chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An hour after my vaccination, I was driving back home. My pulse was going up and down. My heart beat was irregular. I was nauseous like car sickness. I had to pull over so I didn't have an accident. A couple of days later, I went to the ER. I went to my regular doctor and had an EKG with no indications. I was told they had another person with the same situation. After a month this went away. Then a few weeks ago, I had an irregular heartbeat with beating 4-8 and then ship a beat. And I am still experiencing nausea. I went to my doctor again and had an EKG and that was abnormal. I am not going to a cardiologist. I have had an echocardiogram and I am currently wearing a Holter monitor. I do not have the results yet. I was advised to take additional magnesium. I have never had anything like this to happen and no chronic illnesses or heart issues.
Headache, Myalgia, NauseaVomiting, Chills, soreness and swelling at the injection site in the left arm Narrative:
I'm not sure which TDaP shot I was given, but for more than 5 days I couldn't move my arm more than an inch and it was extremely painful even when I wasn't trying to move it. The pain was so bad it would wake me at night (and no, I wasn't sleeping on that side). It continued to hurt and have limited mobility for an additional 7 days.
Hives upon vaccination that lasted for 2 weeks (daily occurance- now resolved) Significant increase in peripheral neuropathy and numbness since vaccination- not resolved
Using aseptic technique, client received flu vaccine IM to left deltoid, tolerated procedure well with no s/s of an allergic reaction at that time.  On 10/26/2020 at 09:30am, I received telephone call from father stating that on Sunday, 10/25/2020, he notice  redness/rash, slight soreness, and swelling to left deltoid (injection site) and on 10/26/2020 he noticed that redness, rash, and swelling had diminished a little but now multiple tiny blisters had developed to injection site. Father instructed to f/u with PMD with further evaluations. Followed up with father on 10/27/20, per father, client was taken to PMD and was prescribed an antihistamine and a topical antibiotic cream. Father also stated redness, swelling, soreness, continues to diminish as the days go by and blisters are gone. Per father, pt is recovering well.
MOC reports arm swollen red, stiff neck, temp; although mom never took temp, mom never took pt to MD; no treatment
suspected vaccination failure; I have had the shot! But I have had shingles! , I also have it again!!; It's like fire; It's like/ itching!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling of warmth and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling of warmth and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shot and had shingles. The patient had shingles again and stated it was like fire and itching. The patient would call physician. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
This spontaneous report as received from a registered nurse refers to a 4 year old female patient. On 26-JUN-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (injection, lot# reported as H017885, expire date, dose and route were unspecified). Nurse reported the patient experienced local reactions, large, swollen, red area, about size of an egg on the thigh after receiving PROQUAD (Merck). Patient went to an unspecified Emergency Room for a swollen right leg on 28-JUN-2013. Patient was diagnosed with cellulitis. Patient was prescribed BACTRIM, but did not take BACTRIM, for unspecified reason. Cold compresses were applied and the cellulitis resolved(unspecified date in 2013). This is one of three reports that received from the same source. Additional information has been requested.
Case number PHEH2014US022295, is an initial spontaneous report from a pharmacist received on 05 NOV 2014. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14581P) intramuscularly on 04 NOV 2014. It was reported that some of the vaccine leaked out of injection site and ran down to the patient elbow. No adverse event was reported.
15 hours after injection I experienced severe joint pain all over my body. This continued until 32 hours post vaccine. Motrin and Tylenol helped but didn?t completely take all pain away. Injection arm was slightly sore. I was lethargic until 36 hours post vaccine. All symptoms subsided the next morning.
This spontaneous report as received from Registered Nurse (R.N.) refers to a patient of unknown age. On 11-APR-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot # L026741, Exp: 18-MAY-2017) orally and RECOMBIVAX HB (lot # L044707, Exp: 16-OCT-2018). Both vaccines were stored under 52.5 degrees Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt states was fine day of vax, 4/25/2000, had joint achiness and Wed 4/26/2000 all over with swelling from shoulder to elbow on left arm, 4/27/00 6" area of hives on left upper arm, states no SOB, wheeze or dysphagia.
This non-valid spontaneous report was received from a registered medical assistant and refers to an unspecified group of unspecified patients. Their medical history, concurrent conditions and concomitant drugs were not provided. From 23-NOV-2018, the patients were vaccinated with improperly stored doses of VARIVAX lot# R011809, expiration date 23-APR-2020 (exact dose, route and site of administration were not reported) or improperly stored doses of PROQUAD recombinant human albumin (rHA), lot# R012417, expiration date 28-OCT-2019 (exact dose, route and site of administration were not reported) diluted in properly stored sterile diluent for prophylaxis. The administered doses of vaccines were stored in 11 Fahrenheit degrees for 45 minutes. Digital Data Logger was involved in capturing temperature excursion. No previous temperature excursion occurred. No adverse effects were reported.
She received her 2nd Covid vaccine on 04/07/2021. She reports when walking to her chair to sit for the 15 min. evaluation time she began to feel like she was SOB. She was monitored by a Nurse at the clinic. Pt reports that her saturations were between 85-95% and that her blood pressure was stable. Pt. reported that she felt like that she could not get her breath and was directed to be seen in the ER. Pt. presented with c/o SOB. Denied chest pain, wheezing, sore throat/swelling, denied feeling dizzy or lightheaded, nausea, vomiting, no rash, itching or abd. pain noted. Pt. reports that she has a hx. of dyspnea had a recent work-up and is currently being treated with albuterol inhaler and pulmonary rehab. Pt. denies any issues after receiving the 1st Covid vaccine.
Large amount of swelling, pain, heat at site of injection. Pt unable to use arm site is Left upper arm. Pt received care from Dr.
After receiving the 2nd dose of the Covid 19 Moderna vaccine started having seizure auras culminating on April 17 with a grand mal seizure. Paramedics came to the scene and took to the hospital. He was evaluated by the ER doctor and given a CAT Scan that didn't show any change from previous scans.
toes on my left foot began to swell and itch; toes on my left foot began to swell and itch; Numbness radiated up my calve; arm pain / toes very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced pain in extremity and numbness. On 21st January 2021, the patient experienced swelling of feet and localized itching. On an unknown date, the outcome of the pain in extremity, swelling of feet, localized itching and numbness were unknown.   It was unknown if the reporter considered the pain in extremity, swelling of feet, localized itching and numbness to be related to Shingrix.  Additional details were provided as follow: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. On Wednesday, the patient received shingle vaccine and experienced bad arm pain which was tolerable but the next evening the toes on left foot began to swell and itch and were very painful.  The numbness and pain radiated up to calve and the patient asked was this a side effect.
Patient's arm began hurting more than expected about an hour after receiving the vaccine. The next day, most of the upper arm was red and warm to the touch. Patient will self treat and monitor for now.
DONOR REPORTED JOINT PAIN IN JAW AND SWOLLEN LYMPH GLANDS IN NECK. TIGHTNESS IN NECK AREA. WITH IN 1.5 HRS OF INJECTION.  TRANSPORTED BY EMS TO EMERGENCY ROOM.
One day following administration, developed leg pain. 10/1/21, diagnosed with extensive left leg DVT extending from superficial femoral vein to proximal tibial vein
left side of face numb, tingling, redness initially bu gone as of time of call 1/21.  Told her to cont to monitor and get evaluated if did not go away in 24 hours or got worse
Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes; No adverse event; patients were given expired vaccine on 30-Mar-2023; patient was administered the vaccine that had undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial had undergone temperature excursions on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes. The vial was initially stored in the refrigerator on 29-Mar-2023.   No treatment medications were reported.  This case contains information for the 1st of 2 adult patients who received the vaccine on 30-Mar-2023 described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-718070 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-718070:Master case-1st adult patient vaccine administer on 27Mar2023.
diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced COVID-19 (diagnosed with COVID). At the time of the report, COVID-19 (diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Moderate headache w/ some nausea, fever in 102's, body aches especially strong back pain, chills, tiredness.   Left arm swelled up with redness felt lumpy and became itchy and very sore in 4 inch radius around injection site.
Information has been received from a pharmacist concerning to a 70 years old female patient. Medical history, concurred conditions and concomitant therapies were not reported. On 13-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles. Dose, route, frequency and lot number were not provided. The pharmacist reported that the patient developed a case of shingles on an unknown location approximately in MAY-2016, reported as "about two months ago". The patient visited the physician and the patient was treated with VALTREX, TYLENOL with codeine and capsaicin cream. The outcome of herpes zoster was reported as not recovered/not resolved. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient reports symptoms of numbness to tongue/roof of mouth/lips approx 30 min after vaccine administration. She contacted the COVID hotline to report symptoms and receive guidance and stated that 30 min prior to phone call her throat started to feel swollen.
expired Menactra being administered; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who received a 0.5 ml once dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U5986AA, expiry date: 24-Aug-2019) via unknown route and unknown site of administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation  It was an actual medication error due to expired vaccine used.   It was unknown if any adverse event occurred.  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 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.  List of documents held by sender: none.
Case number PHEH2015US025181, is an initial spontaneous report received from a health care professional on 01 Dec 2015. This report refers to a 40-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157104) intramuscularly on 01 Dec 2015 which was stored out of temperature range at 53 Fahrenheit for 24 hours. No adverse event was reported following this medication error.
pt came in stating that her lip was swollen and it started this morning.   Suggested taking benadryl and contact her md.
covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 46 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FF2589) at the age of 45 years as dose 3 (booster), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Mar2022) negative; (01Apr2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tuesday evening started to get sick fatigue Ag test neg - then Ag test positive Friday 01Apr as not feeling well and tested positive. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event covid test result=Positive and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Swelling and intense pain in elbow area, redness and hot to the touch, spreading from injection site to wrist. Unable to touch, move or weight bear without dibilating pain. Unable to use left arm at all for over 96 hours. As of 10/14 swelling, redness and minor pain continue.
Swelling, redness, tender at site of injection. Admitted IV abx after PO abx failure and increased pain/redness. Dx: cellulitis.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
Muscle aches; Large red lump in arm; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ethinylestradiol; etonogestrel (NUVARING) and triamcinolone acetonide (NASACORT); both for unknown indications from unknown dates. The patient was allergic to ibuprofen (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021 at 07:00, the patient had a large red lump in arm that lasted until 22Mar2021. On 22Mar2021, the patient experienced muscle aches. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events large red lump in arm and muscle aches. The clinical outcome of the event large red lump in arm was recovered on 22Mar2021 while that of muscle aches was not recovered at the time of the report.  Information on lot number has been requested.
pain at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PAIN (pain at the injection site) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. EN6204 and EN6199) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor.    On 09-Mar-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE PAIN (pain at the injection site) had not resolved. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-746446.
pt recvd vax & w/in 1 hrs pt exp nervousness, anxiety, h/a, nausea, blurred vision, chest tightness;tx DPH
Received flu vaccine at 10:00 A - no immediate reaction. Three hours later, fever spiked to 103.8 degrees. Severe body aches mid-torso and legs causing difficulty breathing and ambulating. Taken to emergency room for IV fluids and antipyretics.
Pt Reports Chills, Fever 101 F, headache, Nausea, Drowsiness by 9PM the day the vaccination was given. Redness and induration at injection site increased through day of report.  Took Alieve in the AM of !1/17. Seen in ER at 4:30 PM 11/17/05. ER physician perscribed tylenol and Benadryl every 4 hours and intermitent ice and heat to injection site.
Information has been received from a consumer concerning her 14 year old daughter with an allergy to AUGMENTIN who on 18-FEB-2008 was vaccinated with the first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 19-MAR-2008 the patient had a positive PAP smear.  Unknown medical attention was sought with the physician.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Noted a depression in the left arm when she started volleybal practice in August. No pain unless itis pushed on that area. Depression observable on photos and seems to be increasing.