chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other adverse effects were reported in the patient; patient received a dose of PROQUAD on 7/15/2020 following a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-JUL-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S015238 was verified to be a not valid lot number, expiration date reported as 01-DEC-2020 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of -11.77 degrees Celsius for 2 hours. There were previous temperature excursions, -10.45 degrees Celsius for 12 hours 45 minutes and -8.77 degrees Celsius for 13 hours on unknown dates. Digital Data Logger was involved. No other adverse effects were reported.
Patient became pale & dusky, shocky, sweaty and clamy & ashen. Patient given epi 1:1000, 0.02 ml after which patient improved and transported by paramedics to hospital.
Pneumovax shot given yesterday on left arm; this morning noticed redness around site and also itchiness. At around mid-morning, site still itchy and redness spread approx 2 inches down (in elongated fashion). Pt took 12.5mg of Benadryl and 400mg of Ibuprofen.
PATIENT GOT FAINT.  SHE LAID DOWN AND WAS GIVEN FLUIDS AND FOOD.  SHE COMPLAINED OF A SEVERE HEADACHE AND TINGLING IN HER HANDS AND FEET.  BLOOD PRESSURE AND PULSE WERE NORMAL.  SHE WAS GIVEN IBUPROFEN 10 MG/KG X 1.  AFTER 45 MINUTES, SHE FELT WELL ENOUGH TO GO HOME BUT STILL COMPLAINED OF HEADACHE.  EXTREMITY TINGLING RESOLVED PRIOR TO DISCHARGE.
Headache & arm soreness began 8 AM after 1st dose administered, Fever started around 12 and progressed from 100.6 to Tmax 102.7 for 6 hours with tylenol.  O2 of 89-92,  SOB, confusion, shaking chills, alternating between hot and cold, severe fatigue.  COVID test performed 2 days after COVID vaccine and day after reaction and negative.  Erythema at site on 2/1/21 w/o spread or cellulitis.
Patient vaccinated 8/18/21, came in with STEMI 8/21/21. Thrombus to mid LAD, received stent. All others angiographically normal, no CAD history. Did have risk factors of HTN, HLD (reports these were controlled) and smoking. Timiline concerning, as this occurred within 72 hours of the first Pfizer Covid-19 vaccine.
The area around the vaccination site is warm to touch, with swelling evident. Appears to be a rash about 5 inches in diameter around the site, very painful. Light tingling and numbness through arm into fingers.
Headaches, fever (100.4), chills, lack of appetite, no energy, diarrhea, swelling, soreness and itchy at the injection site, aches and pains.
Throat ulcer, mild congestion and ear pain, early arrival of period following vaccination, significantly heavier period and increased cramps
fever 101; max, lasted for about 24 hours; fatigue 24 hours; headache 36 hours; sensitivity at injection site 36 hours
4y.o. CPE done 4/27/10 no H/o previous RXN to immunizations. Immunizations given DTAP #5 and IPV #4 and PPD left forearm received or core 4/28/10 patient awakened with hives.
This spontaneous report was received from an immunization coordinator referring 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 the improperly stored doses of PROQUAD lot#: M006106, expiration date on 01-AUG-2016 (strength, dose number, route of administration and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were previous excursions reported as 13.1 degrees Fahrenheit for 3 hours 10 minutes and 7 degrees Fahrenheit for 2 hours, 50 minutes. It was reported total cumulative time out of range 6 hours 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 16 week old patient who in May 2010, was vaccinated with a dose of ROTATEQ (Lot#: not reported). The physician reported a scheduled visit to examine an infant who, after receiving ROTATEQ, had a severe case of gastroenteritis. He was unsure if it was a severe allergic reaction. He said he thought that an adverse experience report was filled by the pediatrician who administered the vaccine. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the physician indicated that he didn't want to received any further follow up mailings because he didn't know anything regarding the patient. No further information is available.
After shot was given, I started experiencing chronic migraines and pain in my eyes, which caused blurred vision double vision, and blackout spells. I was diagnosed with Idiopathic Inter-cranial Hypertension. these symptoms started about a week or 2 after I received my Pfizer booster in Jan.
Return of olfactory sensation, return of flavor sensation; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Return of olfactory sensation, return of flavor sensation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anosmia (diagnosed with anosmia over a decade ago and had not smelled aromas or enjoyed flavors this intensely since the patient was first inflicted many years back. ).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Return of olfactory sensation, return of flavor sensation). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Return of olfactory sensation, return of flavor sensation) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient was diagnosed with anosmia over a decade ago and had not smelled aromas or enjoyed flavors this intensely since the patient was first inflicted many years back. The patient experienced a return of olfactory and flavor sensations after the second booster shot. The patient was never been diagnosed with COVID-19, and did not believe that the patient ever got it. The patient mentioned that this reaction might be coincidental, but it was certainly welcome. It had only been 48 hours, and the patient was hoping it might be permanent.  No treatment information was provided.
Pt reports flat, red, splotchy rash that appeared one hour after being administered FLUVIRIN. She also reports having a massage within hours of vaccine (prior to vaccine). Pt mentioned it looked like heat rash. Rash appeared on abdomen - under breasts to waist not appearing on back. She reported a similar rash appearing after taking ROBITUSSIN and guaifenesin.
Approximately 4 hours after flu shot-extreme fatigue, headache, pain in affected arm and shoulder; temperature 103.0F. Wednesday PM will Friday AM, nausea.
Pt admitted to the hospital with fever, cough, chills, diarrhea, and fatigue with an abnormal chest X-Ray.
Patient is a 6 y.o. female. Today she is accompanied by her mother. At 9:59am 15 minutes after vaccination in left arm patient complained of localized itching at the injection site. No anaphylactic reaction noted. Denies fever, chills, chest pain,  metallic taste in mouth, shortness of breath, wheezing, stridor, headache, dizziness,flushing,nausea vomiting,  abdominal pain, urinary incontinence, itching eyes or nose, sneezing, clear watery eye  discharge, nasal discharge, and weakness. Provided Benadryl 12.5 mg PO X 1 dose at 10:15 am. No cardiopulmonary or neurological distress noted. Monitored until 10:50 am.  Provided crackers and juice prior to discharge, tolerated juice and crackers. Itching resolved. Left office in stable condition with mother.
Fever > 102 degrees, shaking x 90 minutes. Body aches and pain - sxs started to present 12-24 hours after administration.
06/22/2022 He was not hospitalized at death. He was the captain of a charter boat when he went unresponsive.
Woke up early this am with 105 temperature.  Mom took her to ER, but by the time Mom got there temperature was 100.  Given Tylenol and Mom reports at 3:45PM today that baby is doing good.
Pt calls with C/O fever 104, and 9:10 back pain that started 3:30am. Pt received flu and 1st shingles vaccine yesterday in clinic. Pt took two TYLENOL and one hydrocodone at 8:30 (1.5 hours ago). Temp is now 100.3, but back pain has not improved. Pt stated that he normally sleeps on his side, but slept on his back last night (due to both arms sore from vaccines). Pt also has a headache. Pt denies dyspnea, rash, difficulty swallowing, slurred speech, confusion, decreased/painful urination, NV, neck pain/light sensitivity, altered vision. Temperature has responded to TYLENOL. Advised patient alternate ice/heat to help with back pain.
Raynaud's Disease, rheumatoid arthritis, and severe hormone imbalance not previously experienced.
Patient developed large areas of redness surrounding both vaccination sites. The left thigh had erythema and warmth 15 cm x 11.4 cm. The right thigh had erythema and warmth 6.4 cm x 4.4 cm.  The child was prescribed Benadryl with baking soda paste to the areas. Plan includes addition of cefdinir bid x 5 days if increasing despite this.
Hospitalization for hypertension and COVID-19 on dates 10/29/22- 11/3/22. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
For the first day after vaccination I was so fatigued I couldn't get out of bed. My arm was too sore to use for about 48 hours, and I had a headache starting 12/23 and lasting through 12/25. Both arms were very sore then on 12/25. Nausea started 12/26.
Patient went to ER day after vaccinations was given presenting with fever. Patient had febrile seizure and otitis media.
severe itching in throat and mouth  diphenhydramine 50mg   patient declined calling 911, mother picked patient up to take home for observation
Pt received 4 vaccines, fell face first from exam table. Lost consciousness for a few seconds, came to, conversive, responsive. Jaw pain, broken teeth. Sent to ER. Fx. mandible.
Pt received shot at 12 PM 10/23/15 and woke up with chills, shaking, upset stomach and more than normal bowel "movement", not previously know to be adverse effects from vaccine.
Dizziness, lightheadedness, inability to focus/ concentrate. 24 hours in length.
Hives and rash for 6 weeks. Saw PCP - steroid shot and Dose pak, had to stop taking BENADRYL PRN.
day p/vax rt arm swelled up form finger tips to shoulder blades;most of swelling occurred on neck side of arm;no redness or heat to area;lasted 5 days;pt feels in a vacuum out of balance;
Patient developed b/l upper/lower arm rash ~9 days after his initial vaccination, which took another 10 days to spontaneously resolve. He did not try or apply any medications. He describes the rash as "red bumpy, bumpy." No described vesicles, no changes in routine/habits including no changes in clothes, detergent, or limited outdoor activities (although initially stating he "landscapes," this was clarified as helping to water the plants outside the condo where he lives). He currently lives alone and does not know anyone else who had a similar rash. Denies that rash was warm to touch erythematous or swollen. There were some "small kine" areas that were itchy, but he is not sure where they were on his arms. On brief exam, skin over b/l upper and lower arms w/o rash at today's visit.
This spontaneous report as received from a pharmacist refers to an 83 year old female patient with asthma and no know drug reaction/allergies. On 30-SEP-2013 the patient was vaccinated with a 0.5 ml dose of ZOSTAVAX, subcutaneous (lot number J001695). Concomitant therapies included clonidine, propranolol hydrochloride, VERAMYST nasal spray, clotrimazole and betamethasone topical cream. On 01-OCT-2013, the patient experienced injection site reaction which was raised, red and mildly itchy. The pharmacist stated that the reddened area was approximately 4 inches in diameter. She confirmed that no vesicles were present. No treatment was given for the adverse events. No lab diagnostic tests were performed. The patient sought medical attention at the pharmacy. The outcome of the events was reported as not recovered. The casual relationship was not reported. Additional information has been requested.
Pt started running high fever at 4 p on 4/13/12, shortly after patient started having seizure like activity. Pt was transported to hospital by ambulance and was seen in ER.
30MAY pt recv vax @ 3:30 by 5:30 pt wouldn't eat supper by 6:30 pt was lethargic & cranky;31MAY had a fever of 104 & was seen by MD;wouldn't move for 24hr p/vax
Soreness, swelling to right upper and lower arm, axilla and right breast area. No redness. No treatment done. No fever noted.
little rash on both feet; hives on legs, chest, face, back, ears; headache; nausea; Very tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on legs, chest, face, back, ears), RASH (little rash on both feet), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (Very tired and fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma (The patient has a past medical history of underlying condition of cancer (lymphoma). Patient reports she has a rare "B cell "lymphoma"). Concurrent medical conditions included Drug allergy (Allergic to some medications but not anaphylaxis.). Concomitant products included FAMOTIDINE for Acid phosphatase normal, SIMVASTATIN for Blood pressure, LISINOPRIL for Blood pressure high, DOCUSATE SODIUM (COLACE) for Increased stool volume, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Multiple allergies, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN B6 and CYAMOPSIS TETRAGONOLOBA GUM (FIBER MATE KIDDY) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea) and FATIGUE (Very tired and fatigue). On 10-Mar-2021, the patient experienced URTICARIA (hives on legs, chest, face, back, ears). On an unknown date, the patient experienced RASH (little rash on both feet). The patient was treated with PREDNISONE at a dose of 20 mg once a day and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 25 mg. On 11-Mar-2021, URTICARIA (hives on legs, chest, face, back, ears) had resolved. At the time of the report, RASH (little rash on both feet), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (Very tired and fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-231311 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-Jun-2021 Updated patient demographics, medical history, Added concomitant medications, treatment medications, Added new event Fatigue, updated the end date of the event Hives.
8/08/2007 3:45pm Vaccines below administered. 4:45pm Child vomited x 1,scratching hands and feet. AAO,airway patent, lungs CTA. Hives,rash,erythemia present on face,chest,feet,and arms. Edema noted on face and feet. 4:50pm Administered 0.2ml Epinephrine 1/1000 SubQ L.arm 4:52pm Benedryl 0.25ml(12.5mg) IM Left deltoid. 911 called at 4:53pm. Monitored pt. until ambulance arrived. 5:00pm Ambulance arrived,pt. stable,transported to Emergency Room. 8/09/2007  Called mother to follow up on ER visit.  Mom stated" Child observed for a couple of hours. They gave him some liquid medicine(Mom did not know name of medication administered) and let him go home." Mom states"He is doing fine" " Has good appetite, playing and the rash is gone."
Soreness with swelling & redness to the injection site  9 days post vaccine.  Also mildly itchy. Axillary pain that began 2 days ago.  After the vaccine, I had arm pain that radiated up my neck, lasting 3 days, with a headache & fatigue. The headache & fatigue continues to linger.  The arm swelling,redness, etc, with axillary pain are the reason  I?m filing this  report.
Egg shaped swelling (1 1/4 in x 2), redness, heat on 10/2; swelling increased to (1 1/2 x 3") on 10/3; swelling elongated to 5 inches on 10/4 with low grade fever; pt saw her MD on 10/4 when 3 vesicles on one side & 1 vesicle on other side of body appeared.
after about a week my ears started ringing, I immediately thought it might be fro the booster, gave it time to hopefully clear up it did not it kept getting louder,   as time went on I started researching to find answers. after 3 months with no reseloution
Mouth sores; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot Number: Er9231, via an unspecified route of administration on 30Dec2020 at 09:00 (at the age of 28 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included herpes simplex virus 1 from an unknown date, and known allergies to some fruits and vegetables (mild itching), and Neosporin.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included Benzoyl peroxide and tretinoin face cream, and vitamin D, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 31Dec2020, the patient experienced mouth sores. Treatment was not received for the event. It was also reported that since the vaccination, the patient has been tested for COVID-19 using a nasal swab on 31Dec2020, with results of negative. The clinical outcome of mouth sores was recovering.
April 12, 2014 he spiked a 105 fever, brought to the ER, they gave him antibiotics through IV, go the fever to come down, sent us home. The fever came back on the 13th. We brought him to the Hospital and they admitted him for a day. They believed it was viral. The fevers came back monthly. Each time they came back it was between 103-105. Each and every time they said it was viral. It was not until October 2014 that we saw a Rheumatologist and she believe it was a Periodic fever syndrome known as PFAPA. The only treatment he got was TYLENOL and MOTRIN. We tried prednisone but it did not work. He had an emergency T and A done April 19, 2016. He only have a couple fever episodes after the T and A. He did have hallucinations with some of his fevers. He was also diagnosed with ADHD around 2.5 years old, ASD, ADHD, and ODD at 3 years 3 months old. He was also diagnosed with Hypothyroidism at 2 years old. He is currently on SYNTRHOID for the hypothyroidism and DEXEDRINE for the ADHD. He has been doing speech therapy, OT, and PT. He was diagnosed with a speech delay, fine and gross motor delay, and sensory processing issues as well. He is also delayed in bone age.
Pt developed diffuse urticaria about 5 minutes after vaccines given. Lungs clear, vitals stable, no swelling. BENADRYL 9mg given and resolved.
Ear ache; Tiredness; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical information Team. An 88-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 20Apr2021 (at the age of 88-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed an ear ache and tiredness since receiving the vaccine on 20Apr2021. The consumer asked these are normal side effects and how long will they last. Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pt.'s daughter states that after her Mother received the 2nd dose of Moderna 03/04/2021, started experiencing symptoms 03/05/2021 with nausea, vomiting, and severe headache. ER visit 03/07/2021 noted internal bleeding (treated with coils) 03/15/2021 discharged. Blood clot located *heparin treated. No resolve, made comfortable and passed away 03/18/2021 03:00pm. Blood Clot blocking blood flow to bowels. No noted Autopsy, Cause of Death listed (Organ Failure)
ITCHING AT VACCINATION SITE APPROXIMATELY A WEEK AFTER INJECTION. THEN REDNESS, SWELLING, HOT AND ITCHY, FOR THE NEXT SEVERAL DAYS. SPREADING DOWN AND AROUND ARM ALMOST TO ELBOW.  STILL SPREADING.
The injected muscle became painful to motion about 6 hours after injection. About 24 hours after the dose, a circular hot, erythematous, and mildly swollen rash appeared starting approximately 3 cm below the injection site and extending distally. After 58 hours, the red circle has become larger, encompassing most of the upper arm. The underlying muscle pain is now mostly resolved, however the rash is still tender to palpation. It also developed pruritus the morning after it appeared.  Oral antihistamine (loratadine) and topical OTC hydrocortisone cream has been ineffective. It appears worsened after hot shower. Pruritus is responsive to ice.
Within several hours of vaccination, began having pain in upper left leg and tingling in left leg.  Shot was administered in upper left arm.  Days following vaccination: pain in left leg, left side below ribcage felt sore and bruised; developed rashes on legs and burning sensation in arms and hands that would come and go; large bruises on legs and arms began showing up for no reason; extreme exhaustion day of vaccination and for several days afterwards.  3 days after vaccination: extreme abdominal pain lasting several hours. For 2 weeks following vaccination: left arm pain and left shoulder painful and difficult to use; could not lift anything with that arm and had to use heat packs on arm, finally began to get better but still have pain from time to time in my left shoulder.  Blood work performed on 6/18 showed rise in Eosinophils (642) normal range is 15-500.  Did not have a menstrual cycle following vaccination until 58 days later.  Last period ended on May 29, 2012.  Vaccinated June 4th.  Did not have another period until July 28, 2012. Went to doctor on 6/18 and reported complaints, doctor ordered the blood work.  I do not have insurance so I could not afford to make several visits.  I am to return for blood work and follow up appointment with doctor, which I plan to do this week, August 2012.