chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose 1,2,4,5: Pfizer and Dose 3: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 5 (booster), single (Lot number: Gjg49693) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 at 11:00 as dose 1, single (Lot number: ER8732) at the age of 60 years, in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in left arm and on 04May2022 at 12:15 as dose 4 (booster), single (Lot number: Fm9992) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Dec2021 at 14:00 as dose 3 (booster), single (Lot number: 030H21B) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: 14Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Dec2021 at 14:00, outcome "recovered", described as "Dose 1,2,4,5: Pfizer and Dose 3: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid from 25Mar2023 to 29Mar2023. Patient had no known allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146983 Same reporter, same patient, different product, different event;
Left arm at site of injection red/tender. Most c/w allergic rx., not infection. No systemic symptoms.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Within 5 to 10 minutes after administering MMR, left upper deltoid became warm to touch, with erythema.  BENADRYL 50mg P.O. given.
Patient claims that labs studies show an hepatomegaly and claims it was from the vaccines we administered to him.
BREATHING ISSUES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced breathing issues. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing issues. This report was non-serious. This case, involving the same patient is linked to 20221249819.
No adverse event; the patient had already completed the GARDASIL 9 series, so today he received a fourth dose; This spontaneous report was received from a nurse referring to a 21 year old male patient. Information regarding the patient's concurrent conditions, pertinent medical history and concurrent conditions was not provided.     On 24-JUN-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot # T026323, expiration date 22-FEB-2023) dose, route of administration and anatomical location were not reported for prophylaxis. The reporter stated that she did not realize that the patient had already completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination series 10 years prior, so the patient received a fourth dose (extra dose administered). No additional adverse event or product quality concern was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Mother states child was with the parents in the car when the father try to talk to her she did not respond, the cheeks change color (blue) rolled the eyes up and had difficult breathing all these happened for a lapse of Three to five minutes.
This spontaneous report as received from a physician via field representative refers to a 66 year old male patient. On 13-NOV-2013 reported as a month ago, the patient was vaccinated with ZOSTAVAX, dose 0.65 milliliters. Route, lot and expiry date were not reported. On 13-DEC-2013, the patient came into the HCP office to seek medical attention, where he was diagnosed with shingles. He had a painless rash on his abdomen. The outcome of events was unknown. Lab tests were not performed. Additional information has been requested.
Rash on neck/ shoulders/ upper back; This is a spontaneous report from a contactable consumer (patient) A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 16Jan2021 at single dose.  Medical history included spasmodic dystonia and migraines.  The patient's concomitant medications were not reported. On 18Jan2021, approximately 36 hrs after injection, patient experienced rash on neck/ shoulders/ upper back with outcome of unknown.Information on the batch number has been requested.
Pt received first dose pfizer covid-19 vaccine  on 5/4/21. Per pt, she noticed a swollen lymph node in left armpit 3 days after receiving vaccine. The swell reduced for a few days. Swelling is now increased again and slightly larger than when it first appeared. Pt said, she also noticed rash on left arm two nights ago. urgent care appt set-up for patient 5/19/21.
Swollen arm; Arm itchy; Moderna Arm - Itchiness; Moderna Arm - Red Spot; Moderna arm - Swollen; Moderna arm - hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen), VACCINATION SITE WARMTH (Moderna arm - hot) and PERIPHERAL SWELLING (Swollen arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Nov-2020. Concurrent medical conditions included Drug allergy, Dairy intolerance, Food allergy (Wheat, shell fish), Adhesive tape allergy (Band aid), Allergy (Allergic to own body yeast) since 1987 and Vaso vagal attack (Vaso Vagal Syndrome). Concomitant products included LEVOTHYROXINE, METFORMIN, SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS, LACTOBACILLUS), OMEPRAZOLE, FLUCONAZOLE (DIFLUCAN), CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIFLEX SOFT CHEWS), MAGNESIUM, COLECALCIFEROL, UBIDECARENONE (COQ10+D), VITAMIN D NOS, VITAMIN E NOS, VITAMIN B NOS, CAPRYLIC ACID and COLLAGEN for an unknown indication, ASCORBIC ACID (VITAMIN C CITRUS).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen) and VACCINATION SITE WARMTH (Moderna arm - hot). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Arm itchy). On 09-Mar-2021, VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen) and VACCINATION SITE WARMTH (Moderna arm - hot) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Arm itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (nose swab test).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included Cortisone   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: Received VAERS form  included patients minor details, allergies  and current condition ,SAE stop date second dose details concomitant medications and two new events  was added
Joint pain; Bone pain; Pain at the injection site; Fatigue; Malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Sep2021 16:00 (Lot number: FF8839) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "colon cancer", start date: Jul2017, stop date: Oct2017, notes: Pertinent details: complete colectomy; "Broken ankle", start date: Feb2016, stop date: Feb2016, notes: Pertinent details: Ankle reconstruction; "Cholecystectomy", start date: Aug2016, stop date: Aug2016, notes: Pertinent details: Cholecystectomy; "Gall bladder", start date: Aug2016, stop date: Aug2016, notes: Pertinent details: Cholecystectomy; "Hysterectomy", start date: Aug2001, stop date: Aug2001, notes: Pertinent details: Hysterectomy Prolapsed in delivery. Concomitant medication(s) included: LEXAPRO taken for anxiety (ongoing); OXYBUTYNIN taken for incontinence (ongoing). Vaccination history included: Bnt162b2 (Dose Number:01, Time: 9:00 AM, Anatomical site of injection: Left arm , Route of administration: Intramuscular, Batch/Lot number: Pfizer EL9267), administration date: 13Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose Number:02, Time: 9:00 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EN6205), administration date: 06Mar2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Pain at the injection site"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Fatigue"; MALAISE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Malaise"; ARTHRALGIA (non-serious) with onset 28Sep2021, outcome "recovered" (30Sep2021), described as "Joint pain"; BONE PAIN (non-serious) with onset 28Sep2021, outcome "recovered" (30Sep2021), described as "Bone pain". Therapeutic measures were taken as a result of vaccination site pain, fatigue, malaise, arthralgia, bone pain.  Additional information: Simply treated with over-the-counter reaction painkillers, ice, and heat. The pain would have caused me to seek medical treatment if the patient did not know the inciting incident. The pain lasted only 36 hours. Vaccine facility type was Pharmacy or drug store. No prior vaccinations were administered. Lexapro was started from 17Oct and Oxybutynin from 01Oct and ongoing and Advil from 26Sep to 01Oct. The patient received Advil as treatment for the event. Relevant tests were reported as none.  No follow-up attempts are possible. No further information is expected.
10/18/09 Cough and headache and sore throat, fever 101 and achiness continued same symptoms with increase 10/20/09 of shakiness, chills, 103.  10/27/09 f/u with mother - cough persists - has twin sister with s/s
extreme pain at the injection site; difficulty raising arm and lifting objects; Sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
pt recv vax 8MAY96 & mom called 10MAY96 w/pt having area on lt thigh (site of DTP) size of 3 1/2-4 inches redness & streaks, warm to touch;pt w/fever 101 & localized pain;used APAP & DPH & sx improved;pt devel swollen glands & cont fever
Arm swollen, unable to lift arm above shoulder, pain in injection sight, 2 days later...muscle and joint aches and pains, intense fatigue, 3 days later....intense fatigue, muscle and joint aches and pains, nauseous, diarrhea, dizziness, fever. I was unable to get out of bed or eat or drink anything for 36 hours, except to get up for severe diarrhea.  Was unable to work.
NUMBNESS OF LEGS THAT PERSIST; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-OCT-2021, the patient experienced numbness of legs that persist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of legs that persist. This report was non-serious.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # K014040, expiry date: 22-JUL-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
PATIENT INCORRECTLY RECEIVED THE MODERNA VACCINE AS A MINOR INSTEAD OF THE PFIZER VACCINE.
Appetite lost; GENERAL SORENESS; CHILLS; JOINT PAIN, HIP PAIN; LEG PAIN; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced appetite lost, general soreness, chills, joint pain, hip pain, leg pain, headache, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, joint pain, hip pain, leg pain, fatigue, appetite lost, and general soreness. This report was non-serious.
Body Ache; Fatigue; Shivering; Feeling cold; Hot injection site; red area at the injection site; Swollen injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR142881).   On 22nd July 2020, the patient received the 2nd dose of Shingrix and Hepatitis A vaccine. In July 2020, 1 day after receiving Shingrix and not applicable after receiving Hepatitis A vaccine, the patient experienced injection site warmth, injection site erythema and injection site swelling. On 23rd July 2020, the patient experienced general body pain, fatigue, shivering and feeling cold. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling, general body pain, fatigue, shivering and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling, general body pain, fatigue, shivering and feeling cold to be related to Shingrix. It was unknown if the reporter considered the general body pain, fatigue, shivering and feeling cold to be related to Hepatitis A vaccine.  Additional details were provided as follows: The patient received Shingrix in her left arm and a Hepatitis A booster vaccine in her right arm and had red area at the injection site of her left arm where she received the Shingrix vaccine.  The area was about the size of the palm of a woman hand and about 2 inches in diameter.  The area was hot to the touch and it was swollen.  The patient reported fatigue, shivering and feeling cold and stated her symptoms had not resolved. The reporter consented to follow up. Lot and expiration unknown for Shingrix vaccine. Lot and Expiration unknown for Hepatitis A Booster vaccine. The patient consent to follow up. This case linked with US2020141489, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141489:same reporter US-GLAXOSMITHKLINE-US2020AMR142881:
Patient received vaccination on 8/28. Just 2 weeks after, on 9/13, patient presented with fever and chills. PCR COVID test results on 9/15 came back positive for COVID.
Developed a rash only on arms chest and stomach thought it was an allergic reaction so took Benadryl and used calamine lotion but didn't help went to doctor given a cortisone shot and steriod pack. And now skin is very dry scaly
VACCINE WAS FROZEN TOO LONG. VACCINE MAY HAVE BEEN COMPROMISED
3RD DOSE MODERNA COVID VACCINE GIVEN 9/28/22, #AS7165B; pt brought from SNF with AHRF after PEA arrest; intubated; mechanical ventilation; positive for COVID; ICU; stable encough to be dc'd to a specialty Hospital and then Health Center where she passed away
Received injection at 0930 on 12/29/2020 and was observed for 15 minutes after injection.  Around 1630 I developed a headache so I took a Fioricet as I have a history of migraines.  I had a few body aches and only ate toast for supper that night.  By 2330 my headache seemed to be worsening and I started experiencing a fever of 102, tremendous body aches, nausea, sore throat.  At that time I took 500 mg Tylenol at 2330.  By 2 am on 12/30/2020 my fever had reached 103 and I had difficulty walking as my body joints ached so bad.  My headache was unbearable and I asked my husband to drive me to the ER as I could no longer take the pain.  I also was hyperventilating.  In the ER I was given normal saline 500 cc, Tylenol 1000 mg IV, and Zofran 4 mg IV for the nausea.  I did fill prominently better thereafter, except I continued to have a headache. I was given Toradol 30 mg IV and advised not to take my Celebrex that day.  The ER Doctor did call and speak with ER physician, and discussed the validity of lab testing for Covid after vaccination as well as his recommendations as to whether I should receive the second dose of the vaccine. Since I did not really have anaphylaxis, the doctor recommended that I proceed with the second vaccination with extended observation. I was discharged and instructed to take Tylenol 650 mg orally every 4 hours as needed advised for fever/analgesia.
9 days of body aches, weakness, sore throat, nasal congestion, headache pain
Local injection site reaction. Hot, red, swollen, itchy. Reaction site area 2.5 inch circumference. Application of ice and Benadryl cream, anti inflammatory medication
pt recv vax 16JUN97 & 17JUN97 pt exp vesicular lesions 2wk a/coming in contact w/another child;18JUN97 pt was seen by primary care MD & was dx w/a mild case of varicella;