chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came in on 20 Jul 09 to receive VARIVAX. Pt mom stated Monday nite. Patient became itchy, swollen, and warm to the touch at site of injection. 22nd of July mother brought Pt back in for TB test results and to check on sons arm. Treated with oral Benadryl and antibiotic.
Fever began around 1-2 am on 4/9/2021. At the same time I began having chills & sweats. Fever lasted until 4/10/2021 around 1 pm. Ranging from 99.2-101.4. Aches and pains in my muscles that were felt all the way to my bones. The aches went away by about 10 am on 4/10/2021. I took about 5 or 6 doses of tylenol extra strength and motrin to help. Nausea and dizziness began on 4/10/2021 which I am still experiencing today 4/12/2021. I began my menstrual cycle 4/10/2021 and have noticed more shedding than usual.
I am a healthy 39 year old with no major health problems. About 2 weeks after my first vaccine dose I noticed a numbness that spread from my left low back to my left side and left front of my abdomen. It was accompanied by itching and and tingling. The doctor I talked to today said it was consistent with shingles and prescribed the antiviral Famciclovir. I don't know if it is connected to the vaccine, but I want to make sure that it is reported in case there is a pattern.
Presented to hospital with N/V and dizziness. Reported that before presentation he could not ambulate and the room was suddenly spinning.  LKW was 0800 9/6/2021. He had both horizontal nystagmus as well as nystagmus with upward gaze.  CT of the head was negative.  Given concern for stroke and no other contraindication he was a candidate for TPA.   Given TPA. Follow up CT angio negative, and at ~1200 9/6/21 patient began seizing, managed with levetiracetam & transferred to neuro ICU.
paresthesia and tingling down the left arm and down the left side of the back x 3 weeks after the injection. No rash or pain.
Heaviness, extreme redness and swelling appox. 5" vertically and the complete circumference of the arm. Soreness - pain - difficulty lifting the arm - condition continued for 4 days - slightly elevated body temperature for 2 days - still today sensitive and itching but no rash.
Patient fainted approximately 5 minutes post-vaccine. Patient remained in vaccination room while other family members were vaccinated.  Patient was leaning on wall in the corner and fainted after family member was vaccinated. She appeared to have hit part of the door and got a small abrasion on her left shoulder.  Patient was breathing fine and was out for approximately one minute. After waking, she was kept on floor and sat up when ready. She was observed for an additional thirty minutes and was given a snack and water. Upon leaving, she confirmed she was feeling okay.
There were no adverse reaction but we are reporting that it was discovered that patient was only 11 when the vaccine was administered.  His mother lied about his age and lied that he had no insurance.  We had checked store's  system and  had to add him new.  Later once it linked with system, it was discovered that he was only 11 and she lied about his age and insurance.  I phoned her and at first she stated she had a birth certificate to prove his age, but later admitted she lied because she was worried about him going back to school with no masks required.  I told her we could not administer the second dose until it becomes approved for his age.
COVID symptoms started; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms started) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Tylenol. Past adverse reactions to the above products included No adverse event with Tylenol.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID symptoms started). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID symptoms started) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Previously administered products included for Drug use for unknown indication: Vitamins.  No concomitant medication was reported.  Reportedly, the patient was vaccinated with Moderna COVID-19 vaccine.  Caller stated that a day before reporting was a 5th day of COVID symptoms stated that COVID, symptoms started like Satuday night as cough all night,  had a bad day on Sunday, has given a cough medicine and then they went to the doctor, and tested positive. Patient started taking Paxlovid evening a night before reporting day. Caller stated that when patient had a cough, was taking takes the medication a little tiny pill.
Information has been received from a physician concerning a 14 year old patient who was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot #658059/0838U).   Subsequently the patient experienced abnormal swelling and abnormal redness at injection site.  The patient's outcome was not reported.  Additional information has been requested.
Patient came for the second shot of pfizer on 09/22/21 and reported that  her arm still hurts on and off since her  first shot on 09/01/21
3 days after getting injections noticed dry cough, felt congested, no temp, no redness, no swelling at either site.
Body ache; Headache; Chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) 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 reported medical history).    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Incident occurred from possible inviable Covid-19 Pfizer-purple dose (booster) being administered to the patient. Patient's parent reported no adverse events other than typical ones from Covid-19 vaccine. Patient's parent will consider the offer for a replacement booster dose.
Patient presented to the ED with gross hematuria, AKI within 6 weeks of receiving COVID vaccination.
Right deltoid, spreading to right arm, erythema and edematous, consistent with vaccine site reaction. Edu to apply cold compress, give tylenol for pain, warning signs of cellulits to ER/RTC.
2 episodes (1-2 hrs long) of inconsolable crying, fever (controlled w/APAP), painful lt thigh (@ site of inject);
Woke up dizzy, getting headaches from it. Started prednisone on 1/22/10, got steroid shot 1/25/10
she has rash on both sides of her back and also on her stomach; her stomach which is red and itchy; she has rash on both sides of her back and also on her stomach which is red; did not feel well; shivering , chills; headache; shooting pain in the right arm; injection site was swollen; injection site was swollen, red, itchy and had a rash; injection site was swollen, red, itchy; injection site was swollen, red,; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 21st October 2020, 1 days after receiving Shingrix, the patient experienced malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching and injection site erythema. On 23rd October 2020, the patient experienced rash, itchy rash and red rash. On an unknown date, the outcome of the malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching, injection site erythema, rash and itchy rash were unknown and the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching, injection site erythema, rash, itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix her left arm and the next day she did not feel well.  She had the shivering, chills, headache, shooting pain in the right arm and the injection site was swollen, red, itchy and had a rash.  On the day of reporting she had rash on both sides of her back and on her stomach which was red and itchy. The reporter consented to follow up.
I recieved my first dose 4/28 is it to late for second?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I recieved my first dose 4/28 is it to late for second?) 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.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I recieved my first dose 4/28 is it to late for second?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I recieved my first dose 4/28 is it to late for second?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
postherpetic neuralgia; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster and postherpetic neuralgia to be disability.
Mom reports that patient felt pain and nearly passed out immediately after injection on 10/23/18. She recalls the injection was given quite high on the arm near the shoulder joint. On 11/7/18, Mom reports continued right shoulder pain. Painful to touch and motion. Does have a dull ache at rest. Decreased range of motion. No discoloration, swelling or numbness/tingling noted per mom.
PATIENT SEEN IN VACCINATION CLINIC FOR FIRST DOSE VACCINE ADMINISTERED BY RN. DOSE GIVEN TOP OF LEFT SHOULDER INSTEAD OF 2-3 FINGERBREATHS FROM ACROMION PROCESS INTO DELTOID MUSCLE.   PATIENT REPORTED THAT HE ASKED IF "HIT BONE AND IF IT HURT HER" SHE REPORTED THIS TO HER MOM (MWH RN) AND THEY RETURNED TO CLINIC FOR EVAL. SHE ADMITS TO 3/10 PAIN ON NUMERIC PAIN SCALE. NO WORSENING PAIN NOTED WITH RANGE OF MOTION.  MD IN TO SEE PATIENT AND RECOMENDED WARM COMPRESSES TO THE AREA FOR THE NEXT 24-48 HOURS, AS WELL AS IBUPROFEN AS NEEDED FOR PAIN. SHE WILL CHECK IN WITH RN IN OCCUPATIONAL HEALTH IN THE NEXT 24 HOURS TO DISCUSS HOW HER SHOULDER FEELS AT THAT TIME.
A RN provided information concerning a student who had a "sore arm" following vaccincation with a 2nd dose of MMR. He also received TD that day. On 4/21/99, 2 days, post vax, the student exsperienced sore arm. Additional information has been requested.
patient received improperly stored vaccine on 4/25/2019; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  On 25-APR-2019, the patient was vaccinated with improperly stored one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R021078, expiry date 12-JUN-2021; injection site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # R028189, expiry date 06-JUN-2020; exact dose and injection site were not reported), both for prophylaxis. The vaccines were exposed to the temperature of 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was involved.
Entire body was in pain; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Jun2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether, the patient had been tested for COVID-19 since the vaccination. It was unknown whether, the patient received any other vaccines within four weeks prior to the vaccination. On 21Jun2021, the patient's entire body was in pain. It was unknown if the patient received any treatment for events.  The clinical outcome of the event entire body was in pain was recovering at the time of reporting.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previously reported information: Added patient information.  Information about lot/batch number cannot be obtained. No further information expected.
Pt, who had a mild sore throat on day of visit, said she felt "tired" a few mins after the shot. I told her she would likely go to school anyway. A few minutes later she was crying with a bad headache. She was allowed to stay home from school & HA resolved < 1 hr later. She took HPV #2 with no side effects.
Patient was given Pedi Covid Vaccine 6 days before turning 5 yrs old, patient was  given first Covid vaccine series at 4 yrs and 11 months. Patient' parent reported no concernspt can in for 2nd dose at age 5yrs old, patient tolerated well.
An MA reported that a 3 year old male with NKDA and no past medical history who on 05/17/01 was vaccinated in the upper thigh with a first dose of hepatitis A virus vaccine inactivated. The concomitant vaccine was Prevnar, which the pt received in the opposite upper thigh. It is not known which vaccine was given in which thigh. The pt had no illnesses at the time of the vaccinations. On 05/25/01, the pt. was unable to walk and was seen by a physician. The physician did a right hip x-ray that yielded a negative result. On 05/25/01, the pt. was sent to an orthopedic clinic and evaluated by an orthopedic surgeon. The orthopedic surgeon ordered a right hip ultrasound. The ulrasound reported a right hip effusion. On 05/25/01 an arthocentesis was performed. The physician did not think that the right hip effusion was related to vaccinations, but the orthopedic surgeon thought the effussion was the result of the vaccine, not necessarily the injection or technique of administration. It was noted that the child was treated and released from the hospital on 05/25/01. During a phone followup with the mother of the child, it was reported that the child recovered from his inability to walk. It was unknown if medication was ordered after the procedure. Upon internal review hip effusionn was determined to be an other important medical event. FOLLOW-UP information has been received from a HCP which indicated that she was unaware of any changes regarding the patient's status. FOLLOW-UP information recived on 11/13/2001 from a physician indicated that no further information was available concerning the patient. No further infornmation is available.
Pressure in my head; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pressure in my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced HEAD DISCOMFORT (Pressure in my head). At the time of the report, HEAD DISCOMFORT (Pressure in my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
improperly stored administered MMR II, VAQTA and ROTATEQ; No additional AE reported; This spontaneous report was received from a nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent(STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number and route of administration were not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Narrative: COVID infection following COVID vaccine series 10/7, Pfizer, dose #1 10/21, Pfizer, dose #2 12/30 COVID swab, result: detected 1/7 COVID swab,  result: detected 11/15 CXR IMPRESSION:  Pulmonary vascular crowding due to the expiratory technique. 12/29 pt cc: fatigue, cough, loss of taste or smell,  myalgias, rhinorrhea, sore throat exposure: unknown
About 5 minutes post vaccine, reports vasovagal syncope. Was taken to ED and treated with Zofran for nausea. EKG showed HR of 30's but sinus rhythm. Hydrated with PO fluids and discharged home.
Covid Arm.  Raised, red and very itchy patch at injection site about the shape of a lemon.
Prolonged and extreme hives for 1 month which required 2 trips to ER. Oral and shot steroids, allergy testing, doctor visits and 3 prescriptions.
one of them was given bexsero instead of menquadfi,with no reported adverse event; inappropriate dose of vaccine administered with no reportedadverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who had given bexsero instead of(Meningococcal)A-C-Y-W135 (T CONJ) vaccine) MENQUAFDI with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a  dose of Meningococcal)A-C-Y-W135 (T CONJ) vaccine, Solution for injection(lot no- U7576AB, expiry date-28-Feb-2025 ) (with unknown , frequency, strength, dose, route and administration site) for prophylactic vaccination(immunization).  On an unknown date, Patient had given bexsero instead of (Meningococcal)A-C-Y-W135 (T CONJ) vaccine menquadfi(latency:same day),with no reported adverse event (wrong product administered) and Inappropriate dose of vaccine administered(Incorrect dose administered).  It was also reported that nurse said they have two (2) patients, both 11 years old.As per nurse they are not sure at this time which of the two patients were given Bexsero instead of MENQUAFI and needs to look into it.   Action taken:not applicable.  At time of reporting, the outcome was Unknown for the 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.
Woke up with pain to touch near and around injection site. Found a raised about 4cm firm bump at injection site. It was red. During day developed low grade fever of about 100.4, felt tired and had chills. Fitful sleeping and night sweats. This pattern continued on 10/9/11. By 10/10 5pm the area of redness had spread to encompass the entire posterior of the left upper arm shoulder to elbow, however the fever was mostly gone. Visited internist on 10/10 5:00 PM who said that it looked like a classic inflammatory response to the vaccine injection, no infection, and that symptoms should slowly disappear over the next several days. At 6:00AM on 10/11, the redness did appear to be fading slightly at the injection site, although entire affected area still sore to touch.