chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/13/02- seen in our office for pustules lesions on chest, arms and legs  X 1 day. Afebrile. cough and runny nose X 2 days. Decreased appetite X 1 day. Diagnosed with varicella and right OM.
At 10pm the day of receiving the shot, I got a horrific headache. I have never felt a headache so extremely painful. I almost went to the ER because it was that intense. I needed up going to bed, took Tylenol, and put on a heating pad. I then woke up at 4 am and vomited several times and had diarrhea. The following day, I felt better, but had muscle pain and skin sensitivity.
BODY ACHES; SHIVERING; FEVER; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, shivering, fever, and massive headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivering, body aches, fever, and massive headache. This report was non-serious.
I developed swollen lymph nodes above left clavicle.  Injection site was in left arm.  Went to Urgent Care for diagnosis of swollen lymph nodes.  It was recommended I follow-up with my primary care physician to confirm swelling was adverse reaction to injection and not related to any other possible causes.  Appointment made with primary care physician for further testing.
Patient states that the evening after her vaccine, she began to feel ill.  She states that she was sick over the next week and did not feel like even getting out of bed to go to the bathroom, and states she lost 5 pounds despite already being very thin.  She states it worsened her lung condition and she almost went to the emergency room it was so bad.  It did resolve after about 7 days, but she strongly felt that this should be reported.
Patients do not have DTaP vaccine series completed on schedule by 7th birthday; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTPa vaccine (unspecified doses received on an unknown dates).   On an unknown date, the patient did not receive DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-May-2022 Reporter's comments: The physician reported that she was seeing more and more patients in practice that did not have DTaP vaccine series completed on schedule by 7th birthday. The vaccine details and patient details unavailable at the time of call. The consent to follow up was given.  Additional Supportive Information: The patients were not completing DTPa schedule by 7th birthday, which led to incomplete course of vaccination.This case had been linked with US2022079726, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022079726:Same reporter
Information has been received from healthcare worker referring to an 18 year old female patient with none drug reactions/allergies. The patient was vaccinated with her first dose, second dose and third dose of GARDASIL (third dose: lot # K010215, expire date: 05-MAY-2017, dose and route were unknown) on 04-JUN-2015, 06-AUG-2015 and 03-DEC-2015 (also reported as about a week and half ago), respectively. Concomitant therapy included Vitamin D (unspecified). On an unknown date in 2015 the patient developed discoloration and patient's arm and hand were turning purplish color. In December 2015 the patient developed pain at injection site right after administration of her third dose and pain radiated all the way down to her hand from injection site and she was also experiencing tingling and numbness in her arm and hand. The patient was prescribed NSAIDS and hydrocodone (manufacturer unspecified) but non relieved the pain. Patient also tried ice and immobilizing the arm but it did not help with pain either. On or around 09-DEC-2015, the patient went emergency room (ER) after pain became very severe but she was not admitted to hospital and was discharged on the same day. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Pt recvd Engerix-B p/the 1st dose devel Fibromyalgia;
A few hours later was almost at 102 fever.  Was shaking bad. Teeth were chattering. Was crying. Extreme headache and arm pain.
CHILD RECEIVED VARIVAX WAS LAY ON BAD FOR 5 MINUTES THEN WALKING FOR MORE THAN 15 MINUTES, SUDDENLY CHILD PALE AND FAINT, ELEVATION OF LEG, RECOVER CONCIOUS AT 0948 AM BP=86/40,  MOTHER PREFERRED TO GO TO ER, REEVALUATED EVERY 10 MINUTES UNTIL 1215 PM, STABLE, LEFT WALKING.  IN 5/17/09 AT 0626 PM CALL PATIENT FATHER STATED CHILD DOING WELL NO PROBLEMS
Developed fever on 8/25 of 101.5. Had a couple febrile seizure at 7:10 pm, 8/25/16, lasted for 30 minutes.
Day after Tdap vaccine c/o body aches, chills, nausea, headache, pain at injection site and down arm to elbow.  Took ibuprofen 400mg q 6 hours round the clock x3 days.  Area of erythema 2" below injection site grew from day 2 post vaccine to 70mm x 40mm on day 3.  Area was painful, tender to touch but had largely dissipated by day 4.  Previous severe reaction to rabies vaccine #2 given abroad.  Some tenderness there persisted.
Injection site pain; 100 degree fever down to 99 the folloiwng morning and broke by 24 hours; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain and fever.   The patient's medical history was not provided.  No concomitant medications were provided.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced injection site pain and fever about 2 hours after receiving the vaccine.  Her temperature was initially 100°F and remained feverish, hitting 101°F at the highest point.   On 30 Dec 2020, the fever resolved.  The injection site pain went away after 1-2 days.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, fever, was considered recovered on 30 Dec 2020.  The outcome of the event, injection site pain, was considered recovered on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
PATIENTS STATED FEAR OF NEEDLES BEFORE RECIEVING THE VACCINE. AFTER RECIEVING THE VACCINATION, ABOUT 2 MIN LATER PT FELL FROM HIS CHAIR IN THE WAITING AREA AND WAS FEELING VERY LIGHT-HEADED, SWEATING PROFUSELY, WAS FEELING HOT AND WAS PALE. PHARMACY STAFF PROVIDED PT WITH WATER AND COLD ICE PACK TO HELP WITH THE SWEATING. PT ALSO DRANK 2 GLASSES OF ORANGE JUICE AND AFTER 10 MINUTES BEGAN TO FEEL BETTER. AFTER 20 MINUTES, PT'S FATHER CAME AND DROVE HIM BACK HOME.
The patient was administered with an expired Menactra vaccine, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-health care professional via Medical Information (MI) (Reference number- 00751957) and transmitted to Sanofi on 01-Sep-2021.  This case involves a 12-year-old female patient who was administered with an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [Expired product administered].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 31-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number not reported and expiry: 23-Aug-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  No adverse event was reported.  It was reported, "Hello, I am seeking guidance regarding a Menactra vaccine administered to a 12-year-old female. The vaccine expired 23-Aug-2021 and was administered 31-Aug-2021. Do you have any data to support that the dose is valid or should the dose be repeated?"   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.  There will be no information available on the batch number for this case.
PASSED OUT (Passed out, Loss of consciousness) VERTIGO (Vertigo, Vertigo) MASSIVE PROBLEMS (Adverse event NOS, Adverse event This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26 .cov2 .s (suspension for injection, intramuscular, and batch number: 1802068 expiry: UNKNOWN) 0.5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, patient experienced two days of massive problems, passed out, vertigo. The action taken with covid-19 vaccine ad26 .cov .s was not applicable. The outcome of passed out, vertigo and massive problems was not reported. The reporter and company causality between covid-19 vaccine ad26 .cov .s and passed out, vertigo and massive problems was possible. The report was serious (Other Medically Important Condition).
10 hours after 2nd vaccine I got severe body aches and stomach pain.  At 8:00am I went to the restroom and felt very week and sick.  I then passed out on the bathroom floor and my husband called 911.  The paramedics took me to the hospital where I received 5 bags of fluid.
She noted no symptoms or reaction until 3 days when she developed a a red, raised, persistent rash on her trunk and extremities.  She took diphenhydramine with little improvement of the rash. The rash lasted for a little less than a week and has not recurred
Gave Daptacel to a 15 mo old which was expired yesterday/ No side effects reported; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone.  This case involves a 15 months old male patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) on an unknown date.  On 17-May-2019, the patient received a fourth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5202AA and expiry date: 16-May-2019) in the left thigh.  It was a case of actual medication error due to expired vaccine used.  No side effects 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.   Documents held by the sender: none.
This spontaneous report as received from a nurse practitioner refers to a patient (age gender unknown). On 15-JAN-2013, the patient was vaccinated with ZOSTAVAX (lot number reported; exp date on 13-JAN-2013) (route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-JAN-2013, ZOSTAVAX with a expiration date of 13-JAN-2013, was accidentally administered to an unspecified patient. No adverse effect reported. The outcome of ZOSTAVAX with an expiration date of 13-JAN-2013, was accidentally administered to an unspecified patient on 15-JAN-2013 was unknown. Additional information has been requested.
Soon after the vaccine: At first, Area  at the injection site was more red and it was kind of raised a little bit. It was a quarter size area. It was tender to touch and it itched a little bit.  That was there for about a week. It wasn't anything unusual from what was expected. Then in April: I was having severe chest pain. I went to ER and they did tests and gave me meds for the pain. I followed up with my PCP a few days later and she did an EKG as well. My blood pressure was still really high. She wanted me to see a cardiologist that day. She didn't want me to wait. I went there and he said that my blood pressure was really high. He wanted to order a stress test and an ECHO. He doubled my Losartan - he made it 100 mg. The earliest I could I could get in for the other tests was 5/24/2021: I had ECHO and chemically induced stress  test - those were fine. Blood pressure was still really high - Amlodipine - 5 mg - told me to take it and monitor my blood pressure every day. I went back in a month (June 24)- he increased Amlodipine 10 mg and Hydrochlorothiazide  - 25 mg and told me to monitor my blood pressure every day and he'd see me in 2 months. My next appt is in August 27th. It's starting to come down. My blood pressure has never been that high before. It was consistently 160s and 170s over 100s and 110s. Consistently my pulse was 100s and 110s with sometimes it being in the 120s. It's coming down but it's still not where it wants it to be. Some days it's closer to where the dr wants it to be but sometimes it's not. My blood pressure hasn't reached the lowered blood pressure goal that doctor wants.
Received flu vaccine on Thursday 9/6/2017, started to feel symptoms of flu by 9/8/2017 reported illness related to flu vaccine on Monday 9/11/2017, placed off of work till 9/13/2017 returned to work feeling weak and continued to suffer with flu symptoms. Went to scheduled yearly check up on 9/25/2017, diagnosed with bradycardia (heart rate of 38), rushed to cardiologist for review, diagnosis confirmed given stress test and given ZIO PATCH patch x2 weeks at end of 2 week period sent in ZIO PATCH, patch, received call the next day informing me that I needed a pacemaker immediately. Apparently there was a 8 second gap in my heart beat (I beat(I could have died). did). Pacemaker placed within 2 days (as quickly as it could be done. done). No other medical issues and very active individual before flu shot, running 5.8 miles per day.
At 5:00 pm RN administered 0.1 ml dose of Jynneos vaccine lot FDP00014  exp date 11/25/2022 via intradermal route on left arm to patient age 55  and leakage was observed . RN notified clinic lead nurse Regarding incident and per clinical guidance was instructed to give 2nd attempt on same arm away from first dose.   Patient verbalized understanding. RN re-administered another dose of 0.1 ml of Jynneos lot FDP00014  exp 11/25/2022  a wheal was produced with no leakage observed by patient, nurse or lead.  Patient was educated to observe reactions and wait 15 minutes in observation area.
I waited in the clinic for 15 min with no reaction. Upon driving home, I started to get red puffy face, slightly swollen lip, itching in scalp,neck,ears. I took Benadryl at home at approx.  3:00pm and symptoms subsided. I also noted something going on in my throat, but never had any shortness of breath.
Ache joints and muscles, headache, migraines, acid reflux, insomnia, joint pain in right hip, bursitis, anemia, loss of concentration, gastritis, depression.
High fever 104, Balance hard to stand. deep red rash on lower legs and blotchy condition on rest on body. Went to Torrance Memorial Emergency  03/07/2021 for day and half -- every test they could run with Xray, EKG, and covid test
High Temperature for up to 4 days ,severe fatigue and body aches as well as getting out of breath and headaches which have continued since the the day of the vaccine
This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 03-JUN-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 30 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 03-JUN-2022, the patient experienced received the vaccine from a batch that was to be discarded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the vaccine from a batch that was to be discarded and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759113, 20220759160, 20220759219 and 20220761815.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
This spontaneous report was received from a registered nurse and refers to a 18 month old patient. The patient's concurrent conditions, medical history, and allergies were not reported. In approximately June 2017, at the age of 15 months, the patient was vaccinated with the first dose of M-M-R II for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not reported), which was reconstituted with sterile diluent (strength, dose, route, anatomical location, lot number and expiration date were not reported). Then, on 19-SEP-2017, at the age of 18 months, the patient was vaccinated with the second dose of M-M-R II, subcutaneously for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not reported), which was reconstituted with sterile diluent (inappropriate schedule of drug administration). No adverse event was reported.
Received shot at 5:20 PM and by the next day at 11:30 AM I had body aches, fever, body chills, headache, nausea. Then the following day, I was experiencing extreme fatigue and had a full-body rash from my head to my legs.
swollen painful lympth node under arm pit of vaccination side. lasted 1-2 days
Fibromyalgia and rheumatoid arthritis worsens.  Skin tingles and numbness continue.  The nerve pain from the autoimmune disorders magnify to the point of severe pain.  Headaches are unbelievable and still have them.  Symptoms of fibromyalgia gets worse by the day.
patient had a vagal response and partial syncope episode minutes after vaccine was administered. Patient did not recover so 911 was called and ems arrived to take to the emergency room
Arm swollen, painful to lift arm, redness. MD instructed to treat with ZYRTEC or antihistamine. Rph suggested MOTRIN.
17 Years and received his vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Years and received his vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Years and received his vaccine). On 06-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Years and received his vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, no new information
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 05-DEC-2014, the patient was vaccinated with a dose of ROTATEQ, (strength, dose, route and anatomical location were not reported), (lot # J011336, expiration date: 14-MAY-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.