chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: The day after i received pfizer bio booster I developed whole body hives. The same thing happened with the prior booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 03Nov2022 at 02:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AZ [AZITHROMYCIN]; FLONASE [FLUTICASONE PROPIONATE]; HYDROCHLOROTHIAZIDE; LISINOPRIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: All cefalasporins, reaction(s): "Allergy to: Cephalosporin"; Tetracycline, reaction(s): "Allergies to: tetracycline"; Ketamine, reaction(s): "Allergies to: ketamine". Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufactured unknown), for Covid-19 Immunization; Bnt162b2 (Dose 3), for Covid-19 Immunization, reaction(s): "The day after i received pfizer bio booster I developed whole body hives. The same thing happened with the prior booster.". The following information was reported: URTICARIA (non-serious) with onset 05Nov2022 at 01:45, outcome "recovering", described as "The day after i received pfizer bio booster I developed whole body hives. The same thing happened with the prior booster.". Therapeutic measures were taken as a result of urticaria.  Additional information: Adverse event treatment: The patient took Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Hypoaesthesia, Off label use, Paraesthesia, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 12:00 as dose 2, single (Lot number: PF13CLLGH9697) at the age of 28 years, in left arm for covid-19 immunization; influenza vaccine (FLU VACCINE VII), on 03Nov2022 as dose 2, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: PF13ELFP7150; Location of injection: Arm Left; Administration Time: 12:00 PM), administration date: 07Sep2022, when the patient was 28-year-old, for Covid-19 Immunization; Flu (DOSE 1), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 03Nov2022, outcome "unknown", described as "Pfizer bivalent start date: 03Nov2022; Flu shot start date: 03Nov2022"; OFF LABEL USE (non-serious) with onset 03Nov2022, outcome "unknown", described as "pfizer Bivalent/dose 2"; HYPOAESTHESIA (non-serious) with onset 03Nov2022 at 12:30, outcome "not recovered", described as "numbness"; PARAESTHESIA (non-serious) with onset 03Nov2022 at 12:30, outcome "not recovered", described as "pins, and needles sensation in the left side of body - hands, forearm, feet, calf, knee, thigh"; PARAESTHESIA (non-serious) with onset 03Nov2022 at 12:30, outcome "not recovered", described as "tingle". The events "tingle", "numbness" and "pins, and needles sensation in the left side of body - hands, forearm, feet, calf, knee, thigh" required physician office visit. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, paraesthesia.
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free, Tri-iodothyronine, Ultrasound thyroid
Clinical narrative: Thyroiditis following COVID 19(mRNA) vaccine administration; This is a literature report for the following literature source(s):  While cases of Thyroiditis after COVID mRNA vaccination are reported, the recovery duration is not yet determined. Therefore, the authors present the time course of two healthy middle-aged South Asian patients who developed symptomatic, biochemical, and radiological evidence of Thyroiditis following COVID 19(mRNA) vaccine administration. Despite being more than six months post-vaccination, both arestill hypothyroid, requiring levothyroxine replacement. A 41-year-old female presented after the second dose of Pfizer BioNTech vaccine four weeks prior. Initial workup confirmed biochemical hyperthyroidism (TSH0.019uIU/mL, Free T4 -2.52ng/dl, TotalT3-233ng/dl). During five-month follow-up, laboratory workup showed hypothyroidism with TSH -8.570uIU/mL, Free T4 0.98ng/dl, Total T3-111ng/dl, and still requiring Thyroid hormone replacement for the past six months. She was started on levothyroxine 25mcg daily increased to levothyroxine 25mcg nine pills/week to target TSH 0.5 to 5.0uIU/mL. At the time of diagnosis, both had TPO (Thyroid Peroxidase)-negative, TSI (Thyroid Stimulating immunoglobulin)-negative, and no autonomic nodules on thyroid ultrasound. The patient also had a Technetium-99m pertechnetate uptake scan, which showed decreased radiotracer uptake in both the lobes of thyroid gland. Thyroiditis is an inflammatory disorder diagnosed based on clinical and laboratory findings. While there have been cases reports of Subacute Thyroiditis following immunizations, such as the influenza vaccine, the mechanism of thyroiditis after the COVID mRNA vaccine remains unclear. Subacute Thyroiditis typically manifests as a triphasic clinical course of thyrotoxicosis, followed by hypothyroidism and a return to the euthyroid state; however, mRNA vaccine-induced Thyroiditis seems to have a different disease course. In the authours' observation of these case series, both patients remained in the hypothyroid state requiring Levothyroxine replacement eight-and twelve-months post-vaccination, respectively. Whether they developed permanent thyroid damage or are able to recover with prolonged recovery time is still unclear, which needs further follow-up in the future.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Thyroiditis. 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.,Linked Report(s) : US-PFIZER INC-PV202200097378 Same article, drug and event different patient;US-PFIZER INC-202201282285 same article/patient, different drug/event;
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: inflammatory arthritis caused by the BNT162b2 COVID vaccination / flare of existing disease; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "inflammatory arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS (medically significant), outcome "unknown", described as "inflammatory arthritis caused by the BNT162b2 COVID vaccination / flare of existing disease".; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Arthritis. Case will be reassessed when new information is available.  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.,Linked Report(s) : US-PFIZER INC-PV202200097379 Same Article, drug, event and different patient.;US-PFIZER INC-202201280036 Same Article, drug, event and different patient.;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies morphine". Vaccination history included: Influenza vaccine, reaction(s): "known allergies Influenza vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect BNT162b2 can not be ruled out completely.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose 5 Pfizer BioNTech , Dose 4 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 21:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20May2022 at 16:00 as dose 4 (booster), single (Lot number: 038A22A), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing), notes: Other medical history: Obstructive sleep apnea; "psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "ADD" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM CITRATE [CITRIC ACID;POTASSIUM CITRATE], start date: 03Mar2020; CRESTOR, start date: 07Jul2020; CONCERTA, start date: 05Oct2020; STELARA, start date: 06Oct2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022 at 21:00, outcome "unknown", described as "Dose 5 Pfizer BioNTech , Dose 4 Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (31Oct2022) Negative; (02Nov2022) Negative; (06Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), 30 ug single (Batch/Lot number: unknown) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 4), for COVID-19 immunization; Bnt162b2 (DOSE: 3, Route of Administration: Intramuscular), for COVID-19 immunization; Bnt162b2 (DOSE: 2, Route of Administration: Intramuscular), for COVID-19 immunization; Bnt162b2 (DOSE: 1, Route of Administration: Intramuscular), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), 7 days after the suspect product(s) administration, outcome "unknown", described as "developed shingles". The event "developed shingles" required physician office visit.  Additional information: The patient received Comirnaty Bivalent COVID-19 Vaccine Booster. She received the 2 dose primary series and boosted, and this was her 5th dose. The patient received Comirnaty Bivalent COVID-19 Vaccine Booster a week and a half to 2 weeks ago and 7 days after the vaccine developed shingles and was diagnosed by her PCP. Patient did not receive any prior vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose 5 (booster); dose 5 (booster); 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 patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "Early onset Alzheimer's" (unspecified if ongoing), notes: Early onset Alzheimer's. The patient's concomitant medications were not reported.  The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 26Sep2022, outcome "unknown" and all described as "dose 5 (booster)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Nov2022) positive. Therapeutic measures 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.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered at inappropriate site, Tendon disorder
Clinical narrative: Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon; Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon; Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2022 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; anatomical location: left shoulder), for COVID-19 immunization, reaction(s): "issues with my left shoulder", "had first Pfizer shot in my left shoulder/Has issues with my left shoulder"; Bnt162b2 (DOSE 2, SINGLE; anatomical location: left shoulder), for COVID-19 immunization, reaction(s): "issues with my left shoulder", "had first Pfizer shot in my left shoulder/Has issues with my left shoulder"; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), TENDON DISORDER (non-serious) all with onset 2022, outcome "unknown" and all described as "Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon". The events "around 6 months ago i had my 4th pfizer shot in my right hip and now i am having issues with my ti muscle tendon" required physician office visit.  Additional information: It was also reported that around 6 months ago patient had 4th Pfizer shot in right hip and now was having issues with TI muscle tendon Dr said patient need another shot not sure what to do.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills at night; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to penicillin" (unspecified if ongoing), notes: allergy to penicillin; "anesthesia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia.; "gives her tachycardia when she receives very strong anesthesia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia. The patient's concomitant medications were not reported. Past drug history included: Iron, reaction(s): "allergy to iron", notes: allergy to penicillin, iron. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "chills at night", "muscle pain". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills at night"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills at night; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to penicillin" (unspecified if ongoing), notes: She says she has an allergy to penicillin.; "anesthesia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia.; "tachycardia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia. The patient's concomitant medications were not reported. Past drug history included: Iron, reaction(s): "allergy to iron", notes: she has an allergy to iron. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills at night"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  Additional information: The caller wants to get their fourth dose of the Pfizer COVID-19 vaccine and wants to know if the formulation has changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LOZARTAN GEO, start date: Jan2003; PRAVASTATIN, start date: Jan1999; VIT D [VITAMIN D NOS], start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 25Oct2022 to 30Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 42.0
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 (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8731), in left arm and on 11May2021 as dose 2, single (Lot number: EW0179) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "ED" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: TADALAFIL, start date: 01Sep2022, stop date: 24Oct2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Sep2022, stop date: 06Nov2022; VITAMIN D [VITAMIN D NOS], start date: 01Sep2022, stop date: 06Nov2022; VITAMIN C [ASCORBIC ACID], start date: 01Sep2022, stop date: 06Nov2022; IRON, start date: 01Sep2022, stop date: 06Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: New positive antigen test after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8731 and EW0179 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8731, fill lot EP8683, and the formulated drug product lot EP8570, and lot EW0179, fill lot EP8730, and the formulated drug product lot EP8611. A complaint sample was not returned and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GA9694) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 09:00 as dose 1, single (Lot number: EL3249), in left arm, on 11Feb2021 at 12:00 as dose 2, single (Lot number: EL9262), in left arm, on 02Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 30Mar2022 at 23:00 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergy to penicillin" (unspecified if ongoing); "known allergy to iodine contrast solution" (unspecified if ongoing). Concomitant medication included: LUMIGAN, start date: 24Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 28Oct2022 to 01Nov2022. Clinical course: The patient had Covid rebound following Paxlovid on 04Nov2022 at 03:00 AM, which was not treated and had not recovered at the time of the report.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GT5342) at the age of 70 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:30 as dose 5 (booster), single (Lot number: GH9694), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "known allergies: Cilantro" (unspecified if ongoing); "known allergies: Strawberries" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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: I tested positive again after Covid 19 had resolved; Positive, notes: I tested positive again after Covid 19 had resolved. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid as COVID 19 treatment.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: No harm, patient just received an additional dose of  flu vaccination
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Dizziness, Impaired work ability, Lethargy
Clinical narrative: Tested positive on at-home test for Covid-19 on 11/1/22 after displaying symptoms. Began Paxlovid 11/2/22. Ill and off work for 1 week. Back to work 11/8/22 with lasting lethargy, dizziness, sore throat/chest.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Tested positive on at-home test for Covid-19 on 11/1/22 after displaying symptoms. Began Paxlovid 11/2/22. Ill and off work for 1 week. Back to work 11/8/22 with lasting lethargy, dizziness, sore throat/chest.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pain, Headache, Migraine, Myalgia, Neck pain
Clinical narrative: I get a lot of migraines and tension headaches. So, between 10/21/2022 and 10/26/2022, I experienced some headaches that I didn't think much of. However, on 10/26/2022, I woke up with a headache that felt different than my typical headaches and that continued through the day. I tried treating it with ADVIL and TYLENOL which usually takes care of my headaches, but it did not work. It felt more like muscle or nerve pain and as it progressed it felt more like nerve pain coming from my neck and up over my head. This continued on until 11/03/2022, when it began to feel like it was coming from the base of my skull, over the top of my head, and into my eye socket. That nerve pass was causing me an intense amount of pain. I've experienced shingles on my head before and it felt very similar to that pain. However, I don't have a rash. I spoke with my mother, who was previously in the health care field about the possibility of internal shingles. I ultimately ended up going to the doctor and explained all of my pain issues but did not mention my recent vaccine, nor did they ask. It wasn't until I spoke with a friend about my experience, that I made a connection to my vaccine. I then did a bit of research and found that shingles has been reported in others post vaccine. My doctor is not treating me for shingles. They did prescribe TYLENOL with codeine, prednisone, gabapentin, and a muscle relaxer. The only thing they would have done differently, had I come within the first seven days would have been to prescribe an antiviral as well. I did message my doctor about the connection I made between my vaccine and the possibility of shingles, just to inform them of my discovery of the possible connection. I am supposed to contact my doctor again if the pain has not gone away in a few days. The pain is subsiding.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuralgia, Tension headache, X-ray normal
Clinical narrative: I get a lot of migraines and tension headaches. So, between 10/21/2022 and 10/26/2022, I experienced some headaches that I didn't think much of. However, on 10/26/2022, I woke up with a headache that felt different than my typical headaches and that continued through the day. I tried treating it with ADVIL and TYLENOL which usually takes care of my headaches, but it did not work. It felt more like muscle or nerve pain and as it progressed it felt more like nerve pain coming from my neck and up over my head. This continued on until 11/03/2022, when it began to feel like it was coming from the base of my skull, over the top of my head, and into my eye socket. That nerve pass was causing me an intense amount of pain. I've experienced shingles on my head before and it felt very similar to that pain. However, I don't have a rash. I spoke with my mother, who was previously in the health care field about the possibility of internal shingles. I ultimately ended up going to the doctor and explained all of my pain issues but did not mention my recent vaccine, nor did they ask. It wasn't until I spoke with a friend about my experience, that I made a connection to my vaccine. I then did a bit of research and found that shingles has been reported in others post vaccine. My doctor is not treating me for shingles. They did prescribe TYLENOL with codeine, prednisone, gabapentin, and a muscle relaxer. The only thing they would have done differently, had I come within the first seven days would have been to prescribe an antiviral as well. I did message my doctor about the connection I made between my vaccine and the possibility of shingles, just to inform them of my discovery of the possible connection. I am supposed to contact my doctor again if the pain has not gone away in a few days. The pain is subsiding.
Age: 9.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted. She recovered on her own with water. This has happened in the past with vaccine administration.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: During registration process, the patient did not have access to their vaccine reccords. When asked how many doses he received, he stated he did not remember. I looked up his records through the website and it stated that he only received one primary dose of Moderna. I repeated this information to the patient and informed him that since he didn't remember how many dose he received, we will be going off what was provided from the website and that he would be getting the second primary dose. He said okay. When he was with the Vaccinator, she repeated that he was getting a Moderna Primary dose today, he said okay. She repeated herself again, stating it was a Primary dose, and he answered okay again. After..
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Not sure patient got prednisone.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dyspnoea, Pyrexia, Respiratory distress, Wheezing
Clinical narrative: FEVER, RESPIRATORY DISTRESS-WHEEZING, VERY SHORT OF BREATH,  NEEDING OXYGEN AND NEBULIZER TREATMENT, RESCUE INHALER; CROUPY COUGH THAT LASTED MORE THAN 4 MONTHS.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient presented to public health vaccination site requesting second Jynneos dose. Patient's first dose was on 10/18/22 meaning he is on his 23rd day after the first dose. Patient stated he had traveled a long distance to get to the site and transportation is difficult for him. Patient requests his second dose be given early. MD  consulted and approved second dose be given today due to transportation barriers. Patient received dose. No complications.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna Bivalent dosing for adults in 0.5ml,  patient was given 0.25ml of the Moderna Bivalent booster vaccine
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, nausea, vomiting, diarrhea,  fever,  and body aches.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Headache, nausea, vomiting, diarrhea,  fever,  and body aches.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Hypotension, Tension
Clinical narrative: Headache Fatigue Dizziness Muscle Tenseness Hypotension
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Erythema, Flushing, Hypersensitivity
Clinical narrative: Patient received her flu vaccine at 4:45pm within the pharmacy and felt fine when she left, but at 5:15pm she began to feel flushed, her skin began to get red, her skin started itching, she became dizzy, and her blood pressure went up.  She decided to go to the emergency room and was treated for an allergic reaction from the vaccination.  After visiting the emergency room and being treated, she felt fine.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Immunisation reaction, Pruritus
Clinical narrative: Patient received her flu vaccine at 4:45pm within the pharmacy and felt fine when she left, but at 5:15pm she began to feel flushed, her skin began to get red, her skin started itching, she became dizzy, and her blood pressure went up.  She decided to go to the emergency room and was treated for an allergic reaction from the vaccination.  After visiting the emergency room and being treated, she felt fine.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Pt was given a 5 year-llyear dose
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: no known adverse event. Error in vaccine administration due to vaccine given without being mixed or diluted.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Vaccine was mixed incorrectly.    Not enough diluent was added to the COVID vaccine..  No adverse event occurred while the patient was in the office.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Vaccine was mixed incorrectly.    Not enough diluent was added to the COVID vaccine..  No adverse event occurred while the patient was in the office.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: none
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient is 12 years old and the pediatric dose was given
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUR4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Bruising and pain at injection site beginning shortly after administration.  Pain continued from 10/7/22 until present with limited range of motion in left shoulder without pain.  Pain has diminished some since injection, but is still causing discomfort in daily activities.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chest pain, Dyspnoea, Hypoaesthesia, Pain
Clinical narrative: Patient received her flu shot administered very high up on the shoulder that resulted in arm numbness that lasted for hours, chest pain that radiated from the shoulder across the chest, shortness of breath.  This prompted the provider to take ibuprofen and head to the ER.  While being seen in the ER her arm numbness and other symptoms slowly resolved on its own.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Patient reports that 1 day following flu vaccine that he felt faint while lying  down and thinks that he passed out briefly.  He also reports feeling achy and nauseous.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Fear, Musculoskeletal stiffness, Neck pain, Neuralgia, Pain
Clinical narrative: 11/2/22 Received vaccination in left deltoid area. Nothing seemed unusual, no pain during administration 11/3/22 Woke up with some typical arm soreness but also a ?crick? in my left neck. Neck was pretty sore by evening and I laid on heating pad. 11/4/22-11/6/22 Pain progressed to nerve pain, felt like impingement in my left upper back behind my shoulder blade and my left neck was so painful I couldn?t turn my head. My left arm was tingling down to my fingers and palm of my hand, especially my 4th and 5th fingers. The tingling spread to my left face and jaw over 11/5 and 11/6. It was gradual, not sudden. Took some ibuprofen and continued to use heat. Tried massaging it which didn?t seem to help. 11/7/22- Called primary MD Dr. who wasn?t in that day and went to see Dr.. He prescribed a 5 day course of steroids in the mornings and muscle relaxer for bedtime. I am taking the steroids but not the muscle relaxers because I don?t like to take medicine at all. I?m taking ibuprofen and using the heating pad at night instead. 11/9/22- It is day 3 of steroids and while the pain is significantly better, the tingling is still present in my hand and face. I?m scared it isn?t going to go away.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia, Rotator cuff syndrome
Clinical narrative: 11/2/22 Received vaccination in left deltoid area. Nothing seemed unusual, no pain during administration 11/3/22 Woke up with some typical arm soreness but also a ?crick? in my left neck. Neck was pretty sore by evening and I laid on heating pad. 11/4/22-11/6/22 Pain progressed to nerve pain, felt like impingement in my left upper back behind my shoulder blade and my left neck was so painful I couldn?t turn my head. My left arm was tingling down to my fingers and palm of my hand, especially my 4th and 5th fingers. The tingling spread to my left face and jaw over 11/5 and 11/6. It was gradual, not sudden. Took some ibuprofen and continued to use heat. Tried massaging it which didn?t seem to help. 11/7/22- Called primary MD Dr. who wasn?t in that day and went to see Dr.. He prescribed a 5 day course of steroids in the mornings and muscle relaxer for bedtime. I am taking the steroids but not the muscle relaxers because I don?t like to take medicine at all. I?m taking ibuprofen and using the heating pad at night instead. 11/9/22- It is day 3 of steroids and while the pain is significantly better, the tingling is still present in my hand and face. I?m scared it isn?t going to go away.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine was mixed incorrectly.  Not enough diluent was added to the COVID vaccine.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Vaccine was mixed incorrectly.  Not enough diluent was added to the COVID vaccine.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The vial was diluted incorrectly.  It was only diluted with 0.2ml of 0.9% Sodium Chloride instead of the 2.2ml of 0.9% Sodium Chloride causing the concentration of the dose to be off.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The vial was diluted incorrectly.  It was only diluted with 0.2ml of 0.9% Sodium Chloride instead of the 2.2ml of 0.9% Sodium Chloride causing the concentration of the dose to be off.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Lingering pain on ULE, on shoulder/site of injection, radiating down the arm and affecting mostly the upper arm and hand. pain 3/10 constant, at times intensity at 5-6/10.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: pediatric dose was administered instead of adult dose
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: PATIENT ACCIDENTLY GOT TWO MODERNA BIVALENT DOSES INSTEAD OF ONE WITH SEASONAL INFLUENZA VACCINE.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: pediatric dose was administered instead of the adult dose
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash
Clinical narrative: Rash at injection site, patient states cellulitis
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Dysstasia, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: Approximately 2-4 hours after receiving the vaccine, I began to notice a pain in my lower back that was settling into my hips while relaxing in my recliner with my son. The pain became intense to the point where I had to get up and begin walking as I could no longer stand sitting in my chair.  Continued pain on Sunday-Tuesday (November 5, 6, 7, 8). I was taking Tylenol and Motrin with no resolve to the pain Yesterday (November 8) I felt that I was at my worst with symptoms. I began to notice that if I sat too long I would become very stiff and when I would go to stand, I had to receive support to stand and move. Climbing the stairs became unbearable and even walking was difficult.   Today, I am still stiff, but not to the degree where I am as immobile as I was days prior.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness, Sitting disability
Clinical narrative: Approximately 2-4 hours after receiving the vaccine, I began to notice a pain in my lower back that was settling into my hips while relaxing in my recliner with my son. The pain became intense to the point where I had to get up and begin walking as I could no longer stand sitting in my chair.  Continued pain on Sunday-Tuesday (November 5, 6, 7, 8). I was taking Tylenol and Motrin with no resolve to the pain Yesterday (November 8) I felt that I was at my worst with symptoms. I began to notice that if I sat too long I would become very stiff and when I would go to stand, I had to receive support to stand and move. Climbing the stairs became unbearable and even walking was difficult.   Today, I am still stiff, but not to the degree where I am as immobile as I was days prior.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Headache, Insomnia, Photophobia
Clinical narrative: Headache, sensitivity to light, joint aches, chills, insomnia. Per patient, all symptoms started the evening after vaccination and have almost completely resolved
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given Pfizer Bivalent 5-11yrs old instead of the Pfizer peds primary series. Patient was due the 2nd dose in the primary series. Patient didn't have any reaction while being monitored in clinic.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: pediatric dose was administered instead of adult dose
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: DEVELOPED REDNESS WARMTH AND SWELLING TO VACCINE. INJECTION SITE 7X10 INCHES IN DIAMETER WHICH RESPONDED TO ORAL ADMINITRATION OF BENADRYL AND RESOLVED WITHOUT ORAL ANTIBIOTICS AFTER 3-4 DAYS.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 0.25 ml dose