chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 23 year old daughter who experienced dry nostrils that felt like they were scabbing, and bleeding from both nostrils.  At 23 years of age, the pt received a dose on 12/15/03.  The pt had no history of nose bleeds.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  On 12/16/03, the pt experienced dry nostrils (nasal dryness) that felt like they were scabbing (scab).  When she blew her nose, there was a lot bleeding from both nostrils (epistaxis).  The mother reported that the bleeding soon stopped.  No additional information was available at the date of this report. Follow-up information received from the patient provided physician name and address.
Complains of having reaction to injections of fever of 102 through 09/07/13, no other complaints.
Information has been received from a physician concerning a 12 year old female with no known allergies or medical history who in November 2007, was vaccinated with her first dose of Gardasil.  Soon after receiving Gardasil, the patient experienced nausea and did not feel well for about one day following her first dose.  Therapy with human papillomavirus vaccine was discontinued.  Subsequently, the patient recovered from nausea.  Additional information has been requested.
I had severe pain (paralyzed with pain) in my left arm for 3 full days. It got a little better , but I?m a month out, and I wake up with pain daily in my upper left arm.  I still cannot bring my arm halfway across my body. It is painful with every move.  Advil helps, but I don?t want to take that every day. The pain always returns .
Initial information was received on 17 July 2008 from a consumer.  A 26 year old female patient received an injection of TYPHIM VI (lot number A0923-3) on 11 July 2008 at 3:45 pm.  Two hours later, at 5:45 pm, the patient had hives and was seen in the doctor's office.  One day prior on 10 July 2008 she received an injection of Tetanus and Hepatitis A (manufacturer and lot number not provided).  On 11 July 2008 she was given epinephrine.  On 12 July 2008 she was seen in the doctor's office and given BENADRYL and ZYRTEC.  On 14 July 2008 prednisone was prescribed.  The patient resolved from the event.  No further information was provided.
Around 2pm the day of the vaccine, my tongue started to feel like it was burned, rough , and  someone spilled novacaine on the surface of it. My throat also started to hurt, which lasted until about 6pm. The day after the vaccine, (today) my tongue still feels the same, and  i have a metallic taste in my mouth when I eat.
Decrease Dexterity of right hand, unable to send text, getting dress for two days  Narrative:
Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 44 year old female patient who on 01-NOV-2007 at 08:00 was vaccinated IM in the left deltoid with a first dose of PNEUMOVAX (lot #657145/1226U). Concomitant vaccination included FLUZONE (Lot# U2466AA) administered in the right deltoid. On 01-NOV-2007, the patient experienced soreness, warmth and blotchy red discoloration at the injection site and a fever. The patient visited the school district nurse. The patient's outcome was not reported. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is requested.
LIGHTHEADNESS, DIZZINESS, TUNNEL VISION. MONITORED FOR 30 MINUTES RECOVERED  WITHOUT INCIDENT.
Mom reported at 18 M WCC on 4/23/13 7 days after receiving MMR developed hives within 7 more days had resolved.
vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 010M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ESTROGENS CONJUGATED (PREMARIN), THYROID, MONTELUKAST SODIUM (SINGULAIR), FOLIC ACID, DEXLANSOPRAZOLE (DEXILANT), NADOLOL, ATORVASTATIN and CLOZAPINE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 53/0 mmHg (Low) low BP. On an unknown date, Blood pressure measurement: 43/31 mmHg (Low) low BP.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Cardizem and Flonase.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  As per client, MI error in DOB capture   This case was linked to MOD-2021-043689 (Patient Link).
After vaccine, Sore arm around 2 pm and at night time very painful; fever and chills; next day - muscle pains; body aches; headache and I threw up a little bit. It was about three days of these symptoms. The worse was on January 6, I couldn't hear on my left ear. I had a hearing test - they said my hearing was really weak on my left side. They gave me Prednisone for a week and it didn't go away; still had hearing loss after prednisone. There was a little bit of sound - sound of ringing - it was hard to understand people around me. I still have hearing loss today since January 6 in my left ear. I can hear with my right ear - but not on left.
I woke up on April 9th what is stomach pain. At first I thought had a stomach bug. When it lingered on go to the next day on April 10th 2021: I decided to go to the emergency room. It took about 45 minutes for them to tell me did I will need emergency surgery to remove my appendix.
Her current symptoms include, fever, chills, body aches, and fatigue. She also notes a developing sore sore like lesion on her outer upper lip. I let the patient know that other than the lip lesion, the other symptoms were common after the Shingrix vaccine and that they usually subside after 48 hours. She will call back if her symptoms worsen. She confirmed approval for sending adverse reaction report to the CDC.
Patient presented for first dose of Moderna vaccination at 12:13. Patient stated that when he rose from the chair, he felt lightheaded. Patient immediately sat down in a chair and subsequently lowered himself to the floor with assistance from a nurse. Patient remained alert and oriented, appeared pale and diaphoretic. Patient denied SOB, C/P, H/A and nausea. BP 160/108, P 69, R 18, O2 96% RA. Respirations are easy and labored, lungs clear on auscultation. Patient on cardiac monitor presenting with normal sinus rhythm. At approximately, 12:20 assisted to a sitting position and patient verbalized feeling better. Patient was then transferred to a wheelchair and continued to be monitored for an additional 15 mins. BP 160/80, P 58, R 18, O2 98%. Patient verbalized that he felt better and his mother was driving him home.
Was woken up at approximately 6:00 AM (approximately 18  hours after the injection) with difficulty breathing.  Symptoms improved after about a half hour, and were gone about an hour after onset.  No treatment done as the symptoms subsided.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 25-OCT-2012 10:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
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 68-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 05Nov2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged Prostrate" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Patient had no known allergies and other medical history included Enlarged Prostrate, Diverticulitis, Asthma. Concomitant medication(s) included: TAMSULOSIN; FINASTERIDE; MONTELUKAST; OXYBUTYNIN. Other medication in 2 weeks included Tamsulosin, Finasteride, Montelukast, Oxybutynin.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After patient had tested positive for COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Patient received treatment for COVID-19 which included Paxlovid which started on 06Jun2022 and stopped on an unspecified date in Jun2022 with Lot number- GA3594. Patient had tested positive for COVID-19. Patient started taking Paxlovid on 05Jun2022. Patient mentioned it was better to dying from COVID-19.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Few months after receiving Shingles vaccine, the patient got shingles but a mild case. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Nausea/Throwing up- 3/15/21 starting at 3:45  pm ending at 5:15 pm Left arm soreness- 3/13/21 starting around 4 pm ending on 3/15/21 around 7 am
Toothache across the entire lower jaw, which lasted for about 12 hours. Treated with ibuprofen.
Maculopapular rash all over face, neck, head, trunk; 15OCT91 mom says rash lasted 1 wk; saw MD in ER; no dx, no specific inst;
Patient came in for flu vaccine. Upon documentation discovered that patient had received a flu shot on 09/21/22. PCP and patient called.
After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion.  His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23.  Discharged with recommendations to see hematologist.  Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ).  Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?
48 hrs p/vax pt devel a febrile illness, non-use of lt leg & 5 days later dx as having osteomyelitis of lt femur (staph. aureus);
At approx 5:00 AM on 01/06/10 employee awakened feeling "motionless"/did not want to move; difficult to raise her head off bed.  Took shower, laid back down and was late for work.  All day it was a struggle to keep her eyes open and perform normal lab functions where she works.  Felt very irritable with co-workers. Felt like she "could not tolerate anything."  Felt like noises were abnormally loud; felt like her body was "shutting down."  It was a "struggle to even think." Finished work; went home and slept for approx 1 hr; 45 min, then stayed in chair & watched TV for couple of hrs; then went to bed and to sleep.  Next day, called in sick; told dept she had a rxn from flu shot.  This day (01/07/10) her body felt "kind of paralyzed"; body did not want to move nor eyes to open.  She did not want to get up; but was to get out of bed to go to bathroom.  Felt "out of it."  Felt like she was having slower reactions, like answering her parents when they were on the phone. Thinking very slowly also.  About 3 PM that afternoon, could tell she was feeling better.  (Had slept at least until 12 noon).  On Friday, Jan 8, she could tell that "everthing in her body was tingling" (legs and body tingling); she felt "like she was coming out of it."  She worked all day without problems; was happy to be back to work.  She called Employee Health; she also called her Primary MD and talked to the nurse practitioner and asked her to put this reaction to flu shot in her medical file.  Over last weekend she still felt "sluggish".  Today, Jan 12---no problems at all.
Felt bad; My joint and my muscles has been very very aching; My joint and my muscles has been very very aching; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0175 and expiry date was not reported), via an unspecified route of administration, on 02May2021, as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient reported that the patient had second vaccine and believed last week on 09May2021, the patient's joint and muscles has been very very aching and asked was that some-thing have to report and would like to know, how long this effect, do not believe so no. Go ahead had a pen. The patient received Ibuprofen (200mg, tab-let, three times a day) as treatment. The patient reported it started at around, today was 18th. Its second week. Beginning of 2nd week. Its comes and goes like one day its better than the patient felt bad again like yesterday the patient felt not to bad but today was really bad. The patient did not know exactly but sometime its last week when it started guessing, around a week later. Outcome of the events was not recovered.  Follow up needed, further information has been requested.  No follow-up attempts completed. No further information expected.
Information has been received from a nurse concerning a 13 year old female with a history of fainting with vaccines in general who on 21-JAN-2008 was vaccinated with a third 0.5 mL dose of Gardasil (659437/1266U).  Subsequently, on 21-JAN-2008 the patient fainted when she stood up to leave the office.  The patients pupils were dilated, arms were held tight to chest, and she was non responsive.  EMS got called to the office.  Subsequently, on 21-JAN-2008, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from the patient's mother and refers to a 13 year old non pregnant female patient. The patient's medical history included tonsillectomy about 4 years ago. The patient was allergic to penicillin. No other concurrent conditions were reported. On 12-JAN-2017, the patient was vaccinated with GARDASIL 9, dose 1, by "injection" route, (dose, anatomical location, lot number and expiration date were not reported), for "prevention of HPV". Concomitant therapies included ibuprofen and TYLENOL. On 13-JAN-2017, the patient experienced a frequent headache, diarrhoea, some muscle weakness in both arms (muscular weakness), lightheadedness (dizziness), and overall body weakness (asthenia); the patient was tired all of the time (fatigue), had flu-like symptoms (influenza like illness) and dark circles under both eyes; also the patient had "issues having a restful night sleep" (poor quality sleep) and "got out of breath easily" (dyspnoea). No product quality complain was involved. The patient sought medical attention and visited the office 2 times, and, received an unspecified treatment for the events. An unspecified anemia tests and various unspecified thyroid test were performed to the patient, however, the results were not reported. At the time of reporting, the patient only received one dose of GARDASIL 9 and the reporter stated that she would not receive the subsequent doses. On the same date, the outcome of muscular weakness, dizziness, headache, fatigue, diarrhoea, dyspnoea, poor quality sleep, dark circles under eyes and influenza like illness was not recovered/not resolved. Additional information has been requested.
pt devel localized site rxn of redness, swelling & induration the day of vax;
pt recvd vax 22JUL95 & 3wks later pt devel a rash;MD performed a titer @ 5wks post vax & by IgA & IgG there was no detectable antibody;MD felt that the exp was related to therapy w/vax;
The patient received the expired vaccine thet has passed 30 days window period of refrigeration; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received the expired vaccine thet has passed 30 days window period of refrigeration) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received the expired vaccine thet has passed 30 days window period of refrigeration). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (The patient received the expired vaccine thet has passed 30 days window period of refrigeration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a consumer concerning her 14 year old daughter with a history of seizures who on 06-NOV-2006 was vaccinated with a 1st dose of Gardasil. Concomitant therapy included oxcarbazepine (TRILEPTAL). Two weeks after getting the first dose of Gardasil she developed a seizure. She sought medical attention, and no lab diagnostic studies were performed. Subsequently she recovered. As of 24-MAY-2007 she had yet to get the second and third dose of Gardasil. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Hepatitis A Infection; This case was reported by a other health professional via call center representative and described the occurrence of hepatitis a in a 56-year-old male patient who received HAB (Twinrix) (batch number 3C422, expiry date 30th April 2021) for prophylaxis.   On 27th March 2019, the patient received the 2nd dose of Twinrix. On an unknown date, less than a year after receiving Twinrix, the patient experienced hepatitis a. On an unknown date, the outcome of the hepatitis a was unknown.   It was unknown if the reporter considered the hepatitis a to be related to Twinrix.  Additional details were provided as follows: The physician assistant reported that the patient received the 2nd dose of the vaccination at the end of March and the labs report showed immunoglobulin M increased. The physician assistant indicated that the elevated IgM levels were in reference to hepatitis A. On 17th June 2019, the additional lab values indicated that the patient's Hepatitis total IgG and the Hepatitis B IgG are both positive. The reporter also stated in regards to the Hepatitis B testing, the surface antibody was positive, but the core and surface antigen were negative.      Lab Comments: On 17th June 2019, the patient's Hepatitis total IgG and the Hepatitis B IgG are both positive. Reporter continues that in regards to the Hepatitis B testing, the surface antibody was positive, but the core and surface antigen were negative.
Chest pain, SOB, unstable oxygen saturation requiring oxygen, fatigue, anxiety, arrhythmia
1/5/21 approximately 2200 begin to run a fever up to 101.3 with chills, nausea, headache, body aches, shortness of air, mild abdominal pain, this continued off and on through 1/6 & 1/7.
15 min post vaccination today, he felt "something in his " Adam's Apple. Feeling a little tight". Feels "heart is beating fast". HR 63 -- > 103 -- > 56. Given Benadryl 25 mg IM x1. Patient reports feeling much better, stable, released from vaccination site.
ITCHING THEN ABOUT 30 MINUTES LATER A RED RASH APPEARED ON MY ARMS, LEGS, CHEST AREA.   MY DOCTOR TOLD ME TO TAKE OVER THE COUNTER BENADRYL AND IF A BOOSTER WAS EVER OFFERED IN THE FUTURE NOT TO GET IT, AS THE REACTION COULD BE EVEN WORSE.
"a pretty good case of shingles"; This spontaneous report was received from a registered nurse via a company representative referring to an approximately 70 year old female patient who was an unspecified employee from an unspecified doctor's office. Information about medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, "a couple of years ago", the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) reconstituted with diluent for shingles prevention and developed "a pretty good case of shingles". At the time of the report, the outcome of the event was reported as recovered.
inflammation; swelling of his toes; toes are starting to turn purple; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been experiencing "weird side effects" which included inflammation and swelling of his toes on an unspecified date in Jan2021. He said his toes were starting to turn purple and when he went for a health visit, he was told that it was "Covid toe". He wanted to know if there have been reports regarding "weird side effects" like his. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Information on lot/batch number has been requested.