chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a female with Down's Syndrome and no drug allergies, who on 23-MAR-2010 was inadvertently vaccinated with a dose of PNEUMOVAX 23 vaccine, 0.5ml, IV (lot # 664537/1193Y). On 23-MAR-2010 the patient became agitated and diaphoretic. The patient received medical attention. The physician gave the patient PHENERGAN and SOLU-MEDROL for the treatment. There were no labs or diagnostic tests performed. The patient recovered on 24-MAR-2010. Follow up information received from a pharmacist concerning a 38 year old female with Down's Syndrome and pneumonia at time of vaccination who on 23-MAR-2010 at 5:00 pm was vaccinated with a dose of PNEUMOVAX 23 vaccine, IV, (Lot # 664537/1193Y). On 23-MAR-2010 at 5:04 pm the patient became agitated, short of breath, hypotensive and loss of consciousness for 1 minute. The patient was given BENADRYL and SOLU-MEDROL. The patient recovered quickly after initial problem. Agitated, short of breath, hypotensive and loss of consciousness for 1 minute were considered to be other important medical events by the physician. No further information is available.
Soreness; Severe back ache; Toes are throbbing and aching; Fever 101.6F; A spontaneous report was received from a consumer concerning a 53-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, severe back ache, toes are throbbing and aching, fever 101.6F.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 18 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025120-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, prior to receiving mRNA-1273, the patient felt soreness, severe back ache, toes are throbbing and aching, fever 101.6F. Treatment for the events included paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The events,soreness, severe back ache, toes are throbbing and aching, fever 101.6F were considered unknown on 19 Jan 2021.
Fainted once approximately 8 hours after receiving the vaccine. No other adverse reaction afterwards other than fever and chills.  I have no prior history of fainting.
Patient got her flu shot at school around 1:30, has had multiple flu vaccines in past with no reactions or problems. Shortly after getting home from school that day, around 4:00 PM she started to develop hives and by the next morning had hives over her whole body essentially. No other symptoms reported at that time. Mom did take patient to her pediatrician (Dr.) on 10/29/2019 who said that he felt she was likely having a drug reaction rash from her Augmentin course she was just completing. He recommended mom to continue flu vaccines in the future. No other symptoms ever developed, hives had completely resolved within about two full days.
Post vaccine c/o chest pain, sob. bp; 198/112. Given NG 0.4 sl Transported to ED via squad
Subjective: Pt describes overall aches in muscles and joints, a mild fever and general lethargy.
moderna vaccine given @1322. pt. ambulated w/complaint to recovery area where she was advised to stay 30 mins. at 1335, pt reported dizziness, +N/T in arms/hands. BP 118/66, HR 70, RR 20. Pt. was continually monitored closely with frequent VS checks. Pt. then reported + tongue numbness and + throat tightness. Denied SOB or difficulty breathing. EMS called. 0.3 mg IM epinephrine given in R thigh @ 1357. 108/64/72/20
Temperature: 100.8-101.5 Coughing  Nausea, diarrhea, muscle cramps/spasms
Symptoms lasted for 36 hours and started 8 hours post vaccination:  Severe headache Severe body aches  Metallic taste in mouth  Nausea  Fever (101) with Tylenol
This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored dose of ROTATEQ (lot # L020865, expiry date 09-FEB-2017) dosing details unknown. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of four reports received from the same reporter. Additional information has been requested.
Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive diarrhea; severe fatigue; chills; diaphoresis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3248), via Intramuscular on left arm on 28Dec2020 at 10:00 AM at single dose for COVID-19 immunization. The relevant medical history included hypertension. Concomitant medications included acetaminophen. The patient experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis. Following day, bloody stool-diarrhea. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on bloody stool-diarrhea reported cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1 Day after injection (4/1): Aches, chills, hives all over body Day 2 after injection (4/2): Aches, Chills, hives all over body Day 3  (4/3): hives all over body Day 4 - now Day 8: hives all over body, tiredness
Had mild fever, 100.5 and rash with first dose, that one also given with flu. With second dose had more severe reaction--fever 102 with severe chills, without rash, lasting 2 days. Patient states she has chronic disseminated shingles.
Patient had a fever later in the day on 5/17/23 after vaccination. He did not have much of an appetite. He did not sleep well that night. He vomited the morning of 5/19/23.
Person-to-person transmission was being suspected at a care home.  In response, the Department held an on-site clinic for residents and staff of the care home. This resident received a dose of hepatitis A vaccine on 3/16/2023.  She later was admitted to the hospital on 3/23/2023 with symptoms consistent with hepatitis A, including jaundice, abdominal pain, dark urine, loss of appetite, nausea, and vomiting. The patient's blood from 3/23/2023 resulted IgM positive for Hepatitis A in addition to elevated ALT, AST, and bilirubin. The patient ultimately expired on 4/11/2023 with acute liver failure due to hepatitis virus and cardiac arrest. Upon review of her medical record, her reported jaundice onset was 3/16/2023, the same date that she received the dose of hepatitis A vaccine at the clinic.
Right upper arm/deltoid, redness, very painful swelling, area is hot to touch, approximately 8cm x 7cm.
Palpitations Widowmaker, 2 heart attacks, hospitalization Narrative: 2 heart attacks, widowmaker. Continuous heart failure post incident. No prior cardiac history reported.
Starting 11/02/2022, I had a bit of a scratchy throat. The next day I had more of a scratchy throat and congestion/sinus pressure. I tested myself for COVID-19 at home and it was positive. The next day, on Friday, I had a lot of sinus pressure and periods of feeling hot without a fever. I had a hard time cooling off. I called my  doctor and they prescribed Paxlovid (which I started later that afternoon). No coughing to a large degree. The scratchy throat disappeared. Friday the symptoms were mainly sinus pressure, insomnia and temperature regulation. Today, I am still a little congested and my right ear is still clogged. I basically feel like I am recovering from a cold but doing better than expected.
Chills, "burning", tingling in Left arm and hand, lump in arm-under infection site-given steroids and ibuprofen by doctor.
Patient reports that 3-4 days after 2nd dose of Pfizer COVID vaccine, he developed auditory and visual hallucinations, paranoia, depressed mood.  Symptoms lasted about 1 wk and then improved.
Soreness at injection site, headache, fever 100 degrees, body aches, fatigue
4 to 5 cm area of erythema and increased heat at injection site after PREVNAR 13 given preceding day. No streaking/infection. No fever.
Patient recieved both vaccines on thursday morning 9/5/19, and started having redness/swelling symptoms only in her right arm on friday. The redness and swelling grew over the major portion of her right upper arm. Patient stated she ran 100+ fever and admitted herself to the Emergency Room where they ran blood work and examination. Patient's blood work came back with elevated white blood cell count. Upon examination, Dr. diagnosed her with cellucilitis and discharged the patient with Clindamycin 450mg three times daily for ten days (due to PCN/cephalosporin/carbapenem allergy).
Initial unsolicited report received from a non-healthcare professional on 22 September 2015. This case involves a 93-year-old female patient who was vaccinated with second dose of FLUZONE HD (batch number: UI427AA, expiry date: 28 March 2016) intramuscularly in left deltoid on 14 September 2015. The patient's illness at time of vaccination reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergies: none known. Medical history reported as intermittent atrial fibrillation, mitral valve prolapse, hypothyroidism, osteoporosis. Concomitant medications were not reported. On 14 September 2015, few hours following the vaccination, the patient had developed vomiting, feeling of "lead in her feet", fatigue, malaise. Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from vomiting. The patient was not recovered from fatigue and malaise. List of documents held by sender: none. Follow up report received from nurse (ARNP- Advanced Registered Nurse Practitioner) on 28 December 2015. The patient previously received first dose of FLUZONE HD on 2014 without any adverse event. The patient did not receive any other vaccine prior to 14 September 2015. The patient did not have any known drug allergy and patient was well at the time of vaccination. The patient did not perform any lab test. The patient was recovered from the events (reported as feeling somewhat better on 28 September). "It was reported that completely resolved to prior state of health no later than 6 October 2015".
I was sick for 5 days after but since I got the 2nd dose, my arm has been hurting off and one and I get a burning sensation on the site.  I asked one of the health nurses at my place of employment, and from where there is pain, she said that the pharmacist did the vaccine too low and it may have effected my auxiliary nerve.
LEFT ARM BECAME HOT, RED SWOLLEN. HER DR PUT HER ON CEPHALEXIN 500MG CAPS 1 TID 7D ON 9/26/2017.
day p/receiving flu shot pt became very ill w/GI problems, coughing for next 2 wks; did not see MD but remained in bed treating self;
On 01/04/01, this patient became light headed and nauseated 24 hours after receiving Influenza vaccine. It lasted for several hours. Called PCP, and went to the Health Dept, was told to go to PCP or walk-in. The patient felt better and did not go, called PCP and made an appointment for 01/10/01. On 01/10/01, the patient was seen by PCP, he told her it sounded like a reaction, she is fine now.
Pt. came in and had Moderna dose in from on 3/17/22 and her COVID card that had another dose documented 4/14/22,  administered bivalent booster due to 2 documented doses. Was called today to clarify because pt. stated she has only had one dose. They called and they stated the only dose given was on 3/17/22. Pt was educated over the phone that we were under the impression she had 2 doses, due to error she verbalized understanding. Informed she will need to be revaccinated, states she will come in on Monday
Eight days after the vaccination, two red hive-like welts appeared 4 to 5 inches below the injection site.  They were hard and a itchy. By 4 PM, there was increased redness around the welts and some general redness extending upward. By 8PM, the redness had doubled in size and an additional red area existed in an around the area of the injection site.  By 7AM the second day, the two areas of redness had essentially merged.  The area continued to increase throughout the day on the second day and by evening it was approx. 6 inches from top to bottom.  By this AM, the third day,  the redness had essentially disappeared from the upper area, but the lower area of redness was still present and had extended another inch
Beginning about 9pm increasing soreness and pain in arm -by midnight arm was too sore and stiff to lift above waist Beginning about 11pm headache, full body joint pain, full body body aches, chills, fever approaching 99 (NB - my typical body temp is 97.2 - 97.4). As night progressed the symptoms worsened - about 2am intense back pain between shoulder blades radiating to chest, heart was pounding, temperature increased to 101 About 3am was in extreme pain throughout entire body, severe chills/shaking,  fever was 102.2, experienced minor urinary incontinence About 3:30am I finally had to take  2 Advil - within an hour the symptoms had lessened and temp had dropped to 100 By noon (22 hours after injection) I was experiencing only mild body aches, temperature was normal, left arm remained sore but I could move it - other side effects had resolved  I am very stoic and have a fairly high pain tolerance. I had no side effects after shot 1. After shot 2 I was sicker than I have ever been in my life ?- for several hours I was concerned I was going to die.
The patient developed severe headache 13 days after vaccine administration, followed by right-sided facial palsy, then progressive bilateral lower extremity weakness and some intermittent blurred vision.  He was first seen 16 days after vaccine administration, at which time his right facial palsy was the prominent symptom, and was put on acyclovir, prednisone, and artificial tears.  His lower extremity weakness then progressed, and he was re-evaluated 2 days later.  He still had a right facial nerve palsy and sigificant weakness of his bilateral hip flexion, knee extension and flexion, and great toe dorsiflexion and plantar flexion.  Neurology was consulted by phone, the patient was transferred to an ER, and then admitted to Hospital for 4 days, where he underwent a normal brain MRI, an LP that showed 3-4 wbc's, protein of 373, and glucose of 59.  His nerve conduction studies showed absent F waves in median, ulnar, common peroneal, and tibial nerves; normal conduction velocities, but slightly prolonged distal latencies.  He was transferred to another Hospital where he could undergo better monitoring while getting IVIG. 9/17/08-records received for DOS 9/10-9/13/08-DC DX: Guillain-Barre. Treated with IVIG. Presented to ED with C/O right-sided facial weakness and bilateral lower extremity weakness 7 days prior to admission. Symptoms began one week ago with headache with aura on 9/3/08. Next day weakenss on right side of face and face was droopy followed one day later with lower extremity weakness with some difficulty in walking. Diagnosed with Bell's palsy. Two days later developed blurry vision, unable to focus on schoolwork.  Elevated systolic blood pressure.
28nov89 pt vax hepta B. pt ex pain at inject site.  28dec89 pt vax 2nd hepta B.  pt ex prolonged pain at tenderness at inject site which lasted 2 days to 1 week. pt recovered.
Large bruise on upper arm, with pain and heat. Feelings of malaise. Bruise around the edges of arm.
Admitted to hospital 4/12/21 for acute hypoxic respiratory failure due to COVID-19 pneumonia. Treated with remdesivir (full course) and dexamethasone 10mg x1 then 6mg daily x 9 days. DVT treated with heparin IV Ibrutinib held -- CBC at baseline (WBC ranged 23.5 - 35.1) Infectious Disease MD ruled out other infections, including pneumocystis pneumonia  Hypoxemia progressed to severe -- 60L high flow oxygen, unable to wean - patient does not want to be intubated On  4/22 the patient desired for comfort measures only and weaning of oxygen. The patient died on 4/25/21.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  felt flushed, "like I'm about to pass out", pale colored..   Assessment : Time of assessment 0920. Alert and oriented, Anxious, Diaphoretic and Clammy. After sitting for 5 minutes of a 15 minute observation, patient reported feeling like she will pass out. She was flushed, felt hot, color pale, clammy. She was placed on the floor and she says she was starting to feel better. She did not pass out. 0925: BP 108/68 lying on the floor, P 52, 97% oxygen saturation RA. She reported feeling better. 0928: She was assisted to the wheelchair and taken to the triage area. She was assisted to the stretcher. 0931: BP 116/65, P 51   Actions taken:  0943: Vitals sign taken  VAERS form obtained and completed by RN. Standing BP 131/83 P 64 R 16, Oxgen 100% RA, ambulated around with no symptoms.   There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 25 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
30 min after injection-itchiness all over, especially face,  numb sensation, continuing to next morning, administered Allegra, and around 14 hrs after vaccination, additional symptoms of nausea, dizziness, stomach pain, chills, achy joints
I had my vaccination on 10/01/2022. On 11/05/2022 I was coughing with congestion but started out as a dry cough. I had a slight headache and took TYLENOL. On 11/06/2022 I tested COVID-19 positive. My doctor prescribed PAXLOVID. I am feeling ok but not great. I still have congestion and upset stomach.
Rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration on 13Apr2021(at the age of 62 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rapid heartbeat on an unspecified date. Reported as, patient got the first Pfizer vaccine on tuesday this week. patient just want to know if there is epinephrine in that vaccine or not because when patient used to go the dentist and get a shot of novocain patient got a rapid heartbeat and the dentist said that was because of the epinephrine and patient said patient dont want that any more. But when patient got vaccine on tuesday patient had a few minutes of a very rapid heartbeat just like epinephrine in her Novocain. patient read the ingredient for Pfizer and patient didnt see epinephrine so patient did not worry about it patient was fine after few minutes but she gonna be getting her second shot in three weeks and she want to know if she going to have that experience again like worse. Patient did not compliant about this, she sat in the observation and waited the 15 minutes and got the rapid heartbeat for the first for five or some minute and then it went down and then it was fine. Next dose was on 06May2021. The patient underwent lab tests and procedures which included heart rate: rapid on an unspecified date. Outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax on 3SEP92 & on 9SEP92 pt devel soreness, redness & swelling @ the inject site; also devel a temp of 100; pt recovered w/in 4 days; following 2nd dose of vax 8OCT92 pt did not report any noted problems;
This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 76-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm. On an unknown date, the outcome of the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm were unknown. It was unknown if the reporter considered the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that, on an unknown date the patient experienced light headedness, pain in arm, shoulder pain, runny nose, loss of appetite and head hurt. This case was linked with case US2018157965, reported by same reporter for the same patient.
I had 0 adverse symptoms for the week following my vaccination.  On the evening of the 7th day, I developed a rash around my ankles and on my arm around the injection site.  That has spread into a full-body rash which is extremely itchy.  Antihistamines have helped (Benedryl) but only provide temporary relief. Significant discomfort.
5/20/08 - fever 103 and vomiting, 5/22/08 weak strep response and antibiotic given and got better, 5/25 101 fever and ER visit, high wbc count dx acute viral syndrome.  After this extreme fatigue, anxiety, syncope (x2)in June and July, lightheadedness, weight loss (10 #), decreased appetite and floater in vision. 8/18/08-records received for DOS 5/25/08-presented to ED with C/O cough, sore throat, fever, chills, muscle aches and "flu" started 5 days agao. Diagnosed with Strep 4 days ago. Today developed fever. Nasal discharge. Moderate frontal headache.  Impression:Acute viral syndrome.
After receiving seasonal Flumist @ about 4:50pm patient walked from exam room to waiting room, felt dizzy and fainted. Hitting her chin and back of her head when she fell.