chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 days after MMR and Varivax and Pediarix Hib, Prevnar had apnea and was hospitalized.  No etiology found but 2 episodes of apnea is suspicious. 1. DOS 9/4/-9/5/06 DC DX: Gastroenterities, choking episodes with apnea. Episodes of choking and stopped breathing. Temp 100 2. DOX 10/13-10/15/06 DC DX: fever no source (resolved, cultures negative), febrile seizure, beta thalassemia trait, neutropenia (likely viral suppression).  On second day of hospitalization, able to eat but continued temp 102.4.
Cyst breast; Back pain; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain ), PAIN IN EXTREMITY (Pain in arm ) and BREAST CYST (Cyst breast) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Back pain ) and PAIN IN EXTREMITY (Pain in arm ). On an unknown date, the patient experienced BREAST CYST (Cyst breast). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back pain ), PAIN IN EXTREMITY (Pain in arm ) and BREAST CYST (Cyst breast) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided.   This case was linked to MOD-2021-089637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: On 03-JUN-2021 follow up was received, patient's demographics were added. New events were added.; Sender'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.
Fever of 102 degrees Fahrenheit discovered by me when I went to awaken my husband on Saturday February 13, 2021.  Two days later I discovered that he had died when I went to keep him a dose of liquid Tylenol at 4 am on February 15, 2021.
On Saturday, January 28, 2023, I took my dose of lansoprazole and I started to feel not very good. I was lethargic. I wasn't sure why. The next day, I took the second dose and then I felt twice as bad as it was the day before. That night I began to have extreme back spasms. It was radiating on both sides and caused abdomen spasms. The spasms lasted through to the middle of the night. I assumed it was due to EDS. By the next morning the spasms were gone, and I did not take lansoprazole again. On Tuesday night I was having the back spasms again. I spent a couple of hours simple relaxation techniques to relax my abdomen. I went to the chiropractor, twice. Friday night I felt considerably worse with fever, chills, and sweating. When I had a bowel movement it was pale gray, and my urine was bright orange. I noticed I had been scratching all over my body trying to find the itch that moved all over my body. I did not have hives. The small welts were not raised and the only reason they were a bit red is because I scratched the area. I changed my diet a bit after reading about gallstones and drug-induced cholestasis. I have a liver scan scheduled for Friday.
Severe pain in the left arm. Feels like someone hit it with a baseball bat, Cannot use the arm even after 24hrs.
fatigue, aches and pain, dizziness, but only about every other day for about two weeks now.  I had the flu shot with it.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021 (a week ago), the patient was diagnosed with covid infection (suspected clinical vaccination failure) and had never been so sick and the patient was hit with headache, aches, pains, and freezing chills (suspected covid-19 infection). All the patient could do was pray for relief. It was lasted for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000194664.; Sender's Comments: V0: 20210947219-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
mild fatigue 18 hours after injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue 18 hours after injection) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISOLONE ACETATE, TIMOLOL (BETIMOL [TIMOLOL]) and OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Mar-2021, the patient experienced FATIGUE (mild fatigue 18 hours after injection). On 17-Mar-2021, FATIGUE (mild fatigue 18 hours after injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported/unknown.
Muscle pain that began bilateral back around the shoulders and just below the should blades and that extended down to my back and into the abdomen approximately 6 hours after receiving the vaccine. Difficulty sleeping when turning in bed and pain severe with movement. Took Advil and it helped a lot. Also had chills and hot flashes.
I had no symptoms after my vaccine. I experienced COVID symptoms, stuffy headache, cough, post nasal drip, chest irritation and fatigue. I also loss my sense of smell for a few days.  I had at home COVID-19 test and it was positive. I did not go see a doctor. I have no symptoms today.
received the first dose /on 10/21/2020 /not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 21st October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination  No further events were reported. The health care professional agreed to be contacted for follow up.
Worst I?ve ever felt in my life. Major chills, body aches/ major pains, ears hurting, headache, slurred speech. Started bad about 14 hours after shot. Strong effects for 24 hours before tapering off.
started with joint pain in shoulders/knees, hypersensitivity on left thigh,skin felt abraded without any trauma. 10/25/2009 vesicles appeared in left lumbar area and left buttocks, 10/26/2009 fever and left groin swollen, went to physician for treatment
Tired, Shortness of breath, pain in back, cough, runny nose, headache
Pulmonary embolisms; lung infarcts in left and right lungs; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL5269), via an unspecified route of administration at site of left arm at 15:00 on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included psoriasis and known allergies: clarithromycin. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date. The patient experienced pulmonary embolisms and lung infarcts in left and right lungs on 11Feb2021. The patient was hospitalized for these events for 2 days. COVID was tested post vaccination (Nasal Swab covid test with negative result on 12Feb2021). No other vaccine received in four weeks. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient received treatment (blood thinners and CT Imaging) for adverse event. No COVID prior vaccination. The outcome of events was recovered in Feb2021.
PT STATES 4/7 AT 3PM SHE NOTICED SWELLING IN LEG AND WENT TO ER. DIAGNOSED AS SUPERFICIAL BLOOD CLOT IN LEFT LEG. SHE WAS TOLD TO COLD COMPRESS, WALK AND ELEVATE TO REDUCE SWELLING. TODAY SHE FELT DIZZY AND THOUGHT SHE MIGHT HAVE MORE BLOOD CLOTS, SHE WAS REFERRED TO ER AGAIN WHERE THEY GAVE HER ASPIRIN 81MG AND THERE WERE NO ADDITIONAL CLOTS, HER FIRST VISIT CLOT WAS HEALING.
SOB, 45 minutes, post vax. Doctor gave steroid injection and had relief within 15 minutes at office.
Patient received Covid booster with Pfizer 10/.21/22.  The following day he had swelling of his axillary area and pain and swelling of both knees. Per 11/1/22 provider note: "Initially, the pain was greater in the right side but eventually the pain on the left progressively got worse that by the time he presented to the ER the left was worse than the right knee.  ER examination shows that he had mild swelling on the right knee and moderate swelling on the left knee.  The x-rays came back fine.  CBC CRP ESR and uric acid from the ER were fine.  Knee x-rays came back fine.  It was assessed that he is swelling could be related to the Covid vaccine.  He was advised to take ibuprofen.  He has been taking it for the past couple of days.  The swelling has significantly subsided.  Presently he only has minimal joint effusion on both sides"
Was 34 days after booster shot Had an ischemic stroke in my right parietal lobe (not a TIA) Balance issues and problems with left arm hypertension normal with medicine control prior to stroke Taking blood thinner and statins for treatment, getting physical therapy, and wearing heart event monitor to determine if atrial fibrulation exists. My doctor thinks I might have had vaccine induced immune thrombotic thrombocytopenia.
Symptoms: Fever (reached 102 F)*** Fatigue, muscle pain and malaise *** Loss of appetite* Localized sore at the site of injection* *: indicates intensity The above symptoms started as mild fatigue on Friday night (Day #0).  After I woke up on Saturday (Days#1) morning I felt weaker with muscle soreness, cold. Before noon, I wrapped my self with clothes and  slept.  My body Temperature measurement (using oral and touch thermometer) started  to increase from 99, 100, 101 to 102 F on multiple different occasions. I was able to eat but with minimal appetite.   Before eating I took Theraflu which contains 650 mg Tylenol it didn't work well. Until evening I took 2 tabs Tylenol 500 mg , slept for 4 hours,  woke up with sweat, feeling better not very weak and my temperature went down to 99 F.   Took another 2 tabs an hour later and woke up in the morning normal but little bit tired (Day#2).  Monday( Day#3) normal not my usual energy, but better than Day #2.
Swelling and pain at injection site with both doses. Worse with second dose. Full body rash for three weeks which has not completely resolved. Had four days or steroids, cortisone shot and steroid cream to use BID. Went to walk in originally, then went to dermatology and finally primary care for blood work.
Leg is red, warm to the touch and swollen. Not affected walking. Gave ibuprofen but no improvement.
Pfizer 3/29/21, 5/4/21, 12/13/21. Positive on 2/10/22
Narrative: site soreness x day 1; fatigue x2 weeks; cold/chills x21 days.
Vomiting, nausea, numbness in the arm of the injection, severe headache, blurry vision.
Fever and body aches. Treated with rotation of Motrin and Tylenol.  Fever resolved after 2 days.  Then  4 days later started with some chest pain/tightness - thought to be due to inhalation of campfire smoke.  But then next day HR was 138 while sitting doing nothing.   (Also had Meningococcal-ACWY vaccine on 6/17/21, but I don't have Lot#, etc.}
Lightheadedness, dizziness, loss of hearing, then laid down before I fainted.
Aching pain in Left Deltoid and aching and burning across left anterior chest.  Headache.  Symptoms persisting today still.
Patient had a low grade fever and stayed in bed for 1 day; Patient had a low grade fever and stayed in bed for 1 day; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Patient had a low grade fever and stayed in bed for 1 day) and PYREXIA (Patient had a low grade fever and stayed in bed for 1 day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 023M20A and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (Patient had a low grade fever and stayed in bed for 1 day) and PYREXIA (Patient had a low grade fever and stayed in bed for 1 day). On 28-Jan-2021, ASTHENIA (Patient had a low grade fever and stayed in bed for 1 day) and PYREXIA (Patient had a low grade fever and stayed in bed for 1 day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: Her normal temperature is usually at 97.9F and she could feel it was higher but does not remember the reading..         No concomitant medication were reported.  It was reported that patient took booster dose on 11-NOV-2021 of Lot-067F21A.  It was reported that patient had a low grade fever and stayed in bed for one day even after Dose 2 of Moderna vaccine. After the booster, She did not had any side effects.  No treatment medication were reported.
I felt like I had heart palpitation in my chest, and I was coughing. On 10/22/2021 I went to see a doctor. I was diagnosed with ventricular tachycardia. I was prescribed metoprolol 12.5 mg 1xday at bedtime. I still have a little heart fluttering but not as much before. I have an upcoming appointment with a cardiac electrophysiologist on February 3rd.
Moderna vaccine dose number 2 given too soon on 09/24/2021.. The first dose was given on 09/03/2021.  No adverse event reported to clinic.  This report is being completed on behalf of RN, who gave the vaccine.
12/26/06 left upper arm cellulitis, hot, inflamed, swollen-3 1/2 x 5" -following pneumoshot on 12/22/06 treated with Augmentin 875 mg BID x 10 days, warm compress
limited ROM to my left side of the neck; chills; fevers; severe headaches; muscle and joint pain; muscle and joint pain; numbness in my left arm; back pain; nausea; flank pain; abdominal pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 16:45 (Batch/Lot Number: EL3249) (at the age of 38-years old) as single dose for covid-19 immunisation. Medical history included allergies to latex. No concomitant medications were reported (within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL1283) within 4 weeks prior to the second dose, for covid-19 immunisation (at age 38-years old). Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that with her second dose on 11Feb2021 at 03:00 she started experiencing chills, fevers, severe headaches, muscle and joint pain, numbness in my left arm, back pain, limited ROM (range of motion) to my left side of the neck, nausea, flank pain and abdominal pain. The patient underwent lab test and procedure which included nasal swab test on an unknow date in 2021 and the result was negative. Therapeutic measures taken as a result of events and included treatment with ibuprofen. The outcome of all the events were reported as not recovered.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 10-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Swollen site, hot day after itchy a few days after and hot. Treated with heating pad to site, Tylenol for pain, with some improvement.
Monovalent doses administered after the BUD to patients.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) in an adolescent male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.).     No concomitant medications were reported. No treatment medications were reported.
Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA955A, expiry date 31-JUL-2024) for prophylaxis.   On 04-AUG-2023, the patient received Menveo (right deltoid). On 04-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 The reporter was medical assistant. The reporter called to inquire any guidance. No additional details were reported. The reporter did not consent to follow-up. The reporter reported that they had the diluent component of Menveo left and thought that the lyophilized component had been reconstituted with normal saline and administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023109475:2nd patient