chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fever 102.2 F; chills; joint pain; muscle pain; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable physician, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiac dysrhythmia (extra systoles), seasonal allergies, and known allergies to birch pollen trees and nut-bearing trees. The patient did not receive any medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021, after receiving the second dose of the vaccine, the patient experienced headache, fever of 102.2 Degrees Fahrenheit, chills, joint pain, muscle pain, fatigue, and swollen lymph nodes. On 14May2021 body temperature was checked and it was 102.2 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with acetaminophen 325 mg (MANUFACTURER UNKNOWN) and diphenhydramine HCl 25 mg (MANUFACTURER UNKNOWN). The clinical outcome of the events headache, fever of 102.2 Degrees Fahrenheit, chills, joint pain, muscle pain, fatigue, and swollen lymph nodes were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 20-MAR-2017 at 15:43, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000473: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453.
48 hours post administration patient complaining of arm stiffness. Soreness, difficult to move, injection site redness, swollen, and warm to the touch. Rph suggested she continue cold/ice compresses, acetaminophen (since today is friday) and to contact the md prior to the weekend.
Approximately 4.5 days after receiving 2nd dose, developed shortness of breath, cough, high fever, and coughing up blood. Coughing up blood, cough and shortness of breath persisted for 4 days. No previous history of coughing up blood. Was advised to visit ER, ran CT scan, EKG and blood test, and tests came back normal. Had follow up visits with Cardiologist and Pulmonologist, performed breathing and stress tests, and results were normal. No doctor could explain what had happened.
Difficulty breathing, loss of voice, severe headache, blood red eyes, difficulty swallowing.
body aches; can't breath; upset stomach; cough; chills; fever ranging from 100.3 to 101.7; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and PYREXIA (fever ranging from 100.3 to 101.7) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METFORMIN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and PYREXIA (fever ranging from 100.3 to 101.7). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (fever ranging from 100.3 to 101.7) had resolved. At the time of the report, DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.3 to 101.7 (High) 100.3 to 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-JUN-2021 contains no new information.
Patient reported that she noticed localized rash behind both legs (about 10 inches long on each side) She said there was some itching and had taken Benadryl. No other symptoms were reported such as swelling, fever, or rapid heart beat. She did not follow up with any physician as the rash was not spreading and tolerable. I followed up with her on 8/23/19 and she said the rash had spread some but was no longer taking Benadryl due to the drowsiness and topical was not effective. Recommended to follow up with provided if rash continued to spread.
No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
Hives on total body including ears. Pt mother called describing hives appearing about 5 hrs after shots given. WE sent pt to ER. Tx with Benadryl there and at home.
Early period tried to start despite being on birth control which controls timing. Effects were strong enough that bleeding occurred for entire week despite continued use of birth control.
Rash, UrticariaPruritus, small rash at injection site with pruritus Narrative:
SATURDAY PATIENT WOKE UP WITH FEVER AND SORE ARMS.  SATURDAY AFTERNOON HE VOMITED.  HE WOKE UP FEELING FINE ON SUNDAY.  MOM DID NOT KNOW HOW HIGH TEMP WAS.  FEVER/SORE ARMS/VOMITING.
he was diagnosed with Covid; he started not feeling well; fever; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 18Apr2021 at single dose for COVID-19 immunisation. Medical history included cold induced asthma. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine last Sunday. On 21Apr2021 (Wednesday), he started not feeling well and he was diagnosed with COVID. She asked, will the vaccine still work on him. The patient also had a fever on Apr2021. The patient underwent lab tests and procedures which included COVID-19: positive on 21Apr2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
A 86  year old male pt received his first instillation with OncoTICE on 25Feb04. When voiding the first time after 3-4 hours, he detected some dry blood pieces in his urine, followed by clear yellow urine. No further problems were reported.
This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 1 year old male patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009004: US-009507513-1706USA009005: US-009507513-1706USA009006: US-009507513-1706USA009003: US-009507513-1706USA003615: US-009507513-1706USA009007: US-009507513-1706USA009002:
The patient presented to receive his third dose of COVID vaccine.  He received a booster (0.25 ml) dose.  However, he is immunosupressed and should've received a full 0.5 ml, third primary series dose.  The patient was not harmed, though he was undervaccinated.  There is no record of the patient contracting COVID up to this date.
10/23/2020 Within 30 min of receiving  vaccine, the left side of my face from the corner of my left eye down my jaw line to my chin and corner of left lip started to get tingly and numb, the left back side of my neck to the base of my skull started to get tingly and numb, and from the injection site of my arm to the shoulder were swollen, tingly and numb.  Contacting the physician on call who recommend to go to the Er if symptoms do not go away., 6 hours later, i was told to be seen in the ER for evaluation. For the next 4 days (10/24/2020-10/27/2020), I have broken out into a rash on my chest and upper back towards my neck and upper right abdomen. Ringing in my ears has been off and on. Mild dizziness today 10/27/2020.
Shortly after my second dose of the vaccine, I began having continuous tinnitus. It has persisted since July without getting worse or better.
9/30/2021 during morning round resident received resting in bed comfortably. AM care provided. Around 8:20am nurse entered the room to administer morning medication and noticed resident was making a gurgling sound, short of breath and hyperventilated. The resident had a wet non productive cough, tachycardia and temperature of 100.0. Oxygen administered, PRN nebulizer given, 911 activated, MD notify and POA made aware. Resident was transported to local Hospital for further evaluation and treatment. The Resident was admitted.
Child had DTAP on 02/23/04, that evening complained of "leg hurts" this AM.  Mom noted red, hard area surrounding injection site-area 1.5x1 red, warm to touch, no fluctuant.
Employee came in requesting 2nd dose Moderna. The vaccine sheet was pulled and dose was prepared and given. Upon documenting the dose it was noted her first dose was given on 9/10/2021. When employee questioned, she stated she was told to return "today" (9/15/21) to get her second dose. Explained she was to wait 30 days between doses. Notified all necessary parties.
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
This case was reported by a healthcare professional (nurse) and described the occurrence of influenza a virus test positive in a 3-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2013 the subject received a dose of FLULAVAL (unknown details). The nurse did not know the exact date of administration. The nurse did not report if the subject received the trivalent or the Quadrivalent formulation of FLULAVAL. On 20 October 2013, less than one month after vaccination with FLULAVAL, the subject experienced influenza a virus test positive, fever and vaccination failure. The subject experienced fever and went to the ER (emergency room). Per the nurse, the subject "was not experiencing any other symptoms except for a fever." No further details were available at the time of reporting. This case was assessed as medically serious by GSK. Relevant test results included a Rapid Antigen Test administered on 20 October 2013 and "tested positive for influenza A, but not influenza B." At the time of reporting the outcome of the events were unspecified. On case review, this case did not meet vaccination failure criteria and that event has been removed from the case. This case is no longer medically serious and has been down graded to non-serious.
Patient has a history of shingles on face, first episode was around 2014. Typically, when she gets a rash, the shingles shows up on lower left cheek near jawline. Patient has chronic nerve pain on left side of face because of the shingles, which she is taking gabapentin for it as needed. She is also on suppressive valacyclovir. Patient had her second dose of COVID-19 vaccine on 4/21/21 (Moderna) on left arm. About 6 hours after the vaccination, patient developed a facial rash (flat, red) on bilateral cheeks that lasted until 4/23/21. Patient took tylenol for the rash. On 4/24/21, patient began to have episodes of severe nerve pain (sharp, shooting) on the left temple area, lasting 10-30 seconds at a time. Patient took gabapentin and tylenol for this. On 4/25/21, the left temple sharp pain became less intense. The left side of face (temple area, jaw area) is sensitive to touch. Pain is still present (constant) in the left temple and left jaw area, some days are worse than others. Patient states there was one blister that showed up on left jaw area on 4/25/21. Patient states it looked like her shingles rash. Patient has been having difficulty sleeping at night because of the pain. Patient is taking valacyclovir 1500 mg BID for this outbreak of shingles (started on 4/24/21; told by PCP to take this dose). Patient is taking gabapentin 300 mg three times a day for the pain.
Redness, swelling and itching, with warmth in the affected area. Total affected area about 4 x 4 inches and raised approx. 1/2 inch. This report is being submitted 1 week after vaccination. Unknown when syptoms will subside.  Unsure as to actual vaccine brand administred.
patient now has SIRVA and can not move his arm as well anymore and is currently undergoing physical therapy
The following day at about 10:00 a.m. I began to feel weak, nauseated, extreme fatigue. By 3:00 p.m. I had to go to bedsit chills, very cold fever of 100. I remained in bed sleeping,  being checked on by friend. During the night I continued to have chills and a fever up to 103.4.  Sore bones feeling, chills fever. I slept until 7:00 a.m. the next morning and I was all better. No fever, a little ache in body.  Slept 17 hours.   No other issues after I slept 17 hours. Fever gone.
17SEP98 states recv vax & today noticed fluid in both knees;lt is worse than rt;also c/o sore arm when vax given;came to clinic & referred to clinic for eval of bil knee problems;
Caller states that she got her first vaccine on 03/1/21.  Yesterday morning, noticed some swelling and redness at the injection site.  She also stated that she felt fatigued.  Instructed to apply cold compresses to injection site,  increase fluid intake and rest.  Instructed to call PCP if sx still present x 48 hrs.
Body aches; Extreme fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on an unknown date (at unspecified age) as a single dose for COVID-19 immunisation.  On 27Apr2021, the patient experienced body aches and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and extreme fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Local rxn 9 1/2-11 1/2 cm erythema surrounding injection site (L) upper arm slight warmth to touch.
Patient came in complaining of redness, swelling, itching and heat to the area of the vaccination. The redness was the size of a baseball.  Vaccinations were given at 8:30 am.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 09-MAY-2014, the patient was vaccinated with an expired dose of ROTATEQ (dose, route and frequency were not reported) (lot # H020559: expiration date: 17-APR-2014). There were no adverse effects reported. At the time of the report, the patient's outcome of expired dose of ROTATEQ administered was unknown. Additional information has been requested.
Fatigue - occurred from 11/7-11/12 (ongoing) Headaches - occurred from 11/7-11/8 Soreness in injection spot - occurred 11/6-11/7 Muscle soreness (legs) - occurred 11/8-11/12 (ongoing) Menstrual  cycle started 2 days early with severe cramping (not typical) - occurred 11/11-11/12 (ongoing)
ON 09/05/2019 LEFT UPPER ARM RED AND HOT WHICH STARTED AT INJECTION SITEAND WENT HALF WAY DOWN THE ARM AND THE TISSUE HAD WRINKLY WAVY LINES THROUGH IT AND ON 09/06/2019 HE HAD A FEVER ALL DAY AND THE ARM WASNT AS HARD, ON 09/07/2019 REDDNESS AND SWELLING WAS RECEEDING AND FEVER DOWN 09/09/2019 ARM IS MUCH BETTER. TREATMENT CEFDINIR 600MG FOR 10 DAYS AND DIPHENHYDRAMINE 50MG EVERY 6 HOURS FOR 72 HOURS.
Fluid in the ear; Soreness in the arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE EAR EFFUSION (Fluid in the ear), VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No relevant Medical history Reported.  Concurrent medical conditions included Fluid in middle ear. Concomitant products included LISINOPRIL, CHLORTHALIDONE and SIMVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MIDDLE EAR EFFUSION (Fluid in the ear), VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache). At the time of the report, MIDDLE EAR EFFUSION (Fluid in the ear) had not resolved and VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.