chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Additional AE/PQC.; HCP called to state that the patient missed his second dose of MMR II ( first dose 07/07/2023).  HCP states that the facility was out of DILUENT and could not reconstitute the vaccine. No Additional AE/PQC.; This spontaneous report was received from Consumer and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 21-AUG-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 21-AUG-2023, HCP called to state that the patient missed his second dose of MMR II (first dose 07/07/2023).  HCP states that the facility was out of DILUENT and could not reconstitute the vaccine. No Additional AE/PQC.
Employee developed a fever and chills on 01-Apr-21 which he managed with Tylenol. Symptoms resolved as per patient who contributed the symptoms as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and requested a day to rest. On 11-Apr-21, he went to  Hospital to be  evaluated by the physician who ordered some labs which were normal. He was then advised to complete PCR swab and was notified on 12-Apri-21 that his test is positive. As per the protocol, all COVID-19 positive individuals must report to the Health Center within 24 hours of notification and complete 10 days home isolation. During isolation, on 17-Apr-21, patient developed hemoptysis and difficulty breathing a breathing and notified his supervisor who called 112 for an ambulance. He was transferred to  Hospital. Evaluated and started treatment for pneumonia and was transferred to Hospital on 18-Apr-21. His condition started declining on 21-Apr-21 as he became hypoxic and tachypneic and was subsequently sedated and intubated. As he became HD unstable, Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-21 Dr. from the hospital called and stated that patient expired at 0830.
This spontaneous report as received from a registered nurse, and the patient's mother, refers to a 2 month old male infant with a history of failure to thrive when first born, but now he was eating properly. The patient had no drug reactions or allergies. On 11-APR-2014 the patient was vaccinated with the first "round of vaccinations" with ROTATEQ (lot # J010137; expiration date: 14-MAR-2015) and RECOMBIVAX HB (lot #: reported as "H010050; expiration date: 31-OCT-2014") (doses, routes and frequencies were not reported). The patient was also vaccinated with PENTACEL and PREVNAR. There was no concomitant medication. On 12-APR-2014, the patient was seen at the emergency room (E.R.) of an unspecified hospital, due to vomiting, 100.5 fever (units not specified), extreme drowsiness, twitching and at one point he stopped breathing, according to the patient's mother. The nurse reported that the patient was not admitted to the hospital. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention through ER visit. At the time of the report, the nurse reported that the patient recovered from most symptoms on an unspecified date in April 2014, but was still experiencing "some drowsiness". Additional information has been requested.
Called and said he had severe chills and needed to lay down, claimed to have anaphylactic reaction, with symp. noted above. Did not need to take any medications or ER visit. Follow up with him on 1/3/15, said he took BENADRYL and now has the flu that his wife had.
PATIENT DID NOT TAKE THE PRODUCT AS DIRECTED; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced subject did not take the product as directed. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue and patient did not take the product as directed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345977.
Pfizer booster given 1/12/2022 when 2nd dose was 10/1/2021
Patient received 1st vaccine at Walgreens. Showed up for second dose without documentation from pharmacy. Was told she would be given Pfizer and after vaccination it was determined she received moderna
About a week and a half after vaccination, I have a rash on the back of my neck under my hairline. It?s itchy and bumpy. I don?t know ignore related to the vaccine or not, but it?s not normal for me to get rashes and I haven?t come into contact with any known allergens. I haven?t changed my soap or anything like that.
6 1/2 hrs after shot was given could not stand not able to walk (extreme dizzy sick to stomach/shaking. Last about 3 hours. Should have gone to ER.
I took flu shot two months ago. After 24 hours, my right side of face, eye, and right hand were swollen badly. The swollen slowly came down and vanished after two days. I did not go to see my doctor during this period.
G62.9 PERIPHERAL NEUROPATHY 7/7/2022 GESTATIONAL THROMBOCYTOPENIA, UNSPECIFIED, THIRD TRIMESTER
"the chill"; body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ("the chill") and MYALGIA (body ache) 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 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced CHILLS ("the chill") and MYALGIA (body ache). At the time of the report, CHILLS ("the chill") and MYALGIA (body ache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Positive for COVID; A spontaneous report was received from a consumer concerning a 38-year old, male consumer  who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced positive for COVID.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received his first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date following vaccine administration, the patient tested positive for COVID-19. Per the reporter the patient has not experienced any symptoms or side effects.   Treatment details was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event positive for COVID was unknown.; Reporter's Comments: Based on reporter's causality, the event COVID-19 positive  is assessed as unlikely related to mRNA-1273. However, Further information is requested.
On 10/7/2021, I started feeling light heading and my heart was racing. I put a pulse odometer on and the heart rate was slightly elevated at 115. I relaxed and laid down at it the heart rate to low 90's and then as soon as I stood up my head started hurting and felt light headed. I put the pulse odometer went up over 160. I called 911. I laid down and tried to get my heart rate to come down. By the down the EMT left, approx. 30-45 minutes later, my heart rate had come to the low 110s. I elected to make an appt with a cardiologist the next day. The cardiologist ran an EKG which came back normal, and then he recommended an echocardiogram and a heart monitor for 30 days. A similar episode occurred three years ago involving my heart but no diagnosis was given.
rash on the right arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE RASH (rash on the right arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (fatigue). On 11-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the right arm). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) and VACCINATION SITE RASH (rash on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided   This case was linked to MOD-2021-024119 (Patient Link).
lt arm swelling to wrist;baseball sized swelling @ site 1/2" raised higher than other swelling, red, fire, hot;iced arm & site;baseball area became very itchy, w/hives in that area only;area not bruised;felt sicker & sicker w/nausea 19OCT95
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical and concomitant medications were not reported. The patient experienced a burning sensation at the injection site after injection on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
7/19/22 slept poorly (don't know if this is a symptom  7/20/22 scratchy throat, slept terribly  7/21/22 horrible sore throat, tons of phlegm, cough because of phlegm, no energy, sleep 2-3 hours at a time during the day, "buzzy head", slight earache. laryngitis .   7/21/22 - Paxlovid    1st dose 8:00 PM  Took last dose of Paxlovid today at 8:30 AM. Still have some phlegm, "buzzy head" low energy. Voice has not fully returned.  I didn't lose sense of taste or smell - but did notice a taste of "peroxide" for day or so - was after started taking medication - but not sure what day.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received a dose of the Moderna COVID-19 vaccine expired on July 25th) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004C21A) for COVID-19 immunization. No medical history reported. On Jun 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jul 27, 2021, received second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 27, 2021, patient experienced administered expired product (received a dose of the Moderna COVID-19 vaccine expired on July 25th). At the time of the report, administered expired product (received a dose of the Moderna COVID-19 vaccine expired on July 25th): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt. recvd. vax & developed generalized morbilliform rash & fever.
high fever, exterme pain , pounding heart, SOB/winded, dizzy, increased heart palatations
pt c/o pain @ site of inj lt deltoid;inc temp, erythema 37x30mm, warm to touch;1JUL97 t102;Zyrtec given;
DAY AFTER SHOT SOME REDNESS SWELLING SORENESS FOR TWO DAYS THEN DISAPPEARED  8 DAYS LATER ITCHY RED HOT RAISED SPOT THAT HAS NOW GROWN TO OVER THE SIZE OF A BASEBALL.  IT HAS NOT GOTTEN ANY BETTER
Moderna 3rd dose Clinic: 4/12/2022, 10am: Moderna lot number 005M21A Systemic reaction: 4/12/2022- Skeletal, joints & muscle aches and pains including whole body. Excruciating pain to walk and bend over. Upper spine pain, hip joints pain, groin pain, lower back pain. 4/13/2022-pain the same. Took Tylenol. 4/14/2023-pain the same, took Tylenol. 4/15/2023-pain minimized, now in right lower back, possibly kidney, and groin area. Excruciating pain to bend the right hip/upper leg. Took Tylenol in the morning and another dose in the evening. 4/16/2022-pain same as 4/15/2022, took Tylenol 4/17/2022 (today) - pain starting to ease up, I can bend over with not as much pain, and I can sit/stand up with not so much pain. Pain is still in lower back and groin on right side. 11am took more Tylenol. I'm going to my doctor Monday for an evaluation.
Arm painful less than 24 hours, red, swollen, warm to touch, induration 9x9cm 24 to 48 hours. Pt treated with Benadryl, Tylenol Q4 hrs.
Menstruation affected.  Period has been 38-40 days rather than 28.
Information has been received from a registered nurse concerning a 16 week old infant who was vaccinated on 14-DEC-2006 with an oral dose of Rotateq. No problem were reported. It was reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Shingles started  developing 4/8/2021 - with rash starting 4/10/21 - and is still continuing with nerve pain as of 5/14/2021. Treated with antiviral valacyclovir 1 gram/day starting 4/20/21.  As of 4/29/21 using gabapentin 300 mg 2x/day and 500 gm acetominophen, with also tramadol 50 mg as need for 8 to 10 pain (but this doesn't relieve the pain).
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a child who was diagnosed with autism after receiving a Prevnar injection. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. It was reported that on an unspecified date, a child was diagnosed with autism after receiving a Prevnar injection. No additional information was available at the time of this report.
face swelled; lip tingling; throat was itchy; feverish knot like a lump; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received 1st dose of BNT162B2 (Pfizer vaccine for COVID 19, Lot# EW0151) on 03Apr2021 13:50 pm on left arm for civid-19 immunization. Patient History was ongoing mast cell activation syndrome. She states she has had this condition from birth. Ongoing Ehlers-Danlos syndrome. She said she was just diagnosed with this condition 6 weeks before but it is a condition that is present from birth, that it is one of those zebra diseases. Ongoing POTS. She states she has had this condition for quite while; for 10 years or more. She says she does not know what kind of stuff we are looking for she has a list of precious medical conditions. She says her family has a history of high blood pressure diabetes, and that is probably the only two relevant. She says most of them have high blood pressure, her parents her grandparents her grandfather had diabetes, her dad had high blood pressure, her mom had high blood pressure. Concomitant Products included cetirizine hydrochloride (ZYRTEC ALLERGY) Ongoing (She states she has been on this medication for about a month mast cell activation syndrome), cimetidine (TAGAMENT) Ongoing (She states she has been on this medication for about a month. States they work together for mast cell activation syndrome), duloxetine hydrochloride (CYMBALTA) Ongoing (She started this medication about a month and a half ago to help with chronic pain due to Ehlers-Danlos syndrome). The caller says she got the Pfizer vaccine on 03Apr2021 the first one and had reaction where her face swelled, her lip was a little tingly and her throat was itchy. She says the pharmacist gave her 100mg of Benadryl and that stopped it. She says it has been 2 weeks almost since she got the vaccine and she still had a feverish knot like a lump. She states that she has mast cell activation syndrome and she has heard that the second dose is rougher on the body. She says she is seeking guidance, should get the second vaccine because normally the reaction is worse for the second one since she had a face and lip and throat reaction with first dose. She says she does not have a primary physician now that she lives in(Withheld) she has not had a chance to get a primary care provider. She says she had been taking 100mg Benadryl but does not have bottle available at this time. She says he is taking it every 6 hours. NDC lot number expiration date dosage amount not provided due to caller does not have the bottle with her. No Emergency Room, no Physician Office visit. Outcome of the event for feverish knot like a lump was not recovered, for other events were recovered on 05Apr2021.  No follow-up attempts are needed. No further information is expected.
12:50pm shot received, 1:00pm headache started, 97%spo2, head feels heavy. 1:05pm 1,000 mg apap taken. 1:13 pm slightly harder to breath, 65bpm, 95%spo2. 1:18pm 50mg Benadryl taken, 98%sp02, 66bpm, 97.7temperature, headache worsens. 1:24pm breathing improved, headache very strong, 97.7temperature, pt feels cold. 1:30pm nausea gone, very sleepy, watery mouth gone. 1:33pm 66bpm, 98%sp02, 98.2temperature pt no longer cold. 1:35pm head feels tight. 1:35pm 140/85mmHg. 1:46pm 4oomg ibuprofen taken. 1:52pm 151/91mmHg.  2:08pm 158/90mmHg, headache stronger. 2:19pm134/77mmHg.
The vaccine was not given at my clinic. Pt received the flu vaccine on right arm and SHINGRIX vaccine left arm on the same day at a pharmacy.
Patient is a 6 M old male who presents with a one day history of illness. He was well up until 1000 this morning, when he started "screaming", per his parents, which was very unusual for him. He had eaten last around 0500, took 6 oz of Gerber Good Start, so thinking that he was hungry, they offered him a bottle, but then he refused to eat. They took him to ER, as this was the closest. There he started vomiting (NB) about 3 times, appeared yellowish in color. There they did an abdominal ultrasound, which was suspicious for intussusception, thus sent him directly here. They also gave him a dose of TYLENOL and a dose of ZOFRAN prior to transfer. In the ER here, he was able have an air enema performed in IR, but with a difficult reduction. Since then, per his parents, he has appeared more like his baseline. He has had no further vomiting. He took 6 oz of Gerber Good Start here without difficulty. In terms of bowel movements, he has had more watery stools over the past 2 days, yesterday two that appeared green, watery, and one today at 0900 which appeared more dark brown, but negative for blood or mucous. He has had no fevers. He has had at least 3-4 wet diapers today. Here in the ER, he had an air enema with successful pneumatic reduction of ileocolic intussusception. He received a NS bolus of 20 mL/kg due to concern for dehydration initially. He is being admitted for observation overnight given the difficult reduction after discussion between surgery, SRED and SRPAC. The patient was admitted to the General Pediatrics service, and was placed on IVF and allowed to eat normally. He did well, with no return of abdominal pain or vomiting, and his mother felt comfortable taking him home late the following morning.
Fever, constant headache, SOB, slight coughing, body aches, night sweats, fatigue.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored dose of the PNEUMOVAX 23 (dose, site, route of administration, lot# and expiry date were not reported). was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Monovalent mRNA vaccine administered for a bivalent mRNA dose.  I hadn't been made aware that the monovalent vaccine had had it's EUA revoked by the FDA at the time of this vaccines administration..  My supervisor received e-mail notification from our county health department on 05/02/2023 with an update for immediate release to Covid-19 vaccines. This update simply stated that individuals that were previously vaccinated with monovalent Covid-19 vaccines and who had not received a dose of Bivalent vaccine could receive a single dose of bivalent vaccine.   The press release/ immediate release (dated 05/01/2023) did NOT state that the EUA had been revoked  on 04/18/2023.  I received the e-mail forwarded to me  on 05/03/2023 which I then destroyed the remaining of Pfizer monovalent Lot FP7136 vaccine.   This patient did NOT suffer any type of adverse reaction or event.     This  patient  was notified of event and is scheduled to receive the Pfizer Bivalent vaccine on 06-09-2023.
Janssen COVID-19 Vaccine EUA 6 hours after the shot I had chills that lasted for 3 hours. 8 hours after the shot I had a high fever of 103.2, temperature decreased after 7 hours and stayed at about 101.5 for another 10 hours, then slowly decreased to a normal temperature again. About 30 hours after the vaccination all symptoms were gone and I felt fine again.
FATIGUE, MYALGIAS, HOT/COLD FLASHES Narrative: EMPLOYEE WENT HOME 1 HOUR EARLY AFTER RECEIVING THE VACCINE THAT AM
Pregnancy. Individual became pregnant immediately following smallpox administration. Will be entered into registry for monitoring.
Developed myocarditis following smallpox immunization. Also, hypereosinophilia which was attributed to a reactive mechanism following the immunization. Received appropriate care and is doing well. Currently building physical conditioning as tolerated.
At routine provider visit today, patient stated to physician that approximately one (1) hour after receiving vaccine he spiked a temperature and his left arm shook uncontrollably. Symptoms resolved and patient did not seek medical care. Physician is classifying this as a reaction to the vaccine.
Patient came by the pharmacy on 8/25/2017 asking how long her arm should hurt. She was experiencing shoulder pain and difficulty moving her arm upward. She reported pain when putting on clothing such as t-shirts and waking in the night when she rolled over on her arm. She stated the pain started the night of 8/17/2017 (the day she received the  vaccine ). She also stated a tingling pain goes down her arm sometimes.
Pneumonia, Spleen infection, enlarged spleen, diarrhea, hot/cold sweat, runny nose, dizziness. ER records for DOS 7/20/06: DC DX: flank pain, early pneumonia. Continued to have the small area of inflammation and stranding in the tip of the spleen but there was no surrounding involvement of colon. DC home.
Grapefruit size reaction/swelling on back of arm, red, pt states she had shingles Kw/in 24 hours (tiny spots). She suffers from recurring shingles and her MD wanted to see if vaccine would help.
Baseball size welt/hive 1/4 inch away from vaccine site, getting larger as the day goes on.
After the vaccine, I had short of breath, fever, chills, nausea; I went to the doctor on 11/28/2022 because the shortness of breath did not make me to function properly. I got medication and inhaler and steroid shot.