chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a field employee regarding her daughter, a 14 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 25-SEP-2018, the patient was vaccinated with a dose of GARDASIL 9, intramuscular for prophylaxis against cervix carcinoma (anatomical site, lot number and expiration date were not reported). On 25-SEP-2018, immediately after injection the patient fainted with some seizure manifestations and she became hypotensive. The unknown nurse was in the same room with the patient and monitored her closely by "laying her down and elevating her legs". Approximately 30 minutes after the events the physician checked the patients vital signs at the mother's request, and they were normal. The patient was recovered after 30 minutes from the onset of the events. Upon internal review the event seizures was considered to be medically significant. The causal relationship between the event and therapy with GARDASIL 9 was not reported.
Patient states that over 1 week later she had diarrhea, nausea/vomiting and aches/chills. Resolved within 24 hours.
noted small reddened area approx 3x4cm on lt upper deltoid;c/o area itching & warm to touch;
Within approximately 2 1/2 hours the patient presented with erythemetous raised plaques and wheals to face, upper torso, and upper extremities bilaterally. It was then noted by facility staff. The nurse was notified approximately at 12 noon.  Benadryl 50 mg PO was administered. The rash had little improvement. At 17:00 the client was seen at a local emergency room. Decadron and Benadryl were administered by the ER and his diagnosis was Urticaria.  The patient returned back to the facility with an order for Prednisone and Claritin.  The rash cleared within a few hours of returning from the ER. The patient had a follow up appointment with his primary physician on Friday March 9, 2012. At that visit the patient disclosed to the provider he was allergic to vaccines having had a previous reaction. When asked why he did not previously report he stated he did not want to cause trouble. The physician ordered him to complete the prescriptions a per written by the ER and do not administer any further vaccines.
Severe Chills on 11 April 2021 at 1:30 am, duration approximately 90 minutes. Self-administered ibuprofen. Resolved. Moderate to severe headache from 11 April 2021 to 12 April 2021. Treated with ibupofen. Resolved. Mild nausea, interrmittent from 11 April 2021 to 17 April 2021. Untreated, currently ongoing.
SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 145 pounds, and height was 58 centimeters. The patient was non alcohol user, non-smoker, and had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, 1 total administered on 19-MAR-2021 on Left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient had confirmed covid-19 infection and had positive laboratory result. The patient also experienced suspected clinical vaccination failure. The symptoms included coughing and congestion. The patient had not recovered from confirmed covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183455.; Sender's Comments: V0. 20210642919-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Swollen glands, rash symptoms in mouth; treated for a year with no fix. Constantly tired and memory loss.
20 min after the injection of the J&J vaccine in my L shoulder my L arm went numb and cold with a sensation of losing blood supply , lasting for 36 hrs and has continued to go numb multiple times a day and every time my heart rate elevates (working out), This is still occurring up till today. Also 20 min after the J&J injection my L lower eye lid twitches and spasms every day, about 10-12 times a day lasting from 40-60 min, making it hard to focus and concentrate.
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male patient who developed autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. A consumer reported that her son had developed autism. She declined further information stating that she feels that his condition has nothing to do with our vaccine. No additional information was available at the time of this report.
ADVERSE EVENT: NAUSEA, VOMITING, HEADACHE, SWOLLEN TONGUE TREATMENT: BENADRYL ADMINISTERED IM AND OBSERVATION OUTCOME: RELEASED AFTER 1 HOUR OF OBSERVATION
nerve shock sensation on her left arm; numbness on the palm; itchness of the throat; painful left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (nerve shock sensation on her left arm), HYPOAESTHESIA (numbness on the palm), THROAT IRRITATION (itchness of the throat) and VACCINATION SITE PAIN (painful left arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K70A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included OMEPRAZOLE for Gastrointestinal disorder, TRAZODONE for Sleep disorder.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced LIMB DISCOMFORT (nerve shock sensation on her left arm), HYPOAESTHESIA (numbness on the palm), THROAT IRRITATION (itchness of the throat) and VACCINATION SITE PAIN (painful left arm). On 29-Jan-2021, LIMB DISCOMFORT (nerve shock sensation on her left arm), HYPOAESTHESIA (numbness on the palm), THROAT IRRITATION (itchness of the throat) and VACCINATION SITE PAIN (painful left arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment include Tylenol 1000mg. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: the follow up were received on 15-APR-2021 and include below updated information:-address and occupation were updated.reporter-2(HCP) details were updated.patient weight, height and ethnicity were updated.patient allergic condition were updated.second dose details of moderna vaccine were updated.concomitant medication updated.outcome result updated.; Sender's Comments: This case concerns a 41-year-old female who experienced the nonserious unexpected events of pain in extremity, limb discomfort, hypoesthesia, and throat irritation.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen. Events ongoing. Based on 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.
Information has been received from a certified medical assistant concerning "no more than ten patients" who were vaccinated with GARDASIL (lot#, route and dose not reported), which was inadvertently stored in the freezer for 2 weeks.  The medical assistant reported that no adverse event was reported.  No additional information was provided.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
PATIENT STATES SHE HAD PAIN IN ARM OF INJECTION START ON 11/03/2019( 4 DAYS AFTER THE INJECTION)  AND CONTINUING ON 11/04/2019 SHE IS TAKING OTC PAIN MEDICATION TO CONTROL THE PAIN AND IS SEEING DR ABOUT THIS ISSUE LATER TODAY.
vomiting 28JUL93 7PM & 10PM; fever 102.8 first noc; fever 101 2nd day talking isn't making sense & crying & afternoon when woke up - 100.8 when seen by MD;
Warm feeling all over the body possibly a slight fever and  as of now later on in the day a warm tingly sensation on the injected left arm.
Sore throat, headache, sinus drainage, tired, chronic aches, chronic cough. Similar to Flu.  Treatment: OTC Sinus medicine, cough syrup. Doctor prescribed 3 day script of 500MG Zithromax on 10/31/05.
Client stated that she began to have intermittent bouts of palpitations the evening of the vaccine date. SX resolved within 24 hrs. She sought no med advise. She was taking Advil for general malaise and aching during that period.
This spontaneous report as received from a consumer via a physician refers to a consumer's neighbor's child of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot#, strength, dosage and route unknown). On an unknown date the patient experienced a rash after receiving (Oka/Merck) VARIVAX. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
POSSIBLE LOW BLOOD FLOW TO MY  LEFT EYE   STILL BEING TESTED AT EYE CARE
On evening of 9/12/2023 my right thigh felt bruised and a tight sensation. There was an area of swelling an inch and a half across. The next morning at about 4am the area of swelling had increase down the inside of my thigh amount 3 inches in length. The area was more tender. Initially I went to Urgent care and they recommended that I go to Hospital. I had an Ultrasound and it was confirmed that I had an occlusive thrombus in my right greater saphenous vein. I was started on Xarelto 10mg qd because of the area near the femoral and popliteal veins and risk of progression to a DVT. I was referred to Vasular Surgery on 9/18/23.  A repeat Ultrasound showed that I also had DVT in my right soleus vein as well as the thrombus in the anterior branch of the right greater saphenous vein. My dose of Xarelto was increased to 15mg bid for three weeks then to be decreased to 20mg qid. Also, recommended use of compression socks. I do have a  history of varicose veins in both legs with previous surgical intervention in the 1980s. I am not sure if the blood clots are due to the RSV  vaccine, but did have the vaccine one week prior on 9/5/23.
patient also stated that he experienced sore arm with all the shots; fever; chills; tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (patient also stated that he experienced sore arm with all the shots), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 028L20A) for COVID-19 vaccination.     It was unknown that patient has allergies to (medications, food and other products). Patient never had COVID positive test or diagnosis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (patient also stated that he experienced sore arm with all the shots). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 doses. On 30-Mar-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (patient also stated that he experienced sore arm with all the shots) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No other vaccines was given 1 month prior to vaccine.  It was reported that patient has received 4 doses of the Moderna COVID-19 vaccine so far, with side effects getting progressively longer lasting and worse with each dose.  Patient experienced fever, chills and tiredness for 6 hours. Patient also stated that patient experienced sore arm with all the shots. Patient mentioned that lost 45 pounds between 1st dose and 3rd dose of the Moderna COVID-19 vaccine. The patient started losing weight about a year and a half ago. Reported the side effects were significantly increased with each shot of the Moderna vaccine. He was now looking to get the Moderna bivalent vaccine but was not sure if that wasthe right thing to do based on his prior experiences. He wonders if he has a high level of antibodies with all the previous Moderna doses and that was why he has reacted more strongly with each dose.  Adverse events did not cause patient to seek medical care. The patient did not experience a similar event in the past.   This case was linked to MOD-2021-045065, MOD-2022-575425, MOD-2022-672853 (Patient Link).
she felt sick all over again; felt dizzy immediately following the dose (10-15 min later); did not feel good; left arm as being warm to the touch; a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose; left arm was very painful for day,rolling over on that arm hurt (she would jump up); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch), THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)). At the time of the report, ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.  No treatment drugs were reported.
pt had a sz @ home w/in 24 hrs following vax; pt was afebrile; taken to ER; no admitted; no med given; pt recovered;
Sudden hearing loss in the right ear Vértigo  Dizzy  Nauseous  Ended up in the ER  Chest X-rays and EkG were performed
Rash on the tops of both feet and on the tops of toes, including blisters, swelling, and itching
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 10-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Dec-2011. On 04-Jan-2012, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 21-Mar-2012 and incorporated into the narrative: No late occurring adverse event.
Hearing problem/hearing problem happened after receiving the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing problem/hearing problem happened after receiving the moderna vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037A21B) for COVID-19 vaccination.     Previously administered products included for an unreported indication: QUADRIVALENT INFLUENZA VACCINE (quadrivalent flu vaccine) in October 2021.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Hearing problem/hearing problem happened after receiving the moderna vaccine). The patient was treated with PREDNISONE for Adverse event, at a dose of 20 mg; PREDNISONE for Adverse event, at a dose of 60 mg and PREDNISONE for Adverse event, at a dose of 40 mg. At the time of the report, HYPOACUSIS (Hearing problem/hearing problem happened after receiving the moderna vaccine) outcome was unknown.            Patient stated that he had hearing problem after receiving the moderna vaccine. No concomitant medication was reported.
Tenderness at injection site for approximately 3 days, vertigo like dizziness for 2 days (started roughly 2 hours after vaccine was administered), moderate to severe headache for 2-3 days, also slightly lethargic for 2-3 days after injection.
Client received 2nd Moderna COVID vaccine  at 1:12 pm in left deltoid, while sitting in zero gravity chair.  At 1:15 pm, client reports to  EMT she has an itchy feeling in throat, with a metallic taste in her mouth.  Client also reports she perceives a "sense of perfume smell in air" as another client passed by.  Client reports she is allergic to perfume.   Client denies shortness of breath, no trouble breathing, no trouble swallowing, or chest tightening.  RN offers client Benadryl IM, client declines, states Benadryl is not for itchy throat and is concerned it will interfere with the efficacy of COVID vaccine.  Client states she would like to wait and see if symptoms resolve as she believes they are related to the perfume she smelled in the air.  Vital signs are stable.  EMT continues to maintain conversation with client, client reports sensation of "perfume smell" has gone away.   At 1:35 pm, client reports throat itchiness is improving, declines Benadryl once again.  At 1:38 pm, client reports no more throat itchiness.  At 1:40 pm, Client reports throat sensation and itchiness have completely resolved, reports slight headache because of perfume noted earlier.  Client educated on ER precautions.  Client left observation area at 1:50 pm, walking with steady gait.
Swollen and hard at vaccination site with soreness; rash and itching opposite thumb (large knuckle) was swollen and unmovable - as swelling in arm goes down this is going down.
Tdap given to child in (R) deltoid and tolerated well. The HPV was then administered in the (R) deltoid also with appropriate spacing. As soon as the needle was withdrawn, the child fainted and had a slight jerking movement. Within 30-45 seconds was beginning to be fully aroused, but took 45-60 minutes to feel strong enough to be discharged from health dept. Sent to PCP.
Broke out in hives (10/19/07).  Developed a allergy to peanuts which had not been present prior to the immunization.   Long term adverse affect PDDnos.  8/7/09 MR rec'd from PCP.  Infor WCC 10/9/07 with normal exam, no concerns. 10/19/09 hives 2' to eating peanut butter.  DX:  urticaria.  Parental concern 10/14/08 re: not talking yet and rxn to PB.  Assess:  Speech and  Language delay. Failure to thrive dx on 1/22/09. Neurodevelopmental eval 5/2009 with dx:  PDD-Autism spectrum disorder.  .
fever on 8APR93 & 10APR93 recvd APAP lt arm sore near inject site on 8APR93 & on 10APR93 devel sl rash near inject site, then on 11APR93 rash spread further down arm w/itching on 12APR93 pt c/o soreness lt arm, rash down to wrist w/itching;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Additional information: It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient was diagnosed with COVID-19 and prescribed Paxlovid. Took full course of Paxlovid and experienced viral rebound.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX (batch number 37KL2 ?, expiry date 12th February 2021. GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced headache, injection site erythema, injection site swelling and tiredness. On 16th July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the headache, injection site pain, injection site erythema, injection site swelling and tiredness were unknown. It was unknown if the reporter considered the headache, injection site pain, injection site erythema, injection site swelling and tiredness to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX in the left arm. The patient experienced pain during injection. Less than a week, after receiving SHINGRIX, the patient had injection site reaction which included pain, redness and swelling at the injection site. The patient also experienced a low grade headache and felt tired.
Two days after vaccination, pt broke out in hives, itchy, on wrists, hands, elbows, knees, ankles and heels. Pt took OTC Benadryl but hives did not resolve. Pt went to MD, received a steroid shot and was put on a 10 day course of Allegra, oral meds. Pt better now.