chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; Caller states she has a rare auto-immune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 74-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose number unknown, single), for COVID-19 Immunisation, reaction(s): "she can not take the Moderna at all and she is allergic to everything in it,". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Caller states she has a rare auto-immune disease". Clinical course: Reporter called for the new omicron vaccine. She had the bivalent 1 year ago last Nov. She had a rare auto-immune disease and stated they need to adjust medication before she takes the shot. She could not take the Moderna at all and she was allergic to everything in it, and Pfizer had been wonderful as it was the only safe brand she could take. Her allergy Doctor at privacy clinic only wanted her to had Pfizer.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "Aching all over for a day or two". The following information was reported: PAIN (non-serious) with onset 2023, outcome "recovered" (2023), described as "aching all over for a day or two"; MALAISE (non-serious) with onset 2023, outcome "unknown", described as "each of them feeling sick".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two. Caller's last Pfizer COVID-19 injection was in May.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300313159 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313160 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313161 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313162 Same patient/vaccine/event, different dose;US-PFIZER INC-202300313163 Same patient/vaccine/event, different dose;
Age: 51.0
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 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (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 Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Had 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid (Lot number: GJ5741) from 18Sep2023 to 23Sep2023 for treatment of COVID-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312929 Same reporter/patient, different drug/event.;
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Axillary pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain in underarm/armpit on the side of the vaccine; Pain, swelling, redness, and fever at injection site/ Injection site pain; Pain, swelling, redness, and fever at injection site/ Injection site swelling; Pain, swelling, redness, and fever at injection site/ Injection site redness; Pain, swelling, redness, and fever at injection site/ Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL; SEROQUEL; WELLBUTRIN; VYVANSE; HYDROXYZINE. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil". Vaccination history included: bnt162b2 (Dose 1, Single, Vaccination site: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 25Jan2021, for COVID-19 immunisation; bnt162b2 (Dose 2, Single, Vaccination site: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Oct2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; bnt162b2;bnt162b2 omi ba.4-5 (Dose 3 (Booster), Single, Vaccination site: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 17Oct2022, for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain in underarm/armpit on the side of the vaccine"; PYREXIA (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Fever"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 28Sep2023 at 14:00, outcome "not recovered", described as "Pain, swelling, redness, and fever at injection site/ Injection site swelling". Therapeutic measures were not taken as a result of axillary pain, vaccination site pain, vaccination site swelling, vaccination site erythema, pyrexia.  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-202300314962 same patient, different vaccine dose/event;
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Myocardial fibrosis, Pruritus, Urticaria
Clinical narrative: Scarring of heart; Heavy fatigue; cannot walk; anything like physical activity I can not do; Itching now it is kind of hives; Itching now it is kind of hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2 (BNT162B2), on 05Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single), administration date: 15Dec2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 13Feb2022, outcome "not recovered", described as "Heavy fatigue"; PRURITUS (non-serious), URTICARIA (non-serious) all with onset 13Feb2022, outcome "unknown" and all described as "Itching now it is kind of hives"; MYOCARDIAL FIBROSIS (non-serious) with onset 13Feb2022, outcome "unknown", described as "Scarring of heart"; GAIT INABILITY (non-serious) with onset 13Feb2022, outcome "unknown", described as "cannot walk; anything like physical activity I can not do". Therapeutic measures were not taken as a result of myocardial fibrosis, fatigue, gait inability, pruritus, urticaria.  Additional information: Consumer stated, He had a quick question. Yes,  He reported 30 minutes, he was on the phone and he had 30 minutes conversation. He reported a side effects on the Pfizer vaccination. He said he had 30 minute conversation just now and he, phone on the, hello? Okay He had said he had 30 minute conversation. He was making a report on the vaccination (Further not clarified if the caller called in Pfizer Drug Safety, hence captured as initial report in tab), the Pfizer Vaccination He had got side effects on for me and he had, at end of the conversation, He was asking a lady for claim over then she was like, He guess, he did not get one and he was trying to figure out if he was making a report or something and he was trying to follow up and he would had claims number on the report he was making.   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: Malaise, Pain
Clinical narrative: each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "each of them feeling sick", "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two.  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-202300312955 Same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "each of them feeling sick", "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two. Caller's last Pfizer COVID-19 injection was in May.  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-202300312955 Same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: each of them feeling sick; aching all over for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "each of them feeling sick", "aching all over for a day or two". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "each of them feeling sick"; PAIN (non-serious), outcome "recovered", described as "aching all over for a day or two".  Additional information: Caller reported receiving 6 Pfizer COVID-19 vaccine injections in the past (dates and formulations not provided) and after each of them feeling sick and aching all over for a day or two. Caller's last Pfizer COVID-19 injection was in May.  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-202300312955 Same patient/vaccine/event, different dose;
Age: 38.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 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 covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "cholesterol issues" (unspecified if ongoing); "chronic Prostatitis" (unspecified if ongoing); "Known allergies: certain antibiotics" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing); "Known allergies: various other outdoor allergies" (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 Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: negative for covid two days after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 19Sep2023 till 24Sep2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312801 same reporter/patient, different drug/event;
Sex: M
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 28-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 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 treatment from 16Sep2023 to 21Sep2023.  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-202300312786 same patient, different drug/AE;
Age: 72.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694), in right arm and on 16May2023 as dose 6 (booster), single (Lot number: GJ6742) at the age of 72 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL2964), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6199), in right arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from Sep2023 to Sep2023.  Clinical course: Bronchospasm unable stop coughing. Never experienced before could only talk short time before spasmodic coughing Bronchitis and fluid in airways crackling noise in chest that can be heard across the room.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6796) at the age of 59 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks was noted as no. Treatment of COVID-19 was Paxlovid (lot number 00069-0345-30) which started on 18Sep2023 and stopped on 22Sep2023.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain
Clinical narrative: My whole body is just went under pain; my whole body is just aching; Terrible headache; I am not feeling well enough; feel nauseate; 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)), in Sep2023 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: MALAISE (non-serious) with onset Sep2023, outcome "unknown", described as "I am not feeling well enough"; PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "My whole body is just went under pain; my whole body is just aching"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Terrible headache"; NAUSEA (non-serious) with onset Sep2023, outcome "unknown", described as "feel nauseate".  Additional Information: Patient had last covid shot last yesterday and had all of them but never had a reaction and today when woke up, whole body was just went under pain. Patient had a terrible headache and feel nauseate.  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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm; achy body; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Sep2023, outcome "unknown", described as "Sore arm"; PAIN (non-serious) with onset 27Sep2023, outcome "unknown", described as "achy body"; FATIGUE (non-serious) with onset 27Sep2023, outcome "unknown". Therapeutic measures were not taken as a result of pain in extremity, pain, fatigue.  Additional information: Patient did not receive other vaccine in four weeks and did not have covid prior vaccination. He did not test positive after vaccination and did not have known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Mar2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), 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 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Rebound of COVID 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: muscle and joint pain; muscle and joint pain; headache; injection site pain; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 10:30 as dose 1, single (Lot number: HF9275) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 27Sep2023 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 27Sep2023 at 18:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 27Sep2023 at 18:00, outcome "recovering", described as "injection site pain"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 27Sep2023 at 18:00, outcome "recovering" and all described as "muscle and joint pain". Therapeutic measures were taken as a result of myalgia, arthralgia, headache, vaccination site pain, pyrexia.  Additional Information: Patient had no known allergies. Patient took treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: fever; chills; her hands were shaking; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (first booster; unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "her hands were shaking"; HEADACHE (non-serious), outcome "unknown".  Additional Information: The reporter said that she got the new vaccine yesterday afternoon (27Sep2023). Reporter mentioned that this was her fourth booster. She had a bad reaction last night - she had a fever, chills, and her hands were shaking. She also had a headache. She noticed that she had those bad reactions after taking her second booster shot in Apr2022. The caller wanted to know if those were the side effects of the vaccine.  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-PV202300163318 same reporter/patient/events, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: fatigue; chills; mild fever; muscle aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 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 immunization; Covid-19 vaccine (Dose: 2 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 26Sep2023, outcome "recovered" (2023); FATIGUE (non-serious) with onset 26Sep2023, outcome "recovered" (2023); PYREXIA (non-serious) with onset 26Sep2023, outcome "recovered" (2023), described as "mild fever"; MYALGIA (non-serious) with onset 26Sep2023, outcome "recovered" (2023), described as "muscle aches". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, myalgia.  Additional Information: This was the patient's fourth dose of COVID-19 vaccine. The patient did not experienced COVID prior to vaccination and was not tested for COVID post vaccination. Events were reported non-serious, did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating nor resulted to congenital anomaly/birth defect.   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: Ear pain, Mobility decreased, Neck pain, Pain
Clinical narrative: a lot of pain in her neck to the point she can't turn her head; sharp pain in her left ear; pain when moving her head up and down; she can't turn her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: NECK PAIN (non-serious), outcome "unknown", described as "a lot of pain in her neck to the point she can't turn her head"; EAR PAIN (non-serious), outcome "unknown", described as "sharp pain in her left ear"; PAIN (non-serious), outcome "unknown", described as "pain when moving her head up and down"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "she can't turn her head".  Additional information: Patient reported that she had a lot of pain in her neck to the point she can't turn her head, sharp pain in her left ear, and pain when moving her head up and down It was very painful to the point of wincing and she could not drive. She saw on the internet some uncommon side effects of the vaccine were swelling of glands on the side of the head that the vaccine was received on. She had other, more expected types of reactions in the past.  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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID on 26Sep2023; Tested positive for COVID on 26Sep2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 at 16:00 as dose 1, single (Lot number: HH7595) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: PAMELOR; LIPITOR. Vaccination history included: Covd-19 vaccine (DOSE UNKNOWN; MANUFACTURER UNKNOWN; (more than 3 doses received)), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Sep2023, outcome "recovering" and all described as "Tested positive for COVID on 26Sep2023". The patient was vaccinated on 16Sep2023 for COVID boost. He began being symptomatic on 24Sep2023 and tested positive for COVID on 26Sep2023 with Flowflex Nasal Swab. The patient stated there likely was not enough time to build up anti-bodies before he was exposed. The patient was treated with PAXLOVID.  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Body ache; subsided later that day and ran away; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 37-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "Swelling at the injection site"; PAIN (non-serious), outcome "recovered", described as "Body ache; subsided later that day and ran away".  Additional information: The patient was a nurse practitioner and got our Comirnaty vaccine first and had a side effect (reported as Unspecified Bivalent Vaccine). It was reported that "The side effect are from the COVID Comirnaty vaccine. She said she had swelling at the injection site and then 24 hour later she had body ache, and they did subsided later that day and ran away." She reported herself when she got the Bivalent shot (suspect captured as unspecified Bivalent shot) because she said it was side effect of the Bivalent. The date of the shot was unknown.   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: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Chills, Confusional state, Electrocardiogram abnormal, Full blood count, Headache
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Laboratory test, Loss of consciousness, Metabolic function test, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Nausea, Palpitations, Pregnancy test urine negative, Pyrexia, Syncope
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage decreased
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Blood albumin, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Blood urea normal, Chills, Dizziness, Electrocardiogram PR interval, Electrocardiogram QRS complex
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Electrocardiogram QT interval, Electrocardiogram abnormal, Eosinophil count decreased, Eosinophil percentage decreased, Fall
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Fatigue, Glomerular filtration rate normal, Granulocyte percentage, Haematocrit decreased, Haemoglobin normal
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Headache, Immature granulocyte count, Lymphocyte count, Lymphocyte percentage decreased, Mean cell haemoglobin concentration
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Mean cell haemoglobin concentration normal, Mean cell volume, Mean platelet volume, Monocyte count, Monocyte percentage
Clinical narrative: I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.