chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K006135, expiration date 29-APR-2015 or lot # L003777, expiration date 04-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
My symptoms started with back pain, it felt like either a UTI or menstrual pains. It became very intense. The next day, I slept a lot and woke up exhausted. My back was still hurting then I felt intestinal pains. I had an odd taste of metal or blood. I did not lose complete loss of taste or smell, but it was and odd taste and smell. That night, I fell asleep with no appetite. I woke up after that with sore throat, body aches with a stiff neck, and an earache. I took a COVID home test, which was positive. I quarantined and slept. I then started to get a fever. I had chills and woke up the next day with cold sweats and a fever blister. I had hives in between my nose and mouth and also on my neck and chin. I felt itchy all over. On the 28th I tested again and was still positive, but the line was dim. By then it moved to respiratory issues with congestion like sinus issues. I had a headache, sore throat, and fatigued. I felt symptoms for 8 days.
Covid Arm. Swollen and sore lymph nodes and swollen lump in arm at injection site with itching, rash and heat.
Within 24 hours, I began experiencing bouts of severe pruritis starting in the lower extremities. Rash developed in areas of excoriation due to severe itching, pinpoint red macules.  The episodes of pruritis were not responsive to Benadryl Zyrtec or Claritin. For two nights I took Vistaril with mild relief. Medrol dose pack was ineffective. Over the next week the episodes increased in intensity and frequency and were often accompanied by localized redness and superficial swelling of the skin and hive like raised areas of the skin as in urticaria. The areas of localized pruritis migrated  over a period  lasting  7 to 10 days,  first to inner surfaces of both my arms, then to my lower back, and then to my upper back over scapulae and shoulders. Concurrently, the pruritis and rash began resolving in the lower extremities and then on the inner aspect of my upper extremities. Currently,  the intensity and frequency of the pruritis has decreased significantly  and is now localized to my upper back.   Yesterday was the first day that I did not require antihistamines.
pt recvd flu vax & 48 hrs later devel lt supraclavicular & axillary lymphadenopathy which resolved w/o tx over aprox 10 to 14 days;
Fever for nine days, intense arm swelling (couldn't fit arm in shirt sleeve), chills, dizzy, intense stabbing pain at injection site. Symptoms began to decrease after nine days. By second vaccine symptoms were mostly gone, but intense pain still occurs occasionally at injection site.
Patient came in 11 days after vaccine with rash to body. Patient was taking Cephalexin and cough medicine. The rash was measle like. The doctor prescribed Atarax for 5 days and follow up in 72 hours.  1/20/05 Diagnosis: Vaccine sided effect MMR Afebrile
some of the vaccine liquid got into her eye; This spontaneous case was reported by a pharmacist and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT. At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
sore arm-not bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm-not bad) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included GLYCYRRHIZA GLABRA, MENTHA PULEGIUM, MORUS NIGRA, OLEA EUROPAEA, TRIGONELLA FOENUM-GRAECUM (ANTI DIABETIC) for Blood sugar increased.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm-not bad). At the time of the report, PAIN IN EXTREMITY (sore arm-not bad) had resolved.            Treatment medications were not provided. He further reported a history of Type 2 Diabetes under good control with a low carb diet and takes oral antidiabetic medication only as needed for elevated blood sugar. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-139789, MOD-2021-068529 (Patient Link).
This spontaneous case was received from a consumer regarding her daughter, a non-pregnant female patient of unknown age. The patient's concurrent conditions historical conditions and concomitant medications were not reported. On unknown date, the patient was vaccinated with GARDASIL (strength, dosage, route, lot number and expiration date were not reported) for prophylaxis. On unknown date, after the vaccination, the patient started experiencing infertility. The outcome of the event was reported as not resolved. Although the reporter stated that she read online that GARDASIL caused infertility. The causality assessment between the suspect therapy and the event was not reported. This is one of two cases received from the same reporter captured in (MARRS # 1811USA011585). Sender's Comments: US-009507513-1811USA011585.
both doses 2018  and shingles 2022/Suspected vaccination Failure; shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In November 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: The case was reported by patient who was physician. In 2018, patient received 1st and 2nd dose of Shingrix. In November 2022 the patient experienced shingles. The reporter consent to followup. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Child cried hard before received vaccine - c/o funny feeling back of neck 3 minutes after receiving intranasal. 10 min later c/o tingling lips/cheeks. Monitored - mother stated no issues 3 hrs later.
Pt received 1st dose of Pfizer on 3/30/2021. Pt came back to the clinic for 2nd dose of Pfizer on 4/20/2021 and received a dose of Moderna not 2nd dose of Pfizer.
Pt stated that she had pain at the injection site  radiating to her hand. She's unable to lift up her arm. There are no other symptoms reported.
Acute urticaria from the Moderna COVID-19 booster. It caused persistent hives and itchiness.
SATURDAY IN THE EVENING OF JUNE 18TH PATIENT NOTICED ITCHING ON THE BACK OF THE RIGHT SHOULDER. WITHIN NEXT 2 DAYS THEY ALSO CAME ON THE RIGHT BACK SIDE OF THE ARM HAS A POCK, AS WELL AS ON THE SIDE OF THE RIGHT WRIST, RIGHT ARM, CHEST, BACK AND BACK OF SHOULDER.  SPOTS ARE ITCHY AND RED, LOOK LIKE A MOSQUITO BITE. CHILLS EXPERIENCED TWO DAYS AGO, TREATED WITH ADVIL.
Numbness and parasthesia to left hand and forearm for less than 3 days.
TOOK ONE DOSE OF VIVOTIF AND DID NOT COMPLETE THE REMAINING DOSES; This spontaneous case (PVX2019-1460) was received from a consumer on 06-Jun-2019. It describes a female consumer who "took one dose of Vivotif and did not complete the remaining doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took only a dose of Vivotif on 31-May-2019. Then, left the remaining doses out of the refrigerated and did not take the remaining unrefrigerated doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one dose of Vivotif and did not complete the remaining doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of Vivotif and did not complete the remaining doses" was considered as not applicable.
Fever 101.5 degree; Body ache; Nausea; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.5 degree), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Severe headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood pressure high and Heart disease, unspecified.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 101.5 degree), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Severe headache). At the time of the report, PYREXIA (Fever 101.5 degree), MYALGIA (Body ache), NAUSEA (Nausea) and HEADACHE (Severe headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) fever 101.5 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-103538 (Patient Link).
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA304966, 2018SA304964, 2018SA304936 and 2018SA304935 (same reporter). This case involves an 88 years old male patient who accidentally received an expired dose of FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 26-Oct-2018, the patient received a dose of 0.5 ml suspect FLUZONE HD (lot number: UI842AB and expiry date: 04-Apr-2018) via intramuscular route in left upper arm. It was a case of actual medication error due to expired product administered. It was unknown if the patient had any adverse event. 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 and Module VI of the 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.
Pt developed skin rash, eye swelling last night (07/24/07) at 10pm. Pt received Boostrix and HPV at 5 pm, no difficulty with breathing, no abd. pain, no vomiting, + itching. Took Benadryl at 7am today (07/25/07).
This case was reported by a physician and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The case was reported by the dentist. The event lasted for several days. The events experienced by the patient did not cause any hospitalization overnight or also did not prolonged an existing hospitalization. The reporting healthcare professional did not consider the events experienced by the patient to be life threatening. The events had not resulted into any persistent or significant disability. The events had not required any surgical or medical intervention. The events had not resulted in any sort of congenital anomaly or birth defect. The reporter stated that he can be contacted for more information about the reaction he had experienced with the vaccination.
82 y.o. female with PMHx CAD, GERD, HTN presenting to the ED c/o rash. got first dose moderna COVID19 vaccination in her L deltoid this am. Around 10:30am she developed an itching, burning rash over her L forearm/wrist. Her daughter called the clinic and was advised to bring patient to the ED for eval. Other than the rash, she denies SOB, DIB, difficulty swallowing, n/v, fever, chills, HA, or any other symptoms. She did well with antihistamines and was discharged home urticaria from the vaccine. Patient has allergies to verapamil, penicillin, lisinopril and vancomycin
given an extra dose of FLUZONE QIV-NP to a patient with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was given an extra dose of Influenza Quadrival A-B Vaccine [Fluzone Qiv] to a patient with no reported adverse event.  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 0.5 ml  total (1 X) of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT8040MA) (Expiry date: 30-Jun-2024) (strength: standard) (Frequency: once) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was given an extra dose of Influenza Quadrival A-B Vaccine to a patient with no reported adverse event (extra dose administered) (unknown latency).  It was reported, Nurse called to inform that they have given an extra dose of FLUZONE QIV-NP to a patient. Licensed Vocational Nurse told that the patient received the vaccine 4 weeks ago from another facility and the patient came to their clinic and was injected an extra dose of the vaccine. Licensed Vocational Nurse informed that she cannot share any information on the patient and only provided the lot number, expiration date and NDC number of the vaccine. This situation is reported as a medication error due to vaccine double dosing.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Covid arm, 8 inch red, swollen, itchy welt beginning 03/03/21,  worse on 03/05/21.  Fatigue and headache on 03/05.    Slightly improved 03/06/21.
PT WAS GIVEN COVID VAX @ 1343. PT STATED TO IMMEDIATLEY EXPERIENCE TREMBLING IN THE R & L HANDS. BOTH HANDS WERE OBSERVED TO BE TREMBLING. PT VITALS WE WNLS. PARAMEDICS WERE CALLED PT REFUSED TREATMENT AND HOSPITALIZATION. PARAMEDICS LEFT PT, REQUESTED PARAMEDICS ONCE AGAIN. PT LEFT W/ PARAMEDICS TO LOCAL HOSPITAL.
Patient requested booster dose of Moderna shot (0.25mL) and given a dose of 0.5mL.
It started off with a headache and later in the night severe headache with chills. I also started exp palpitations. The next morning 2/2 still exp symptoms from the day before and fever of 102.4 with a lingering cough.I still have the cough ad all other symptoms lasted 48 hours.
skin red and some white blotchiness. small raised ares( hives) warm to touch.  exceptionally itchy  legs,back, abdomen, arms, armpit,elbow, behind knee - all affected.
awoke @ 1PM screaming & burning up, shaking, fever of 105 R @ 7AM; given APAP from PM of 1APR93 to PM of 2APR93 also fluids; fever dec to nl by PM 2APR93;
Information has been received from a registered nurse concerning a 7 year old male child with no known allergies who in November 1995 was vaccinated with varicella virus vaccine. On 06/15/2001 the child presented to the physician's office with a chicken pox/rash breakthrough characterized by 30-50 lesions on scalp, neck, abdomen and extremities. Follow-up info has been received and indicated that the registered nurse does not have nay additional information. No further info is available.
Deep muscle pain in left glute: very painful for about 2 weeks, lessening over following 3-4 weeks
Severe, dyshidrotic eczema on hands and feet. Doctors did not immediately diagnose; believed it was fungal. I suffered for almost one year before prescribed prednisone taper. As soon as the 3-week treatment ended, eczema returned. I received an intramuscular injection of triamcinolone. I plan to get a shot every 3 months.
2 days after the administration of the vaccine, the patient started having worsening shoulder pain and decreased range of motion on left arm. Positive Neers test.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and had zero reaction). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, injection site pain, nausea, headache and tiredness. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain and nausea were unknown and the outcome of the headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, nausea, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. On Friday, the patient received a dose of SHINGRIX. On Saturday, the patient had a fever of 100 degrees F, which was sub-norm and it was an increased by 3 degrees. Less than year after vaccination, the patient experienced injection site pain, a little nausea, throbbing headache, very tired and the patient was slept most of the day. Then the fever went down and his stomach was great, but the patient still had a headache and kind of tiredness. These was persisted for about 7 days. The patient wanted to know, how long it looked for most patients that call in. The patient declined to provide any patient identifiers or complete full safety report. Lab Comments: On an unknown date, the fever was 100 degree C and it was increased by 3 100 degree C.
Rash on both lower legs. Rash extends from ankles to top of calf, it was somewhat itchy that night, but next day itch was gone and redness had diminished. As of this report, I still have the rash.
"This message is to inform patient that you have been successfully scheduled for your first dose of the Pfizer COVID-19 vaccine. You are scheduled to receive the vaccine on Saturday February 13, 2021 at 12:45 PM."  Almost immediately after, I was ro take my wife for her 1st dose (Saturday February 13, 2021 at 2:15 PM); however, I was already disoriented and had trouble picking her up. My wife called police to try and find me.  When I finally go home, I couldn't remember anything of the events of the day.  The following morning (Sun. Feb. 14th) @7:00AM, I collapsed in the kitchen and 911 was called as my heart stopped.  10 minutes passed by and I was turning blue. I still can not remember getting the vaccine or any of the events of 02/13/2021.
Symptoms started immediately after vaccines. The initial signs and thoughts were that after all vaccines children become fussy,sleepy and irratable. But as each day past her symptoms worsened. She started to cry for no apparent reason, she lost control of her bladder functions, complained of being cold, thirsty, she would fall(her legs became very limp),clumsy,loss of appetite,very lathargic,weakness, leg pains, difficulty walking, have to hold on when walking or climbing stairs,loss of balance, complete personality change(loss of interest in activity) she has reverted back to an infant stage. All these changes progess in about a 3 week time span. At this time she is in physical therapy two days a week. Her symptoms are still the same. Her newest symptoms are being cold all the time and very thirsty. At present she walks with a limp and very slow, she can not run and has not return to her normal activities.
Pt stopped by pharmacy and notified us that her arm is still hurting after her flu shot. She can manage doing her routine daily work but painful when she wants to change her clothing/some specific movements. no redness/bruise on the arm.
BEDRIDDEN FOR THREE MONTHS FROM THE JANSSEN VACCINE; This spontaneous report received from a consumer via media through company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown) dose not reported, frequency 1 total, start therapy date were not reported administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date it was reported that the patient was bedridden for 3 months after vaccination. The reporter stated that, "And my neighbor has been bedridden for 3 months from the J & J vaccine. Her Dr (doctor) and the hospital also refuse to admit it's from the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bedridden for three months from the Janssen vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211223490.; Sender's Comments: V0:20211223119- JANSSEN COVID-19 VACCINE Ad26.COV2.S -bedridden for three months from the Janssen vaccine.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Massive headache, and sever joint ache.  I took Tylenol, Motrin & Aleeve.  After 48 everything was fine.
Chest pains, felt like a heart attack.  Severe chills and aches that woke me up.  I am a VERY deep sleeper.  I will sleep until 10AM if allowed and I have 4 kids.