chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 19 year old female who was vaccinated with the first dose of GARDASIL 0.5 mL. The physician reported that the patient experienced tingling and numbness in her arm which progressed into paralysis of an entire one side of her body after receiving the vaccination. The patient sought medical attention and was seen by the physician. At the time of reporting, the patient had not recovered. The physician considered tingling and numbness in her arm and paralysis of an entire one side of her body to be disabling. Additional information has been requested.
Feeling sick; He felt pressure in his hands; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; Lethargic; cant sleep night; sense of feeling of a warm oil running through his veins; He still feels terrible; This is a spontaneous report received from a contactable consumer (patient) (this is 1 of 3). A 64-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177) intramuscularly in left deltoid on 14May2021 at 11:40 (at the of 64-years-old) as unknown, single dose for COVID-19 immunization. Medical history of the patient included COVID-19 in the first week of Sep2020. High blood pressure (after covid-19 it has been high as 200/130 and 180/120). Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), via an unspecified route of administration, from an unspecified date in Feb2021 and ongoing at unknown dose and frequency for blood pressure high. Patient had no prior Vaccinations (within 4 weeks) of COVID vaccine and had no AE(s) following prior vaccinations. On 14May2021, within an hour after vaccination, the events started, patient was not feeling well. He stayed at the pharmacy for a while to make sure there wasn't an immediate reaction. Once he got home, he wished he hadn't taken the shot. He felt pressure in his hands; he already felt comprised. Events were still ongoing but are at different times of the day, they were happening off and on throughout the day. Patient also gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time. After three weeks of vaccination patient was still feeling sick, lethargic, could not sleep at night, and has a sense of feeling of a warm oil running through his veins. Patient went to his medical doctor (physician office visit due to events) and he was basically sent on the way. Patient also went back to the Walmart where he got the shot and they told him there was nothing that could be done, it would just have to work through his body. Patient still feels terrible. Patient reported that it wouldn't be so bad or he wouldn't be so concerned if it wasn't already 3 weeks since having the shot. He was worried and so was his wife. The clinical outcome of the feeling sick, he felt pressure in his hands, he also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time, lethargic, cant sleep night, sense of feeling of a warm oil running through his veins, he still feels terrible were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Fever x 2 days - diarrhea x 1 week spit up mucous tinged with blood.
Left arm 0from injection site up into chest, shoulder, neck, down through entire arm causing fingers to cramp and drawing fingers into fist. Sever headache. Arm hurts on about a pain scale of 9 and constantly got worse through the day and the left arm will not raise any higher than 8 ins at waist and will not extend fully without causing extreme pain .
Chills, fever, chest pain, abdominal pain, stomach ache, fatigue, nausea, dry heaving and gagging, joint pain, muscle cramping, headache
Baby had vomiting starting 6/26/20 that persisted until 6/27/20 when she was sent to the emergency room for evaluation of bowel obstruction. She had ultrasound of the abdomen that diagnosed intussusception which was reduced with air enema. Baby was able to tolerate feeding of pedialyte at that time and discharged home.
pt recv vax 19MAR97 or 20MAR97 pt exp a hot sensation in face, a numbing sensation on both sides of cheek, felt weak all over & felt like had a fever;
Had Moderna and Pfizer vaccines; jeopardize his and his wifes health; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713239 (Moderna).  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose number unknown (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Had Moderna and Pfizer vaccines"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "jeopardize his and his wifes health".  Additional information: The caller stated that he had Moderna and Comirnaty vaccines and has learned information since that could jeopardize his and his wife's health. The reaction did not lead to death/ Life threatening/ hospitalization/ Disability/ Congenital anomaly/ Other medically important condition.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a 4 yr old male who on 08May04 was vaccinated SC in the left thigh with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The RN reported that on 10May04, the pt developed injection site redness and swelling from the site of injection to just above the knee. The pt was noted to be able to walk. Unspecified medical attention was sought. It was also noted that the pt's mother has applied lidocaine (+) prilocaine (EMLA) cream to the injection site in the hours preceding vaccination. At the time of this report, the pt's injection site redness and swelling persisted. Additional information has been requested.
Had flu shot about 10am 10/31/05. Approx 3pm experienced chills, fever, felt weak, decreased appetite. Reports no fever or chills next day 11/01/05 but continued to have low energy and low appetite. Episode lasted 2 1/2 days did not consult a doctor.
About 2 hours after the vaccine being administered, patient experienced hives, ger face became red and swollen, and she was itching all over her body. She went to the ER ,  her heart was racing, they gave her benadryl injectable. Soon after, she started to feel tired and sleepy, and during the next day she was feeling still tired. The day after, she is feeling much better, still experience a little bit of itchiness at forehead and arms, seldonly.
Information has been received from a physician concerning a male who on 19-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 26-MAY-2007 the patient developed an unknown rash across his abdomen and lower rib.  "The rash also went away from under the armpit to the chest".  At the time of the report the patient was still experiencing a mild case of postherpetic neuralgia (PHN).  The patient sought unspecified medical attention.  The physician reported that the patient was not sure if he had chickenpox before.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested. Follow-up received 04/16/2008. Follow-up information received on 27-NOV-2007 indicated the patient was vaccinated subcutaneous in the right upper arm on 19-MAY-2007 at 16:00 with his first dose of zoster vaccine live (Oka/Merck) (lot # 65B08Z/0744U). The patient was well at the time of vaccination and had no pre-existing allergies or medical conditions. On 26-MAY-2007 the patient developed a zoster like rash - herpes zoster like rash, shingles rash on upper right chest in a 8" x 6" area. Burning and pain were the chief complaints with post herpetic pain that lasted several weeks. In September 2007 the patient recovered. Additional information is not expected.
Patient received DTaP and IPV in right lateral deltoid on 5/18/04. He awoke 5/19/04 with right arm swollen/warm from humerus to elbow.
Shortly after the injection she noticed an enlarged lymph node in  her neck on the side of the injection.
Patient was initiallye anxious about getting the immunization as per patient herself, and her   daughter. After 1 5 minutes of her 30 minute after COVID19 vaccination observation time patient reported,   she "felt funny". Pt  was immediately brought into the vaccination room for assessment; BP,   Pulse, & Respirations was initiated (all BPR were WNL's). she was flushed and continued to be anxious.
Side effects of moderna:: pain on arm, developed a itchy bump 7 days after, lasted a day. I take Claritin for my allergies, not sure if that helped.
Administration error: Patient inadvertently given Moderna vaccine for second dose on 4/20/2021 after receiving 1st dose Pfizer vaccine on 3/30/2021 resulting in mixed dose vaccination series. Patient tolerated vaccination well with no adverse events.
This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (Lot # unspecified) intramuscularly in September -2011. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient would received her second dose of 0.5 ml GARDASIL (Lot # unspecified) intramuscularly at time of the report. No adverse effect reported. Additional information has been requested.
a bit of warmth at site; Initial information was received on 30-Jan-2021 regarding an unsolicited valid non-serious case from a consumer or other non-professional via media.  This case involves a patient (age and gender unspecified) who had a bit of warmth at site (vaccination site warmth), after patient received INFLUENZA VACCINE.  The patient had medical history of Influenza and almost died twice. At the time of event patient had ongoing COVID.  The patient had no other medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details not reported] for prophylactic vaccination between corona virus disease (COVID) vaccine.  On an unknown date, the patient developed a non-serious bit of warmth at site (vaccination site warmth) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, COVID sucked patient's strength like vampire also patient reported that, it is up to Individuals to decide if they can Live with guilt if they don't get Shots and give these sicknesses to somebody who never recovers.  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was reported as unknown for vaccination site warmth.  There will be no information available on the batch number for this case.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 41.86 on 14-Feb-2021.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM and 03 PM, temperature was 32, 32, 32, 35 and 35, Total doses given for the day 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.   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 Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Injection site sore, with redness, warmth, and swelling. Continued to expand in size becoming at least 2 inch firm lump. Remains red, warm to touch. Itching began on 1/14/21. Took Benadryl 25 and Aleve 200 on 1/14/21 at 2130. Some symptom abatement in am of 1/15/21. Some decrease in swelling. Remains hot, red and itchy. Applied hydrocortisone cream and notified PCP.
Patient received vaccination 8/4/2011, on 8/5/2011, patient had 1.5in x 2in red, tender, swollen area at injection site ((L) deltoid). On 8/5/2011 at 7pm pt had oral temp of 103.5 degrees F that would not go down with MOTRIN. ATARAX had been given to pt. per mom, pt was sleepy, not eating, not drinking so she took pt to ER that night. Pt went home that night. On 8/6/2011 pt had no fever & felt better. (L) arm still red/tender. 8/7/2011 pt had no fever & no redness/swelling. Pt doing well.
I got the shot and still got shingles; Still got shingles; Horrible rash; horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient got the shot and still got shingles. It was horrible rash and pain. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
right arm started hurting, patient can hardly raise arm without a shooting pain at shot sight; There is also some swelling; This is a spontaneous report received from a contactable consumer, the patient.   A 73-years-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6198) via an unspecified route on 03Mar2021 at 08:45 AM (at the age of 73-years) as a single dose in right arm for COVID-19 vaccination. The patient's past drug history included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EM9810) via an unspecified route on 02Feb2021 at 07:45 AM as a single dose in left arm for COVID-19 vaccination. Medical history included diabetes, high blood pressure and obesity. The patient was allergic to dye injected for tests, shrimp, penicillin, amphetamine and barbiturates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a hospital. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included insulin, glimepiride, simvastatin, lasix and vitamin d3. The patient received these medications within 2 weeks of vaccination and exact therapy dates and indication for these medications were not reported. On 10Mar2021 at 04:00 PM (a week after the shot), the patient's right arm started hurting which was coming and going. Sometimes the patient could hardly raise her arm without a shooting pain at shot sight. There was also some swelling. The patient did not receive any treatment for these events. At the time of this report, the patient was not recovered from the events vaccination site pain and vaccination site swelling. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates between 07-JUN-2016 and 08-DEC-2016, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009377 with expiry date on 17-JUN-2017 and lot # M011116 with expiry date on 17-JUN-2017; dose and route of administration were not reported) for prophylaxis. On 07-JUN-2016, doses of VAQTA underwent a temperature excursion of minimum 25 degrees Fahrenheit for 12 hours prior to being administered. There were no known adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010752: US-009507513-1612USA004642: US-009507513-1612USA010751:
Muscle pain in my leg; Did not sleep last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 22Feb2021 (Lot number: EM6200) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (first dose), for COVID-19 immunisation.  The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "Muscle pain in my leg"; INSOMNIA (non-serious), outcome "unknown", described as "Did not sleep last night". The events "muscle pain in my leg" and "did not sleep last night" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, insomnia.  No follow-up attempts are possible. No further information is expected.
Tylenol 2 tablets 500mg every 6hrs. Extreme pain in arm of injection and weakness throughout my legs and arms. Headache, fever
103 degrees fever started day after IZ's given. Cough & bronchospasm. Mom called 8-3-12 to report. Home treatment with ibuprofen, albuterol x 2 ABT's. Rx for ORAPRED.
Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
mom states pt well when recvd vax; approx 3 hrs p/vax adm to hosp pt c/o h/a, stomachache, cramps, drowsiness, no v & some d; MD changed insulin to regulate BS;  BS inc to 200's; 26AUG BS out of control; vomiting;cont w/ stomachache, v, d;