chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mouth soreness and tender gums; Mouth soreness and tender gums; sore throat; fever up to 102.1 F; injection site soreness; This spontaneous case was reported by a non-health professional and describes the occurrence of ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness). At the time of the report, ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: upto 102.1 F.         No concomitant medications were reported. It was reported that fever lifted after 48 hrs. Still have sore mouth, gums, throat. It was unknown if the patient experienced any additional symptoms/event. No treatment medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, Wrong product administered
Clinical narrative: Fatigue; incorrectly administered 2 Pfizer Comirnaty; Received 2 Comirnaty 12 and up Vaccines instead of 1 Pfizer Covid Vaccine and 1 Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, 0.3 ml single (Lot number: HF9298, Expiration Date: Dec2024), in left arm and on 17Oct2023 as dose 2, 0.3 ml single (Lot number: HF9298, Expiration Date: Dec2024) at the age of 40 years, in right arm, all intramuscular for covid-19 immunisation. The patient didn't receive influenza vaccine (FLU [INFLUENZA VACCINE]). The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (1st dose), administration date: 21Apr2021, when the patient was 37-year-old, for COVID-19 immunisation; bnt162b2 (2nd dose), administration date: 19May2021, when the patient was 38-year-old, for COVID-19 immunisation; bnt162b2 (3rd dose), administration date: 20Dec2021, when the patient was 38-year-old, for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "Received 2 Comirnaty 12 and up Vaccines instead of 1 Pfizer Covid Vaccine and 1 Flu Vaccine"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "incorrectly administered 2 Pfizer Comirnaty"; FATIGUE (non-serious), outcome "unknown". Additional information: NDC number of Comirnaty: 00069236210. Patient was incorrectly administered 2 Pfizer Comirnaty 12 and up vaccines today. The patient was supposed to receive the Pfizer vaccine and the flu vaccine but was given 2 Pfizer vaccines. Pharmacist expects the patient to have minimal adverse effects and he was not feeling any effects currently. This was 2 hours ago. Patient experienced normal side effects of a booster (fatigue, etc).  Follow-up (08Nov2023): Follow-up attempts are completed. No further information is expected.  Follow-up (21Nov2023): This is a spontaneous follow-up report received from the same contactable reporter(s) (Pharmacist). Updated information included: historical vaccines, vaccination facility details, new event (fatigue).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient has not reported any symptoms; Nurse who called to report an expired dose of GARDASIL 9 was administered to a patient.; This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On 06-NOV-2023,  the patient was vaccinated with an expire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9),  lot # U034200, expiration date 21-OCT-2023, for prophylaxis(quantity dose and route were not reported) (expired product administered). The patient had not reported any symptoms (no adverse event). The vaccine had not experienced any temperature excursions. Also, no product quality complain was reported.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 52 year old female patient received only one dose of Twinrix series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 04 July 2021, batch number 75C72 and expiry date 13 June 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 52 year old female patient received only one dose of Twinrix series). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-NOV-2023 The pharmacist reported patient received the only one dose of Twinrix in series. At the time of reporting, no further doses have been administered which led to incomplete course of vaccination. In structural field of source document vaccination date reported as 04 June 2021 however in case narrative vaccination date reported as 04Jul2021 due to this discrepancy, conservatively dates were captured as per narrative. The reported consented to follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pharyngeal swelling
Clinical narrative: she could feel her throat swelling up; she felt very sick her arm swelled up; her arm was red and spread out to her upper arm; 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)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine, for IMMUNISATION, reaction(s): "allergic to the flu vaccine". The following information was reported: ERYTHEMA (non-serious) with onset 12Nov2023, outcome "not recovered", described as "her arm was red and spread out to her upper arm"; PHARYNGEAL SWELLING (non-serious) with onset 12Nov2023, outcome "unknown", described as "she could feel her throat swelling up"; PERIPHERAL SWELLING (non-serious) with onset 12Nov2023, outcome "not recovered", described as "she felt very sick her arm swelled up". The events "she could feel her throat swelling up", "she felt very sick her arm swelled up" and "her arm was red and spread out to her upper arm" required physician office visit. Therapeutic measures were taken as a result of pharyngeal swelling, peripheral swelling, erythema.  Additional information: Caller stated she was allergic to the flu vaccine and was advised to take Benadryl after each dose of the Pfizer Biontech COVID 19 vaccine which she has always done. After she got the Pfizer COVID-19 booster her arm was red and spread out to her upper arm. The last dose of Pfizer Covid-19 vaccine she could feel her throat swelling up even after taking Benadryl immediately after. She had the dose on Friday (10Nov2023) and on Sunday (12Nov2023) she felt very sick her arm swelled up and was really red, however she felt better after eating something. Today (13Nov2023) she does not feel great but not bad either. Saw her doctor today (13Nov2023) briefly. Her arm was red. It is spread out very big on her whole upper arm where she had the shot. All on the left side. It is maybe the size of a small dollar pancake. Outcome reported as worsened. Treatment: Doctor advised her to take Benadryl right after the shot.  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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skeletal injury
Clinical narrative: left arm feels like it is tickling; ike she hit her funny bone; 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 received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Lot number: Unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Primary series), for covid-19 immunisation. The following information was reported: SKELETAL INJURY (non-serious) with onset Oct2023, outcome "not recovered", described as "ike she hit her funny bone"; PARAESTHESIA (non-serious) with onset Oct2023, outcome "not recovered", described as "left arm feels like it is tickling". Additional information: the patient is having an adverse reaction or thinks she is having a reaction and can't seem to find out about it or wonders if anyone has reported this but the vaccine was administered to her left arm and since she received it in her left arm, she is not having a fever or a break out but it feels like it is tickling and like she hit her funny bone and it is all the time.  It does not last all day but it is every now and then and she has to shake her arm and feels like tickling and she did not have this before the vaccine. This dose of the covid vaccine was administered 16Oct2023 and the arm feeling like it was tickling began about a week after she got the vaccination and she started to notice it and thought what's wrong with her arm and the tickling is ongoing and persisting.  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: Blood pressure measurement, Cardiac disorder, Hypertension
Clinical narrative: he experienced rubbing of the inner and outer portions of his heart; high blood pressure/his blood pressure was very high; 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 male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation. The following information was reported: CARDIAC DISORDER (hospitalization) with onset Oct2022, outcome "recovered" (2023), described as "he experienced rubbing of the inner and outer portions of his heart"; HYPERTENSION (non-serious) with onset Oct2022, outcome "recovered" (2023), described as "high blood pressure/his blood pressure was very high". The events "he experienced rubbing of the inner and outer portions of his heart" and "high blood pressure/his blood pressure was very high" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 180/99, notes: had a high blood pressure. Clinical course: The caller was calling about the Pfizer BioNTech COVID-19 Vaccine that he received last year in Oct and this was his third dose of Pfizer BioNTech COVID-19 Vaccine that he received. He said when he got the COVID-19 Vaccine last year, he experienced rubbing of the inner and outer portions of his heart and have high blood pressure. He said if he took an Aspirin or Ibuprofen, it would cause his blood pressure to go up to 180 over 99 and he said he could not eat anything like salt, sugar or vegetables because it made his blood pressure go high. He said at the end of the Oct last year, his symptoms started to go away and then he was able to eat chocolate, pizza and spicy food and he said it took about a year to get over it, he has his strength back and he can do things now but he could not do it before." He stated he saw two different cardiologist who didn't know what it was. They had no recommendations or medication to give him.   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: M
Vaccine: COVID19
Symptoms: Ill-defined disorder, Near death experience
Clinical narrative: dying and his Doctor said he may not reach the end of the month; dying and his Doctor said he may not reach the end of the month; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), ILL-DEFINED DISORDER (medically significant, life threatening), outcome "unknown" and all described as "dying and his Doctor said he may not reach the end of the month". The events "dying and his doctor said he may not reach the end of the month" required physician office visit. Clinical course: Agent stated the caller reported he has had 2 doses of the Pfizer COVID Vaccine and he is now dying and his Doctor said he might not reach the end of the month. Agent stated he wanted to report this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: COVID 19 Treatment. Therapeutic measures (Paxlovid therapy start date: 06Nov2023, therapy stop date: 10Nov2023) were taken as a result of drug ineffective, covid-19.  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-202300380580 as same patient, different drug/event.;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: mushrooms" (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 Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 07Nov2023 to 12Nov2023.  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-202300384671  Same reporter/ patient; different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 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 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 at 16:00 as dose 1, single (Lot number: HG4671), in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN, start date: 01May2023, stop date: 10Nov2023. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 10Nov2023, outcome "unknown", described as "Treatment of COVID-19". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient received Paxlovid on 10Nov2023 until 15Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 at 11:45 as dose 1, single (Lot number: PHZERHG9497) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's 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; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID from 08Nov2023 to 13Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE at 04:00 PM, Batch/lot number: 013M20A, Anatomical location: Arm left), administration date: 04Feb2021, for COVID-19 immunization; moderna (DOSE 2, SINGLE at 03:45 PM, Batch/lot number: 031M20A, Anatomical location: Arm left), administration date: 08Mar2021, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE at 02:30 PM, Batch/lot number: 045C21A, Anatomical location: Arm left), administration date: 25Oct2021, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: A5714nl, Anatomical location: Arm left), administration date: 04Sep2022, for COVID-19 immunization; bnt162b2 (DOSE 5 (BOOSTER), SINGLE at 02:00 AM, Batch/lot number: FT5682, Anatomical location: Arm left), administration date: 12May2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 04Nov2023 to 09Nov2023. Patient experienced symptoms on 03Nov2023 and tested positive 04Nov2023.   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-202300384752 same patient, different drug/AE;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (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 Nov2023, outcome "recovered" (Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2023) Negative; (17Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Nov2023 to 16Nov2023. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300384620 same patient/ reporter, different product/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "breast cancer stage 3" (unspecified if ongoing), notes: Previous breast cancer stage 3, in 2016-2017, with double mastectomy and radiation treatments; "double mastectomy" (not ongoing); "radiation treatments" (not 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 Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 10Nov2023 to 14Nov2023. Clinical course: Patient had no known allergies.  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-202300384621 same patient, different product/event;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, vaccine location: Right arm), administration date: 21Jun2023, for COVID-19 Immunization. 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 with Paxlovid treatment from 31Oct2023 to 04Nov2023.  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-202300381441 same patient, different event/ drug (Paxlovid case);
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obese" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Allergies: bees" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Allergies: demerol". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: Day 5: tested positive; (Nov2023) Negative, notes: Day 7: tested negative and was symptom free. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received Paxlovid treatment from 08Nov2023 to 13Nov2023.  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-202300381442 same patient, different event/drug;
Age: 46.0
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 reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 13:30 as dose 1, single (Lot number: HH7595) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty original/omicron ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, lot number: GJ2524, Anatomical location=Left arm, ), administration date: 17Sep2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Nov2023 to 13Nov2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381467 same patient, different event/ drug;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non 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 15Oct2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Nov2023 to 14Nov2023. Clinical course: 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384631 Same patient, different product, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: 6L0446), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 10Nov2023 to 14Nov2023. Clinical course: After taking the Paxlovid for 5 days, patient took a test the next day and it was positive and then 2 days later she started feeling sick.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300384571 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Ear congestion, Hypoacusis
Clinical narrative: got infected with COVID-19; got infected with COVID-19; difficulty of hearing; ears are stuffed up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (172086). The reporter is the patient.  A 76-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Lot number: FD8448) and as dose 2, single (Lot number: FP7138) for covid-19 immunisation. The patient's relevant medical history included: "Sinus infection" (ongoing), notes: Yes, I am on antibiotics because I have sinus infection. The patient took concomitant medications. The following information was reported: HYPOACUSIS (medically significant) with onset 2023, outcome "unknown", described as "difficulty of hearing"; EAR CONGESTION (medically significant) with onset 2023, outcome "unknown", described as "ears are stuffed up"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "got infected with COVID-19". The events "got infected with covid-19", "difficulty of hearing" and "ears are stuffed up" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (Nov2023) Unknown results, notes: I had a blood test about may be two weeks ago. Therapeutic measures were taken as a result of drug ineffective, covid-19, hypoacusis, ear congestion with paxlovid. Clinical course: She mentioned that she has had the Pfizer COVID-19 vaccine in the past. She said the original one and two boosters and she reports that she's recently got COVID-19 infection and she was prescribed Paxlovid. Her ears are stuffed up from this virus as well and so she just turned on 76 and she was having a little bit difficulty of hearing. She said she was on antibiotics because she had sinus infection. So, she was on two kinds of antibiotics. She was on a lot. She had a blood test about may be two weeks ago. She met with her doctor this week and besides her normal little issues (Further clarifications unknown) he did not mention anything that is abnormal. She said got the first two that came out and she had two boosters. She asked if she need to take a third booster after having COVID.   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-202300381460 Same reporter/patient, different product/event;
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 07Nov2023 to 12Nov2023. Known allergies: No, Other medical history: No.  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-202300384794 same patient, different drug/AE;
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Atropine, reaction(s): "Known allergies: Atropine". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive; (Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 07Nov2023 to 12Nov2023.  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-202300384553 same patient, different event/ drug;
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Peripheral nerve injury
Clinical narrative: from his knee down is dead. He has blood flow but all the nerves are dead.; from his knee down is dead. He has blood flow but all the nerves are dead.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16-year-old 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: Bnt162b2 (dose 1, single), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL DISORDER (medically significant), PERIPHERAL NERVE INJURY (medically significant), all with latency 9 days after the suspect product(s) administration, outcome "unknown" and all described as "from his knee down is dead. He has blood flow but all the nerves are dead.". Therapeutic measures were taken as a result of musculoskeletal disorder, peripheral nerve injury.  Clinical course details: Reporter's grandson got 2 of your Pfizer COVID shots at 16 and 9 days later he woke up and from his knee down is dead. He has blood flow but all the nerves are dead. Even electrical stimulation does not make him respond. He was still the same way and was wondering if you were doing research to see if it can be fixed. Reporter know at least 20 teenagers who lost the use of an extremity or ended up with drop foot all within 14 days of their 2nd shot of Pfizer 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: This morning he is "feeling horrible."; He took the Covid test today at about 11:30 and he saw that he tested positive; 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 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 at 18:00 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 included: "stroke", start date: 2023 (unspecified if ongoing), notes: 12 weeks prior to this report. The patient took concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 21Nov2023, outcome "unknown", described as "He took the Covid test today at about 11:30 and he saw that he tested positive"; MALAISE (non-serious) with onset 21Nov2023, outcome "unknown", described as "This morning he is "feeling horrible."". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Heart rate, Heart rate irregular, Palpitations
Clinical narrative: heart issues (PVCs and pots disease); heart issues (PVCs and pots disease); more and more palpitations; it was getting progressively worse after every vaccine; My blood pressure is all over the place; Fluctuating heart rate; 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 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 included: "severe immune deficiency" (unspecified if ongoing); "heart issues" (unspecified if ongoing), notes: patient already had heart issues before vaccinations; "palpitations" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations aggravated", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Blood pressure abnormal", "Heart rate irregular", "Palpitations aggravated", "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "heart issues (PVCs and pots disease)"; PALPITATIONS (non-serious), outcome "unknown", described as "more and more palpitations; it was getting progressively worse after every vaccine"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "My blood pressure is all over the place"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Fluctuating heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: "Before I had any of the vaccine I already had heart issues. After I had the vaccine and the boosters I have had more and more palpitations. I have been having a lot of PVC's. My blood pressure is all over the place. I have Fluctuating heart rate. All of that is because of all the vaccines. I noticed it was getting progressively worse after every vaccine. It has gotten better the longer I haven't taken a vaccine. My last vaccine was in September 2022 and it has improved while not having any more vaccines".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185235 same patient, same vaccine, similar events, different dose;