chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient came in for a booster Moderna shot. An immunizing technician drew up the shot and administered the shot. Per the patient's report and based on the pharmacist visually inspecting later, the technician administered the vaccination much lower on the patient's arm than the middle of the deltoid muscle. Based on palpitation and visual inspection, it felt as though the obvious hole under her bandaid was in some muscle, whether it was the tail-end of the deltoid or the bicep muscle, I am not sure. The patient reported in a follow-up letter that the next morning she had a raised, tender, red lump distal and medial to the entire deltoid muscle. According to the patient, the location of the lump was in.subcutaneous tissue, indicating that the injection was given at an angle and had ended up mostly in subcutaneous tissue rather than muscle. The patient reported that the redness left after 10 days but the tenderness and a small lump remained. I have not had additional follow-up with her to know how long the tenderness or lump lasted. The patient contacted her primary care physician by phone the day after the injection and was told to monitor for any signs of infection and call back if that happened. She was told it was not recommended that she receive an additional or replacement booster dose. I do not believe she ever saw a health care provider in person for this event.
Wide spread vesicles DX chickenpox 03/03/2006, post vaccination 10/08/2001, TX Acyclovir.
Redness and swelling at injection site of the KINRIX vaccine, hot to the touch w/small bruise at injection site.
Pfizer vaccine was undiluted when administered to patient and discovered later.  Resulting in a higher than expected dose for the patient.
Pt. reported that injection site was red and inflamed by the time she got home (about 30 minutes) from clinic.  Next day site/surrounding area became more itchy and irritated.  by 2 days post inj. (Sat.) arm was red and swollen from shoulder to elbow.  It was itchy, not painful.  She had no systemic complaints.  No hives, no other symptoms of adverse reaction. Saw her own MD  on Day 4 (Monday.  Used Caladryl on site for comfort through days 1-3.  Stopped this on advice of MD on Day 4.  Called vaccine administrator on Day - still had reddened area she reported as about 6 inches in diameter around injection site.  Advised to seek further medical evaluation if condition did not continue to improve.  Reported signs of all local reaction had resolved in about 1 week.
Administered a dose of expired J&J vaccine. The vaccine was stored in accordance with manufacturer's storage requirements but was beyond its expiration date at the time of administration. Exp date 9/21/2021.
Mild tinnitus that has shown up a few times. Each time it comes it stops shortly after.
1. Rush and dizzy, lasted about 1 min - 5 mins after injection 2.  started about 24 hours later - Dizziness, sluggish feeling, tired, massive eczema flare up all over my body.   - still happening today (9 days later) 3. Massive back pain, hip and left foot pain. about 48 hours after injection.  Pain level about 7.  Lasted for 3 days
Pt presented to ER on 12/19/21 after having one day of symptoms-drooping eye and mouth, difficult to understand speech. On evaluation pt dx with Bell's Palsy.
LUA red on 15JAN91, then looked fine, felt hot, but temp not measured, rash-hives, wheezing, redness & swelling of joints; maculo-papular rash on face/torso/arms; t101, some edema in legs & arms, purulent rhinorrhea, injected eyes;
had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "wrestles with anxiety" (unspecified if ongoing), notes: other medical history: wrestles with anxiety, otherwise unknown. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "had Covid". Clinical comment: It was unknown if patient received any other vaccine in four weeks or took any other medications in two weeks. Adverse events: (Withheld) said on Thursday evening that they had Covid. They did not provide other details. Likely took a test to confirm but did not explicitly say so. Age 23 or 24 years old, and do not believe pregnant but cannot confirm. Not sure dates of vaccination for each dose, but individual was a nurse so likely had access earlier. May have had at least two doses by June, but cannot confirm. Cannot remember which vaccine received, but believe could have been Pfizer from when originally told me (at least for first two doses). It is unknown if patient had covid prior vaccination. Known allergies: Unknown. Had told individual that they started not feeling well prior to an event that was held on 02Jan2022-03Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided, a causal association between reported events drug ineffective, covid-19 and the suspect BNT162B2 cannot be excluded.
Child give MMR 8/29/12. Developed redness, swelling 4 days after administration of vaccine. Seen in ER 8/31/12. Dx cellulitis given AUGMENTIN -> developed allergic reaction to med -> on clindamycin.
complaints of her left arm being sore after receiving the first dose of the purple cap Pfizer Covid-19 vaccine in her left deltoid; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 09Nov2021 (Lot number: FH8020, Expiration Date: 28Nov2021) at the age of 34 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 22Mar2019 (ongoing); "Sleep apnea", start date: 29Sep2020 (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "complaints of her left arm being sore after receiving the first dose of the purple cap Pfizer Covid-19 vaccine in her left deltoid".  Additional information: She said that her arm hurt really bad and she felt like it was going to fall off and that is why she wanted the second dose in the gluteal area. She did not have prior vaccinations (within 4 weeks). She did not have any AE(s) following prior vaccinations. She did not have any family medical history relevant to AE(s). The AE(s) did not require a visit to: emergency Room or physician office.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 12 year old male who on 23-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). On 24-AUG-2007 the patient developed a localized cellulitis rash at injection site. The patient sought unspecified medical attention. Subsequently, after therapy was stopped, the patient recovered. Therapy was not reintroduced. Additional information has been requested. The same physician also reported on the experience of the patient's brother WAES# 0703USA04942.
My period ended about a week before getting the first dose of the Pfizer vaccine at the local pharmacy . I have prior infection and my serology revealed  that my antibodies level was extremely high . My job announced that it made to be vaccinated by 10/7/21 since I work in a home care agency as a clerk and due to fear to lose my job , I went after work to take the first dose On 10/6/21. On 10/12/21, I started bleeding while at work . My period came back . It last for about four days .  On 10/27/21, I went to take the second dose at my local pharmacy . The next day, I started bleeding again . My period last for about 5 days . I told my colleague , called my doctor doctor but office was closed . I reported to the PA  and one of the nurses director at my job what I was experiencing.I didn?t go to the hospital because I knew they was nothing they would have done for me . Last month November I bled twice . Today is 12/4/21, I have not gotten my period yet . Not sure why this happening to me . A nurse who works at my agency instructed me to re
Systemic: Patient was found at home passed away.  no autopsy was performed to determine cause of death-Severe, Additional Details: Patient received his vaccine from our pharmacy.  He waited for 15 minutes after vaccine and no adverse effects were reported.  Niece states he went home and was found passed away in his room two hours later
After the vaccine was administered she went to work as a dishwasher, her work day was no different than other days. When she got off, she could not move her left arm. Her daughter applied BENGAY and she took 2 TYLENOL 500mg tablets with little improvement. Her pain was 10 out of 10. It started on the left side of her back, went down her arm and continues around to the left side of her chest. The injection site was sensitive to the touch. The next day her pain lessened to 4 or 5 out of ten with the same pain area. She took 2 more TYLENOL 500mg tablets. She also complain of shortness of breath and chest pain, which she claims was resolved with ALKA SELTZER. No abnormal changes to her diet and she does not normally have heartburn. Today she complains of the same pain area with her pain being a 4 or 5 out of ten. The injection site is red and is warm and sensitive to the touch. She has taken 1 TYLENOL 500mg tablet today. After discussing with a provider in the clinic, we recommend that she go the the ER to make sure that there is not something else going on.
Patient pulled away while vaccine was being administered. A portion of the vaccine got on the patient's arm. Unable to determine how much of the vaccine the patient received.
Fever of 101.4, nausea, diarrhea, body aches and headache, fatigue. I slept all day and woke up around 11/09/2021 at 4pm. At 7pm I went back to bed and had centralized lower back pain. Throughout the night the centralized pain moved up the middle of my back. Around 11/10/2021,  1:30pm the pain was in my neck to the point I could not turn my head. I left work and went to bed. By 6:30 pm the pain reached the back/top of my head with intensity of a migraine. Around 1pm it was gone.
Second dose of Jynneos was administered on day 18 instead on day 28; Case reference number US-BN-2022-002182 is a spontaneous case report initially received on 31-Aug-2022 from other health care professional via Communication (reference number: USBAV22-1237) and concerns a male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 12-Aug-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis.  On 30-Aug-2022, 18 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received on 31-Aug-2022 from Bavarian Nordic included local BN number.  The case is linked with US-BN-2022-002180, US-BN-2022-002181, US-BN-2022-002183, US-BN-2022-002184 due to the same reporter.; Reporter's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient, was vaccinated with the second dose of Jynneos (18 days after the first dose), at dose of 0.5 ml, at an unknown route or anatomical site for monkeypox prophylaxis which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
11FEB9 3AM sz. Temp 104 (ax) by ambulance attendant; parent noted child was asymptomatic,  other than "Feeling warm", prior to convulsion. Pt was not hospitalized. Rx w/Tylenol per parent.
"Harold patch" rash in her torso; right arm sore; breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of PITYRIASIS ROSEA ("Harold patch" rash in her torso), MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) and PAIN IN EXTREMITY (right arm sore) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding). On 11-Mar-2021, the patient experienced PITYRIASIS ROSEA ("Harold patch" rash in her torso) and PAIN IN EXTREMITY (right arm sore). On 03-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) had resolved. At the time of the report, PITYRIASIS ROSEA ("Harold patch" rash in her torso) and PAIN IN EXTREMITY (right arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment information was reported.
stroke; congestive heart failure; cardiovascular event; Information has been received from a lawyer regarding a case in litigation referring to an elderly female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 22-MAR-2016 (at approximately 67 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: stroke, cardiovascular event and congestive heart failure. The outcome of the events was unknown.   Upon internal review, events stroke and congestive heart failure were determined to be medically significant.
Generalized body pain, numbness/tingling in feet and legs starting 10/24/18-Gillian-Barre Syndrome.
A report was received from a consumer concerning a patient with unknown gender and age. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient administered with transmammary FLUMIST. The reporter stated that she was administered FLUMIST and she were nursing. At the time of reporting the outcome of the event of was administered FLUMIST and she was nursing was unknown. According to the reporter the report was considered to be non-serious. Corrected report on 25-Feb-2014: coding of the event of was administered FLUMIST and she is nursing changed from maternal exposure timing unspecified to exposure during breast feeding, narrative updated.
Became dizzy, eyes rolled up in head, fainted & fell to ground, became ghost white.
Severe left arm pain with any movement. Pain at elbow without any movement.  Pain to left axillary, left forearm, left hand feels tight. Inability to raise left arm above head without assistance
Within 5 minutes after the vaccination I felt really dizzy and took had to take  a couple deep breaths to calm down which went away pretty quickly.  Almost immediatly afte,r I got a sharp shooting inside nerve pain from shoulder under the armpit area down to my wrist area.  The pain was bad and constant until 1/14, aleve, ibuprophen or tylenol made it better.  On 1/10-1/11 the pain was the worst and woke me up from sleeping it hurt so bad with a pain level of  a 8/10.  The pain was more nerve pain over muscle pain and the intensity never changed  whether I moved or not.
FEVER; This spontaneous report received from a consumer via a company representative concerned a female 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: Unknown) 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 fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Covid rebound after taking Paxlovid. Had all initial vaccine and all boosters (5 in all of Moderna). Got Covid 2/20, positive antigen test. Took Paxlovid 2/22-2/27. Tested negative 2/29 Had rebound symptoms 3/10 with positive antigen test. Tested negative 3/15.
Nausea, severe sweating, unable to stand to get out of chair lasting +/- 5 min
On 1/28/21, 2 days following the 2nd injection of the Shingrix vaccine series, Patient reported that she had diarrhea, nausea, body aches, and tired feelings. She stated that these symptoms started one hour following her injection on 1/26/21. Patient stated that symptoms are not severe. Pharmacist suggested that patient seek medical attention if symptoms worsen.
The patient stated that the morning two days after Pfizer administration he peed blood. He said it lasted a day and a half with the blood diminishing with every evacuation. He stated he noted no other side effects from the vaccine.
Patient felt anxious about the vaccination and afterwards felt  dizzy/faint, and warm. We had him sit down put an ice pack on his neck, and had him drink some juice. After about 10 minutes he felt much better.
UTI; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced UTI (urinary tract infection) on an unspecified date with outcome of unknown. She was currently on antibiotics due to the UTI and wanted to know if that would effect the 2nd dose of the vaccine she was scheduled to get the 2nd dose next Friday 12Feb2021.  Information on the Lot/batch number has been requested.
He developed Shingles; This is a spontaneous report from a Pfizer-sponsored program through a contactable consumer. A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on unknown date as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that the patient suffered from shingles. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Localized reaction to back of right arm 5cm by 4cm raised hot to touch and red.
Dark rash multiple places on chest and arms; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0181) via an unspecified route of administration on 18Jun2021(at the age of 48-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jul2021 at 16:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021, the patient experienced dark rash multiple places on chest and arms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dark rash multiple places on chest and arms was not recovered at the time this report.
Tinnitus and continuous headache behind eyes since shot. Diet has changed. Activities haven?t changed.
Patient is fully vaccinated.  COVID + 1/3/2022.  ED visit on 1/11/2022.  Complaining of pleuritic chest pain, shortness of breath with exertional activity.  Component of diffuse body aches fatigue.  Now having diarrhea. Denies fever.  No vomiting.  No history of PE DVT.EKG reviewed and interpreted by myself, sinus tachycardia, left axis, nonspecific ischemic findings.  Blood work within normal limits.  Serial troponins negative.  D-dimer negative.  Tachycardia has resolved while in the ED.  Patient remains in no acute distress on reevaluation. Has a portable pulse oximetry device at home, told to return if levels fall below 90%.Discharged home from ER.
Rash under breast -- started 2/27/2021. Treated with triamcinolone cream.
This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (flared up), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site redness). On 19-Feb-2021, the patient experienced CONDITION AGGRAVATED (flared up). The patient was treated with CORTISONE for Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (flared up), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. The redness was spreading throughout the upper arm.