chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a 4 years old female patient. The patient's concomitant medication included FLOVENT and multivitamin. The patient's pertinent concurrent conditions included Thalassaemia minor and asthma. The patient was allergic to dogs, cats, pollen, trees and dust. On 10-JUN-2014, the patient received first dose of M-M-R II (lot number and expiration date unspecified) with sterile diluent (lot number and expiration date unspecified) subcutaneously for prevention of measles, mumps, rubella. On 26-JUN-2017, the patient received second dose of M-M-R II (lot number and expiration date unspecified) with sterile diluent (lot number and expiration date unspecified) subcutaneously for prevention of measles, mumps, rubella. The patient had negative measles titer on 01-MAR-2018. On 17-MAY-2018, the patient received a third dose M-M-R II (lot number N014485, expiration date 10-MAY-2019) with sterile diluent (lot number and expiration date unspecified) subcutaneously for prevention of measles, mumps, rubella (extra dose administrated). The patient had negative measles titer on 02-NOV-2018. Treatment was given for the events and the patient saw physician for seeking medical attention. The outcome of the events was reported as not recovered. The causality assessment between the events and suspect therapies was not provided.
felt sick; ache; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), PAIN (ache) and FATIGUE (tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant medical history).   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (felt sick), PAIN (ache) and FATIGUE (tired). At the time of the report, ILLNESS (felt sick), PAIN (ache) and FATIGUE (tired) outcome was unknown.            Treatment medicines include Tylenol  No Concomitant medications
passed out after getting the vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than a month after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). In August 2020, the outcome of the passed out was recovered/resolved.   It was unknown if the reporter considered the passed out to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The age at vaccination was not reported. After receiving Shingrix, the patient passed out but came a couple of hours later. The reporter stated that, he was not the one who administered the vaccine to the patient, she got that at a different pharmacy, but reporter was a pharmacist.; Sender's Comments:  US-Pfizer-2020328749:
arm pain; slight chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain) and CHILLS (slight chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and CHILLS (slight chills). At the time of the report, PAIN IN EXTREMITY (arm pain) and CHILLS (slight chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-403262, MOD-2021-403028 (Patient Link).
Given Varicella 9/20/06 on 9/22/06 return to office, with fever, diarrhea, vomiting, streaks on tongue, won't eat or drink. Continues Motrin, advised liquids in small amounts only for 12 hours and call DR if no improvement.
This information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. Between 10-MAY-2017 and 16-MAY-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX with lot number M035693 and expiration date on 07-NOV-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 90 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA008472: US-009507513-1705USA014918.
Information has been received from a medical assistant concerning an 6-year-old male patient who on 22-FEB-2005 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
rash on the left side of the torso that looks like shingles or hives, very itchy with a burning sensation sometimes.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-APR-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with (Oka/Merck) VARIVAX that was exposed to 43.1 F for 29 hours on 03-MAR02014. This is one of several reports from the same reporter. Additional information has been requested.
I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Soreness, redness, warmth/heat, swelling at injection sight. Tenderness in armpit of arm where injection was given.
Pt was not due to receive any vaccine at this visit but was mistakenly given a Bexsero that was intended for another patient. Her mother was informed of the error. Patient was unharmed by the vaccine. The vaccine is approved for her age.
Baby received 5 shots and died the next day of unknown cause - pending coroner report.  6/8/07 Received Autopsy Report which reveals COD as SIDS.
Pt recv vax on 11/23/98; post vax pt exp inconsolable crying > 4 hr
After vaccination on 09 April, the patient expressed to the clinic staff that he was experiencing blurry vision. He was evaluated by a provider after vaccination and was release without limitations.   The patient was evaluated again on 13 April by his primary care provider and reported headache, vision changes, body ache, fever, chills, and lightheadedness when standing or changing positions. The patient was instructed to hydrate and follow up with his primary care provider for further assessment in 2 days.   During his follow up on 15 April, the patient reported a resolution of symptoms. He had continued to increase his water intake. and supplemented with electrolyte beverages as well.
This case was received from a health professional on 03 October 2007.  A patient (gender not reported) received an injection of Adacel (lot number not reported) and subsequently experienced "nodules and a rheumatological type reaction".  No further information was available.
FEVER ,CHILLS, BODYACHES, RASH, HEAD ACHE, FATIGUE, IRATTIC HEART BEAT
sore throat; congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Immediately after last injection of HPV, client became pale, and stated "I don't feel well". We placed client in supine position. Clients BP was 112/78, 10 min later stated I feel better". Sitting BP was 110/78.
today w/pt 13OCT95 reported that 4hrs p/vax pt had episode of 3hrs of uncontrollable crying w/o fever & did not seek medical attention;ped DT given
15 MINUTES AFTER RECEIVING ADACEL, PATIENT EXPERIENCED MINOR RASH AROUND THE NECK LINE AND BOTH ARMS. SHE ALSO FELT SOME SWELLING ON THE THROAT, BUT NO DIFFICULTY OF BREATHING. 25MG DIPHENHYDRAMINE WAS ADMINISTER BY MOUTH IMMEDIATELY WHEN THE PATIENT REPORTED THE ALLERGY SYMPTOMS. 5 MINUTES AFTER DIPHENHYDRAMINE DOSE, THE PATIENT FELT BETTER, THE RASH SUBSIDED, NO THROAT SWELLING WAS FELT.
2 day hosp stay next day 16JUL96 TD given c/o fever, severe h/a, stupor, body aches, nausea & vomiting;
contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 (contracted COVID). At the time of the report, COVID-19 (contracted COVID) outcome was unknown. Not Provided           No concomitant medication was reported.  Treatment medication included Tx: Inhaler, Zpack, Cough Syrup.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090465 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090465:
"Covid arm"- red raised circle with visible hives, approximately 3 inches in diameter, around place of injection; appeared exactly one week after first dose of vaccine in the evening; very itchy but not painful; lasted three days
21APR lt arm, red, swollen, itching;22APR lt arm, itching, 40 x 85 reddened area inferior to inj site;24APR all sx completely resolved;
Patient had high fever, localized pain, high blood pressure for a few days. Patient was admitted to ER on the first day due to really high blood pressure
This spontaneous report was received from a female patient of unknown demographics regarding herself. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. The patient reported that she had shingles 12 years prior to receiving ZOSTAVAX vaccine, which is other than indicated in the prescribing information. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). After receiving the ZOSTAVAX vaccine, the next day (unspecified date), she had a fever blister on her lip. She then had painful, inches rashes over her trunk area. The patient sought medical attention for the adverse events. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was filed. Additional information is not expected because the reporter details were not provided.
Following are my symptoms and severe side effects and events after receiving the COVID-19 Vaccine.  1- Receive COVID 19 vaccine at 4.00 PM on 01/15/21. 2- Stay about 20 minutes after Vaccination and observe no reactions and symptoms. Dive back home. take dinner and sleep well whole night. 3- Next day morning when I wake up feel till bit of Nausea/Vomiting. 4- Take breakfast at about 10.00 AM and after that feeling of Nausea got increased and i also start feeling weakness. These symptoms remains all day. 5- At about 5.15 PM I went to take Shower. After about 2 minutes during shower, i feel shortness of Breath,pressure on chest and Dizziness 6- These Symptoms was for about 4 to 5 second and goes off. 7- After about one minute I feel second time shortness of Breath, pressure on chest and Dizziness. It was bit intensive and for a longer period for about 10 second. 8- At this point I realized that this is something serious happening to me.  9- I came out from the Vertical Shower and called my wife that I am not feeling well. She was at this time at first floor. 10- I think it is about 1 minute after when I came from shower, I feel third time shortness of Breath, pressure on chest and Dizziness. I was very severe and within a second or so I passed out and fell down into the Jacuzzi which is beside the Vertical Shower. 11- Within a minute, my wife and my son came to the scene. At this time my wife finds me unconscious with my eyes open.  12- She shouted my name and then I came into my senses and told them to get me out of Jacuzzi.  12- My wife and my son get me out and carried over to the bedroom. I was feeling no shortness of             Breath and Dizziness but mild pressure on chest, shivering and chill. 13- Thanks GOD I did not get any body injury except little bit of hit at my Neck and back of the Head. 14- My wife immediately called to my Primary Care Nurse and then I talk to her explain the whole situation and then asking for advise. 15- She advise me to go to any near Hospital Emergency for any urgent Medical care. 16-A about 6.00 PM I went to Emergency. At this time I was feeling Nausea and Shortness of breath. 17- The Nurse immediately check my blood pressure, temperature, oxygen and pulse. These all was normal. Nurse also provide me IV medicine for Nausea. 18- During my stay at Emergency, I again feeling mild tightness/pressure in chest beside shortness of breath and shivering, therefore Emergency Doctor advise me that will admit to the hospital and do the complete check of any stroke and heart attack. 19- I was in the Hospital for 2 nights. During this stay I was under care of: -Attending Physicism: -Cardiology Physician 20- They have carried out Multiple Blood and Radiology Test as stated below. As per Doctors, all of my Test results are Normal, and they did not find any sign of Stoke and Heart Attack. -Multiple Blood Lab test. -XR CHEST 1 V  -CT C-SPINE WO CONT. -CT HEAD-BRAIN WO CONT. -CT ANGIO HEAD W&WO CONT. -CT ANGIO NECK W&WO CONT. -CTA CHEST FOR PE  -MRI BRAIN WO CONTRAST . -STRESS TEST. 21- I was discharge from the Hospital on 01/18/21 at 17.34.
On Feb. 17th, 9 days after the vaccine began to experience what I thought was TMJ ( which i've never had before) on the left side of my face, over next 2 days pain went from left jaw to right jaw to back of neck, then under left jaw, then sinus pain/headache.  I mananged it from FEb. 18th - to Feb. 19th with Excedrin then went to see my primary care doctor on March 1st  because I was due for the 2nd vaccine on March 2nd and wondered if I should take the 2nd dose.   She couldnt give me a full yes on that because not enough was known about the vaccine, so I went to Penn Hospital on March 2nd for my 2nd dose and asked them . While I was sitting there the nurse made a call to someone to ask and they said to go ahead.    I received the2nd dose and the next day on March 3rd I woke up with banging head pain ( felt like sinus) and had it every day/night until Sunday, March 14th when I went to the emergency room of Abington Hospital with double vision, eye and head pain.  Just FYI, From March 3rd to 12th, I saw my primary dr. my ear nose and throat dr. and a neurologist to try and find out what was going on.  In the hospital, I was diagnosed with Temporatl Artereitis, and 3rd nerve palsy.   I was in the hospital for 3 days - given 60 mgs. of prednisone, and pain killers.  Still on prednisone now, tapering off.
Myalgia, Fever, injection site pain, chills, fatigue Narrative:  Employee reported myalgia 4/21/2021 with chills and fatigue. "I could not get out of bed. Symptoms stared to go away 4/22/2021. Self treated with 1 tab acetaminophen and "felt better and was able to sleep".
Myalgias/arthralgias; shoulder & hip bursitis dx by MD; still symptomatic w/painful limitation of ROM;
broke out in hives on my chest and upper back.; This is a spontaneous report from a contactable other healthcare professional (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685) intramuscularly on 18Dec2020 10:45 at a single dose for covid-19 immunisation. Medical history included moyamoya disease, asthma and allergies to crustaceans. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.) and azithromycin. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced drug allergy. On 18Dec2020 23:59, the patient reportedly broke out in hives on the chest and upper back. Outcome of the event recovered on an unspecified date on Dec2020.
I am reporting this as an error in administration of the vaccine. The patient did not experience any symptomatic adverse reaction. My child received the vaccine and then we left the office. About 15 minutes later I received a phone call from the doctor's office asking that I come back because there had been a mistake in dosage. The nurse told me that she had accidentally given a lower dose than prescribed and that my child needed a second dose. My child has not experienced any adverse symptoms as a result of this error but it was very inconvenient and caused my child unnecessary anxiety by having to go back for a second shot.
Numbness and tingling to bilateral lower extremity. Complete and total loss of bladder control. This has never once happened to me prior to the 2nd COVID-19 vaccine.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 2nd dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient had pain in extremity (sore arm), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
I awoke at 0345 on 9 January and felt nauseated.  I got up and went to the bathroom and vomited.  I then vomited 1 hour later and then every 30-60 minutes for the next 12 hours.  After the first 4 episodes of emesis, I was only vomiting bile.  I felt wiped out and very weak and slept when I wasn't vomiting.  On the 10th, I had generalized muscle aches but no more vomiting.  On the 11th, I am finally feeling better but not really normal yet.
About 7 days after vaccination the injection site became itchy,  red,  burning and a rash approximately 10x6 cm erupted.  The site hurt the day after the vaccine then was fine until the symptoms started on 8/11.
HOSPITALIZED FOR CORONAVIRUS PNEMONITIS. DIED 4/10/21 HX OF MANTLE CELL LYMPHOMA, CAD, CHF, DM
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 12 hrs after receiving SHINGRIX, the patient experienced nausea, headache, pain in arm, fever, muscle pain, vomiting and chills. On an unknown date, the outcome of the nausea, headache, fever, muscle pain, vomiting and chills were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the nausea, headache, pain in arm, fever, muscle pain, vomiting and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. On 28th August 2018, the patient experienced nausea, vomiting, headache, chills, fever, muscle pain, and arm soreness about 12 hours after receiving SHINGRIX vaccine. In August 2018, all of the adverse events resolved after about 24 hours except the arm soreness. The HCP did not have vaccine information available.
Extreme exhaustion; Headache; My arm was sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable healthcare professional (HCP, patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Dec2020, the patient experienced extreme exhaustion, headache, her arm was sore. No symptoms at all till 72 hours after the vaccine. The outcome of events was unknown.   Information on Lot/batch number has been requested.
Patient states she had a large red swollen spot at injection site w/ itching and headache.
Information has been received through the Merck pregnancy registry from a health professional concerning a female who on 07-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil. Per the reporter, the patient was 3 weeks pregnant at the time of vaccination and subsequently experienced vaccine exposure during pregnancy. On approximately 05-JAN-2008 the patient experienced elective termination of pregnancy (gestation = 7 weeks). No other information was available. Elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.
About 12 hours after receiving my booster I started feeling muscle pain, burning and tingling in my  lower legs and feet extreme fatigue and muscle spasms (thighs). Shortly therafter I started developing insomnia , increased weakness and and a decrease in my thought process over the course of a month. I have also developed an unstable gate and lightheadedness. My physician referred me to a Nephrologist (appointment pending).
Patient having range of motion difficulties up to 1 month after injection. She states she has hard time lifting her arm over her head and has some mobility pain moving her shoulder.  Patient did not need to seek medical treatment.
Rash - vesicles/pustules - 8-10 in number on the chest, back and groin.