chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT CALLED 11/30/09 SAYING HER ARM/SHOULDER WAS STILL HURTING FROM AFTER GETTING HER FLU SHOT.  HAS BEGAN TO INTERFER WITH DAILY FUNCTIONING.  HAS BEEN TWO MD'S.  THEY HAVE TOLD HER THE SHOT COULD HAVE POSSIBLY HIT A NERVE.  SHE CALLED THE PHARMACY 11/30 AND ASKED IF THERE WAS ANYTHING SHE COULD DO.  SHE WAS TOLD TO KEEP WATCH ON IT AND WAIT IT OUT, IT COULD TAKE A WHILE TO GET BETTER
I started having abdominal pain, cramping, nausea, frequent urination. The next day I had extreme fatigue, headache, joint pain, and low-grade fever 99.8. No cough until Sunday 09/19/2021. I had chest tightness and increase cough and SOB. I spoke with my doctor on 09/20/2021. I got a Covid test on Tuesday 09/18/2021 because I was going to have an outpatient colonoscopy on Tuesday. I thought these symptoms were just my body reacting to the vaccine. I have trying over the counter medications, Tylenol, Ibuprofen, Oscillococcimum, increasing vitamin D, multi vitamins. I was positive to Covid. My husband and son were positive too. I am fatigued.
Patient reported having 2 seizures at 7:30am and another around 9:15-9:30am the day after vaccination.  She has had seizures in the past and is not on any maintenance medication for this condition.  She did not require immediate medical attention.
10/11/12 - Mild reaction as reported by patient: Low-fever 100.5, vomiting, nausea, can't left left arm, can't get out of bed.
Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her throat, tingling of lips and tightness on her throat. Dr. was immediately called. Orders for Benadryl 100 mg IM was given and medication was administered on right gluteus.  Vital signs were taken and recorded on chart.  Patient was monitored and verbalized improvement within 5 minutes of adminstration.  Patient was monitored for another 30 minutes.   Patient stated that she was feeling better.
Employee reported, via telephone, left arm became swollen several hours after receiving Heplisav-B injection. She also stated the left side of her face is affected with swelling but denies hives, urticaria, itching, swelling of tongue-denied difficulty breathing. Employee waiting in ER at time of VAERS write-up and was in no distress during phone conversation.
REPORTS " BAD SICK" W/NAUSEA AND DIARRHEA FOR ABOUT 12 HOURS 2 DAYS FOLLOWING 2ND VACCINE.
About 1 hour post vax, experienced flu-like symptoms. Light-headed, dizzy, flush, pain in the joints, muscle aches. A couple of hours later, the symptoms have subsided somewhat.
Dose number 3; Chills; pain at injection; Arm pain; Chest pain; This is a spontaneous report from a contactable reporter (consumer or non HCP).    An adult male patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE 1, SINGLE, Lot No: UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE 2, SINGLE; Lot No: UNKNOWN), for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number 3"; CHILLS (non-serious), outcome "recovered", described as "chills"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at injection"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm pain"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pain". It was unknown whether therapeutic measures were taken for the events chills, vaccination site pain, pain in extremity and chest pain.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks the prior to the COVID-19 vaccine. It was reported that during conversation with a friend, he said that he experienced chills, pain at injection, arm pain, and chest pain a day after receiving a booster dose. He said it was resolved in a few days. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a consumer concerning a 12 month old patient who in August 2005, was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Suspect vaccination included a dose of varicella virus vaccine live. In August 2005, the patient developed a systemic rash and fever. Unspecified medical attention was sought and the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Got Shingles shot at Wed. 11:00am. About 4:00pm started shaking like I was cold even though having a coat and blanket on. Felt like I was running a fever. That lasted for about 12 hrs. The next day, Thur upset stomach, headache, nausea, felt sick. Arm a little sore. Fri started having significant diarrhea that lasted 2 days. All or some of these symptoms continued for 7-10 days.
States had flu shot about 11am and started not feeling well about 3pm-felt chilled, achy, tired, throat felt raspy. States also had lower back discomfort (pre-existing problem). Took Tylenol about 7pm and checked her temp at about 8pm and temp was 100.8 degrees. States L arm felt hard and hot and sore. States her sx. reminded her of times she reacted at times to past allergy injections. Did not seek medical attention. States OK next day except for feeling tired.
Req epi, Benadryl, Albut, Atrovent, Decadron and hospitalization at hospital. Resp distress.  07/02/2008 MR received for ER visit 6/13/2008 with DX: Anaphylactic reaction to vaccine. Pt developed acute onset of cough, wheezing and retractions ~ 15-20 after receiving YF and Typhoid vax. Became cyanotic and required O2 en route to hospital.  Parent reports perioral and lip swelling now resolved. Tx with O2, nebs, Benadryl and Decadron.  Observed o/n and d/c next day.
extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
I received the shot around lunchtime and felt fine until 6pm when I had a bad headache. I took some tylenol and continued do school work. I laid down and took a nap at 9-11:30 pm. I woke up with body rigors/fever and an even worse headache. I was walking around the house, went downstairs to use the restroom, came back upstairs to get another dose of tylenol and rehydrate. As I was walking around the kitchen getting those items, I started to feel heart palpitations and I felt very nauseated. I collapsed on the hardwood floor. My spouse heard me hit the ground and saw me laying there with my muscles twitching for a few seconds before I was stiff. He called 911 and I woke up within about 30 seconds but I was confused.  EMS got my VS and my pulse was 126 and my BP was 110/something.  I was transported to the ER and had lab work and an EKG. My EKG showed a right axis shift. I followed up with my PCP today to have a repeat EKG and cardiology follow-up.
a rash "broke out" where the shot was/she thinks she is allergic to one of the Prevnar 13 ingredients; broke out in a rash up and down her arm; arm started getting hot; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2019 (reported as 2 years ago June) as second dose, single for immunization. Medical history included influenza immunisation from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) on an unknown date for immunization. The patient had a Prevnar 13 shot 2 years ago in the summer, a rash "broke out" where the shot was, on an unspecified date. She will receive the Johnson & Johnson COVID-19 vaccine and she wants to compare their ingredients list with the ingredients in Prevnar 13, as she thinks she is allergic to one of the Prevnar 13 ingredients but doesn't know which one. She requested the prescribing information via email during the call to check on the ingredients.The J&J ingredients she wants to compare are: ad26.cov2.s 5x1010 virus particles, sodium chloride 2.19 mg, citric acid monohydrate 0.14 mg, trisodium citrate dihydrate 2.02 mg, polysorbate 80 0.16 mg, 2 hydroxypropyl-b or 3-cyclodextran, ethanol 2.04 mg, genetically modified organisms GMOs. Mentioned there's no lactose, PEG, gelatin, egg-derived components, not derived from human animal origin, no adjuvant, no preservatives. Patient stated she has an appointment for the vaccine with Johnson and Johnson and her pharmacist told her to call us. Patient stated that she had the Prevnar 13 Pneumococcal shot 2 years ago June and she broke out a week later in a rash up and down her arm had to go to the doctor and got antibiotics. She had no problem with the flu shot or the first Prevnar 13 Pneumococcal shot, just the second one. States she talked to someone at Johnson and Johnson for the Covid vaccine to see what is in that vaccine and would like to get information about what ingredients are in the Prevnar 13 Pneumococcal shot. Patient stated that 9 days later she had a rash down her arm and her arm started getting hot on an unspecified date and she waited a few days and called her doctor and he wanted to see her. Relayed that when she went in her arm was warm, like hot and the doctor told her she needed an antibiotic, and they were horse pills and she took that for 10 days and they told her to ice it to get it calmed down. Therapeutic measures were taken as a result of the events. Clinical outcome of the events was unknown.   No follow-up attempts are needed, information about lot/batch number has been requested.
vaccinated with PPSV 23 on 30-SEP-2013 and PCV 13 on 20-OCT-2015; Information has been received from a nurse referring to a 67 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 16-APR-2008 and 30-SEP-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, frequency, route, lot # and expiration date were not reported) separately for prophylaxis. However, on 20-OCT-2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) for prophylaxis (inappropriate schedule of product administration).   This is one of two cases about the same patient (split from legal case).; Sender's Comments:  US-009507513-1801USA002424:
On 9/10/08 patient had terrible pain down right side of chest and right arm; went to ED and was discharged with "sprained arm" and a splint. Went to family physician the next day and was diagnosed with shingles; was referred to dermatologist for second opinion and diagnosis was confirmed.  Patient placed on Valtrex.  Sts pain and swelling on right elbow was excruciating. States "felt like a huge boil that wouldn't erupt." Unable to bend arm for a few days.  Pain lasted approx. 3 weeks.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) were 216, 34 and R. The storage criteria was R. 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 13 year old female patient with no pertinent medical history and no drugs reactions or allergies who in 2008 was vaccinated with a dose of GARDASIL (lot # unknown). There was no concomitant medication. The physician reported that the consumer's mother stated that her daughter was given the GARDASIL shot incorrectly. "It was administered incorrectly". At the time of report, the patient outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Patient received multiple vaccines on 05/18/2011 including MMR Varicella Hep B, Hep A, HPV, IPV, DTAP. Fever occurred on 05/28 with rash on 05/31 remarkable for pink papules on cheeks, forehead, neck and chest; no vesicles. Treated with Claritin and Benadryl for itch.
noticed a knot that afternoon.started applying warm compresses.That next morning noticed redness and swelling. Gave Tylenol 2 times a day.Was itching Benadryl cream applied.
c/o swelling and itching rash around mouth approx 6 1/2 hrs after receiving immun-lasted approx 30 hrs. Felt feverish didn't check temp; Took Benadryl 25 mg. Also had "really bad headache", felt tired and achy. Took 3 reg Tylenol.
This spontaneous report as received from a registered nurse refers to a 4 years old male patient with walnut allergy. The nurse reported that the patient received series dose of live (Merck) VARIVAX (Lot# not reported), 1st dose on 23-FEB-2009, and 2nd dose on 27-FEB-2012. Concomitant medications included: EPIPEN for walnut allergy. On 03-JAN-2013 the patient contracted the chicken pox. Nurse reported that "the rash started on the patient's buttocks and was spreading throughout his body." The patient visited office for medical attention. BENADRYL and calamine lotion were given for treatment. At the time of this report the patient had not recovered from chicken pox. Additional information is not expected.
Muscle in lower area of throat started to feel slightly tight. Could still breath and swallow. Several staff members checked on me. Blood pressure top number was 175, ten minutes later it dropped to 155. Staff member stated my pulse was elevated. Although, I only felt the slight tightness in my throat. My oxygen level stayed at 98. They had me stay for an hour and then I went home. By then the tightness started to lessen. After an hour or two the feeling was total gone. My blood pressure had gone back to normal when I checked it at home. The next day at 2 pm [13 hours later] I had a temperature of 99.1, had the chills yet felt warm, started a slight headache and became very tired. At 2 am in the morning everything was over. I woke at my normal time and felt great. Have been doing well ever since.
bilateral sensorineural hearing loss; Tinnitus; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 10-MAY-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered constant ringing in his ears along with hearing loss and was diagnosed with bilateral sensorineural hearing loss (deafness neurosensory) and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to the resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the pt's sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of deafness neurosensory and tinnitus. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered deafness neurosensory and tinnitus to be disabling events.  Upon internal review, deafness neurosensory was determined to be a medically significant event.
Significant fatigue, low fever, required 2 days away from work to sleep (have never had this type or degree of reaction before).  Significantly impaired ability to perform normal daily tasks.
Vaccine was inadvertently administered 5 days after the BUD of refrigerated vaccine. Pfizer was contacted and their recommendation was for the dose to be repeated, CDC appendix D.  Vaccine administration errors and deviations guidance was also followed Patient was contacted and advised to return for another dose.
Hospitalization: admitted 7/19/2022; discharged 8/18/2022. Presentation to the ED: patient presented to the emergency department due to progressively worsening shortness of breath associated with wheezing,overall fatigue and generalized weakness, and decreased oxygen saturation. COVID-19 + date: 8/28/22 Treatment: increased supplemental oxygen, no COVID prophalyxis was given. Discharge to: SNF.
Information has been received from a 61-year-old female, with no pertinent medical history or allergies, who on 28-JAN-2008 was vaccinated intramuscular with a 0.65 mL does of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 28-JAN-2008, the patient experienced injection site redness, swelling and warmth. The patient sought unspecified medical attention. At the time of the report the patient status was not reported. No diagnostic labs were performed. A product quality complaint was not involved. Follow-up information received via medical records indicated the following: A 61-year-old female, with no pertinent medical history or allergies, on 28-JAN2008 was vaccinated subcutaneous with a first 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658085/0882). On 14-APR-2008, the patient was seen by the physician complaining of persistent left arm tenderness at the injection site in January. Initially the patient noticed bruising as well as redness and warmth. Those symptoms resolved within a week or so. Although the tenderness improved the patient continued to experience tenderness when she laid on her left side or when she abducted her shoulder. An exam of the left shoulder showed no swelling or deformity. No erythema. There was fairly localized tenderness over the deltoid muscle about 3 or cm distal to the shoulder joint. The shoulder itself was non-tender to palpation. Full range of motion of the left shoulder with discomfort with internal rotation. Muscle strength was normal in upper extremity. Deep tendon reflexes were 2 plus and symmetrical in upper extremities. Assessment: Tenderness, left upper arm. The physician noted she could not be absolutely sure this is related to the injection. The patient seems to feel the two are related. The physician also noted she was not sure why the patient would be having tenderness at this point, but assured the patient that there was no sign of infection or any swelling to suggest calcification or scar tissue. If the shoulder pain does not continue to improve over the next month the patient was instructed to call back for a referral. Additional information has been requested.
Severe fatigue 01Apr2021 to 04Apr2021 Chills 01Apr2021 to 02Apr2021.  Sweating 01Apr2021 to 02Apr2021 Entire body aches  01Apr2021 to 02Apr2021  Took Tylenol for body aches (650 mg) twice
This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and chills. On an unknown date, the outcome of the myalgia and chills were recovered/resolved. It was unknown if the reporter considered the myalgia and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced myalgia and chills lasted at least 8 hours. The reporter agreed to be followed up. This case has been linked with the case US2018GSK172977, reported by the same reporter.
This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 63-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for immunisation, HUMALOG, via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient medical history and patient's concomitant medications were not reported. It was reported on an unspecified date that the patient allergies: is allergic to environmental, HUMALOG, NSAIDs, Penicillins, Pneumococcal vaccine. The action taken in response to the event for insulin lispro was unknown. The outcome of the event was unknown. Information on the batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.