chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thursday morning, 12/10/09, around 6pm started to have fever, headache, difficulty in walking, red face, rash on skin. The symptoms continued and on the third day the fever did not go down. Had a severe infection in the throat, slightly fast pulse, nausea, body aches, shivers. When had fever had difficulty breathing. On Friday, 12/18/09, 8 days after the administration of the vaccine finally felt better. Visited an ER and 2 private doctors. Was administered CIPRO and PANADOL.
Injection site "started getting a little red, itchy, and hot or warm; Injection site "started getting a little red, itchy; Injection site "started getting a little red; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included mesothelioma (The patient receives chemotherapy for mesothelioma). Concomitant products included chemotherapy, nos (Chemotherapy).   On 27th April 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2020, 2 days after receiving Shingrix, the patient experienced injection site warmth, injection site itching and injection site erythema. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site warmth, injection site itching and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site itching and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received first dose of Shingrix on left arm and following the vaccination the injection site started getting a little red, itchy, and hot or warm. The patient also reports that she receives chemotherapy for mesothelioma.  The patient was prescribed generic bactrim by her HCP for the injection site.  The reporter consented to follow up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 24-MAY-2013, the patient was inoculated with ZOSTAVAX at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 08-DEC-2015, the patient was treated at the same physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir and silver sulfadiazine for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
itching all over; This spontaneous case was reported by an other and describes the occurrence of PRURITUS (itching all over) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PRURITUS (itching all over). At the time of the report, PRURITUS (itching all over) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-089713 (Patient Link).
Two days post MMR/HIB titer vaccinations, patient developed redness and swelling of cheeks and upper neck. Afebrile. No change in appetite. Normal activity.
Information has been received on 06-MAR-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 06-MAR-2017 the patient was vaccinated with a dose of VARIVAX lot # L001329 expiration 13-JAN-2017, subcutaneous for prophylaxis which was expired. No adverse effects were reported. No further information was provided. Additional information has been requested.
FEVER, HEADACHE, ACHY BODY, NAUSEA AND VOMITING
Nausea (lasted 24 hours, no alleviating factors)  Severe Headache (lasted 12 hours, alleviated with acetominophen)  Fever (peaked at 102°, lasted 12 hours, alleviated with acetaminophen)
big red mark on my arm, like a big red circle/I had a big red patch on me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I take high blood pressure medication" (unspecified if ongoing), notes: further clarification unknown. The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "big red mark on my arm, like a big red circle/I had a big red patch on me".  Additional information: The patient had a big red mark on arm, like a big red circle (described as covid arm or booster arm).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Sedation, Myalgia, NauseaVomiting, chills Narrative:
4 hours after receiving FLUZONE HD patient began severe vomiting, dizziness and stomach cramping. Patient passed out and ambulance was called in to take him to ER. Patient appears to be recovered as of today 10-1-10. His primary Dr. told his wife this is the 2nd case they heard of with HD vaccine.
This spontaneous report as received from a licensed nurse practitioner refers to unspecified number patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and route were not reported) lot # L014265 and expiry date: 28-APR-2017. No concomitant medications and adverse events were reported. The call was due to a data logger. No further information was available. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
localized redness & swelling @ site;both arms swollen & pink;swelling of face, congestion, SOB, emesis x 1;
Started out with the chills when I went to bed. Then got acky and couldn't sleep or get warm.  Felt like crap all day . Upset stomach, sore, freezing. Felt fine the next day. Was also fine with first shot.
2 hours after the injection:  Sore Arm 9 hours after the injection:  Chills and fever 24 hours after the injection:  Same as before and extremely painful headache started 36 hours after the injection: Took Tylenol 40 hours after the injection: The fever broke and I started to feel better 72 hours after the injection: Felt better and went to work, arm was still sore for another day.
Developed a very itchy rash on my back. It was about the size of my fist and lasted 3 days; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Apr2021 at 12:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, ragweed allergy (allergy to plants) and somewhat allergic to bee sting. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient developed a very itchy rash on the back.  It was about the size of the patient's fist and lasted 3 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy rash on the back was resolved 13Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt reported to health unit with left arm pain; onset after receiving influenza vaccine a few hours earlier.  Pt given Motrin 800mg per mouth three times per day.  Two hours later, she presented again with arm pain worsening, and onset of left side neck pain.  Treatment: Decadion injection and oral Prednisone for 2 days.
Immunization 10/04/10, symptoms began 10/06/10 eye matted and itching, with rash on face - swollen. 10-11-10 pt feels better. She doesn't knew if her adverse effects well related to the flu shot or other allergies.
muscle pain, tired, fever, chills, swelling, headache, nausea, shivering, redness, arm pain. Tylenol used.  Could not get out of bed on day 2. Total 4 days until all side effects over. Worse side effects ever from any vaccination. I would never repeat Shingrix unless it gets changed.
I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021  12 hours later, about 12pm I start having side effect:  Left Arm sore, hurt to lift (arm that was injected)  Farting up a storm in my sleep Wednesday night, waking me up constantly, horrible weird smell, my poor husband, I moved to the couch and stunk up the first floor.  Then diarrhea few hours later, about 4am, slight intestinal cramps, not bad.  I was able to get ready and go to work for 6am. On Thursday January 28 Farting was over, thank goodness.  As the morning went on I felt like I did when I originally had the Covid19 in May. I had to leave work at 10:30am due to: aches every where in body Especially neck hurt My left arm hard to lift or use (injection was in left arm), hard to think and concentrate (brain fog), chills Able to eat some soup Slept several hours at home, felt slightly better, than slept nine hours that night  On Friday January 29th felt much better and arm hurt less to lift it.  On Saturday January 30th Under my arm, glands are swollen and hurt to touch. All other symptoms have subsided  Sunday January 31, glands under arm are better, much less sore  Monday February 1st glands under arm, back to normal
Robust take 10 cm consistent with viral cellulitis possible bacterial cellulitis. Treated with cephalexin 500 mg po qid  for 5 days.
Palsy in left arm. Unable to move it beyond 90 degrees. Neurologist advised against second shot.
PT SUFFERED APPROXIMATELY 4 SEIZURES, 1 IN LINE TO VACCINE CLINIC AND 3 IN OBSERVATION POST VACCINATION.  SEIZURES WERE MILD LASTING NO MORE THAN ONE MINUTE EACH. PT CAREGIVER ADAMANT THAT SEIZURES WERE WITHIN SPECTRUM OF NORMAL FOR PATIENT.
12 hours post vaccination woke up and barely could lift right arm, chills, body aches, headache, fever 99.8, extreme fatigue for about 18 hours.  Took 650 mg with 800 mg Motrin twice.  Symptoms resolved after 18 hours. Fatigue lasted for over 24 hours.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: After getting the flushot pt fainted and was unresponsive and had involuntary movements synoyms of a seizure! Per mom this has happened before with medical related procedures, covid vaccines and flushots in the past. He became responsive and normal within 3-5 movements! The immunizer tech and Rph on duty caught his body as he almost fell and laid him down on the bench he was actively having a seizure for about 1-2 mins. Per mom he has vagul disease they didnt want call medics!
Information has been received from a physician concerning a 5 year old white female, who had her tonsils out four months ago, who on 16-MAY-2006, at 3:00 pm, was vaccinated with a 0.5 ml intramuscular first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 647562/0579R). Concomitant vaccine administered on the same day included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (Lot# C2396AA). It was reported that it was unknown which vaccine was given in the thigh. The physician saw the patient on 17-MAY-2006 with a 3.5 by 4.5 inch severe local tissue reaction with a yellow ring on the outer edge. The patient also had fever of 100 to 101F, was irritable, and had local tenderness. The patient was seen in the emergency room, but not admitted, on 18-MAY-2006 and was treated with diphenhydramine hydrochloride (BENADRYL), a cold compress, acetaminophen (TYLENLOL), and cephalexin (KEFLEX). The physician noted that he did not known if the patient's reaction was caused from measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. At the time of the report the patient had not yet recovered. No product quality complaint was involved. Follow-up information from a health professional indicated that on 18-MAY-2006, at 10:44 the patient was bought to the emergency room by her mother with a chief complaint of left leg cellulitis. The patient had an injection site erythema, which was 3-4 inches on 17-MAY-2006 and was 6x8 inches on 18-MAY-2006 encompassing her cheek, and a fever of 102. The duration of the event was 2 days at the time of the report. The patient had mild pain, medium fever, chills, moderate erythema, and moderate swelling. It was noted that all systems were otherwise negative. It was reported that the patient had recovered. Additional information is not expected.
That second shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that be prepared, that the second shot hurt but worth it in the long run. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Within 15-minutes of vaccination, the patient experienced a syncopal event. EMS evaluated the patient on-site.  The patient was hypotensive (54/31) and bradycardic (42bpm). EMS transferred the patient to  Medical Center Emergency Department. In the ED, the patient reported a syncopal event that lasted 1-minute. Th patient was resting comfortably in no acute distress and reported feeling improved. Physician administered 1L IV normal saline. After noted improvement, the physician discharged the patient with diagnoses of Vaccine reaction and secondary Near syncope.
pt recv vax 9APR96 & 24APR96 pt devel a rash @ inj site, vesicular rash on hip, lower leg & scalp, malaise, chills, fatigue, & low grade fever;1MAY96 pt recovered;
High blood pressure lasting approx 1 month. Pain in both calf muscles extensively for approx 1 month, but ongoing,  and chest pain, and pain in both arms mostly subsided.
By 3 pm on July 13, 2021, I started feeling very nauseated. Then fever began. I started throwing up in the bathroom. My whole body started hurting, especially in my legs. Injection site soreness in my left arm. This continued for the next 3 days. On July 14 at 8:45 am spoke with someone (on the phone visit) from health center about how I was feeling. She advised me to drink plenty of fluids and just rest and keep her up to date if things got worse. By Friday, July 16th, my fever was gone, nausea was gone, pain in my legs was gone.  I started to feel a little better!
Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine; Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified and Diabetes.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 24-May-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine). On 23-May-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-May-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication included diabetes medications and Heart stent medications.  Treatment medication use information was not provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followed up Received on 25-MAY-2021 That contains Email Id updated and dosage regimen updated and concomitants were updated and event updated On 25-May-2021: Non-Significant follow up appended to AER On 25-May-2021: Follow-up received does not contain any significant information. On 29-Jun-2021: Follow-up received updated medical history, lab data and outcome of the events.
pt recvd vax & several months later pt was seen 6y MD & dx w/measles; f/u nurse reported that pt was lost to f/u; No further details are available;
Fatigue, full body aches, head felt full and hot and heavy but had no fever or congestion. This was after the second shot. This lasted from the evening on the day I got the second dose through the next two days.   (Also, after the first shot on the 26th of Feb I had a short bout of intense nausea that came and went quickly the same day I got the shot but later in the evening.)
headache; This is a spontaneous report from a Pfizer sponsored program. This consumer reported for an Unknown female patient that : A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration on 11Aug2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Aug2021 the patient experienced headache. The caller stated that patient had headache right now because patient got the first dose today as well of Pfizer BioNTech COVID-19 Vaccine and also the caller queried regarding if patient can take a Tylenol for the headache and also if, patient will able to use or take Benadryl because patient had like mosquito bite and got before the vaccine. So, patient want to use Benadryl soap for that mosquito bite as well. Reporter stated, "Yes, Tylenol extra strength (Captured as Tylenol) and Benadryl." Reporter was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Reporter stated that she got an answer on whether she can get patient medication for itching and for headache. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hives treated with prednisone x 5 days On 7th day large bruising on arms and legs
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: 330268D), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 038A21A), in right arm and on 20Apr2021 as dose 2, single (Lot number: 006B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 07Jun2022, stop date: 09Jun2022; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE], start date: 07Jun2022, stop date: 10Jun2022; BENADRYL, start date: 08Jun2022, stop date: 10Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid starting from 07Jun2022 to 11Jun2022. Clinical course: Vaccine and Other medication in two weeks were received. The patient had no known allergies.
This case was reported by a physician via a sales representative and described the occurrence of throat tightness in a 20 year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline. On 18 September 2008 the subject received 1st dose of TWINRIX (UNKNOWN). On 18 September 2008, at an unspecified time after vaccination with  TWINRIX. The subject went to the emergency room and was treated with BENADRYL and Dexamethasone. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with TWINRIX. Follow-up information received on 28 October 2008 indicated that the events were all resolved and the reporter considered them to be related to treatment with TWINRIX. A strep test was performed on 18 September 2008 which was negative. It was reported that TWINRIX was administered intramuscularly. No additional information was provided.
Dose preparation error; the 0.5 mL dose given to this patient was drawn from the residual amount left in two used vials.  At the time of error detection, no sign/symptoms of injection site reaction or infection have been reported by the patient.