chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 2, single (Lot number: EW0162) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have controlled reflux" (unspecified if ongoing), notes: I have controlled reflux; "autoimmune disease ITP" (unspecified if ongoing), notes: autoimmune disease ITP that has been in remission for about 8-10 years; "intersistial cystitis" (unspecified if ongoing), notes: intersistial cystitis; "known allergies: antibiotics" (unspecified if ongoing), notes: Yes, most antibiotics; "known allergies: pain meds" (unspecified if ongoing), notes: pain meds,; "known allergies: spicy or acid foods" (unspecified if ongoing), notes: spicy or acid foods; "known allergies: seasonal allergies" (unspecified if ongoing), notes: have seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 that includes: Paxlovid from 11May2022 to 12Aug2022 for COVID-19 treatment.  Follow-up attempts are completed. No further information is expected.
Reported to local health department by physician office. Patient reported lower left leg swelling that started on 4/11/2021.  Also, reported shortness of air.  Venous doppler performed and positive for DVT on 4/12/2021.  Patient admitted to hospital on 4/12/2021.  Inpatient currently at facility. On Eliquis.  Also, tested positive for COVID upon admission to hospital.
Breakthrough case admission after 4 vaccines; Moderna 3/6/21 Lot# 027L20A; Moderna 4/2/21 Lot# 032H20A; Moderna 5/20/22 Lot# 056M21A; Pfizer 11/23/22 Lot# GJ6738
0.25 ml fluviron given to patient.  Rec for 74 yrs.  Box marked but not on actual vial.  Patient had no reaction.
Developed hives on his torso and chest; rash was likely normal reaction to his MMR vaccine/ it could be an allergic reaction to the MMR vaccine; developed a rash on his stomach; Ear infection; Great discomfort; Pain; This spontaneous report was received from a consumer and refers to a 13 month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot number, expiry date, formulation and route of administration were not provided; frequency was reported as routine 12 month dosage) for routine vaccination.  On 07-FEB-2022, the patient developed a rash on his stomach (rash). In February 2022, he was diagnosed with ear infection, treatment was given for it by prescribing amoxicillin. The consumer reported that the pediatrician also noted the rash was likely a normal reaction to his MMR vaccine and expressed no concerns. On 13-FEB-2022, the patient developed hives on his torso and chest (urticaria). Amoxicillin was discontinued on approximately 13-FEB-2022 at 19:00. On 14-FEB-2022, the rash and hives began to spread and became worse. In February 2022, it was reported that the ear infection had healed. Furthermore, on 14-FEB-2022, the rash continued to get worse. It was reported that it could be an allergic reaction to the MMR Vaccine (allergy to vaccine) (on 07-FEB-2022). In February 2022, the patient was in great discomfort (discomfort) and pain. Treatment was given for discomfort and pain by giving diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC); it was reported that they were not addressing it. On 15-FEB-2022, the rash was even worse than before. In February 2022, the patient was administered steroids and he will continue to receive steroids for the next 13 days.  The outcome of rash and allergy to vaccine were reported as not recovered. The outcome of ear infection was reported as recovered. The outcome of the adverse events of urticaria, discomfort and pain were not reported. The relatedness between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the adverse events of rash and allergy to vaccine was reported to be as related. The relatedness between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the adverse events of ear infection, urticaria, discomfort and pain was not reported.
Severe Anemia- first time noticed in May 2021, then had to be hospitalized in August 2021 due to severity of Anemia. He has been treated with blood transfusion a few times so far. We have recently been told by his doctor that it might be an autoimmune condition and recently started treatment with steroids and will be tested on a regular basis  to determine the effectiveness and of the treatment results.
pt recv vax for travel & inadvertently gave td SC instead of IM;advised pt to apply ice to inj site if it became red & swollen & report to PHN;
Information has been received from a medical assistant concerning a 66 year old female who on 13-Oct-2008 was vaccinated with PNEUMOVAX vaccine (injection route and site not reported). On 15-Oct-2008 the patient had a large red area that was warm to touch and was diagnosed with cellulitis at the injection site. The patient sought medical attention by coming to physician's office. The patient was treated cephalexin for 10 days. No further information was available from the caller. This is one of several cases reported by the same source. Additional information has been requested.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported  Reporter stated that No symptoms or quality issues to report   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant follow up, patient details updated
Diarrhea and stomach ache on the 15th. On the 16th 4am high fever, nausea, chest hurt, bad cough, pains. Fever all day on the 16th highest 104, averaged 102.5 for a 12 hour period. Took to doctor and was told he probably got the flu from flumist in school.
Patient 5 to 10 minutes after immunization became unresponsive, The rn helped check out patient with other nurse.  Pt had low blood pressure, and was not diabetic. RN gave patient .3 mg epi and patient vitals improved and was observed for 30 minutes by nurse and RN. Nurse later told RN that patient had pacemaker and had similar episodes at least 2 to 4 times in the last 2 to 4 weeks. Patient was fine when we left clinic.
Information has been received from a physician concerning a female who was vaccinated with a dose of varicella vaccine. Subsequently three weeks after vaccination, the pt developed a papulovesicular rash and fatigue. There were only 3 lesions (hand, back and abdomen). The fatigue lasted approximately 1 week. The outcome of the papulovesicular rash was unknown. Additional info has been requested.
This spontaneous report as received from a licensed practical nurse refers to nine (9) patients of unknown age and gender. On an unspecified day in May 2014, the GARDASIL was stored improperly. On an unspecified date(s), the nine patients were vaccinated with the GARDASIL, .5 ml, intramuscular. No adverse events were reported. The outcome of improper storage is unknown. Additional information has been requested.
Initial and follow-up information has been received from a pharmacist concerning a 70 year old female who on 20-OCT-2008 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (Lot# 660717/0224X), which was the recalled lot from a health care supplier. On 21-OCT-2008 the patient experienced redness and pain at the injection site. The arm was hot to touch and sore. Subsequently, the patient recovered from redness and pain at the injection site. No lab tests were performed. The patient consulted with the pharmacist and sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Pt presented to the pharmacy specifically looking for prevnar 13 via doctor recommendation. We went over prevnar 13 vs 20 and the series itself. Pt wanted prenvar 13 and is aware it needs to be followed up in a year with pneumovax 23
Initial report received on 27 December 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3697AA received on 08 September 2010, on 30 March 2011 (lot number not reported), and lot number C4001AB received on 19 October 2011 (routes and sites of administration not reported). The subject developed a cough on 12 November 2012, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 25 November 2012. The subject also developed cold like symptoms on 17 November 2012, and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 27 November 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 November 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 December 2012, the subject's cough was not persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. This is one out a cumulative total of 179 cases solicited from the database during the surveillance period from 01 January 2010 to 27 December 2012. These 179 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
The patient reported having a new onset of chest pain 5 days after getting the first injection.   He says he continues to intermittently get the chest pain.  He does not want to get any more doses of the mRNA vaccines at this time.
Swelling at site of injection, which spread to upper arm and an hour later it spread down to elbow and then continue to spread to hand/thumb.
My face got a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My face got a rash) in a patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced RASH (My face got a rash). At the time of the report, RASH (My face got a rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
drove 12 hours which led her not able to stand up; sweating; she had sever reaction after receiving 2nd dose; could not lift her head up off the pillow for 24 hours; had temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours) and PYREXIA (had temperature) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Non-smoker. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours), PYREXIA (had temperature) and CHILLS (chills). At the time of the report, DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours), PYREXIA (had temperature) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-334391, MOD-2021-335707 (Patient Link).
Approximately 5 days post vax the pt developed a rash described as red, round, raised areas, about 12 spots peppered on face and hands. The pt had itching but no fever. The pt did not have blisters, so no crusting occurred. Follow up information from a registered nurse reported that the pt subsequently recovered.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions and allergies were reported. On 02-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency and route were not reported) lot # L014418 with an expiry date of 13-APR-2017. No concomitant medications were reported. No symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Headache, Sedation, Fever, chills, lymphadenopathy Narrative:
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 01-JUL-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
patient went to Pharmacy received a COVID booster and Flu vaccine at same time and passed away next day
Pt claims to have very bad muscle ache that she never experienced from any other vaccines in the past. Pain has radiated down the arm.
Information has been received from a registered nurse concerning a 22 year old female healthcare worker with no known history who in 1999 - 2000 was vaccinated with a first, second and third dose of RECOMBIVAX HB. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently "now" in 2007 the patient has a negative hepatitis B antibody titer. Unspecified medical attention was sought. No other adverse experiences were related to this event. There was no product quality complaint involved. Additional information has been requested.
12/22/2021  Pt is 40 yr/o female who presents to ED c/o onset today of cough and congestion, headache, myalgias, fatigue, chills.  She denies any shortness of breath or chest pain.     Objective:  Nondistressed and alert.  Nontoxic-appearing Neck supple without JVD or meningismus Heart RRR without MGR Lungs clear Abdomen soft, nontender without masses, organomegaly or peritoneal signs Extremities without deformity, cyanosis, edema
Treatment of COVID-19; Treatment of 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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 55 years, in right 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 18 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 18-JUL-2017, the patient was vaccinated with ENGERIX (manufactured by GlaxoSithKline) 10 microgram. On 17-SEP-2017, the patient received a second dose of RECOMBIVAX HB, 10 microgram for prophylaxis (route, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved.
a swollen lump on my left collar bone; I was in bed for about 5 days sleeping 18-24 hours a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "I was in bed for about 5 days sleeping 18-24 hours a day"; BONE NEOPLASM (non-serious) with onset Mar2021, outcome "unknown", described as "a swollen lump on my left collar bone". Additional information: The patient reported that, On 07Mar2021 he took his first vaccine and was in bed for about 5 days sleeping 18-24 hours a day and a swollen lump on his left collar bone. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Noticeable swelling at injection site accompanied by increased surface temperature beginning one week after initial injection - "Covid arm"
Injection site is upper left deltoid. Within 4 hours injection site was tender but I had begun to itch about 3 inches below the injection site. Itching continued and by Thursday morning my left arm was itching, swelling, sore, hurt to move, and was turning red from bicep to elbow. Became hot to the touch. Stayed swollen, red, and painful all day. Returned home after work and took BENADRYL and iced my arm. It was quite painful and still red and swollen. Had improved some by Friday morning. Still sore and red. Went to Clinic to have evaluated. This is where I have vaccine. Diagnosis was cellulitis. Antibiotic prescribed.
Arm swollen, painful, red, difficulty raising arm up 2 days after vaccine, fevers 2 days later, oral antibiotics x 3 days no better.
Mild dizziness followed by jitteriness and heart pounding. Increased blood pressure. Lasting for about 1-2 hours.
Sever headache: sever body aches: redness, swelling, itching, and heat at injection point. Left arm severe soreness. Chills and small amount of diarrhea.
Patient hospitalized for labor and delivery without complication of a baby girl who weighed 9 pounds 3.6 ounces. This was within 6 weeks of receiving COVID vaccination.
Within 30 days of receiving the 2nd dose of the vaccine, my doctor noticed that my bilirubin levels were starting to go up and that I have liver enzymes as well. Now, I also have rashes that are showing up everywhere all over my body. It looks like a chemical burn on my body. At first I thought they were spider bites. They look like tentacles under my skin and they are burning. I was given steroids, a cortisone cream, antiviral and antibiotics. I asked the dermatologist why he won't scrape it and take a sample. He said that he is chalking everything up to the vaccine. I asked him if there was any chance that my liver could be affected because of the vaccine. My PCP told me that I am now insulin resistant.
Pt began with rash approx 2 hrs after injection. On hands and spread to trunk ? red papules. About 48hrs after pt quit eating and became dehydrated requiring hospitalization. No fever's, ? Annual Follow up received on 08/20/2003: "Vaccine recipient (yes) recovered from the adverse events that were reported for this vaccination."
I started feeling dizziness and thought I would give it a week or so, since I thought it was just a side affect that would go away. It feels like I am intoxicated, but not having fun (how the dizziness feels). Heart palpitations, thumping on my heart. I had a phone conference with my doctor yesterday and then went to ER, tested heart, sodium was a bit low. I got a CAT scan on brain and they found no abnormalities in my brain. My blood work looks good. Thyroid was checked but have not gotten the results back for that. I had numbness and tingling in my feet as well. No treatment. I am still experiencing the thumping heartbeat last night and the night before I had chest pain on my left side and cramping in the chest. I added electrolytes to my drinks, trying to get my sodium back up again. I am still experiencing the dizziness and the numbness and tingling in my feet, as well. The dizziness is interrupting my daily activities such as cooking and cleaning the house.
Pain in Left arm since injection. Pain radiates to the hand. The left elbow and left shoulder are in the pain the most. I thought it might be sleeping wrong but have changed all my habits. Still aches.