chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever/her mother is running a fever of 101; tiredness; cough; headache; muscle pain; chills; joint pain; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for different patients. This is the second of two reports.   A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the consumer that both her parents got the first dose of the covid 19 vaccine and afterwards they got fever (mother has a running fever of 101), tiredness, cough, headache, muscle pain, chills and joint pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021080983 same drug, similar events, different patient
Patient received both vaccinations (pneumonia and flu) in the left arm on 10/17/14. Patient came to pharmacy on 10/18/14 complaining of warmness and soreness in that arm; on the underside of the left arm. An area (7x7) was red.
When giving the vaccine some of vaccine  leaked out Per the vaccinator, 0/1ML leaked (leaked) out.            out of aRm after vaccination. Examined PT No advers reastion. no fillers, no mass, etc.
Upper Right arm still sore with movement to back. From 1st  vaccination. Don?t know if it will heal eventually or not. The second shot in the other arm has healed with no problems.
Fever, 100.3, bodyaches, chills, mild headache, extremely sore arm, joint pain.  Began 11 hours post vaccine, right nowFour hours and counting.
Vaccine administered 2 days outside of the 31 day window after thawing.  Patient was informed and advised to receive booster Pfizer covid dose again without a wait period or have vaccine already administered as her booster dose. Patient declined receiving dose again, dose received will be listed as her booster dose.
1. Fever of 99.9 for about 12 hrs. 2. Body aches for about 12 hrs. 3. Tingling in left hand and 2 fingers (ring and pinky) for 5 days. Has not fully gone away but slowing getting better. 4. Diarrhea for 3 days
severe muscle spasm; Chills everyday for one month; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe muscle spasm) and CHILLS (Chills everyday for one month) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02520A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .  Concomitant products included TOFACITINIB CITRATE (XELJANZ) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (severe muscle spasm) and CHILLS (Chills everyday for one month). At the time of the report, MUSCLE SPASMS (severe muscle spasm) and CHILLS (Chills everyday for one month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Resident of long term care facility. Tested positive for COVID-19 on 9/16/2021 with headache and muscle ache. Retested 9/25/2021 with hospital admission (PCR +) with reported edema and altered mental health status. Patient history of chronic liver disease and cancer. Died 9/25/2021.
Patient lost consciousness after GARDASIL vacc.  Applied cold compress to back of neck and placed her on reclined chair.  Regained consciousness in 20-30 seconds.  Continue to observe for 30 minutes - offered cold water and glucose tablets - called patient's mother and they left pharmacy.
This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 06-FEB-2019, the patient was vaccinated with a pediatric dose of VAQTA (dose, strength, batch/lot # and expiration date were unknown) intramuscularly for prophylaxis. The outcome of the event was unknown. No PQC presented.
Shortly after receiving the vaccine I had loose stools consistently for 3+ weeks.  On 9/11/21 I began throwing up and continued to be nauseous and vomit through 9/13.  At approximately midnight on the 13th I went to Hospital where I was admitted with severe dehydration and my liver enzymes were very elevated. I was kept there through 9/17.  I then returned to the ER on 9/18 with high blood pressure and a vicious headache.  I was treated with Zofran, IV fluids and released from the ER.
Patient is a 69 y.o. male with a history of untreated metastatic lung CA, recent admission 3/17/23-3/25/23 with low back pain found to have new met to the sacrum and discharged on pain control who presented to RMH 3/27/2023 with worsening cancer related pain. Recommended outpatient radiation once COVID-19 isolation completed. Discharged to home w/ HHC 3/31/23.    1. Cancer Related Pain: recent admission for same in setting of newly found mets in known metastatic diease. Presented with recurrent low-back and right calf pain. Continued home po morphine. Increased Gabapentin, continued Robaxin, continued Decadron, Ativan. Restarted sch Tylenol. VIR and RadOnc followed. Plan for OP radiation for further pain control. 2. COVID-19 Infection : s/p vaccination x3 (Pfizer). Denied with fever, general malaise. Symptom onset ~3/24/23, Positive test 3/27/2023. Intermittent LFNC requirements on admission. Discontinued remdesivir 3/29/23. Continued decadron as above. Stable on room air. 3. Acute Diarrhea: suspected secondary to bowel regimen/medication induced following recent prolonged episode of constipation. Stool PCR negative. Supportive care. 4. Metastatic NSCLC of RUL: (Dx 2019). Follows with Dr (Oncology). Recommended radiation at time of diagnosis, however declined treatment and later lost to follow-up. Recent admission as above, found to have new metastasis to sacrum, discharged with plans for outpatient follow-up with radiation oncology. Awaiting scheduling for outpatient full body scan. Oncology navigator followed.
Pain in arm and at injection site - red spot slightly larger than a quarter - tender to touch and warm
a little pain in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.   A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "a little pain in his arm".  Additional information: Reporter calling to report AE for herself and states her son received the Pfizer Covid vaccine and doesn't have symptoms, he just has a little pain in his arm, but only for one day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine Thursday afternoon, Friday noticed a little knot. Saturday morning had erythema and tenderness. Went to ER. Received prednisone x one dose and Rx for CLARITIN and antihistamine cream. Reaction resolved by Monday morning. Pt never filled either prescription but is doing well now.
MMRV on 3/26/18 2 seizures back to back on 4/3/18.
TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
Swelling and soreness in right armpit. Aches and pains in whole body.
Patient complained of fingers and feet turning purplish/black starting about 24 hrs after it was given and it took a few days for it to go away completely. She also felt some tingling sensations but said she has some neuropathy.
Nine days after receiving vaccination patient developed a new onset of numbness, tingling, and burning in his hands, feet and lower extremities for four days.  Patient had diminished patellar deep tendon reflexes on exam.  Patient also c/o right sided neck pain.  Further workup indicated with PCP or at Emergency Department.
Febrile Seizure. This is a clinical trial report, Phase 4, open, comparative, multicenter study of the immunogenicity and safety of this vax. This report refers to an 18-month-old male (with recent history of otitis media) who 2 days post vax, became febrile, began vomiting and had an episode in which his eyes rolled back and body stiffened for approximately 3 minutes. He was transported to the emergency department because of fever and vomiting, no note was made of the eyes rolling back and body stiffening. Upon presentation at the hospital, the child's behavior was described as age appropriate and his rectal temperature was recorded as 103.4. He was dx with a viral infection. The child recovered without sequelae. The investigator indicated that the episode of eyes 'rolling back' and body stiffening was a febrile seizure and was suspected to be related to study vax, although the intercurrent viral infection and otitis media were acknowledged as possible contributing factors. The event was considered serious because it was medically important. Follow-up information received on 03/01/2000 has clarified that the investigator considered the previously reported events of vomiting, viral infection, otitis media and 'winter vomiting disease' to be non-serious.
Of note, the patient is not in state registry. Date taken from nursing flowsheet in medical records. This date may not be an estimate.  9/22/21: Pt received covid vaccine 1 week ago, since then has been c/o weakness, fatigue, loss of appetite, fell today NOBT. BGL 523 pt hasn't been taking metformin bc he ran out. hypotensive in route given 1L NS. a&ox3, clear speech. pt lethargic. Per patient's significant other, he had not taken his Metformin for 4-5 days because he complains that his medications make him sick and sleepy. She also mentions that patient has generalized fatigue and weakness with decreased p.o. intake since he stopped taking his medications.  10/15/21: Discharge summary: This is the care of 62 year old male who has a medical history of DM2 and HTN  presenting with generalized fatigue.  Patient was lethargic during interview and was mostly responding with "I'm tired". Patient was found to have hyperglycemia, AKI and leukocytosis. Patient was admitted to ICU with DKA and DKA protocol was started. Patient was also found to have bilateral pneumonia and was started on Abx. His AKI developed to ESRD and he was started on HD with midodrine for hypotension. Upon admission and during the course of his stay he was found to have NSTEMI, pulmonary edema, acute on chronic systolic CHF, and LLL pulmonary embolism. His ARF resolved and he was started on Eliquis. Patient was also seen by vascular surgery for lower extremity DVT and near occlusion of left common iliac, internal iliac and external iliac arteries, 50% narrowing of right common iliac artery, no indication of surgical intervention at this time. Patient was discharged to facility after HD chair was secured. Patient will follow up with PCP, cardiology and vascular surgery as outpatient. He maximized his benefit from his inpatient stay.   10/20/21: Patient was recently hospitalized for several weeks last month and was discharged only 5 days ago.  He was initially hospitalized for diabetic ketoacidosis, however patient then developed rhabdomyolysis with acute renal failure and NSTEMI.  He had multiple arrhythmias during a hospitalization including AFib with RVR and bradycardia with sinus pauses.  He did receive cardiac catheterization with Dr. on September 24th which revealed diffuse coronary artery disease.  He had PTCA of the circumflex with incomplete revascularization.  Leadless pacemaker was placed on September 30.  Patient was discharged on oral amiodarone and anticoagulation with Eliquis.  10/21/21: Cardiomegaly noted on chest CT. Prior imaging notes normal heart size. Admitted 10/20 for cardiac arrest.  12/1/2021: Pt expired. Major medical illness: shock.
From initial information received on 11/10/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a 5 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1131AA, administered intra-muscularly in the right deltoid on 10/23/2003.  48 hours later, the patient developed Raynauds of both feet and hands.  The patient has a history of egg allergy which reportedly resolved.  At the time of this report ANA, metabolic panel and thyroid testing had been completed (no results provided) and the patient was continuing to undergo tests to determine etiology.  Reportedly, the patient did not recover from this event.
Started experiencing nausea and vomiting after cosuming meals of any kind in mid January 2022. Administration of ondansetron 4mg did not alleviate symptoms. HIDA scan performed in early February, result showed static abnormally low gallbladder ejection fraction, and physician advised cholecystectomy. Upon removal of gallbladder on Feb 28th, pathology showed evidence of chronic inflammation. Symptoms resolved after removal. After the surgery, episodes of hypersomnia began to occur starting around the 2nd week post-surgery. The episodes began reccuring starting approximately one month later, with around 4-5 weeks in between episodes, each lasting 3-4 days. The episodes consisted of hypersomnia lasting for 18+ hours each day, anoerxia, along with severe apathy and fatigue. After episode resolution, no symptoms were experienced between episodes.
patient felt chilled through out body immediately after receiving vaccine with full body shaking showed signs of low blood sugar but said he did eat lunch he was unsure of what medications or insulins doses that he had taken today. gave sugar and water and no improvement  symptoms progressed oover 10 minutes patient developed ragged breathing 911 was called and epi pen administered.  was taken to hospital by ems.
Pt "recently" recvd Engerix-B & exp a fever up to 102F, myalgias, nausea, & vomiting; Events abated p/1wk;
Muscle aches and fever, beginning 10/22/2023 and ending 10/26/2023
no adverse response.  was given the primary dose vaccine by pharmacist by accident when was supposed to get the bivalent booster
pt recvd vax;devel redness,swelling,tenderness at inject site;lasted 2 days;
Tinnitus; felt exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus"; FATIGUE (non-serious), outcome "unknown", described as "felt exhausted". Therapeutic measures were taken as a result of tinnitus.  Additional information- It was reported that Physician gave him steroids for the management of the Tinnitus and it did not worked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021575706 Same reporter/drug/event for different patients
Patient reported being at a Church meeting Saturday morning when she suddenly felt dizzy, her neck muscles tensed up and she couldn't turn her head. She felt nauseous and like she was going to pass out. This feeling lasted for 15-20 minutes before finally going away.
headache; achy; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, achy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) headache. achy.  Treatment details included tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, achy was unknown.
Pain and red patch 4-5 inches in diameter over shoulder injected with PNEUMOVAX (R). Patient aches all over and is sleeping more than usual. Patient states she is tired.
felt depressed; started crying and everything; it was really bad; weak; feels a little tired; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (felt depressed), CRYING (started crying and everything), FEELING ABNORMAL (it was really bad), ASTHENIA (weak) and FATIGUE (feels a little tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression, Crying, Tiredness and Weakness.    On 07-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (felt depressed), CRYING (started crying and everything), FEELING ABNORMAL (it was really bad), ASTHENIA (weak) and FATIGUE (feels a little tired). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, DEPRESSION (felt depressed), CRYING (started crying and everything), FEELING ABNORMAL (it was really bad), ASTHENIA (weak) and FATIGUE (feels a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
24  hours after injection was given, his left arm, where TDaP injection was given, is painful to move and swelling around injection site with pain worsening. No signs and symptoms were present the day of injection.
Rota given at 32 weeks and 10 days (too late for 3rd dose to be given).
Patient seen 8/11/17 for MMR vaccination. At that time reported one week ago had dysuria that resolved, one day only. Had fever around that time (brother had fever same day, also only lasted one day). She does occasionally have day and night time urinary accidents, never fully dry. Therefore, urine obtained, but patient unable to give sample. MMR was administered. Patient subsequently was able to bring urine back and showed >100,000 E.coli, started on KEFLEX. Today, comes back to discuss possible seizures since the MMR vaccine. Mother states patient has had a total of 4 episodes starting August 12, the day after her MMR, over a four-day timeframe. Episodes consisted of a sudden stop of conversation, often midsentence, where she seemed nonresponsive with eyes blinking. The eyes did not roll back or have any nystagmus. Episodes lasted about 20 seconds each time. After which she could not remember the sentence that she had started. For the time period immediately following the events she seemed mildly confused and to have word finding difficulty. There was no abnormal movements associated with the events other than the eye blinking, she did not drop with any of the events, no muscle tightness or weakness that they appreciated. She is otherwise been her normal self. Her activity level is normal. She did not have fever at any of the episodes, or otherwise since receiving the MMR. She has had no abdominal pain, nausea, vomiting, diarrhea. She has had no rashes. She has had no joint pains, swelling, redness. She is sleeping normally. Her behavior and mood have been the same as normal. She has had no episodes for the last 2 days.
she didn't get her second dose one month after her 1st dose because her husband; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband) in a female patient of an unknown age 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information were not provided. No Concomitant drugs were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: The Followup received in which dosage information is mentioned.(The patient chose to receive her second vaccine even though it was past the recommended time frame).Changed the patient gender male to female as per follow up document.
Information has been received from a registered nurse concerning an 18 year old female with no allergies and with a urinary tract infection who on 12-JUN-2007 was vaccinated intramuscularly with the third 0.5 mL dose of Gardasil, (Lot number known by the reporter). Concomitant therapy included "birth control" "antibiotic" (unspecified) and sulfamethoxazole/trimethoprim (BACTRIM). On 14-JUN-2007, approximately 36 hours after vaccination, the patient developed severe neck pain and spasms on the same side (unspecified) of her injection. The patient was seen and her neck was described as "crooked" and "off center". The back of the patient's neck was palpitated up to the skull and the patient expressed severe pain. Also, the site of injection was warm to the touch with signs of inflammation. The patient lost a day of work. The patient sought unspecified medical attention. It was reported that ice was used along with ibuprofen (MOTRIN) for the symptoms. On the morning of 15-JUN-2007, the patient felt a little better but her neck was still "crooked". The patient had an appointment with an orthopedist. No further information was available. At the time of the report, the patient had not recovered. The reporter considered the patient's neck pain, spasms, neck described as "crooked" and "off center" and injection was warm to the touch with signs of inflammation to be disabling. Additional information has been requested.
intern inadvertently gave the J&J vaccine. J& J COVID vaccine is not approved for a 13 year old
01/05/22: LOSS OF TASTE/SMELL, COUGH, HA, NAUSEA, DIARRHEA, FEVER
Pt had Hep B #1 and approx 1 week later developed a red raised rash mainly on extremities and joints (itchy). Pt received Hep B #2 11/15/11 developed same rash about 2-3 days later. Denied SOB. Treated with topical steroid cream.