chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 03-FEB-2016 the patient was vaccinated with improperly stored PROQUAD (Merck) (dosing details and route not reported) lot # L034931, expiry: 03-MAR-2017. No concomitant medication was reported. It was reported that the vaccine was exposed to the temperature of 20.3C during a time frame of 5 hours and 22 minutes. There was no previous temperature excursions. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Itchy rash appeared on locations throughout body: both arms, back, back of neck, front of torso, and legs.
Severe muscle aches beginning in left arm and spreading both down to wrist/hand, and up into shoulder, neck and down back. Dull throbbing ache that is much more painful when moving. Headache. Chills.; Dull throbbing ache; Headache; Chills; This is a spontaneous report from a contactable Non health care professional, the patient. A 31-year-old non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot/Batch no: Not available, Dose number:1) solution for injection via unspecified route of administration in the left arm on 16Mar2021 at 15 hrs 45 min for Covid-19 immunization. Medical history included Lupus, post-traumatic stress disorder  and allergy to Sulfa. Concomitant medication(s) were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination and was neither tested positive since the vaccination. The patient experienced chills, headache, throbbing pain and muscle ache beginning in left arm and spreading both down to wrist/hand, and up into shoulder, neck and down back on 16Mar2021 at 16 00hrs. Therapeutic measures were not taken The patient was not recovered from the events chills, headache, throbbing pain and muscle ache. Information about lot/batch number cannot be obtained. No further information is expected.
Patient was diagnosed by a medical doctor on Nov. 3 as having H1N1 after receiving the mist for H1N1 on Oct. 14.
20min p/vax pt devel coryza, edema under lt eye, DPH given;
IMMENSE PAIN; ABDOMINAL PAIN; UNCOMFORTABLE  TO TOUCH BODY; PAIN IN EYEBALLS; FEELS HOT AND COLD ON AND OFF; CHATTERING OF THE TEETH AND JAW; PAIN IN BACK MUSCLES; FEVER; This spontaneous report received from a consumer concerned an 18 year old female. The patient's weight was 155 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-202111:50 in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On an unspecified date, the subject experienced immense pain, abdominal pain, uncomfortable to touch body, pain in eyeballs, feels hot and cold on and off, chattering of the teeth and jaw, and pain in back muscles. Treatment medications (dates unspecified) included: metoclopramide hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, immense pain, abdominal pain, uncomfortable to touch body, pain in eyeballs, pain in back muscles, chattering of the teeth and jaw, and feels hot and cold on and off. This report was non-serious.
I have had on and off facial numbness which began within half an hour after receiving the Janssen vaccine.
red, hot area on (L) bicep area. cool arm tingling down arm. told to alternate heat and cold to site. watch for x/s of cellulitis or worsening s/s. Call if s/s get worse.
I woke up at 5:30am with shaking chills, then got nauseated and had the dry heaves, as well as headache & tiredness. It is now 11:30am and I feel better, but still have occasional queasiness, slight headache and still somewhat tired, but overall better.
papules; blister; lesions; Itchy papule; This case was reported by a nurse via call center representative and described the occurrence of papular rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. In August 2019, 3 days after receiving Shingrix, the patient experienced papular rash, blister, skin lesion and itchy rash. The patient was treated with steroid shot (nos) and prednisone. On an unknown date, the outcome of the papular rash, blister, skin lesion and itchy rash were recovered/resolved.   The reporter considered the papular rash, blister, skin lesion and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and it was unknown if it was administered IM or in what arm because it was administered by another provider.  Three to four days later that, the patient had red, itchy papules that started behind the knees and spread to other body areas. The patient noticed single large blister between fingers but was unsure when this developed. On 4th September 2019, the patient received a steroid IM injection that provided short term benefit. On 13th September 2019, the patient began oral prednisone for 14 days. The nurse stated the prednisone has helped with symptoms and lesions are smaller but patient does continue to develop new lesions, hundreds of them (on trunk, extremities, and a few on the face). On 20th September2019, the patient's provider (dermatologist) thought they were probably an adverse reaction to Shingrix. A skin biopsy was obtained on 20th September2019, the day of the visit, and the HCP decreased to prednisone to 20mg/day to saw if that helped diminish symptoms. The pathology was obtained and determined reaction was due to medication. The nurse called patient and patient stated that the lesions were doing much better. The lesions had stopped coming. The patient felt that, it was now resolved.  The reporter consented to follow up. This case has been linked with US2019AMR184058, reported by same reporter.
My daughter is 11 months old and received the Novartis H1N1 vaccination.  I think she received the full adult dose.  She should have received the Sanofi brand since she is <4 years old.  Did well.  No treatment needed thus far.  Would like to know if she needs revaccination.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. It was reported that vaccine that shows as expired August 14, 2021 but also expired on October 14, 2022.
About 10 minutes post vaccine, patient  felt faint,  hot, like he needed air, and "panicky"
Information has been received from a registered nurse concerning a 17-month-old female with a history of congenital vesicoureteric reflux and no known allergies who on 15-AUG-2007 (in the morning) was vaccinated subcutaneous in the right thigh with her first 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 657154/0411U). There were no illnesses at the time of vaccination. There was no concomitant medication. On 26-AUG-2007, the patient developed a fever. Twelve days after vaccination the patient developed erythema multiforme. Unspecified medical attention was sought. The patient was put on prednisone and ZYRTEC. On an unspecified date the patient had a WBC of 5.5. On 07-SEP-2007, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
immed p/vax pt was crying, pt arched back, eyes rolled back & appeared SOB lasting 10-15sec;then acted alert & quiet like a/vax;mom gave hx of prev sz x3 & states pt under MD care;
16APR93 upon awakening was unable to move rt wrist, very painful this worsened the next day 17APR93, unable to use rt wrist; 18APR93 upon awakening unable to ambulate due to knee stiffness;
Patient reported that she had a history of fainting after receiving other vaccines, so she had her friend drive her and got the vaccine administered in her car. A few minutes after getting the vaccine, the patient appeared to have a vasovagal episode where she stared off into the distance and stopped responding to questions for about 30 seconds to 1 minute before coming to. She reported having some tingling in her fingers and feeling a little weak afterwards. Provided the patient with a wet cloth for her forehead and some candy. Patient was a little shaken up but seemed to be back to normal in a few minutes. Contacted EMS just to be sure, and they checked her pulse and blood pressure, which were a little elevated but within normal limits. Patient said she was feeling better and did not need to go with them to the hospital. After waiting a few more minutes, she reported that she was feeling mostly back to normal and her friend drove them back home.
Information has been received from a medical assistant concerning a patient who was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) by mistake due to an office error. No adverse reactions reported. It's unknown if the patient had sought any medical attention. Additional information has been requested.
Mom in clinic with son. States he noticed arm was red and told mom. Area is warm to touch, erythema approx 2 1/2 cm. Last night had Atrovent for allergies taken by mouth.
Over three year period following vaccine heart rate increased from approx. 70 bpm to approximately 100 bpm. By July, 2015 resting heart rate exceeded 120 bpm.
This spontaneous report was received from a physician assistant via a company representative and refers to a 65-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration, lot# and expiration date were not reported) for prophylaxis. On 11-OCT-2017, the patient experienced soreness of the left deltoid, inflamed left lymph node and axilla, redness, tenderness and induration at the injection site. On an unknown date in October 2017 (reported as "then"), the patient developed a zig-zag streak from her neck to her axilla, headache and chills. The patient has improved at only had a pink spot at the injection site at the time of the reporting. The outcome of the events was recovering. The causality assessment was not provided. Upon internal review, the event of Lymphangitis was determined to be medically significant.
Pt had first dose of Pfizer COVID vaccine on 3/9/2021 and second dose on 3/31/2021.  Pt tested positive for COVID-19 on 5/18/2021 and did have symptoms, such as diarrhea, myalgia, and cough/chest congestion.  He presented to the ED on 6/2/2021 and was admitted for COVID-Pneumonia and afib with RVR.  Pt still inpatient.
Swollen and painful armpit (right); Fever over 102; Severe headache; Loss of appetite; Swollen and painful armpit (right); Severe joint and muscle pain; Severe joint and muscle pain; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 18:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; PRILOSEC [OMEPRAZOLE MAGNESIUM]; ALIGN; CLARITIN [CLARITHROMYCIN]; MINASTRIN 24 FE. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose Administration Time: 05:00 PM, Prev dose vaccine location: Right Arm), administration date: 24Mar2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Prev dose Administration Time: 05:30 PM, Prev dose vaccine location: Right Arm), administration date: 14Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 18:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Dec2021 01:00, outcome "recovering" and all described as "Swollen and painful armpit (right)"; PYREXIA (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Fever over 102"; HEADACHE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Severe headache"; DECREASED APPETITE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Loss of appetite"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2021 01:00, outcome "recovering" and all described as "Severe joint and muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, pyrexia, headache, decreased appetite, lymphadenopathy, myalgia, arthralgia.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose given after beyond use date, patient and parent are aware on 12/29/22.
Pt recv vax on 10/22/98; on 10/25/98 pt exp fever, achiness, disturbed sleep, sore throat, productive cough, diarrhea, stomach cramps, dec appetite & headache x 1 wk
Large red circle around injection site. Very tender to the touch and warm. Was very itchy all over my body 2 days before this showed up but not itchy today.
Red raised warm swollen area at injection site and around site measuring approx 4.2 cm in diameter.  Extreme pain at injection site.
there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials). At the time of the report, PRODUCT STORAGE ERROR (there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  She states that there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials on 1NOV2021. The vaccine was stored in the refrigerator at the time of excursion and was in thawed condition. The maximum temperature reached was 51.2 degrees Fahrenheit and the maximum duration of excursion was 35 minutes. Caller states that the vaccine was administered to employees on 3NOV2021 and 5NOV2021, after the excursion had occurred.
01/17/2010 7:30 AM Rash on face. Dimished after 8 hours. 01/17/2010 7:00 PM Joint pain in wrist. Dimished after 8 hours. 01/19/2010 9:00 PM Swollen, painful with redness in joint in toe of left foot.  Diminished after 8 hours.
Following vaccination, the patient was seated. After a few minutes they approached the pharmacy counter asking to use the bathroom as they felt nauseous, and was visibly sweating, red in color. They seemingly lost consciousness, fell forward into the plastic divider, and then backwards onto the store floor, possibly hitting their head. Pharmacist alerted the pharmacy intern to call 911, and entered the store floor to assist the patient, who had quickly regained consciousness and sat themselves up. They were offered water, after which point they reported starting to feel better, and was able to make it back into a chair on their own power until paramedics arrived, and the pharmacist relayed the details of the adverse event.
Narrative:  Covid+, J&J #2, resp failure, pneumonia, oxygen. Sedated/venilator/ICU. Expired Preliminary Cause of Death multi-system organ failure Comments COVID 19 with heart kidney and lung issues, eventually made comfort care by family and expired comfortably with family present and comfort medications
12 mo F presented with multiple bruises, petechia, mild bleeding from gums and red pigmented stool x 1. Admitted for IVIG x 1.
Started getting numbness in right hand and face. Was having trouble with finding words, didn't go to the doctor until a few months later and they did brain scans and blood tests. Said there was inflammation in her brain after several tests and ruling out many different things. Inflammation progressively became worse in her brain, she had 2 brain biopsies in 2015 that came back inconclusive. Facility could not diagnose her. Inflammation still worsening by the end of 2015. Hardly able to walk anymore, can't use her right hand at all anymore, can't speak well at all either. By December 2015 was diagnosed with a brain tumor and died on 01/16/2016.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Pt recv vax on 12/15/98; on 12/26/98 pt exp fever (100), red rash most of body x 3 day; pt imp 12/28/98
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored VARIVAX (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. (2) The vaccines experienced the following temperature excursions during 6 hours of more than -10 degree celsius (C) but less than 8 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA009844: US-009507513-1703USA001136: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001139:
Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe
Expired VAQTA was administered to a patient; This spontaneous report was received from the physician's office manager, concerning a 2 year old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 19-NOV-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5ml lot # S010727 with expiration date of 26-JUL-2020, for prophylaxis (frequency, route of administration and anatomical location were not provided). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010727; expirationdate: 26-JUL-2020; 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
Mild nausea started around 6pm, 10 hours after initial dose. Chills started around 10:30pm and progressed to a 103 degree fever by 12:00am. Fever and chills persisted for the next 12-14 hours preventing me from going in to work.  Nausea became noticeable again as the chills subsided. Fever broke around 6:00pm the next day, 01/20/2021.  Significant soreness at the injection site was present almost immediately and through 01/20/2021
After an hour of injection felt a lump in my throat like I do with bee sting, whole body turned red and got nauseous
In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (Hamstring pain), PERIPHERAL SWELLING (swollen left leg) and ARTHRALGIA (Left shoulder Soreness). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (Hamstring pain), PERIPHERAL SWELLING (swollen left leg) and ARTHRALGIA (Left shoulder Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient took Percocet and had reaction afterwards.