chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; Dehydration; blood presser 60/44; while sitting in a chair fell out of it and had to go to the hospital; creatine levels in kidney was 4 times higher; felt like had flu; then woke up in the middle of the night soaked; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had flu), BLOOD CREATINE INCREASED (creatine levels in kidney was 4 times higher), DIARRHOEA (diarrhea), DEHYDRATION (Dehydration) and BLOOD PRESSURE DECREASED (blood presser 60/44) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had flu) and NIGHT SWEATS (then woke up in the middle of the night soaked). On 01-Aug-2021, the patient experienced BLOOD CREATINE INCREASED (creatine levels in kidney was 4 times higher), DEHYDRATION (Dehydration), BLOOD PRESSURE DECREASED (blood presser 60/44) and FALL (while sitting in a chair fell out of it and had to go to the hospital). On 02-Aug-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with NORMAL SALINE for Adverse event, at a dose of 5 bags and OXYGEN for Adverse event, at an unspecified dose and frequency. On 02-Aug-2021, BLOOD CREATINE INCREASED (creatine levels in kidney was 4 times higher), DEHYDRATION (Dehydration) and BLOOD PRESSURE DECREASED (blood presser 60/44) had resolved. On 03-Aug-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt like had flu), FALL (while sitting in a chair fell out of it and had to go to the hospital) and NIGHT SWEATS (then woke up in the middle of the night soaked) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Blood creatine increased: 4 times higher (High) creatine levels in kidney was 4 times higher. On 02-Aug-2021, Blood pressure measurement: 60/44 (Low) 60/44.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Information has been received from a male consumer, a pharmacist, with no pertinent medical history and a sulfonamide allergy, who on 14-SEP-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  It was reported that the patient had a sore throat and some malaise prior to being vaccinated with Zostavax (Oka/Merck).  On 17-SEP-2007 the patient stated that "the symptoms have become worse over the last few days, and now include a runny nose and cough", and he reported "having difficulty breathing with the cold".  No medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
6Mar91 pt had T of 105(R) & apparently had some seizure activity, taken to hosp for evaluation, Seen in ER,MD said Rt ear was slightly red, antibiotic RX, grandmom informed ER of date of admin of vaxs,pt D/C. Grandmom states pt T101 this am
Female caller stating she had her second COVID Moderna Vaccine Lot # 036A21A administered to her left arm, yesterday on 3/5/2021 at 0854. She stated she began having chills and a headache yesterday evening accompanied by a headache. Her temperature ranged form 100.2-100.6 with some relief from Tylenol (one doe) last night. She did experience a low grade temperature with her first dose that subsided within that day. Today 3/6/2021 she states her symptoms are persistent and she wanted to know if she took more Tylenol now would it affect the efficacy of the vaccine. This RN informed her "No" . This RN to make 24hr CB on 3/7/2021 to f/u on AE's. RN 3/6/2021 @1421
Pt reported feeling warm and her heart racing. She also complained of a headache.  Patient was given water and after 40 minutes was feeling fine, no longer feeling flushed or warm.
no other AEs reported; PROQU AD was accidentally administered intramuscularly on 22Jun2021.; This spontaneous report was received from a nurse who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 22-JUN-2021, the patient was accidentally vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 1 injection, via intramuscular route (lot number T016989 was confirmed to be valid; expiration date was not reported but upon internal validation process, it was established as 11-NOV-2021; strength, dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse events were reported.
2 1/2 weeks after shot lost vision in right eye and had extreme spike in BP resulting a 10 hospitalization. Neurologist recommended submitting this form b
Chest pressure at 09:37. Patient given 25 mg Benadryl. At 10:10 patient reported chest pressure and lump in throat. Patient treated with another 25 mg Benadryl.
Narrative: pain at the site x1 day  Other Relevant Hx: Symptoms:  & injection site pain Treatment:
Initial case was received on 04 November 2010 from a healthcare professional. A male patient (age not reported), received an injection of "FLUZONE" (lot not reported) a few days after being discharged from a three day stay in the hospital for pneumonia. The pneumonia had been treated with unspecified antibiotics. Four days after the FLUZONE vaccination, the patient experienced bilateral lower extremity weakness from the feet up to the knees. He stayed at home for three weeks with these symptoms. He fell at home and wife couldn't pick him up, so 911 was called and he was admitted to the hospital with marked bilateral lower extremity weakness. An MRI was consistent with transverse myelitis from T9 to the conus. He was treated with a pulse of steroids for five days and the weakness improved. However, the weakness worsened again and the patient was back on steroids, but with minimal improvement. He lost his bowel and bladder control. An lumbar puncture (LP) revealed lymphocytosis. The cerebrospinal fluid (CSF) was sent for an extensive viral panel and the only positive result was West Nile IgG positive, IgM negative. A CT scan showed mild splenomegaly, but not lymph node enlargement. His medical history included indolent lymphoma, but was not treated for many years. A bone marrow biopsy was being done on the day of this report (04 November 2010). Despite an extensive work-up, no etiology has been identified. As of this report, the patient has not recovered. Documents held by sender: None.
Vaccine was given 10/26/17. That evening patient stating area became a bit red, also slight fever and chills. Continued to worsen/enlarge, painful and itchy, was seen in PCP office 10/27 and Keflex 500 mg qid x 10 days was started. 10/28 she went to Urgent Care as area was worsening in redness, itching and pain were some improved. Area was circled and patient was to watch for worsening redness.  Patient called office the next day as area again was increasing some. Was instructed to monitor and continue Keflex. Have had no further communication from patient regarding this matter.
A few minutes after he received the vaccine he came back to the counter and said his throat felt itchy. He said he had approval from his doctor to get the vaccine and he took 50 mg of Benadryl 30 minutes before receiving the vaccine. His face continued to feel itchy and we gave him another 25 mg Benadryl, offered an Epipen but patient declined. A few minutes later he collapsed and had a seizure. His sister was with him at the time and said he had a history of seizures. EMS was called and several minutes later he did regain awareness and was responding to the EMT's providing care. He was transported to the ER by EMS for further observation.
Nausea in early evening of shot. 330 am that night I thought I was getting flu, chills, nausea tired . Even today 1/31 still tired, but the other symptoms seem to be going away. I am resting.
4cm x 4cm area of redness and induration Lt upper arm. Rx diphenhydramine and reassurance.
4-5 hours after vaccination patient was in dad's arm and mom witnessed infant pallor/cyanosis and lethargy. and shallow breathing.  No seizure seen.  She did stimulation a few times and he started to breath more routinely but stayed pale/cyanosis.  EMS came and his oxygen saturations were 70s and oxygen applied and brought to ED.  In ED normal eval and exam and some basic labs done and observation overnight w/o further events.  Concern for BRUE - brief resoled unexplained event
sore arm; a fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEART RATE INCREASED (a fast heart beat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation since an unknown date. Concomitant products included FLECAINIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEART RATE INCREASED (a fast heart beat). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On Sunday, March 28th, I started experiencing intense nausea past noon. About twenty minutes later, I started to vomit, and couldn't stop. In less than an hour, I had vomited over 8 times. I couldn't drink water (let alone hold any liquid down) before the next vomiting episode. I started to see blood in my vomit after the 2nd time (the doctors say this was due to my stomach aggressively contracting and causing little tears in the muscles). Around 1:30 p.m., my mother took me to the ER to get fluids and anti-nausea medication (magnesium oxide, sodium chloride, lactated ringers, and zofran). After my puking episodes stopped, I was discharged from the hospital and was prescribed more ondanestron (which I've used again at home after feeling nauseous again). Other than these symptoms, I have also experienced muscle aches, chills, and a very sore arm. I understand that nausea/vomiting is a reported side effect with Moderna for some people, but considering I've never experienced this symptom in any other vaccine (and never vomited back to back so quickly in a short period of time) I figured I would report my symptoms.
Suspected Clinical Vaccination Failure; Suspected COVID-19 Infection; This spontaneous report received from a patient concerned a 20 year old male. 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: 201A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-SEP-2021 for prophylactic vaccination on right arm (dose number in series 1). No concomitant medications were reported.  On an unspecified date the patient experienced headache, feeling tired, chest felt tight and sinus problems. The patient tested positive for COVID-19 with two rapid tests twice. Laboratory data (dates unspecified) included: COVID-19 rapid POC (point-of-care) test (NR: not provided) Positive. On 22-DEC-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) (suspected clinical vaccination failure and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and sinus problems was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208241.; Sender's Comments: V0: 20211250977-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
Refrigeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 12:35 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 12:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant medication was reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.  Date vial moved from freezer to refrigerator was 07-Sep-2022.  No adverse reactions reported for the patient.  No treatment information was provided.
PATIENT REPORTED SWELLING, HEAT, PAINFUL INECTIONSITE, RED AND RAISED RASH
No additional adverse events reported; A patient received a dose of PNEUMOVAX23 one day past the expiration date; This spontaneous report has been received from a pharmacist referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 18-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S026366 with expiration date of 17-SEP-2020 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis (expired product administered).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Slight to mild sore throat, followed by slight to mild cough (getting worse at the moment).; followed by slight to mild cough (getting worse at the moment); upper respiratory tract infection; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 58 years old) via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:00 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. Medical history included allergic to rabbits and cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naproxen (took one about a week before vaccination) and paracetamol (ACETAMINOFEN GENFAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight to mild sore throat, followed by slight to mild cough on 24Feb2021 22:00 which was getting worse at the moment. The patient guessed that he got an unrelated upper respiratory tract infection, but just a guess. The events were not treated. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Fever, chills, headache, all over body aches started 10 hours after administration, followed by hearing loss in right ear 43 hours after administration. Treatment consisted of one 600mg ibuprofen 15 hours after vaccine administration and another 600mg 31 hours after vaccine administration. Fever, chills and body aches gone 51 hours after vaccine administration, with hearing loss still remaining
Pain over entire body (sensitive to bed sheets touching the patient's skin), migraine with nausea, fatigue. All symptoms lasted 2 days before resolving completely.
Child became tired and mom put her to sleep between 6pm - 7pm.  At 10pm, mom checked on her and she was very, hot, flushed and her temperature was 102-103F.  Mom gave her Motrin 2 tsp. and repeated it in the morning.   She contacted her doctor on 12/11/2009 who had them meet him at the ER at 5pm on 12/11/09.  He diagnosed flu (fever, chills, sore throat) and sent them home.  No Tamiflu was given.  No other symptoms noted.  Mom continued with alternating Motrin and Tylenol for 3 days.  Gave Pedialyte.
severe cough, nausea, chills, fever, body aches, headache, vomiting, neurological
Woke up about 11 hours later.Leg was numb and I was unable to walk.leg numb from thigh and perinium area and went to ER where I had CT,4;MRI, X-rays,EKG,EMG later after two weeks leg still numb and foot can?t hold a shoe on.feels like a thick sock under my foot..some incontinence.At ER had a very large Bowel Movement that just fell out
This case was reported by a healthcare professional and described the occurrence of arm pain in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Headache, Myalgia, NauseaVomiting, HA, Generalized aches / pain, fever, lethargic, nausea, chills, hallucinogenic dreams night of the vaccination Narrative:
Pt arrived to get her booster shot and stated that she had palpitations for 3 days following her second Moderna shot on 02/26/2021. She said she spoke to general doctor and thought it might be because she was on gabapentin.  I mentioned that because Moderna has had reports of patients having palpitations following covid vaccine that she should seek out her cardiologist.  This might be indicative of myocarditis or pericarditis.
After vaccination, she had muscle pain,  nerve damage, dizziness. Went to a walkin clinic, they said she had vertigo, and will pick up prescription Dr. prescribed.  Will have to have treatment every two weeks.
pt recvd vax 22SEP94 & 23SEP94 pt presented in sick call w/either fever &/or local or systemic rxn;sxs resolved p/several days;
Rash(possibly shingles) treated with acupuncture and cortisone, Fatigue and Brain fog(no current treatment) After 2nd shot had an event where she had nausea, vomiting, weakness, extreme fatigue(hard to stand and walk) dizziness. Lasted 3 days. (until 2/1)
Pain similar to carpal Tunnel in left hand 16 hours after vaccine.  No pain or symptoms prior to booster shot.  Ice and naproxen QID at start of symptoms.  Pain moderate to severe.   Today 12/22/21 woke  up with pain in both elbows, some swelling at elbow.  Pain moderate to severe.  Unable to lift heavy objects without stabbing pain (7-8 ).  Otherwise dull throbbing pain consistent with an inflammatory response.
severe rash, malaise started 12 days p/vax, worsened x 2 days then started to improve;
first dose of Shingrix and experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced shingles after vaccination. The reporter asked if patient could receive the 2nd dose. The reporter consented to follow up.
About 20 minutes after vaccination, patient complained of feeling really tired initially. About another 5-10 minutes later, patient complained that her "throat hurt" and subsequently complained of "tightness" in her throat. Pt was  given 15 ml of Liquid Benadryl (12.5mg/5ml) and subsequently given an IM injection of Epinephrine 0.3mg in office with reported improvement. EMS was called immediately for patient to be taken by ambulance to the Emergency Department for further observation and evaluation.
Headache, Myalgia, Fever, Chills, Fatigue Narrative: