chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash on both forearms, worse on right arm (opposite of injection site). Small raised bumps with mild itch. Lasted about 2 days, left dry white bumps like little pimples for the next week or so but didn't itch. Still a few there, looks like I have goosebumps.
This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient experienced petechiae (it looks like petechiae, these little red dots all over my skin), depressed mood (she is very upset about everything) and anxiety (she is anxious), onset 2021, with outcome of unknown. Additional information: The dermatologist doesn't know, the doctor, no one knows. It happened six days after the second, the booster (third shot), and it was late Aug within six days developed. It looks like petechiae, these little red dots all over skin. Product details (expiration date, NDC# and UPC #), purchase details and other details unknown and limited information was available. There was no product complaint to report. During call back, reporter stated he was a companion to the patient. The patient was "having issues since the vaccine shot." Patient had red spots all over arms, which disappeared and came back. Upon further research by patient, she found out it may be an indication of possible serious problems. Patient was seen by the dermatologist, family doctor and a nurse; but they have no idea what the patient had. They wanted to know what should they do about it. The lot number for BNT162B2 not provided and will be requested during follow-up.
Patient passed out immediately after getting the pfizer covid vaccine for approximately 1 minute.  EMS was called and the patient seemed to be okay, EMS took over.
1. Last year in our facility, a nurse administered the high dose flu vaccine instead of the regular flu vaccine due to labeling confusion. There is no specific dosing on any of the flu vaccine products. 2. The high dose Fluzone syringe from Sanofi has hard to read green print. RN notified pharmacy of difficulty in reading light green print on high dose Fluzone syringe. 3. The boxes for the Flublok and regular Fluzone with different manufacturers have similar dark blue/white coloring. If stored together, these products can be mixed up.
Hello, immediately after the shot I began Having pain in the arm which I expected.  On the third day after the shot, I began Having red swelling skin , with a rash that was itching and the skin is hot to the touch. I am Now 11 days after the shot and the injection site is still hot to the touch, itching, red and now swollen. I am A bit concerned as I did Not think the reaction would last this long. I also Still have soreness in the arm. I thought the symptoms would decrease , not increase. Can I please Speak with someone on your staff about this please?
pt recvd vax & 2wks later exp gen rash all over body;treated w/Pred;pt still exp pruritic type rash when exposed to inc temp
There were NO adverse patient reactions. Continually refrigerated Moderna vaccine was given past, recommended 12 hours of opening multi dose vial. Moderna manufacturer notified of issue.
Patient received a pneumococcal vaccine on 12/6/17. Following the injection, the patient developed cellulitis of the right arm and was seen at a walk-in clinic where she was prescribed BACTRIM. Symptoms worsened and the following day she went to the hospital and was admitted for 3 days. During the hospital admission, pt developed phlebitis of the right arm. She received IV antibiotics and steroids while in the hospital and was discharged on AUGMENTIN and MEDROL DOSEPAK.
Information has been received from a pharmacist concerning a 38 year old white female with an allergy to penicillin who on 4/7/03 at 9:00AM was vaccinated with the first dose of varicella virus vaccine live. On 5/5/03 in the PM, about 3 weeks after vaccination, the patient developed vasculitis on the palms of her hands and on her knees. No treatment has been given. Unspecified medication attention was sought. There was no product quality complaint. Follow up information indicated that on 5/5/03 in the PM the patient developed vasculitis on the palms of her hands and on her knees. The duration was reportably approximately 2 weeks. As of 5/23/03 the symptoms are slowly subsiding, and the reporter indicated that the outcome is recovered. The patient sought medical attention for the diagnosis. The vasculitis consisted of broken blood vessels, severe swelling, some blisters. No relevant diagnostic tests or laboratory data were reported. Upon internal review, vasculitis was considered to be an other important medical event (OMIC). No further information is expected.
From initial information received on 13/Jun/2005 from a registered nurse regarding an adverse event, it was reported that a 26-year-old male patient received a dose of DECAVAC, lot number U1206CA, administered in the right deltoid.  The route of administration was not reported.  The following day, the patient developed local redness, warmth and streaking along the right arm.  He was seen in the emergency room on 17/Jun/2005 and was diagnosed with staph infection.  Reportedly, KEFLEX was prescribed.  The patient did not recover from these events.  From additional information received on 05/Jul/2005 from a physician, it was reported that the patient received DECAVAC intra-muscularly.  Per the reporter, this was the patient's first dose of DECAVAC.  The patient received his last tetanus shot nine years ago with no adverse reactions.  It was also reported that no culture was obtained.  The patient fully recovered on 16/Jun/2005.  No further information is anticipated.  This case is considered closed.
Initially only headache.  Second day swollen lymph nodes, particularly under arm on left (injection) side.  Iced armpit area and took ibuprofen for three days.  Lymph nodes were still generally sore from neck through torso, even to today (tenth day post immunization).  Additionally, experienced chest pains day 5 and 10, each one day after routine swims.  (1500 yds over 30 min).  Generally fatigued, and had rested days 1-3.
Within two days of this third vaccine, I began experiencing abdominal pain in the upper right quadrant (liver).  This varied from acute to moderate for 8 - 10 weeks.  I was familiar with what I was experiencing since I had already experienced similar symptoms (and elevated liver enzymes as documented by lab work) during my first and second doses of the vaccine (which are chronicled below).  I still (to-date) periodically experience transient episodes of mild to moderate liver area pain.  I would have DECLINED this third dose (booster), given my previous symptoms with the vaccine, BUT it was being REQUIRED by my employer, in order to continue employment.  Previous symptoms - as already reported under Adverse Event #1 and #2: Within a few days of the first COVID vaccine dose (vaccinated 1/15/2021) I began experiencing moderate to significant upper right abdominal quadrant pain.  After looking at an anatomy diagram I was able to identify this as the affected area as my liver.  I had routine labs done on 1/22/2021 (1 week later) and these labs showed elevated ALT.  Prior to this I have never had elevated ALT.   This upper right abdominal pain continued persistently for approximately 8 weeks.  During these 8 weeks I received my second dose of the COVID vaccine (Pfizer/BioNTech, also Lot# EK9231) on 2/5/2021.  Immediately after the 2nd dose I experienced an increase in acuity of the upper right abdominal quadrant (liver) pain.  The acuity eventually subsided with moderate pain persisting and moving to periodic through July/August 2021.   To date (6/1/2022) I still periodically experience transient episodes of mild to moderate liver area pain.  On 3/23/2021 my follow-up labs showed ALT barely back in range (23 U/L).    On 9/14/2021 some follow-up labs showed ALT back to "my personal normal" (pre-vaccine) range of 17 U/L.
Pt recvd 3 doses of Engerix-B 30OCT90, 27NOV90, & 29APR91 & 15SEP91 & it was determined that pts titer was neg p/3 doses of Engerix-B;
mom states started running fever 25JUN93 & would go up to 103 & only come down sl w/APAP; red rash over entire body including in mouth rash faded by 1JUL93; did not contact MD until 29JUN93 & was not seen by MD was improved by 30JUN93;
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # 669579/0595AA, expiration date 30-AUG-2012) that expired (reporter stated that expired on 31-AUG-2012) on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Pt. received SHINGRIX shot at 11:30 AM. Within 5-10 min pt. stated dizziness and warm flushing feeling. We called 911 and I sat by pt. with EPIPEN in hand if needed. Ambulance arrived within 5 mins and took pt. to hospital.
COULD NOT BREATH; FELT REALLY TIRED; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included previous stroke, and aneurysm, and concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0402A214, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced could not breath. On 07-APR-2021, the subject experienced felt really tired. On 07-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt really tired, headache, and could not breath. This report was non-serious.; Sender's Comments: V0: As per standard protocol, MAC comment is not required for non-serious case
1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-NOV-2022 Reporter's comment: The reporter stated that 2 years prior to the reporting, the patient's wife, brother, nephew, niece and patient himself, received only 1 single dose of Shingrix. The patient never informed that Shingrix was given as 2 doses series and never received a second Shingrix dose. It was stated they all received the shot in the arm. Additional supportive information: Till the time of reporting the patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up. This case is 1 out of 5 cases reported by the same reporter and this case is for the reporter's niece.; Sender's Comments:  US-GSK-US2022AMR179085:Same reporter US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179084:Same reporter
Pt recvd vax 10APR92 & w/in 24 hrs pt devel burning throat & nose, wheezing, SOB & felt headachy; seen by MD & treated w/steroids;
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Doctor ordered Hep B. I thought I gave Hep B when I did my vaccine count I found I gave HIB instead of Hep B because my count was off for the two (L/F). Informed of incident 6-23-08 9:30 AM. Called family, baby had low grade fever 100.5 with mild local swelling, warm to touch injection site 1st 24-48 hrs after the shot. Given TYLENOL infant drops every 4 hours prn. Today doing well, no fever, nor redness, swelling, tenderness. Feeding good ISOMIL.  Recovered.
Patient stated that he had normal symptoms after the vaccine for the first couple days and fatigue for at least five days. On the 16th of march patient felt flutterers in his heart he went to the ER and was there for over 8 hours. They ran test and advised he see a cardiologist. He has been going back and fourth to the DR. since March about heart and blood pressure.
it itches too; swollen; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a day after receiving Shingrix, the patient experienced swelling. On 17th August 2020, the patient experienced pruritus. On an unknown date, the outcome of the swelling and pruritus were unknown.   It was unknown if the reporter considered the swelling and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and get swollen but on the day of reporting it itches too.  was that ok  The reporter consented to follow up.
she had vaccine in left arm and had an outbreak on 09/21 with hidradenitis on her entire left side only.  She also had cold sores break out in her mouth, lips and in her nose.
Pt experienced injection site reaction characterized by pain, swelling and redness. Pt also experienced weakness, elevated temperature, malaise. Treated with Tylenol
psoriasis/plaques were on my elbows/legs; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis/plaques were on my elbows/legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to all OTC cough medications), Allergy to arthropod bite (fire ant bites.) and Psoriasis (Psoriasis for as long as he can remember - certainly back as far as 1970s or 80 s, perhaps more. Usually treated with tropical steroids, to little effect.).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (psoriasis/plaques were on my elbows/legs). At the time of the report, PSORIASIS (psoriasis/plaques were on my elbows/legs) was resolving.            concomitant medication include tropical steroids for psoriasis  No treatment medication information was provided.
This spontaneous report has been received from a 73 year old female patient referring to herself.  The patient's concurrent condition, concomitant medication and medical history were not provided. In 2012, the patient was vaccinated with ZOSTAVAX (one time injection, lot# and expiration date were not known) for shingles (prophylaxis). On 04-JUL-2017, the patient experienced shoulder and right chest pain with bumps. She went to the doctor and was advised she had the shingles. No treatment was given to the patient. The outcome of shingles was unknown. The causality between ZOSTAVAX and  shingles was unknown.
Spots on Face (red rash)on 8/15,  8/16/2011 red rash on stomach, face, fever 101,  8/17/2011 red rash on arms, legs, stomach, face, fever 102.7. 8/18/2011 rash every where including palms of hands soles of feet. Less skin showing than rash. Discomforted, swelling of face fever 100.9  Treatment: DR. sent away for labwork, waiting it out with Tylenol if fever increases.
medical assistant had administered an expired vaccine to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00628493) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 75 years old female patient who received 0.5 ml of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA, expiry date: 19-Apr-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 24-May-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Expired vaccine used (latency same day)  At the time of report, no adverse event was reported.  Caller stated a medical assistance accidentally administered the diphtheria tetanus (TD) vaccine. Caller asked if there is anything they need to do, were there any adverse effects and what were the next steps  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right arm upper swollen and extended to shoulder neck, and right cheek. reaction occurred first 24-48 hours. Patient went to ER, Benadryl given. No shortness of breath. F/U at PMD, with decreased swelling localized right deltoid and clavicular area. Continued Benadryl and cool compressed.
Began as muscle soreness in right upper arm, limited mobility, constant sharp pain in upper shoulder, feels like shoulder is dislocated.
Covid vaccine given August 2021, then case admitted to hospital for Covid treatment in January 2022. Covid onset 1/15/22, of shortness of breath. Hospitalized with Covid pneumonia and hypoxic respiratory failure. Treated with steroids and Tocilizumab. Discharged to home on baseline oxygen of 2-3 litres per nasal canula.
I developed mild to moderate symptoms of Covid 19 on July 27th and tested negative with a rapid at home test.  I retested on July 28th and received a positive result.  Reporting occurrence per V-Safe call I received.
Patient received moderna this afternoon at 12:22pm. The patient called back at 6:19 reporting  rash with blisters across neck/shoulder area and down here forearm. The patient reports taking Benadryl in response. I told her to monitor and to seek medical help if needed.
Patient said starting Wednesday 10/3/2018 (evening hours) had swelling and extreme pain through the night. She also said arm felt hot. On Saturday 10/6/2018 patient went to a walk in medical facility to have arm checked. Patient called pharmacy on Monday 10/8/2018 to report incident. Said during the past week she could hardly lift her arm and had pain. She had been putting ice on ram and taking Tylenol. On Wednesday 10/10/2018 patient felt much better and was able to lift arm. Spoke with patient again on Thursday 10/11/2018 and was told she is feeling much better but still has slight pain in arm. Patient had said she wanted incident reported. Verified patient's address, DOB, phone number and asked if her personal information could be reported to Vaers site.
Multiple episode of irregular HR for about 7 hours.  Severe pain in the left shoulder and joint, with muscles involvement.  The pain extended down the arm to the wrist.  Muscles were weak and unable to lift arm higher than chest, unable to perform ADL's with left arm as there wasn't any muscle strength to lift a thin blanket covering.  Severe pain lasted about 48 hours with continued joint pain, although much less severe, in the left shoulder.  Used Benadryl and Motrin.  Didn't notice any different outcomes.  Arm remained elevated on a pillow for some pain diminishment.
Went to local hospital ER about 1 1/2 hours after receiving Tdap shot with c/o itching, chills, "a little SOB" pain at inj site and anxiety. Dx'd with 1. anxiety 2. adverse drug reaction - rx'd with ATIVAN: DC'd in improved cond - pt left ER and took 2 BENADRYL pills feels better.
The patient received Fluzone HD Quad vaccine 0.7ml intramuscularly in right arm on 10/14/21.  She reported arm/shoulder pain and having pain difficulty when raising her arm since receiving the vaccine.  She reported this to the pharmacy the week of 11/15/21.  She contacted her doctor and is having an x-ray and ultrasound performed.  Her physician has been notified by the pharmacy and the patient has a follow-up appointment scheduled on December 9th.
Itchy eyes, cough, wheezing. He was already on Allegra for two days for runny nose at home. So no hives.
Soreness in left arm and side of neck. Feeling mentally  foggy and a bit of restless leg type jitters. Unable to sit still for about 10 hours or so.
pt recv vax; induration of thigh at site of inject, noticed by PAR 7 days p/ immunization;
3 CM AREA OF ERYTHEMA, WARMTH, AND TENDERNESS AT THE SITE OF VACCINATION.  SYMPTOMS WERE CONSISTENT WITH CELLULITS, AND THE PATIENT RECEIVED A COURSE OF TRIMETHOPRIM/SULFAMETHOXAZOLE.
experienced some lower back pain achy; This case was reported by a consumer and described the occurrence of low back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was unknown.   It was unknown if the reporter considered the low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced some lower back pain achy and no fever.