chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. states that after the 1st dose of Shingrix 10/22/2021 (Received High-Dose Influenza 10/22/2021) , started experiencing symptoms 10/23/2021 of sore arm (at injection and throughout), headache, and fatigue. No noted Primary visit/communication.
(L) shoulder pain resulting in decreased mobility - possible bone contusion and/or tendon injury and nerve irritation.
high pitched, unusual cry, lasted 3 hrs, occured within 24 hrs of DTP shot;
Patient was felling very Fatigue, loss of appetite, body soreness, Headaches. Body soreness from neck al the way down to the lower body.
Patient is reporting tingling/numb feet about 5-10 minutes after vaccination. After about 30 minutes he said he was feeling fine, and walked around the store for a bit to make sure he was ok. Than he left.
pt recvd vax;on 6sep95 devel blisters on arms, legs & torso;
CHEST PAIN; SEVERE WATERY DIARRHEA; LIGHT HEADED; SWEATING; CHILLS; FEVER; HEADACHE; NAUSEA; DIZZY; HOT AT THE INJECTION SITE; VOMITING; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported.  The patient's past medical history included hysterectomy, and concurrent conditions included asthma, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23/JUN/2021) .5 ml, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced hot at the injection site. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced dizzy. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced severe watery diarrhea. On 14-APR-2021, the subject experienced light headed. On 14-APR-2021, the subject experienced sweating. On 14-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot at the injection site, and vomiting on 13-APR-2021, and had not recovered from headache, nausea, dizzy, severe watery diarrhea, light headed, sweating, chest pain, chills, and fever. This report was non-serious.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# I011083, expiration date, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
first dose of Twinrix on 8/21/2019, received the 2nd dose 01-JUN-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 21st August 2019).   On 1st June 2022, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-June-2022 Reporter's Comments: Pharmacist stated that a patient received the 2nd dose on date of reporting 1st June 2022. The reporter consented to follow up via email. Additional Supportive Information: The patient received the 2nd dose later than the recommended standard interval, which led to lengthening of the vaccination schedule.
I experienced menstrual cramps, brownish pink discharge that concerned me could be cancer symptoms. I was diagnosed with Post Menopausal spotting after a pelvic exam and Sonogram on 08/02/2022. I am still experiencing menstrual cramps and spotting daily. I was advised that it would resolve itself in time, and that my physician has seen this frequently after COVID-19 vaccination.
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Hospitalized; missed dose; A Spontaneous report was received from a pharmacist, concerning a female patient of unspecified age, who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized and missed dose  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.   On 29 Jan 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On an unknown date, the patient was hospitalized for unknown reason and had not received the second dose in recommended timeframe.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event missed dose was considered as  recovered. The outcome of the event hospitalized was unknown.; Reporter's Comments: Very limited information regarding this event of hospitalization has been provided at this time.  Further information has been requested. The causality assessment for the event of missed dose remains not applicable.
pt recv vax 6OCT97 & 7OCT97 pt devel a fever to 102 & sore arm;seen @ MD office that day;9OCT97 pt recovered;
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who experienced rash, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. The patient developed a non-serious rash following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. (Other relevant tests included No lab data.) Final diagnosis was rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for rash.
Pt s/p fall on 9/6 and seen in ED. Pt is resident of assisted living facility. Returned on 9/14 with general body weakness, wheezing and dry cough x 5 days. Testing for RVP in the ED is positive for COVID 19 and RSV coinfection
Moderna COVID-19 Vaccine EUA Five (5) days after the vaccination,  on Apr03, 2021, a painful lump was noticed under the left armpit. As of today 06Apr21 the lump is still present and painful to the touch or as the arm is moved. Although painful, is tolerable and from a scale from 1-10, I'd give it a 6.
Pt contacted the vaccine healthcare center in order to file a report for atrial fibrillation he developed following receipt of the anthrax vaccine in 1999. He was in her usual state of good health when he received the vaccine and received no other vaccines simultaneously. He received Anthrax Vaccinations #1-3 on 3/25/99, 4/12/99, and 4/29/99. He reports after after shot he experienced episodes of rapid heart beat. He does not recall the time of the exact onset of the episodes related to receipt of the individual vaccine, but that they started after #1 and were intermittent. He reports they would last 30 sec to 20 minutes, were often accompanied by lightheadedness and were not related to activity. They did not cause him a particular problem and he ignored the episodes and did not seek medical care. However after Anthrax #4 on 9/29/99, he experienced an tachycardic episode that lasted 4 hours. He became concerned at this and sought treatment at an ER. He was subsequently evaluated by several military and civilian cardiologists and diagnosed with atrial fibrillation. He was placed on medication and was temporarily retired from the military in 2000. He also reports that sometime in 2000 he began to experience significant fatigue compared to his previous energy level.
Swollen face; severe head and body aches; severe head and body aches; fever; chills; muscle weakness; joint pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via unspecified route of administration in left arm on 19Mar2021 12:15 PM (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included anxiety and depression from unspecified date. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO) 20 mg, losartan 50 mg, fish oil and beet root, all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took niacin and he experienced allergy. On 21Mar2021 05:00 AM the patient experienced swollen face, severe head and body aches, fever, chills, muscle weakness and joint pain. Fever and swollen face only occurred for 24 hours (22Mar2021). All other symptoms persisted for 6 days (27Mar2021). The case was reported as non-serious. The events resulted in emergency room (ER)/department or urgent care. Treatment received due to the events included ER visit on 25Mar2021, intravenous (IV) (as reported) and Zofran was given. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved on 22Mar2021 for swollen face and fever and on 22Mar2021 and resolved on 27Mar2021 for all other events.
Information has been received from a RN concerning a patient who in approximately 1999, at the age of 18 months, was vaccinated with one dose of varicella virus vaccine live. On 08-01-2000, the patient developed "quite a few lesions and a fever". The patient sought unspecified medical attention. Also reported was a female patient who was vaccinated and experienced similar events. Additional information has been requested.
STORAGE IN REFRIGERATOR (2C-8C) UP TO 30 DAYS (VACCINE USED AFTER 10/16/2021)
'Extreme' Joint Pain, Fatigue, Feverish but no measurable fever.  Loss of appetite. Overall Flu like symptoms.
Pt had sz & was taken to hosp; mom stated pt had a fever of 107 while @ hosp; now @ home w/t103;
chills; headache; nausea; This is a spontaneous report from a contactable consumer or other non hcp.     A 68-years-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (age at vaccination: 68 years) at single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. She received the second dose of the Covid 19 vaccine on 23Feb. On February 24th, she felt a twisting in her entire abdomen, lasted 25 minutes, it was awfully painful, but went away. She went to the ER, her lipids were elevated, they told her that it may be a side effect of the vaccine. She also had shoulder pain, bicep pain and headache. On 01Mar 2021 she experienced the same abdominal pain, lasted 15 to 20 minutes, and then subsided, she went to the ER again and they couldn't find anything abnormal. She had a follow up appointment with her doctor on (March 2nd), it happened again and lasted 15 minutes then subsided. It was an entire abdominal spasm and, in the back, too. On an unspecified date, After the first dose she experienced chills, headache and nausea. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-MAR-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 03-APR-2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
12/28/2020 around 5:30 PM she started getting itchy. Progressing as night went on.  On 12/29/2020 around 5-6:00 AM you woke with hives, hoarse voice and eyes swollen. A little SOB with talking. Also had weakness and tingling. Tingling was "everywhere".. Went to ER.  Treated in the ER and released. Also on this day she had additional reaction to prednisone and she found out she is allergic to this. On 12/31/2020 she had to return to ER.  She was at work and not feeling the greatest. Feeling light headed on and off.  Continued to work and while driving home felt confused and light headed and called co workers. Felt weak again.. Called co workers who work for ambulance service  They came and checked her out and her  B/P was high and having PVC's per the heart monitor Transported to ER per the ambulance. 1/1/2021 she is feeling better.  Received fluids last night. ER felt it was  due to receiving vaccine and then additional allergic reaction to prednisone.
Within hours post vax, this pt experienced 4 inch area of redness at the injection site which was also indurated, swollen, and warm.
lost consciousness; blindness; complete paralysis; severely brain damaged; Initial information received on 24-Oct-2023 regarding an unsolicited valid serious case received from pharmacist.  This case involves a 9 months old female patient who lost consciousness, blindness, complete paralysis and severely brain damaged after receiving vaccine Yellow Fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Yellow Fever vaccine-Solution for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date, the patient developed lost consciousness (loss of consciousness) (latency: same day) following the administration of Yellow Fever vaccine. This event was assessed as medically significant. The patient was hospitalized for this event.  On an unknown date, the patient developed blindness, complete paralysis (paralysis) and severely brain damaged (brain injury) (unknown latency) following the administration of Yellow Fever vaccine. These events were assessed as medically significant. The patient was hospitalized for these events.  No lab data was reported.  Action taken was not applicable.  An unknown corrective treatment was received for all events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all events.; Sender's Comments: Sanofi company comment dated 01-Nov-2023: This case involves a 9 months old female patient who lost consciousness, blindness, complete paralysis and severely brain damaged after receiving vaccine Yellow Fever vaccine - [YF-VAX]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Itching at injection site; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   Concurrent medical conditions included allergic reaction to antibiotics (Allergy to Biaxin (clarithromycin)).   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left deltoid. The patient experienced baseball sized area of redness. The patient experienced itching at the injection site a couple days later, over the weekend The redness had improved and the area was now pink.  The patient denied rash and denied pain.
flu like symptoms; Fever; chills; body aches; lethargy; lips swelled; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On 3rd June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd June 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, general body pain, lethargy and lip swelling. On an unknown date, the patient experienced influenza-like symptoms. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fever, chills, general body pain, lethargy and lip swelling were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, lethargy and lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm and a pneumonia vaccine. The patient reported that flu like symptoms presented that night. fever, chills, body aches and lethargy. She also said her lips swelled and she took Benadryl and it resolved. She was not sure if the swelling happened that first night or the second night.  The reporter did not consent to follow up. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, lethargy and lip swelling to be related to Pneumococcal vaccine
Increase thirst  Frequent urination  Rapid weight loss of 30 lbs within 1 1/2 months Blurry vision  Elevated A1C
Fever 102, chills, low blood pressure 77/44,  Total lasted about 18 hours.  Took Tylenol
Within 6 hours of vaccine had 105 temp which remained high 103-105 for 3 1/2 days, with delirium, nausea, swollen lymph node in left axilla under site of injection. Fever was poorly responsive to antipyretics. A fine, macular rash appeared on forehead at the end of day 3, followed by extension of rash onto torso and limbs. NO pruritis - fever dropped after 84h, appetite returned day 5.
Red spot with healing vesicles at site of Varivax injection. L groin lymph node-slight swollen.
Pt. rec'd o.25 QUAD FLU #1 at 11/01/16 9mo WCE. Also placed on OMNICEF 125/5 SIG: 5ml po qd x 10 days for persistent LOM. Woke from nap 11/02/16 with scattered wheal and flare rash to face, trunk and extremities - afebrile. Tx with BENADRYL (PRN).
Pfizer booster was given early. Last covid-19 dose was on 12/14/21. Booster was given on 01/25/2022.
Pt reports started to have symptoms of coughing, wheezing and mild shortness of breath.  He reports he gave himself an albuterol sulfate breathing treatment and felt better  Also, states allergies environmental have flared up as well the past 1-2 weeks Ran out of fexofenadine 180mg once a day - recently Pt managed at home, did not go to the ER or urgent care as he felt better after a few hours
I experienced a breakthrough case of COVID-19 with general fatigue, headaches, breathing difficulty, shortness of breath and cough.