chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE), administration date: 01Mar2021, when the patient was 48-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE), administration date: 01May2021, when the patient was 49-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 01Jan2022, when the patient was 49-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 01Aug2022, when the patient was 50-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE), administration date: 01Feb2023, when the patient was 50-year-old, for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: Aug2023, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 11Jan2024, stop date: 16Jan2024) were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Aug2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 22Jan2024, stop date: 26Jan2024) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The patient reported had the very weird reaction for the last two shots (confirmed to be Pfizer's) that he/she had from the vaccine for COVID and he/she was worried because the first one he/she was sick for hours, the second time he/she was sick for the whole day, he/she could not get off the bed and he/she was wondering what should he/she do and if should take a third one or never.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400031190 same patient/vaccine, different dose number/AE;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis, Muscle spasms, Nasopharyngeal swab, Peripheral swelling
Clinical narrative: DVT; cramping pain started in right lower leg; then leg swelled up; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "minor arrhythmia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; CALCIUM + VITAMIN D3. Past drug history included: Mynocin, reaction(s): "Allergies:mynocin". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant, life threatening) with onset 12Oct2022 at 10:00, outcome "recovered with sequelae", described as "DVT"; MUSCLE SPASMS (life threatening) with onset 12Oct2022 at 10:00, outcome "recovered with sequelae", described as "cramping pain started in right lower leg"; PERIPHERAL SWELLING (life threatening) with onset 12Oct2022 at 10:00, outcome "recovered with sequelae", described as "then leg swelled up". The events "dvt", "cramping pain started in right lower leg" and "then leg swelled up" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Nov2021) Clotting, notes: results showed no clotting disorders; Nasopharyngeal swab: (Nov2021) Positive; SARS-CoV-2 test: (Nov2021) Positive; Ultrasound scan: (unspecified date) DVT, notes: results showed DVT. Therapeutic measures were taken as a result of deep vein thrombosis, muscle spasms, peripheral swelling. Clinical course: Within 5 days of receiving COVID Vaccine cramping pain started in right lower leg that would not abate, then leg swelled up. Drove patient self to local hospital emergency room, had ultrasound on right leg, results showed DVT. Was given shot of heparin. Given script for apixaban (ELIQUIS) 5mg twice daily. Follow up w GP physician. Ordered bloodwork, results showed no clotting disorders. Advised to stay on apixaban, at follow up visit, was advised to remain on apixaban for life since cause was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound scan
Clinical narrative: DVT; cramping pain started in right lower leg; then leg swelled up; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "minor arrhythmia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; CALCIUM + VITAMIN D3. Past drug history included: Mynocin, reaction(s): "Allergies:mynocin". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN, lot number unknown), for covid-19 immunisation. The following information was reported: DEEP VEIN THROMBOSIS (medically significant, life threatening) with onset 12Oct2022 at 10:00, outcome "recovered with sequelae", described as "DVT"; MUSCLE SPASMS (life threatening) with onset 12Oct2022 at 10:00, outcome "recovered with sequelae", described as "cramping pain started in right lower leg"; PERIPHERAL SWELLING (life threatening) with onset 12Oct2022 at 10:00, outcome "recovered with sequelae", described as "then leg swelled up". The events "dvt", "cramping pain started in right lower leg" and "then leg swelled up" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Nov2021) Clotting, notes: results showed no clotting disorders; Nasopharyngeal swab: (Nov2021) Positive; SARS-CoV-2 test: (Nov2021) Positive; Ultrasound scan: (unspecified date) DVT, notes: results showed DVT. Therapeutic measures were taken as a result of deep vein thrombosis, muscle spasms, peripheral swelling. Clinical course: Within 5 days of receiving COVID Vaccine cramping pain started in right lower leg that would not abate, then leg swelled up. Drove patient self to local hospital emergency room, had ultrasound on right leg, results showed DVT. Was given shot of heparin. Given script for apixaban (ELIQUIS) 5mg twice daily. Follow up w GP physician. Ordered bloodwork, results showed no clotting disorders. Advised to stay on apixaban, at follow up visit, was advised to remain on apixaban for life since cause was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid in Sept2022; had Covid in Sept2022; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 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 Sep2022, outcome "unknown" and all described as "had Covid in Sept2022". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400032078 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202400032077 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 as dose 1, single (Lot number: HG467) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Jan2024 to 25Jan2024. This case was reported as non-Serious.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 omi xbb.1.5 to the events Vaccination failure and Covid-19 cannot be ruled out.
Age: 69.0
Sex: M
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 a Consumer or other non HCP from product quality group.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1 (toppac); single (Lot number: HG4629) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot No.: EL3249, Vaccine location: Left arm), administration date: 13Jan2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot No.: EL9265, Vaccine location: Left arm), administration date: 03Feb2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Lot No.: 30130ba, Vaccine location: Left arm), administration date: 23Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose: 4, Lot No.: FM9992, Vaccine location: Left arm), administration date: 06Jun2022, when the patient was 68-year-old, for COVID-19 immunization; moderna (Dose: 5, Lot No.: AS7163B, Vaccine location: Left arm), administration date: 18Nov2022, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2024) Positive, notes: I started feeling bad and I tested positive for COVID on Sun, 21Jan2024; (27Jan2024) Negative, notes: I tested negative on Sat. 27Jan2024 and was feeling very good; (30Jan2024) Positive, notes: I started feeling bad again on Tues 30Jan2024 and once again tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID-19 treatment from 21Jan2024 to 26Jan2024.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Investigation, Lipoma
Clinical narrative: lipomas on legs; extreme fatigue/debilitating fatigue; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LIPOMA (medically significant), outcome "unknown", described as "lipomas on legs"; FATIGUE (medically significant), outcome "unknown", described as "extreme fatigue/debilitating fatigue". The patient underwent the following laboratory tests and procedures: testing: Unknown results. Clinical course: It was reported that patient experienced extreme fatigue, debilitating fatigue, cannot function a normal life after receiving 5th Pfizer COVID vaccine and messed up and had lipomas on legs that were huge and seem to be growing in quantity.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
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 a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. Patient had no known allergies. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "BC" (not ongoing), notes: recovered. The patient's 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid 17Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna, Dose Number: 2 ; Name of Drug as Reported: Pfizer / BioNTech, Dose Number: 3; This is a spontaneous report received from a Nurse.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2021 as dose 1, single), on 06Jun2021 as dose 2, single) and on 04Oct2023 as dose 4 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis with axial involvement" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lidocaine, reaction(s): "known allergies: Lidocaine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Oct2021, outcome "unknown", described as "Name of Drug as Reported: Moderna, Dose Number: 2 ; Name of Drug as Reported: Pfizer / BioNTech, Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid form 26Jan2024 to 31Jan2024.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective , COVID-19 cannot be ruled out. Based on the current available limited information in the case provided, the causal association between the event Interchange of vaccine products,  and the use of suspect product cannot be fully excluded.
Sex: U
Vaccine: RSV
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: got long COVID which made it lot worse so I got the fatigue symptoms with the long COVID which made it much much worse/ after I got your vaccine I had so much energy; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "chronic fatigue syndrome", start date: 2014 (unspecified if ongoing), notes: had chronic fatigue syndrome for 10 years; "long COVID" (unspecified if ongoing); "got way worse" (unspecified if ongoing), notes: probably got the long COVID and my chronic fatigue just got way worse. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "got long COVID which made it lot worse so I got the fatigue symptoms with the long COVID which made it much much worse/ after I got your vaccine I had so much energy".  Additional information: Something in pfizer RSV Vaccine helps the long COVID for a day. Consumer stated, this is actually a good thing patient just realize patient need to call. patient has had chronic fatigue syndrome for 10 years and then after patient had COVID, patient probably got the long COVID and patient's chronic fatigue just got way worse, so right now it's a lot worse, patient had COVID in Aug. So, what happened is, patient had the Pfizer Abrysvo vaccine, for the RSV. The day after patient had the vaccine it was like patient's fatigue that was from couple of years ago, it is like patient felt absolute energy, patient felt fantastic, patient wanted to dance, patient didn't because patient didn't want to next day have a bad effect. Patient has chronic fatigue syndrome for 10 years, patient also got long COVID which made it lot worse, so patient got the fatigue symptoms with the long COVID which made it much much worse. So, patient is exhausted overtime and it made it a lot worse. Patient then got Abrysvo vaccine, for the RSV. The day after patient got vaccine patient had so much energy. Patient felt so good that patient has not felt like that for years, in such a long time, at least a year and patient felt fantastic. The after day that patient was back to normal, but patient just want to let know, patient know pfizer are doing a lot of research in to long COVID and chronic fatigue and patient knows for sure because patient has lived with this for so long. Something in RSV Vaccine helps the long COVID for a day, but patient just felt it's very important to tell. Consumer stated that just in case it helps in the research.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain in extremity, Vomiting
Clinical narrative: Chest Pain; Headache; Left Arm Pain; Vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN. Patient did not receive other vaccine in four weeks. The following information was reported: CHEST PAIN (hospitalization, life threatening) with onset 01Sep2022, outcome "not recovered"; HEADACHE (hospitalization, life threatening) with onset 01Sep2022, outcome "not recovered"; PAIN IN EXTREMITY (hospitalization, life threatening) with onset 01Sep2022, outcome "not recovered", described as "Left Arm Pain"; VOMITING (hospitalization, life threatening) with onset 01Sep2022, outcome "not recovered". Therapeutic measures were taken as a result of chest pain, headache, pain in extremity, vomiting.  Batch/lot number is not provided, and it cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG, start date: Feb2012, stop date: 01Feb2024; ADDERALL, start date: 17May2023, stop date: 01Feb2024; LEVOTHYROXINE, start date: Jan2016, stop date: 01Feb2024. 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 Jan2024, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid administered from 22Jan2024 to 27Jan2024 for the treatment of covid-19. Adderall XR administered as concomitant drug.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 14:30 as dose 1, single (Lot number: EN6202), in right arm, on 24Mar2021 at 15:45 as dose 2, single (Lot number: EP6955), in right arm and on 07Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FE3952) at the age of 52 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Dec2022 at 15:00 as dose 4 (booster), single (Lot number: 015H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing), notes: post TIA in 2000; "TIA", start date: 2000 (unspecified if ongoing); "congenital heart defect- atrial /septal" (unspecified if ongoing); "Known allergies: Monosodium glutamate, Belsomra, Cipro" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Dec2022 at 15:00, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: Yesterday I tested negative twice. Therapeutic measures were taken as a result of drug ineffective, covid-19 as paxlovid from 24Jan2024 to 29Jan2024.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1 (toppac), single (Lot number: HG4664) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Soya allergy" (unspecified if ongoing); "Peanuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (dose number unknown  5, lot number: FF2590,  left arm), administration date: 21Oct2022, when the patient was 63-year-old, for COVID-19 Immunization; pfizer / biontech (dose number 4, lot number: GJ6665, left arm), administration date: 14Oct2022, when the patient was 63-year-old, for COVID-19 Immunization; pfizer / biontech (dose number 3,  lot number: FM7553, left arm), administration date: 13May2022, when the patient was 62-year-old, for COVID-19 Immunization; pfizer / biontech (dose 2, lot number: ER8731, Left arm), administration date: 15Apr2021, when the patient was 61-year-old, for COVID-19 Immunization; pfizer / biontech (dose 1,  lot number: ER8727), administration date: 24Mar2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2024) Positive; (01Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was treated with Paxlovid  from 22Jan2024 to 26Jan2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400031602 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic pills only" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergies: penicillin, Ceclor" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; AMLODIPINE; LEVOTHYROXINE; LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 27Jan2024 to 01Feb2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
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 Consumer or other non HCP.  A 46-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (29Jan2024) and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jan2024) Negative, notes: tested fully negative on Monday 29Jan. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 22Jan2024 to 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Injection site pruritus
Clinical narrative: itching at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itching at the injection site". Additional information: The product was given to the patient 22 days ago. Patient had itching at the injection site.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, vaccine location=Right arm), administration date: 11Mar2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, vaccine location=Right arm), administration date: 08Apr2021, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine location=Right arm), administration date: 10Nov2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, vaccine location=Right arm), administration date: 10May2022, when the patient was 54-year-old, for COVID-19 Immunization; moderna (DOSE 5 (BOOSTER), SINGLE, Vaccine location=Right arm), administration date: 23Oct2022, when the patient was 54-year-old, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2024, outcome "not recovered" and all described as "COVID 19 Treatment.". Therapeutic measures were taken as a result of vaccination failure, covid-19. No known allergies. Patient was healthy.    The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He got Covid 30Sep2023; He got Covid 30Sep2023; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, 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 30Sep2023, outcome "unknown" and all described as "He got Covid 30Sep2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Positive, notes: He got Covid 30Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: He had the Pfizer Covid vaccine in, he thought, Nov or Dec2022, a year ago he stated.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400031253 Same patient, different product, different event;
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Dec2023 at 17:00 as dose 1, single (Lot number: HD9876) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Some heart issues (PVCs)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 39 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: Apr2021, when the patient was 39 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2021, when the patient was 40 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: Nov2022, when the patient was 40 years old, for COVID-19 immunisation. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Jan2024 to 07Jan2024. Clinical course: Patient had COVID-19 for the first time starting 01Jan2024. He was exposed / infected on 29Dec2023. While his symptoms were relatively mild to begin with, he was prescribed Paxlovid.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: 6J2S24) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Sulfa Drugs allergy" (unspecified if ongoing); "Cipro allergy" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 03Dec2018; POTASSIUM CITRATE, start date: 01Mar2019; SERTRALINE, start date: 01Jan2020. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FL9231), administration date: 26Dec2020, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EL8982), administration date: 18Jan2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FD8448), administration date: 08Sep2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FJ4989), administration date: 15Apr2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 22Jan2024 to 27Jan2024.
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 Physician.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral; ALLOPURINOL oral; EDARBI oral. 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; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Right arm), for COVID-19 immunisation. Patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Jan2024 to 18Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Myelin oligodendrocyte glycoprotein antibody-associated disease
Clinical narrative: MOGAD following mRNA booster vaccination; relapse following SARS-CoV-2 mRNA booster; This is a literature report.  A 45-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: Sars-cov-2 mrna vaccination (DOSE 1, SINGLE (UNKNOWN MANUFACTURER)), for COVID-19 immunization, reaction(s): "New-onset MOGAD after first-dose SARS-CoV-2 mRNA vaccination"; Sars-cov-2 mrna vaccination (DOSE 2, SINGLE (UNKNOWN MANUFACTURER)), for COVID-19 immunization. The following information was reported: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (medically significant), outcome "unknown", described as "MOGAD following mRNA booster vaccination"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "relapse following SARS-CoV-2 mRNA booster".  No follow-up attempts are possible.; Sender's Comments: The events myelin oligodendrocyte glycoprotein antibody-associated disease, and disease recurrence are conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Osteoporosis" (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; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 22Jan2024 until 27Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. Still with us.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: muscle pain down into elbow
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Patient was given wrong vaccine. Was suppose to only receive HIB vaccine.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Was given wrong vaccine. Was to only receive HIB vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Exposure during pregnancy, Premature delivery, Premature separation of placenta, Tinnitus
Clinical narrative: Onset of tinnitus!! Still suffering 2+ years later.  Early birth of child as palsenta separated from uterus premature and had an emergency c-section.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck mass, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Left arm swelling, pain, fever, headache, and lump on neck; started 5 hours after receiving vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Injection site pain, Laboratory test
Clinical narrative: First injection in upper left arm at 12 noon on 03/18/2021: Pfizer Ep6755. Severely bit tongue during sleep, 04/19/2021 to 04/20/21. Went to Hospital ER 04/21/21, no real diagnosis; just confirmed that tongue had been bitten. Tongue stayed swollen for several days. Upper left arm continued to be sore or tender for quitea few days after injection. Severely bit tongue again during sleep, 06/30/21 to 07/01/21; two less serious incidents (possibly mini-strokes or seizures?) on 07/02/21, morning and afternoon. Again, upper left arm remained sore or tender for many days after the injection. Went to Hospital ER, 07/05/2021. Neurologist, was given case, admitted patient; ran several tests overnight. Dr. said that only seizures would  cause patient to bite tongue so severely, and denied that COVID vaccines had anything to do with seizures. Dr. prescribed Levetiracetam Oral 500 mg, 1 in morning and 1 at bedtime.  Had no seizures for 12 to 13 months; stopped taking Levetiracetam 500 mg from 08/05/2022 to 09/12/2022. Had seizure, again bit tongue severely overnight 09/09/2022 to 09/10/2022. Dr. ordered blood test then prescribed same medication, but changed dosage to 1 in morning and 2 at bedtime and told patient he should expect to stay on medication for rest of his life. Prescription was re-started on 09/13/2022. Seizures have affected patient's memory; memory will likely never recover to pre-seizure status. (Rest of answer on Continuation Page)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Seizure, Swollen tongue, Tongue biting
Clinical narrative: First injection in upper left arm at 12 noon on 03/18/2021: Pfizer Ep6755. Severely bit tongue during sleep, 04/19/2021 to 04/20/21. Went to Hospital ER 04/21/21, no real diagnosis; just confirmed that tongue had been bitten. Tongue stayed swollen for several days. Upper left arm continued to be sore or tender for quitea few days after injection. Severely bit tongue again during sleep, 06/30/21 to 07/01/21; two less serious incidents (possibly mini-strokes or seizures?) on 07/02/21, morning and afternoon. Again, upper left arm remained sore or tender for many days after the injection. Went to Hospital ER, 07/05/2021. Neurologist, was given case, admitted patient; ran several tests overnight. Dr. said that only seizures would  cause patient to bite tongue so severely, and denied that COVID vaccines had anything to do with seizures. Dr. prescribed Levetiracetam Oral 500 mg, 1 in morning and 1 at bedtime.  Had no seizures for 12 to 13 months; stopped taking Levetiracetam 500 mg from 08/05/2022 to 09/12/2022. Had seizure, again bit tongue severely overnight 09/09/2022 to 09/10/2022. Dr. ordered blood test then prescribed same medication, but changed dosage to 1 in morning and 2 at bedtime and told patient he should expect to stay on medication for rest of his life. Prescription was re-started on 09/13/2022. Seizures have affected patient's memory; memory will likely never recover to pre-seizure status. (Rest of answer on Continuation Page)
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult given a peds dose