chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days; Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Pharmacist called and stated patient received a dose for a vial that had been stored in refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication were provided. No treatment information was provided.
Immediate red rash from elbow to shoulder left side which lasted 1 week. Arthralgias have persisted since day of shot (8 hours after shot).
Nausea, vomiting, joint pain, overall flu symptoms but tested negative for flu, dizzy when standing, unable to drive, difficulty functioning because my elbows, wrists, hands and fingers hurt the most. Went to walk in clinic the day after the shot and my rheumatologist the next day.
pt exposure to varicella in NOV97 & 1JUN95 pt recv vax & 14NOV97 pt exp a chickenpox outbreak & was treated w/zovirax syrup;pt recovered;
Taken to the Hospital due to COVID-like symptoms (strong cough). At the Hospital she is diagnosed with COVID-19, problems with kidney and hemoglobin levels.  Dies at the Hospital due to COVID-19.
Extreme pain in arm (where shot given) painful rash entire length of arm, Fever and chills, Headache, achey all over. I rested and took Ibuprofen for 3 days. Feel fine now.
I gave the patient the vaccine. She bleed through 1 bandage, so I went to grab another. By the time I put another 1 on (30 seconds to 1 minute), there was a quarter-sized patch of red around the vaccine site. I grabbed a cool water bottle from our fridge and instructed the patient to hold it over the area. Over the next 10 minutes, the area went from pink to red and grew to about 2 inch in diameter with mild swelling under the skin. The patient reported tenderness, but no itching. After 10 minutes of the cool compress (water bottle), the area went back to a light pink/ skin tone and the area had shrunk to nickel-sized. The patient's husband came and followed her home. I instructed her to continue using an ice pack 20 minutes on/ off, especially if the redness came back. I called her this morning. She said that she had not had any further episodes, that the area was tender, but the swelling was gone. She said that she took a tylenol right before bed, and that she was feeling fine today.
Redness, slightly swollen and firm, warm, no fever, tender to touch, told by her MD's nurse to give Benadryl and bring to office if he doesn't get better.
This spontaneous report was received from a medical assistant and refers to an adult patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 10-JAN-2019, the patient was vaccinated with PROQUAD, intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. No known adverse effects were reported.
This non-serious initial spontaneous case, was received from other-non- health professional, concerns a patient of unspecified age and gender. This was a quality complaint report (number: 1025284). At the time of this report, it was not clear whether the dose was administered as the information currently reported was conflicting. On 16-Oct-2017, the patient was possibly administered with FLUAD (batch no. 179403, expiry date: Jun-2018, dose, route of administration and anatomical location: not reported). While administration, the fluid came out from the base of the hub of the needle (not where the needle was screwed in) which was explicitly coded as syringe leak. It was reported that, the leak was underside of the luer lock assembly. When the plunger was being pushed to administer the injection, the fluid came out and ran down the patient's arm. As per the reporter, the dose was not administered and there were no any signs of damage on the syringe. The reporter did not provide the seriousness assessment. Non-significant case correct received 18-Oct-2017 and 02-Dec-2017: number (1025284) was added. Amended narrative accordingly.
Still experiencing: (12/21 - 8 days post booster) - EXTREME fatigue - EXTREME body aches - Nausea - Chest pain - Runny nose
there were no Adverse reactions it's just that The Tdap was given to a 15mos old not recommended until age 7yrs and older it should have been Dtap given. The MA who gave the vaccine realized she had given the wrong vaccine and notified the Provider and the Provider looked into it and stated that it's not recommended but it will be ok and the child will just need it again at the time needed per the vaccine schedule. Mother was notified as well and I contacted program and got this info back : As long as the Tdap was given as dose # 4 or 5 of the DTaP series it can be counted as part of the DTaP series. The child still needs a dose of DTaP at age 4 years and yes, it will go into system correctly. Please let me know if you have any other questions.
Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a female patient (age unknown) who experienced large injection site reaction, while she received vaccine ADACEL. The patient's past medical history included was reaction to excipient allergy to a bovine component of ADACEL. The patient's past medical treatment(s), vaccination(s) and family history were not provided. In 1969, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a non-serious large injection site reaction (vaccination site reaction) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included no lab data.) Final diagnosis was large injection site reaction.It was not reported if the patient received a corrective treatment. The patient outcome was not reported for large injection site reaction. List of documents held by sender: none.
Bladder pain; Bladder spasm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLADDER PAIN (Bladder pain) and BLADDER SPASM (Bladder spasm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced BLADDER PAIN (Bladder pain) and BLADDER SPASM (Bladder spasm). At the time of the report, BLADDER PAIN (Bladder pain) and BLADDER SPASM (Bladder spasm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Blood urine: present (abnormal) present.         Treatment informations include Botox and Percocet.
2 hr p/vax pt became fussy & feverish; pt was seen 24hr later @ ER where a CXR showed pneumonia & a CBC was consistent w/infect; WBC 17.6;
After first shot patient had uterine bleeding felt like super heavy period about 3 to 7 days after Moderna vaccine; Felt like super heavy period about 3 to 7 days after Moderna vaccine/ The bleeding episode happened anywhere from three to seven days after the first dose; Intentional Dose omission; This spontaneous case was reported by a pharmacist and describes the occurrence of UTERINE HAEMORRHAGE (After first shot patient had uterine bleeding felt like super heavy period about 3 to 7 days after Moderna vaccine), HEAVY MENSTRUAL BLEEDING (Felt like super heavy period about 3 to 7 days after Moderna vaccine/ The bleeding episode happened anywhere from three to seven days after the first dose) and INTENTIONAL DOSE OMISSION (Intentional Dose omission) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     The patient's past medical history included Uterine abrasion (Patient has a history of uterine abrasions).    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UTERINE HAEMORRHAGE (After first shot patient had uterine bleeding felt like super heavy period about 3 to 7 days after Moderna vaccine), HEAVY MENSTRUAL BLEEDING (Felt like super heavy period about 3 to 7 days after Moderna vaccine/ The bleeding episode happened anywhere from three to seven days after the first dose) and INTENTIONAL DOSE OMISSION (Intentional Dose omission). At the time of the report, UTERINE HAEMORRHAGE (After first shot patient had uterine bleeding felt like super heavy period about 3 to 7 days after Moderna vaccine) and HEAVY MENSTRUAL BLEEDING (Felt like super heavy period about 3 to 7 days after Moderna vaccine/ The bleeding episode happened anywhere from three to seven days after the last dose) outcome was unknown and INTENTIONAL DOSE OMISSION (Intentional Dose omission) 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 concomitant and treatment information was provided.; 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.  Patient´s history of uterine abrasions is a confounder for the event.
Hearing loss in left ear. Not complete but high pitch sounds. Ear has been ringing since onset. Came on abruptly while sleeping at 5 am. There was pain initially. I am not sure if it is related as this did not occur until 1 week after I had the vaccine. However, I thought it was worth mentioning as the vaccine is so new.
extreme covid headache that comes and goes,  parosmia with the smell of cigarette smoke off and on all day and night and makes me nauseous
The spontaneous report was received from a licensed practical nurse concerning to 15-month-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided. On 24-NOV-2021, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707496, expiration date: 29-MAR-2022) (dose and vaccination site were not provided) as prophylaxis. 15 month old received a dose of ROTATEQ in error on 24-NOV-2021 (product use issue). Caller reported that patient previously completed series appropriately (extra dose administered). Caller did not provide detailed information regarding previously completed series. No further information provided. No additional adverse events reported (no adverse event).
L/thigh ecchymotic, hard, mobile nodule, non-tender. Tx: warm compresses & Ibuprofen.
The pt developed an injection site reaction characterized by a 6 x 3 inch area of redness and swelling. The pt recovered.
Patient was seen by an outpatient provider and was referred to the emergency department due to hypoxia and respiratory distress. He was found to have a COVID-19 infection. He was admitted to hospital for further management. On 4/28/21, his condition declined and resulted in intubation and transfer to ICU. He is intubated at time of writing.
Received Menveo immunization in Right deltoid in the Clinic.  Mother reports on 03/21/2015 her son after baseball practice C/O an swollen armpit, in "the hollow area was filled with fluid and bouncy." Saw PCP same day and placed on a 10 day course of antibiotics.  Denies fever, chills or diarrhea.  Recovered with side effects reported by mother.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "splenectomy" (unspecified if ongoing); "removed gall bladder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Thimerosal, reaction(s): "Allergies: Thimerosal". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 17Sep2023 to 21Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
16 days p/vax pt devel more than 50 skin lesions. addl info requested
Convulsions (seizures) approx. 1 day after shots.  6/26/09 Received hospital medical records for 6/18-6/19/2009 admit. FINAL DX:  seizure-like spells, right clavicular fracture Records reveal patient experienced 3 episodes of eye rolling, staring.  Transferred from outlying ER.  Seen by PCP due to parent noting right shoulder swelling & crying when touched.  En route to PCP office, had first episode of staring & eyes rolling back in his head lasting approx 1 min.  Had another episode of same in PCP office followed by hypotonia.  Neuro eval done & felt no tx needed.  Referred back to PCP. 6/26/09 Received ICD9 codes: 780.39 convulsion recurrent NOS; 810.02 closed fracture of shaft of clavicle ; and 729.5 pain in limb.
Anaphylaxis; Hives; A spontaneous report was received from a healthcare professional concerning a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis and hives.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021 at 4:50 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021 at 4:50 pm, after receiving the vaccine, the patient experienced anaphylaxis and hives. She was given epinephrine and 50 mg of diphenhydramine. Emergency Medical Services (EMS) and the fire department were called.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylaxis and hives, were unknown.; Reporter's Comments: This case concerns a 31 year old, female patient, who experienced serious unexpected event of Anaphylactic reaction, a non-serious unexpected event of urticaria. The event occurred 1 day (few min) after mRNA-1273 (Lot# Unknown). Treatment included EpiPen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Pulsative Tinnitus with embolization of right dural  AV fistula by angiogram performed by neurosurgeon. Still have tinnitus but slight improvement after embolization. Quality of life is greatly affected
Monday morning, February 17, 2020, I awoke with red itching rash over my upper body, face and lower body.  I thought I had been given shingles, no treatment. After seeing several doctors and receiving different diagnoses, I finally saw a dermatologist on April 17, 2020, who declared my condition caused by contact dermatitis.
A month after my second vaccine my period did not show up. I knew I could not be pregnant and this concerned me but I waited. this happened for four months in a row.  I saw my Gynecologist their who told me I was not the only woman who was reporting her menstrual cycle not coming and it should come back. It did come back. But I developed a lump in my right breast. I have had a mammogram and other testing done. I have stage two breast cancer. Breast cancer does not run in my family
One week following vaccine began complaining of Chest pain, loss of appetite, abdominal pain. Seen in an ED, sent home on pepcid. 3 weeks after his second dose came to another ED labs done- cardiac enzymes were normal. EKG and echo WNL. Lipase and LFTs mildly elevated. Coming weeks his symptoms progressed with addition of vomiting. Lipase and LFTs worsening. Elevation of ferritin (but less than 500), fibrinogen, CRP, ESR.  Also noted to have generalized lymphadenopathy (axillary L, supraclavicular, mesenteric, mediastinal, peri-pancreatic. Began spiking fevers one month following his second dose.  Received IVIg with no improvement. Continued to have fevers, abdominal pain, chest pain, vomiting and new lymphadenopathy (submental, post auricular, mandibular). LN biopsy of inguinal area showed paracortical hyperplasia with reactive sinus histiocytic hyperplasia. Flow cytometry negative. ID work up including - endemic mycoses, Quantiferon TB gold, PPD, toxo, brucella, bartonella, CMV, EBV, Parvo, mycoplasma unremarkable. Blood and urine culture negative.
Fever of 102F; Sleep was uncomfortable; Aches and pains which felt like muscle tension; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Sleep was uncomfortable), MYALGIA (Aches and pains which felt like muscle tension) and PYREXIA (Fever of 102F) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced POOR QUALITY SLEEP (Sleep was uncomfortable) and MYALGIA (Aches and pains which felt like muscle tension). On 11-Mar-2021, the patient experienced PYREXIA (Fever of 102F). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 at a dose of UNK dosage form. At the time of the report, POOR QUALITY SLEEP (Sleep was uncomfortable), MYALGIA (Aches and pains which felt like muscle tension) and PYREXIA (Fever of 102F) outcome was unknown.            No relevant concomitant medications were reported.  The patient reported that later that same evening of vaccination, his sleep was uncomfortable due to aches and pains. On the day of reporting the patient was feeling better.
VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned a 9 month old female. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.
Patient was given 3 vaccines on 9/27/18. He came in today with a raised red rash around FLUAD injection site. Still ongoing.
vaccinated on 1/25/21 & 2/15/21 and diagnosed with Covid on 8/8/21 U07.1 - COVID-19
pt recv vax & 10 mins later c/o having trouble breathing; devel SOB & was croupy; It was felt that pt was having anaphylactic rxn; tx Epi & DPH;
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics received. Additional information was received on 12-May-2009: product complaint investigation results.
Shakes; arm pain; lost 10 lbs; nauseous; 102.2 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs), NAUSEA (nauseous) and PYREXIA (102.2 F. fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (102.2 F. fever). On an unknown date, the patient experienced TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 18-Jan-2021, PYREXIA (102.2 F. fever) had resolved. At the time of the report, TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 102.2f (Inconclusive) 102.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient already received the second dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome and product information updated