chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and tender. The reporter stated that the patient, who received the third dose of GARDASIL on an unspecified date approximately in 2011 (reported as 2-3 years ago), on 09-AUG-2014 was inadvertently administered with the fourth dose of GARDASIL (intramuscular injection, dose 4, 0.5 ml, intramuscular, strength, anatomical location, lot # and expiration date not reported). No adverse effects reported. No further information provided. Additional information is not expected since the reporter did not consent to be contacted for further follow up.
After taking the 2nd vaccine she is having the horrible itching, red blisters popped up. She is having tiredness, the left side of her nose hurts, headaches and she is having cramps like menstrual cramps in her stomach.
Approximately 10 minutes after patient received initial COVID vaccine he started complaining of itching and scratchy throat.  He then broke out in hives and vomited.  At that time patient received Epi pen 0.3mg and a rapid response was called as it was suspected that patient had anaphylaxis to the vaccine.  Patient was transferred to the ER for further care and monitoring.
Patient has pain in her shoulder and cannot move it. She claims she may have gotten bursitis. She visited her doctor and the doctor said it may have been caused the flu shot. RPh recommended ibuprofen.
Patient received ZOSTAVAX injection on 10/17/12. The patient noticed a rash developing the next day. I spoke to husband on the weekend and told him if any worse have MD look at it. She was seen by MD 10/22/12.
Information has been received from a health care worker concerning a 17 year old female with pertinent medical history and concomitant medications reported as unspecified, who on approximately 29-FEB-2008 (2 months ago), was vaccinated with her first dose of GARDASIL, IM, (Lot# not reported).  A few hours after her vaccination, she developed injection site swelling and sought unspecified medical attention.  It was reported that the swelling measured 6 inches by 3 inches, and resolved about 5 days later (approximately 05-Mar-2008).  No product quality complaint was involved.  Additional information has been requested.
Initial information was received from a health care professional on 25 September 2008.  A 51 year old female patient with a history of hypertension, diabetes, and an allergy to penicillin developed symptoms two days after she received the YF VAX (lot number UF305AA) subcutaneously in the left arm and a second dose of oral TYPHOID vaccine (manufacturer Berna, lot number 3001400) on 25 September 2008.  The patient received a first dose of oral TYPHOID vaccine (manufacturer Berna, lot number 3001400).  The date was not reported.  On 25 September 2008 the patient presented to the doctor's office with pain at the injection site in the left arm, quarter size redness, swelling, left neck and jaw pain, left sided weakness, and shortness of breath.  She was being evaluated at the time by a physician.  The patient was not recovered at the time of the report. 12/15/08-records received-presented 9/25/08-C/O SOB, left sided weakness, left sided numbness, left side of neck and jaw hurts. Small localized red area at injection site, warm to touch. Sudden onset of pain at injection site travels to back of arm and associated with numbness and burning sensation, neck stiffness on left. Assessment: possible reaction to vaccine, possible infection at injection site with lymphatic response.
Fever (101.1), Chills, Fatigue, Light-headed, Arm pain/swelling
This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's concomitant medication included a sterile diluent (manufacturer unknown) (lot number M037018, expiry date 01-MAY-2019) that was properly stored. The patient's concurrent conditions, historical conditions and drug allergies/reactions were not reported. On 31-JAN-2018, the patient was vaccinated with a dose of improperly stored PROQUAD (lot number: N000336 and expiry date: 30-JUL-2018) (dose, strength, frequency and route not reported) for prophylaxis. It was reported that the PROQUAD vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. It was reported that this call was made because of a data logger. No adverse effects were reported. No additional information was provided. There was no product quality complaint present.
I feel as if I've been hit by a truck. My whole body hurts. It's like a fibro flare but so so so much worse. My wrists, elbows, neck, and back hurt very very bad. I used all of my energy to get up and slide a window open and it hurt my wrist so bad it literally brought me to tears. I'm dehydrated and hot, but no temperature. I'm tired and in pain. I've taken Ibuprofen and acetaminophen today. I'm going to bed and hope it's better tomorrow.
Headache, Sedation, Fever, CHILLS AND BODY ACHES Narrative:
cramps in stomach; Slept most of the day; bowel movement at 3am; felt nauseous; Very tired; had the chills; threw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous) and FATIGUE (Very tired) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE, THYROID (ARMOUR THYROID), RIVASTIGMINE, ZINC, FISH OIL (OMEGA3 JACK), DIOSMIN, HESPERIDIN (FLAVONID), MONTELUKAST SODIUM (ADKAST), DONEPEZIL and SIMVASTATIN for an unknown indication, ABC COMPLETE SENIOR 50+.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous), FATIGUE (Very tired), CHILLS (had the chills) and VOMITING (threw up). At the time of the report, ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous), FATIGUE (Very tired), CHILLS (had the chills) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    This case was linked to MOD-2021-021461 (Patient Link).
Information regarding PREVNAR was received from a pediatrician regarding a 15-week-old male patient who experienced Pneumococcal meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008. He also received the first doses of HIB (manufacturer unknown), Poliomyelitis Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on 15-Jul-2008. Relevant medical history was not provided. Concomitant therapy included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and fever. He was hospitalized and diagnostic tests were performed (see test results), however serotyping was not performed. The blood culture and cerebral spinal fluid culture were positive for Pneumococcus. The patient was diagnosed as having Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be ineffective in preventing Pneumococcal meningitis, but stated that she realized that only receiving one dose in the series did not confer immunity to the disease. No further information was available at the time of this report. The cause of death was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood culture (results: positive for Pneumococcus); body temperature (results: fever); CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare provider was ill day prior to office visit. 8/25/08-fever and seizure.  9/25/08-records received-urgent care center visit 8/12/08-C/O irritability and vomiting without fever. Sent to ED. Presented to ED with vomiting and screaming. Large projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid 80's. Transferred to another facility. 10/16/08-records received for DOS 8/25-8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable, agitated.  11/06/08-records received-Cause of death:meningitis due to pneumoccal meningitis.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patients involved were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (thimerosal free) lot number: M037248 (expiration date: 21-FEB-2019) for prophylaxis (strength, route, dose or units were not provided); ROTATEQ lot number: N030150 (expiration date: 29-AUG-2019), lot number: R002521 (expiration date: 18-SEP-2019), orally, for prophylaxis (strength, route, dose or units were not provided) and LIQUID PEDVAXHIB lot number: N031492 (expiration date: 02-MAY-2020), lot number: R005118 (expiration date: 28-NOV-2020) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 0°C to 1°C (0.9°C) for 30 minutes - Previous temperature excursion: 0°C to 1°C (1.4°C) for 7 minutes. No adverse effects were reported. Follow up information has been received from the reporting medical assistant and stated that this case refers to a 13 month old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-OCT-2018, the patient vaccinated just with a dose of improperly stored LIQUID PEDVAXHIB lot # N031492, expiration date: 02-MAY-2020, for prophylaxis (strength, dosage, frequency and route were not provided). This case was previously considered as non-valid, but upon receipt of follow-up it was determined that the case is now valid (patient identifiers were provided). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA003267.
Vaccine administered, within 20 min. pt complaint of left side facial weakness, slurred speech, dilated left pupil, weakness/tingling in left upper extremity.  CT scan, transferred to ICU and pt states all symptoms had resolved.  10/16/2008 MR received for DOS 8/1-4/2008 with D/C DX:  Post-partum TIA ( IUP at term, delivered.  Protracted labor.  2' midline episiotomy. Repetitive severe variable decelerations). Pt admitted for L&D. Received TDaP postpartum and w/in 20" developed L-sided facial weakness, slurred speech, dilated L pupil and numbness and weakness of the LUE. Symptoms resolved quickly.  Later neuro exam (+) for depressed reflexes except absent at the achilles, otherwise WNL.  Started on heparin and D/C on ASA.
Patient started breathing heavily a few minutes after receiving the vaccine, was able to say words not full sentences. said he was feeling hot. he lost muscle control and uncontrollably urinated. EMR was contacted; patient retained muscle control and got back to normal in about 2 minutes after the start of the adverse events. and was able to walk with the EMR outside to get medical check.
Friday afternoon 4/9/2021 - headache, body aches, face beet red, felt hot then later shaking with chills.  NO temperature. bundled up and slept.  woke middle of night and symptoms had subsided.   Saturday mid morning, neck felt sore, it is swollen and warm and very tender to touch.  Swelling is at base of neck towards shoulder rughly 2x3 inches and maybe 1/2 inch or so high. swelling covers the collarbone and lower part of neck is also a tad puffy.
pretty strong reaction; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (pretty strong reaction) 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 HYPERSENSITIVITY (pretty strong reaction). At the time of the report, HYPERSENSITIVITY (pretty strong reaction) 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.   No concomitant and No Treatment Medication was provided.
Patient developed generalize allergic reaction with itching and hives treated with antihistamine Benadryl she did visit her family Doctor.
6 weeks after vaccination developed severe diffuse oral ulcerations (>50 ulcers) present on buccal mucosal margins, lips, gingivitis, oropharynx.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with twelfth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 17-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 20-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore, no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. The narrative was amended accordingly. Non significant case correction received on 10-Aug-2017: The narrative was corrected.
On approximately 3/22/21 right thigh pain started. This increased to difficulty walking. Resulting in the need for an additional cane and a walker. Pain rates from 3 to 6 depending on the day.
REDNESS, SWELLING, HOT TO TOUCH AT INJECTION SITE, FEVER. IMPROVED WITH BENEDRYL AND MOTRIN.
7cm x 3.5cm cellulitis at injection site.  24 hours after vaccine administered.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female with no pertinent medical history and no drug allergies, who on 22-JUL-2009 was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 662404/0312Y), and on 27-SEP-2009 she received the second dose (0.5ml, IM, lot # 663558/0819Y). There was no concomitant medication. The patient was found to be pregnant at a later time. A pregnant test was done prior to the second vaccination and was negative. Ultrasound showed the time of conception was around the second dose. "Special studies are fine to date". The patient had visited the office for medical attention. The patient's last menstrual period was around 27-SEP-2009, and estimated delivery date was around 04-JUL-2010. The patient had 20 weeks gestation at time of report. Follow-up information has been received from a physician concerning a 25 year old female non-smoker, gravida 5, para one, with a history of tonsillectomy, 1 live birth with group B strep positive bacteria (January 2006), and 3 elective abortions (2004, 2006, 2009), who on 22-JUL-2009 was vaccinated with a dose of GARDASIL (0.5ml, IM, lot # 662404/0312Y). The patient's last menstrual period was 02-SEP-2009 (previously reported as 27-SEP-2009). Her estimated due date was 16-JUN-2010 (previously reported as 04-JUL-2010). On 27-SEP-2009, the patient received the second dose (0.5ml, IM lot # 663558/0819Y). It was noted the patient experienced gestational diabetes for which she was started on glyburide twice daily prior to delivery. On 05-JUN-2010, the patient delivered a normal, healthy male baby weighing 6 pounds 14 ounces. Postpartum glucose challenge will be scheduled. Patient currently using condoms and has decided on PARAGARD IUD. All available medical records will be provided upon request. No additional information is expected.
Moderate local skin reaction peaking within 2 days of administration. May have been related to non-IM administration of an "IM" vaccine.
0735 Patient presented with c/o hives; throat swelling; flushed feeling; 0740 Patient given 0.3 mg of epinephrine via Epipen auto injector to right outer vastus lateralis; 0745 Patient reported "feeling better" Hives were less visible and she felt less flushed; 0745 Adult Medical Emergency Team transported patient to ED.
Progressive tinnitus followed by severe hearing loss and fullness in right ear accompanied by nausea and vertigo
11 days after Varivax pt broke out in chicken pox however, chicken pox outbreak was present in community.
Son reported patient could not talk, mouth was twitching 1:45pm, then again approximately 45 minutes later, at 6pm she was also confused.
Left arm swelling post vaccine x 1 day. Treated with Augmentin ES 600mg give suspended 5 ml take 25 ml BID Orapred 15/5 ml 2 teaspoons QD.
Herpes Zoster - Information has been received from a consumer concerning her 43 month old female family mumber who in August, 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown).  In January 2000 the patient developed whingles on her arm and recovered at an unknown date.   Prior to 11 Apr 2000, the patient developed shingles on the name arm again, and the outcome is unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
First sign that I had was a runny nose.  I thought that was just normal runny nose but Tuesday night & Wednesday morning I had a little sore throat. I thought I just had post nasal drip. Around noon on Wednesday I felt tired and not myself, so I did an at home rapid COVID-19 test and it was positive. I felt feverish, headache, cough, runny nose, body aches, sore throat and tired. I contacted my doctor on Thursday and she prescribed me Paxlovid and I started taking it on Thursday and took the last dose this morning.  Because I have some kidney issues because of medications I take it was a reduced dose. Today I still have a little bit of post nasal drip and cough.
pt devel hives approx 1 1/2hr p/vax rash on face, trunk, legs;denies new food, soap, detergent & no med;given DPH & rash resolved in 1 1/2 days;pt not ill, no fever, did not see MD;inj area all reddened but nothing unusual
R29.810 RIGHT FACIAL MUSCLE WEAKNESS 3/27/2023 DISTURBANCE OF SKIN SENSATION R29.810 RIGHT FACIAL MUSCLE WEAKNESS 3/27/2023 BLURRED VISION
Patient is a 35 yo male with a PMH significant for depression, HTN, HLD, and tremor who received his pneumococcal 23 vaccine in left deltoid on 05/16/19. He developed some redness moving toward the axilla. There was no fluctuance and no swelling. He denied fever or chills. No medical intervention was needed. ErythemaMultiform
Swelling, pain, fever at injection site. By 6 PM The arm was very swollen from shoulder to elbow with tenderness, redness, pain, inability to move arm. Pt. experienced low grade fever. 09/03/2010 swelling continued, arm extremely hot to touch, muscle pain extended to L. chest wall. Difficulty drawing deep breath. Pt. continues to experience muscle pain in L. shoulder and chest wall. Continues to have intermittent difficulty with deep breaths.
received a partial 2nd dose due to it leaking; Fatigue; Heavy Lidded; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced accidental underdose, fatigue and eyelid disorder. On an unknown date, the outcome of the accidental underdose, fatigue and eyelid disorder were unknown.   It was unknown if the reporter considered the fatigue and eyelid disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a partial 2nd dose due to it leaking, which led to accidental underdose. The patient was immediately given a full 3rd dose of Shingrix and felt fatigued and heavy lidded. The reporter did not consent to follow up. No additional details were provided.
Some of patient's 2nd dose ran down her left arm; some of the vaccine came out of the syringe and ran down her arm; A spontaneous report was received from a consumer who is a 35-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine came out of syringe and ran down her arm.  The patient's medical history was not provided. No concomitant product use was reported.  On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: J3202JA) in the left deltoid intramuscularly for prophylaxis of COVID-19 infection. During administration of the vaccine, some of the vaccine came out of the syringe and ran down her arm.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, some of the vaccine came out of syringe and ran down her arm, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 35 year old female who received her second of two planned doses of mRNA-1273  (Lot number: J3202JA) intramuscularly for prophylaxis of COVID-19 infection and during administration of the vaccine, some of the vaccine came out of the syringe and ran down her arm. There were no reported adverse events after the vaccine was administered in the case of underdose.