chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US001112 is an initial spontaneous report received from a consumer on 13 Jan 2014. This report refers to a 39-year-old female patient. She had a significant medical history of dysautonomia. She denies any allergies but explains that she gets sick to her stomach after eating eggs. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on either Dec 2004 or Jan 2005. She experienced an adverse reactions immediately after receiving the flu shot stating that her heart was beating fast, the room was spinning, sweating, vomiting and couldn't breathe. She did not receive any medical care after the incident. Outcome of the events was unknown. Seriousness and causality were not reported.
Day after receiving DTaP mother presented at ED with child presenting with edema to injection site. 10 cm induration. Dr. treated with prednisolone and alternating hot / cold packs. 2nd day after receiving injection, mother notified health department of adverse event and stated that swelling was much better.
6-9 hours from administration: Patient reports severe nausea, fatigue, abdominal pain ("it feels like someone took a baseball bat to me a hand's width above my belly button"), joint pain, shivering, and fever (avg temp 96.7, 12 hour peak following administration 100.3).  13 hours following administration: patient reports finally falling asleep 16 hours following administration: pain at injection sight ("it may have hurt all along, but I was distracted by how bad the rest of me was feeling") Symptoms have started to improve ~24 hours following administration of recombinant zoster vaccine.
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight  feeling in chest).
Dizzy; Brain fog; Diarrhea; stomach cramping; Menstrual spotting; Cramps 2 weeks early; Body aches muscles and joints; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 14Aug2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 at 19:00, the patient experienced dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy, brain fog, diarrhea, stomach cramping, menstrual spotting, cramps 2 weeks early, body aches muscles and joints was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
patient was administered Shingrix vaccine/ stored out of range for more than 72 hours; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received the Shingrix vaccine which was stored out of range for more than 72 hours, which led to incorrect storage of drug. No further events and information were reported at the time of the call. The reporter consented to follow up by email.
While waiting in the lot, patient stated she experienced sensation of heart racing,  slight SOB, mild anxiety.  Monitor called RNS and NP.  Patient reported to them that s/s were resolving.  Vital Signs were monitored.   B/P 100/78, HR 72. RN stayed with patient for 20 minutes.  Patient ambulated steadily.  Denied further s/s.  Left lot at approximately 1300.  B/P 108/70, HR 72  Respirations 18.  Instructed to continue to monitor and to seek medical attention if symptoms return.  RN called patient ! 1435.  Patient reported no further s/s.  Also mentioned that sehhad hypothyroidism and that synthroid dose had been decreased within that past week.
Develop headache and slight nausea approximately 5 min after vaccine dose. Progressed to chest pain radiating to L arm then abdominal pain and finally vomiting over the course of about 30min. Patient was placed in an ambulance and transported to the nearest emergency department. He received 1 dose of 0.3mL epinephrine IM in leg from an autoinjector en route to the ED. In the ED he received promethazine for nausea/vomiting and tylenol for the headache and chest pain. Vital signs were normal. Patient was monitored in the ED for three hours with improvement in symptoms and then discharged home.
Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.
Temp of 100.4F, localized pain at injection site. On 11/20/12 he complained of increased arm pain and fatigue. Temp increased to 102.8F. Mom noted swelling and redness at site of injection. After calling our office at 7pm on 11/20/12 he was started on a burst of prednisolone (15mg twice daily for 3 days). He was evaluated in our office at 9:45am on 11/21/12. He was playful, alert, and non-toxic appearing in the office. Exam normal except for erythematous posterior oropharynx and 3 x 5.5cm area of erythema, induration, warmth, and tenderness over left deltoid.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # M032141; expiration date 02-OCT-2017 (dose, dose number and anatomical location were not reported). Concomitant medications were not reported. It was reported that the patient received less than a full dose of ZOSTAVAX due to a needle leakage. No adverse effect was reported. A Product Quality Complain was not involved. Additional information has been requested.
Patient present at clinic requesting to report that she had developed shingles - diagnosis made by primary Dr by physical assessment but no laboratory specimen taken. Per client developed rash on abdomen on 12/12/2011. Seen by primary Dr and diagnosis per client was shingles - verbalized treated with oral antiviral medications. Does verbalized "less pain with this occurrence of shingles" as compared to initial case of shingles in 2000. Client request report of developing shingles after vaccine.
Information has been received from a physician concerning female about 17 years old who on unspecified dates was vaccinated IM with all three 0.5 ml dose of GARDASIL (lot number not reported). Recently, during the last cervical smear (PAP) the physician discovered that the patient developed high grade cervical dysplasia. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Patient developed a mild to moderate headache within 10 minutes of receiving the vaccine. The headache developed into a migraine. The patient went to healthcare facility and received Nurtec ODT 75 mg disintegrating tablet in the clinic.   Within 12-15 hours patient developed moderate joint and muscle pain systemically. Patient took extra strength Tylenol during the night. During the night, 12-15 hours after the vaccine administration, the patient reported "pins and needle" type sensations down her arm and into her fingers. The patient rated the pain a 8/10 on the VAS. The patient also described the pain as "insects with daggers for feet" crawling on her skin on her right arm and shoulder. At about 7:30AM, the patient took a shower and found a painful "golf ball" sized lump in her right axillary region. Patient experiences moderate nausea when right axillary is palpated.  Patient has developed a rash covering her neck, shoulders, axillary, and right arm. Patient describes skin sensations through her body as raw and sunburned.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 50-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). On 19th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 20th September 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site redness, injection site pain, injection site warmth and injection site swelling were recovering/resolving. The reporter considered the injection site redness, injection site pain, injection site warmth and injection site swelling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by an employee health nurse. The patient experienced redness, swelling, heat and soreness at the site of injection after vaccination with FLULAVAL QUADRIVALENT on left arm. The patient was not given any treatment recommendations at the time reporting. The employee health continued to follow up with the patient.
HEADACHE; MUSCLE ACHES; CHILLS; PAIN IN THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight was 145 pounds, and height was not reported. The patient's past medical history included eczema, and cancer breast, and concurrent conditions included enzyme deficiency, sulfate allergy, non-smoker, and non-alcohol user. The patient experienced drug allergy when treated with amoxicillin, and tramadol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced pain in the arm. On 08-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle aches, chills, pain in the arm, and tiredness, and had not recovered from headache. This report was non-serious.
Asthma, arm/body aches, congested sinus, ears, runny nose. Hard to breathe for 4 days, arm body ache 7-10 days, congestion over 2 wks, fatigue terrible 2 weeks.
Information has been received from a health professional concerning a 15 year old female with a history of attention deficit disorder and sickle cell disease who in September 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included STRATTERA and FLUVIRIN(unspecified). On 27-NOV-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil. A few hours post dose two, the patient experienced many, small, slightly raised, itchy bumps on both arms. Subsequently, the patient recovered from many, small, slightly raised, itchy bumps on both arms after she was given 50mg of over the counter BENADRYL. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a health professional concerning a black 15 year old female with a history of attention deficit disorder and sickle cell disease who in September 2007, was vaccinated with her dose of GARDASIL. Concomitant therapy included STRATTERA. On 27-NOV-2007 the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (lot# 98219/0680U). Concomitant therapy included FLUVIRIN intramuscularly in the right deltoid (lot# 80432). A few hours post dose two, the patient experienced many, small, slightly raised, itchy bumps on both arms. Subsequently, the patient recovered from many, small, slightly raised, itchy bumps on both arms after she was given 50 mg of over the counter BENADRYL.
Developed fever 101.7, very cranky. Right leg 1.5x1cm pink area. Treated with TYLENOL TID, warm compress, ZYRTEC 3ml BID 3-4 days.
It began with the prickly, somewhat painful spot on my left side above and at the waistline.  On May 12, 2019 a small rash appeared but no blisters. By the next day blisters had appeared, the rash had spread and became very painful.  After the rash appeared I saw Dr, he confirmed that it was  shingles and called it a "trigger response" to the vaccination.  He gave me the antiviral pills, 4 a day for one week and also prescribed Gabapentin.  The rash is fading and the pain is becoming less but still flairs up in the late afternoon and evening.  I get fatigued very easlily.
Pt recvd vax on 12SEP92 & on 19SEP92 devel optic neuritis;
Patient was found unresponsive on 4/15/2021. Patient seemed to pass in his sleep per family member. The coroner deemed myocardial infarction. No autopsy completed.
, Additional Details: three days after vaccination, patient came back into the pharmacy and her left arm was clearly very red and swollen. Patient stated that her upper arm was very sore to the touch. She had not taken anything for it at this time. I advised her to try Benadryl and to contact her doctor if the swelling and pain does not subside.
received 2nd dose less than one month interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number D49FM, expiry date unknown) for prophylaxis.   The patient's past medical history included hepatitis b (might have Hepatitis B infection, but was not sure as there was no other information or medication details on the record). Previously administered products included Shingrix (received 1st dose on 7th October 2021, batch number B4Z44, expiry date 27th December 2023).   On 20th October 2021, the patient received the 2nd dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was diaphoresis, minimum tremors, AO x 4 time, place, date and situation. VS taken @ 0830 BP 56/38, HR 65, O2 sat 98%. Patient was offered water to drink and wet towel was applied to front head.  Another set of VS was taken @ 0837 with BP 92/50.  911 was called @ 0850 and AMR (department #338) arrived @ 0855. Patient was assessed by medic, 12 leads EKG was done NSR. Patient denied transfer to the hospital. Medic left @0900 after explaining to the patient the risks and need to go to the hospital. Patient called his wife. Wife came at 0903. Patient was assessed, no complains of dizziness, was able to walk steadily,  before leaving with wife @ 0905.
Mom called Friday 9-19-08 stating her son had swollen and red upper right arm where he had received varicella vaccine and was also having generalized itching but did not have a rash. She took him to see family doctor and he said it was a reaction to vaccine but there was no infection, instucted mom to give benedryl for itching. Mom states today he is no longer itching and arm is not longer red and swollen, only a small bruise at injection site.
Sore arm; sore neck; sore back; sore muscles; Fever of 99.9; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscularly, administered in left arm, on 26Feb2021 at 02:45 PM (Batch/Lot Number: EN6198) (at the age of 57 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism, high blood pressure, and COVID-19. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was concomitantly taking unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, sore neck, sore back and muscles and fever of 99.9 on 27Feb2021 at 06:00 AM. The patient underwent lab tests and procedures which included fever: 99.9, on 27Feb2021. The patient has not been tested for COVID-19 since the vaccination. The patient has not taken any treatment for the events. The patient did not recover from the events on the time of the report.  No follow-up attempts are needed. No further information is expected.
Sore arm, swelling and rash at injection site, about 2 inches in diameter, headache
Client vomited several times and had a low fever (100.2). She developed swelling above her right wrist to above her right shoulder which was warm and tender. Client was given cool packs, BENADRYL and CLARITIN. Symptoms started the evening after vaccination.
DTaP/Hib, MMRV, Prevnar, Hep A administered 08152007. 08242007, child developed fever as high as 104. Was seen by PCP and no cause for fever found. Fever returned to normal but child continued to be extremely fussy and cried almost continuously and slept less than one hour at a time until 08282007. Child was again evaluated on 08272007 with no s/sx illness found.
full body aches, sensitivity to light, massive headache, stomach pains, inability to hold down food or water
J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 HEMATURIA J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 CKD STAGE 3B (GFR 30-44) J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 GOUTY ARTHROPATHY
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M000756, expiration date 06-JAN-2018; site, doses and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent for follow up.
Intense, severe itching in low back by spine, more I scratched the worse it got. Came on suddenly, no warning. Lasted a good 20 minutes, very inflamed. Retired at 10:30 pm and it subsided. Back was clear in morning. Also, my right upper arm is still sore this 13th day after shot.
24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial infarction. It lasted 24 hours. I had difficulty doing my job. I considered going to the ER to rule out a myocardial infarction not related to the vaccine. I also had bone pain in right forearm and hand which lasted 24 hours. In addition, I had muscle pain in my entire upper body but not lower body. On day 2 I had right axillary swelling and pain.
Information has been received from a pharmacist referring to a 76 year old female patient. Relevant medical history was unknown. The patient was given 1 dose of PREVNAR 13 last year in 2015 and the patient got a flu shot from this pharmacy in September or October of 2015 and 2016. The pharmacist was not aware of any other previous PNEUMOVAX 23 doses given at any other facility. On 22-SEP-2017, the patient was vaccinated with the PNEUMOVAX 23 (lot # M024673, expiration date 17-NOV-2017; dose and route were not reported) once in her right arm for prophylaxis. On the same date, the patient got the PREVNAR 13 in her left arm. Last night on 22-SEP-2017 after getting the PNEUMOVAX 23, the patient's right arm from her shoulder to her elbow was hot, swollen, red and warm to the touch. The patient did not have hives and she was not having trouble breathing. In the morning of 23-SEP-2017, the patient's symptoms worsened so she was getting nervous and worried about it. No relevant lab tests were done at this time. As of 23-SEP-2017, the patient was no longer getting the PNEUMOVAX 23 and her arm was still hot, swollen, red and warm to the touch and she was worried and nervous about it. The causality between the events and PNEUMOVAX 23 was unknown.
Vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccine reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccine reaction). At the time of the report, VACCINATION SITE REACTION (Vaccine reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  No treatment information was provided.
I inserted syringe into arm to inject imz and realized that the syringe was empty;  I explained situation to patient;  i apologized; I retrieved a new syringe and imz and administered
Night time bedwetting began after vaccine given. Urine and bowel incontinence occurred after vaccination was given.
Site: Swelling at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild