chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 12 hours after receiving my second dose I experienced nausea, constant vomiting,  uncontrollable shaking, muscle cramps that affected my arms and legs, and experienced periods of cold chills that changed to feeling extremely overheated back and forth for several hours. After experiencing these symptoms for about 6 hours the only symptom that remained was the muscle cramps which ended after 24 hours after symptoms first appeared.  I did not receive any medical treatment nor did I take any over the counter pain medication. I would rate the severity of my symptoms as an 8/10 when comparing it to previously experienced flu like symptoms.
I had normal side effects initially but around 24-36 hours after 2nd dose I started with chest pain. It began in the front and radiated to behind my shoulder blade. Thought it was musculoskeltal. Lasted approx 4-6 weeks. Got Covid in February 2022 and within 12 hours started with the same chest pain, starting in front and radiating behind my shoulder blade. Initially assumed another muscle pull but 24 hours later pain began to radiate down arm. Went to ED where ekg showed t wave inversions and echo showed a pericardial effusion. Diagnosed with pericarditis at that time. Took colchicine x2 months, 4 weeks after stopping had another pericarditis flare with ST elevation on ekg and chest pressure / shortness of breath.
an older unspecified child passed out,; seizure; incontinent after receiving MMRII; This spontaneous report was received from a registered nurse and refers to an "older" child patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, and drug reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, frequency, lot #, and expiration date not reported) for prophylaxis.   On an unknown date, also reported as "after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)", the child passed out (loss of consciousness), had a seizure, and was incontinent. On an unspecified date, the patient went to the emergency room due to the events. It was noted that the reporter inquired about the availability of measles virus vaccine, live (Enders-Edmonston) (ATTENUVAX) and mumps virus vaccine live (MUMPSVAX). The outcome of the events was unknown. No further information provided.  The causal relationship between loss of consciousness, seizure, incontinence and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review, loss of consciousness and seizure were considered to be medically significant events.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA011146: US-009507513-2002USA011164: US-009507513-2002USA011167: US-009507513-2002USA011163: US-009507513-2002USA011165: US-009507513-2002USA011166: US-009507513-2002USA011162: US-009507513-2002USA011180:
Pt received Hep B #2 on Thursday 6/2/05 at 1pm, by 6/3/05 2pm she began experiencing adverse rxn sx.  Pt describes feeling severe joint pain, edema of the hands and feet, and rash on legs and arms.  Today 6/6/05, rash has subsided but joint pain and fatigue is still present.  I have made an appt for MD evaluation today @ 2pm.  Pt has been taking a Goody Powder combo with aspirin and acetaminophen.  I have instructed pt to d/c this and to use only plain Tylenol or Ibuprofen for joint pain.
Big red square on the arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red square on the arm) and PRURITUS (Itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for Headaches cluster.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Big red square on the arm) and PRURITUS (Itching). At the time of the report, ERYTHEMA (Big red square on the arm) and PRURITUS (Itching) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Rash on lower torso, right side from lower back around the side to the front Saw primary care doctor on Wed. 04/14 who diagnosed shingles and prescribed valacyclovir HCL.  At this time patient is taking the valacyclovir and the condition is healing.
Tinnitus (pulsatile) in my right ear started started in about two days. Loss of hearing in my right ear occurred gradually.
This is a spontaneous report from a contactable consumer reporting for herself. This 67 year-old female patient of other race received the first single dose of PREVNAR 13 via an unspecified route of administration on 09May2017 at 4 pm in left arm for immunisation. Medical history included allergy from an unknown date and unknown if ongoing. The patient was concomitantly taking some other unspecified medications. No family medical relevant history was present. No other vaccines were administered the same day or within four weeks prior. The patient experienced injection hurt real bad on 09May2017. The evening of the next day, on 10May2017, she noticed pain in her left arm, generalized to the shoulder area. She rubbed her arm in ASPERCREME, and then iced it because the cream didn't do any good. Because she was still having pain and weakness in her left arm up to the shoulder area, she started taking ADVIL, that evening as well. On 11May2017, she went to work and was still icing her left arm and taking 2 ibuprofen per day. She also started feeling very sleepy, had muscle aches and pains, and fatigue. That continued for 11May2017 and 12May2017. On 13May2017, she started having headaches behind her right eye. She described them as funny kind of headaches but not migraines. On 14May20017 she was tired and lethargic, and just laid around and slept all day. She went to work the next day even though she was still tired and lethargic, and her co-workers told her that she needed to go to the doctor. She stated that she also noticed, on that day, that her arm was very red and irritated. On 15May2017 or 16May2017 she went to the doctor due to the events. The doctor measured the area on her left arm that was red and irritated, and it was about 3 inches. It was also really itchy. The doctor prescribed a 4 day dose of prednisone. The redness and itching resolved a couple of days after she finished prednisone on an unspecified day in May2017. She had also stopped the trolamine salicylate by this time because it wasn't working. She was still having headaches behind her right eye, but since last week, the headaches were getting better. They were still there, but they were intermittent. She also still had the weakness in her left side up in the should area. It was bad the first week, but it has improved. She could feel the pain going up the left side of her neck if she raised her left arm. On 26May2017 she felt like the whole thing was coming on her again. She clarified that she felt like she did the day that she went to the doctor. It lasted into the evening, about 4-5 hours. She has never had that feeling before in her life, so she recognized it immediately. The patient recovered from redness and itching on an unspecified day in May2017, she was recovering from weakness in her left arm up to the shoulder area and headache, she was not recovered from pain in her left arm, generalized to the shoulder area and pain going up the left side of her neck if she raised her left arm, outcome of the other events was unknown.
onset of joint pain 15-16 days  p/adm of MMR-subsiding;
Quadracel by mistake in the right thigh, Instead, the patient should have received hepatitis A, and separate vaccines for MMR and varicella/no AE; 12 months old patient received Quadracel/no AE; Initial information was received on 18-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 12-month-old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]  (lot C5763AA, expiry date not reported) via an intramuscular route in the right thigh and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD), by mistake instead, the patient should have received HEPATITIS A VACCINE (HEPATITIS A) and separate vaccines for MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE [VARICELLA] (lot number, expiry date route and site were unknown) for prophylactic vaccination on 01-Mar-2021 (wrong product administered) and (Product administered to patient of inappropriate age).   Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Local redness; warmth, swelling, hives on injection site 5 minutes after injection - No resp distress; pt alert and crying. 2 x 2 inch area.
Admit for hypoxemic resp fx d/t COVID PNA, severe sepsis. Hx DM, ESRD, HTN. Tx w/abx, steroid, remdesivir, O2. DC to SNf on 2L NC.
Back pain from left to right along waist, difficult to start from sitting position and pain when bending and sitting
Two episodes of syncope on morning of Saturday, December 11th after a poor night of sleep with flu like symptoms following the Covid 19 booster on Friday, December 10th at 1:00pm.  Went to hospital via ambulance after hitting my head.
very tired; painful at site of injection; very red and hot to touch; very red and hot to touch; patient was inadvertently given meningococcal group b rlp2086 instead of PPD intradermally on the left forearm; This is a spontaneous report from a contactable healthcare professional. An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), intradermal on 29May2019 at a single dose for immunization instead of tuberculin PPD intradermally on the left forearm. The patient's medical history and concomitant medications were not reported. On 29May2019, the patient was inadvertently given meningococcal group b rlp2086 instead of PPD intradermally on the left forearm. On 31May2019 (reported as after 48 hours), the patient reported that she was very tired and painful at site of injection. The injection site was 128 mm x 68 mm and very red and hot to touch. The outcome of the events was unknown.  Information on the batch number has been requested.
Redness, painful to touch, lymph node under the armpit was swollen, and itchy.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR that had been improperly stored. The patient received a dose on an unspecified date. The patient received PREVNAR that had been improperly stored in 2009. No adverse event was reported. The outcome was unknown. No additional information was available at the time of this report.
Brain fog, vision issues, fatigue/still ongoing.  Began 6/2/21
Fever, muscle spasm, left arm pain, clavicle pain and sharp pain in right arm.
Swelling, hardening and heat at and surrounding the injection site 7 days after vaccine administration, now continued throughout post-vaccine day 8
Right thigh with erythema and a hardened area approx. 7cm X 3cm. No fever. Child jumping, running and playing. Advised warm compresses, warm bath and Tylenol or Motrin.
34 YO male patient with no past medical history presents with sudden stroke-like symptoms including right sided arm and leg weakness, numbness, slurred speech and facial droop.  Symptoms lasted for roughly 45 minutes.  Suspected CVA.  MRI done in hospital was found to be consistent with microinfarcts in the left hemisphere of the brain, mostly along the cortical ribbon with a single lesion in the left parasagittal/lateral pons.  Full neuro and cardio workup is currently being done. ECHO w/ bubble study was weakly positive and plans are for TEE today.  Otherwise, no exact cause identified and few risk factors. Found out that the patent was taking no medications prior and had no past medical history and was otherwise a 34 YO healthy male, who received their first dose of Moderna COVID-19 vaccine on 4/22.  3 days later the patient had this event.  The timing of everything makes me report this as the potential is there that this is a  vaccine ADE and plausible reason for this thrombotic event.
1/29/2021 at apx 5:00am patient stated to have an upset stomach. Later in the day at apx. 12:00pm patient stated to have a fever of 102.0 F and beginning of a rash throughout her body. Symptoms continued through the following day.   1/31/2021 at apx 5:00am patient stated to have swelling of her throat and went to the emergency room. Patient given IV and gastrointestinal cocktail. Patient sent home steroid and diphenhydramine prescription.
Heart attack; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This consumer reported information on additional patient. Caller reported that person in her county just had someone die from heart attack right while they had The Vaccine in the office-he was 56 and healthy. Caller mentioned they've had people who had autopsies who were administered the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. This is serious report for results in death.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack
localized rash with itching.  No SOB,  no wheezing.  BENADRYL given PO, patient watched for 15 min.
This spontaneous report was received from a physician refers to a male patient of unknown age. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 22-JUN-2015 the patient was vaccinated with second dose of GARDASIL (dose/frequency, lot #, expiry date unspecified). Concomitant medications were not reported. Reporting physician stated that the patient was administered with the first dose in the series of GARDASIL on an unspecified date in 2014 (reported as a year ago) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Felt like the pharmacist injected too high. At first it wouldn't inject, then moved needle slightly. When injected felt a great pressure in arm. Arm has been hard to move without pain since then.
Pharmaceutical product complaint; sprayed back; product went on his face; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental occupational exposure to product in a adult male patient who received Herpes zoster (Shingrix) (batch number 74Z97, expiry date 21-NOV-2025) and (batch number 4JP7M, expiry date 21-NOV-2025) for prophylaxis. This case was associated with a product complaint.   On 07-NOV-2023, the patient received Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced accidental occupational exposure to product (Verbatim: sprayed back) and exposure via skin contact (Verbatim: product went on his face). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental occupational exposure to product, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 and 08-NOV-2023 Pharmacist stated that he was reconstituting a dose of Shingrix, the liquid product which also contained antigen sprayed back. The product went on his face and up his nose, the pharmacist washed his face and blew his nose and rinsed with water. Batch number of adjuvant was 74Z97 and antigen was 4JP7M. The reporter consented to follow up. The liquid product of Shingrix which also contained antigen sprayed back and the content came into contact with his face and nose, which led to accidental occupational exposure to product and exposure via skin contact. The Vaccine Administration Facility was the same as Primary Reporter. The reporter injected air from the syringe into the vial during preparation. Up to 0.5 ml air injected into adjuvant vial to draw it out. It was unknown if the leak coming from the stopper at the neck of the vial or from a needle puncture in the stopper. The vial rubber stopper/metallic skirt did not detach or become loose during handling or without any manipulation. The plastic flip-off or also the metallic skirt/ring of the vial before handling. There was no evidence of leakage in package or carton.
Fever of 101; severe headache; severe neckache; body aches; extreme fatigue. Treated with sleep, taking time off of work, pain relievers, ice pack/heat pack. Fever resolved in 24 hours, though mild symptoms lingered for 48 hours.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1416 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
2 DAYS AFTER VACCINATION  I WOKE WITH WHAT SEEMS LIKE SOMEONE PUNCHED ME IN THE NOSE.  THE CARTILAGE ON THE UPPER PART OF MY NOSE WAS EXTREMELY TENDER.   ALSO  I HAD A HEADACHE WHICH  EMANATED  IN A RADIUS OF MY NOSE.  WASN'T REALLY A HEADACHE AS MUCH IT WAS A FACEACHE.   THREE DAYS OF TAKING NAPROXEN  AND I AM STARTING TO FEEL BETTER.
After the second injection, my face swelled up. Where I have Sculptra injection, hard bumps began to form and which are still there today.
Intense headache; Chills; low grade fever; Aches; minor soreness in my right arm; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via unspecified route of administration in the right arm on 25Mar2021 at 09:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient did not have a medical history reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medications included norethisterone acetate; ethinylestradiol; ferrous fumarate (BLISOVI 24 FE ORAL) and cetirizine hydrochloride (ZYRTEC) since unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the right arm on 04Mar2021 at 09:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. On 25Mar2021 at 21:30, the patient experienced intense headache, chills, low grade fever, aches and minor soreness in her right arm. The patient also reported that it was very difficult to sleep through the night and the chills, feverish feeling and aches lasted for roughly 24 hours. The headache lasted for roughly 30 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of the events chills, low grade fever, headache, aches and pain in arm was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from a consumer on 07-Feb-2017. This case involves a 69-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (flu Vaccine) via intramuscular route (Batch number: 5673JA; expiry date, dose, and dose in series were not reported) in right deltoid on 22-Sep-2016. Patient's illness at time of vaccination was reported as none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included multiple allergies. Concomitant medications were not reported. On 22-Sep-2016, immediately after the vaccination patient had developed arm stung and burning sensation and had pain in that arm and shoulder. The patient had been seen by primary care physician and to be seen by orthopedist on 02-Aug-2017. Laboratory investigations and corrective treatment were not reported. Patient was not recovered from the events. List of documents held by sender: none.
The morning after I received the Fluvirin Multidose Vial 2013-14 5 ML in my left arm, I woke up with my left eye swollen and irritated.  The swelling lasted 7 days.  An eye twitch onset around the 7 day mark and continues, without improvement.
Pt believes that her fluctuations in blood glucose were caused by AFLURIA. She was sight impaired for a period and lethargic and unable to do anything over the weekend.
Sore arm.  My blood pressure, which is usually 90s/60s started spiking along with heartrate. Nothing that was dangerous, but I could feel the pressure in my legs and my head. The highest I recorded was 142/98 on 4/16. This started 4/14/21, the Wednesday after the shot and continued for about 2 weeks. By 4/28 I was back down to 90s/70s.  However, I was also under a lot of job stress in that same time period and the shot might be unrelated.