chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to an approximately approximately 4-month-old (also repotred as 5-month-old) female patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 22-SEP-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event). On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours.       This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA003147: US-009507513-2311USA002927: US-009507513-2311USA002932: US-009507513-2311USA002931: US-009507513-2311USA002929: US-009507513-2311USA002930:
Patient states swelling/redness/warmth began appearing on her left arm a few days ago, almost a week after receiving her vaccination.   Patient states that it is warm to the touch.  I drew a margin around the red area and instructed her to take ibuprofen 800 mg po q6h wf for the pain and inflammation.  At this time the patient was not running a fever; I instructed her to see a physician if the margin extended outside the sharpie line or if she began running a fever.  I told her I was concerned that she may have a secondary infection from the vaccination despite following sanitary protocol.  Later in the day I received a prescription for cephalexin 500 mg q6h x 10d.  The patient returned to the pharmacy for her prescription same day and stated she had begun to run a fever >100.  I instructed her to take one tablet now (4pm) to get the medication started and one before bed with food.  I will follow up with the patient; patient is in good spirits despite the complication.
Patient had weakness unable to diagnosis specific cause. On site EMS was called vitals BP 80/80 HR 74 BG  87  99% O2 Patient refused evaluation or care and released against medical advise.
Information has been received from a nurse concerning an approximately 25 year old female patient with diabetes who in "November or December 2009", was vaccinated in the deltoid with a dose of PNEUMOVAX 23 (lot number not reported). In "November or December 2009", the patient had an injection site reaction after vaccination. The symptoms were swelling and redness radiating to her elbow. It was unknown if medical attention was sought. On an unspecified date, the patient recovered. Follow-up information received from the nurse's office which reported that the patient was vaccinated the PNEUMOVAX 23 at another office and they had no details of the event. No additional information is available.
Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Patient denied any side effects following vaccine at the time of report.
acute ITP, platelet count 2,000 with petechial rash, bruising, fatigue, herpes labialis simplex one - petechia occurred 7 days post vaccine; hospitalization 9 days post vaccine.  responded to steroids and normalized platelet count 180,000 14 days post vaccine
Extreme fatigue, muscle aches, cold symptoms- sneezing/runny nose/ sinus pressure
Initial unsolicited report received from a physician via Pfizer under reference number 2016346937 on 03 January 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetatnus Vaccine) (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination the patient had allergies. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
10 minutes after vaccination patient complained of dry mouth, tightness in throat and trouble swallowing. checked bp and pulse which was normal, pt was talking and breathing fine. Gave a drink of water and 5ml of liquid benadryl. monitored for 20 more minutes. patient continued talking and breathing normally with no other symptoms. pt said she felt fine at the end of 30 minutes of monitoring
Headache, Fever, Diarrhea, NauseaVomiting, Chills Narrative:
I started coughing on February 12th, 2023. I tested positive for COVID19 two days later. I had coughing, fever, headache, chills, and sinus congestion. I was traveling at the time and contacted my PCP by phone. I was prescribed anti-viral medication but because of the potential side-effects I did not take it. I took TYLENOL and cough syrup with expectorant and bed rest. I also lost my sense of taste and smell, had trouble sleeping and experienced heart palpitations, as well as a terrible sore throat. The fever stopped after 24 hours and I was able to travel home and was able to recuperate. After a week or so I was able to regain partial taste and smell. My cough continued about 7 weeks. The nasal congestion cleared up after 3 weeks.
Two hrs after the vaccination (Seasonal Flu vaccine) patient experienced extreme muscle aches and weakness. She had problem walking and going up and down the stairs. It was not relieved by Advil. After 3 days the aches persist but much less and weakness has resolved. She chose not to go to her PCP, but we faxed the report to her PCP FYI.
Symptomatic on 8/14/2021, Positive COVID 19 antigen test on 8/15/2021
Patient said that her arm was black and blue/bruised. Said she had a lump the size of a golf ball where vaccine was administered. Also said arm was swollen and hot to the touch.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # L031459, expiration date 30-APR-2017, lot # M043424, expiration date 06-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014982: US-009507513-1704USA015042: US-009507513-1704USA015043:
Almost  immediately  pain at injection  site, tingling down arm and through fingers, dizziness and nausea. Within 5 hours progressed to fever, extreme body pain, headache, dizziness shakiness and feelings of doom.
7:00 PM client C/O feeling "funny" - hot of itchy. Red rash/whelps noted on entire face--red/blotchy; blisters noted under each eye. Redness noted on head under hair. Ears and neck noted to be red. Whelps noted on each arm, chest, and legs. C/O itching. Denied SOB, or tongue swelling. Generic BENADRYL 2 tabs given approximately 7:10 PM. One hour later - redness had decreased. Sxs began at church approximately 7:00 PM 3/28/18. States he felt "hot and itchy". He was seen and evaluated by his mother, who is an RN and another RN, school nurse, at church. BENADRYL generic tabs was given by his mother at church (not at the clinic). He was in his mother's sight and care for the entire reaction. By 8:00 PM the redness was decreasing. Stopped itching at 8:30 PM. By 9:30 PM the redness and whelps were gone.
Shingles outbreak on my upper back  Start acyclovir -1gram -3 x per day
feels like he has COVID; feel ill; fever that rose from 99 degrees to 101.2 degrees; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (feels like he has COVID), MALAISE (feel ill) and PYREXIA (fever that rose from 99 degrees to 101.2 degrees) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COVID-19 (feels like he has COVID), MALAISE (feel ill) and PYREXIA (fever that rose from 99 degrees to 101.2 degrees). At the time of the report, COVID-19 (feels like he has COVID), MALAISE (feel ill) and PYREXIA (fever that rose from 99 degrees to 101.2 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2020, SARS-CoV-2 test: positive Positive. On 17-Mar-2021, Body temperature: 99 to 101.2 (High) rose from 99 degrees to 101.2 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Patient received covid vaccine around 4pm and reported feeling like she was having a seizure around 4:10. Her eyes starting rolling backwards and she could not verbally respond. 911 was called and she was sat on the floor and monitored by the pharmacist until paramedics arrived. She was responsive when paramedics arrived and took her to ER
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      No concomitant drug was reported. It was reported that patient took a Moderna booster shot 6 months ago, patient had no problem, other than sore arm. No Treatment medications were reported.   This case was linked to MOD-2022-554456 (Patient Link).
Left eye is blurry; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Left eye is blurry) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VISION BLURRED (Left eye is blurry). At the time of the report, VISION BLURRED (Left eye is blurry) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt was given two injections in the left arm on 2/23/09. She called the clinic on 2/24/09 and advised us that she woke at 0300 with pain in her left axilla that radiated to the back and chest. Pain was a 9/10 and constant--she described it as a muscle ache. Pt states she took pain medication with relief. Pain in the morning was a 5/10, pt did repeat the pain medication at 0900 because the pain seemed to be coming back but not near as severe. Pt advised to use heat to the axillary area and arm for 15 minutes four times daily and was given rx for Prednisone 40 mg daily for five days.  She was advised to call if any shortness of breath, increasing pain or redness at injection sites or increasing pain.
SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; followed by fevers 101.0-101.5 overnight. Next day chills, ?feeling of burning from the inside out bilaterally in my lower extremities,occassionally drifting to arms.? Also fatigue.
Cellulitis, per UC notes "diffuse erythema over 50% of left upper arm".
At first, after the shot was administered my entire arm burned like it was on fire and then went numb for about 45 mins. My throat starting burning but didn't swell up. My neck on the side of the injection site is painful all the way up to my ear. My arm started swelling up and within 30 mins it was the size of a golf ball at the injection site, about 2 hours later it was about the size of a baseball and has stayed that way. Now it in has petichiae and the swelling hasn't gone down with Advil and ice. This can be related/unrelated but 24hrs after the shot I now have a sore throat and headache.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not reported. On 07-MAR-2016, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 (lot # K010523 and expiry date 25-FEB-2016) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Fever, Chills, Headache, Muscle pain, extreme fatigue for 8 days.  Continued with chills and extremem fatigue for 8 more days
mom reports pt had a high pitched cry starting about 4 1/2hr p/vax w/T103.6 ax temp uncontrolled w/appropriate dose of infant APAP;went to ER;fever now controlled;no pertussis use in the future;
Days 2-4 fatigue,  fever,  chills,  body aches,  low appetite. Days 5-8 fatigue,  mental fog,  body aches Days 9-14 fatigue,  shortness or breath,  difficulty breathing,  chest pains. Days 15 to present increasing chest pains,  fatigue,  difficulty breathing.  Been in to ER twice.  Diagnosed with mild enlargement of the heart,  reduced ventricular blood flow,  waiting to see a heart specialist  for care (they seem to be very busy,  am on a waiting for cancellations )
DIARRHEA; STOMACH FELT BIG; UPSET STOMACH; NAUSEA; FEELING BAD AT NIGHT; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 30-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced feeling bad at night. On an unspecified date, the subject experienced diarrhea, stomach felt big, upset stomach, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach felt big, diarrhea, feeling bad at night, upset stomach, and nausea. This report was non-serious.
Weak feeling; felt sick; body was sore; This is a spontaneous report from a non-contactable consumer (patient reporting for himself). A 69-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 12Mar2021 (at the age of 69 years old) as 2nd dose, single dose, for COVID-19 immunisation. The patient's medical history included stroke from May2019 to an unknown date. The patient has no known allergies. The patient had no COVID prior vaccination and was not tested post-vaccination. The patient's concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 16Feb2021, for COVID-19 immunisation. On 13Mar2021 at 02:30 A.M, it was reported that the patient felt sick. His body was sore and felt as if he got hit by a truck, and he has a weak feeling. The outcome of the events was recovering.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart rate increased). At the time of the report, HEART RATE INCREASED (heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: 105 (High) 105 heart rate to 136 for two days since getting 2nd shot..         No treatment information was provided.  No relevant concomitant medications were reported.   Reporter did not allow further contact
Rash all over body and puffy eyes for 1 day. Provided benadryl. Patient came back more than 1 year later to report that he still has puffy eyes up to today
After 2nd dose (in right arm): Fullness in left ear going on 2 months (ENT reports no hearing loss). Vertigo, some ringing in ear, sporadic tingling in extremities.  After 1st dose only (in left arm): rash on left side including on left breast developing two weeks post shot. Dissipated 2 weeks later.
Woke up shaking with chills that lasted for about 1/2 hour.  Was uncomfortable the rest of night.  Got out of bed at 6 am and had a head ache for most of the next day.
Still having generalized malaise; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Still having generalized malaise), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Still having generalized malaise), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, MALAISE (Still having generalized malaise), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Two weeks after vaccine I had a rash on the upper arm near the site of vaccination. It was warm to the touch. They stated that it was infected. Localized cellulitis. Antibiotics prescribed. It improved within four or five days.  No reaction from second dose.
Didn't have the strength to stand/wife could not pull  patient up; Standing up and fell backwards; Daughter said I was acting kinda funny; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Daughter said I was acting kinda funny), ASTHENIA (Didn't have the strength to stand/wife could not pull  patient up) and FALL (Standing up and fell backwards) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 630MZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ABNORMAL BEHAVIOUR (Daughter said I was acting kinda funny). On 19-Feb-2021, the patient experienced ASTHENIA (Didn't have the strength to stand/wife could not pull  patient up) and FALL (Standing up and fell backwards). On 21-Feb-2021, ABNORMAL BEHAVIOUR (Daughter said I was acting kinda funny), ASTHENIA (Didn't have the strength to stand/wife could not pull  patient up) and FALL (Standing up and fell backwards) had resolved.            Concomitant medications were not provided.  Treatment medications were not provided.  Action taken with the product mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Non-significant Follow-up received: Email address obtained.
Liver pain in RUQ, which changed to a stabbing pain after meals, gradually improved but continued through 12/22/04, fatigue, light headedness, numbness in phalanges 3,4,5 of left hand 12/08/04 and 12/09/04, severe bilateral back (Kidneys) pain 12/14/04 and 12/15/04.
Pt went to ER & site measured at 15cm x 18cm in diameter/bright red & warm to touch. No cough, fever, or HA.
I was administered the Moderna vaccination on January 20, (lot # 032L20A). Exactly two weeks afterwards, February 2. I began to notice small red dots to the front of my lower extremities. As each day followed the red dots became larger and have progressed to the calfs, and behind my tricep area. They do not hurt but occasionally itchy. I am applying Cortizone cream to the areas affected.         To your knowledge, has this rash been reported by anyone post vaccination?Should I be concern? Is it safe to take the second dosage? I am schedule to receive it February 18.
Pt recvd 3 doses of Engerix-B 30OCT90, 7DEC90, & 2MAY91 & it was determined that pt's titer was negative p/3 doses of Engerix;