chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse refers to a 1 month infant, of unknown gender. Medical history and concurrent conditions were not reported. On 21-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
I tested positive COVID-19 on 8/7/22. I had a fever of 102, body aches all over, severe chest pains, I felt weak, light headed, and no appetite. I noticed that the day before I rested positive, the floaters in my eyes were a got worse, and I was able to hear my pulse in my ears. I also had chest pains, which is typical when I have pneumonia, but it got better after taking Paxlovid.
I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine I had hives all Over my body which were treated with Benadryl. On Tuesday the hives persisted but treated during the day with Benadryl, at about 10:30pm the hives started to show on my face, my lips got swollen, and I felt like a pit in my throat That was stuck. I went to the ED and I was treated with IV Benadryl,  IV Pepcid, and IV Solumedrol. I left the ED upon signs of improvement and was given prescriptions for Epi pen and steroids for 4 days.
I had really bad sinus pain, it felt like they were on fire. It felt like they had been sandpapered and then had alcohol poured on them. It was if I had the worst sinus infection I could ever have in my life. I awoke with a fever and my sinuses were still hurting. I decided to go to a testing sight on 12/17/2023, the COVID-19 test did come back positive, but they did not give me medication because of my blood pressure medication. I came home and called my doctor, he called in a prescription of the PAXLOVID, I started taking it immediately and started feeling better within days. My fever broke by the 19th of December, I was just very tired. My sinus problem seemed to linger, I had an ENT appointment for another issue, they gave me a sinus rinse and sinus sprays to help clear the issues. As of two weeks ago I feel completely back to normal. I do feel that I got a rebound COVID-19, I tested negative then right on Christmas day I tested positive again.
Patient reports severe headache that lasted all day as well as temperatue of 100 degrees F. Next day (03/16/2019) back to normal/she was fine.
severe pain on whole / (right) arm/painful arm/achy arm; right arm was tingly; heavy arm; right arm was / with zingers (zaps) of burning sensation.; cannot bend her right thumb; Anterior interosseous nerve syndrome; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of anterior interosseous syndrome in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd November 2020, 1 days after receiving Shingrix, the patient experienced anterior interosseous syndrome, injection site pain, pain in arm, tingling of extremity, heaviness in arm, burning sensation and stiff fingers. In November 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the anterior interosseous syndrome, pain in arm, tingling of extremity, heaviness in arm and burning sensation were unknown and the outcome of the stiff fingers was not recovered/not resolved.   It was unknown if the reporter considered the anterior interosseous syndrome, injection site pain, pain in arm, tingling of extremity, heaviness in arm, burning sensation and stiff fingers to be related to Shingrix.  Additional details were reported as follows: The patient got her first Shingrix shot in left deltoid. The next day she had pain at the injection site which resolved after 2 to 3 days. She also had more severe pain on whole opposite (right) arm. Her right arm was tingly, heavy, painful, achy with zingers (zaps) of burning sensation. This still continued with the right arm. Patient was unable to bend her right thumb and saw a hand doctor for this 1 week ago from reporting date. He diagnosed anterior interosseous nerve syndrome and told it might resolve on its own. At the time of reporting, patient was still unable to bend her right thumb and it was not swollen. The reporter did not consent to follow-up.
Moderate pain on right side of mandible onset ~48 hrs after injection. Pain only experienced during flexion and extension of mandible such as yawning or chewing. No pain experienced when mandible is still. Symptoms are ongoing and currently present
After receiving the vaccine I was sick to my stomach and couldn?t move for 4 days. The left side of my body has been in severe pain. After 1 week my INR dropped drastically and nothing else has changed. Constant headache, fatigue
sick; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who got sick (illness), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Teen noted onset of wheezing, back pain, headache, dizziness within 3 hours of vaccine administration.
I have oral herpes. I get it 2-3 times a year. Valicyclovere is taken and it goes away without exception. It came up the day after receiving the vaccine and has lasted 5 weeks and the Valicyclovere isn't working. it went away by 03/10/2021. I also experienced fever and weakness 03/06/21 and then when it resolved the herpes came up. Went to the doctor at a walk in clinic on 02/24/21 because I had high fever and nausea and weakness for about 10 hours. I got an infected tooth(root canal and crown on this tooth) and an infected jaw. Dentist put me on antibiotics and I have to have the tooth pulled. I went to the dentist on 02/11/2021.
pt tested positive in the nursing home for COVID; DNR; comfort measures; O2 supplementation and steroid pack given; pt died in the facility; per death certificate, cause of death COVID 19
Information has been received from the authors of a published literature article, entitled as above, concerning a 28 year old male with HIV infection and idiopathic thrombocytopenic purpura (ITP) who in approximately November 2000 was vaccinated with his first dose of pneumococcal 23v polysaccharide vaccine (manufacturer not reported). In November 2000, after the administration of PPV, the pt underwent splenectomy for ITP. At the end of November 2000, the pt developed overwhelming pneumococcal bacteremia (serotypes were unknown) complicated by meningitis. In March 2001, the pt again developed overwhelming pneumococcal bacteremia (serotypes were unknown) complicated by peripheral gangrene. In March 2001, PPV was administered again. At that time, the pt's CD4 cell count was 441 cells/uL, and his viral load was 253 copies/mL. In January 2002, the pt developed septic shock.  S. pneumoniae serotype was 6b isolated from cerebrospinal fluid and blood. The pt's CD4 cell count was 475 cells/mL, and his viral load was 25,900 copies/mL. His convalescent serum had no detectable immunoglobulin to any of the polysaccharides, either before or after a third dose of PPV was administered. The pt subsequently received three doses of Prevnar at monthly intervals. Subsequently, he had IgG to all of the PSs contained in Prevnar including serotype 6B (see laboratory data table).  The reporter felt that the capacity to respond to 23-valent pneumococcal polysaccharide vaccine by producing IgG is genetically regulated, and that some proportion of adults do not respond: "Recurrent pneumococcal bacteremia in patients who have undergone splenectomy may indicate a genetically regulated failure to respond to 23-valent pneumococcal polysaccharide vaccine; heptavalent protein-conjugate pneumococcal vaccine may stimulate production of IgG to PSs in such patients". No further information is available. Upon internal review, meningitis was considered an other important medical event (OMIC). The article also discussed the experience of a 57 year old male while on therapy with pneumococcal 23v polysaccharide vaccine (WAES0503USA04442). A copy of the published literature article is attached as further documentation of the patient's experience.
5 minutes after 1st shot (administered in left arm) my face turned red, about 20 minutes later I felt a prickly feeling in my cheeks and ended up with a rash on both cheeks that was gone by next day.  Felt very run down/tired.  2nd does (3/20/21) felt prickly feeling in cheeks ended up with a rash on both cheeks that lasted 2 days. Felt very run down/tired for 3 days. Rash cleared 1 week after.
Friday morning I work up with a terrible headache, that worsened tremendously when I opened my eyes; Could hardly move; Everything hurt; Nauseated; Injection site was swollen; The injection site was red; Injection site was hot; Chills; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), fibromyalgia, osteoarthritis and COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient take concomitant medications quite a few, but no room to put them was reported by the patient. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 06:30 (she had the shot Thursday morning), on friday morning she woke up with a terrible headache, that worsened tremendously when she opened her eyes. she could hardly move. Everything hurt. she was nauseated. The injection site was swollen and was red and hot. She had chills, no fever. But she think she would have to die to feel better. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19 The clinical outcome of the event terrible headache, could hardly move, everything hurt, nauseated, vaccination site was swollen, vaccination site was red, vaccination site was hot and chills were recovering at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report was received from a consumer on 16 May 2011. A 35 year-old female patient had received ADACEL (lot number, route and site of administration not reported) on 05 or 06 May 2011 (reporter unsure) and within 24 hours experienced swelling on face and in gums, difficulty breathing, a fever of 102 F, "swelling under skull" and "water under skull". The patient went to the emergency room twice but was not admitted to the hospital. The reporter was unsure of allergies or pre-existing conditions. No further information was known by the reporter. Contact information was not provided for follow-up. The patient's outcome was not recovered. Documents held by sender: none.
Pt came to pharmacy on 11/6/15 saying that his left arm has hurt, felt weak, and painful all down his arm since his shot on 9/21/15. He also stated his right arm has also stated hurting. He went to the ER and received treatment.
The nurse gave my son the vaccines. At night when I changed him to go to sleep I noticed his leg swollen and red. The next day I called his pediatrician to let them know if it was normal and the nurse said that it was fine as long as he wasn't vomiting or having fever. The next day after that, my son kept touching his leg and he was limping and the area where the vaccine was had a big red circle, it was still swollen, and in the middle of the red circle was a bruise and it was warm to the touch. I took him to the hospital at five because I wasn't comfortable about it and the doctor told me that it was an allergy reaction. My son received diphenhydramine and hydrocortisone for medications.
Patient received 0.5ml dose of AFLURIA vaccine on 19 Oct 2010.
Immunized on 5-12-14 in the A.M. On 5-13-14 8:30 p.m. c/o itching and red lump warm at injection site and small lumps/hive started on the rest of body. BENADRYL given 9:15, 2 a.m., and 6:30 am hive got worse and spread over entire body. TYLENOL given also. Contacted family to see how patient did over the weekend and his Mother explained that he had another flare up on Friday, May 16th and went to the Emergency Room. Client stated it was hard to breathe or regulate his breathing. There was mention that the doctor was concerned about the steroids he was taking. He did also see a Pediatrician in follow up from the E.R. visit and was given an EPI-PEN. He did have a flare up that evening but not too bad. On Saturday, May 17th mom stated he had a huge flare up. She did realize that he seemed to be panicking and once she was able to calm him his breathing improved. He did have hives all day Saturday she gave him prescribed medications (ZANTAC and a lotion) and he continued with hives until around 2 a.m. Sunday morning. After that he began to clear and has been clear since. Mother did state that the doctor said this certainly was an atypical reaction to the injection. She also shared that there is an aunt in the family who also had a reaction to this shot.
after the shot was given, patient's back tensed up and she was unable to stand. I had her sit, took her blood pressure 139/84 with pulse of 85.  i gave her water as she sat for 10 min. when i checked back she felt better. she claims she had the flu shot before without any problems.
fully vaccinated with the Pfizer COVID 19 vaccine and they have both contracted COVID; fully vaccinated with the Pfizer COVID 19 vaccine and they have both contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "A little bit of high Cholesterol" (ongoing). Concomitant medication(s) included: MAGNESIUM; SELENIUM; VITAMINS NOS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "not recovered" and all described as "fully vaccinated with the Pfizer COVID 19 vaccine and they have both contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202200949948 same reporter/drug/AE, different patient.;
on 7/1/2008 developed bilateral rash on arms,legs and groin.  Blisters.  Now all crusted.
Prevnar 13- Puffiness; Prevnar 13- Redness; Prevnar 13- Swelling; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe; lot number and expiration date unknown) via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced puffiness, redness and swelling. Outcome of the events were unknown.  Information on batch number has been requested.
This spontaneous report as received from a physician concerning a patient of unknown age who was vaccinated with GARDASIL doses (dosages, route and lot number not provided) on the following dates 21-SEP-2010, 22-FEB-2011, and 05-OCT-2012. No adverse effects were reported. Additional information has been requested.
Probably not related but website asked me to report that I began having serious heart palpitations amd high blood pressure on June 17 l, which led to two hospitalizations for testing. Doctor will be performing an ablation in November to treat a-fib and possibly Supraventrical Tachycardia. Most likely genetic, but I had never previously been diagnosed with heart palpitations or high blood pressure.
No additional AE details available; vaccines were administered after experiencing temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 07-OCT-2021 the patient was vaccinated with with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # T032317 was confirmed to be valid with expiration date 22-SEP-2022 (dose, route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 8.5 degrees Fahrenheit (F) for 18 minutes and 11.9 F for 1 hour. There were no previous temperature excursions. No additional adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007766:
SORE THROAT, CONGESTION, FUNNY FEELING IN CHEST (UNSURE HOW TO DESCRIBE), TEMP 99-100, MILD ACHINESS
Terrible side effects with the booster shot (none with the first shot): headache, aches and chills, heart palpitations. A month later and I still have random, stabbing head pains and a sluggish heartbeat.
TINNITUS; BRAIN FOG; PRESSURE BEHIND RIGHT EYE (WHERE HEADACHE PAIN WAS) ON AN OFF; ACHY BODY; INSOMNIA; HEADACHES; FEVER (LOW GRADE); LETHARGY; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced lethargy. On 07-MAR-2021, the subject experienced achy body. On 07-MAR-2021, the subject experienced insomnia. On 07-MAR-2021, the subject experienced headaches. On 07-MAR-2021, the subject experienced fever (low grade). On 09-MAR-2021, the subject experienced pressure behind right eye (where headache pain was) on an off. On 10-MAR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, headaches, and fever (low grade) on 08-MAR-2021, achy body on 07-MAR-2021, and brain fog on 15-MAR-2021, was recovering from insomnia, and had not recovered from pressure behind right eye (where headache pain was) on an off, and tinnitus. This report was non-serious.
Patient presented with rash to bilateral forearms approximately 5-10 minutes post vaccination accompanied by pruritis.  Patient escorted to "Procedure room 2" for direct observation and assessment.  No other symptoms present.   discussed medication therapies with patient.  Rash and pruritis had resolved in the time medication therapies were discussed.  Observed patient for an additional 15 minutes, no further adverse reaction and the rash resolved spontaneously.  Patient discharged from the vaccine clinic.
Developed shingles in his left eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received Shingrix (intramuscular). On 3rd November 2019, 6 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   The reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The case is a legally significant case.  The patient received Shingrix in left arm. The patient experienced shingles in the left eye.  The patient saw more than one doctor about it and was told there was a good likelihood that he would lose vision in his eye because of the shingles. The patient believed Shingrix caused the shingles. The reporter consented to follow up. The reporter saw a junior doctor first. He then saw a senior doctor, but did not have the name available. He preferred to contact the senior doctor who diagnosed him with shingles. The reporter stated his attorney would be in touch with GSK.