chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.            No concomitant medication were reported. It was reported that study showed that vaccines of messenger RNA (mRNA) against Covid-19, as the Pfizer and Modern can produce myocarditis after application of the second dose.  No treatment medication were reported. As per "Cardiology", 23 vaccinated patients, between 20 and 51 years old reported acute chest pain. These manifestations occurred within four das after inoculation. The symptoms of the 23 patients were classified as "significantly elevated levels of cardiac troponin", a type of protein found in the muscles of the heart. They suggested that this condition is associated with an inflammatory response. Another vaccine that has been associated with episodes of myocarditis is the one that prevents smallpox.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  company comment This spontaneous case concerns a patient of unknown age and gender and with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of Myocarditis, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that study showed that messenger RNA (mRNA) vaccines of covid 19 can produce myocarditis after application of the second dose.  No further clinical information on comorbidities, risk factors, concomitant medications and treatment details were available in the report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender and with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of Myocarditis, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that study showed that messenger RNA (mRNA) vaccines of covid 19 can produce myocarditis after application of the second dose.  No further clinical information on comorbidities, risk factors, concomitant medications and treatment details were available in the report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Large, red and swollen area of back left arm and itchy. Doctor told her to take BENADRYL. She picked up BENADRYL 4-19-19. She is to call Dr. if it gets worse.
Mild fever, intense body aches (especially in calves), migraine headaches, dizziness. I was also on the fourth day of my mensuration cycle, which was very heavy. After receiving the vaccine, my flow almost completely stopped.
Fever, red raised area is hrad, warm and tender to touch, looks like a " bug bite".
The inmate was at a previous facility and received the above vaccine. When we did our mass vaccine at  our facility, inmate signed for the Johnson and Johnson vaccine (Lot number 1808609). He signed he has never received a vaccine. He was given the vaccine. I found out today that he received  the first dose of Moderna on 3/12 at previous facility.
Redness, warmth, swelling from injection site in deltoid muscle down to elbow. Recommended Pt use cool compress to the area. Can take acetaminophen or ibuprofen for any pain/discomfort. Seek medical attention if worsening or difficulty breathing/systemic reaction.
Within 15 min: Muscle weakness, pain in leg-unable to stand very long due to pain. Within a couple hours: severe vomiting, high fever, lethargic, rash and swelling of entire thigh 1 1/2 times the size of other thigh. 1 week later: still severe vomiting, had to have IV fluids at ER, fever off and on, still lethargic, rash/swelling starts to dissipate, severe itching in both legs.  Weeks later: still bouts of vomiting, lethargy, weight loss. Months later: No more vomiting. things have resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 27-AUG-2014 the patient was vaccinated with 0.5 ml dose of PNEUMOVAX23 lot # J010396, Exp date: 16-FEB-2015, frequency was reported as once, intramuscular. On an unspecified date in August 2014 the patient experienced  redness, pain and swelling at injection site. The patient did not seek medical attention. The reporter stated that no treatment was given, just watching at this ponit. The outcome of redness, pain and swelling at injection site was unknown. The reporter stated that there were 3  injections administered from vial and the reaction happened in 2 of the 3 injections (another one was captured in 1409USA000523). Additonal information has been requested.
Congestion, headache, and that was about it and I had a different about every single day that I had it when I had my breakthrough infection with COVID-19.  I was sick about 14 days. The doctor gave me Paxlovid.
Customer had blisters on arm & heart palpitations. She reported symptoms on 9/14/12 (got ZOSTAVAX shot on 9/13/12). Called a pharmacist who told her to take BENADRYL. Symptoms resolved completely.
p/vax pt could possible be preg, starting 10/4/98; pt devel flu; MD stated that pt had a spontaneous abortion
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ lot # L013204, expiry date 28-JAN-2017 and lot # L029617, expiry date 09-MAY-2017 (dose was not specified). The administered doses of ROTATEQ underwent temperature excursion at 49 Fahrenheit degrees for 15 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 20-MAR-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), lot # J008229, expiration date 12-JUL-2015 (dose and route not reported) with worst case exposure of 39F for 588 hours, but must be used within one month. On 04-MAY-2014, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), lot # J008229, expiration date 12-JUL-2015 (dose and route not reported) that exposed to 39F for 1154 hours, Dates of excursions: 01-FEB-2014 to 04-MAY-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling of L upper arm. Redness & warmth encompassing bicep, tricep & eventually spreading just past elbow over 72 hrs. Sore upper arm. Fever, body aches & nausea during 1st 24 hours. Disturbed sleep & excessive sleep for 48 hrs. Have received a flu shot annually for many years w/o adverse events.
This spontaneous report was received from a 65 year old male patient, who referred to himself. The patient had no drug reactions or allergies. The patient was receiving corticosteroids for about 10 years. He received his last injection in May 2017. On an unknown date in June 2017, the patient was vaccinated with ZOSTAVAX subcutaneously for prevention of shingles (dose, side of administration, lot # and expiration date were not reported). On an unknown date in 2017 (reported as about 12 hours after receiving ZOSTAVAX, he could not move his arm (unspecified arm). About 48 hours after receiving ZOSTAVAX, every muscle in his body began to hurt. The patient stated he heard that ZOSTAVAX should not be given to patients who use corticosteroids. The patient reported that he had a stent (reported also as stint) in his heart and he took some unspecified blood thinners (dates unspecified). He stated that he has never had any of these types of side effects from any medications or injections in the past, and they could only be a result of the ZOSTAVAX injection. The patient sought a medical attention by seeing his physician. The physician was not able to determine the cause of his symptoms. The outcome of the events was reported as not recovered. The patient reported also that he was not at liberty to give his physicians information at this time, but he might be able to provide it later. Upon internal review, the events of "stent in his heart" and "he took some unspecified blood thinners" were considered to be medically significant.
-Within 18 hours: achy muscles throughout the body & chills. Continued for 24 hours. Controlled with Advil. -3/11 @ 7:00 a.m. noticed swelling and redness just below the injection site and itching on arm (left). Took Benadryl tablet and applied cortisones cream.  8:00 a.m. rash and itching on both arms. Took a Benadryl capsule. 3:00 p.m. itching  and rash continued. Rash on side of neck. Took Benadryl capsule.
4 hours after injection: Fever 99°, chills mild headache. 8 hours after injection: Fever 101.8, chills, severe migraine headache. 24 hours after injection: Fever 101.4, chills, severe migraine headache, eye pain, lethargic, weakness, no appetite, rapid heartbeat of 125 bpm. Day 2: Fever: 99.6, headache, no appetite,  lethargic, heartbeat between 108-120 bpm Day 3: Fever 99, mild headache, no appetite, lethargic, heartbeat 94 bpm, weakness, unsteadiness  Day 4: No fever, heartbeat 84 bpm, some appetite, weakness, lethargic, unsteadiness.  Day 5: No fever, heartbeat normal, appetite returned, weakness. Day 6: Normal
Shot given 9/16/12 patient presented with hot, red swollen arm on 9/17/12 am. There are bumpy inflamed area around injection site - per pt.
A patient came into the clinic for PPD tuberculin skin test. After the provider evaluated the patient and ordered the PPD test, the medical assistant (MA) was instructed to give the test to the patient. After the test was given, the patient was discharged by the MA. Within an hour or so, the lead supervising MA noticed a vial of FLUVIRIN sitting out on a desk. The lead MA asked all the other MAs and providers if anyone ordered the FLUVIRIN vaccine and why it was sitting out instead of in the refrigerator. The provider's MA admitted that she accidentally gave FLUVIRIN instead of tuberculin intradermally in the patient's forearm. Multiple attempts were made to contact the patient without success. The incident was reported to the County Dept of Public Health. 48 hours later, the patient returned to the clinic for PPD read and this was when the incident was disclosed to the patient. The patient had a 3cm area of erythema and mild swelling at the injection site where FLUVIRIN was administered. The patient denied any other problems or history of allergies. The PPD was then correctly given in the other forearm.
headache, nonproductive cough, ear pain, post nasal drainage, sneezing starting 10/19/21
No adverse event, treatment required, or negative outcomes due to the incident. Vaccine given against age recommendations.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015 23:30, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 8.5 and -2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
severe diarrhea w/in days of shot;noticeable regression shortly p/;dx w/autism @ 3 1/2;this was pt first MMR shot;
Case number PHEH2015017657, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a 42 years old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN, (batch number: not reported) for thrice on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly into the left deltoid at a dose of 0.5 ml on 08 Sep 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow-up information received from a nurse on 27 Oct 2015: updated patient's demographics, vaccination history, time of vaccination, site of vaccination and other clinically relevant information in the narrative.
PARENT DESCRIBES HIVES AND FACIAL SWELLING AFTER RECEIVING 2ND COVID VACCINE, WHICH RESOLVED WITH BENADRYL.
Tiredness, sore ears, throat; weakness 9:00 PM. 6:00 AM, next day, fever, spikes to 103 F, then sweating and fever drops to 102 then to 99. by 8:00 a.m.
Rash on left arm near injection site. Rash has gone down left arm. Flu-like symptoms since 03/21/2000, date of 6th shot.
One day after DTaP, arm became swollen, red, hot, tender 10x10cm.
devel red & swollen arm from shoulder to elbow & low grade fever;went to MD 3 days later;said it was an infect & prescribed ATB & anti-inflammatory rx; sx lasted 7 to 10 days;
My Left arm got really sore, then later my granddaughter brushed up against my arm below my elbow and it was really sore to touch, when I looked at it it was red and whelps around my veins and nots down near my wrist and in the back of my hand. today Friday 4/23/21 my arm below my elbow is sore without touching it & touching it. I also had a very large lymph node appear under my left arm pit last night, starting to go down. I had a headache, my neck hurt, just didn't feel very good all day, some chills. I took Tylenol after 6 hours and Ibuprofen at bedtime.
Pt reported fever of 103F. Pt did not seek medical tx and recovered on own within 24 hours.
Patient complains of pain in shoulder that radiates down to fingers lasting 2 weeks or longer. Patient seeing physician soon.
Headache; Fever; Joint pain; Muscle pain; Felt sick to her stomach; Threw up; Dehydration; A spontaneous report was received from a consumer concerning 71-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, fever, joint pain, muscle pain, feeling sick to her stomach, vomiting, and dehydration.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient went to the emergency room for headache, fever, joint pain, and muscle pain. Patient reports feeling "sick to her stomach" and vomiting several times. She was treated for dehydration and nausea. She was discharged when her symptoms improved. Treatment for the events included IV fluids and an unspecified anti-nausea medication.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, headache, fever, joint pain, muscle pain, feeling sick to her stomach, vomiting, and dehydration, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.; No adverse event; Vaccine administered after beyond use date 28-jan-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023), PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023), PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023) and PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.).    No concomitant medications were reported. The vaccine administered after beyond use date of 28-jan-2023. No treatment medications were reported.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient seemed out of it. Tried to give her water and took her pulse and blood pressure. Called emergency number.
Received recombinant shingles vaccine and less than 2 hrs later he states he started with low grade fever and aching. Sx progressed overnight to T102/chills/soaking sweats/body aches. Left Arm was very sore at injection site. Denied redness. The next morning he felt slightly better, still run down/achy and had a headache. No cough or other flu like Sx. Denied SOB, wheezing, chest pressure.
Stiff joints, fever, body aches, severe fatigue, loss of appetite,  headache, increased thirst, muscle weakness
I visited my doctor.  After he examined and questioned me about recent activities, he diagnosed me with a Stevens-Johnson response and said that my shot of the Moderna vaccine was the most likely cause of the incident.  Much of my body was covered with red blisters and inflammation.  It was uncomfortable and itched a lot.  He prescribed a six-day course of methylprednisolone tablets for me, 21 - 4mg tablets over six days.  That seemed to stop the reaction, but I still had badly inflamed hands and feet afterward.  My doctor then prescribed prednisone, 1 - 10mg tablet per day.  After another week, the inflammation was gone and I discontinued the prednisone.
On 01/18/2021,  a couple of hours after the vaccine, pain at the injection site.  And then any time I would move my right arm, a typical injection site pain, but certain movement that it lasted for 3 months that I had pain in my arm. I tried  hot packs and stretching to relieve the pain.   I had a normal follow up, yearly appointment and the doctor  took a look at it.
"ON 12/29/2020 I got my vaccine at 5:13pm. I waited the 15 minutes after getting it and then went home. I woke up the next morning and noticed a rash on the right cheek/face as the day went on  I noticed face where rash was starting to feel numb/tingle like after the dentist." Reports that she did not ever have any respiratory or airway problems, yesterday or today.
I'm on hormone replacement therapy (HRT) since January 2021.  I had no menstrual monthly periods, no vaginal bleeding  since starting HRT in January 2021.  After 2nd dose of Moderna covid vaccine on 4/15/21, I had vaginal bleeding from 5/30/21 - 6/29/21.  My MD suspected cancer and I had a work up which was negative.  She was never able to determine the bleeding cause.  Later I saw news articles about abnormal vaginal bleeding after covid vaccine and I made the connection.
Developed dizziness and red rash to upper chest. Benadryl 50mg IM.
I went to the ER on 4/17/21.  Had Pulmonary Embolism in both lungs. I was in the hospital 3 days.  I have no personal history of blood clots and no family history of blood clots.  Now I must be on blood thinners the rest of my life, because the science does not know?  I understand from the doctors that 4 out of 1,000,000 cases are happening with the Pfizer vaccine.  Why is this information not being released to the public?  I almost died from the Pfizer vaccine and am not permanently disabled by it.
This is an initial spontaneous report by a medical assistant. This female medical assistant reported on behalf of a 4-year-old female patient who began on PREVNAR13 0.5 ml suspension for intramuscular injection unknown frequency on 23MAR2011. Relevant medical huistory was none. Relevant concomitant medicatons were none. On 24MAR2011 she experienced rashes, redness, swelling and ow grade fever of 99 which she mentioned it as warm to the touch. Therapeutic measures incldued BENADRYL in response to the rashes, redness, and swelling. Relevant lab data was none. At the time of the report it was unknown if she was taking PREVNAR13 At the tine of the report she had recovered from rashes, redness and swelling. At the tine of the report she was recovering from remaining event. Follow-up (13MAY2011): Follow-up attempts completed. No further information expected.
Information has been received from a consumer concerning her son with no medical history (APGAR scores noted to be 9 at birth) or drug allergy who on 07-JUN-2001 was vaccinated with a dose of MMR II when he was 1 year old. There was no concomitant medication. After receiving MMR II he had high fever, eyes were glassy, and he started to stare ahead and was not very responsive to his mother's voice. The fever broke the patient's temperament changed from a very happy baby to very cranky and upset and at night time he started to have night sweats, to the point where his head and hair was soaked. The patient also then started to stare at walls and line cars up. He had test done for seizures, hearing and vision which all came back fine. His mother stated that he had brain damage and he was now 8 year old with one year old mind set, where he was still in diapers. He did not speak and at this point was having aggression issues. His mother also mentioned that he did not have normal bowel movement because they are constantly loose. The patient did not recover at the time of reporting. The patient sought unspecified medical attention. Upon internal review, did not speak was determined to be an other important medical event. Additional information is not expected.
I had a dripping nose and a slight sore throat. Very mild symptoms. They lasted 5 days. I also had a 99.1 fever on 1 day.
72 hours after vaccine administered pt developed a festering lesion about 1 in x 1/2 in under arm (R) that did not itch or hurt. Also had numbness in upper (R) arm and nausea.