chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unbearable pain in vertebrae down to her ankles; May kill myself due to pain; cannot sleep; pain in bones; destroyed her daily living condition; inability to walk; pain in vertebra; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (May kill myself due to pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025621A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis (Rheumatoid Arthritis for 45 years  Recommended: advil, tylenol, Performed epidural in spine with zero effect).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced INSOMNIA (cannot sleep), BONE PAIN (pain in bones), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (destroyed her daily living condition), GAIT DISTURBANCE (inability to walk) and SPINAL PAIN (pain in vertebra). On 22-Jun-2021, the patient experienced SUICIDAL IDEATION (May kill myself due to pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (unbearable pain in vertebrae down to her ankles). At the time of the report, SUICIDAL IDEATION (May kill myself due to pain), INSOMNIA (cannot sleep), BONE PAIN (pain in bones), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (destroyed her daily living condition), GAIT DISTURBANCE (inability to walk), SPINAL PAIN (pain in vertebra) and ARTHRALGIA (unbearable pain in vertebrae down to her ankles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the Moderna vaccine series and experienced adverse events. Symptoms included inability to walk, unbearable pain in vertebrae down to her ankles, pain in all her bones, cannot sleep and and its destroyed her daily living condition and she wants the antidote or may kill herself. Medical history includes rheumatoid Arthritis for 45 years. HCP was consulted. Second Injection: LOT #049C21A with administration date: May 31, 2021.Patient stated she does not like the Moderna vaccine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by a self-reported medical history of rheumatoid arthritis.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by a self-reported medical history of rheumatoid arthritis.
Arm is very very swollen (size of golf ball); First dose was Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is very very swollen (size of golf ball)) and INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is very very swollen (size of golf ball)) and INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer). At the time of the report, PERIPHERAL SWELLING (Arm is very very swollen (size of golf ball)) and INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Pt wasn't feeling well at 11:30 AM. Went home and did a nebulizer treatment, felt achy and chest tightness. Was seen by NP at a family health center in the afternoon. Peak flow of 380. Was given Benadryl po and another nebulizer treatment. NP does not feel that vaccine caused problem but would like advice as to how to proceed with the next 2 doses. No further problems and she returned to school, the next day. Takes albuterol, Claritin and Singulair.
The patient did not experience any symptoms; did not receive a full dose of PROQUAD; This spontaneous report was received from a registered nurse, concerning a 4 year old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.   On 23-JAN-2020, the patient did not receive a full dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, dose number, route of administration and anatomical location were not reported) (lot # S013711 and expiration date on 01-NOV-2020) administered for prophylaxis. The patient did not experience any symptoms.   Since the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  sprayed in the physician's eye during the administration the case MARRS # 2001USA008752 was also created.; Sender's Comments:  US-009507513-2001USA008704:
Had an early, off-cycle period that was heavier than usual. It started about a week after my first shot. It was about 2 weeks early. Prompted me to go to the OB/GYN for an ultrasound and exam because it was so out of the normal for me and my body.
pt recvd vax in 1983 & devel a hearing loss; it was uncertain as to whether the hearing loss was a pre-existing condition, No further details were provided;
Left arm pain, armpit pain, body aches, shaking chills, nausea, extreme tiredness
Vesicules, papular rash, started on trunk, spread to extremities, face, afebrile, happy, playful. One vesicle at approximately VARIVAX inj site.
Received Moderna vaccine at age 17 for first dose, only licensed for 18 and up, second dose given per CDC guidance, okay to receive second dose if received first dose in error
Dizziness, nausea, vomiting, diarrhea, primary doctor sent him to ER. Pt did not return phone calls.
Exhibiting rash like inflammation on right arm. Covers 80% of her arm, 20cm by 8cm, skin is red and swollen. No treatments at this time. Waiting for Dr. to Sign response and plan.
Painful red and swollen with possible infection at the injection site x2 wks right deltoid. Treated with cephalexin and valacyclovir. Caused by ZOSTAVAX.
Patient with witnessed syncope following administration of vaccine. No injuries. Recovered within 20 minutes.
Unresponsive, limp with eyes rolled back in his head (according to grandmother). Entire episode lasted 2-3 minutes. Pt was taken to ER and later transferred.  9/18/07 Received vax record & VAERS database updated w/same.  9/28/07 Reviewed hospital medical records which reveal patient experienced irritability followed by moaning, decreased alertness, eyes rolling back in head, hypotonia, pale then period of postictal unresponsiveness for approx 30 min.  Evaluated at outlying ER & transferred to higher level of care.  Admitted & d/c to home on 9/12/07.  Neuro consult done. FINAL DX: Seizure, likely related to immunizations. 10/2/07 Reviewed ER medical records which reveal patient experienced unresponsive episode.  Family refused LP in ER & requested transfer to higher level of care.  Hypertensive in ER.  Peds consult done. FINAL ER DX: change in mental status; possible seizure; hyperglycemia; borderline HTN for age.
Nausea; swelling, heat + reddness at injection site. 4x4 size. Hardness developed under site. Then ran low grade fever 99 degrees 7/2/19 but on 7/3/19 ran 100.8 degrees Appetite loss; fatigued; light headed. Itching at site 7/6 - present
Within 12 hours of receiving the vaccine, I became very nauseous and remained so through the next day (4/7).  I could not eat anything and by 3pm on 4/7 I threw up.  I could not keep food down through 4/9 - my stomach was acidy and I was throwing up bile.  I did not have a fever.  On 4/9 I went to the Urgent Care  and was advised to take an anti nausea medicine and get some Pepcid and try electrolyte drinks until I could keep down solid food.  I slept and only had liquids on 4/10 and 4/11.  Today - 4/12, I am able to keep down crackers.  I have never had a reaction like this (except when I had stomach flu - and then I had a fever).  Even today I am very weak.   I believe it is related to the COVID vaccine.
This spontaneous report as received from a 60 year old male pharmacist who is also the patient who has been prone to heat rash in the summer for the last three or four years and AUGMENTIN allergy. On 18-DEC-2013, the patient was (route not provided) vaccinated with ZOSTAVAX (lot number and expiry date not provided). Concomitant therapies included LIPITOR, vitamin D (unspecified) (manufacturer unknown), PRILOSEC and aspirin (manufacturer unknown). On 29-DEC-2013, 12 days after onset of therapy the patient experienced rash with blisters and peeling on his face and part of his neck. The pharmacist stated that the rash "looks like sunburn". The pharmacist was taking prednisone (manufacturer unknown) and FLOMAX (manufacturer unknown) to treat the rash which he has since stopped. The blisters went away; however, the redness, flaking and peeling is still occurring. The patient sought medical attention. The outcome of rash with blisters and peeling on his face and part of his neck was reported as recovering/resolving. Additional information has been requested.
No additional AE information provided; the patient was administered an improperly stored dose of ROTATEQ; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 11-MAR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660112 with expiration date 18-OCT-2020 orally for prophylaxis (dose number and exact dose were not provided) (product storage error).  The temperature excursion was above 47 degrees Fahrenheit (52.1 Fahrenheit) for a time frame of 15 minutes. There was a previous temperature excursion of above 47 degrees Fahrenheit (55 Fahrenheit) for a time frame of 21 minutes. The digital data logger was involved. No additional adverse event was provided. No PQC was reported.
38 yo male with complaints of localized chest pain on the left side. Progressed to have chest tightness without breathing difficulty. Stated he had facial and oral numbness and numbness of top of L hand. Declined any intervention initially then agreed to take 25mg of benadryl solution orally. Lungs clear, tachycardic but regular rhythm, throat clear, uvula midline. Patient left with EMT's
Fever of 100.7 for about six hours, muscle pain, delayed red inflamed skin around injection site a few days after injection which was also itchy and sensitive to touch
Information has been received from a health care worker concerning an 8 year old male with no medical history or allergies, who on August 31, 2001 was vaccinated subcutaneously in the left thigh with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On January 09, 2006 the patient experienced chicken pox. The patient's mother called the office on January 10, 2006, to report the chicken pox. No labs or diagnostic studies were done. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included iodine allergy and latex allergy. Concurrent medications included CLARITIN and an unspecified nasal decongestant. Historic vaccination included tetanus vaccine (non-gsk, manufacturer unknown) given in 1988. The subject (a school teacher) received a human bite at school and on 20 March 2012 at 15:30 the subject received a dose of BOOSTRIX at 0.5 ml in the right arm. In March 2012 (on or prior to 27 March 2012), less than one week after vaccination with BOOSTRIX, the subject experienced swelling injection site, nodule injection site, injection site redness, injection site soreness (and pain) and injection site warmth. The reporter stated that the physician told the subject that she should take ibuprofen for the swelling and the pain, but no other treatments were suggested. At the time of reporting the events were unresolved (subject still "having problems" from the injection).
Gum bleeding; dizziness; light headaches; ears ring; palpitations; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Apr2021 at 16:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 17:00 the patient experienced gum bleeding, dizziness, light headaches, ears ring, palpitations and tiredness. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events gum bleeding, dizziness, light headaches, ears ring, palpitations and tiredness were not recovered.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Immediately have injection, pins and needles feeling over most of body with extra intensity in throat - with a metallic taste.
After approximately 8 minutes in the "after vaccine" waiting room,  my tongue began to feel strange. I notified the staff and an EMT person took me to a private room. My lips, tongue and the back of my throat began to swell.  I was given a Benadryl, epinephrine shot, IV solumedrol were given at the vaccination clinic. I was taken to Hospital ER. They gave me IV pepcid and observed me for a few hours until the symptoms decreased. I was discharged from the ER with a prescription for an Epi pen and instructions to use Benadryl.  I will call my primary care doctor Monday 2/15/20201.
This spontaneous report was received from a licensed practical nurse and refers to 3 patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 16-FEB-2017, improperly stored doses of PROQUAD (lot # M036294, expiry date 13-FEB-2019, dose, route and site of administration were not reported) were administered to the patients. The vaccines were stored in the temperature between - 10 and 8 degree Celsius for 14 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
First time for flu shot. Right upper arm felt sore after injection and had pain sleeping on right arm. Next day felt pain with normal activities. Still feels tenderness at site. Still has pain with certain movements such as lifting objects.
low white and red blood cells; low white and red blood cells; low potassium; low sodium; low magnesium; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included history of lupus, myocarditis, heart attack and chronic kidney stage 3, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that "I have received the first vaccine and my second dose is scheduled for 08Apr2021. I have read the literature which indicates to get the second dose 21 days apart." It was added that the patient has been recently discharged from ICU. She reported low white and red blood cells, low potassium, low sodium and low magnesium. She cannot have a heart transplant. She is on wheelchair and bed rest currently. She doesn't want to wait 4 weeks to get the second dose because it states clearly in the fact sheet to get the second dose 3 weeks apart. She believes the CDC has a political agenda and they are trying to get as many to get first dose, so the number looks good. She states" I know all about corporate world and the pharmaceutical bureaucracy. It's disaster." The patient wanted to know if she can override and get the vaccine sooner as the clinic refuse to give it to her earlier then the scheduled appointment. The CDC has information on the prioritized population and distribution process during an Emergency Use Authorization. In the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was allowed to be given 19-23 days after the first dose.  We are independent of CDC recommendations anything outside of the 19-23 day interval. It was also stated that the patient had taken the vaccine 11Mar2021 and wanted to know what would happen if she taken it outside of the 3 week window period. She was told that she can go and take it within four weeks. The patient also said she had a lot of medical issue and wanted to know if its okay for the four week period. The outcome of the events was unknown.
1 mo reaction to MMR site. 7x8 cm R lateral redness, swelling and tenderness. Immunization received on 07/12/06 Dtap, MMR, IPV, hep A.  Benadryl and Keflex prescribed. Recheck not better 1 day.
mild symptoms with change in mentation in a nursing home patient dx pn 8/7 at hospital per note
Pt received his 2nd Covid vaccine yesterday and today had a fever of 101.9 axillary at home.  Mom gave tylenol around 1030 and about 20  Min later he had an episode where he slumped over a bit and breathing was irregular and even though his eyes were open, he seemed to not respond for several minutes when parents were calling his name and trying to get his attention.  They called 911 and their doctor and were referred to ER.  On arrival to ER he is alert and interactive and asking for food.  He is responding and making eye contact now.  Mom says he looks much better than when this episode occurred.
Paresthesia in right mid lateral leg and left thumb (more in thumb than leg).  Duration was unclear.  No treatment was needed.
PT REPORTED HIVES, ITCHINESS. PT MONOTRED FOR AN ADDIOTNAL 15 MINUTES. REFUSED ALL MEDICATIONS. SYMPTOMS BEGAN TO RESOLVE. PT SENT HOME.
Fatigue, general punkiness, joint pain Intense Headache ( 2 weeks) Non productive, intermittent  dry cough persistent for four weeks ( still have the cough intermittently now 1 year later) Symptoms lingered for 2 months. Thought perhaps I'd gotten COVID, but not the case.
fever day after 101.9 Next day dizzy and dizzy sill after 2 days
This spontaneous report as received from a nurse refers to a 27 years old male patient. The reporter reported that the patient came to receive his third dose of GARDASIL (lot # was unknown) on unknown day. The patient received first two doses of GARDASIL (lot # was unknown) when he was 26 years old but he turned 27 before his third dose was due. No adverse effects reported. Additional information is not expected.
bad side effects; cramps in her stomach; gas in her stomach; kept awake for two nights; hot and cold flashes; rashes; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights) and HOT FLUSH (hot and cold flashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights), HOT FLUSH (hot and cold flashes), RASH (rashes) and HEADACHE (severe headache). At the time of the report, VACCINATION COMPLICATION (bad side effects), ABDOMINAL PAIN UPPER (cramps in her stomach), FLATULENCE (gas in her stomach), INSOMNIA (kept awake for two nights), HOT FLUSH (hot and cold flashes), RASH (rashes) and HEADACHE (severe headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided    Reporter did not allow further contact
Patient required hospitalization due to breakthrough infection. Patient received J&J vaccine on 03/11/21. Patient was hospitalized from 08/01/2021 - 08/17/2021. Below is copied from patients discharge (death) summary:  Hospital Course: a 67 y.o. male with a PMH of Type II DM and HFpEF who initially presented to the ED complaining of shortness of breath with a recent COVID positive result. Patient stated this started around 7/26/2021 along with a nonproductive cough, subjective fevers, loss of appetite and nausea, with minimal diarrhea. He described the cough as being nonproductive. On the morning of 8/01/2021 the cough worsened which prompted him to call EMS. On arrival to the ED his SpO2 was at 81%-86% on room air. He was then placed on HFNC at 60L and FiO2 on 60% which brought his SpO2 at 94%.  Pt stated he was vaccinated on March with J&J. He finished coverage. MICU consulted for increasing oxygen requirements. At the time of consult, he was sating 90% of max settings on HFNC, however pt was intubated on 8/9 due to respiratory failure. Upon discussion patient confirmed he is full code. On 8/10 pt desatted with development of SubQ emphysema. Stat CXR revealed large pneumomediastinum and pneumothorax. Emergent right sided Pigtail catheter was placed with increase in O2 sats. Patient self-extubated on 8/14 followed by desaturation to the 50s, he was subsequently re-intubated.    I was called to patient?s bedside to pronounce that patient has expired. No spontaneous movements were present. There was not response to verbal or tactile stimuli. Pupils were dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses or peripheral pulses were palpable. No heart sounds were auscultated over entire precordium. Patient pronounced dead at 1903. Dr. notified. Family were notified.  Condolences offered. Chaplain and postmortem services offered. Pt was Full code. Time of death was 1903, confirmed and witnessed by Nurse.
Approx. 3min after administration pt became pale and  light-headed. Pt reports feeling weak, blurred vision, and difficulty speaking.  Denies SOB or LOC.