chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feel really bad; Had a headache; 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 FEELING ABNORMAL (Feel really bad) and HEADACHE (Had a headache) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel really bad) and HEADACHE (Had a headache). At the time of the report, FEELING ABNORMAL (Feel really bad) and HEADACHE (Had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.
I received the pneumonia and flu vaccinations on Thursday, Sept. 12th, 2013. As stated and shown to the pharmacist on Friday afternoon (September 13), my left arm was swollen with an indentation, feverish to the touch, and very painful. It was extremely difficult to lift my arm and hindered my sleep for four nights. When I came in to the pharmacy on Friday, I was dizzy, weak, and lethargic I could barely walk when I left work on Friday and came by the pharmacy. We had several teachers out our school on Friday as well as other schools in our district. I asked the pharmacist if it was a live or a dead virus, he stated it was a dead virus, PNEUMOVAX. Today is Tuesday, Sept. 17, 2013. My arm remains red, about 3" x 3", much smaller than initially (5" x 3"), it is not feverish to the touch, but still sore. I am continuing to take ibuprofen to keep the inflammation down, as suggested by the pharmacist and my doctor. I also took 2 doses of BENADRYL on Saturday as recommended by my doctor. Saturday and Sunday, I remained dizzy, sore, and coughed and sneezed all day. By Monday afternoon, those symptoms had stopped.
I had bad headache, was very tired, a lot of sinus congestion, I used home COVID -19 test that came back positive. I called my doctor to have a telehealth visit to discuss my symptoms and let him know I had tested positive for COVID-19. I was prescribed the antiviral Paxlovid, I was able to start the medication the next. It took about four or five days until I started to feel better.
A 49 year old caucasian female received a flu vaccine and 15 minutes, post vax, she began to feel flushed, itchy and a scratching in her throat. The RN got help from the other RN. ER was called the order was given to give pt .3cc SC and 50mg Benadryl IM. Pt waited 10 minutes after meds were given and her niece picked her up and took her to ER for monitoring. Pt was monitored in ER for 1 1/2 hours. Pt called the next AM and stated she had difficulty sleeping last night and continued to feel a bit itchy, but doesn't complain of throat itchiness. Pt was recommended to follow-up with her physician before receiving further flu vaccines.
SYNCOPE- Patient received vaccination at 1pm, her sister was with her because she sometimes passes out when getting blood drawn. After leaving the vaccination room the patient sat in a chair and felt fine and was talking on the phone, around 1:05, her sister alerted us that she thought she was passing out and was talking to her trying to keep her awake. I grabbed smelling salts and when I got to the patient, she was hard to wake up so I used the smelling salts on her and she came to. Gave water and juice to patient and moved her into the vaccination room to give her space to recover. She complained of being dizzy and ears ringing, we monitored her for 30 more minutes and all symptoms had resolved. Did not seek further treatment.
administer an expired vaccine to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer an expired vaccine to a patient) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 17-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer an expired vaccine to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer an expired vaccine to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  It was unknown when the vial was initially stored in the refrigerator. The vial does not undergo any temperature excursions.
My left arm is swollen and red. Additionally, my left lymph node in my armpit has been swollen and in pain for 3 days now. I have been icing the injection sight and taking ibuprofen
Information has been received from a licensed practical nurse concerning a 12 year old female patient with no previous medical history and allergies reported, who on 13-NOV-1997 when she was 13 month old was vaccinated with a dose of VARIVAX vaccine (Oka/Merck). There was no concomitant medication. On 23-FEB-2009, the patient was diagnosed with shingles. The patient's shingles persisted. The patient sough medical attention at the office. Additional information has been requested.
Pt received vaccine BUD. Vaccine expired 7/7/2022, vaccine given to patient on 7/9/22
Severe fatigue from date of shot until present time.  Unable to perform normal daily routines.
COVID-19 positive; COVID-19 positive; Moderna, Date: 19Feb2021, Dose Number: 2 / Pfizer, Date: 02Mar2022, Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2022 as dose 3 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 as dose 1, single (Lot number: 013L20A), in left arm and on 19Feb2021 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Mar2022, outcome "recovered", described as "Moderna, Date: 19Feb2021, Dose Number: 2 / Pfizer, Date: 02Mar2022, Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jan2023, outcome "recovered" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Positive, notes: At home (Nasal Swab). Therapeutic measures were taken as a result of drug ineffective, covid-19 included Dayquil, Theraflu, Advil.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Patient noted redness and swelling at the site of injection 10-18-2019.  Was told this was a normal possible reaction and to ice the site and to contact MD if swelling increased and redness enlarged with heat radiation.  Patient noted next morning swelling had grown by 2 inches and reported to emergency room where she was diagnosed with cellulitis.  Treated with antibiotic and reported to Pharmacy for reimbursement.
pt. is a 79 y.o. male with a past medical history significant for CAD, hyperlipidemia, aortic stenosis, chronic back pain, chronic hip pain who was admitted with a fall overnight, and positive COVID-19 test .  He has completed COVID-19 vaccination in March 2021.    His wife has been admitted in the hospital for non-COVID illness.  She is an immunocompromised individual.  The patient has been her caregiver, and has been visiting the hospital daily.  Because of stress the responsibility of taking care of his wife, he is not able to eat regularly (living), and has a weight loss about 10 lbs over the past 1-2 months.    Patient had been overall well and independent until 2 days ago when he n
Urticaria and blotchy erythematous rash; most notable on torso and groin; more mildly on extremities spares palms /soles and face no respiratory distress
9/10/08 dizziness, back pain - seen ER - home.  9/11/08 weakness, shortness of breath - ER - PICU oxygen, Bipap, IVIG, IV antibiotics, IV fluids, labs, CXR.  10/09/2008 MR received for  ER 9/9/08 and DOS 9/12-15/2008 with DX: Acute respiratory failure 2' to chest wall and neuromuscular weakness due to Guillain Barre Syndrome.  Chronic suppurative otitis media.  Chronic mastoiditis.  Central perforation of L tympanic membrane. Initially presented to ER 9/9/08 with c/o 24' hx of dizziness, back pain, H/A, vomiting, diarrhea and syncopal episode with head injury. Also ear pain and cough-previously dx otitis media with perforated ear drum. Tx with IVF and D/c. Returned 9/12/08 with c/o lethargy, 2nd syncopal episode, generalized weakness, SOB, inability to stand and head, neck and back pain. PE (+) for pallor, L ear drainage, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased WOB, and decreased strength-3/5 upper, 2/5 lower extremities. Admitted in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Tx with IVIG with good response. Neuro will consider EMG/NCS if sx recur. ENT consult with Assessment: Chronic supporative OM, chronic mastoiditis, OM, central perforation of L TM.
Patient informed us 4 hours after receiving shot she had an asthma attack. To treat symptom she used her short acting bronchodilator. Currently has a headache with body aches and slight shortness of breath.
Pt recvd vax in 1992 & exp arthralgia, paresthesia, numbness of fingers, shoulder & knee pain;
Fainting- pt had to lie down, offered water. left after about 10-15 minutes
No local reaction. At 2 PM patient noted (6 hrs after vaccination) numbness in the left leg especially the left big toe. Symptoms resolved in a couple of hours. Next day, 06/29/2006, the left leg feels heavy.
(R) t103.4R 4hrs p/DTP inj; reduced w/Motrin suspension over 48hr period;
Fever; Extreme chills; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left on 19Feb2021 at 16:00 (at the age of 73-years-old) as single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient did not had known allergies. Concomitant medications included verapamil, olmesartan medoxomil and dexlansoprazole (DEXILANT). Patient did not had COVID prior to vaccination and has not been tested for COVID post vaccination. On 19Feb2021 at 00:00, the patient experienced fever and extreme chills. The patient did not receive treatment for the events. The outcome of the events was resolved.  Information on the lot/batch number has been requested.
At 10 minutes after vaccination the pt develops dysphagia,salivation and recurrent cough. We treat inhouse facilities w solumedrol 125mg IV and she was under observation during 1 hour and half without any other complications and was sent home.
FEARFULL NIGHTMARE; FELT BAD AND DIE, NEVER RETURN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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, the subject experienced fearful nightmare, and felt bad and die, never return. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fearful nightmare and felt bad and die, never return was not reported. This report was non-serious.
The day after shots both deltoids were very swollen, erythematous and tender. Swelling started decreasing 2 days later. Seen on 3rd day after injections.
Very sore arm, woke up morning after shot with fever, aches, chills, headache and severe arm pain at injection site, these symptoms lasted about 24 hours. I now have redness at injection site
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 31-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
Patient had a local reaction to Zostavax vaccination recieved on 06/18/08.  Administered into left arm. Swelling occured. Two days later patient described back pain (6/20/08).  Blistery rash developed on 06/23/08.  Patient saw physician to verify diagnosis of shingles
Erythema, warm to touch, swelling, redness, only near VARIVAX injection; nothing by MENACTRA injection site redness; swelling spread on back of arm.
Patient's left arm was red, inflamed, and warm to the touch. She also had a headache 24 hours post vaccine administration.
shortness of breathe / hard time breathing / difficulty of breathing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported via Medical Information Team. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot/batch number and expiration date were unknown) via an unspecified route of administration on 09Feb2021 as single dose for Covid-19 immunization. The patient medical history was allergic to fish oil and Zocor. The patient's concomitant medications were not reported. On 10Feb2021, patient experienced shortness of breathe / hard time breathing / difficulty of breathing later and was seen by urgent care on 14Feb2021 for shortness of breath and difficulty breathing. Patient received his first Pfizer covid vaccine on 09Feb2021. He experienced some shortness of breathe later & was seen by urgent care. Patient received steroid injection (unsure of the name) when seen at Urgent Care and a prescription for an inhaler. Patient asking that if he should still receive the second dose of Pfizer covid vaccine. Patient had a hard time breathing after 1st dose. The patient was asking how long will the difficulty of breathing less. He was experiencing heavy breathing at the time of reporting. Patient received steroid injection (unsure of the name) when seen at Urgent Care and a prescription for an inhaler and prednisone. Patient had an x-ray (negative for any findings per patient) and was prescribed prednisone. Patient reported that the symptoms got better but never went away. The patient underwent lab tests and procedures which included x-ray: negative on 14Feb2021. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
No other AE; Caller reported a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 01-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme frequency, route of administration, lot number S038177, which has been verified to be valid, expiration date reported and validated as 26-NOV-2021). The vaccine administered experienced a temperature excursion of 30 degrees Fahrenheit (F), for a time frame of 72 hours, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Received Hep B vaccine 12pm 7/18/2002. Returned to facility 7/19/02 stating she had been to ER 7/18 pm due to dizziness, confusion, difficulty with speech, difficulty breathing. Released from ER at 630-7pm. Patient states ER DR says questionable allergic reaction to thimerosol. Follow up with private physician.
Patient woke up in the early morning with a fever (101.3 axillary) and occipital headache 4/10.  Denied reacent head injury, history of migraines, stiff neck, body aches, rash on LE.
Per mother 2 hours after the shot patient complained of sever ringing in her right ear and decreased hearing. She was seen by ENT in 24 hours and DX with sudden decreased hearing loss.
Patient received COVID-19 vaccinations on 1/28/21 and 2/18/21 . The patient tested positive for COVID-19 on 6/30/21 and was hospitalized.
Information has been received from a physician concerning a 23 year old female who in 1999 was vaccinated with two doses of varicella vaccine. Subsequently, the pt failed to seroconvert. The pt did not seek medical attention. Additional info has been requested.
Initial case received from a health care professional on 28 January 2011.  A 37-year-old male patient received an intramuscular right deltoid injection of ADACEL (lot number C3487AA) and an intramuscular left deltoid injection of FLUZONE No Preservative 2010-2011 (lot number U3567CA) on 28 October 2010.  The day of vaccination, the patient began experiencing muscle soreness in his right deltoid.  He reported that he "could not raise his arm above his head".  He had seen his physician twice for his symptoms, and was due to see his physician again at the time of the report.  He denied any incident which would have caused the injury; there was no redness or swelling at the injection site.  An MRI had revealed abnormal muscular strain injury.  At the time of the report, the event had been ongoing for 3 months.  The patient was not ill at the time of vaccination, had no pre-existing conditions, and was not taking any concomitant medications.  Documents held by sender: None.
Information has been received from a physician concerning a female with no pertinent medical history or allergies who on 04-JUL-2009 ("10 days ago") was vaccinated with VARIVAX (lot#, route and site of administration not reported). The physician reported that the patient developed rash all over her body after receiving the VARIVAX. She called the office for medical attention. No lab diagnostics studies performed. At the time of reporting the patient was not recovered. Additional information has been requested.
A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.
the physician administered a dose of GARDASIL 9 to an unspecified pregnant patient.; No adverse effects reported; This spontaneous prospective pregnancy report has been received from a nurse via company representative referring to a unspecified pregnant female patient of unknown age. The patient became pregnant with last menstrual period (LMP) of 20-MAR-2019 and estimated date of delivery(EDD) of 25-DEC-2019. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 06-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency, route, lot # and expiration date were not reported) for prophylaxis due to human error(exposure during pregnancy). Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 33 weeks. The pregnancy outcome was outcome pending. The fetal outcome was unknown. No adverse effects reported.
The patient tested positive for Covid19 after being vaccinated with Johnson and Johnson vaccine EUA 04/01/2021
On 8/29/2021, decedent presented to the ER with a three day duration of worsening shortness of breath. He was admitted to the hospital and discharged home on 9/1/2021 with COVID pneumonia.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reaction or allergies were not reported. On 31-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in Refrigerator, and, the highest temperature of excursion of 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.