chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertrophic cardiomyopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Floroquinolones, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157983 same patient, different drug and AE.;
1.5 inch circular wheal at injection site,  occurring 8 days after injection, after resolution of initial tenderness on the day of the injection. Slightly elevated, with erythema, edema, tenderness, and warmth. Waxed and waned for 6 days. Treated with cool compresses only.  Accompanied by mild fatigue
Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient).  A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine.  She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown.    Information on lot number/batch number was requested.
Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain, overlying skin edema requiring multiple antibiotics (bactrim, azithromycin, clindamycin) and steroids including ER visit
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: 3032282), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 20Oct2023 to 24Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351051 same patient, different drug/event;
Caller stated that he experience a delayed reaction. His main concern is this rash that spread from his upper right shoulder blade to his lower back to the underarm.  It is a painful rash that  tingles and is keeping him from sleeping. He started that it is time for his second vaccine and he does not feel like he should get it with this reaction.
Pyrexia; headache Information has been received from a consumer concerning her 14 year old daughter who on approximately August 2004 and on 30-AUG-2005 was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated, respectively. Illness at the time of vaccination included a viral infection. On 30-AUG-2005 in the evening, she developed a fewer up to 102.1 F and had a headache associated with the fever. It was noted that she continued to have a fever 36 hours later. It was noted that there were no other symptoms. At the time of this report, she had not recovered. Additional information is not expected.
If a cat or dog scratches her it itches; Red itchy bumps on her hands and a few other places; Red itchy bumps on her hands and a few other places; Inflamed and itches; This is a spontaneous report from a contactable consumer or other non hcp.  An 18-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 30Apr2021 12:45 (Batch/Lot Number: EW0170) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in right arm13:30 (Batch/Lot Number was ER0729) as single dose for covid-19 immunisation.It was reported that, Caller stated she is calling about the COVID 19 vaccine,Caller stated a few days after the second dose she started getting red itchy bumps on her hands and a few other places which was very spontaneous and the only time she had this happen before was when she had mono. Caller stated she also is not allergic to cats or dogs but now if a cat or dog scratches her it itches. The outcome of the events erythema wound complication and pruritis was not recovered the event inflammation was unknown.  No follow-up attempts are needed. No further information is expected.
tingling sensation on lip; This is a spontaneous report from a contactable other-HCP. A 44-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, allergy to fish. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure abnormal and vitamins daily from an unspecified start date and ongoing. The patient previously took compazine [prochlorperazine edisylate], reglan [metoclopramide hydrochloride], gabapentin, dilaudid. On 28Jan2021, the patient experienced tingling sensation on lip (not serious). Therapeutic measures were taken as a result of tingling sensation on lip (paraesthesia). The outcome of the event recovered  Follow-up attempts are completed. No further information is expected.
shingles after second vaccine/suspected vaccination failure; shingles after second vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles which lasted for 7 weeks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LIGHTHEADED/DIZZY; This spontaneous report received from a consumer  via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lightheaded/dizzy, and patient got covid (suspected covid-19 infection and suspected clinical vaccination failure). Consumer reported that, "Never had the shot my father has a heart problem he gets the shot after dad comes home dizzy and lightheaded everybody in my family got covid had it for 2 days its the flu with respiratory issues." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure and lightheaded/dizzy was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000215711.; Sender's Comments: V0:20220204846-Covid-19 vaccine ad26.cov2.s- suspected clinical  vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a certified medical assistant concerning a 67 year old male patient with hypertension, Raynaud's syndrome, arthritis and hypercholesterolaemia.  Who on 1998 was vaccinated with 0.5 ml of a dose of PNEUMOVAX (I.M.) (Lot#:  661528/0867X).  Subsequently, the patient developed redness, swelling, and pain of his arm at the injection site.  The patient also experience a fever with a temperature of 100 degrees F.  The patient sought medical attention by phone and was treated with TYLENOL (manufacturer unknown).  At the time of reporting, the outcome of the patient experiences was unknown.  Additional information has been requested.
This spontaneous report as received from a 48 year old female consumer with no drug reactions/allergies. The patient's medical history included that the patient may have had a case of shingles before receiving ZOSTAVAX. On 04-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route reported as injection, lot#/expiry date not reported) as recommendation from doctor. Concomitant therapies included SYNTHROID, estrogens, CYMBALTA and LYRICA. On 05-NOV-2013, the patient developed a mild case of shingles that involved her being itchy and a rash breaking out after receiving ZOSTAVAX, the patient also reported she went to the emergency room for radial nerve palsy of her left wrist after receiving ZOSTAVAX. The patient sought medical attention (doctor's visit). On an unspecified date, X-ray, blood work and CT scan were performed and the results were not reported. There was no treatment received for the adverse events. The outcomes of the events were reported as not recovered/not resolved. Upon internal review the event radial nerve palsy considered to be medically significant. Additional information has been requested.
15 patients received a dose from vials that have a light orange tinge; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (15 patients received a dose from vials that have a light orange tinge) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (15 patients received a dose from vials that have a light orange tinge). On 19-May-2021, POOR QUALITY PRODUCT ADMINISTERED (15 patients received a dose from vials that have a light orange tinge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Non-Significant Follow up
On 6/16/03, 2 days after his scab fell off, pt experienced T 103.9, alternating fever and chills, night sweats and dysuria. He was dx with prostatitis and started Cipro. Two days later fever remained high/symptoms worse.
Headache, Myalgia, Arthralgia, Fever, rigors, sweating, extreme fatigue Narrative:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Aug2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ranitidine, reaction(s): "Known allergies: Ranitidine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result, notes: indication: Treatment of COVID-19; (unspecified date) Negative, notes: Testing + COVID after testing negative; (unspecified date) Positive, notes: Testing + COVID after testing negative; (29May2022) Negative, notes: Tested + again today 11s/p initial +, tested negative 2 days ago and today had stuffy nose again and tested + again; (31May2022) Positive, notes: Tested + again today 11s/p initial +, tested negative 2 days ago and today had stuffy nose again and tested + again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported as patient had Paxlovid on 21May2022 to 25May2022 for Treatment of 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 there is limited information in the case provided, the causal association between the events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #U015678, expiration date: 18-MAY-2023, administered subcutaneously (SQ), (strength was not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 10.9 degrees Fahrenheit (F) for 1 hour and 25 minutes without previous excursions.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000438: US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000374:
Mild swelling in throat during 15 minute watch period. Stopped about 4 hours after.
Around Dec 3, 4, 5, 6, 7th I started feeling like I had a cold, allergies, and cough. By the time Dec 7th arrived, I had the worst headache. I felt like my head was to explode. My nose was completely stuffed up. I could not breath through my nose. I first went to Urgent Care Clinic, but that doctor would not see me face to face. I took Covid test in my car. It came back negative. I talk with dr on phone. He prescribed 10 day antibiotics 2X daily. My cough was very bad as I felt my chest banging On Sunday 12/12/21, I went to Emergency Room. I was diagnosed with Viral Upper Respiratory illness or as they refer to as the "common cold." Because my chest hurt, nurse too xray of my chest which came back fine. The hospital prescribed steroids for 6 days, couch medicine, allergy medicine.
Hives over scalp, forehead, two on face. No periorbital or personal edema. Resolved with 1 dose of 1mg/kg benadryl oral suspension.
After I took the vaccine, I experienced lower back pain, fatigue, just feeling off. The next day it was the same just amplified. Even my cough was stronger. I decided to go to the urgent care afterwards where I was taken a chest Xray and was given amoxicillin to treat a raspatory infection. I was also diagnosed with COVID.
Within 24 hours of my third vaccine, all of the lymph nodes in my body were palpable. I had severe pain throughout most of my body and arthritis in my joints. I contacted my physician and we discussed a plan. I continue to have palpable and painful lymph nodes in my throat clavicle area and armpit and axilla area. I still have intermittent palpable lymph nodes in my groin area and behind my knees. I continue to feel rundown and achy.
Sudden and serious dizziness. Almost puked  from walking 10ft.; Sudden and serious dizziness. Almost puked  from walking 10ft.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:15 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced sudden and serious dizziness. almost puked  from walking 10ft. followed by an abnormal feeling on an unspecified date with outcome of unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible. No further information is expected.
HSV2 outbreak - took valcyclovir and acyclovir  Hives? Or other rash
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced arm pain. The reporter was consented to follow up. This case was linked with case US2020144253, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144253:same report
pt exp rash on rt side of chin & bone pain;seen by MD 28OCT96 & given med;APAP used for pain;bones very sore w/sl pressure plus constant pain in bones;not sleeping well;very sore areas around elbow shoulder joints;serum sickness like rxn;
Patient awake at 0400 following the injection, experienced nausea and then vomited once. She quickly recovered after the bout of emesis.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Pt was given expired Moderna Vaccine. Vaccine expired on 7/13/22. Nurse manager, drew vaccine from vial and provided us with syringe's with vaccine. Nurse manager notified us at approximately 1411 by text & voicemail at 1412 informing us of vaccine being expired per Director of Nursing Services for Public Health region, and "Do not give vaccine." Spoke with Nurse manager who was going to speak with Dr. regarding next steps in process since vaccine had already been administered. Contacted pt on 7/21/22 informing them of expired vaccine and offered to provide new vaccine if wanted. Pt refused vaccine at this time stated we will just wait for the next booster.
It was reported that a 16 month old female pt received an Act-Hib and Tripedia (combined as TriHibit) vaccination along with an IPOL and a Varivax vaccination on 8/2/00. Reportedly, 4 hours, post vax, the pt became fussy and the injection site was red and warm to the touch. By the next day, the reddened area had increased 1" in diameter (3" X 3" area). Further information requested.
8-2-07 - was seen in office for rash on back only. Started on Keflex for folliculitis. 8-6-07 Rechecked in office since new lesions continued to appear - dx with chicken pox. Per triage note dated 6-15-07 mom dx with shingles.
p/vax p/removing needle site began to swell, noted bleeding @ inj site - pressure applied then ice to site, swelling decreased p/10min;