chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain; body pain; tinging sensation at her finders, toe, leg; tinging sensation at her finders, toe, leg; stomach cramp; nausea ; still feels nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg) and ABDOMINAL PAIN UPPER (stomach cramp) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Lupus enteritis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg), ABDOMINAL PAIN UPPER (stomach cramp) and NAUSEA (nausea ; still feels nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg), ABDOMINAL PAIN UPPER (stomach cramp) and NAUSEA (nausea ; still feels nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the known safety profile of mRNA-1273.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the (Oka/Merck) VARIVAX (lot# and expiration date not provided) (dose not reported). On an unknown date the patient received dose of (Oka/Merck) VARIVAX that was exposed to temperature above the recommended temperature range. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423). Additional information has been requested.
Very large induration, on leg that Prevnar was given 3" x $' in size. Bright red and hot to touch, fever of 102 for 1 week and rash resembling chicken pox (but without the pustule) lethargic and arthralgic type pain.
Started that the pain started right after shot.  Also stated that she had dizziness, headache after shot for a little while.  Complained of edema 2-3 inches below injection site and pain, pressure put on area.  No redness or fever.  Continues to have these symptoms 1 month after injection. 12-2-03 patient stated arm much better almost back to normal.
Day of vaccination arm tingling and both hands went numb for 2 days, 4 days later woke up with a headache that lasted for 3 weeks. By Apr 5th all joints started to stiffen and swell up. Got so bad knee on left side was 4 times its regular size but all joints were swollen and stiff in the whole body. Started taking benadryl nightly. Saw PCP on May 17th and started pregnisone, lost 6lbs of water off my joints after 6 days of pregnisone. Saw Dr. (rheumatologist) May 25th. Still stiff and swollen joints but 50% better after benadryl and steroids. Took benadryl for 3 months daily. All the blood test came back negative for rheumatoid, lupus, gout, genetic disorder. But liver, kidney and white blood cells counts are off since the vaccination. Couldn't walk for two months from all the pain in the joints. Still stiff and swollen and headaches 5 days out of 7 in a week.
redness at injection site; itchiness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site).                Reporter did not allow further contact
Patient became mildly short of breath with some chest tightness and light headedness approximately 23 minutes after receipt of the vaccine.  She notified the nursing counter who notified me.  Patient was A&Ox3 upon my arrival and able to speak in full sentences.  Heart rate was noted to be 105 bpm.  50mg oral Benadryl was administered and patient was monitored for 25 minutes.  Heart rate improved as did patient's work of breathing, chest tightness, and her dizziness subsided completely.  Her final heart rate at time of discharge was 93 bpm and patient was able to ambulate under own power to depart the site.  She was escorted to her husband's vehicle and he received instructions to take her to the hospital to fill her epi-pen prescription which was placed at the time of the incident as well as reasons to use the epi-pen and report to ED if needed.
04/23/22 presents to ED for "SOB" "Fever". PMHx of "prostate cancer and lymphoma (Current in remission)"
Fainted in the waiting room as he was preparing to leave the office immediately after the doses were administered.; This spontaneous report was received from a physician via company representative, referring to a 11-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions was unknown. On 20-NOV-2019, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, lot#, expiry date and route of administration was not provided) in the left arm for prophylaxis. On the same day, the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) and unspecified meningitis vaccine, both in the right arm (strengths, doses, schedules, lot#, expiry dates, routes of administration and indications was not reported). On the same day, the patient fainted (syncope) in the waiting room as he was preparing to leave the office immediately after the doses were administered. The patient sought medical attention in the office. It was unknown if the patient underwent any lab diagnostics/studies or received any treatment for the event. There was no associated product quality complaint. Outcome of the event was reported as unknown. Causality assessment between the suspect therapies and the event was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
No additional AEs were reported; The medical assistant is reporting that a patient received an improperly stored vaccine today; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not reported.  On 14-APR-2022, the patient was vaccinated with 1 dose of improperly stored vaccine (temperature: 66 Fahrenheit degrees, time frame: 15 hours and 10 minutes) (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number: 1837116 was found to be valid, expiration date: 24-MAR-2023, route of administration defaulted to oral, for prophylaxis. No additional adverse events were reported. It was reported, that there were no previous temperature excursions. It was unknown if the temperature excursion occurred as a result of a reading from Data Logger. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005479:
pt recvd vax t100, h/a, nausea, gas, loose stool, h/a severe, difficult to focus; seen @ ER poss meningitis w/ c/o stiff neck; feels unwell;
Pt recv vax on 10/15/98;on 10/16/98 pt exp fever (101.4) &Rt arm red, swollen &warm; tx=Tylenol &ice.
Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.
Seizure like shaking and jerking in my sleep since week after COVID vaccine, symptoms: shaking and jerking and difficulty breathing and can?t wake up
No additional adverse events; a patient was administered an improperly stored PROQUAD that was reconstituted with a properly stored DILUENT; This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. The patient's concomitant therapies included sterile diluent.  On 21-FEB-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), lot # S022913, expiration date 19-JAN-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events. The administered vaccine experienced a temperature from 15 degrees Fahrenheit to 46 degrees Fahrenheit (36.86 F) for 9 hours and 49 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit (19.13 F) for 1 hour and 30 minutes. No data logger was involved.
Violent convulsions the night I got the shot for 3 hours. Could not stop shaking couldn?t open fingers. The Wednesday after 10/6 woke up at 6:30 am with both legs numb knees down. During the day the numbness moved up my left thigh. Today, 10/10 my legs are still numb and can?t feel them.
Moderna COVID?19 Vaccine EUA On 3/17/2021, my injection site began to itch. When I woke up on 3/18/2021, it was itching more and there is a red oblong rash around the injection site and a slight burning/numb sensation.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:17 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.61 for dose administered on 02-Mar-2021 and 70.68 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range of 33 to 35 degrees Fahrenheit from 12:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 am. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
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 39-year-old male patient received bnt162b2 (BNT162B2 NOS), on 06Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative, notes: two days after testing negative via antigen test; (Oct2023) Positive, notes: tested positive for covid via antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Oct2023 to 07Oct2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330419 same patient, different drug/AE;
pt recvd vax & pt devel fever, upper resp, OM & restlessness; no further details were provided;
A patient came in to receive a Hepatitis A vaccine, among others. In the process of drawing up the vaccines, a PEDVAXHib was pulled from the fridge instead of the Hepatitis A and was administered to the Pt. In result, the Pt. now has an extra dose of PEDVAXHib on his vaccine record and is still in need of a Hepatitis A vaccine. Age of patient at time of event:  4 years 8 days.
Odd taste, elevated blood pressure, loud pulse, sharp pain in ribs, slight nausea. I then doubled my doasge of Lisinopril to bring the blood pressure back down a little. I haven't had a chance to see my doctor over the weekend but will try to see him tomorrow as this is not normal.
about 30 min after vaccination, pt reports numbness in mouth that lasted about 1 minute then resolved. After that, he had nausea, which resolved quickly as well.
Swollen Upper Left Arm.  Red discoloration.  Per patient area feels Hot.  Painful to the touch.  Bruise on lower region of swollen area, but not at injection site.  Started evening after the shot.  Headache the next day.  Told patient no normal reaction, contact primary care physician or urgent care.  Per patient will send photo to primary care.
Patient noticed a blister on her right arm after removing the Band-Aid, and also had some stiffness in her right arm and neck. She took some ADVIL and just figured blister was from adhesive Band-Aid and stiffness was normal reaction. Woke up Sunday and was having difficulty raising her right arm. She took more ADVIL. She reported to work Monday and was having difficulty sitting at her microscope due to right arm stiffness and weakness. Next day, she went to Urgent Care and while waiting to be seen, developed difficulty swallowing, shortness of breath and chest pain. Urgent Care Center referred her to Emergency Room. She was seen in the ER and was released later that day.
Pt. presented 22 days after receiving the Varivax vaccine with a mild case of Varicella.  Supportive treatment prescribed.
Only got liquid part of vaccine; Only got liquid part of vaccine; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th May 2022, the patient received Menveo. On 25th May 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-JUN-2022 Reporter's comment: It was reported that patient may only got liquid part of vaccine. The reporter noted 1 powder vial left over in box. On 15th June 2022, the patient came back to office and received a full dose of Menveo. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the liquid vial of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.This case was linked with case US2022088510, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088510:Same reporter US-GLAXOSMITHKLINE-US2022AMR095683:Same reporter
Patient developed shingles rash 02/22/21.  Treated with  VALACYCLOVIR 1 g tablet oral 1 tab(s) orally  TID x 7 days 3/9/21 and topical domeboro.
Client had been sitting almost 15 minutes when she alerted EMT she was feeling dizzy at 2005. EMT provided client with water and goldfish snack. Client drank and ate. PHN arrived at 2012, client sitting upright in chair, alert and oriented x4. Client stated she was on her phone and when she looked up she "felt dizzy for a few seconds". Vitals at 2012 by EMT: blood pressure 116/76, pulse 83, oxygen 98%. Client denied blurry vision, headache, nausea, chest pain or shortness of breath. Per client no pertinent medical history, no current medications and no known allergies. Per client ate prior to getting vaccine. PHN advised client to complete 30 minute observation, per client would try to stay as long as she could. PHN advised client to follow up with provider and gave ER precautions. EMT stayed with client remaining of observation. At 2019 client stated dizziness had resolved. Vitals at 2019 by EMT: blood pressure 110/66, pulse 83, oxygen sat 98%. Per client "feeling fine". EMT had client stand and take a few steps, per client no dizziness. Client accompanied by Mother who would drive client home. Client left facility at 2025 with steady gait.
Patient had Td vaccine 9/29/06-she notes warmth, swelling at the site for a few days. Resolved. Has had persistent discomfort in left upper arm. No nausea or weakness. Not taking meds for discomfort. She made physician appointment 11/9/06 for xray. No obvious abnormality on xray.
rash to face, ears, trunk & pubic area inc temp, as noticed per mom on the morning of 10MAR95; MD dx rash as having reacted w/mild case of the measles d/t MMR vax;
Itching; did not sleep; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and INSOMNIA (did not sleep) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia. Concomitant products included METOPROLOL, GLIPIZIDE, CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, SIMVASTATIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRURITUS (Itching) and INSOMNIA (did not sleep). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and INSOMNIA (did not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported included giordian and one other that he is unsure.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.