chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a 61 year old female registered nurse with no known drug allergies who on 22-JAN-2008, at 8:00, was vaccinated IM in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot #659203/1540U). On 22-JAN-2008, four hour post-vaccination, the patient's arm had signs of edema and became swollen and warm which started at the injection site and extended four inches across and two inches down. The patient had no fever, although, experienced bad chills. On 23-JAN-2008, at 19:00. The area four inches in diameter on the patient's arm, with the injection site in the center, became red, hot and indurated. The arm was sore to touch and the patient experienced pain with movement. She was seen by a physician at the office where she worked and the physician felt it looked like an allergic reaction. The patient was treated with diphenhydramine HCL (BENADRYL) and ibuprofen (ADVIL). The area was marked, and it was reported that it had not grown any larger, although, had not decreased in size either. It was also reported that the four inch in diameter area around the injection site remained darker in color (gray) "for several weeks." On an unspecified date, the patient recovered from the the injection site erythema, warmth, induration, and discoloration and extremity soreness and pain with movement. The outcome of the allergic reaction with chills, peripheral swelling and edema was not reported. The patient reported that in 1995 she was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and did not have a reaction. No further information is available.
I was fine after my 1st dosage Moderna Covid vaccine on March 6th.  I got my 2nd April 6th and 2 weeks and 2 day after on April 22nd suddenly I lost hearing in my left ear, started immediately with tinnitus in my right ear.  Probably in my left ear also but can't hear it.   My ear canal in my left ear felt plugged up.  Tried cupping it to unplug it and sounded like a tin can.  Any sound that is able to get thru vibrates in my head.  I can not use my cell phone with my left ear because nothing but vibration sounds when the person is talking.  Using cell phone with my right ear sounds like talking into a tin can.  I can't lay on my left side because my when my ear rubs again pillow case it sounds like interference between radio stations on old fashion radio.  I have had tinnitus before during peri-menopause but NOTHING to this level.  My right ear because of this is hyper sensitive to sounds.
Patient 1st dose on July 2021 has not received 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In July 2021 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comment: The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Entire body ached for 24 hours, difficult to move. Self medicated with 800 milligrams of ibuprofen to relieve symptoms
Report 2001003926-1 describes rheumatoid arthritis in a 68 year old male who received Lyme disease vaccine. This report was received from the patient and has not been verified by a physician or other health care professional. This patient is a avis hunter and fisher. He received his first injection of Lymerix on 04/14/99, no adverse experience was reported following the receipt of this injection. He received his second injection of Lymerix on 05/19/99. By 08/99, approximately three months following the second injection, the joints in the patient's fingers and wrists became "extremely" swollen. In 10/99, the patient was seen by a neurologist, who performed unspecified test and x-rays to rule out carpal tunnel syndrome; the results of these procedures were not provided. The neurologist referred the patient to an orthopedic physician. The patient was seen by the orthopedist in 11/99, at which time Lidocaine was injected into the patient's hand. This provided no relief. The orthopedist referred the patient to a physiatrist, who conducted motor nerve conduction tests and unspecified muscle tests. The physiatrist made a cast and brace for the patient's right hand and prescribed physical therapy. The patient received physical therapy twice weekly from 12/99 through 04/00. The patient stated, "My hands were still swollen so much I could not tie my shoestrings of brush my teeth and were extremely painful". The patient received his third injection of Lymerix in 07/00. The patient's hands and wrists became "worse than ever". He was seen by his internist. A diagnosis of rheumatoid arthritis was reportedly made and the patient was referred to a rheumatologist, who prescribed  Medrol. As of 02/01/01, the patient stated, "I never had RA before. However, due to the Lyme vaccine, my blood work showed a RA factor of 95, which should have been 20." The adverse event of rheumatoid arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Patient received his 2 vaccines and was fine, stood up and stayed with his mom. His younger brother went next and he had the same 2 vaccines. The younger brother bled a little bit after his second shot, the older brother then felt dizzy and lightheaded and went to his knees then passed out. His mom stayed with him and he became alert again while I was finishing up with the younger brother. The younger brother then witnessed this and he became lightheaded and passed out as well. Both boys were breathing and eyes open after each of their initial incidents, but I called EMS. The paramedics came and evaluated both boys and they were not having an anaphylactic reaction. The parents decided to have them taken to the ED for further evaluation. A couple hours later the father called to inform us that the boys were back home and fine. It was determined to be an "emotional reaction" to the blood and then fainting of the one brother, not the vaccination or administration.
140PM inject recvd & mom stated pt had been in good hlth a/inject given; 320 call from mom pt is shaking uncontrollably; pt temp 101 ax; shaking subsiding 420; eyes hazy;
I also had covid 3 times despite being vaccinated; I also had covid 3 times despite being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP.. The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I also had covid 3 times despite being vaccinated".  Additional Information: Patient was reported that he also had covid 3 times despite being vaccinated so not sure how well it really works and he was know that if he was in decent health, he should be ok so he was not terribly worried about it right  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FLU-LIKE SYMPTOMS, FEVER, BODY PAIN AND HEADACHE; This spontaneous report received from a consumer concerned a 24 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 16-MAR-2021, the subject experienced flu-like symptoms, fever, body pain and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, fever, body pain and headache on MAR-2021. This report was non-serious.   Additional information was received from consumer on 24-MAR-2021 following information was updated and incorporated into case narrative: The outcome of the event flu-like symptoms, fever, body pain and headache was changed from recovering to recovered and event stop date added.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ with lot # M040268 and expiration date on 31-MAY-2018 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 47 to 77 degrees Fahrenheit (°F) for a time frame of 7 hours and 15 minutes; but there was a previous temperature excursion reported, with a temperature of 32°F to 35°F for 10 hours. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002269: US-009507513-1705USA011335: US-009507513-1706USA002266: US-009507513-1706USA002267:
Site: Redness at Injection Site-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe
05/11: Fever 05/12: Rash started on back 05/13: Covered with rash amd miserable.  Used herbals and hydro-cortisone.  Felt asthma might be bothering her a little.  No major breathing problems.  Did not take to MD.  Rash clearing by 05/14 and 05/15.  Gone except could see where it was on skin.  Then mother no problems with vaccine.
EXTREMELY HUNGRY; BODY ACHES; COTTON MOUTH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included drug allergy, smoker, and non alcoholic, and other pre-existing medical conditions included drug abuse/illicit - no. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) vaccinated at right deltoid ,dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced cotton mouth. On 24-MAR-2021, the subject experienced extremely hungry and body aches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cotton mouth, extremely hungry, and body aches. This report was non-serious.
Reports 100 degree F fever through night, at 7am noticed red area larger than hand underside of right arm.  Area red, hard and extremely tender.  On 11/7/2012 states has seen improvement.
Redness, induration, pain and tenderness at injection site. Lasting at least 8 days. Fever (>38.5), chills, fatigue, headache, myalgias lasting 4days
patient called and said 10 days post she had a heart attack and was hospitalized. no further information given
First shot no issues. Immediate pain in arm and then into muscles. Tightness up into left side of neck. Upset stomach, headache, felt like I was in a fog, aching
Abdominal pain starting next day evening, last 7 days, day 5 shivering at evening  with night sweet and low grade fever, day 6 evening high grade fever from 6pm to 12 am
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 03-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
neck pain, numbness [diffuse], inability to walk, urinary retention, diagnosed with transverse myelitis, underwent imaging in hospital.  hospitalized for several days.  received iv steroids and clinically improving now
Initial report received from a health care provider on 07 May 2010.  A 39-year-old female patient, who denies any medical history and has no known allergies, had received an injection of ADACEL on 16 April 2010, lot number Sanofi Pasteur Ltd. C3170 and lot number Sanofi Pasteur Inc. U2936BA, developed muscle aches and flu like symptoms which started on 16 April 2010 for approximately 3 days and on the third day developed a metallic taste in her mouth that still persists.  The outcome for the events was reported as did not recover.  Documents held by sender: None.
9 month-old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 10th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that that a 9 month-old male was administered the Kinrix vaccine inadvertently, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Initial report received from a consumer's parent on 05 May 2010. A male patient, with medical history not reported, had received an injection of MENACTRA, lot number not reported, on unknown date ("three weeks ago") and developed severe trembling, chills, vomiting and three weeks later developed type 1 diabetes. The patient was reported as being extremely healthy until he received the vaccine three weeks ago. That night he woke up with severe trembling and chills so bad that he could not get out of bed. His temperature was not taken but he did not appear to be feverish. He was given TYLENOL and he calmed down after about 45 minutes, however, he then vomited several times before he was able to go back to sleep. Three weeks later, the patient's blood sugar was over 400 (units not provided) and was told he had type I diabetes. The outcome for the events was not reported. Documents held by sender: None.
(Fever 102.3, Head ache, Nausea, Fatigue., DIB, First shot for 3.5 days)  (Nausea, Fatigue, Head ache from 2nd shot lasting7 days)
This spontaneous report was received from a consumer refers to his wife a 76 year old female patient. The patient's medical history included shingles virus, chicken pox from head to toe, measles, outbreak of mumps and polio. The patient's husband reported that his wife experienced an outbreak of shingles after receiving ZOSTAVAX, 0.65 ml, subcutaneous (date and lot not reported) for prophylaxis on an unspecified date. His wife initially had the shingles virus 4 years ago at the age of 72 years, on an unspecified date. The patient then received ZOSTAVAX, on an unspecified date after the first case of shingles had abated. Since then the patient had had 3 more outbreaks of the shingles virus. She was currently experiencing her 3rd outbreak after receiving the vaccine. The patient was in a lot of pain and was very slow to recover that time. The patient was taking VALTREX, codeine and administering lidocaine cream prescribed by an unspecified physician, to assist with the pain and itching. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Swollen and rashes around the injection site for almost 14 days; More details on the next page; 1. Day 0 (4/1/21) at 7 hours after vaccination:  swollen site of injection and rashes around the injection area and below it measuring about 1 inch x 0.5 inch;    - applied ice on injection site to reduce swelling; 2. Day 1 to Day 3 (4/2/21 to 4/4/21): area where rashes have increased to 2 inches x 1 inch; 3. Day 4 to 5: rashes became smaller; 4. Day 6:  rashes almost gone and replaced with pale yellow skin discoloration; 5. Day 8 (4/9/21): area around the injection site became swollen again, and very itchy; redness (rashes) about 2 inches x 1 inch;      - started taking Zyrtec 10 mg;      - applied ice on swollen area; 6. Day 9  to Day 10  (4/10/21 to 4/11/21): itchiness persisted and rashes increased size to  3 inches x 2 inches;       - also took Zyrtec 10 mg. 7. Day 11 to 13 (4/12/21 to 4/14/21): rashes increased in size to 3.5 inches to 2.5 inches; 8. Day 14 (4/15/21): redness /rashes almost gone except at the periphery; 9. Day 15 (4/16/21): rashes gone  Note: applied 1% Hydrocortisone cream on area where there were rashes from Day 0 to 14.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject aged 64 or 65 years old who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  The subject received unspecified concomitant medication(s).  In February 2005, April 2005 and December 2005 the subject received the first, second, and third doses of hepatitis B vaccine (unknown).  In July 2007, 19 months after the third vaccination with hepatitis B vaccine, a hepatitis B titer was negative.  This result was confirmed on 23 July 2007 by the reporting health care professional.  On an unspecified date, the subject also experienced an elevated alkaline phosphatase.  At the time of reporting the outcome of the events was unspecified.
09:50.  Reported feeling lightheaded, dizzy. Diaphoretic.  09:52 VS BP 136/94; P 65; Sat/ 98% on RA 10:25:  BP 107/61; p. 63;  Sat 98%  Offered water and a cereal bar snack.  Felt better 30 minutes later. All s/s resolved. Discharged @10:30
Transient global amnesia; short term memory loss; fever; nausea; fatigue; dizziness; This case was reported by a consumer via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced fever, nausea, fatigue and dizziness. On 24th October 2019, the patient experienced transient global amnesia (serious criteria hospitalization) and short-term memory loss (serious criteria hospitalization). In October 2019, the outcome of the fever, nausea and fatigue were recovered/resolved. On 26th October 2019, the outcome of the transient global amnesia and short-term memory loss were recovered/resolved. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the transient global amnesia, short-term memory loss, fever, nausea, fatigue and dizziness to be related to Shingrix.  Additional details were provided as follows: Seven days after vaccination, the patient experienced short term memory loss and was admitted to hospital for observation and was diagnosed with transient global amnesia (TGA). The patient was discharged on 26th October 2019. Less than 2 weeks after vaccination, the patient expereinced some dizziness. The reporter consented to follow up.
On 11/16/17 pt reported the following:  States no pain at time of injection but by late afternoon she could barely lift her arm x4d. By end of the first week she could move the arm but felt like her shoulder was frozen. Had pain in the upper deltoid, 9/10 that radiated to the posterior shoulder blade. Describes throbbing pain at rest which became sharp & stabbing with movement. States shoulder would lock, "pop" when she attempted to raise. Was unable to lift 5 lb weight. Symptoms improved with warm weather, but worsened again with colder weather. Reports "jabbing" pain, 7/10. Had tried heating pad, ROM exercises, Advil 800 mg BID-TID x2 weeks which she had not taken for one week prior to presentation. States was not helpful. Denies previous injury to the shoulder or previous problems. Was given Naproxen 500 mg PO and instructed to take BID. Referred to Ortho for further evaluation.  On 12/4/17 follow up was made. Pt stated she did not go to Ortho as symptoms improved with Naproxen which she took x6d. Continues to feel some discomfort on occasions, but otherwise significantly improved. Instructed to f/u with Ortho if symptoms returned.
Difficulty breathing, hoarseness, wheezing, heightened BP & pulse, bloodshot eyes. Treatment: OTC allergy pills.
3/13/16 - diarrhea x12, nausea, vomiting 3/14/16 - low grade fever 99.5 degrees F 3/15/16 - abdominal rash resolved on 3/16/16 3/15/` - headache.
Patient reports she did not experience any side effects from the vaccine; Patient reports that she was administered two doses of the GARDASIL 9 vaccine at 61 years old; Patient reports that she was administered two doses of the GARDASIL 9 vaccine at 61 years old; This spontaneous report was received from a currently 62 years old female patient with liver injury. Patient reported that she needed a liver transplant but she had not received the liver transplant yet, but her health status had improved. There was no information about the patient's allergies, drug reactions, concomitant therapies or medical history provided. Patient reported that she was administered two doses of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine at 61 years old (product administered to patient of inappropriate age). Patient also reported that her HCP recommended she receive the vaccine because their was evidence to support the administration with liver damage.  On 11-NOV-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (exact dose, lot #, expiration date, route of administration and anatomical location were not reported). On 12-JAN-2022, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (lot#T039466, expiration date: 20-MAY-2023)(exact dose, route of administration and anatomical location were not reported). Vaccines were administered for prophylaxis. She reported that she was due for her third dose of the vaccine but did not receive the third dose. The patient reported she did not experience any side effects from the vaccine.
Had fever, nausea, weakness, dizziness, chills, and headache like I did with dose 1 and 2.  However, this time (and it cold be unrelated) I developed a sty / eye infection that was unlike one I have ever had before.  It was extremely red, swollen and painful.  Infection / redness spread down to m y cheek and eye socket.  I had to reach out to Telemedicine and start taking antibiotics.