chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 12 month old female who on 08-MAR-2007 was vaccinated with a first dose of PEDVAXHIB (Lot# 654070/0071U). On an unspecified date, the patient was vaccinated with a second dose of PEDVAXHIB (Lot#655545/0074U) and in approximately July 2007 received a third dose of PEDVAXHIB (Lot#656274/0079U). The nurse reported that the patient had received all three doses and "6 months later" ("in the last week"; approximately 16-JAN-2008) developed epiglottitis and was hospitalized. At the time of the report, the patient had not recovered from epiglottitis. Epiglottitis was considered to be immediately life-threatening. Additional information has been requested.
Patient was transported to ER for itching, feeling hot.  10:10 am, patient has allergies to antibiotics (gets hives).  EMTs advised patient to get Benadryl IV and get fully checked at the hospital.
The day after the shot I felt pain in both upper arms, progressing to severe pain down the arms and into the hands. Hands and shoulders became very stiff and painful. Pain and stiffness eventually moved to many joints, bi-laterally. Loss of weight. Pain and swelling continue, primarily in the hands. Diagnosis - Parsonage Turner Syndrome, rheumatoid arthritis, small fiber neuropathy. Treatments, Prednisone, pain medications, Gabapentin, Leflunomide, REMICADE.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Recieved pfizer booster vaccine 2/6/2022 at outside facility.  To clinic 2/10/2022 with reports 2/7/22 developed intermittent chest pain, sob, heart palpitations.  Vs in clinic 122/82, pulse 62bpm, temp 97.8 degrees F, resp 16 rpm, o2 sat 99%.  No visible distress, lungs clear, heart regular rhythm on ascultatation, s1s2.  Referred to ER for further cardiac/respiratory workup.
Case number PHEH2014US004722 is an initial spontaneous report from a pharmacist  received on 05 MAR 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number not reported) intramuscularly on 20 FEB 2014. No adverse event ws reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014 of the data received on 05 MAR 2014. It was identified that  BPI labeling of the event "inappropriate age at vaccine administration"  was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Pt expired at 11:30 AM on 11/3/01. Death certificate states cause of death as cardiopulmonary arrest due to congestive heart failure. Other significant conditions noted were endstage cardiomyopathy and IDDM.  Cause of Death as per Death Certificate was cardiopulmonary arrest.
This spontaneous report as received from a nurse via a representative refers to a female patient of unknown age. On 25-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (lot # 672232/1495AA, exp date 22-AUG-2014). The nurse reported to representative that the patient developed an ovarian cyst at an unspecified date. The patient saw an unspecified OB/GYN physician. Therapy was reported as discontinued. At the time of the report, the outcome of the event was unknown. Additional information is not expected.
NO TREATMENT PERFORMED. THE AREA OF INJECTION STILL APPEARS TO BE SOMEWHAT SORE WITH A MILD "PIMPLE-LIKE" CYST UNDER THE SKIN.  THE ARM HAS ALWAYS BEEN SOMEWHAT SORE SINCE TIME OF INJECTION.
seizures began 20 days after MMR/DTaP, HepA vaccinations.  Perfectly healthy before vaccinations.  Extremely unbalanced 2 days before first seizure.  Spent 5 days in special care.  Has had 7 grand mal seizures (40 seconds - 2 minutes long) in last 5 months, and 6-8 drop seizures. 1/2/08-records received-4/18/07 well baby visit. 5/7/07-C/O cold symptoms for past week, temperature 99-100, pulling on his ears. Been swimming. Seemed to be falling and little more unstable than normal. PE: WNL-viral illness with otitis media-5/8/07-Reeval. Episode where he rolled eyes back in his head and had jerking of arms and legs. 7/14/07-Fevers last night and for last one to two days. Mild runny nose. Couple of episodes over past few days where he appears to suddenly fall. 7/18/07-continues on antibiotics for ear infection. 8/15/07-episode of wheezing seen in ED DX asthma. 8/28/07-URI with history of viral encephalitis and subsequent seizrues. 9/6/07-Otalgia. No evidence of ear infection. 10/29/07-C/O fever and cough over past two days seems to be off balance. Grand mal seizure. Continues to have fluid in right ear. Probably sinusitis. 115/07-vomiting night prior. Diarrhea. Presumptive gastroenteritis.  1/8/08-records received-11/13/07-neurology consult-seen for management of seizures. First seizure at 15 months of age, 20 days after his 15 month immunizations. upper respiratory tract infection with fever approximately 1 week after immunication were given. Experienced seizure approximately 2 weeks after URI resolved which was approximately 20 days after receiving immunizations. Genreralized tonic-clonic lasting approximately 2 mintues or less. Prior to discharge he experienced fever and 2 generalized tonic- clonic seizures. Four months ago began to experience "drop seizures" characterized by generalized muscle jerk and forceful fall backwards while either sitting or standing. None since 10/24/07 when medication changed from Trileptal to Keppra. Some speech delay. On target developmentally except for expressive speech. Impression: findings are consistent with an infectious or post infectious process, suggestive of acute diseminated encephalomyelitis (ADEM). krk Per 60 day follow up: Still experiencing seizures, currently being evaluated for developmental delay in speech & cognative areas. Also immune system has been weakened since this event.
Suspected Vaccination failure / get shingles pimples; shingles; shingles pimples on my forehead; vaccinated with Shingrix for both doses in March 2019; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pimples. On an unknown date, the outcome of the vaccination failure, shingles and pimples were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pimples to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received Shingrix both doses and had shingles pimples on forehead. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the left side of the neck.  It became increasingly painful on March 19 in the evening (especially after dinner) and overnight (around 3 a.m.) and more painful in the evening on March 20th after dinner.  On March 20th, I took 800 mg ibuprofen (4 tablets) at 6 p.m. to relieve the pain.  My husband is an Emergency Physician and indicated that is the dose I should take given the pain.    At 1:00 p.m. on Sunday the lymphnodes on the left side of the neck began hurting again (excruciating pain) and I again took 800 mg of ibuprofen to relieve the pain.  This occurred after having lunch (a burger) at noon.  However, at 1:30 p.m. the left side of my face began to feel numb. I had little control of the left side of my mouth and could not close my left eyelid properly.  The numbness lasted for about 20 min and then subsided.  After 40 min (2:10 p.m.) it felt better and I had a few potato chips left over from my lunch.  The numbness started again about 10 min later and lasted about 20 min.  The face went numb again the evening of March 22nd for 20 min despite remaining on ibuprofen 3 times a day.
FOLLOWING THE ADMINISTRATION OF THE THIRD VACCINE (VARIVAX), PATIENT STATED THAT HE WAS FEELING DIZZY, FLUSHED, CHILLS, NAUSEA, VISUAL AND AUDITORY DISTURBANCE. PATIENT'S HEART RATE HAD DROPPED TO THE MID 50S AND DID LOOK PALE. HE ALSO STATED THAT HE DID NOT EAT ALL DAY, HE WAS GIVEN FOOD/WATER TILL THE PARAMEDICS ARRIVED AND WAS "FEELING MUCH BETTER" AT THAT TIME (15 MINUTES LATER). HE WAS THEN CLEARED BY PARAMEDICS AND RECOMMENDED TO FOLLOW UP WITH PRIMARY CARE PROVIDER.
Patient given covid-19 vaccine at 1218, Symptoms started at 12:25 (dry cough, dry mouth). Benadryl 25mg by mouth given at 1238. No previous history of vaccination reaction. Of note: recent history of Clinically diagnosed bronchitis and treated with OTC medication (mucolytic) by pcp, no ATB given.  No NKDA, no recent fever or illness in 24hours. Initial VS: BP: 142/84, HR: 111, RR: 24 Spo2% 99/RA, . End VS: BP: 118/94, HR: 82, RR: 16,, SpO2: 100%/RA.  Patient denies shortness of breath or difficulty breathing, Lung sounds are clear. Patient states she feel better and is conscious alert and oriented X4. She was placed in  he monitoring room within the vaccination clinic for intermittent monitoring of VS and reaction response at 1317.
After about 5 minutes of administration of the vaccine the patient began to feel tightness in her chest. She was able to breathe and speak freely so I administered benadryl. After about 5 minutes she said she felt better.
Expired Engerix  administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-week-old male patient who received HBV (Engerix B) (batch number k329e, expiry date 24-APR-2023) for prophylaxis.   On 25-APR-2023, the patient received Engerix B. On 25-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix  administered). The outcome of the expired vaccine used 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 Information: GSK Receipt date: 28-APR-2023 The reporter was a medical assistant. The vaccine administration facility was the same as primary reporter. The reporter reported that the patient received the expired Engerix-B vaccine, which lead to expired vaccine used. The reporter did consent to follow up.
Shingles; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203), dose 1 via an unspecified route of administration in left arm on 06Mar2021 at 13:30 (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history included Sulfa (drug allergy) from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included atenolol, dexlansoprazole (DEXILANT), levothyroxine sodium (SYNTHROID), pitavastatin calcium (LIVALO), colecalciferol (VITAMIN D 3); all from unknown dates to unknown dates for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shingles on 14Mar2021. The adverse event was resulted in doctor or other health care professional office/clinic visit. Anti-viral and topical cream was given as a treatment for event. The outcome of the event was reported as resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
Developed hives, started @ 9:30 pm 2-19-08 and covered body by 11:30 pm. Seen at hospital ER after 11:30 pm by Dr. Treated with oral Benadryl and Oralprerd. Symptoms beginning to subside 2-20-08 am.
Case number PHEH2014US025044, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 34-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 8-month-old male patient who received DTaP vaccine. Co-suspect products included HAVRIX 720 Junior and ENGERIX B PEDIATRIC (batch number unknown, expiry date 6th February 2015) and (batch number AHBVC200AA, expiry date 6th February 2015). Previously administered products included ENGERIX B pediatric with an associated reaction of no adverse event (1st dose). On 19th February 2015, the patient received the 4th dose of DTaP vaccine (unknown), the 2nd dose of HAVRIX 720 Junior (intramuscular) .5 ml and the 2nd dose of ENGERIX B PEDIATRIC (unknown). On an unknown date, the dose was an unknown doses. On 19th February 2015, not applicable after receiving DTPa vaccine and ENGERIX B PEDIATRIC and an unknown time after receiving HAVRIX 720 Junior, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced injection site swelling, expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the injection site swelling, inappropriate age at vaccine administration, expired vaccine used and drug dose administration interval too long were unknown. Additional information received: The patient was a 8 month-old male who received his 2nd dose of ENGERIX-B on 19 February 15, but the dose had expired on 06 February 15. First dose of Hepatitis B vaccine was given on 01 September 2014. The interval between the 1st and 2nd dose of ENGERIX-B was too long. The patient also received a DTap vaccination in the opposite thigh (right), which may or may not have been INFANRIX for 3rd or 4th dose. He had swelling on the right leg (uncertain if at injection site or more of leg) and was taken to urgent care clinic for evaluation. The patient also received HAVRIX vaccination, which was noted as 2nd dose, but that conflicts with patient's age. Reporter was not very reliable.
Five hours after receiving the seasonal flu shot Afluria, I had a fever (99.7) and aches all over. I also woke up with a headache.
Migraine, followed by severe eye pain and a very bad broken blood vessel in right eye.  Eye pain has continued over time.
Excessive swelling at injection site approx 3.5 x 4" itching, discoloration and few bland spots.
Information has been received from a nurse practitioner concerning a female with no known allergies and no reported medical history who on 10-DEC-2007 was vaccinated with Gardasil intramuscularly.  Concomitant therapy included MENACTRA in the same arm as the Gardasil vaccination.  On 11-DEC-2007 the patient experienced numbness in her fingers and fingertips, and had described that it almost felt like she had slept on her arm.  It was also reported that the patient was holding her arm as if it were in a sling because it was so sensitive.  No further information was provided and no lot number was given.  Additional information has been requested.
pt recvd vax & craned her head & neck uncontrollably for 5 days; pt twitches very badly before going to sleep;
I feel tired; headache; nauseated; sometimes and I have no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 16:30 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfonamides, notes: Verbatim: Sulfa antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I feel tired"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nauseated"; DECREASED APPETITE (non-serious), outcome "unknown", described as "sometimes and I have no appetite". Therapeutic measures were not taken as a result of fatigue, headache, nausea, decreased appetite. Therapeutic measures were not taken as a result of fatigue, headache, nausea, decreased appetite.  Additional information: I feel tired, I have a headache, I feel nauseated sometimes and I have no appetite, for two days now I've only had two noodles and a couple snacks, this started late Monday. device timestamp: 18May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24Jun2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a physician assistant refers to about 17 years old, non-pregnant female patient. Patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, Expiry date, dose, route were not reported) (dose number unspecified). Concomitant medications were not reported. Subsequently on an unknown date, the patient experienced seizures. The patient sought medical attention- she went office visit. The outcome of seizures was not reported. The relatedness between the event and GARDASIL was not reported. It was reported that therapy was not discontinued. Upon internal review the event "seizures" was considered to be medically significant. This one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 16 week old male patient with allergy to iodine, thimerosal and tetanus toxoid who on an unspecified date was vaccinated with four vaccines. The nurse thought two of the four vaccines the patient received was MMR II and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On an unspecified date the patient developed a severe allergic reaction after administration of the four vaccines. The reaction took place over 14 years ago but she thought it was already reported. The patient was sent to an allergist. At the time of report the patient's status was recovered. No further information is available.
Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.   No Medical History information was reported.  On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine were administered on 29Sep2021 and they had expired on 28Sep2021) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported. No treatment information was provided.
had them after the shot/ suspected vaccination failure; had them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after the shot, had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with cases US2021AMR194989 and US2021AMR195008, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR194989:same reporter US-GLAXOSMITHKLINE-US2021AMR195008:same reporter
Received vaccine on 1/16/21, on 1/17/21 started with coughing, white phlegm, SOB and on 1/18/21 developed fever to 101 and increased need for oxygen.  Home requirement increased from 3L O2 to 6L O2. On 1/18/21 presented to hospital. Quickly defervesced with steroids and cefepime. Possible post-obstructive pneumonia vs immune response to vaccination.
urinating often; fever; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of POLLAKIURIA (urinating often), PYREXIA (fever) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced POLLAKIURIA (urinating often), PYREXIA (fever) and HEADACHE (headache). At the time of the report, POLLAKIURIA (urinating often), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 28-Oct-2021 reporter denies to consent for follow-up.
Received hep B #1 dose 11/23/2004 at approximately 2:00pm. At 8:00pm became nauseated (quite severely) temp 99 degrees. At 3:00AM vomited, dizzy and slept till 11:00AM and now legs are achy.