inside my arm and cause the swelling, redness and soreness.  9/23-26/23: swelling and redness and soreness getting less each day for 3 days 9/26/23 - 10/7: injection site has a knot inside arm and it is painful, wakes me up with pain.  slowly got less but still a little painful if rubbed, had to put off a covid shot due to the knot and pain.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Sleep disorder
Clinical narrative: expiration of vaccine:2/4/2026 first day: soreness, red around injection site  Second thru 9/22/23: Red area became the size of 10 inches down my arm & 6 inches around my arm, very red, hot, sore. This area was very swollen like a giant red angry lump on my arm, almost looked like the vaccine ran down my arm inside my arm and cause the swelling, redness and soreness.  9/23-26/23: swelling and redness and soreness getting less each day for 3 days 9/26/23 - 10/7: injection site has a knot inside arm and it is painful, wakes me up with pain.  slowly got less but still a little painful if rubbed, had to put off a covid shot due to the knot and pain.
Age: 40.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 16:00 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Quinolone antibiotics, reaction(s): "Known allergies: quinolone antibiotics". 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; Covid-19 vaccine (DOSE 6 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Oct2023) Positive, notes: Rebound COVID symptoms and positive testing. Therapeutic measures were 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.  Clinical course: The patient tested positive for covid-19 on an unspecified date. He was treated with PAXLOVID from 26Sep2023 to 30Sep2023 He later experienced Rebound COVID symptoms and positive testing, mild so far, rebound symptoms began four days after final PAXLOVID dose (04Oct2023).  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:  ~~~
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: dizziness; nausea; headache; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 10:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ORTHO-CEPT. The following information was reported: DIZZINESS (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering"; FATIGUE (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering", described as "extreme fatigue"; HEADACHE (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering"; NAUSEA (non-serious) with onset 05Oct2023 at 07:00, outcome "recovering". Therapeutic measures were not taken as a result of dizziness, nausea, headache, fatigue.  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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years 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: "Chronic Sensory Neuropathic Cough" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Sep2023) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: finished the medication on Wednesday and tested negative on Saturday. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 02Sep2023 to 06Sep2023 as COVID 19 Treatment.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320654 same patient, different drug/event;
Age: 17.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Head injury, Syncope, Tooth fracture
Clinical narrative: fainted; broke a tooth; hit her head; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 17 years for covid-19 immunisation; influenza vaccine (FLUVACCIN), on 06Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH FRACTURE (medically significant) with onset 06Oct2023, outcome "recovering", described as "broke a tooth"; SYNCOPE (medically significant) with onset 06Oct2023, outcome "recovering", described as "fainted"; HEAD INJURY (non-serious) with onset 06Oct2023, outcome "recovering", described as "hit her head". The events "fainted", "broke a tooth" and "hit her head" required emergency room visit. Therapeutic measures were taken as a result of tooth fracture, head injury. Clinical course: It was unknown that patient received any other vaccines within 4 weeks prior to the COVID vaccine. 17-year-old adolescent had the Pfizer COVID and flu vaccination. She returned home where she fainted and hit her head and broke a tooth and was taken to the emergency room. Adverse event treatment: Stitches, tooth removal. It was unknown that that prior to vaccination, was the patient diagnosed with COVID-19. It was unknown, since the vaccination, has the patient been tested for COVID-19?: Unknown.  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation
Clinical narrative: Body irritation/itching, especially back and scalp; Body irritation/itching, especially back and scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Minor Afib" (unspecified if ongoing). The patient's 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, manufacturer unknown), for COVID-19 immunization. The following information was reported: SKIN IRRITATION (non-serious), PRURITUS (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "Body irritation/itching, especially back and scalp". Therapeutic measures were not taken as a result of skin irritation, pruritus. Additional information: The current dose is patient's 4th COVID-19 vaccine. Patient has no drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for 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.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Decreased appetite, Fatigue
Clinical narrative: Fatigue; chills; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 06Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 29Sep2023 as dose number unknown, single. The following information was reported: FATIGUE (non-serious) with onset 06Oct2023 at 16:00, outcome "recovering"; CHILLS (non-serious) with onset 06Oct2023 at 16:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 06Oct2023 at 16:00, outcome "recovering", described as "loss of appetite". Therapeutic measures were not taken as a result of fatigue, chills, decreased appetite. Additional information: no known allergies.  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: Dizziness, Nausea
Clinical narrative: nauseousness; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 15:30 as dose 1, single (Lot number: HG2282), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Statin drugs" (unspecified if ongoing). There were no concomitant medications. 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: DIZZINESS (non-serious) with onset 06Oct2023 at 17:00, outcome "recovering"; NAUSEA (non-serious) with onset 07Oct2023, outcome "recovering", described as "nauseousness". Therapeutic measures were not taken as a result of dizziness, nausea.
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hoshimotos thyroid disease (hypothyroidism)" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder, start date: 01Sep2010; ZOLOFT taken for depression, start date: 01Nov2021. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 2023 to 2023.  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-202300320619 same patient, different drug and event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got COVID; I got COVID; 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, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Consumer stated, they got COVID, they had all 6 of vaccines that were available up until this latest one. Patient had two of the Bivalents but not the latest one, they were all Pfizer Vaccines. Patient got COVID couple of weeks ago, was prescribed Paxlovid.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321075 same patient, different drug/AE;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Lip swelling
Clinical narrative: allergic reaction; numbness on her lips; lips started swelling; 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 70-year-old female patient received bnt162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EK4176) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction"; LIP SWELLING (non-serious) with onset 2021, outcome "unknown", described as "lips started swelling"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "unknown", described as "numbness on her lips". Therapeutic measures were taken as a result of hypersensitivity, hypoaesthesia oral, lip swelling.  Additional Information: Patient is reporting side effects to her previous doses of the Pfizer COVID-19 vaccine. She said all of her COVID-19 vaccine have been Pfizer Products. She said a total of five doses. She said when she got her first dose, she started to develop an allergic reaction. She got numbness on her lips and her lips started swelling. She was at the hospital when it occurred and they treated her with an anti-histamine and they observed her for an hour.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: she developed the fluttering heart 2 weeks later; 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 72-year-old female patient received bnt162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EK4176), administration date: 15Jan2021, for COVID-19 immunisation, reaction(s): "allergic reaction of numbness and swelling of her lips", "allergic reaction of numbness and swelling of her lips", "allergic reaction of numbness and swelling of her lips"; bnt162b2 (DOSE 2, SINGLE), administration date: 10Feb2021, for COVID-19 immunisation, reaction(s): "no reaction"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: 301US8A), administration date: 29Sep2021, for COVID-19 immunisation, reaction(s): "she developed the fluttering heart". The following information was reported: CARDIAC FLUTTER (medically significant) with onset Apr2022, outcome "unknown", described as "she developed the fluttering heart 2 weeks later". Therapeutic measures were not taken as a result of cardiac flutter. Clinical course: She said on her last three doses, she took an anti-histamine prior to getting those doses. Before her last three dose of this Pfizer COVID-19 vaccine, she took an anti-histamine prior to getting those doses and she did not have an allergic reaction. However, she develops fluttering of the heart two weeks later. She developed a fluttering heart two weeks later, on all of three of her last doses.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320687 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321099 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321098 same patient/vaccine, different dose number/event;
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Oct2023 to 05Oct2023.  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: 71.0
Sex: F
Vaccine: COVID19, 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 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Aug2023 at 13:30 as dose 6 (booster), single (Lot number: GNO928) at the age of 71 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2023) negative, notes: On day 7 after completing Paxlovid I still had a stuffy nose and tested with an  at-home-test kit negative; (07Oct2023) positive, notes: On day 9 I tested again because I woke up with laryngitis and was positive with an at-home-test kit. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Aug2023 at 12:00 as dose 6 (booster), single (Lot number: GM1767) at the age of 69 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN, start date: 01Jan2023, stop date: 02Oct2023; BABY ASPIRIN, start date: 01Jan2023, stop date: 03Oct2023; FEXOFENADINE HYDROCHLORIDE, start date: 01Jan2023, stop date: 08Oct2023; MULTIVITAMIN [VITAMINS NOS], start date: 01Jan2023, stop date: 08Oct2023; VALSARTAN HCTZ, start date: 01Jan2023, stop date: 08Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid (lot number: GF6049) from 04Oct2023 to 08Oct2023.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: very hard heart palpitations/She had her oximeter thing that she places on her finger and her pulse was 177.; very hard heart palpitations/She had her oximeter thing that she places on her finger and her pulse was 177.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: before any of the Pfizer shots. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1; Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (Dose 2; Lot: EW0172), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (Dose 3; Lot: FE35 then it looks like a percent sign after so she is not sure of the lot number for this dose), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (Dose 4; Lot: FM7553), administration date: 13Jun2022, when the patient was 74-year-old, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (Dose 5; Lot: GJ5342), administration date: 21Sep2022, when the patient was 74-year-old, for COVID-19 Immunization; Flu shot, administration date: Sep2023, for Immunization (she had the flu shot (it is the one for older citizens), had this flu shot a week before the most recent covid shot, clarified as she got the flu shot on 28Sep2023 or 29Sep2023). The following information was reported: PALPITATIONS (medically significant), HEART RATE INCREASED (medically significant) all with onset 04Oct2023, outcome "recovering" and all described as "very hard heart palpitations/She had her oximeter thing that she places on her finger and her pulse was 177.". Clinical course: She had a Pfizer covid shot on Tuesday, she called it a booster but it is the new current covid shot that is out. She is having a fairly strong reaction. She has reacted to all the Pfizer shots she has had. She also had covid before any of the Pfizer shots. Her reaction this time was different than other times, describes her reaction as having very hard heart palpitations. She had her oximeter thing that she places on her finger and her pulse was 177. The patient underwent the following laboratory tests and procedures: Heart rate: (04Oct2023) 177, notes: Result: 177; Unit: Not Provided.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269511 same patient/drug, different dose/AE;