chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 4 year old female with no allergies and no past medical history who on 1/24/02 was vaccinated SC, in the left arm with a 0.5ml dose of MMRII. There was no concomitant medication. On 1/28/02, the pt developed hives on her face (predominantly on 1 side). The pt presented to the office on 1/29/02 and the rash had affected the whole face and the pt's voice became hoarse. The rash was described a s pruritic, red, blotchy and slightly raised and began to spread to the chest. The pt was administered Benadryl as needed. On 1/30/02, the rash had spread to her arms per the pt's mother. The rash on her arms was described as a white pimple-like rash. Additional info has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 30-JUN-2008 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose, route not reported), on 04-JAN-2012 the patient was vaccinated with the second dose of GARDASIL (Lot # not reported) (dose, route not reported) and on 20-May-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # not reported) (dose, route not reported). No adverse effect reported. Additional information has been requested.
Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 minutes then was ok After 1 hour I had I think like brain fog and hard time to navigate my phone.  Seem just like confused or light headed kind of during day. Misplaced phones or things next day   Next day at night just felt around 11pm getting ready for bed my head was ok and I could think ok again
Pt received 1st dose of Moderna on 03/23/2021. 2nd dose was administered 04/28/2021. Pt is not within the expected age for Moderna. Caught the vaccine error on 04/28/2021.
Fever, headache, body aches, stomach ache, vomiting, sore throat.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 71-year-old male patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 29th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, gastrointestinal disorder and headache. On an unknown date, the outcome of the fatigue, gastrointestinal disorder and headache were unknown. The reporter considered the fatigue, gastrointestinal disorder and headache to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced fatigue, headache and gastrointestinal problems. The heath care professional was unsure when the symptoms began, if the patient required an emergency room or doctor visit, hospitalization, intervention, or if the symptoms were disabling. No further information was available.
LIP SWOLLEN; LIP BLISTERED; LIP SORENESS AND  SENSITIVITY; LIP DISCOLORATION; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling of full face, and swelling of neck, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced lip swollen. On 30-MAR-2021, the subject experienced lip blistered. On 30-MAR-2021, the subject experienced lip soreness and sensitivity. On 30-MAR-2021, the subject experienced lip discoloration. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lip swollen, lip blistered, lip soreness and sensitivity, and lip discoloration. This report was non-serious.
Pt was vaccinated  with the above and then about 3 minutes afterwards stood up and was going through her goodie bag and lost consciousness and was lowered to the floor. Pt then loss control of bladder about 30 seconds later. Several nurses rushed in to assess patient and take vitals. Pt was noted to have pale skin and blueish lips. She was hypotensive and bradycardic. Pt was unconscious for about 1.5-2 mins and then opened her eyes and the color started coming back to her skin. Patient was kept on the floor until her HR and BP rebounded. She was given juice box and snack and then she sat up and then stood up. Her vitals were assess for 10+ minutes after the episode. We called pediatrician and mom was suggested to take the pt to the Urgent Care.
FATIGUE, MYALGIAS, FEVER Narrative:  "FLU-LIKE SYMPTOMS" LISTED IN ADDITION  TO ABOVE SPECIFIC SYMPTOMS; SYMPTOMS LASTED X 1 DAY
Supraclavicular lymphadenopathy following COVID-19 vaccination. Left supraclavicular lymph node is swollen and tender to the touch.
On 04/20/2021 I had a miscarriage I was 6 weeks pregnant. My due date was around Christmas.
Information has been received from a Registered Nurse referring to a 13 month old (reported as 15 month old) male patient. On 13-APR-2016 at 11:51, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB (third dose, lot # K0099553, dose was unknown). No adverse effect was reported. This is one of several reports received form the same reporter. Additional information is not expected as all correspondence was received.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 75-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.
I received the vaccine dose at 34 weeks of pregnancy (due date 4/27/21), no preceding pregnancy complications. I had decreased fetal movement at 36 weeks and the baby was born 3/30/31 by emergency C-section, found to be severely anemic due to spontaneous massive fetomaternal hemorrhage. She received a blood transfusion and supportive care in the NICU for 8 days and was discharged in stable condition.
Lump on left thigh red (marble size) grade, high grade fever 2nd day post vaccine.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medications were not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K020181, expiration date 24-JUN-2016, exact dose was not reported) route of administration defaulted to oral. No adverse effects reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 12MAY95 & MAY95 pt exp swelling in both feet & both hands;19MAY95 pt exp swollen lymph nodes in neck & rt occipital area;23MAY95 pt exp joint pain;pruritus, red macular rash on 3cdm spherical, moveable, non tender lt ax lymph
Case number PHEH2015US006775 is an initial combined spontaneous report received from a pharmacist on 07 Apr 2015 with a follow up information received from the pharmacist on the same date. This report refers to a 34 years old male patient. His medical history and concomitant medications were not reported. The pharmacist reported that the nurse administered the patient with 1 ml FLUVIRIN (batch number: 1413801) intramuscularly on 07 Apr 2015 instead of 0.5 ml of FLUVIRIN. No adverse events were reported following the maladministration.
Staff reported individual face and nose were swollen.  Assessed by nurse swollen lips, nose, ears, and hard of hearing to voice.  Respiratory rate is even and regular non-labored.  Low grade fever 100.04 F (37.8 C)noted.  Referred to medical clinic.  In no distress assessment noted mild reaction to influenza immunization, use acetaminophen PO if needed for pain or fever. Progress note makes no comment on swelling unclear if still present at time of assessment.  APAP 650 mg administered 11/15/19 11:24AM, 11/16/19 8:15AM, 11/17/19 915PM.  Resolved.
Today 08/27/21 the patient  came in to get her second dose of the Pfizer covid-19 vaccine. The vaccine was administered by pharmacy technician. About 5 minutes after the administration the patient was about to faint and was caught by her mom and was stabilized. Then she started vomiting. 911 was called and her vitals  was checked and everything was normal.  The patient and mom left the pharmacy around 11:18am. Pharmacist called the mom around 4:30pm to check on patient and the mom stated that she is doing okay.
9 or 10 out of 30 pts did not respond to a 3 doses series of Engerix-B;
Hives all over body. Treating with Benadryl but the hives have not gone away yet.
Around the middle of June or the beginning of July, I started having problems with my eyes. At first, it was like pink eye in one eye, and then it was both eyes. I went to the ER. I was told that it should clear up on its own. They said it looked like pink eye and they were going to treat it like pink eye. I was prescribed a gel medication but it didn't do any good. About two weeks later, I was traveling and I couldn't even drive anymore, I had to pull over. I decided to go to the ER and I was basically told to just deal with it. It feels like someone is poking my eye with a needle. I have never had pink eye or any other infections or problems with my eyes during my whole life.
Per pt; she felt pain shooting down her arm and upper back shoulder. After 2 wks, she noticed about 25% loss of range of motion of her arm and she still noticed a knot on the injection site.
vaccine, not reconstituted properly; injected only one of the vials; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th April 2021).   On 23rd August 2021, the patient received the 2nd dose of Shingrix. On 23rd August 2021, unknown after receiving Shingrix, 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 details were provided as follows: It was reported that the patient had received his 2nd dose of Shingrix  When the pharmacist gave the patient the vaccine he/she did not reconstituted properly, thus, he/she injected only one of the vials (patient could not specify if the lyophilized or the adjuvant), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. On that same day, the patient got the properly reconstituted 2nd dose of Shingrix. The patient nor the Doctor had any information regarding the vaccines, such as lot numbers and expiration dates. No further details were provided at the time of the reporting.  The reporter consented to follow up.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of PEDVAXHIB (lot# and expired date unspecified) and other vaccines were administered to unspecified patients (dose, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/temperature excursions on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
sleeping 3 hours a day; rash mostly all over back,neck to waist, upper arm,side of legs; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleeping 3 hours a day) and RASH (rash mostly all over back,neck to waist, upper arm,side of legs) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dermatitis since 23-Jul-2021. Concomitant products included LOSARTAN, LEVOTHYROXINE and ROSUVASTATIN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INSOMNIA (sleeping 3 hours a day) and RASH (rash mostly all over back,neck to waist, upper arm,side of legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at a dose of 1 dosage form and CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) for Itching, at a dose of 1 dosage form. At the time of the report, INSOMNIA (sleeping 3 hours a day) outcome was unknown and RASH (rash mostly all over back,neck to waist, upper arm,side of legs) had not resolved.            The patient went to urgent care on 23 Jul 2021 finally diagnose the rash as "dermatitis unspecified and also said that to take 14 pills a day.  The patient also took ulcerative colitis medication and Hydrochloride.  The patient had an appointment with dermatologist on 17 Aug 2021.
got the flu every time patient took a shot; Initial information received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient who had got the flu every time the patient took a shot (influenza) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu every time the patient took a shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My stupid dad got the flu every time the patient took a shot. No the patient was not a lib sheep, but just listened to them I guess. the patient would get the flu every time for listening to them. Maybe it was not as intense with a shot first, but I rarely had the flu in 70 years without a shot."  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event got the flu every time the patient took a shot.  There will be no information available on the batch number for this case.
"little sore arm"; "slight headache"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ("little sore arm") and HEADACHE ("slight headache") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-May-2021, the patient experienced MYALGIA ("little sore arm") and HEADACHE ("slight headache"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-May-2021, MYALGIA ("little sore arm") and HEADACHE ("slight headache") had resolved.            No concomitant medication was provided.
Day of vaccine: Arm pain and heat near injection area. , Next day: Lymph node in under arm of right arm became swollen.  Both arms have on/ off tingling from shoulder to fingers. Burning feeling across back from shoulder to shoulder.  Day 3: body muscle and joint aches and discomfort down entire length of right side.    Day 16: Lymph node under armpit is still size of thumb and has not gone down, area of lymph node has constant pain. pressure/ discomfort moving to right breast .   I also missed my minstrel cycle this month.
Sore arm for one day. Rash started with pain left upper torso on day 7, diagnosed as shingles.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Dizziness, fever 102.7, rash on arm of injection, nausea
Left upper arm became swollen and red at injection site. Patient c/o "flushed"feeling and warmth in face last night and a skin felt like it was "crawling". Patient given Benadryl and an antibiotic ointment to apply topically to affected area.
Active Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Active Colitis) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and MESALAMINE for an unknown indication.    Concurrent medical conditions included Crohn's disease.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and MESALAMINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced COLITIS (Active Colitis). At the time of the report, COLITIS (Active Colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, Colonoscopy: active colitis Active colitis.         No concomitant medication was reported. No treatment medication was reported.
got hot from top of her head to the bottom of her feet and her heart rate with to 150 all happen within seconds of taken the vaccine
This spontaneous report as received from a licensed practical nurse via field representative refers to a 65 year old male patient. Patient's current conditions included prostate cancer, heart disease and hypertension. Drug reactions/allergies were none. On 30-OCT-2014, 0.5 ml, intramuscular in the right arm) (physician recommended). Concomitant medications were none. On 01-NOV-2013, the patient was seen in the office because his right arm and was red, swollen (unspecified location on right arm) and he had developed a fever. The patient was prescribed KEFLEX (manufacturer unknown) as treatment at that time. No lab diagnostic studies were performed. The outcome of the events was reported as recovered/resolved on an unknown date. No product quality complaint was involved. Additional information has been requested.
Anthrax Given on 6/20/07 Lt upper arm and SM noted pain under his arm, about 2-3 inches away from armpit, still c/o pain.
approximately two weeks later, experienced painful, swollen joints and bruising at the injection site; approximately two weeks later, experienced painful, swollen joints and bruising at the injection site; approximately two weeks later, experienced painful, swollen joints and bruising at the injection site; Nurse practitioner reported the mumps and rubella titers showed immunity, where the measles titer did not show immunity; This spontaneous report was received from a nurse practitioner (also reported as Nurse Prescriber), referring to a 26-year-old female patient. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were unknown by the reporter.  On an unknown date, the patient received her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, and anatomical location were not reported; and route of administration, lot number and expiration date were unknown by the reporter) as immunization for graduate school (prophylaxis). On an unknown date (also reported as approximately two weeks later), the patient experienced painful, swollen joints and bruising at the injection site (injection site joint pain, injection site joint swelling and injection site bruising). On an unknown date, the patient saw an unspecified physician, who advised her that she could receive the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On an unspecified date, the reporter stated that the patient had titers drawn for measles, mumps and rubella, and reported the mumps and rubella showed immunity, while the measles titer, less than 13.5 (units not provided) did not show immunity (measles antibody negative).  It was unknown by the reporter if any treatment was given for the adverse events.  The reporter considered the events as no life threatening.  The outcome of injection site joint pain, injection site joint swelling, injection site bruising and measles antibody negative was unknown by the reporter. The causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the events was not provided.
1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache.  1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol  and chills.  1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough.  1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.