chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
patient is age appropriate for this vaccine  and patient did not have any reaction to this vaccine. Patient is 17 year 11 month old and standing order age limit is 18 year so thats what filling out VARES. pts is ok and no harm
extra dose of IPOL given in error with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received via nurse. GMI number: 01570626  This case involves 7 years old male patient who experienced extra dose of ipol (IPV (VERO)) given in error with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2023SA113922 and 01570409.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunization.  On an unknown date, the patient received extra dose of suspect IPV (VERO) at dose 0.5ml frequency unknown (lot: U1A452M, expiry date: 20-Feb-2023) via subcutaneous route in unknown administration site for Immunization given in error with no reported adverse event (extra dose administered) at same day latency.  It was reported that "Nurse has questions on how to proceed. She states the PENTACEL components were all given separately, and an extra dose was given by accident. The nurse states that their clinic did not receive the immunization records on a new patient until after extra doses of DAPTACEL, IPOL, and ACTHIB were given in error. Extra dose of ACTHIB given on 21Jun2022. Clarified as NOT PENTACEL as all 3 vaccines (DAPTACEL, IPOL, and ACTHIB) were given on separated dates and as separate injections. The nurse asks if these are valid doses or should they be reinjected. The HCP inquired if the patient would experience any adverse event because of this."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event extra dose administered.    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.
Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting 03/07/2021 Body aches(48 hours) Chills(48 hours) starting 03/07/2021 Severe Headache(36 hours) started 30 min. after vaccination.
Left axillary pain for 3 days.  Very sore left axilla. NO redness. no edema.
Frightened young pt who hates needles sat & took inject well; A few seconds later appeared to be dizzy, then lightheaded, appeared to have sl sz w/eyes rolled back lasting 10 seconds or so; Still a little faint but p/lying down felt better;
13AUG91 fever, swollen lymph, sore throat w/blisters in throat & back of tongue; Strep negative; started on E-mycin; Back to MD 16AUG better; 23AUG91 doing fine;
While attempting vaccine administration fluid was noted on patient arm and jacket.  Appeared that entire dose of vaccine leaked out from the needle hub.  Executive director of the clinic notified physician liaison and recommendation to redose and administer vaccine.  This was completed.  No adverse reactions after wait period.
Severe red rash or hives symptoms on my upper torso. My chest down to my rib cage, then on my back down past to the middle of my back. There is extreme itching sensation, maddening. There is no water blister or ooze, from the rash. Also on my arms to lesser extent. 4-3-18 My doctor observed the symptoms. He did not have any positive comments. I was given an injection of some type of steroid, and recommended to apply some type of topical cream. I have been applying generic BENADRYL with some mild results. Itchiness, still persists, and 5 to 6 hours I have to re-apply more cream.
Temp increase 104.9 evening of immunizations, followed by 2 minute seizure with staring eyes rolling.
Information has been received from a physician, via a company representative, concerning an approximately 36 year old female, with an unknown medical history, who on 17-MAY-2006 was vaccinated with a single dose of pneumococcal 23v polysaccharide vaccine (Lot#650649/0790P).  Following the vaccination, on 17-MAY-2006, the patient developed at the injection site, skin that was very red, tender and swollen.  The patient also had difficulty raising her arm.  Unspecified medical attention was sought.  Outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Child received nasal spray flu vaccine and fell asleep shortly after. Immediately upon waking up the following morning, the child had extreme difficulty speaking and exibited a very pronounced stutter. Child previously had no trouble speaking and expressing herself in very fluent sentences with zero occurrences of stuttering whatsoever. The heavy and pronounced stutter lasted 2 weeks after which there was some improvement which has plateaued. After 6 weeks, she still stutters, but not as bad as the first 2 weeks.
-Fatigue x 3 days -Nerve pain in  feet bilaterally, onset 2 days post shot, involve entire foot -Symptoms persist 3 weeks post shot-no improvement
Patient received vaccine, was observed for 15 minutes, and left. Patient came back a few minutes later with red swollen fingers. Patient brought to observation room and given 25mg of benedryl. Redness improved by 1843, and was cleared to leave by RN.
soreness of right wrist; stiffness all fingers; swelling of area; discomfort level 7; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 23Feb2021 at 10:30 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veterans administration facility. Medical history included blood thinner from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not 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. On 25Feb2021 at 19:00, the patient experienced soreness of right wrist, stiffness all fingers, swelling of area, discomfort level 7, limited use of hand. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Cellulitis on injection site 5mm on left forearm  Rx. Augmentin 1 teaspoon twice a day for ten days.
received 2 doses of polio (IPV) virus vaccine today with no reported adverse event; Initial information was received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old female patient who received 2 doses of IPV (VERO) [Ipol] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) and pneumococcal vaccine conj (pneumococcal conjugate vaccine) for Prophylactic vaccination.  On 18-Oct-2023, the patient received a 0.5 ml (dose 3), once of suspect IPV (VERO) (Suspension for injection) (lot V1A022M,  expiry date: 17-Feb-2024, strength: standard) via intramuscular route in Right thigh for Immunization and received 2 doses of polio (ipv) virus vaccine today with no reported adverse event (extra dose administered) (Latency: same day).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Intestinal pain and burning particularly at night.  Visited personal physician no diagnosis given.  Scheduled and had a colonoscopy in May to rule out any possibility of cancer issue.  Colonoscopy was clear with a few areas that could become diverticulitus.    Burning persisted at night keeping me awake and subsequently scheduled 2 visits to personal physician and included a sonogram of the kidneys.  negative results on any issues with the pancreas or kidneys, small fatty tumor on right kidney not seen as an issue.  Burning pain particularly painful at night.  I stopped eating any meat or carbohydrates at dinner and the pain subsided until my booster shot on November 12, 2021 when great pains returned.  Pains continue periodically and injure my sleep patterns.
Fever 100-102 for 2 days after vaccine Redness below vaccine site about 4" in length
Patient developed CP SOB Chest Congestion, tested positive for COVID 19 on 7/8/2021
Diffuse macular rash, hyperemic involving the face and progressively the trunk and thigh. Onset one day after vaccines were given. No documented fever, baby playful, east well no behavioral change. Zyrtec 2.5mg PO don't if improved by about 50-60%. Had immediate local reaction to left thigh.
This spontaneous report was received from a registered nurse regarding an unknown number of patients of unknown age and gender. The nurse reported that an unknown number of patients were vaccinated with GARDASIL (lot number and expiration date not provided) (dose and route not provided), or VAQTA (lot number and expiration date not provided) (dose and route not provided), stored as low as 30F for an unknown number of times and for an unknown total amount of time. No adverse effect was reported. Additional information has been requested.
After about 11 hours of the vaccine, I began to feel a little achy and nauseous , followed by extreme dizziness and weakness. I blacked out every time I stood up or even sat up. I had violent chills for several hours, extreme nausea, weakness, stomach pain . This lasted for several hours. Then I went to sleep. The next day, I felt weak and exhausted.
This spontaneous report was received from a healthcare professional concerning a 27-year-old female patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   In August of 2013, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), In October of 2013, the patient received the second dose of the vaccine and on 26-NOV-2021, the third dose was administered (Inappropriate schedule of vaccine administered) 0.5 milliliter (route of administration, lot number and expiration date were not provided) all vaccines administered as prophylaxis.  No additional adverse events were reported.
This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's medical history and concurrent conditions were not provided. Concomitant therapy included sterile diluent (lot # M015992 and expiration date 26-NOV-2018). On 17-OCT-2018, the patient was received unspecified doses of improperly stored varicella VARIVAX (lot # R002509 and expiration date 25-JAN-2020), subcutaneously for prophylaxis (product use issue and product storage error). The vaccine was exposed to temperature of 28F for less than one hour and the data logger was involved. No previous excursions were reported. The reporter did not report sterile diluent was improperly stored. No adverse effects reported. This is one of three reports received from the same reporter (Linked case # 1901USA001564 and 1901USA001175). Sender's Comments: US-009507513-1901USA001564: US-009507513-1901USA001175:.
Patient was vaccinated on 04/27/2022 at 4:30pm and began to experience symptoms (primarily joint pain) at 9AM on 04/28/2022. Symptoms included joint pain throughout entire body (mostly upper body), nausea, whiteness at fingertips, and overall progressive worsening up to time of reporting symptoms via phone call on 04/29/2022 around 10AM. There was no redness, no fevers, no chills, and no shortness of breath (patient denied all).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.  No Medical History information was reported.   On 11-Jan-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The age of patient was provided as 71.69.  No concomitant medications were reported.  On 11-Jan-2021, excursion time was 9 AM, temperature was 34 and 2 PM, temperature was 35. Total doses given for the day was 98, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. 9 vials were sent to clinic on 11-Jan-2021.  Vial was stored on cooler 1 on 11-Jan-2021 with excursion duration at 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 PM: 35, 1PM: 36, 2 PM : 37 and 3 PM: 37.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
cough; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), CHILLS (chills) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (cough), CHILLS (chills) and HEADACHE (headache). The patient was treated with TRANEXAMIC ACID (TX) at an unspecified dose and frequency and CAFFEINE, CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (CORICIDIN F) at an unspecified dose and frequency. At the time of the report, COUGH (cough), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
SHE SAID THAT 3 DAYS AFTER GETTING THE 2 ABOVE VACCINATIONS, SHE HAD A BULLSEYE RING RASH ON HER LOWER LEFT ABDOMEN AND A RASH ALL ACROSS HER ABDOMEN. SHE QUESTIONED IF IT WAS A TICK OR SPIDER BITE BUT WASN'T SURE. SINCE WE DON'T KNOW, I AM REPORTING IT.
Information has been received from a medical assistant concerning a 16 week old patient who on 07-MAY-2010 was vaccinated with the first dose of ROTATEQ orally. No adverse symptoms were reported. Additional information has been requested.
experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported.  The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
Information has been received regarding a case in litigation concerning a male minor who was administered vaccines containing mercury and/or thimerosal. He has suffered devastating injuries caused by mercury toxicity through IM injection of mercury. He was exposed to highly toxic emissions from certain facilities in the environmental zone of his residence which contributed to his total mercury exposure and total dose of poisonous mercury. Emissions from mercury emitted facilities toxins include mercury, lead, chromium, and other heavy metals. Because of his heightened vulnerability to heavy metal poisoning and his compromised condition related to the mercury poisoning, he was and is unable to process heavy metals and suffered neurological compromise as a result of heavy metals contributed by medical waste burning utilities. His impaired condition is compounded by these exposures and his injuries made worse by them. It was reported that the patient was poisoned by the cumulative doses of mercury emitted by these facilities, and as a result, suffers from, and in the future will continue to suffer from, the toxic neurological effects of mercury poisoning. Follow up information received in a pediatric vaccine administration record indicated that the patient received a third dose of hepatitis B vaccine administered in the right leg on 6/30/99. Concomitant therapy on 6/30/99 included a third dose of diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid (batch # 462313) in the left leg, a third dose of HIB conjugate vaccine (batch # 411003X) in the right leg, and a third dose of poliovirus vaccine live oral (0800L112) PO. Other vaccinations included: the first, second, and fourth doses of diphtheria toxoid (+) pertussis acellular 4component vaccine (+) tetanus toxoid (batch # 457788, 457794, 467011 respectively) in the left leg on 2/16/99, 4/20/99, and 3/16/00, respectively; the first, second, and fourth doses of HIB conjugate vaccine (batch # 402203A, A02203A, and 570403A, respectively) in the right leg (fourth dose administered in the left leg) on 2/16/99, 4/20/99, and 3/16/00, respectively); the first and second doses of poliovirus vaccine inactivated (batch # N0726 and O0957, respectively), in the right leg and left leg, respectively on 2/16/99 and 4/20/99, respectively; a first dose of MMR (lot # 632344/1081J) administered in the right leg on 12/17/99; a second dose of hepatitis B virus vaccine )Batch # ENG2721B9) (first dose noted as OMH) administered in the right leg on 2/16/99; a dose of Mantoux (batch # 2520-11) in the left arm on 7/10/00; a dose of varicella virus vaccine live (lot # 631524/1012J) administered in the left leg on 12/17/99; and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (batch # 484206) administered in the left leg on 4/4/02. Upon internal review, mercury poisoning, devastating injuries, neurological compromise, and the toxic neurological effects of mercury poisoning were considered other important medical events (OMIC).
No adverst events.  Patient received a vaccine that was indicated for 18 years and older.
Dizziness, Headache, Arthralgia, Fatigue, Injection site pain, pain in right axillary Narrative:
Information has been received from a physician concerning a 7 year old male who was vaccinated SQ with a 0.5ml dose of varicella virus vaccine live when he was 12 months old. On approximately 02/21/2005 the pt presented to the office with chickenpox lesions. Unspecified medical attention was sought. There was no product quality complaint. Additonal information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2005.