chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C2 1A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021 at 10:00 PM, the patient experienced PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Body ache), PYREXIA (Fever) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; 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 (BNT162B2), on 02Jun2022 as dose 2, single (Lot number: 17804), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 17Nov2022 at 13:00 as dose 3 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received the treatment for event COVID-19 included Paxlovid, treatment started on 02Jan2023 and stopped on 07Jan2023.
Information has been received through the pregnancy registry through a 22 year old female who on 20-OCT-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included sertraline HCl (ZOLOFT) and zolpidem tartrate (AMBIEN). On approximately 27-OCT-2007 the patient found out she was pregnant (not further specified). On approximately 24-NOV-2007 the patient experienced a miscarriage. The patient sought unspecified medical attention with a physician. Upon internal review, miscarriage was determined to be an other important medical event. No additional information is expected.
Rash x 1 day. Multiple papules and vesicles on face and trunk, some on extremities approx. 50 on trunk approx. 20 on face.
Multiple erythematous papules some with vesicles, some with scabs in center located chest, back, upper legs supportive at home care.
like covid symptoms after dose 2; sick after dose 2; really bad after dose 2; chills; fever after dose 2\fever, like covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Hypertension.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms). At the time of the report, SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Antibody test: positive (Positive) Tested positive for antibodies back in march right before the second vaccine.         Concomitant medications included ADH for unknown indication. No treatment medications were reported. It was reported the patient  first dose was in March and had no side effects. After his second dose the patient was sick, chills, fever, like covid symptoms, really bad. The symptoms eventually went away. Tested positive for antibodies back in march right before the second vaccine.  Company comment: This case concerns a 49-year-old male patient, with medical history of hypertension, who experienced the non serious unexpected AESI of Suspected COVID-19 after the second dose of mRNA-1273. No information regarding start date of the event. It was reported that symptoms recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-429358 (Patient Link).; Sender's Comments: This case concerns a 49-year-old male patient, with medical history of hypertension, who experienced the non serious unexpected AESI of Suspected COVID-19 after the second dose of mRNA-1273. No information regarding start date of the event. It was reported that symptoms recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Moderna COVID-19 Vaccine EUA approximately 9minutes after receiving dose, (this was my 2nd)  began feeling very dizzy while sitting in chair, flushed, heart rate was checked and it was 134, BP elevated 203/111.  The dizziness subsided after about 10minutes.  I remained sitting for about 40minutes until I felt fine to leave at that time my heart rate had come down to the low 90's.
pt recv vax in AM & the next day pt devel redness & swelling @ the inj site;this is 1 of 12 pt from this site to have an adverse rxn;
Approximately 10-15 minutes post vax, the pt's mom noted blotchy skin, and alerted staff. The Child had grunting respirations at 44 per minutes, BBS, CTA, ears reddened bilaterally, rash to extremities, upper eyelids swollen. The pt was given epinephrine and Benadryl and was admitted for observation. The pt was discharged on 6/23/01.
Patient lost consciousness, fell off exam table, was rigid for approximately one minute.  She regained consciousness, vital signs remained within normal limits during entire adverse event.
I developed a fever, body aches and chills on Friday April 16 around 8pm. I then used Tylenol and night time sever cold medicine and it knocked out those symptoms while sleeping. The next morning I woke up with: Rash and blisters on hands, feet, elbows It is now April 18th and I continue to have these symptoms.  Benadryl relieves it temporarily but it keeps coming back. Applying aloe Vera soothes the blisters temporarily. Waiting for symptoms to end.
Cold sweats began about 11 hours after receiving the vaccine followed by diarrhea, vomiting, fatigue, and dizzyness. The majority of the side effects continued for 3 days after receiving the vaccine but the vomiting was only done twice on 5/12/21.
Is a 53 year old male with a past medical history of opiate abuse and back pain who presents to the emergency department complaining of left upper quadrant pain starting about 2 days ago. Patient thought it was due to constipation so. He took laxatives at home with a large amount of stool that was brown with no bright red bleeding per rectum. Pain is constant, spot specific, sharp and moderate. He is unsure exactly what makes it better or worse. Denies chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea. Seen f/u clinic 5/5/21   Taking xarelto 15mg BID as prescribed primary Care and Follow up: Has appt with Dr next Friday.
Received a phone call from patient 6-9-09 stating c/o fever, headaches, generalized body aches and nausea hours after receiving Tdap on 6-8-09.
Information was received on 14-OCT-2016 from a healthcare worker via a field representative. The healthcare worker reported that on an unspecified date, an unspecified patient (gender and age not reported) was "supposed to" received ZOSTAVAX however the patient "may have" received (Oka/Merck) VARIVAX by mistake. It was documented that the patient received a dose of (Oka/Merck) VARIVAX, however it could have been a dose of ZOSTAVAX and they just wrote it down incorrectly. Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. No further information was provided. Additional information is not expected as physician did not wish to be contacted.
Developed inconsolable crying for greater than 4 hrs. following 2 month immunizations. Was fussy for >24 hours. No fever. Received two doses TYLENOL following.
Fever, chills, body aches, even with Tylenol.  Had 102.5 temperature 6.5 hours after taking two Tylenol, 36 hours after vaccination.  Had 101.4 temperature 72 hours after vaccination and had taken 2 Tylenol 4 h ours previous to that measurement.  Well into day 4 I was still running a fever but was in the 99s.  By 72 hours, I also had a severe migraine with nausea.  I finally had no fever 96 hours after vaccination and felt better but had another 12 hours of migraine.  108 hours later and I could leave the house.
Weakness, headache, sweating, slept for 36 hours, chills, metal taste, no appetite., loose stolls.
A report has been received from a Health Professional concerning a 55 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. Concomitant medications included Glucosamine and Vitamins NOS. FLUMIST QUADRIVALENT started on 01-Oct-2013. Medical assistant reported that they inadvertently gave FLUMIST QUADRIVALENT to a 55 year old patient which started on 01-Oct-2013. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a 55 year old patient is unknown. The report was considered to be non-serious.
PAIN AT SITE OF INJECTION, HEADACHE, GENERALIZED BODY ACHE,
Patient had a 1 1/2 inch red circle around injection site on Saturday. Then on Sunday another 1 1/2 in red circle formed - she went to E.R. on Sunday where the P.A. diagnosed cellulitis & said it came from the shot. Patient was given Rx of cephalexin 500 mg - to take 1, 4 x a day.
On again off again rash under his injection arm and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (On again off again rash under his injection arm and chest) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 0121m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 RASH (On again off again rash under his injection arm and chest). At the time of the report, RASH (On again off again rash under his injection arm and chest) had not resolved.            No concomitant product use was provided by the reporter.   No treatment medications were reported.
Shaking, swesting, migraine, severe nausea and vomiting, extremely lethargic
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006064: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
EVENT: increased mucus discharge from lungs through tracheotomy cannula of a thicker than usual consistency. TREATMENT: increased fluid intake, sterile water droplets in trach, increased suction, nebulized sterile water. OUTCOME:  4 days out - resolving slowly
Pain and warmth and firmness felt at injection site on upper left arm. 2 1/2 cm at area of induration felt there, no erythema
Night of shot began feeling tired and a slight headache with minimal nasua. At approximately 9pm 12/31/20I began having extreme nausea followed by vomiting. Throughout the night into the next day 1/1/21 had several readings of a fever highest 103.2, vomiting after eating or drinking. would have varying spouts of extreme body sweats (had to change bed sheets/clothing, strong bouts of chills in which I felt extremely cold and would shake uncontrollably. 1/1/21 this continued however I was able to take Zofran (from doctor) for nausea to help control the symptom, I would have to re-medicate after 4-6 hours. Continued symptoms from prior night into the night of 1/1/21. 1/2/21 I began feeling better. Had feeling of exhaustion, but nausea symptom and chills/sweats stopped.  by about 11am 1/2/21 symtopms had largely ended.
no additional AE; vaccines were exposed to high and low temperatures and administered to two patients; This spontaneous report was received from a healthcare professional referring to a 4-year old patient of unspecified gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On  01-JUL-2021, the patient was vaccinated with an improperly stored dose of   hepatitis b vaccine (recombinant)(RECOMBIVAX HB) pre-filled syringe, lot # T004378 (expiration date not reported, but upon internal validation established as 01-NOV-2022) for prophylaxis (dose, route and site of administration were not reported).  The administered dose of the vaccine experienced multiple high and low temperature excursions from below 33.9°F to above 49.7°F, for 4 hours and 05 minutes. There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T004378; expirationdate: 01-NOV-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; Sender's Comments:  US-009507513-2107USA005117:
This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 19th March 2019, 28 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The reporter reported that, the patient had shingles infection 4 weeks post SHINGRIX vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. No additional information was provided.
extreme chills, fever 101.8ºF, Advil 24 hour duration
The pt states has dull continueous pain since vax. Also, off and on numbness and tingling in left hand. Now pain has spread to shoulder. Has applied heat this has helped the pain temporarily.
1/25/2021 vaccination 1/26/2021 woke up with massive HA, shoulders and upper back, neck in 'misery'. Lasted till afternoon and then subsided with ibuprofen.
This spontaneous report was received from an other health professional referring to a 1-year-old infant patient of unspecified gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies was not reported. Approximately on 26-FEB-2019 (also reported as three weeks ago), the patient was vaccinated with M-M-R II (strength, dose, unit, dose number, anatomical location, lot # and expiry date were not reported) subcutaneously for prophylaxis. On the same day, it was reported that while vaccinating the patient some of the vaccine came out. The outcome of needle issue and incorrect dose administered was unknown. Causality assessment of the event was not reported. No product quality complaint (PQC) was involved.
Recurring UTI since receiving this vaccine. Pain urinating, frequency, urgency, etc.   Received the vaccine in April '21, and UTIs started in May. I've been on so many antibiotics to clear it but it just keeps coming back. This never happened prior to the vaccine.
Narrative:  Stable vitals. Patient took claritin, flonase, and albuterol prior to vaccination. History of anaphylaxic reaction per verbal report. 30 mins after vaccination patient reported chest tightness and itchy throat. IM benadryl 50mg admin and ED notified and transferred for further monitoring.
Had achieved appropriate milestones at 6 month check. Within the next few weeks, his social interactions changed; he failed to advance with motor milestones. He continues to have significant global developmental delays.
Pt has febrile seizure 10-11 hours post INFLUENZA vaccine. Vomited 15 min prior to seizure.
pt recvd vax & 48 hrs p/vax exp flu-like sx which resolved; 48 hrs p/2nd dose again exp flu-like sx which lasted 5-7 days;
I got the shot on a Thursday (3/4) and on Sunday (3/7) it started to itch. It  was  hard and red and was about 1.5 inches by 0.75 inch. Today is Saturday, 3/13/21, and it still itches and is red and hard. I did get headaches  and muscle tenderness for two to three days after the shot. By Monday and Tuesday I felt like I had the flu.
Information has been received from a registered nurse (RN) concerning a 23-week-old patient who on 05-JUL-2006 was vaccinated by mouth with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653915/0389F). It was unknown if medical attention was sought and no adverse were reported.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/8/2006.  Information has been received from a licensed practical nurse (LPN) concerning a 23-week-old female with no medical history who on 05-JUL-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #6539315/0389F).  Concomitant vaccinations administered on that same day included the second IM dose in the left thigh of PEDIARIX (Lot #AC21B065AA), the second IM dose in the right thigh of ACTHIB (Lot #UE793AA) and the second dose in the right thigh of PREVNAR (Lot #B08658C).  Medical attention was not sought and no adverse events were reported.  On 08-AUG-2006, the patient was vaccinated PO with the second dose of ROTATEQ (Lot #653915/0389F).  Additional information is not expected.
Prior to vaccine administration, he had normal function in left arm, which was site of vaccination. He was able to drive himself home. Injection site pain peaked within a day, and was lessened by day two. However, he woke late morning fearing he had a stroke. His symptoms were primarily related to range of motion in vaccinated arm. He had difficult dressing. Exam findings consistent with adhesive capsulitis and course of physical therapy recommended.
pinkish spot across from the injection site, not on it/red spot on her; leg cramp; needle hurt so bad; screamed; This spontaneous case was reported by a consumer and describes the occurrence of SCREAMING (screamed), RASH MACULAR (pinkish spot across from the injection site, not on it/red spot on her), MUSCLE SPASMS (leg cramp) and INJECTION SITE PAIN (needle hurt so bad) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included VITAMINS NOS for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced SCREAMING (screamed) and INJECTION SITE PAIN (needle hurt so bad). On an unknown date, the patient experienced RASH MACULAR (pinkish spot across from the injection site, not on it/red spot on her) and MUSCLE SPASMS (leg cramp). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Leg cramps, at an unspecified dose and frequency. At the time of the report, SCREAMING (screamed), MUSCLE SPASMS (leg cramp) and INJECTION SITE PAIN (needle hurt so bad) outcome was unknown and RASH MACULAR (pinkish spot across from the injection site, not on it/red spot on her) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also includes unspecified supplements.
hand feel numb; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen). At the time of the report, HYPOAESTHESIA (hand feel numb) and VACCINATION SITE SWELLING (arm was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.    This case was linked to MOD-2021-384207 (Patient Link).