chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with fourth dose of GARDASIL (dose and route of administration not provided) in error (extra dose administered). No concomitant therapy was reported. The reporter had no information about patient identifiers, date of vaccination or lot number of vaccine administered. The reporter did not know if the patient had experienced any adverse effects. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
5-10 minutes status post vaccines, developed respiratory distress, apnea; given O2. Saturation initially 70% increasing to high 80s with O2. EMS activated. Taken via EMS to ER. Received 5Q Epi and corticosteroids. Observed as inpatient. Discharged next morning.  2/7/06 Discharge Summary reviewed stated patient experienced premature birth w/cleft lip & palate (s/p repair), glaucoma, developmental delay (decreased speech), cyanosis, apnea, urticaria, wheezing, uvular & facial swelling, hypoxia.  Final dx: acute anaphylactic reaction, life threatening event, possible egg allergy.
Felt really sick; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 20th June 2019) for prophylaxis.   On 26th March 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Shingrix was discontinued. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient refused to receive the 2nd dose of Shingrix because it made her feel really sick after receiving the 1st dose of Shingrix.  No additional details were provided.
severe constipation; nervous; sever abdominal discomfort; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via unspecified route of administration on 30Jan2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included blood pressure and cholesterol. The patient concomitant medication included amlodipine besilate (NORVASC) and simvastatin. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) for COVID-19 immunisation. On an unknown date in Jan2021 the patient experienced severe abdominal discomfort and developed severe constipation on 31Jan2021. The patient felt nervous on an unknown date in Jan2021. The patient wanted to know if the events caused were due to vaccine. The patient took Miralax and a suppository (not specified) as treatment to severe abdominal discomfort and severe constipation. The seriousness of the events was reported as non-serious. The outcome of the event severe constipation was not recovered while for other events was unknown.
3RD DOSE MODERNA COVID VACCINE GIVEN 12/1/21, #027H21B; 4TH DOSE MODERNA COVID VACCINE GIVEN 8/18/22, #059A22A; pt had a positive COVID test in  Center; in hospice care with Hospice; pt passed away in hospice
Information has been received from a physician concerning a male (age unknown) who was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot #651356/0089F).  On approximately 13-NOV-2006 ("within the last week") the patient developed redness and a rash from the shoulder to the elbow.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
lymph nodes swelling in left armpit, left collarbone, left side of neck, pain in armpit and collarbone area, pain in injection site, pain radiating down arm
Case had covid vaccine x 2. Last dose on 1/15/2021. Tested positive for COVId 19 on 8/13/2021. Was admitted to medical center on 8/30/2021 with COVID Pneumonia. Case expired while still hospitalized on 9/9/2021.
Mom reported on 9-12-11 to me at PE visit approximately 1 1/2 days after vac's infant had "5 sec" shaking or tremor of face to (R) - she & GM "not sure" if it was a seizure. She attributes event to vaccines add. vacc not on hold at present.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 12Nov2021 as dose 3 (booster), single (Lot number: FH2808), in left arm and on 30Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, stop date: 22May2022; LEVOTHYROXINE; VITAMIN D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Child slept for 7-10 hours after 2 month shots. This was not know to doctor until the 4 month check.
Information has been received from a physician concerning a female patient who was vaccinated IM on 22-SEP-2006 with a first dose of GARDASIL. The physician reported that the patient received her first dose of GARDASIL and "claimed it affected her menstrual cycle". She said her cycle went from being every four weeks to being every six weeks. The patient refused to go on to get the second and third doses. The physician did not believe the adverse experience was related to GARDASIL. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow up information it was indicated that "patient said her periods became irregular after receiving the first dose of GARDASIL vaccine." The patient recovered. Additional information is not expected.
Temp. chills - severely swollen arm from injection site, up to shoulder down arm - red, painful. Body aches, general weakness, numbness from waist down. HA - 3 days duration, except arm remained swollen painful & reddened for about a week.
Pain at site, hot to touch, red, raised and swollen about 1 inch in diameter
w/in 24 hrs of 1st dose of Engerix-B & devel cervical adenitis; p/2nd dose of Engerix-B devel sore throat, more severe adenitis, muscle aches & nausea; MD advised pt not to get 3rd dose of vax;
Weight loss; Herniated disc; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Herniated disc), WEIGHT DECREASED (Weight loss), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In May 2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc). In 2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Herniated disc), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and WEIGHT DECREASED (Weight loss) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: FORTY FIVE POUND WEIGHT LOSS.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  Treatment Drugs Not Reported.  The reporter's causality for the event(s) of HERNIATED DISCS, FORTY FIVE POUND WEIGHT LOSS, FATIGUE AND SOREARM FOLLOWING VACCINES onset in 2021 and FATIGUE AND SOREARM FOLLOWING VACCINES onset in 2021 was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact
Achiness in the left arm radiating to the right arm and neck, mild headache, tingling of the roof of the mouth and zinc taste in the mouth within first 10 minutes following the administration of the vaccine.  No shortness of breath or difficulty swallowing.  No chest pain.  Given Diphenhydramine 25mg capsule and to take one every 4-6 hours as needed for allergic reaction.  to call the clinic to let us know that she got home safely and to call 911 if she became short of breath or difficulty swallowing.  Instructed to take a Diphenhydramine 25mg before returning for the second vaccine on 3/2/2021
I woke up in the middle of the night (approx. 1AM) hot and sweaty, thirsty, and with body aches (arms, legs, torso, etc.). I could not sleep most of the rest of the night. When I got out of bed at 7:30AM, my neck was sore and I took my temperature and it was 100.7 degrees. I took two Tylenol and by 3PM on May 9 I felt better. By the next day (today) I feel fine - just a little tired from not sleeping much Saturday night.
Pt admit to hospital with COVID pna 2/9/22 s/p 3 doses of Pfizer (4/5/21, 4/26/21, 9/11/21); pt had positive test on 1/31/22 -- but admit 2/9/22 d/t worsening symptoms
Approximately 10 mins after vaccine, my eyelids and tongue swelled up. My left arm muscle ached at the site. Immediate fatigue and went home and took a nap. My body ached and was very painful. I felt pain in my liver and my liver swelled. I contacted my doctor, they could not get me in immediately. When I would eat, I would get drowsy. My heart would pound hard when I would walk. I had diarrhea, uterine cramping, bleeding which I have been in menopause for 10 years now and this is completely abnormal. I have a hard time remembering things. I have ringing in my ear intermittently. I am off balance at times. I have muscle aches and pin and needle feeling in my calf muscle. I also have deep bone aches and continual back ache. I had constipation for 10 days after vaccine. I have brain fog and I have blurry vision. It affects my work, like I can not process information with brain fog. I have cognitive impairment with what I see and perceived with letters, numbers, and sentences, kind of like a stroke. The doctors said it could be inflammation on my brain. Once I seen my doctor, I was referred to a Rheumatologists, allergist, gastroenterologist, and gynecologic. I was sent to get vaginal ultrasound and to see a gynecologist which I have not been yet. My doctor ordered lab work showed my enzymes ALT was elevated. I feel exhausted in the morning and takes me 45 minutes to try to get out of bed. I am a foster grandparent specialists at work and it is very difficult to work. I come home exhausted and sleep for 2.5 hours. I wake up and eat dinner then go back to bed. This has affected my life. For my employment, it was mandated to get the vaccine even though I have a chronic condition.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. It was reported that the patient received the first and second dose of GARDASIL (Lot # not reported) (dose and route not reported) in 2006 and the third dose was received on 25-JUL-2013. Concomitant therapy was not reported. No symptoms reported. Additional information is not expected.
Patient said he  started having chills and all-over body aches on the evening of the day he got the vaccines. He said the injection site of the Pneumovax23 was swollen and red. He put a thermometer on the site at the reading was 102 degrees. He stated he took his temperature orally and it was 101.6. He took Tylenol and his body temperature returned to normal but the injection site remained inflammed and hot to the touch. On 9/17/20 he was not feeling any better and sought care at Urgent Care. He was given Diphenhydramine 50mg, 2 adult Tylenol tablets and a prescription for Clindamycin 300mg. I spoke with him today (9/18/20) and he said his arm was still red but "not as puffy and swollen." He said he was instructed to continue to take Benadryl and to seek medical attention at the emergency room if the redness expanded outside the line drawn on his arm. He said the redness was outside the line but he is feeling much better and the swelling was subsiding.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY ACUTE DVT, UNSPECIFIED VEIN  1/31/2022 - RECURRENCE OF SAME SYMPTOMS
No appetite; Headache; Whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), HEADACHE (Headache) and MYALGIA (Whole body hurts) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (No appetite), HEADACHE (Headache) and MYALGIA (Whole body hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetite), HEADACHE (Headache) and MYALGIA (Whole body hurts) outcome was unknown.            Concomitant product information. Action taken with mRNA-1273 in response to the events is not applicable.
10/31 flu shot administered approximately 1400, asymptomatic. 11/01 complaint of severe headache, myalgia. 11/2 fever (up to 108) chills, myalgia. 11/6 presents with complaint of chills, low grade temp. and myalgia. Referred to work comp. pysician.
Death.  Ischemic and Hypertensive Heart Disease. No signs.  Active and athletic middle age man.  Was riding bicycle on a trail, stopped pedaling and dropped dead.  Died instantly. CPR was performed.  No vitals upon arrival.
Patient called pharmacy stating she experienced low grade fever and flu-like symptoms. Had a fever of 100.7, took Tylenol and woke up drenched.
MYALGIA, FEVER Narrative: SYMPTOMS LASTE x 1 DAY
chills, followed by fever of 101.9  started 24 hours after shot lasting until next morning
Sudden onset heart pounding, feeling in throat like wanted to swallow but never went away.  Persistent.  Seen in Emergency Room.  No hx prior cardiac dx.  Had negative cardiac stress test 1 yr ago.  Discharged home with still occasional abnormal heart beat.  Never had this before. (4/3/03) continued problems resulted in another ER visit 4/6/03 with admission to hospital.
Information has been received from a MA concerning a 64 year old female who on 05/17/04 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647657/0947N). On 05/19/04 the pt called the physician's office stating that she had pain all night in her left arm from the shoulder to the wrist. The pain had somewhat subsided but her left arm was not hot to touch with splotchy welts. No treatment was required. No product quality complaint was involved. It was also reported that 2 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed adverse reactions (WAES # 0405USA02064 & 0405USA02065).  Additional information has been requested.
Information has been received from a registered nurse concerning an 8 year old male weighing 59 lbs and height of 49 1/2 inches, with no pre-existing medical history and no known illness at time of vaccination, who on 15-FEB-2007 was vaccinated subcutaneously in the right thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot# 632368/1460J) and subcutaneously in the left thigh with a dose of measles-mumps-rubella vaccine (lot # 633705/1660J). The registered nurse reported that on 01-MAY-2007, the patient developed lesions. He was seen in the office on 02-MAY-2007 with less than 50 lesions in various stages. The patient recovered on 04-MAY-2007. Additional information has been requested.
patient received 1st dose of covid-19 vaccine at approximately 12:00pm. she experienced first symptoms at approx. 12:27pm. she felt pain in her jaw and lightheaded. patient also reported not eating that morning. at approx. 12:30pm she was given glucose tablet by pharmacist to treat possible hypoglycemia as a result of not eating that morning. at approx. 12:32pm, patient reported lightheadedness improving. at approx. 12:45pm, patient reported feeling cold, but room temp was also cool. patient's temp was 97 degrees. she also had just finished a meal (sushi). patient's husband was informed and picked patient up from pharmacy. called patient later that night at 7:35pm and she reported she had headache and sore neck and went to sleep for most of the day. her headache and sore neck had improved after waking up. she no longer felt lightheaded.
First dose given inadvertently on 4/7/2021. Error noted during second appt. 2nd dose administered per MD & CDC guidelines. Next day phone encounter with urgent care re: facial swelling, fatigue, nausea, poor PO, Temp 100.  MD recommended supportive care, Tylenol, Ibuprofen, Benadryl prn and gave ER precautions.
Large, red, itchy area around vaccine site.  I took Benadryl and Advil for 2 days.  In 4 or 5 days rash had completely disappeared
DIZZY, SYNCOPE, DIAPHORETIC, PALE, BS: 62, ATE SMALL MEAL EARLY AM,SEEN BY PARAMEDICS, VSS, PROVIDED GATORADE AND FOOD, SX IMPROVED, REFUSED TRANSPORT, AMA SIGNED.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3247) and on 05Feb2021 as dose 2, single (Lot number: EL3247) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety disorder" (unspecified if ongoing); "sensitive to stimulants" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient received Anti-viral as COVID-19 treatment from 29Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Upon coming in for the second dose. Patient reported side effects starting one hour after receiving the vaccine. Patient reported shortness of breath and itching all over. Patient took Claritin and the itching/shortness of breath subsided. Patient also reported intermittent numbness,  palpitations, and fatigue. Declined second vaccination, and advised she may be a candidate for the Janssen one dose vaccine.
Fever, body aches, pain in low back, muscle aches, fatigue, headache, night sweats
patient is only 17 years old. Moderna is not approved for those under the age of 18
ELEVATED LIVER ENZYMES; DIAGNOSED WITH LIVER ISSUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced elevated liver enzymes. On AUG-2021, the patient experienced diagnosed with liver issue. Laboratory data included: Hepatic enzyme (NR: not provided) Elevated. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) No cancer and hepatic issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated liver enzymes and diagnosed with liver issue was not reported. This report was non-serious.
Pain at injection site. Fever and chills, severe body aches with joint pain, severe fatigue. This lasted for about 30 hours. After 36 hours, hives on upper and lower arms and face. Hives cleared over night with benedryl; feeling mostly normal 66 hours after vaccine
Fever, Injection site swelling, edema, errythema. Chills Narrative: Day after pt vaccine pt experienced injection site swelling, edema, errythema. Fever and Chills.
Severe itching - scalp - bumps - like bugs crawling - also palms of hands, feet, stomach - raised welt if scratched, stays red for hours. Burning feeling on toes. At times itched all over. Has subsided slowly over the year.
Multi-dose vial of Pfizer Covid Bivalent booster vaccination was removed from refrigeration and opened at 0815 on 01/24/23. Dose administered from that vial, at 0940 on 01/25/23.  No adverse reaction observed or reported. Per PCP, no recommended treatment or testing needed.
Starting within 8 hours of receiving the vaccine, I developed a "dead arm" where it was numb and heavy (barely able to hold it up) and no medicines would alleviate the discomfort. This lasted for about 24 hours. Once that went away, I thought everything was okay. About 1 week after that ended I found the nodule in my arm pit. I called my doctor to tell them about it and they wanted me to come in. The doc felt it was just a swollen lymph node and that it should go away within a few days. It ended up resolving within a few days.
1. Covid toe on left foot, second toe. Hydrocortisone cream for itching. Not yet resolved. 2. Sore left shoulder joint. Improving today, 10/5/22.