chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 30Mar2021 at 12:00 as dose 2, single (Lot number: ER8732), on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3590) and on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 at 12:00 as dose 5 (booster), single (Lot number: AS7144B), in left arm and on 15Jun2023 at 12:00 as dose 6 (booster), single (Lot number: AS7184B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Supp. O2" (unspecified if ongoing); "Chronic Heart Failure" (unspecified if ongoing); "Hypertrophic Obstructive Cardiomyopathy" (unspecified if ongoing); "Pulmonary Hypertension" (unspecified if ongoing); "A-fib" (unspecified if ongoing); "other abnormal heart rhythms" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Peripheral Polyneuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Piroxicam, reaction(s): "Known allergies: Piroxicam"; Benazepril, reaction(s): "Known allergies: Benazepril"; Meloxicam, reaction(s): "Known allergies: Meloxicam". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 25Sep2023-30Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321886 Same patient, different product, different event;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; terrible aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; PAIN (non-serious) with onset 2023, outcome "unknown", described as "terrible aches and pains".  Additional information: Reporter stated that she never took her temperature but had chills, but she had terrible aches and pains, but they all vanished. Reporter mentioned "Two other people that had very similar side effects just like herself". Reporter stated that two friends of her reported the same thing and they never had the same response like this before.  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: Cough, Feeling abnormal, Illness, Malaise, Nausea
Clinical narrative: was feeling as awful as he was; achy all over; nauseous; coughing; they both got really sick; feeling lousy; 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 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose number unknown, single (Lot number: HG4680) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 06Oct2023, outcome "unknown", described as "feeling lousy"; ILLNESS (non-serious) with onset 07Oct2023, outcome "unknown", described as "they both got really sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "was feeling as awful as he was"; PAIN (non-serious), outcome "unknown", described as "achy all over"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; COUGH (non-serious), outcome "unknown", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Her and her husband were exposed to a friend with Covid on Thursday. They got the Covid shot the next day on Friday.  They usually get Moderna, but they were out of Moderna so they got the Pfizer Covid vaccine. Then they both got really sick, Saturday. Her husband tested positive for Covid this morning. She has taken two home Covid test and has been negative twice.  She was feeling as awful as he was, achy all over, nauseous, coughing. Caller had the BioNTech COVID-19 shot on Friday, on COVID vaccination card the number is HG4680, which caller guesses is the lot number. Caller's husband and caller tested at home for Covid, caller's husband is positive, but caller tested negative, but caller has the same symptoms caller's husband has. Caller has been feeling lousy since getting the shot on Friday. Are those side effects of the shot that caller could be feeling lousy?   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: Pain, SARS-CoV-2 test
Clinical narrative: was feeling as awful as he was; achy all over; nauseous; coughing; they both got really sick; feeling lousy; 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 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose number unknown, single (Lot number: HG4680) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 06Oct2023, outcome "unknown", described as "feeling lousy"; ILLNESS (non-serious) with onset 07Oct2023, outcome "unknown", described as "they both got really sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "was feeling as awful as he was"; PAIN (non-serious), outcome "unknown", described as "achy all over"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; COUGH (non-serious), outcome "unknown", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Her and her husband were exposed to a friend with Covid on Thursday. They got the Covid shot the next day on Friday.  They usually get Moderna, but they were out of Moderna so they got the Pfizer Covid vaccine. Then they both got really sick, Saturday. Her husband tested positive for Covid this morning. She has taken two home Covid test and has been negative twice.  She was feeling as awful as he was, achy all over, nauseous, coughing. Caller had the BioNTech COVID-19 shot on Friday, on COVID vaccination card the number is HG4680, which caller guesses is the lot number. Caller's husband and caller tested at home for Covid, caller's husband is positive, but caller tested negative, but caller has the same symptoms caller's husband has. Caller has been feeling lousy since getting the shot on Friday. Are those side effects of the shot that caller could be feeling lousy?   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: 73.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Blood calcium increased, Dizziness, Glomerular filtration rate decreased
Clinical narrative: EGFR was low; Sodium is high; high in calcium; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2023 as dose number unknown, single (Lot number: 370271) for immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GLOMERULAR FILTRATION RATE DECREASED (non-serious) with onset 04Oct2023, outcome "unknown", described as "EGFR was low"; BLOOD SODIUM INCREASED (non-serious) with onset 04Oct2023, outcome "unknown", described as "Sodium is high"; BLOOD CALCIUM INCREASED (non-serious) with onset 04Oct2023, outcome "unknown", described as "high in calcium"; DIZZINESS (non-serious) with onset Oct2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, glomerular filtration rate decreased, blood sodium increased, blood calcium increased.  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: M
Vaccine: COVID19
Symptoms: Chills, Hyperaesthesia, Pain, Pain in extremity
Clinical narrative: Skin sensitivity; Chills; Arm pain; Achiness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. 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: PAIN (non-serious) with onset 08Oct2023, outcome "recovering", described as "Achiness"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "recovering", described as "Arm pain"; CHILLS (non-serious) with onset 08Oct2023, outcome "recovering"; HYPERAESTHESIA (non-serious) with onset 08Oct2023, outcome "recovering", described as "Skin sensitivity". Therapeutic measures were not taken as a result of hyperaesthesia, chills, pain in extremity, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Pyrexia
Clinical narrative: Febrile 102F; Sore armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 10-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose 4, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: COVID prior vaccination. 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: PYREXIA (non-serious) with onset 08Oct2023, outcome "recovered" (Oct2023), described as "Febrile 102F"; AXILLARY PAIN (non-serious) with onset 08Oct2023, outcome "recovered" (Oct2023), described as "Sore armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, axillary pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: The patient had fever, chills, body aches, and headaches; The patient had fever, chills, body aches, and headaches; The patient had fever, chills, body aches, and headaches; The patient had fever, chills, body aches, and headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 22:00 as dose 1, single (Lot number: HG2282) at the age of 31 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 06Oct2023 as dose number unknown, single (Lot number: UT8076JA) for influenza immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROBITUSSIN [MENTHOL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITIN [CLARITHROMYCIN]; BIOTIN. 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. The following information was reported: PAIN (non-serious), PYREXIA (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 07Oct2023, outcome "recovered" (Oct2023) and all described as "The patient had fever, chills, body aches, and headaches". Therapeutic measures were not taken as a result of pain, pyrexia, chills, headache.  Additional information: Concomitant medications (or Other medications in two weeks) also included Womens Multivitamin, Stress Relief Gummies, Vitamin D Gummies. Patient had no known allergies. No COVID prior vaccination. Not tested for COVID post vaccination. Facility type vaccine was Pharmacy or Drug Store. No other vaccines received within four weeks.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 38-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years 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) and as dose 3 (booster), single (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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19 from 30Sep2023 to 04Oct2023.  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: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322298 same patient, different drugs and events;
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 70-year-old female patient (not pregnant) 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 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 Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Sep2023 to 04Oct2023.  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-202300322300 same patient, different drugs and events;
Age: 67.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 06Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Sep2023 at 16:45, outcome "recovered" (02Oct2023) and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: home test showed positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Sep2023 to 04Oct2023. Clinical course: On (PRIVACY) ship on cruise from (PRIVACY) to (PRIVACY), had cough and fever took home test showed positive, went to medical on ship.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment.; interchange of vaccine products; 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 male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; bnt162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 24Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 3 (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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 24Sep2023 to 29Sep2023.  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-202300322656 Same patient/same product, different dose/event;US-PFIZER INC-202300322528 Same patient, different product, different dose/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 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 May2022, outcome "unknown" and all described as "COVID 19 Treatment.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid from 12May2022 to 16May2022 as treatment of COVID-19. Patient had no known allergies.  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-202300322260 same patient, different drug/event;
Age: 51.0
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: gj3277) at the age of 51 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ew0170), in left arm, on 07May2021 as dose 2, single (Lot number: ew0182), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: fh8030), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: fj9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild anxiety" (unspecified if ongoing); "Allergy: sulfa drugs" (unspecified if ongoing); "Allergy: fish, shellfish, banana, avocado, kiwi, persimmon, mushrooms, broccoli" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 29Sep2023 to 04Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322813 same patient, different drug/ event;
Age: 33.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Chest pain, Palpitations, Tachycardia
Clinical narrative: Heart palpitations; tachycardia; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 09Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 09Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "PCOS" (unspecified if ongoing). There were no concomitant medications. 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. The following information was reported: PALPITATIONS (non-serious) with onset 09Oct2023 at 19:00, outcome "recovering", described as "Heart palpitations"; CHEST PAIN (non-serious) with onset 09Oct2023 at 19:00, outcome "recovering"; TACHYCARDIA (non-serious) with onset 09Oct2023 at 19:00, outcome "recovering". The events "heart palpitations", "tachycardia" and "chest pain" required emergency room visit. Therapeutic measures were taken as a result of palpitations, tachycardia, chest pain with "Torodol."  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.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: had covid; had covid; vaccinated 5 times with both Moderna and Pfizer Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 65 years, in arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FG3527), in arm and on 10May2022 as dose 4 (booster), single (Lot number: FK9894), in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2021, outcome "unknown", described as "vaccinated 5 times with both Moderna and Pfizer Covid-19 Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "had covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 02Oct2023 to 05Oct2023 (06 tablets every 12 hours).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322857 same patient/reporter, different drug/AE;
Age: 77.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Headache, Muscle spasms, Rhinorrhoea
Clinical narrative: Muscle cramp; Headache; Little Diarrhea; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Sep2023 at 13:00 as dose number, unknown,single (Lot number: HH7595) at the age of 77 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Sep2023 as dose number, unknown,single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle cramp"; HEADACHE (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "Little Diarrhea"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose". Therapeutic measures were taken as a result of muscle spasms, headache.  Additional information: The patient had COVID shot (Pfizer COVID shot) and also the influenza shot (Name could not be specified) on 03Sep2023. The patient was having reactions from it. She has muscle cramp, headache, little diarrhea, and runny nose. Patient was treated with Tylenol extra strength 500 milligram. Patient was wondering if those are some of the side effects from the shot and also asked how long it will last. Pfizer lot number is HH7595; they have another number LBS1137.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Laboratory test, Thrombosis
Clinical narrative: I had  Blood clot in my armpit; Vaccine administered Intravenously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years intravenous, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCIN), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "Heart disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset Oct2023, 4 days after the suspect product(s) administration, outcome "unknown", described as "I had  Blood clot in my armpit"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Oct2023, outcome "unknown", described as "Vaccine administered Intravenously". The event "i had  blood clot in my armpit" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: (Oct2023) Unknown result. Therapeutic measures were not taken as a result of thrombosis. Clinical course: Patient got the Pfizer Vaccine (Pfizer COVID-19 Vaccine) on Friday and now on Monday four days later he had Blood clot in her armpit. Before that he had the flu shot (Unspecified Flu shot) on Monday. Patient stated that the flu shot was not  the issue it was COVID. He just found out today and was still waiting to see the doctor in the emergency room now. He had Heart disease, that was why he had the COVID Vaccine shot to protect her from getting sick. He just went today for lab test. They did not know yet. He just had done.  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: 46.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: 24 hours of chills; fever; body aches; fatigue; redness at site of injection; itchiness at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years intramuscular, 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 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED., UNKNOWN MANUFACTURER.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "24 hours of chills"; PAIN (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "fever"; VACCINATION SITE PRURITUS (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "itchiness at site of injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "redness at site of injection". Therapeutic measures were not taken as a result of chills, pyrexia, pain,  fatigue, vaccination site erythema, vaccination site pruritus.  Additional information: the patient did not have covid prior to vaccination, and not tested for covid post vaccination.  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: 46.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: 24 hours of chills; fever; body aches; fatigue; redness at site of injection; itchiness at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years intramuscular, 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 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED., UNKNOWN MANUFACTURER.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "24 hours of chills"; PAIN (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "fever"; VACCINATION SITE PRURITUS (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "itchiness at site of injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "redness at site of injection". Therapeutic measures were not taken as a result of chills, pyrexia, pain,  fatigue, vaccination site erythema, vaccination site pruritus.  Additional information: the patient did not have covid prior to vaccination, and not tested for covid post vaccination.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: contacted COVID; contacted COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-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), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contacted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: tested positive, notes: tested positive after getting booster; Weight: approximately 115 (Pounds). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient stated that every single COVID shot that she have gotten and all the booster from top to bottom from the original shot all the way down to the 19Sep2023 dose they have all been Pfizer. The patient further mentioned that she tested positive after getting booster shot. So what happened was she was prescribed Paxlovid by the doctor.  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.
Age: 30.0
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 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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 had no relevant medical history. The patient has no known allergies. 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 27Sep2023 to 01Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: 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 (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glaucoma, Vaccination site erythema, Vaccination site pain
Clinical narrative: glaucoma; Inject site pain and minor redness; Inject site pain and minor redness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 14:00 as dose 1, single (Lot number: HF9275) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "acne" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Allergic to latex" (unspecified if ongoing); "Known allergies: environmental/seasonal" (unspecified if ongoing); "Known allergies: Rabbit meat, some plants" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Known allergies: Rabbit meat, some plants" (unspecified if ongoing). The patient did not receive other vaccines in four weeks. Concomitant medication(s) included: KARIVA; ATIVAN; CALCIUM.  The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 08Oct2023 at 23:00, outcome "recovering" and all described as "Inject site pain and minor redness"; FATIGUE (non-serious) with onset 08Oct2023 at 23:00, outcome "recovering"; GLAUCOMA (medically significant) with onset 09Oct2023, outcome "recovering". The event "glaucoma" required physician office visit.  Clinical course: Inject site pain & minor redness, fatigue, and on 08Oct2023 eye redness on both eyes. Sore on right eye socket. On 09Oct2023, the patient went to an eye doctor and was diagnosed with glaucoma. It was reported that a scheduled surgery is planned to treat the patient in response to the event.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: Wag12325), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: Ew0150), in right arm, on 23Apr2021 as dose 2, single (Lot number: Ew0176), in right arm, on 17Nov2021 as dose 3 (booster), single (Lot number: Fj1620), in right arm and on 18Apr2022 as dose 4 (booster), single (Lot number: Cus374), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hemophilia A (mild)" (unspecified if ongoing); "Known allergies: Contraindicated for aspirin and all products with aspirin" (unspecified if ongoing), notes: Contraindicated for aspirin and all products with aspirin. Concomitant medication(s) included: SIMVASTATIN oral, start date: 01Oct2021, stop date: 07Oct2023; C 1000 oral, start date: 01Jun2020, stop date: 07Oct2023; MULTIVITAMIN 6 oral, start date: 01Jan2021, stop date: 07Oct2023. 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. Treatment included Paxlovid from 08Oct2023.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right 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 immunisation. The patient's relevant medical history included: "sarcoidosis" (unspecified if ongoing); "dermatomyositis" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "allergies: tomatoes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Erytab, reaction(s): "Allergy"; Ciprofloxacin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 30Sep2023 to 04Oct2023 for 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.
Age: 64.0
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 (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Asparagus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (dose 1, single; lot number: EW0153; site: left arm), administration date: 09Apr2021, when the patient was 62-year-old, for COVID-19 immunization; bnt162b2 (dose 2, single; lot number: EW0176; site: left arm), administration date: 30Apr2021, when the patient was 62-year-old, for COVID-19 immunization; bnt162b2 (dose 3 (booster), single; lot number: FH8027; site: left arm), administration date: 20Nov2021, when the patient was 62-year-old, for COVID-19 immunization; bnt162b2 (dose 4 (booster), single; lot number: unknown; site: left arm), administration date: 18Apr2022, when the patient was 63-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (dose 5 (booster), single; lot number: GH9693; site: left arm), administration date: 14Sep2022, when the patient was 63-year-old, 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: (07Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The event was treated with Paxlovid from 01Oct2023 to 05Oct2023. 2 days after finishing Paxlovid course, the patient felt great and tested negative 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 39-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), on 25Mar2021 as dose 2, single (Lot number: ER8732) and on 07Jan2022 as dose 3 (booster), single (Lot number: 33036BD) for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing); "vestibular migraines" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: controlled; "PCOS" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sumatriptan, reaction(s): "known allergies: Sumatriptan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 28Sep2023 to 03Oct2023.