chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fullness in the ears began 48 hours after vaccination, has continued still today at time of reporting. Currently it?s 8/25 9:00am Pain in the injection site, started 18 hours after injection and master for 24 hours.
Administered after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20th May 2024) for prophylaxis.   On 13th January 2023, the patient received Shingrix. On 13th January 2023, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The physician called to report that Shingrix suffer temperature excursion and was administered to a patient. The vaccine was exposed to minus 10 degree Fahrenheit. The reporter consent to follow up via email. Additional supportive information: The vaccine was exposed to -10 degree Fahrenheit, which led to incorrect storage of drug.
This case was reported by a consumer via market research programs and described the occurrence of fever in a 43-year-old male patient who received FLUARIX. Co-suspect products included salbutamol sulphate unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included asthma. On 3rd October 2014, the patient received Influenza vaccine unspecified 201-2015 season. On an unknown date, the patient started salbutamol sulphate at an unknown dose and frequency. In October 2014, less than a week after receiving Influenza vaccine unspecified 2014-2015 season and not applicable after starting salbutamol sulphate, the patient experienced fever, pain in arm, stomach virus and tiredness. Influenza vaccine unspecified 2014-2015 season was discontinued. Salbutamol sulphate was continued with no change. On an unknown date, the outcome of the fever, pain in arm, stomach virus and tiredness were recovered/resolved. It was unknown if the reporter considered the fever, pain in arm, stomach virus and tiredness to be related to Influenza vaccine unspecified 2014-2015 season. The reported considered the fever, pain in arm, stomach virus and tiredness to be unrelated to salbutamol sulphate. Additional details provided as follows: The market research program number is ADVAIR00165. The flu vaccine took only 15 minutes and was painless. The patient felt a little feverish for a days or so after. His arm was alittle bit sore. The patient described a terrible stomach bug. The patient decided that will not take the flu shot next year.
blister had developed about an inch and a half from the injection puncture site; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 26 years old female patient who experienced blister had developed about an inch and a half from the injection puncture site after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Sep-2022, the patient received a 0.5 ml  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once ( lot UT7689JA; 30-Jun-2024) via intramuscular route in the right arm for Immunization.  On an unknown date the patient developed a non-serious event blister had developed about an inch and a half from the injection puncture site (Vaccination site vesicles) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Vaccination site vesicles).  At time of reporting, the outcome was Unknown for the event.
Pt received two vaccines at 10 AM in the morning. on 2/23/06 (PPD and Varicella). At around 12 pm, pt had no eye contact and his eyes were rolling back. I called the Dr. and he said that "vaccines don't do that" My son has not received any more vaccines since 2006. He stopped talking and no eye contact.  9/17/2008 Records recd from PCP. WCC 2/23/06-age 14 months. ? Autism . Varivax given at that time. 08/18/2008 Neuro consult dated 02/01/2007 received with DX: Autistic Disorder. Pt presented with language delay, impaired social adjustment and repetitive manner/abnormal sensory response. Parents report regression of language and social skills at about age 18 months. Had 5-6 words, now non-verbal. Parent notes hand tremors during sleep. Follow-up: After shots patient eyes were rolled backed and he would not move or bable or say anything, maybe 3 to 4 hrs after shots. He lost his eye contact. He was acting like a zombie. No treatment was given.  1/26/2010 Follow-up: From the day my son got this vaccine, he lost complete eye contact and lost any speech he had.
Patient's skin became red, & hives appeared at home swelling two hrs later PCP sent pt to ER (3PM).
6/9 37y.o. male who presents with 4 weeks of RLE pain and swelling. Pt states pain started in his calf and began progressively worsening.
resurgence of post-hepatic neuralgia, after a break of over a year intensity of arthritis pain, particularly in neck and right knee intensification of tinnitus
No additional AE; temperature excursion for VARlVAX / 1 dose of the vaccine had been administered after the excursion occurred; This spontaneous report was received from a register nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.    On 19-FEB-2021, the varicella virus vaccine live (oka/merck)(VARIVAX) with lot number T017682 and expiration date of 21-MAY-2022 was improperly stored dose . The vaccine was exposed to a temperature excursion of 31.4 °F with a time frame of 30 hours. There was no previous temperature excursion. A "data logger" was involved.   On an unspecified date in 2021, was identified that 1 dose of the varicella virus vaccine live (oka/merck)(VARIVAX) was administered after the excursion occurred; at a dose of 0.5 milliliter, once, subcutaneously for prophylaxis (anatomical location was not reported). No adverse effects were reported.
Rash; This spontaneous case was received on 08-Jan-2021 from physician via regulatory authority (reference number: SEQW21-00112) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Flucelvax Quadrivalent on 25-Oct-2018, after which the patient developed rash.  On 04-Oct-2019, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was P100109697 and expiry date was 22-May-2020.  On an unspecified date, unknown amount of time after receiving Afluria Quadrivalent, the patient developed rash.  The outcome of the event was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked with cases 202100471 and 202100473 (the same patient).  Company comment: The event of 'rash' is considered as related to Afluria Quadrivalent.; Sender's Comments: The event of 'rash' is considered as related to Afluria Quadrivalent.
Exhaustion, fatigue, nauseous, burning skin, aching body, overall body fatigue. Was extremely ill. Had to use all personal vacation & sick days for civilian job wasn't able to return to work forced to resign.
The facility was not aware of prior doses and thought the patient was due for a 2nd dose but it was their 4th full dose.
pt recv 2 doses of vax 21NOV95 & 11JAN96 & on  22APR96 lab eval revealed a borderline titer of 0.40;titer was tested twice;no further details were provided;
Significant hives started 13 days after first COVID vaccine. No prior history of hives. He is on day 6 of having the hives and they have spread significantly since they first appeared.
pharmacist reported after pt inadvertently recv a Td vax instead of PPD, pt developed ``quarter sized'' area of redness & swelling at inject site.
48 hours after receiving the vaccination the patient reported experiencing tachacardia and vertigo.  The patient has also had an increase in her resting pulse rate from a usual of 60 to now a resting rat of 80.
Patient became faint and pale. About 2 minutes later, after patient was seated, patient began have tonic clonic type activity and became incontinent of urine. Lasted about 30 seconds. About 5 minutes later patient had a similar episode that also lasted about 30 seconds. Patient became alert after both episodes and was able to answer questions appropriately.
rt leg became red, swollen, hot in area of lateral thigh where DTP/HIB inj was given;pt cried for 1hr, t101;parent gave APAP, ice packs to leg;seen by MD who advised no more pertussis vax be given to pt;pt recovered completely
By afternoon of vaccine Rt arm redness at injection site by 10/8/12 hot to touch, itchy, red, diameter size of quarter.
The child had a 9-month WELL CHILD visit on 2/22/18. At that time, she refused the patient getting #2 flu shot. She told the provider that after the child got her 6-month shots, and flu shot #1, that she had unconsolable crying for 8-hours. However, the mother did not call and report this to anyone at the time, nor did seek medical attention.
I had some initial adverse effects that were among the expected: extreme fatigue, chills, fever, body aches. I'm an avid ocean swimmer & these initial effects kept me out of the water for 3 days with the 1st shot, 2 days with the 2nd. The 1st shot had more intense initial effects than the 2nd, for me. However, because I'm an ocean swimmer, I have noticed some long-term effects, which did not set in until after the 2nd shot. I swam through the winter in 56-59 degree water wearing a 4:3 full wetsuit. In March, the water had warmed to 60+ and I was  using a 1mm spring suit, occasionally going no wetsuit. After the 2nd shot, my cold tolerance plummeted, causing me to go back to the 4:3 full wetsuit. I was even shivering after a normal 3 mile swim with the full wetsuit in 66 degree water. My swimming friends were all surprised. I've also noticed being cold more often, even out of the water. But, because I'm so aware of my temperature tolerance from swimming, I think I'm probably in the minority of people who would report this kind of effect. I've also been experiencing long-term fatigue. It's not as strong as what happened immediately following the vaccine, but it is daily, & this, plus the body temperature problem, have caused me to have trouble keeping the same exercise schedule I used to. I was swimming 4 days/9-12 miles per week, but in June, I was down to 1 day per week, maybe 2 miles. I'm trying to work my way back, but it's not easy. I was cold on my swim this morning & the water was 67.
Blurry vision, dizziness, chills and throwing up, achey joints and overall feeling weak
After administration of the TST PT presented with delirium-like symptoms(i.e, a blank stare and incoherent speech). PT fell back into the exam bed, and hit the back of his head on the exam bed (Exam bed was positioned in the Fowler position). At that moment, I proceeded to catch the PT before he could slide off the exam bed. Called RN. As he got a hold of the nurse, the patient halted convulsions and regained semiconsciousness. As I assessed his LOC, I put the exam bed in supine position and helped PT get into the recovery position. By the time RN got there, PT was A&O x 3 and was no longer convulsing. RN assessed patient.  PT was instructed to rest on exam bed for 15 minutes. Vital Signs were taken twice(#1 - 1132,  #2- 1137) before being brought down to clinic at 1145.
Fever 103.2 for 24 hours; Fever 102.1 for next 24 hours; chills for 6 hours; heart racing for 6 hours ; fatigue 1 week; diarrhea 3 days; headache on going;  severe bruising to injection site about 1.5 weeks after the injection
3 Hours after vaccine: PATIENT STATES SHE EXPERIENCES NAUSEA, VOMITTING, DIZZINESS,FATIGUE, WEAKNESS, ATAXIA RESULTING IN A FALL, PALLOR, AND FORGETFULNESS   THE DAY AFTER THE VACCINE WAS ADMINESTERS SHE CONTINUED TO HAVE FATIGUE AND WEAKNESs  She rested the day after, no medical treatment needed.
This spontaneous report refers to a 44 year old male patient. In June 2013 the patient received a dose one of GARDASIL (lot number, dose, route and site of administration were not reported), when the patient was 44 year old. The patient received dose 2 of GARDASIL (lot number, dose, route and site of administration were not reported) in August 2013 (44 year old). The patient received a dose of ZOSTAVAX (lot umber, dose, route and site of administration were not reported) in August 2013 (44 years old). No adverse effects were reported. Additional information has been requested.
Pt received FLUZONE HD on 9/25 1:30 pm. She experienced severe diarrhea (5-6 times that night), vomiting and joint/hip/back ache cold extremity (no fever). Very sensitive to touch 7-8 hr after. 14 hr after still had lingering fatigue. Lethargic. She said she fully recovered 48 hr after the shot.
Patient is here with complaints of left calf pain. Started after returning from city on 4/12. Drove home. Was very sore, treated with aspirin. Helped at first but now pain and swelling have persisted. Did go jogging while on vacation and thought this may have attributed, now more concerned about DVT. Brother with history of blood clots but is a smoker.
low white blood cell count; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset Feb2021, described as "low white blood cell count". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills; Muscular pain (arms & shoulders); Joint pain (shoulders & elbows); fatigue.
Information has been received from a nurse practitioner concerning an 18 month old female with mental retardation, pulmonary hypertension, ventricular septal defect, congestive heart failure, patent ductus arteriosus and no known allergies who on 02-OCT-2007 was vaccinated intramuscularly in the right arm with the 1st 0.5ml dose of PEDVAXHIB (lot#656521/0436U). The nurse practitioner was calling from a long term care facility for mental retardation. The reporter stated that the patient was on numerous medications but did not specify them. On 08-OCT-2007, the patient went into cardiac arrest and was rushed to a local hospital 10 miles away. On the same day the child was transported via helicopter to another hospital. on 13-OCT-2007 at 7:30 pm, the patient died at the hospital. The cause of death was cardiac arrest and multiple symptom organ failure. Cardiac arrest and multiple symptom organ failure were considered to be immediately life-threatening, disabling, other important medical events and congenital anomalies by the nurse practitioner. Additional information has been requested.  1/11/08 Reviewed hospital medical records from initial hospital which reveals patient arrived in cardiac arrest w/cpr in progress on 10/8/2007.  Reportedly playing in state school home when suddenly became unresponsive & apneic/pulseless.  Resuscitated & transferred to higher level of care. FINAL ER Dx: cardio-pulmonary arrest. 1/11/08 Reviewed hospital medical records from transfer hospital which reveal patient admitted to PICU on pressors, antibiotics & ventilator.  Developed multi-system organ failure includeing renal failure, liver failure, cardiac failure, respiratory failure & refractory shock.  Admitted 10/9-10/13/2007 when expired.  5/15/09 Death certificate states COD as brain death; hypoxic ischemic injury; multiple congenital anomalies.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided No treatment information provided
Client is a 57 year old male who presented to the ED today from outpatient COVID testing and was hypoxic there (50% on RA), they placed a nonrebreather at 15 L and transferred him to the ED.  In the ED he was transitioned to HFNC 60 L 100% FiO2 saturating 92-93%.     His medical history is significant for obesity, T2DM, and hyperlipidemia.  He was vaccinated for COVID-19 with Pfizer in December/January.   He reports 2 days shortness of breath, generalized malaise, nonproductive cough. He just returned from a trip.   Pertinent labs from the ED include lactate of 9.6, VBG with pH 7.34/CO2 34.  He received 1 L IVFs and 6 mg Dexamethasone.  He was admitted to the ICU in the setting of COVID pneumonia
Headache, Fever, Syncope, Tachycardia, Site discomfort, Chills, Fatigue Tachycardia et near syncope 8 days after receiving 2nd Covid vaccine
Rash on thigh noted on day after shots given in thighs. Seems to be itchy quite a bit and kept her awake overnight.
14 days following 2nd dose of Moderna patient had stroke as informed by mother-in-law.  Still remains in the hospital at this time.
TDAP Given : 1513 Pt with allergic reaction, tightness in chest, dizziness, sweating,  lungs CTA BP 160/100, HR 42's, SPO2 93% 2 L Patient's own EPI pen given at 1525 1530: HR 143, SPO2 2 L, lungs CTA 1533: HR 77, 91% SP02 Patient transferred to ED via nursing staff for monitoring
Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. four other siblings had similar rash. One receved Td, one Received Tdap, two recevied DTaP
Vertigo, especially when going from lying or sitting to standing. I had some traces of this from an accident over four years ago, but it had become quite manageable. All the sudden it became almost as bad as it was right after the accident. This is ongoing, and I am seeing a Chiropractic for treatment.
Per H&P 10/26: "presents to the emergency room with complaints of dizziness that started suddenly around 1430 yesterday.   According to patient, around 2:30 PM, she got up and suddenly felt that she could not walk well as she was very unsteady on her feet things were spinning around her.  She did not notice any change with the positioning of her head.  When she tried to walk, she noticed that she was walking sideways to her right.  She did not fall but felt very uncomfortable.  The sensation of dizziness got worse when she laid down.  When she sat up in a chair, she felt warm all over.  After some time, she got up to use the bathroom but was so unsteady that she needed the help of her husband.  She then became very nauseous and had multiple episodes of vomiting and bathroom.  Since then, she has been having what she described as pain in the back of her head radiating towards the front.  Patient noted that she does have numbing sensation on her right face since her surgery that has changed. Patient denied actually having any lightheadedness, palpitations, blurring of the vision, double vision, numbness or tingling in any part of her body or in her limbs.  Her husband was present at bedside also was stated that the patient did not have any change to his speech or any new facial changes such as droop. He also did not notice any abnormal movements except for the fact that the patient was having difficulty balancing herself.  Concern for possible posterior circulation stroke"  Per progress note 10/27: "Patient continues to complain of dizziness specially when she looks on the left side.  She also reports gait instability and falls on the left side when she is ambulating.  Suspect BPPV as dizziness gets worse when she looks on the left side.  No vertigo when she looks straight.  Likely from inner ear pathology as she does have history of recurrent ear infections on the left side MRI of the brain came back negative for stroke though TIA cannot be ruled out Continue with meclizine and antiemetic"
Comparison of intensity of adverse events per dose; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The registered pharmacist reported that most patients who do get the second dose of Shingrix, the adverse events were not as bad as with dose 1 but sometimes just as bad and sometimes worse. No further details were provided by registered pharmacist. The reporter gave permission to follow up.
Breakthrough case. Allergies started flaring up with nasal congestion. Took Home test and it was Positive. Quarantined and took a lot of vitamins. Five days later he felt better.
When dose was injected I got a bruise right after she finished administering shot.  She was surprised of bruise and mentioned that i shouldn't have bleed but I did. Were injection was administered I had a marble size  bump all day yesterday even mid evening I put ice for swelling and pain took Tylenol also. This morning  my arm still hurts and  my hand continues to get numb feels like if i am not getting enough circulation.
Malaise; One episode of diarrhea; Rash; Pain in arm; Heat in arm; A spontaneous report was received from a consumer, concerning a 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm, heat in arm, malaise and one episode of diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: O26L20A) for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced pain in arm and heat in arm. On an unknown date, the patient experienced malaise, rash, and one episode of diarrhea.   The patient was treated with Ibuprufen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.