chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: He has chills; He probably got a fever/fever was 100.6 (unit not reported); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 89-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 89 years, in arm for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (Dose 3), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 2), for COVID-19 immunization; Pfizer covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 05Nov2023, outcome "unknown", described as "He has chills"; PYREXIA (non-serious) with onset 05Nov2023, outcome "unknown", described as "He probably got a fever/fever was 100.6 (unit not reported)". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient's spouse reported that they got the shot on 04Nov2023. The vaccine was administered to the patient in the upper arm. Reportedly, the patient woke the next morning and said he has chills and that he probably got a fever. It was confirmed that the patient's fever was 100.6 (unit not reported). 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, FLUX
Symptoms: Chills, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Severe chills; nausea; headache; extreme fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 10:45 as dose 1, single (Lot number: HJ7221), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Nov2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Gerd" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HCT; TYLENOL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered", described as "Severe chills"; FATIGUE (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 04Nov2023 at 13:00, outcome "not recovered" and all described as "injection site pain and swelling"; NAUSEA (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered". Therapeutic measures were not taken as a result of chills, nausea, headache, fatigue, vaccination site pain, vaccination site swelling.  Additional information: Patient took also Vitamins.  No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site swelling
Clinical narrative: Severe chills; nausea; headache; extreme fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 10:45 as dose 1, single (Lot number: HJ7221), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Nov2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Gerd" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HCT; TYLENOL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered", described as "Severe chills"; FATIGUE (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 04Nov2023 at 13:00, outcome "not recovered" and all described as "injection site pain and swelling"; NAUSEA (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered". Therapeutic measures were not taken as a result of chills, nausea, headache, fatigue, vaccination site pain, vaccination site swelling.  Additional information: Patient took also Vitamins.  No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1 , single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Oct2023 to 29Oct2023.  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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300356711 Same patient, different product, different dose/event;
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 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Sep2023 as dose 1, single (Lot number: HG4629), in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer - removed in surgery 2013", start date: 2013 (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 2013; CHLORTHALIDONE, start date: Apr2023. Vaccination history included: pfizer / biontech (Dose Number: 6, Batch/Lot No: GK1337, Location of injection: Arm Right), administration date: 24Apr2023, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 5, Batch/Lot No: GH9693, Location of injection: Arm Right), administration date: 27Sep2022, when the patient was 66-year-old, for covid-19 immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 4, Batch/Lot No: FK9894, Location of injection: Arm Left), administration date: 16Apr2022, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 3, Batch/Lot No: Ff8841, Location of injection: Arm Left), administration date: 30Sep2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Right), administration date: 18Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "COVID-19".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: sore entry point; 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 79-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore entry point". Additional information included: No reaction but a sore entry point. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy Mango" (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 Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 27Oct2023 to 31Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357108 same patient, different drug/event;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 27Oct2023 to 02Nov2023.  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-202300357905 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: was sick for a week; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "was sick for a week". Additional information: Her son and daughter in law both got the flu and covid vaccines at the same time and got one in each arm and her daughter in law always is sick after the flu shot and this the caller does not know whether the daughter in law got the Moderna or Pfizer covid vaccine and caller thinks it was the Pfizer but the daughter in law was sick for a week; caller declined to complete a report on her daughter in law or her son.  Her son did not get sick at all with the flu shot and it is unknown if her son got the Pfizer or Moderna covid vaccine.    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: COVID19
Symptoms: Feeling cold, Peripheral coldness
Clinical narrative: 06Nov2023 Patient c/o her hands, thighs, legs, and feet feeling really cold.; 06Nov2023 Patient c/o her hands, thighs, legs, and feet feeling really cold.; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: HF9300) at the age of 73 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "gastritis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine; Phenergan, reaction(s): "known allergies: Phenergan", notes: known allergies: Phenergan. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING COLD (non-serious), PERIPHERAL COLDNESS (non-serious) all with onset 03Nov2023, outcome "recovering" and all described as "06Nov2023 Patient c/o her hands, thighs, legs, and feet feeling really cold.". Therapeutic measures were not taken as a result of feeling cold, peripheral coldness. Additional information: Patient c/o her hands, thighs, legs, and feet feeling really cold. She stated that it started on 03Nov2023 and has gotten some better today. No COVID prior vaccination. Not COVID tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Tinnitus
Clinical narrative: severe tinnitus symptoms; His are very debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 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 and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "severe tinnitus symptoms"; ASTHENIA (non-serious), outcome "unknown", described as "His are very debilitating".  Additional information: the reporter and her husband (patient) received the covid vaccine and we are both experiencing severe tinnitus symptoms. His are very debilitating. The wife would like to know if they woulll they ease up and is there something they can do for help and relief. Its been over 10 days.  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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, 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 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "asthma secondary to them" (unspecified if ongoing); "elevated cholesterol" (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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: elevated. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Oct2023 to 21Oct2023.  Additional information: Patient had 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable consumer. The reporter is the patient. A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient has no known allergies. Patient received PAXLOVID from 20Oct2023 to 25Oct2023 for COVID-19 Treatment. Outcome of the events was 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: 49.0
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) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:00 as dose 1, single (Lot number: HG4664) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Cataracts" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hiatal hernia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GH9703, Location of injection: Arm Right), administration date: 04Oct2022, when the patient was 48-year-old, for Covid-19 Immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: FF2589, Location of injection: Arm Right), administration date: 01Oct2021, when the patient was 47-year-old, for Covid-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Right), administration date: 08Jan2021, when the patient was 47-year-old, for Covid-19 Immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right), administration date: 18Dec2020, when the patient was 47-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2023) Positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (paxlovid).  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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (COVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 11:00 as dose 1, single (Lot number: HD9876) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 14Sep2022 at 12:15 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-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 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid vaccine (dose 5), for covid-19 immunisation; Covid vaccine (dose 4), for covid-19 immunisation; Covid vaccine (dose 3), for covid-19 immunisation; Covid vaccine (dose 2), for covid-19 immunisation; Covid vaccine (dose 1), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 29Oct2023 to 02Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Bone pain, Dizziness, Feeling hot
Clinical narrative: bones started to ache; really sick to the stomach; felt hot and kind of weak and sweaty; not feeling good; nausea; dizziness; felt hot and kind of weak and sweaty; felt hot and kind of weak and sweaty; 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 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 2, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 3, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 4, unknown manufacturer), for covid-19 immunisation. The following information was reported: BONE PAIN (non-serious), outcome "not recovered", described as "bones started to ache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "really sick to the stomach"; HYPERHIDROSIS (non-serious), ASTHENIA (non-serious), outcome "recovered" and all described as "felt hot and kind of weak and sweaty"; FEELING HOT (non-serious), outcome "unknown", MALAISE (non-serious), outcome "unknown" and all described as "not feeling good"; NAUSEA (non-serious), outcome "recovered"; DIZZINESS (non-serious), outcome "recovered". Additional information: patient was calling about COMIRNATY 2023-2024. She reported that she had a reaction where her bones started to ache, caller got really sick to the stomach, felt hot and kind of weak and sweaty. Patient stated that she was still experiencing bone pain and generally not feeling good. She stated that she wanted to know if there was any lasting issue about this. Patient didn't have anything else but the bone pain and she was hoping that this won't last long. She added that her weakness, nausea, sweating and dizziness only lasted for 5 minutes but the bone pain had been going on since. Patient stated that she exercises everyday and she is not the type to sit down and do not feel like doing anything right now. Caller mentioned that this is her fifth shot and the first time she experienced these side effects after the shot. Patient wants to know how long will the bone pain may last.  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: Hyperhidrosis, Malaise, Nausea
Clinical narrative: bones started to ache; really sick to the stomach; felt hot and kind of weak and sweaty; not feeling good; nausea; dizziness; felt hot and kind of weak and sweaty; felt hot and kind of weak and sweaty; 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 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 2, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 3, unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 4, unknown manufacturer), for covid-19 immunisation. The following information was reported: BONE PAIN (non-serious), outcome "not recovered", described as "bones started to ache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "really sick to the stomach"; HYPERHIDROSIS (non-serious), ASTHENIA (non-serious), outcome "recovered" and all described as "felt hot and kind of weak and sweaty"; FEELING HOT (non-serious), outcome "unknown", MALAISE (non-serious), outcome "unknown" and all described as "not feeling good"; NAUSEA (non-serious), outcome "recovered"; DIZZINESS (non-serious), outcome "recovered". Additional information: patient was calling about COMIRNATY 2023-2024. She reported that she had a reaction where her bones started to ache, caller got really sick to the stomach, felt hot and kind of weak and sweaty. Patient stated that she was still experiencing bone pain and generally not feeling good. She stated that she wanted to know if there was any lasting issue about this. Patient didn't have anything else but the bone pain and she was hoping that this won't last long. She added that her weakness, nausea, sweating and dizziness only lasted for 5 minutes but the bone pain had been going on since. Patient stated that she exercises everyday and she is not the type to sit down and do not feel like doing anything right now. Caller mentioned that this is her fifth shot and the first time she experienced these side effects after the shot. Patient wants to know how long will the bone pain may last.  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: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: they gave me those when I had pneumonia; they gave me those when I had pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "they gave me those when I had pneumonia". Clinical course: The patient was over 65 years old now and her doctor recommended she get a pneumonia shot. She started filing for it but they called her and told her she didn't need any pneumonia shot since she had Prevnar 13 back in 2016 and Prevnar 23 (as reported) (PPSV 23) in 2018 when she was 61 years old. The patient mentioned she had had pneumonia at least twice in the past and she thought the vaccines were administered while caller had pneumonia.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: got numbness and it ran with the vaccinations/numbness in her legs sometimes; 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 received bnt162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: EW0158) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: ER8732), administration date: 02Apr2021, for Covid-19 Immunization, reaction(s): "she got numbness/numbness in her legs". The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "got numbness and it ran with the vaccinations/numbness in her legs sometimes". The events "got numbness and it ran with the vaccinations/numbness in her legs sometimes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: Patient stated that she called about the Covid vaccination, a shot from Pfizer. She got three Pfizer vaccines. She had numbness in her legs sometimes. She clarified that she reported this previously. After the first vaccination she got numbness and it ran with the vaccinations. She was told that it was not from the vaccinations in the ER. She just kept going and she has got numbness in her legs. They emailed her all the time and asked how she was doing and they stopped doing it. She did a report on the phone previously. She later clarified that she reported this online with Pfizer previously. They were testing her for months and months and asked how she was feeling on a scale of 1-10 and then they stopped. She did not have anything medical she just went for the vaccination. She called because she went to a doctor because she was still having this numbness and was told that it was probably from the vaccinations because she has been having it since then. She went online and they sent something to ask how she was doing and how many days what was going on.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353354 Same patient, different dose/ AE;US-PFIZER INC-202300353366 Same patient, different dose/ AE;
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: When he woke up it is like all of his muscles was not working/his leg did not, it was weak; He can really move it, move his arm and that never happened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson" (ongoing), notes: He has Parkinson but the Parkinson he just have like his hand shaking and everything. The patient's concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious) with onset 08Nov2023, outcome "unknown", described as "He can really move it, move his arm and that never happened"; MUSCULAR WEAKNESS (non-serious) with onset 08Nov2023, outcome "unknown", described as "When he woke up it is like all of his muscles was not working/his leg did not, it was weak". Additional information: reporter was calling for sharing COVID-19 shot in her husband's status that her husband took it yesterday. Reporter believed he could be having a side effect. Patient has Parkinson but the Parkinson he just have like his hand shaking and everything but after he take, this morning when he woke up it is like all of his muscles was not working. He was like when he was getting off the bed his leg did not, it was weak. He said he can really move it, move his arm and that never happened and he took the shot yesterday morning.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: My pain always goes away with the covid vaccine . I suffer from sciatic severe spinal stenosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sciatic severe spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "My pain always goes away with the covid vaccine . I suffer from sciatic severe spinal stenosis".  Additional information: The patient wanted to know if there were people like them as their pain went away with the covid vaccine. They suffered from sciatic severe spinal stenosis.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Aortic stenosis, Pain, Pulmonary valve stenosis
Clinical narrative: Aortic stenosis/aorta stenosis; pulmonary stenosis; extreme pain in my whole body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: AORTIC STENOSIS (disability, medically significant), outcome "unknown", described as "Aortic stenosis/aorta stenosis"; PULMONARY VALVE STENOSIS (disability, medically significant), outcome "unknown", described as "pulmonary stenosis"; PAIN (disability, medically significant), outcome "unknown", described as "extreme pain in my whole body". Clinical Course: Patient was perfectly healthy until patient took ER Covid vaccine. Patient's health went to hell and now on disability. WHY? Patient felt like human test rat. Patient had to go on disability and could not pay for daughters wedding on top of had to give car back and also almost lost house!  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Impaired healing, Scab, Skin lesion, Tooth loss
Clinical narrative: making me sick; blurred vision; my teeth are falling out; Sores on my body scabs never heal right; Sores on my body scabs never heal right; Sores on my body scabs never heal right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "making me sick"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; TOOTH LOSS (non-serious), outcome "unknown", described as "my teeth are falling out"; SCAB (non-serious), SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "Sores on my body scabs never heal right".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: making me sick; blurred vision; my teeth are falling out; Sores on my body scabs never heal right; Sores on my body scabs never heal right; Sores on my body scabs never heal right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "making me sick"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; TOOTH LOSS (non-serious), outcome "unknown", described as "my teeth are falling out"; SCAB (non-serious), SKIN LESION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "Sores on my body scabs never heal right".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: got sick for a week "with like, COVID symptoms"; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001361 (Novavax).  A 64-year-old female patient received bnt162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got sick for a week "with like, COVID symptoms"".  Additional information: It was reported that each time the patient got a vaccine or booster, she got sick for a week "with like, COVID symptoms" and fatigue. The patient reported she had COVID-19 prior to receiving any COVID-19 vaccines and stated that her doctor said it could be because she had COVID-19, and the long-term antibodies could be making her ill.  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-202300358320 same patient/ event, different vaccine dose number;US-PFIZER INC-202300358321 same patient/ event, different vaccine dose number;
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Vasculitis
Clinical narrative: Vasculitis; Anti-Body level was extremely high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient in his 40's received bnt162b2 (BNT162B2), 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: VASCULITIS (non-serious), outcome "unknown"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "Anti-Body level was extremely high". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated that "A good friend of mine, roughly in his 40's, suffered similar side-effects from the Pfizer vaccine and his doctor diagnosed it as, I believe the term is, vasculitis. His recovery was swifter than mine because of his age". The reporter also stated that "My friend's doctor presented an important theory. By testing my friend's Anti-Body level (Body's immune response), he discovered that his Anti-Body level was extremely high, which meant, receiving the vaccine created more unnecessary Anti-Bodies and his immune system saw this more as an attack, and the response, was major inflammation".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Reporter's daughter tested positive for covid. Reporter mentioned that she and her husband have not been able to have the Pfizer covid 19 vaccine because because it is not readily available. Reporter mentioned that they feel urgent now and wanted to know if they can get one because they are exposed to a covid patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: TINNITUS (non-serious), outcome "unknown", described as "severe tinnitus symptoms". It's been over 10 days.  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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Very ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Very ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.