chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed rash a inch and a half diameter; Also Itchy; Also Itchy and warm; Injection was given in the tricepes area half way between the shoulder and elbow; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who was administered Moderna's COVID-19 mRNA-1273 vaccine in the triceps area half way between the shoulder and elbow, later she developed a rash a inch and a half diameter, also itchy and warm .   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, patient received 1st dose of the Moderna vaccine mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  The patient was administered mRNA-1273 vaccine in right arm slightly lower than where she should receive it, she states it was given in the triceps area half way between the shoulder and elbow. On 31 Jan 2021, approximately 8 days after vaccine administration, patient developed a rash of an inch and a half diameter, which was also itchy and warm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The event,  "vaccine in the triceps area half way between the shoulder and elbow" was considered resolved on 23 Jan 2021. The outcome of the events vaccine site rash, itchiness, and warmth was considered as unknown.; Reporter's Comments: This case concerns 80-year-old, female patient  experienced non-serious events of  Vaccine administered at inappropriate site (Injection was given in the triceps area half way between the shoulder and elbow) for 1st dose of the Moderna vaccine mRNA-1273 (Lot number: 032L20A).Additionally, eight days later patient experienced  Vaccination site rash, Vaccination site pruritus and Vaccination site warmth. The events of Vaccine administered at inappropriate site and Vaccination site warmth are unexpected, Vaccination site rash is expected, and Vaccination site pruritus is expected for SmPC and Swiss SmPC. The company causality for reported event of Vaccine administered at inappropriate site is not applicable all other events were assessed as possibly related to Moderna vaccine mRNA-1273.
Loss of consciousness approximately ten minutes after GARDASIL, episode lasting less than 30 seconds.
Fever, body aches, chills, nausea for approximately 24 hours from time of symptom onset which was approximately 5 hours after vaccine.
LOSING WEIGHT; LEFT ARM STARTED HURTING DOWN TO ELBOW; COLD SENSATION; MUSCLE NUMBNESS; This spontaneous report received from a patient concerned a 63-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: pneumonia, and concurrent conditions included: copd, asthma, and smoker, and other pre-existing medical conditions included: The patient had no known allergies, did not had any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced losing weight, left arm started hurting down to elbow, cold sensation, and muscle numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sensation, and had not recovered from left arm started hurting down to elbow, muscle numbness, and losing weight. This report was non-serious.
chronic fatigue; Her WBC's  went up; RCB were up; iron was very low; her B12 was low; noted she could not get out of bed; had shingles in her mouth, nostrils and throat; sick; as high as 104; sore throat; couldn't lift her head from the pillow; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lyme disease (noted that was not an issue when she received the Shingrix). Previously administered products included Zostavax (in 2009).   On 14th January 2019, the patient received the 1st dose of Shingrix. On 15th January 2019, 1 days after receiving Shingrix and an unknown time after starting Zovirax, the patient experienced shingles, malaise, fever, sore throat, muscle weakness and bedridden. In January 2020, the patient experienced white blood cell count increased, red blood cell count increased, iron decreased and vitamin b12 decreased. On an unknown date, the patient experienced chronic fatigue. The patient was treated with acyclovir (Zovirax), prednisone and iron. On 1st February 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the malaise, sore throat, muscle weakness, white blood cell count increased, red blood cell count increased and bedridden were unknown and the outcome of the fever, chronic fatigue, iron decreased and vitamin b12 decreased were not recovered/not resolved.   It was unknown if the reporter considered the shingles, malaise, fever, sore throat, muscle weakness, chronic fatigue, white blood cell count increased, red blood cell count increased, iron decreased, vitamin b12 decreased and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the day after the vaccine, that morning, she arose and had shingles in her mouth, nostrils and throat. She noted she was sick, couldn't lift her head from the pillow, sore throat and fever that started the following day that started low but got to as high as 104. She noted she could not get out of bed. She was seen by her private physician on Monday and prescribed Zovirax. She states she got sicker. She saw her private doctor prednisone shot and dose pack were prescribed. She noted she still has low grade fever off and on a year later along with chronic fatigue. She also noted her bloodwork was out of whack. Her WBC went up, her RCB were up, her iron was very low, and her B12 was low. She was placed on shots for the low iron, which it did come up but then has gone back down low and she was back on shots. The caller noted she had a history of Lyme disease, but noted that was not an issue when she received the Shingrix.  The reporter consented to follow up.
Nausea and abdominal pain building over several hours leading to syncope. Patient was unconscious for at least 10 minutes. Nausea dissipated then built again for several more hours. Observation and lab tests at Emergency room. No treatment. Symptoms resolved.
Temp 101 degrees F for 2 days, localized redness and swelling at injection site, headache for 3 days. Treatment: alternated acetaminophen and ibuprofen.
patient arrived  on 11/4/2021 with c/o headache and intermittent double vision for five days. patient was admitted and treated for stroke for 2 days (11/4-11/6/2021) and discharged home with diagnosis of non-traumatic intracerebral hemorrhage.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Around 2 am on 5/9 I woke up with chills and body aches. About 2:30 I got diarrhea, and then about 6AM I was throwing up green bile. The vomiting lasted only about half an hour, but the diarrhea lasted 2 full days during that same time I was nauseous. I saw my PCP who put me on dexamethasone on 5/10. I had prior proscriptions for Zofran and Lomotil which helped with the symptoms. Symptoms tapered off to 5/13 and by 5/15 I felt fully recovered. I was also sore at the injection site for about 3 days.
Severe nausea  from the 2nd to 3rd day after receiving the vaccine. Nausea has continued into the second and third week after my Pfizer booster (3rd) vaccine. Also experienced severe dizziness along with the nausea, especially after waking in the morning and later at night before bedtime. Overall feeling of not feeling well, feeling sick with nausea being almost unbearable. I did not have this type of reaction with my first two Pfizer Covid Vaccines, however those two doses were administered by medical professionals where I work, which is a large hospital system.
At 8:30PM patient started experiencing bilateral hand numbness tingling and bilateral foot numbness and tingling. Patient advised that foot numbness only went away if she slept sitting up. Patient stated that the hand numbness/ tingling felt as if her hands have fallen asleep and that even her fingernails were painful. Patient had home health RN at her house and was hypotensive, oxygen saturation was ranging between 90-92.  Paramedics were called for patient and vitals stabilized, patient stable enough to stay at residence. Precautions and worsening symptoms were given to patient and instructed to seek immediate medical care over the weekend if needed.
Patient had localized redness, swelling and warmth to touch on the left thigh where the injection was given. Mother was instructed to do cool compresses and give Tylenol and to return to our office tomorrow for a follow up.
pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL1284, via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol (abnormal) and asthma. Concomitant medication included budesonide, simvastatin for cholesterol and benralizumab (FASENRA) for asthma. She has got a lot of other medications (at least 15 medications). The patient was hospitalized this week due to a pneumonia on 13Feb2021 (in between 1st dose and 2nd dose). The patient was in a hospital for 7 hours in and out. She was hospitalized in 13Feb2021. She missed the 2nd appointment today (16Feb2021) 11:30AM and they were informed that they need to call. The healthcare professional advised not to as she was on antibiotics (levofloxacin 750 mg) for pneumonia which was contracted after the first dose. She then wanted to reschedule her second dose. The patient underwent lab tests and procedures which included blood, x-rays, CAT scan and tested for virus, influenza. The tests were done in the hospital and she way okay.
Received DTaP (1), HIB (1), Prevnar (1), and Rotateq (1) on 6/26/07. On 7/23/07 seen in office with C/O vomiting with each feeding starting after administration of Rota vaccine. Occasionally projectile. Positive hematochezia. Began alimentum and Zantac and Abd U/S ordered. Adm for vomiting/dehydration 7/24/07; D/C 7/25/07. 9/11/07 Reviewed hospital medical records which reveal patient experienced vomiting, watery stools, excessive crying & arching in pain & poor weight gain x 1 month.  Episode of pallor, difficulty breathing & limpness after vomiting on day of admit.  Admitted 7/24-7/25/07.     FINAL DX: Rotavirus; GERD
Employee received both of her vaccines and has now tested positive for COVID-19.    Dates of vaccines 12/28/2020 and 1/20/2021
Around 830pm I started feeling aches all over the body.  By 10pm I was in chills By 1am I was sweating, freezing cold, terrible headache By 3am I was using 3 blankets to keep warm and somewhere between 3-5am my fever broke 9am the next day most issues are gone but slight headache remains
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old male patient who received Shingrix for prophylaxis. On 28th August 2018, the patient received the 1st dose of Shingrix. On 28th August 2018, 9 hrs after receiving Shingrix, the patient experienced general body pain, pain in arm, chills and sleeplessness. On an unknown date, the outcome of the general body pain and pain in arm were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the sleeplessness was unknown. It was unknown if the reporter considered the general body pain, pain in arm, chills and sleeplessness to be related to Shingrix. Additional details were provided as follows: At 11:00, the patient received the Shingrix the day before reporting on the right arm. On the same day evening, his whole right arm was hurting and also his whole body. The patient experienced difficulty laying on his side due to his arm and he could not sleep. The patient noted chills also but did not believe that he had a fever. The patient was unhappy because this representative could not to provide medical advice.
1 MINUTE AFTER RECEIVING HIS FLU SHOT AND HPV VACCINE HE APPEARED TO SEIZURE, HIS ARMS STARTING FLAILING AND HIS HANDS STARTED CLENCHING AND RELEASING. HE TURNED VERY PALE AND WENT UNCONSCIOUS. JUST BEFORE HE LOST CONSCIOUSNESS HIS EYES ROLLED IN HIS HEAD.
Swelling, redness, bruising, formation of lump, fever. Swelling and redness starting at deltoid, radiating toward elbow and behind arm - worst symptoms lasted approximately 48 hours, took about 7 days to resolved. Treated with TYLENOL.
In February of 2022 I was nursing my baby and I felt a lump. I thought it was a clot of milk, so I went to my primary who sent me for a mammogram and ultrasound. The mammogram was not done then but they took a biopsy based from the ultrasound. The results came back non cancer. In June, it got bigger and was getting more painful, however I was still nursing. So I went for another appointment and got the mammogram this time and another biopsy. I was diagnosed with cancer of the left breast. At this time I have had 15 rounds of chemotherapy so far and have one more round to go.
had welts on the site where he got the shot; rash; Today he has whelps on the other arm and arm pit.; This is a spontaneous report from a contactable consumer or other non hcp (Patient's wife). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 12Apr2021 11:00 (at the age of 62-year-old) at dose number un-known, single for covid-19 immunisation. Medical history included diabetes from 2011 and ongoing (Verbatim: Diabetes). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On 12Apr2021 the patient experienced had welts on the site where he got the shot, rash and on an unspecified date in Apr2021 Today he has whelps on the other arm and arm pit. Reporter mentioned that she and her husband received Pfizer COVID Shot yesterday at 11:00am. At about 3pm, her husband had welts on the site where he got the shot and a sort of rash. They noticed that it had spread underneath his arm as well. She mentioned that upon looking at the paper, it mentioned that once a rash develops on the whole body, only then should they see a doctor. She called this line because it was on the paper to call if there were any problems. She is asking for what to do because the rash is not in his entire body yet. Event: rash was reported as worsened. Event: whelps was reported as worsened. Additional Context: Reporter and her husband received the Covid-19 vaccine yesterday. She is speaking on behalf of her husband Vince. He had the vaccine at 11:00am. A couple hours later he started getting a rash and whelps on the left arm. It is a little like he was bitten by a mosquito. Today he has whelps on the other arm and arm pit. She read the pamphlet and it says if you rash all over to contact the doctor. Does he not do anything for it since it is a little bit and not all over or what he should do. Should he see the doctor. Adverse Event: rash, whelps. Time of Onset (24 hour clock): a couple hours later. Adverse events did not require a visit to emergency room, physician office. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 High.         The patient was running a fever of 102 after receiving my second dose. No concomitant medications were reported. No treatment medications were reported
Nurse injected an empty syringe (no vaccine) to pt's right arm. When she realized that she could not push the plunger as it is empty, the needle was already intramuscular. She withdrawn the empty syringe/needle from the right deltoid muscle and proceeded to reinject with a prefilled vaccine syringe in the left deltoid.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  It was reported that, the 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 7 of 27 adult patients described by the reporter.
Reported N/V and chills 5/20/13 resolved 5/21/13. Reported pruritis, raised red inj site 5/22/13.
- Pt has a severe egg allergy, which causes a full body rash - Pt developed severe allergic response to flu shot that was not immediately evident to providers since it was a skin allergyt.
RASH, PAIN IN ARMPIT, NAUSEA, PATIENT REPORTED FEVER/CHILLS, AND BODY ACHES. PATIENT HAD TEMP OF 99.0 AT ARRIVAL IN CLINIC.
This spontaneous prospective pregnancy report was received from a physician regarding a 20 year old female patient. Information on her concurrent condition was not reported. She had no pertinent medical history and drug allergies. On 12-JAN-2016, the patient was vaccinated with first dose of MMR II (lot and expiry date were not specified), and on 02-MAR-2016, second dose of MMR II (lot and expiry date were not specified) both 0.5 ml, subcutaneously (inappropriate schedule of drug administration). There was no concomitant medication reported. On un unknown date the patient became pregnant. The Last Menstrual Period and Estimated Due Date were not known. The pregnancy outcome was unknown at the time of reporting. On 31-MAR-2016 (today), the patient had performed a "home pregnancy urine test" that was positive for pregnancy (exposure during pregnancy). There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 21st August 2018, the patient experienced headache, tiredness and general body pain. On an unknown date, the outcome of the pain in arm, headache, tiredness and general body pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, tiredness and general body pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient experienced pain in the right arm following the injection. The patient stated that the day after he received SHINGRIX, he experienced tiredness, achiness all over and had a headache. The patient stated that these symptoms lasted for approximately 2 days. Emergency room visit was required. The contact details of the physician were provided. The reporter gave consent to follow up. For tolerance to next dose, refer case US2018GSK222617.
pt recvd vax & had n & v; wife found pt unresponsive & not breathing;