chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever for two days immediately following vaccine. 5 days later, she broke out in a rash on her face, chest, stomach, back, arms, and legs. It has been over 2 weeks since her vaccine and she still has the rash, and has run a fever for 2 days and also has diarrhea. The diarrhea has caused a terrible diaper rash on top of all other issues.
Right deltoid rash (large hive) over area of injection. Treated with triamcinolone cream.
Initial and follow up information has bee received from a registered nurse and a physician concerning a 62 year old female with no drug allergies and with hypertension, diabetes, hypothyroid, high cholesterol, depression and myalgia, who on 19-JUN-2007 was vaccinated intramuscularly with a dose of PNEUMOVAX 23. Concomitant suspect therapies included losartan potassium-HCTZ, tablet (MSD) (dose, duration and indication not reported) and simvatatin, tablet (MSD) (dose, duration and indication not reported). Other concomitant therapy included levothyroxine Na, glipizide, metformin, ZOLOFT, ACIPHEX and ALLEGRA. On 05-JUL-2007 the patient's temperature was 101F. On 06-JUL-2007 the patient experienced a wheezing, and tickling in throat. On 19-JUN-2007, (also reported as 06-JUL-2007) the patient developed a cough. The patient was seen in the office on 27-JUL-2007 and was still coughing and wheezing, no fever. She was seen on 08-AUG-2007 with coughing and wheezing in her chest. The patient was treated with an unspecified cough syrup. The cough coincided with receiving the vaccination. The physician thought it was a coincidence, however the patient insisted. On 27-JUL-2007 a chest x-ray was taken and was negative. The patient was given pulmonary function tests and a sinus x-ray, which were both negative. The patient was also given a peak expiratory flow rate test with the value being 25 to 75. The patient has an appointment with the pulmonologist on 10-SEP-2007. No product quality complaint was involved. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). In July 2014, the subject received an unspecified dose of KINRIX (unknown route and injection site, batch number not provided). In July 2014, less than 2 weeks after vaccination with KINRIX, the subject experienced swelling injection site. This case was associated to a product complaint. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. The reporter reported 2 other cases of swelling injection site after vaccination with KINRIX (cases A1083480A and A1083482A). These cases were associated to a product complaint since the reporter said that these cases happened in a relatively short period of time so she was afraid they were related to a specific lot of the vaccine. Follow-up information received on 11 August 2014: A safety statement was requested, an evaluation was performed and the conclusion shows that: "The review of the currently available safety data for batch number 94F5K and family does not highlight a safety issue. It is unlikely that the reported events are related to a manufacturing problem. No investigation required." GlaxoSmithKline Biologicals considers this product complaint as unsubstantiated.
GENERALIZED WEAKNESS Narrative: 79 yo male with PMH: aortic valve disease, seizure disorder, hyperlipidemia, DM2, HTN, CHF, BPH reported that after his first covid19 Moderna vaccine on 2/13/2021, his "blood sugars skyrocketed to 400, BP hit the floor, and was weak as a coon." This was reported on 3/4/2021 when patient was contacted for his second dose of covid19 vaccine. Chart review did not show that patient sought medical care for his ADR. There isn't enough information to report as "moderate" and it sounded like symptoms self-resolve.
This spontaneous report as received from a doctor of pharmacy concerning an approximately 76 years old female patient who on an unspecified date was vaccinated with ZOSTAVAX (dose, route and lot # not provided) on 11-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that yesterday on 11-DEC-2012, 7 hours post vaccination client developed pain in the left arm and has a firm, quarter size area at the injection site of left arm, but no rash, no streaking. The pharmacist also stated that client also complained of muscle aches in her legs. The patient would go to the ER to rule out cellulitis. The pharmacist described that the client would also follow up with her health care provider. No treatment was given for the adverse events. The outcome of pain in left arm, muscle aches in her legs and firm, quarter size area at the injection site of left arm, but no rash, no streaking was reported as not recovered. The relatedness for firm, quarter size area at the injection site of left arm, but no rash, no streaking, muscle aches in her legs and pain in left arm was unknown for ZOSTAVAX. Additional information is not expected.
Immediate pain in shoulder - symptoms intense x 2 days, then decreased symptoms. Flare up pain 1 1/2 wks later.
Onset of bloody stools, 10 hours, post vax. Since then, continuous diarrhea. Has developed various food allergies since the administration of vaccine.
Not sure if I have the 'lot number,' correct.  I took it off of the receipt the clinic gave me.      Five hours after receiving injection, I felt ill and muscles began to ache.  Eight hours after injection, I went to bed, but could not sleep as had chills then sweating, heart racing for the next 10 hours.  Felt like I was on speed with serious muscle aches throughout my body. Nineteen hours after injection, I was able to get some good sleep for a few hours.  Twenty-three hours after injection I'm still feeling a bit achy and sluggish, but was able to go to work.
Patient claims to have fatigue that started since she had the vaccine and is still persistent,  also claims to have tinnitus.
12/31/2021  History of Present Illness  The patient presents with 76 year old male with a medical hx of pneumonia and leukemia presents with worsening shortness of breath and associated yellow nasal drainage onset of x4 days ago. Patient reports of recent sick exposure from wife. Pt notes of getting pneumonia yearly and is worried for that. Patient denies any chest pain, fevers, chills, diarrhea, vomiting, back pain, nausea or vomiting..  The onset was 4  days ago.  Risk factors consist of age.
I had a miscarriage on 01/01/2021  Estimated date of Delivery 09/7/ 2021
possible ear infection; 50% hearing loss; Ruptured left eardrum; bleeding from ear; sores near left side of mouth; Left jaw pain; inflamed gums; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of ear infection in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingrix. On 24th August 2022, 2 days after receiving Shingrix, the patient experienced fever. On 27th August 2022, the patient experienced ear infection, partial hearing loss, perforated eardrum, ear hemorrhage, skin ulcer, jaw pain and gingival inflammation. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and antiinfectives, otological (nos) (Antibiotic Ear Drops (Nos)). On an unknown date, the outcome of the ear infection, partial hearing loss, perforated eardrum, skin ulcer, jaw pain and gingival inflammation were not recovered/not resolved and the outcome of the ear hemorrhage was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the ear infection, partial hearing loss, perforated eardrum, ear hemorrhage, fever, skin ulcer, jaw pain and gingival inflammation to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The reporter was the patient. The reporter stated that after received Shingrix vaccine the patient experienced a slight fever, 5 days after received Shingrix vaccine the patient had sores near the left side of mouth, left jaw pain, inflamed gums, ruptured left eardrum with bleeding from ear and 50 present hearing loss. The patient visited primary care physician and was given an unknown antiviral pill for 10 days.  Patient visited an ear, nose and throat (ENT) healthcare professional (HCP) and was told patient had a possible ear infection and was given an antibiotic ear drop.  Patient had a follow up appointment with the ear, nose and throat (ENT) today (on the reporting day).  Reporter had nothing else to report. The reporter declined consent to follow up with healthcare professional. The reporter consented to follow up only with her.
Initial report received from a health care professional on 10 April 2007. A 21 month old, female patient (with no medical history) developed hives within a week after receiving her fourth dose of Daptacel (lot number C2565AA) intramuscularly in the right thigh and her fourth dose of IPOL (lot number not reported) intramuscularly in the left thigh on 21 March 2007. It was reported the hives started at the injection site and spread all over her body. She was seen at the pediatrician's office on 10 April 2007 and the generalized hives persisted with itching. Hydroxyzine was prescribed. The patient did not have any illness at the time of the vaccinations. At the time of the report, the patient had not recovered. Follow-up information received on 30 April 2007. The patient had no known allergies. She received dose 3 of IPOL (lot number Z0547). As of 1 week ago, she still had a rash.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
As soon as I received the vaccine about 1 minute after I started with racing of heart, feeling like my oxygen supply is being cut off, lost my hearing basically felt like I was going under with like anesthesia that lasted 5-6 minutes and then I reported it to the front staff who told me they could give me Epi pen but I refused Bc they would have had to call ambulance so they gave me 2 Benadryl I stayed for 5 more minutes then left absolutely exhausted. My hubby and I came home and went to take nap and later about 1 -2 hours after I woke up to SEVERE itching! It was horrible!!! Then I couldn?t stand much, very dizzy and unsteady on my feet. Every step I took was painful my whole body hurt and felt like I had been beaten! This went on all day then I woke up Sat morning could not walk still was in lotttt pain, so my hubby takes me to er . Long story short they provided wheelchair for me, and 45 minutes later found me bed, did chest X-ray, blood work , iv , EKG everything normal. The dr shook his head Bc he had no idea what else to do kept apologizing to me. I left the way I came basically.  Sunday I was exactly same but Tuesday the limp seemed to get better and then I discovered a knot on my left upper thigh and freaked so I called my dr. My Thursday I was struggling again limping, dizzy etc. Friday I went to the dr she said muscle was very tight in my upper tight and given all my symptoms I could have Guillan Barre and she gave me handout told me what possibly look for. Symptoms are scary! She also referred me to neurologist which she said I should get a call soon. I went home couple hours later stiff when I stand, walking painful but I almost fell 2 times! Very unsteady on my feet, then I noticed pins needle feeling in my leg right arm hand goes numb now. I?m absolutely exhausted struggling to get to the bathroom! A week ago I was pretty healthy 39 year old who worked out and on the go now I struggle to walk!
I had an allergic reaction at the site of injection on my left arm. I applied alcohol and a new bandaid at 10:30 pm and went to bed. I woke up at 3 am with my left arm in serious pain. I removed the bandaid and the top skin was removed at the site of the bandaid. The area was swollen and inflamed red with a large circle on my upper left arm.
Running a high fever (101) even though my normal temp is 97.4;  could not lift my body to get out of bed; Nausea; headache; muscle aches; pain at injection site; never felt this sick in my life.
Patient became dizzy and felt "pressure in her head" 10 minutes after vaccine administration. Vitals signs monitored and patient placed in a supine position. Symptoms resolved within 30 minutes.
Approximately 1 hour after immunization experienced nausea, headache behind eyes and neck pain on both sides of neck. Seen at clinic. He reported to the physician at the Health Clinic that he also experienced fatigue and hot feeling. All symptoms resolved within 24 hours.
Moderate abdominal cramping; diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old male patient receive the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine batch/lot number: Eks730), via an unspecified route of administration on the arm left on 16Dec2020 16:15 at a single dose for immuninzation at the hospital.  Medical history was reported as none. The patient had no allergies to medications, food, or other products.  There were no concomitant medications. Prior to vaccination, the patient not diagnosed with COVID-19 and the patient has not been tested for COVID-19 since the vaccination. On 16Dec2020 17:30, the patient experienced moderate abdominal and diarrhea. The patient did not receive any treatments for the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
11/2/06 Experienced pain the day after Pneumonia injection with a 2-3 cm red area.  11/3/06 Temperature 102.9 entire left shoulder and inner aspect of left arm 7 x 8 cm bright red, swollen and warm to touch. 11/4/06 left arm got worse before getting better.  Patient got weakness, headache and dizziness.
Monday October 18th I had diarrhea. I went to work the next day on October 19th. After I ate lunch I had some type of pressure in my chest so I left work. October 20th I went to Walk-In Clinic. They ran some test, but the doctor said he couldn't find anything wrong with me. I came home and laid down. I didn't feel any better. I went back to work that following day, and I have been feeling good ever since then.
No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 13-NOV-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020, for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA011816: US-009507513-1912USA011814: US-009507513-1912USA011815:
Developed redness, swelling, warmth, itching and pain to right deltoid injection site.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Urticaria, Spinal stenosis, Thyroiditis NOS, Heartburn and Hives. Concurrent medical conditions included Cholesterol. 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient Date of birth/age was reported.
pt recvd vax 22AUG95 & 13SEP95 pt devel a generalized varicella-like rash;there were a couple of lesions on both arms, legs, & chest; devel lesion on toe & forehead;
Tenderness, redness approx 2.5 inch around injection spot, hardness is same area ~~~ now 3 day since injection
headache; pain around her eyes; pain around her eyes and face; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first and second shot, patient experienced headache, pain around her eyes and face. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
09/27/2006 pt reported, left deltoid hot to touch hard, red and no rash. Follow up 10/13/06 pt states 9/28/06 that area cleared.
Blood clots after the 2nd dose; Blood clot split and some went into side of lung; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 14Feb2021 at 15:45 (Lot Number: EL3247) (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, family history, or concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: E10142 (as reported)), in the right arm, on 24Jan2021 at 15:45 (at the age of 73-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced blood clots after the 2nd dose and blood clot split and some went into side of lung in Feb2021, which required hospitalization from 27Feb2021 to 28Feb2021. The clinical course was reported as follows: The patient stated he did not know what date the blood clots occurred and can't tell when that happened, but it was maybe a few weeks after the second dose of the vaccine. He stated that one blood clot is in the right leg near the calves and the blood clot broke and split some and went up into the side of his lung as it was detected in a doppler on 27Feb2021. The patient was hospitalized from 27Feb2021 to 28Feb2021. The doppler was performed as soon as he went into the emergency room and they went through a series of tests with unknown results on 27Feb2021 and 28Feb2021. The patient stated that the right leg is bigger than the other leg and they told him it might stay that size and may not go down. The patient is now on apixaban (ELIQUIS) 5 mg for the rest of his life. In the beginning, they gave him an unspecified shot in his stomach, then after that he began taking apixaban at two pills in the morning and two pills at night, then they cut him down to 1 pill in the morning and 1 pill in the evening, and he started it right when he went into the hospital immediately. Therapeutic measures were taken as a result of the event as aforementioned. The clinical outcome of blood clots after the 2nd dose and blood clot split and some went into side of lung was unknown.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of  9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H01999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 11-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.