chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 15:00, on 8/8/01, pt woke up choking, difficulty breathing, limp and pale. This lasted approx. 40 minutes, then baby had a crying episode that lasted 45 minutes and unable to comfort baby by feeding or holding. Tylenol was given at 16:00.
PATIENT'S DAUGHTERS REPORTED PATIENT WAS HAVING ISSUES MOVING. PATIENT WAS TAKEN TO THE HOSPITAL EMERGENCY ROOM
Patient stated arm was red swollen heat to touch circular around injection site-went to her primary care and described as cellulitis-like reaction; patient given Keflex 500mg bid x 10 days as prophylaxis; on Tuesday 6/20/16 patient came to pharmacy-reaction already dissipating; came to pharmacy to inform administrator.
This non-serious initial spontaneous case, was received from other health professional on 20-Sep-2017, concerning an adult female patient. The patient's concomitant medications included: Ibuprofen (high dose) for unknown indication. On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). One week after receiving the flu vaccination, patient developed bursitis, tendinitis and the patient had difficulty in raising arms that affected the task as difficulty in dressing themselves. The patient was treated with ice packs, Ibuprofen and steroids. The outcome of the event was not recovered (ongoing). The reporter assessed the events as non-serious.
Initial and follow-up information has been received from a physician concerning a 77 year old female consumer with rectal polyps, benign hypertension, vertigo, rhinitis, hyperthyroidism, rheumatoid arthritis, megaloblastic anemia, allergies to LESCOL, RELAFEN, ZOLOFT and TAGAMET, and a history of shingles, chickenpox, diverticulitis, diverticulosis, complete colectomy in 1978 and hysterectomy who on 17-APR-2008 was vaccinated in the left upper arm with a first dose of Zostavax (Oka/Merck) (lot # 659323/0164X).  Concomitant therapy included folic acid, SYNTHROID, BENICAR and CLARINEX.  On 18-APR-2008, the day after vaccination the patient developed zoster-like blisters under her breast and around her back.  The patient experienced mild tenderness.  On 25-APR-2008 the patient was examined by the physician.  There were no lab studies performed.  The patient had a generalized, very sore, blister-like rash.  The rash was on her groin area, her chest, her neck, and her arms.  It was reported that the patient experienced syncope while in the waiting room.  When she regained consciousness she vomited.  The patient was sent to the hospital to be admitted.  At the time of the report the patient had not recovered.  there was no product quality complaint involved.  Additional information from the physician indicated that the patient also developed lesions in her groin and on her buttocks.  The lesions looked like shingles.  The patient was prescribed VALTREX.  Follow-up information from the physician confirmed that the patient was admitted to the hospital and they were "working her up."  The physician reported that the patient's rash was a bilateral rash with a dermatomal distribution.  The rash was now also in her pelvic area and on her arms.  Initially the rash was not painful, however there is now tenderness in the areas.  The rash is vesicular in type with lesions crusted.  Follow-up information from the physician indicated that the patient developed more than 20 lesions on her neck, thighs, genitalia, and arms.  The patient also developed pain (rated 10 on a scale of 0 to 10).  It was also noted that there was no recent exposure to chickenpox or herpes zoster.  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain.  The sample of the lesions was collected on 25-APR-2008 and sent to the laboratory on 29-APR-2008.  The sample was taken from a papular lesion.  The physician considered the events to be disabling.  Additional information has been requested.
Macular erythema with tenderness at immunization site measuring 8x5 mm (R) and 4.5x5 mm (L) arm. No wheezing both lungs clear. Rx = cold compress PRN; BENADRYL cap 25mg q6h PRN; TYLENOL or ibuprofen PRN for pain; RTC if it gets worse or having problems breathing.
Vomiting, several times in night and into following day.  No fever or other issues noted.  Lethargic but not unusually fussy.  Would nap and take some breastmilk.
Started with itching at injection site that spread to red itchy bumps on both hands, fingers, toes, soles of feet, elbows and knees.
On 10/07/01, pt died. Possibly SIDS. COD as per autopsy report -- SIDS
Fever of 102.4 x 2 days, loose stools x 2 days.
Immunizations given 5/20/02 @ 1:30 pm. PR call 5/21 from mom stating child had fever and prolonged crying  X 24 hrs. Motrin and Tylenol given every 4 hrs. Fever would not decrease, 101 degrees F. PMD contacted by mom - to continue meds and tepid baths and contact PMD on 5/22 early am if not resolved.
p/vax pt started vomiting x 12hr;also exp diarrhea x 8hrMD attributed sx to vax;pt father exp vomiting & diarrhea x 24hr;pt grandma, mom & neighbor exp same onset & sx;required ER visit;all adults had severe V & D more than child;
Patient selected flu shot on her online form for Pharmacy and in-person, thinking she needed the flu vaccine. However, she had already received the high dose flu shot at the clinic on 09/27/2023. Technician confirmed with her that she wanted the flu shot and continued to process it. Insurance did NOT give any hard halt and vaccine was processed through her insurance. In clinic room, Pharmacist verified the name, DOB, and vaccine. During preparation of vaccine site, the name of the High Dose flu vaccine was mentioned and confirmed numerous times and then administered. Only after the patient was getting up and Pharmacist was completing final counseling, did she realize that she did not need the Flu vaccine again this season.
Our perfectly healthy baby suddenly became lethargic one morning, and was vomiting by afternoon, we took her to Emergency Room, she received an abdominal x-ray - nothing was found, sent home with viral diagnosis. Baby vomited most of the night, anti-nausea medication helped, however baby was very ill through the night. The following morning baby presented with gooey bloody poop diaper, so took baby to Pediatrician immediately. Baby was admitted to hospital by late morning for possibly dehydration, and continued to vomit and be lethargic through the day. At around 11 pm, baby was diagnosed with  Intussusception, a life threatening blockage of intestine.  Baby was in surgery by 2 am, and had a somewhat slow 5 day recovery in the hospital.  No other illnesses since, not even a common cold.
patient's mom said patient had sore arm and shoulder the following day that lasted for "more than a day or two" and resolved with ice and nsaids
Generalized hives within several hours, post vax. Treated with topical steroid ointment.
Patient received vaccination on 4/22 and started developing chest pain on 4/24. patient presented to the Emergency Department on 4/25 and was evaluated and found to have a troponin of 1500 and was diagnosed with myocarditis. The source is unknown at this point but may be related to the vaccine.
Hair loss; Scar; Skin breakout; Drug dose administration interval too short; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss), SCAR (Scar), RASH (Skin breakout) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too short) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ALOPECIA (Hair loss), SCAR (Scar), RASH (Skin breakout) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too short). At the time of the report, ALOPECIA (Hair loss), SCAR (Scar) and RASH (Skin breakout) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too short) outcome was unknown.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment details were reported. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of TOOK EXTRA INJECTION/TOOK INJECTION A WEEK EARLY with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of BREAKOUT ON HANDS, LOSING HAIR and SCAR ON FACE was not provided. 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.
IPV and MMRV given on 8/7 in right leg. On 8/8 - 8/10 progressive red swelling laterally from vaccine, raised, itchy extending from knee up to within 2-3 inches of up. No trouble swallowing/breathing. No other rashes.
p/ pt recv vax approx 8 mos later pt exp 10 lesions, rash & slight fever lasting approx 5 days.
The day of the vaccine not much trouble, the injection site was a little sore. As the evening came I started feeling the body aches, the chills. The next morning  I had a headache, I had joint pains (elbow, knee and hip). My arm pain was really severe. I could not even sleep on that side of my arm, the pain was excruciating.  I also noticed as I woke up that I also had hives, and it was red and hot and itching, blisters, all over my hand. I then contacted my PCP and they suggested Benadryl capsules. It took about a week for the rash to go away, I finally can wear my ring back (hands were very swollen). Now, I noticed I developed a cough about after a week after the vaccine. The rash is gone off my hands but the skin looks like it is peeling (reminds me of when a person has a real bad sunburn on skin and the burnt skin starts peeling off) from all the blistering and the rash on my hands. I did have COVID in late November, early December. I tested positive on 11/30/2020. The new skin that is being exposed is really tender and sore. I notice with each passing day skin feels better not so sensitive.  I get a little bit better each day, a little more energy each day.
Expired Kinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Kinrix vaccine after expiration date. The reporter consented to follow up. Additional supportive information: The patient received a Kinrix which was already expired, which led to expired vaccine used.
Pt. received imm at 11AM - took usual nap - woke at 3 pm will fever to 101 - seemed well. Went to sleep 8 pm slept 16 hour & woke the next day with fever & unsteady gait - fever lasted < 48 hours but unsteady gait lasted 6 days.
Had event of uncontrollable "shaking" then broke out in rash, was crying inconsolable.
This was my second dose of Moderna COVID?19 Vaccine EUA. I noticed my hands starting to hurt around 3pm, a couple hours after my arm started to stiffen up.  Then at 5:30 pm I was suddenly SO achey. My feet even burned and I was shaking.  I still managed to eat a sandwich then I went straight to bed under an extra blanket.  The actual terrible aches and shivering only lasted four hours, but I seemed to be unable to settle all night and I tossed and turned and had horrible dreams.  Today my stomach is very sour and hurts.   I?m still sick and while o know it is just my immune response this has been REALLY unpleasant.
Red, hot itchy raised after injection. Started with sore throats, fever, chills, Muscle aches, Cold, Flu. Now permanently disabled.
Very drowsy sleepy; Muscle pain; Severe pain in the neck on right side; Severe pain in the shoulder on right side; The pain started to migrate over next couple days over to his right arm from his triceps to his biceps where it is now; This is a spontaneous report from a contactable 27-year-old male consumer reported for himself received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 27Aug2021 (at the age of 27-year-old) (2 weeks ago from Friday(10Sep2021)) as SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Aug2021 (2 weeks ago from Friday (10Sep2021)), about an hour or 2 hrs after the vaccine he had got very drowsy sleepy and had muscle pain. In Aug2021 (that Friday into Monday), he woke up with severe pain in the neck and shoulder on right side, opposite injection site on left side. He took Tylenol to try and relieve but it didn't do much. Also the pain started to migrate over next couple days over to his right arm from his triceps to his biceps where it was now. It was been like that for over a week and a half. Some days not so bad and other days wake in pain to the point of tears, bad. Stating he was a heavy guy over 400 pounds. He was taking 3 Advil 200mg each about every 6 hours, which was helping. He states he does forget it sometimes and states, it was slow onset that builds then he has to take the Advil. The reporter considered the events as non-serious. The outcome of the event very drowsy sleepy was unknown whereas other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient received booster shot 3 months after their 2nd dose. Patient reports having chest heaviness
Chills (shivering) and muscle ache throughout the body for approximately 3 to 4 hours
Patient received MMR, VARIVAX and Hep A vaccines on 01/18/2018. Parent notified the office of fever 101 and rash on 1/29/2018. Patient was seen in the office on 01/30/2018. Upon exam, redness and vesicles were noted on the site where the Varicella vaccine was administered. No pus, or warmth noted. Upon further exam it was noted that child has otitis media, which could also be a reason for the fever.
Pat. stated she had swelling on (R) arm plus rash on both arms and partially on torso area.
Severe anxiety; Chest pain; Left arm and shoulder pain; Left arm and shoulder pain; Pain in neck; Headaches; This is a spontaneous report received from a contactable other HCP (patient) reported for himself. A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8732) via an unspecified route of administration, administered in Arm Left on 12Apr2021 14:00 as single dose for covid-19 immunisation. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Medical history included blood pressure increased from an unknown date and unknown if ongoing. Concomitant medication(s) included candesartan (CANDESARTAN) taken for an unspecified indication, start and stop date were not reported. On 15May2021 the patient experienced severe anxiety, chest pain, left arm and shoulder pain, left arm and shoulder pain, pain in neck, headaches. The patient underwent lab tests and procedures which included cardiac function test: unknown results in 2021. The patient did receive any treatment for the adverse events. Treatment received for the adverse event with Heart test, Neuro visit, Psychiatrist visit. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of severe anxiety, chest pain, left arm and shoulder pain, left arm and shoulder pain, pain in neck, headaches.  No follow-up attempts are possible. No further information is expected.
Moderate muscle and tendon stiffness from injection site on left arm and radiating up shoulder to left trapezius and left neck to base of skull.  Stiffness was severe enough to cause significant pain when turning head more that 30 degrees left/right and when tilting head up/down.  This pain significantly limited head's range of motion from normal.  Symptoms much worse when also extending left arm overhead, downward 30 degrees from horizontal, placing any body weight on arm when prone, or when tensing muscles for normal activities such as lifting light weight, levering up out of a chair, or rising from prone.  Symptoms commenced 24hrs after vaccination and became more severe over the course of 10hrs.  Symptoms moderated somewhat overnight and have continued to lessen during the following day.  Stiffness and pain remain 30hrs after first onset.
Information has been received from a 38 year old female with a history of uterine fibroids who on 31-OCT-2006 was vaccinated with the third dose of GARDASIL. The patient reported that on 27-DEC-2007 after receiving the third dose of the vaccine, she had a PAP test and HPV test done. The results of the PAP test came back negative for lesions and malignant and the test for HPV came back positive for high intermediate HPV. the consumer reported that her PAP test previous to getting the vaccine has always come back negative. The patient's status was not reported. No further information is available.
Extreme headache; chills; just had a sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER3736) via an unspecified route of administration in the left arm on 16May2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. It was unknown if the patient had any known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 14:00 the patient experienced extreme headache, chills two hours after the shot. The patient was better by the next day and just had a sore arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with tylenol started from unspecified date. The clinical outcome of the events extreme headache and chills was recovered on the next day on 17May2021, while that of the event sore arm was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Throat tightness; not feeling well; Upper chest pressure; A spontaneous report was received from a pharmacist concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat tightness, upper chest pressure and was not feeling well.  The patient did not have any relevant medical history. The patient denied any previous history of adverse reactions to vaccines. No relevant concomitant medications were reported.  On 23 Dec 2020 at 09:40 am, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020 at 9:45 am, the patient experienced throat tightness and not feeling well. The patient was pale and hypertensive. She was carried on a stretcher and placed on oxygen. Rapid response team was called in and treatment with intravenous (iv) fluids including iv push of famotidine at a dose of 20 mg was initiated. Patient was transported to the Emergency Department (ED) for further evaluation. Additionally, the patient received iv treatment with methylprednisolone succinate at a dose 125 mg and diphenhydramine at a dose of 25 mg. Throat tightness and upper chest pressure were reported to be relieved. The patient was discharged with prescriptions for oral prednisone, famotidine, and diphenhydramine to be taken as needed for recurrent symptoms.  Action taken with mRNA-1273 in response to the events of  throat tightness, upper chest pressure, and not feeling well was not reported.   The events, throat tightness, upper chest pressure, and not feeling well were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 52-year-old, female subject who received their first of two planned doses of mRNA-1273 (Lot 039K20A), experienced the unexpected events of not feeling well; upper chest pressure and not feeling well. The onset of events occurred 5 min after the first dose of vaccine administration. The reporter causality assessment for the events was not provided. Due to the temporal association between the events and the administration of vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.
Patient complaining of feeling ill about 4 minutes after vaccine was given.  Patient complained about nausea and felt like she was going to vomit. She never did vomit.  She then complained of trouble breathing " my throat feels like it is closing"  She continued to complain of trouble breathing therefore EMS was initiated and 0.3mg of epinepherine was given in right thigh via epipen.  This was at 2:14pm.  EMS arrived and patient was taken to Hospital ER.
pharmacist did not dilute and gave patient the whole 1.8mls of undiluted vaccine
pt recv vax; devel pain in shoulder which in days to come traveled to back then chest; hosp for heart condition; "pericarditis" resulting in disability;
After the vaccine I felt heat and pain in my body and I felt rapid palpitations, but then I thought it was my sugar, I did the test and I had it a little elevated and then my pressure went up, I went to sleep because I was tired. The next day I had a temperature at 100F, bone pain, chills and headache, I was like this for 3 days. By Wednesday I was better. I saw the Cardiologist later.