chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports experiencing Bilateral mostly upper extremity swelling later in day after receiving TDAP vaccine accompanied by joint pain making it difficult to move & hold things. Reports some facial swelling. Bump at injection site but no redness. Swelling decreasing by 4th day (9/15 when patient notified OB office).
Fever of 101.7 since the day of shot fever began around 5pm  severe body aches, headache, nausea, chills accompanied the fever.
Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD. Concurrent medical conditions included Immunocompromised. Concomitant products included OXYGEN for an unknown indication.    On 12-Apr-2021 at 12:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 12-Apr-2021 The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No treatment information were reported.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death
06-08-10 Arm sore within 1 hour of getting vaccine-Next day 06-09-10 came home from work at 9AM with fever 102.5 and called HD. Left arm sore-hot-swollen the whole upper arm- at 500 went to ER due to dizzy and fever 102.5 and felt bad all over. ER did EKG and CXR, labs with thyroid-gave IV fluids, ibuprofen and was told was from shot at HD and Strep test neg. 06-10-10 went to work with fever.
Expired 5 doses had been given at that point.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given at that point.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given at that point.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given at that point.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the Moderna vaccine was pulled from freezer on 16-Dec-2021. The Beyond use date of 15-Jan-2022 was printed in red and taped to the top of the boxes.  On 26-Jan-2022, the staff brought it to attention that it was still in the fridge and expired-5 doses had been given at that point. On 27-Jan-2022, the remaining sites checked. All other clinics found to have some error of not noticing the beyond use date. Moderna contacted and report filed. The beyond use date added to the daily Covid usage report. Staff re-education provided.  On 31-Jan-2022, Moderna responded- revaccination not required, but VAERS needed to be completed.  It was also reported that the patient was notified of error and that a repeat vaccine was not required. The patient denied any adverse effects.  The patient had no known drug allergy.  No treatment information was provided.
red raised area appeared w/in 12hr on rt hip area is 11.5m x 6cm;pt denies pain;T98.7 sx went away on 2OCT988;
Large >10 cm oval area of edema & erythema (L) lateral aspect arm with 1-2 mm vesiculation in center. No fever. Treated with MOTRIN. Local care & cephalexin r/o cellulitis.
I developed 3 cold sores on my upper lip. I have had them before many years ago but thought this vaccine might have triggered something and you might want to be aware. Back when I first starting getting cold sores, I got very sick.  The doctor at the time told me I had herpes simplex 1. It's not something I'm worried about.  I'm treating it with abrevia and it is responding very well. No other ill affects were noted other than a sore arm.
Dizzy, chills, nausea - came on suddenly (7 days after shot) and lasted about 4 hours.
Fever and seizures fever to 103 in ER convulsion at home-to ER no known sz activity.
pt recvd vax; devel severe local rxn of redness at inject site; also exp fevers & body aches;
Information has been received from a medical assistant concerning a female with no known drug allergies who on 01-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot no. 659962/1740U) 0.5ml via intramuscular route. Site of injection was not reported. The patient developed red ankles and feet with minor swelling after administration of her first dose. On an unspecified date the patient was recovered. The patient sought unspecified medical attention via telephone. No additional information was reported. Additional information has been requested.
patient was administered an improperly stored dose of MMRII; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 03-APR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S006048, expiration date 27-FEB-2020, for prophylaxis (dose, strength, frecuency androute of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent.    On an unknown date, the  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine was stored at a temperature of 47.3F for 14 minutes, no previous temperature excursions were reported. Digital data logger was involved.
patient received her COVID vaccine elsewhere (unknown) - she presented to our Emergency Department on 4/8/2021 with complaints of hives and redness to arms and legs.
Muscle pain; Joint pain; Feeling dizzy/dizzness; Unwell; Swollen lymph nodes; Swelling of throat; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 05Sep2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications from an unknown date for an unknown indication and unknown if ongoing. On 06Sep2021, the patient experienced muscle pain, joint pain, feeling dizzy and unwell, swollen lymph nodes, swelling of throat, dizziness and weakness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, joint pain, feeling dizzy/dizzness, unwell, swollen lymph nodes, swelling of throat and weakness was not resolved at the time of report.
Patient was vaccinated with the COVID-19 vaccine on 1/20/21 and 2/10/21, so was fully vaccinated when he tested positive for COVID on 8/17/21.
This case was reported by a nurse and described a patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). The nurse reported that several patients were non responders, however, subject identifiers were not provided. Medical history included renal failure (cause not specified requiring hemodialysis). On an unspecified date before July 12 2005, the subject received the 3rd dose of Engerix B. Approximately two months following the third dose of Engerix B, on an unspecified date on or before 07/12/2005, a hepatitis B surface antibody titer was negative.
red inner and outer arm (progressive); swollen inner and outer arm (progressive); warm arm (progressive); painful to touch arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red inner and outer arm (progressive)), PERIPHERAL SWELLING (swollen inner and outer arm (progressive)), SKIN WARM (warm arm (progressive)) and PAIN IN EXTREMITY (painful to touch arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Heart disorder and Hypercholesterolemia. Concomitant products included ETANERCEPT, LISINOPRIL and DIPHENHYDRAMINE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ERYTHEMA (red inner and outer arm (progressive)), PERIPHERAL SWELLING (swollen inner and outer arm (progressive)), SKIN WARM (warm arm (progressive)) and PAIN IN EXTREMITY (painful to touch arm). At the time of the report, ERYTHEMA (red inner and outer arm (progressive)), PERIPHERAL SWELLING (swollen inner and outer arm (progressive)), SKIN WARM (warm arm (progressive)) and PAIN IN EXTREMITY (painful to touch arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 29-MAR-2021 treatment for the events was taken with Benadryl and ice pack, self administered by the patient. Patient's past history also includes multiple joint replacements.
itchy; red; There is like a sensation of being sting; not sleeping; now is worst; severe rash on all the body/ started with a rash in the thorax, abdomen, breast, and then on the arms; really big bumps/smaller bumps on the neck/the bumps are not on the face but they are on the ears/swollen with huge bumps; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (really big bumps/smaller bumps on the neck/the bumps are not on the face but they are on the ears/swollen with huge bumps), PRURITUS (itchy), ERYTHEMA (red), PARAESTHESIA (There is like a sensation of being sting) and INSOMNIA (not sleeping) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced SWELLING (really big bumps/smaller bumps on the neck/the bumps are not on the face but they are on the ears/swollen with huge bumps) and RASH (severe rash on all the body/ started with a rash in the thorax, abdomen, breast, and then on the arms). On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (red), PARAESTHESIA (There is like a sensation of being sting), INSOMNIA (not sleeping) and VACCINATION COMPLICATION (now is worst). The patient was treated with PREDNISONE on 16-May-2021 at a dose of 1 dosage form. At the time of the report, SWELLING (really big bumps/smaller bumps on the neck/the bumps are not on the face but they are on the ears/swollen with huge bumps), PRURITUS (itchy), ERYTHEMA (red), PARAESTHESIA (There is like a sensation of being sting), INSOMNIA (not sleeping), VACCINATION COMPLICATION (now is worst) and RASH (severe rash on all the body/ started with a rash in the thorax, abdomen, breast, and then on the arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow-up information received on 11-Jul-2021 narrative translation updated.
10 days post MMR #1 and TDAP #1 client felt OK in am Monday. Then in afternoon started vomiting all thru Tuesday 2/19/08 had diarrhea and noted spots in her throat on that day.  Still feeling very weak.
Double vision and couldn't focus; Slept for over 30 hours; Bad arm pain; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208 6/21) via an unspecified route of administration in the left arm on 13Mar2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar 2, obsessive-compulsive disorder (OCD), anxiety, depression, sensory processing disorder and insomnia. The patient had no allergies to medications, food, or other products. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR), gabapentin (MANUFACTURER UNKNOWN), eszopiclone (LUNESTA) started on an unknown date and was taking for close to an year with no issues for sleep, omeprazole (MANUFACTURER UNKNOWN) and patient had been on unspecified sleep medication for 7 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient had some bad arm pain. Starting on 15Mar2021 at 04:00 and also on 16Mar2021, the patient slept for over 30 hours and those were her days off. On 16Mar2021, when she did manage to stay awake for 6 hours she had double vision and could not focus. She had to take off on 17Mar2021 as well. The patient stated it was real worrying thing. On 30Mar2021, the patient slept for 18 straight hours, woke up showered and still felt asleep again after only being awake for 3 hours. No one seemed to have any information and the patient was pretty sure when she would go to sleep on the day of report at night, she would sleep for 20 hours again as that was her day off. The patient had never slept for more than 12 hours before. The patient stated that she had been on sleep medication for 7 years and eszopiclone cannot be blamed as she had no issues with it. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events bad pain in arm, slept for over 30 hours and double vision/couldn't focus were not resolved. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 13 year old male patient. The patient's historical condition included wrist pain. The patient's had no concomitant medication or drug reaction/allergies. On 07-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot #: M024261 with expiration date 30-JUL-2018 (route was not reported). Then, on 02-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M032650 with expiration date 31-MAR-2019 (route was not reported), both therapies as prophylaxis. On approximately 16-DEC-2016 (reported as "approximately 2 weeks after the vaccine was administered"), the patient had complaint of slight itching (injection site pruritus) with a ring like lesion (injection site reaction). The patient did not receive treatment for the injection site pruritus or the injection site reaction. The outcome of injection site pruritus and injection site reaction was reported as unresolved. There was no product quality complaint (PQC) involved. The reporter did not assess causality between the injection site pruritus, injection site reaction and the use of GARDASIL 9. Additional information has been requested.
Evening of injection, one week later and 6 months later face became extremely red and burning and felt like it was going to blister Since injection felt muscle ache at injection and in specific part of bicep near crease of arm off and on
pain in shin bone/hurt from left ankle to hip; could not walk or stand on foot; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in shin bone, could not walk or stand on foot, hurt from left ankle to hip.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) pain in shin bone, could not walk or stand on foot, hurt from left ankle to hip.  Treatment details included Tylenol, Morphine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in shin bone, could not walk or stand on foot, hurt from left ankle to hip was unknown.
1 (one) day after vaccines rec'd, pt developed, swelling and warmth to (R) thigh. Mom using TYLENOL for pain, and cool compress as directed. On day 2 child returned to office for evaluation, continued to have swelling, warmth and painful to walk on (limping).
Developed an allergy - like skin rash on thighs buttocks and arms and extremely red cheeks. refusing to eat and cranky. Doctor completely dismissed possibility of immunization induced allergy, rather suggesting a "suddenly developed allergy" to the formula he's been taking from birth. Sound strange!
Pt recv vax on 11/13/97; on 11/20/97 pt exp red, raised area of vax site-LA
PATIENT EXPERIENCED MILD UNILATERAL HIP PAIN AFTER 1ST DOSE, RECOMMENDED BY PROVIDER TO GO AHEAD AND GET 2ND DOSE. AFTER SECOND DOSE PATIENT EXPERIENCED BILATERAL HIP PAIN AND WAS TOLD THERE WAS SEVERE INFLAMMATION IN BOTH HIPS THAT REQUIRED A BILATERAL HIP REPLACEMENT.
I was fine after the vaccine, no symptoms. I went to a doctor in Jan for a biannual Check out. The doctor did not like what she heard; he she sent me for EKG, after reding it he sent me to a Cardiologist. I am wearing a heart monitor for another 2 weeks; it is 4 weeks monitor. I have an appointment with the doctor at the end of April to get results.
Administered 11/19/07 at 1500. started itching on arms at 1700. By 2100 had hives whole body even on scalp. Took 25mg Benadryl PO went to bed. 11/21/07 Woke up swollen lt lip and lt cheek. No edema at site lt deltoid, swollen area numb and tingling. No throat or resp problems at all. Lt side of face and lips still swollen at 0930.
attempted to inject but most of the medication leaked out; This case was reported by a physician via sales rep and described the occurrence of wrong route of administration in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 5th October 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 5th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the physician. The age at vaccination was not reported. The physician stated that nurse at the office attempted to inject Rotarix into a patient, most of the medication leaked out instead of the oral route, which led to wrong route of administration. The physician also stated that it was unknown whether any was successfully injected into the patient. The reporter consented to follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 31st July 2019) for prophylaxis. The patient's past medical history included respiratory disorder (had a history of respiratory issues). Concurrent medical conditions included immunocompromised. Concomitant products included SHINGRIX. On 9th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 22nd July 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received the first dose of SHINGRIX on 2nd May 2018 and the 2nd dose of SHINGRIX on 9th July 2018 at 1:30 PM and she went to an urgent care on 22nd July 2018 and was diagnosed with shingles. The patient indicated that she was immunocompromised and had a history of respiratory issues.
Chills; Fever; Throwing up everything; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fever and throwing up everything.  The patient's medical history was not provided.  No concomitant medications were reported.  On 30 Dec 2020, approximately three days prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient experienced chills, fever and throwing everything up. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events chills, fever and throwing up everything was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Tired the first day of the shot, exercised to keep it moving but felt rundown. Arm hurt for a couple days after, like a normal shot, then went away. 1 week to the day I leaned on my arm and felt intense pain, looked down and it was very swollen with a red center. It?s hot to the touch, looks filled with fluid but also firm. Hurts to do anything with that arm and I am completely drained of energy. I?m about to fall asleep typing this.
Onset myalgia/joints shoulders, elbows, wrist, hips, back, knees, ankle, fingers. Headaches, neck pain. 12 hr after injection-Had 10 cm x 8 cm erythema (R) upper arm at site of Injection - afebrile (H/O portugese man o'war multiple stings 8/24/05)