chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(L) upper arm warm, red & edematous from mid upper arm to cap of shoulder. Was instructed to take ZYRTEC & MOTRIN per package direction. Apply cold compresses prn. Go to ER if condition worsens.
Patient was fussy and approximately 12 hours after the shots his skin went a translucent pale color and his body went completely limp. He was given oxygen by the police and ambulance that responded. He spent the night in the hospitol on an apnea monitor. He had blood work, a chest x-ray, an EEG, and an EKG and nothing came back abnormal. The medical record received on 2/24/04 states reflux. The medical record received on 2/25/04 states GERD.
Information has been received from a health professional concerning an 8 week old male with a history of gastroschisis repaired shortly after birth and no allergies, who on 16-JUL-2007 was vaccinated with an oral one tube dose of Rotateq (Lot# "0240U"). Concomitant vaccines included a dose of COMVAX, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IPOL and a dose of PREVNAR. The patient's mother informed the reporter that the patient had loose stools, up to 6 or 7 daily since the date of vaccination, on 16-JUL-2007. A stool culture was positive for rotavirus. No other symptoms were noted. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Patient given Pneumococcal vaccine, Developed fever, malaise, headache, pain and induration at inj site. Increased WBCs noted. Admitted, treated and released. No sequelae noted.9/15/06 Received medical records from hospital which reveal patient was hospitalized for surger 1/17/06 for exp lap, liver biopsy & partial gastric resection for gastric tumor.  D/C to home 1/19/06.  PMH: h.pylori infection w/ulcerations; cholecystectomy & endometriosis.  Treatment unsuccessful & a mass was detected along the lesser curvature of the stomach consistent with a submucosal mass.  Liver biopsy revealed spindle cell neoplasm & GI stromal tumor.  No h.pylori identified on biopsy.  Patient returned to ER on 1/23/06 & was admitted w/fever, HA, N/V & possible internal hemorrhage as well as cellulitis at pneumovax site.  Temp max 102.4.  RUE with 5cm indurated, reddened & exquisitly tender lesion.  CT of head showed possible sinusitis.  All cultures were neg.  ID was consulted & patient placed on multi antibiotics with good improvement.  LFTs were newly elevated.  D/C to home on oral antibiotics on 1/30/06/ss
she has Comirnaty that was diluted at 10:48am and place an expiration time of 4:48pm.The vial was stored on the counter at room temperature; she has Comirnaty that was diluted at 10:48am and place an expiration time of 4:48pm.The vial was stored on the counter at room temperature; His arm is a little sore this morning but he feels good; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A 21 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 05Oct2021 18:15 (Lot number: FC3182, Expiration Date: 31Jan2022) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 05Oct2021 18:15, outcome "unknown" and all described as "she has Comirnaty that was diluted at 10:48am and place an expiration time of 4:48pm.The vial was stored on the counter at room temperature"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "His arm is a little sore this morning but he feels good".  No follow-up attempts are possible. No further information is expected.
3/11 ED Patient admitted for urinary tract infection without hematuria after recurrent falls. She reports that the weakness was actually in all 4 extremities. She did not hit her head or lose consciousness.  ED work-up including a CT of the brain was unremarkable.  She had a lumbar puncture as well which did not reveal any acute signs of infection or other etiologies. The patient was concerned that this could have been a result of receiving her Covid vaccination. She will be discharged home on cephalosporins.  She was encouraged to follow-up with her primary care provider within 1 week and to call neurology office for follow-up particularly if she has any more episodes.  She was encouraged to return to the emergency department if she continues to have episodes as well.
Patient came in for his Well Child Check and was due for Immunizations. Patient's Mother wanted him to get his immunizations completed while they were in the office. Patient received Dtap instead of what he should have gotten which was Tdap.  Patient received vaccine and he had no reaction to the vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced vesicular rash, burning skin and pruritus. On an unknown date, the outcome of the vesicular rash was recovering/resolving and the outcome of the burning skin and pruritus were recovered/resolved. It was unknown if the reporter considered the vesicular rash, burning skin and pruritus to be related to SHINGRIX. Additional details were reported as follows: The reporter was patient. The patient received the SHINGRIX in the first week of September. In 2018, a few days after she started getting little dots on her skin that were spread out and were itchy. They look like chickenpox and they look viral. The patient developed them on her right side, which was opposite to where she got the SHINGRIX vaccine. The patient had them on her upper arm, lower arm, hand, upper leg and lower leg. The patient also said that the dots on her leg were burning when they came out. At the reporting time, the dots did not itch anymore but she still had them and she could see them. The patient had denied permission to contact their physician.
Patient went into his Primary Care Physician the day after the vaccines were adminstered when the Nurse Practioner was told by the parent about the swelling in the left deltoid. The Nurse Practioner described the reaction as a large local reaction that was red and warm. The Nurse Practioner mentioned that she measured and marked it. It measured 12 by 11 cm. The following day the patient retured to the doctor's office where upon they stated that it was healing and decreasing in size. Patient was assured that this type of reaction can occur with the 5th Dtap.
pt recv vax & seen in ER next day w/ c/o myalgia & nausea;
scratching, itchiness at site of injection; rash in area of injection 2 in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (scratching, itchiness at site of injection) and VACCINATION SITE RASH (rash in area of injection 2 in diameter) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (scratching, itchiness at site of injection) and VACCINATION SITE RASH (rash in area of injection 2 in diameter). At the time of the report, VACCINATION SITE PRURITUS (scratching, itchiness at site of injection) and VACCINATION SITE RASH (rash in area of injection 2 in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Neosporin taken as a Treatment medication.
Information has been received from a Registered Nurse who was the mother of a male pt who in 1999 was vaccinated with a dose of MMR II, (lot number not reported). In 1999, ten days post-vaccination the pt developed a "measles rash." Medical attention was sought. Subsequently, the pt developed "tracheitis" which required hospitalization. The pt was sent to ICU to be placed on a ventilator. At the time of the report, the pt was four years old. Additional info has been requested. Follow up info received on 1/28/03 from the physician revealed that the pt had not been to their clinic since 12/15/99 and MMR II was not given there. No additional info is expected.
no adverse effects reported; received one dose of M-M-R II intramuscularly; This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 01-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(strength, frequency were unknown) (lot # R030809, expiry date 24-OCT-2020) dose 1 intramuscularly for prophylaxis (incorrect route of product administration). No adverse effects were reported (no adverse event). No product quality issue was reported for this case.
1st dose in 2018,  has not yet received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that the patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The pharmacist was inquiring if his patient should restart the Shingrix vaccine series because she received her 1st dose in 2018. No further information was reported. The reporter consented to follow up.
She started with a  fever 102, chills, headache, body pain. As of today she still exp sinus pressure, ear pain both sides (side going down gland to neck), headache and body pain. She was taken to the doctor informed to give Tylenol and Ibuprofen.
No problem reported during the first trimester of pregnancy. Anatomical ultrasound at 19 weeks of pregnancy, report of irregular heart beat.  No anatomical defect reveled.   Estimated date of delivery 11/05/21
felt sick; Sore arm; This case was reported by a consumer and described the occurrence of feeling unwell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine and shingles.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced feeling unwell and pain in arm. On an unknown date, the outcome of the feeling unwell and pain in arm were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and pain in arm to be related to Shingrix.   Additional details were provided as follows: A patient received 1st dose of Shingrix about 6 months ago from the date of reporting, and experienced a sore arm and felt sick for a few days, and symptoms were resolved. The reporter did not consent to follow-up. For tolerance in 2nd dose refer case US2021AMR063718.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063718:same patient, same reporter
On the above date and time, I while on duty as the Site Manager at the above listed location, was notified of a mishap while vaccinations were being administered.  It was reported to me that Employee, who was assigned to Vaccine Runner, delievered a Moderna Booster (Lot #033H21A) to Employee, who was assigned as a Vaccinator.  The Moderna Booster Vaccine was intented for (Mother of the above listed). Mother was next to receive her vaccine after her son received his Pfizer Pediatric Vaccine by Vaccinator.  Vaccinator inadvertently picked up the Moderna Booster and administered 0.25ml I/M to patients left arm  into the deltoid muscle. Employee was immediately notified, who stated that he was enroute to my location. .  I notified his parents of the incident.  I obtained the partents contact information and supplied them with any information requested.  I requested that patient remain in Observation for 30 minutes as a precaution. Employee arrived on scene, speaking to the parents and providing information to them.  I spoke with patient prior to the leaving the clinic, with over 30 minutes in observation, he was COAx4 and showing no signs or symtoms of any adverse reactions to the vaccine.
Feeling of pressure on the left abdomen after 2nd half dose booster; Numbness on the left side of the body after 2nd half dose booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Feeling of pressure on the left abdomen after 2nd half dose booster) and HYPOAESTHESIA (Numbness on the left side of the body after 2nd half dose booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001H21A, 004F21A, 025A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient experienced ABDOMINAL DISCOMFORT (Feeling of pressure on the left abdomen after 2nd half dose booster) and HYPOAESTHESIA (Numbness on the left side of the body after 2nd half dose booster). At the time of the report, ABDOMINAL DISCOMFORT (Feeling of pressure on the left abdomen after 2nd half dose booster) and HYPOAESTHESIA (Numbness on the left side of the body after 2nd half dose booster) outcome was unknown.            No concomitant medication reported. Patient received first booster dose on 10 Sep 2021 and received second booster dose on 20 Apr 2022.  No treatment medication reported. Reporter reported he visited doctor and ran tests in the hospital, then ruled out a stroke.   This case was linked to MOD-2022-549082 (Patient Link).
Varicella vaccine administered in rt thigh.  Almost 3 months later, pt developed a clustered vesicles in L2 dermatomal distribution on rt side. Dx presumptive shingles, acyclovir started, no cultures done.
One month post vax, the pt experienced joint stiffness, mild bilateral hand and heel pain, and mild right hip pain. He describes his mild pain as arthritic-like. He reports he had no joint swelling or warmth. Pt has been evaluated by a physician who has drawn lab work. Pt received no treatment for the events.
NASAL CONGETION, RUNNY NOSE, DRY COUGH AND HEADACHE
the vial cut finger of staff member when removing from carton with no repoted adverse event; Initial information was received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that the vial cut finger of staff member when removing from carton with no repoted adverse event after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (lot U7584AD) (strength, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of the vial cut finger of staff member when removing from carton with no repoted adverse event (accidental exposure to product) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event the vial cut finger of staff member when removing from carton with no repoted adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red, hot, sore right arm and developed a nodule on the right side of throat pt noticed symptoms 1/14/16 vaccine receive 1/8/16.
Mother called and states child had fever of 104 degrees and TYLENOL given -fever decreased to 101 degrees -
Groin pain; Knee pain on the right side; Upper pain in his arms; Elevated c-reactive proteins; unable to move both arms; Diagnosed with Polymyalgia Rheumatica; Unable to move both arms; Myalgia; This case was reported by a nurse via call center representative and described the occurrence of polymyalgia rheumatica in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), paralysis of arms (serious criteria GSK medically significant), myalgia, groin pain, knee pain, pain in arm, c-reactive protein increased and mobility decreased. On an unknown date, the outcome of the polymyalgia rheumatica, paralysis of arms, c-reactive protein increased and mobility decreased were unknown and the outcome of the myalgia, groin pain, knee pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, paralysis of arms, myalgia, groin pain, knee pain, pain in arm, c-reactive protein increased and mobility decreased to be related to Shingrix.  Additional details were received as follows: The reporter was the wife of the patient and also a nurse.  Myalgia presented 2 to 3 days after the vaccine and continued throughout the month of October.  He visited a doctor on 15th September 20.  He had groin pain and knee pain on the right side.  He was referred to an orthopedist and had 4 appointments.  The knee pain was thought to be referred pain from the groin.  He had a shot in his knee on 2nd October 20 and 8th October 20.  On 15th Oct 20 and 28th October 20 he was seen for upper pain in his arms.  He was unable to move both arms.  He visited a rheumatologist  on 5h November 2020 and blood work showed elevated c-reactive proteins. He was diagnosed with Polymyalgia rheumatica. The reporter consented to follow up.
After receiving the vaccine, my arm ached at the injection site for half a day, and I had a headache. I started feeling systems of a sore throat, headache and stuffiness on 12/11/2022. On 12/14/2022, I tested positive for COVID-19 at a testing center. I contacted my doctor that day and got a prescription for PAXLOVID.
At 4pm yesterday mom noticed some slight redness at DTaP site now today at 1pm area 4"x4" in size, red, hot and painful - mom to begin to ice area, motrin Q6-8 hours, Benadryl Q 8 hours.
On 6/21/09 mother put infant to sleep on his back at 8:30 pm. She then checked him at 9:00 pm and found him face down and not breathing. Grandpa performed CPR because no breathing no pulse. Taken to ER and admitted, d/c after one night. No labs or x-ray done at ER.  7/13/09 MR received for DOS 6/21-22/2009 with D/C DX:  ALTE or near SIDS event.  Infant found face down, limp and cyanotic in crib.  Rescue breaths delivered by family member with fairly quick recovery.  Admitted for monitoring with no further apneic events.  ICD9-786.9
Temp 100.2, headache, fatigue, muscle or body aches and pain at injection site
On 9/30 around 10pm, I developed moderate chills that interfered with sleep as well as moderate muscle aches.  10/1 around 2pm I had felt better with the muscle aches being mild. Around 6pm on 10/1 I had severe lymph node pain in my right armpit. There was also a very large, swollen bump at the injection site. I went to work the night of 10/1 into the morning of 10/2, and by 3am I had started to develop very severe chills, muscle ache, and intensified lymph node pain in the right armpit. By 6am on 10/2, my injection site bump had grown in shape as well as had swelled more. 10/3 the chills and muscle aches have gone back down to moderate, however as of 3pm on 10/3 I have developed a severe headache to the point of pain with turning my neck as well as light sensitivity. As of right now  at 2:40am on 10/4, I continue to have moderate muscle aches and chills, severe headache, severe right arm lymph node pain, a very enlarged red and swollen injection site, and  a small, mild irritated cough. This reaction seems to be much more elongated and severe as compared to my 2nd Covid shot, as I only ever had moderate symptoms and it lasted 24 hours as opposed to over 3 days .
Monday 5/13/19: Patient had vertigo in the afternoon. Parent thought she was dehydrated, so they gave her some water. Tuesday 5/14/19: Dizziness persisted off and on during the day. Then her eyes started feeling painful. Later that night she had eye pain, pain with movement and pressure, and frontal headache. She had 2 small lymph nodes on the back of her head. Wednesday 5/15/19: Eye pain and headache worse, new onset of fatigue, more lymph nodes. Crying at night, but the dizziness resolved. Thursday 5/16/19: Fatigue in the morning, pain in the eyes. Difficult to get patient to school; she wanted to lay around. Mom let her go to school late. That night patient said the eye pain was present, but it did not get worse late at night. Friday 5/17/19: Patient said she felt much better but in the morning mom saw that she had a full rash over her face and chest, with large submandibular lymph nodes bilaterally.