chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100.5 fever, day of event. Fatigue, Intermittent chills 3 days prior to chills. Cough. 24 hours duration of fever.  Felt fine the following day and proceeded to take dose #2 of Moderna vaccine on 3/12/2021 (Lot # 026A211A). Public Health Department,
I received the first shot on a Tuesday and developed side effects starting the following Sunday. I woke up with a sore throat and fatigue and body aches and headache. I continued to have the same symptoms without relief from tylenol and Claritin around the clock for the next two days. When the symptoms were not relieved, that week following Thursday (12/30/2020)  from the shot, I got rapid Covid tested, flu, and strep tested. All were negative and send off covid was negative as well. On Friday, 12/31/2020, all my symptoms had resolved and I felt 100% better.
Fever, muscle ache, fatigue, nausea, vomiting, headache- advil/tylenol alternating with epsom salt baths, liquid IV hydration packs in water Body rash on trunk- oatmeal baths, calamine lotion,and on hand steroid cream (mometosone,),  advil/tylenol Shortness of breath- rest  Symptoms lasted  appro36 hours and body rash subsided in 3-4 days
Arm was very sore at injection site.  Took about a week  to feel better.  Had some body aches and was cold day after the shot but had no fever. The body aches went away in a day's time
Swelling, pain, warmth of the arm of the injection.  possible angioedema of arm
Waited over 20 min without resolution of nausea .Patient with hx of Gerd on PPI . Patient without cardiopulmonary symptoms . Patient encouraged to take PPI and make dietary changes x 24 hrs .Patient reported dizziness during questioning (mild) . Ambulance
Pt. rec. immunizations on afternoon of 3-9-11. Later that evening - c/o pain in neck, jaw, headache and tightness in face and jaw. Began to feel better, no further s/s of above after 3-14-11 - F/u call on 4-12-11.
Minor fainted 20 minutes after receiving all vaccines. He fainted again 30 after that and a few minutes later, he vomited. Minor continued to complain of feeling dizzy even after taking two sugary drinks and a granola bar. Vital Signs were stable during this time, but  because minor continued to complain of feeling dizzy, he was sent to the ER via ambulance in stable condition.
sore left arm; inadvertent subcutaneous administration of the vaccine/patient was given the Covid vaccine subcutaneously and not intramuscularly; it was given way too low on the arm and not within the deltoid; This is a spontaneous report from a contactable other HCP. This other HCP reported for a female patient with unknown age that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, Expiry Date: 31Dec2059), via subcutaneous at left arm on 05Jan2021 at 0.3ml single for COVID-19 immunization. Medical history and concomitant medication were none. The inadvertent subcutaneous administration of the vaccine was reported. On 05Jan2021, patient was given the Covid vaccine subcutaneously and not intramuscularly. It was also reported that the sore left arm started immediately after immunization. The patient reported that it was given way too low on the arm and not within the deltoid. Outcome of event was unknown.
Severe Headache, Severe Muscle Aches, Disorientated, Fever.
Headache, Myalgia, Fever, NauseaVomiting, cold, body ache Narrative:
Administered SQ instead of IM; Injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2022, the patient received Shingrix (subcutaneous). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site reaction. On 24th August 2022, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The pharmacist who works at the same hospital reported a nurse received a Shingrix at her physician 's office that was administered subcutaneous instead of intramuscular. The healthcare professional called in to get efficacy data for a subcutaneous Shingrix dose, at the end of the call she mentioned in passing that the patient had an injection site reaction. The reporter gave consent to follow up via email. Additional Supportive Information: Shingrix administered subcutaneous instead of intramuscular which led to intramuscular formulation administered by other route.
Pt presented to the  emergency room due to sore throat over the last 2 days.  She states that feels like her throat on fire and she has difficulty swallowing because of this.  She has complaints of midsternal chest pain with shortness of breath.  She has cough productive at times of yellow sputum.  She denies any fevers or chills, diarrhea/constipation, dysuria.  In the emergency room, she did drop her pulse oximetry as low as 85% when on room air, this improves to 92-94% on 3 L of oxygen via nasal cannula.  She admits to a past history of smoking, is not typically on oxygen at home.  Lab work from the emergency room reveals sodium 139, potassium 3.6, albumin 3.3, glucose 91, BUN 30, creatinine 2.4, HS troponin 160.4, CK 35, CK-MB less than 2.5, magnesium 1.9, WBC 8.01, hemoglobin 10.6.   Patient has a persistent dry cough.  Continues on Decadron and remdesivir, oxygen protocol.  Patient refuses IV fluids for acute renal failure, encouraged to auto hydrate.  Home medications and diet has been resumed.  Requires 2- 3 L of nasal oxygen to maintain satisfactory oxygenation.   Today, 01/05/2022 patient's respiratory status has improved.  She is now oxygenating quite adequately on room air.  She is very insistent on being discharged home today.  Renal function is improving with blood urea nitrogen 35 and creatinine down to 1.6 today.  Serum electrolytes are normal, WBC 12.2, hemoglobin 9.7, platelets 289 K.  CRP is decreased to 10.0 in D-dimer has decreased to 1762. Blood pressure stable and she is afebrile.  On auscultation her lungs are clear, with decreased breath sounds at the right base as before.   We discussed the need to continue quarantine, have follow-up with PCP and of course the patient may return if her symptoms recur or worsen.
Four hours after the vaccine I experienced an uncomfortable swelling in back of my throat; difficulty swallowing; rapid heart rate (twice normal); vomiting x 1. The throat swelling and difficulty swallowing lasted 8 hours. (I haven't vomited in decades; this was clearly abnormal).
Rash (small fine bumps) on face, neck, around hair line, on trunk, upper and lower extremities. Rash appears slightly pink. No swelling noted, parent states child has been afebrile. Parent states she has been giving child Benadryl for itching and also using aveeno cream on rash. Parent denies child being in distress.
The pt was given the first dose of Engerix B IM (left arm) in error. He should have been vaccinated with PPD. Subsequently, the pt experienced redness at the injection site. The most recent information received, reports that the condition of the pt is ongoing.
developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan; site injection pain; headache; muscle pain; joint pain; nausea without vomiting; fatigue; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No. EK9231), via an unspecified route of administration at site of left deltoid on 13Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan, sudden onset tinnitus at 11:30am. Stated that he had other symptoms that resolved. Stated that on Friday that the tinnitus was continuing. The other symptoms that resolved were site injection pain, headache, myalgia, muscle and joint pain, queasy stomach, nausea without vomiting and fatigue on 13Jan2021. Stated they were more severe the first day and resolved by Friday night. Stated that the was fine Saturday morning. Stated that they all had acute onset. The outcome of event tinnitus was not recovered. The outcome of rest events was recovered in Jan2021  Information on the lot/batch number has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine on 21 Jul 2022 where the expiration date was on 13 Feb 2022), PRODUCT STORAGE ERROR (Date vial was moved from freezer to refrigerator was on 27 JUN 2022, stored even after expiration date) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial came out of a refrigerator at 40 degrees Fahrenheit and kept in room at temperature 81 degrees Fahrenheit) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine on 21 Jul 2022 where the expiration date was on 13 Feb 2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial came out of a refrigerator at 40 degrees Fahrenheit and kept in room at temperature 81 degrees Fahrenheit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was moved from freezer to refrigerator was on 27 JUN 2022, stored even after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine on 21 Jul 2022 where the expiration date was on 13 Feb 2022), PRODUCT STORAGE ERROR (Date vial was moved from freezer to refrigerator was on 27 JUN 2022, stored even after expiration date) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial came out of a refrigerator at 40 degrees Fahrenheit and kept in room at temperature 81 degrees Fahrenheit) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was a pediatric patient receiving vaccine for patients 6 months through 5 years of age. No concomitant medications were reported. It was reported that the vial had reached maximum temperature of 81 degrees Fahrenheit, and minimum temperatures of 40 degrees Fahrenheit. The duration of excursion was about 1 hour. It was reported that the date vial was moved from freezer to refrigerator, was on 27-Jun-2022 and they were returned to the refrigerator after vaccination. The vaccine was inspected and no changes in the state were observed. Proposed desired Use by date was on 21-Jul-2022. Number of vials/doses impacted was reported as one vial. The vial was punctured at 11:15 AM. No treatment medications were reported.
She had 2 blood clots in her right leg, and she was now on Eliquis; she had right leg swelling; she had right leg pain; flu; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 06May2021 (Batch/Lot Number: Not Provided) as a single dose,  for covid-19 immunisation, with first dose given 15Apr2021. Medical history and concomitant medications were not reported.  The patient  said she had the flu 3 days after getting her second COVID-19 Vaccine, had right leg swelling, right leg pain, and had 2 blood clots in her right leg. The patient said she was now on apixaban (ELIQUIS), and financial assistance, due to being on unemployment. The outcome of the events was not reported.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; ACHES AND PAINS; UPSET STOMACH; CHILLS; VERGE OF VOMITING; This spontaneous report received from a patient concerned a 68 year old female, unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis, reflux, formaldehyde pesticides and chlorine allergy, paint and natural gas allergy, detergent allergy, sulfa allergy, mold allergy, dust allergy, mites allergy, pollen allergy, dogs and cats allergy, asthma attack, cigarette smoke allergy, and fragrance allergy. The patient experienced bad headache, itchy and not feel good when treated with pneumococcal vaccine, and cyanocobalamin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: 23-AUG-2021) dose was not reported, one total administered on 01-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included apremilast for psoriatic arthritis, salbutamol sulfate for reaction causing asthma attack, pantoprazole sodium sesquihydrate for reflux, bupropion hydrochloride, epinephrine, and thyroid.  On 01-APR-2021 patient experienced chills and upset stomach (verge of vomiting), which started at afternoon. The patient reports chills, and aches and pains that began in the evening 01-APR-2021. The patient reported that symptoms started feeling better/improving about 24 hours later, in the afternoon on 02-APR-2021, however, reports she felt much better on 03-APR-2021. The patient reported she had an antibody test performed 30-JUL-2021 which came back with a negative (confirmed immunological vaccine failure). The patient was not certain on which type of serologic test was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, upset stomach, chills, and verge of vomiting on 03-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210805910-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical immunological failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient described a tightness in chest with difficulty breathing within 5 minutes of getting the vaccine.  Patient was given an injection of epinephrine sub-q and 911 was called.  She was transported to Hospital where she still remains as of today, 5/20/2009.  6/4/09 Hospital records received DOS 5/18/09 to 5/21/09. FINAL DIAGNOSIS: Anaphylactic reaction with recurrent symptoms. Post vaccination developed chest tightness and difficulty in breathing. Given epinephrine. Difficulty in breathing recurred while being transported to hospital. Again given epinephrine and Benadryl. Hot flashes. At hospital given: Steroids, Benadryl, Pepcid IV. Xanax.  9/17/09 ICD-9 Codes: 999.4 Anaphylactic shock due to serum, 401.9 Essential hypertension unspecified, 722.6 Degeneration of unspecified intervertebral disc, 272.4 Other hyperlipidemia, 300.4 Dysthymic disorder, 443.9 Peripheral vascular disease, V58.63 Long-term (current) use of antiplatelets/antithrombotics, V10.3 History of breast cancer, E849.7 Injury or poisoning in residential institution, E9499 Adverse effect of other and unspecified vaccine and biological substances. \ksk
Rash in face, 101 fever for 3 days. 05/31/2013 -> swollen groin lymph node (right side); lasted for 3 weeks; brussel sprout sized swelling; verified with physician abroad (on vacation) to be common side effect of mumps portion of the MMR.
Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat  or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.
pt admitted to hosp with respiratory distress and positive for COVID; COVID pneumonia; hypoxic (O2 sats 70-80s on RA); required ventilator; given steroids, dexamethasone, and antibiotics; developed AKI and ultimately renal failure; pt had seizures during hospitalization; while being transferred for further imaging work up, pt coded and died
This spontaneous report was received from a registered nurse (other health professional) and refers to a male patient of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies/reactions were not reported. On 18-AUG-2017, the patient was vaccinated with unspecified dose (1DF) of RECOMBIVAX HB immunization series with (lot # N002202, expiry date:04-NOV-2019) which were improperly stored (Incorrect product storage). No adverse effects were reported. The vaccine was stored at 3.7F at worst for 7 hours. There was previous temperature excursion at 48F for 1 hour. Data logger was involved. The outcome were unknown. No product quality complaint was involved. No further information was provided. This case is cross-referenced with MARRS#1708USA010841 and  MARRS#1708USA010842(same reporter).; Sender's Comments:  US-009507513-1708USA010841: US-009507513-1708USA010842:
Beginning roughly 11 hours after receiving vaccination, patient began feeling general malaise. Most symptoms were expected responses. The adverse response was the feeling of lung tightness that lasted continually for 12 hours beginning at 2330 on 2/9/21 and then following normal daily activities such as walking. No history of asthma but patient did have COVID-19 virus in October. No imaging or testing performed
Redness and swelling. Pus at injection site. Patient returned to pharmacy on 3/7/12.
Patient started to have on and off palpitation two days after the vaccination.  No SOB.  No chest pain.  Was more frequent in the first week after the vaccine.  Less frequent in the second week following the vaccine.  Mother called on 6/12/21 to report about the complaints since it has not completely resolved.  Will request for Cardiology consult within the next 48 hours to perform initial work up of EKG, troponin level, and inflammatory markers such as C-reactive protein and erythrocyte sedimentation rate.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 22-AUG-2016, the patient received improperly stored doses of RECOMBIVAX HB and ROTATEQ (orally, dose was not reported). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
I received Moderna dose 1 on December 29th, 2020 around 10:30 a.m.  I did experience chills, body aches, extreme fatigue, pain and swelling at injection site for about 36 hours.  However, symptoms seems to resolve after a couple of days.  On Tuesday, January 5th around 5 p.m. at the injection site in my right arm it began to itch.  By 9 p.m. I had a huge red circle around 3 inches in diameter around the injection site, it was sore, swollen, warm to the touch. itchy and lymph nodes under right axilla were swollen.  I contacted my Dr. immediately the morning of Wednesday, January 6th and after assessing me she felt it was a skin infection. She prescribed Doxycycline antibiotic and Zyrtec by day, Benadryl by night.  I began the antibiotic treatment with first dose on 1/6/21 at 1:30 p.m., dose 2 9:00 p.m. and dose 3 on Thursday, January 7th 2020 around 8:00 a.m.  I have responded well to the treatment and already my arm is much improved.  My Dr. felt it could have been the technique of the administration of the vaccine that caused infection.  However, I wanted to report in case anyone else with this batch also experienced similar response.
Reddened, swollen area at site, extending down under her axilla and into her breast area.
A week  after the vaccination I got a rash at the injection site, exhaustion, weakness, headaches. I went to see the doctor to have blood tests and to get it checked out. He noted my symptoms. After the rash and other things subsided, the pain started to set in and has grown progressively worse.   I have lost some of the use of my left arm, about 50%. I need help brushing my hair and sometimes getting dressed. I can't do many of the things I used to, have trouble with many household chores. I wake up 3-4 times a night due to the pain, so I never get a good night's sleep anymore.
Vaginal bleeding off normal menstrual cycle; Vaginal bleeding off normal menstrual cycle; Body chills; Weakness; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 49-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 27Oct2021 (age at vaccination 49-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of dose 1 and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unknown date as dose 1, single and as dose 2, single for covid-19 immunisation. After 3 days, the patient began vaginal bleeding off normal menstrual cycle on 30Oct2021, Bleeding was also darker than normal cycle. The bleeding followed day of body chills and weakness on unspecified date of 2021. The outcome of the events was unknown.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.