chrisvoncsefalvay/vaers-outcomes huggingface dataset:
next morning p/vax, bumps on tongue sore on lips & back of throat-face was swollen chills & weakness, neck stiffness & pain; mouth was very painful, unable to sleep lasting over 2 wks;
Two days after booster started getting hives. Itchy small clusters of hives. Took antihistaminesand used cortisone cream. So far lasted five days.
Patient due to receive Moderna Booster (0.25 mL). Patient received full dose (0.5 mL).
Dizziness/lightheadedness upon rigorous exercise. Continued for several hours after exercise.
Aproximately 15 minutes after vaccine administration client c/o, tingling of her upper lip and a hive forming above her left eyebrow. Shortly there after she began to feel diaphoretic.Client took benedryl and laid down on a clinic bed for about 30-40 minutes, at which time she felt better and was taken home by a friend.
I have a large red swollen area and extreme pain at the injection site.  Additionally, my head and body ache and it feels like I am running a low grade temperature.                                 Your system does not allow me to enter Bioport was unable to provide you the name of the manufacturer.
Flu Like Symptoms, Fever, sore throat, aches, fatigue, runny nose, sneezing. Took OTC meds, missed 1 day of work, Did not see medical treatment.
Patients received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant medication was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up was received. Narrative was updated.
Expected normal soreness of (R) arm. Starting the day after was unable to reach above my head, to remove a loose fitting shirt. Pain upon range of motion. This is pain which interferes with ADL. Please investigate as there is no other cause or trauma I can think of.
Parent heard "strange" sounds coming from baby's crib, went to check on her and observed her having seizure. Took baby to ER, blood work was done, no other tx given
Vaccines. Flu like symptoms, 101 fever, body aches. Chills. Started 7 pm 9/19. 9/19 at 12:00 got shots. 9/21 - Urticarial red rash.
pt recvd vax & stiffen up; gritting teeth; quivering, blank stare & cold to touch;
patient who had a total body rash; This spontaneous report was received from a registered nurse referring to a 9-week-old male patient. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were unknown by the reporter.  On 13-FEB-2008, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) as prophylaxis and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) the indication was unknown by the reporter ( for both vaccines: concentration, number of administered dose, vaccination scheme frequency route and anatomical location of administration, lot number and expiration were unknown by the reporter).      On 13-FEB-2008, the patient had a total body rash (rash). It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if any treatment was given to the patient.     The outcome of rash was reported as resolved.   The causality assessment between both suspect therapies and the aforementioned event was not reported.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. On 08-AUG-2015, the patient vaccinated with improperly stored dose of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
14 hrs after receiving the second dose I had what I would compare to as a vertigo reaction. The room spun while I was sitting down, no fast movement, no quick turn of my head, just severe room spins. I also had a severe headache within a few hours after that, but, I expected it. It has now been2 and a half full days and I am still experiencing the dizziness, not as severe, but, noticiceable.
Let arm very red and inflamed. Warm to touch, Knot under skin at injection site. Redness goes all the way down to the elbow.
This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine administered to a patient) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 032B21A) for COVID-19 immunization. No medical history reported. On Sep 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 30, 2021, patient administered expired product (expired vaccine administered to a patient). On Sep 30, 2021, administered expired product (expired vaccine administered to a patient) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Originally when the reporter looked-up the expiration date for the Moderna COVID-19 vaccine, it stated it was good until Oct 5, 2021. After administration when the reporter looked-up the expiration date, the website stated the vaccine expired on Sep 24, 2021.
Patient presented to emergency department on 10/21/2021 following a fall and generalized fatigue. He was found to be COVID-19 positive. His symptoms were relatively mild during admission. He was treated with dexamethasone and albuterol inhaler. He was discharged to home with home health care on 11/2/2021. He was readmitted on 11/4/2021 for increased weakness and rehab placement. He was treated with dexamethasone and supplemental oxygen and discharged on 11/9/2021 to a rehab facility.  Patient expired on 11/15/2021.
I, pharmacist accidentally gave Mr. a Pfizer covid shot which is 2 days past expiration date .
Patient received the first dose of Janssen vaccine lot # 1822809 Exp 03/07/2022 at 0923am while sitting on a chair inside a laundry mat during the event. At 0940am the client stated I feel dizzy. The client reported a history of vertigo, hypertension, hypoactive thyroid, arthritis, fibromyalgia, neuropathy, asthma, and COPD. She said feeling dizzy was normal for her but said it was worse than usual and began after receiving the vaccine. Pharmacist gave the client a juice.  The client was alert and oriented x 4. Her skin was warm and dry. At 0944, her vitals were BP 130/87, RR 18, SpO2 100%, HR 71. The client said, I'm feeling a little better. Pharmacist gave the client an apple squeezy snack. At 0949am, the client's vitals were BP 138/83, RR 12, SpO2 100%, HR 78. At 0950, the client stood up suddenly. She said she had pain when sitting for too long. The client stated, I feel fine right now. Pharmacists referred the client to true care to follow up on her health care and educated the client to see a doctor if her symptoms returned.  The client started packing her things and preparing to walk away. Her gait was steady. Pharmacists also educated the client's friend who was with her to call for help if symptoms returned. At 0957am, Pharmacists left the area and continued with patient.
At the injection site - it was a little sore after about three days. A week after vaccine, it hurt to touch my eye - I thought I had pink eye but it wasn't itchy. I treated it with hot compress. I did that at least 3 times a day for two days. It was really swollen  - lower eye lid of my left eye - right in the middle of it - on the inside of the eyelid I can see a bump in the middle of it and so I was kind of pushing on my eye a little and it looked like fluid was coming out of my tear duct and so I put a hot compress on it often and it's getting a little better each day. I'm 70% better.
This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with PROQUAD (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Swelling lips, sore in mouth (similar to a canker sore), and a "bite" on back left side (resembles a spot that she had when she had shingles in February 2020 on right side of back)
This spontaneous report was received from a 74 years old female patient regarding herself. The patient reported that last year she received sulfamethoxazole/trimethoprim and had a toxic reaction from this. She had spots with the similar appearance of age spots all over her body. The patient was in bed for three days and had lost 8 pounds in 3 days. The patient's current condition included leukemia. The patient's medical history included atrial fibrillation and prolapse irregular heartbeat. Concomitant medications included PIRAM/HCPZ, metoprolol, simvastatin (manufacturer unknown) and TOPALA TARTOR. On 01-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot # and route not reported) and immediately started to have some adverse experiences. The patient experienced red welt at the injection site and was not feeling well. On 02-OCT-2012, the red welt was as big as a "50 cent coin" and was raised in a few spots, but it was better than yesterday. The patient now had a fever of 99.7 and was having some heart irregularity. The patient has leukemia and this was contraindicated for this medication ZOSTAVAX. Patient also provided the pharmacist's information who had administered the ZOSTAVAX shot to the patient. No treatment was given. Patient had not sought medical attention. No laboratory tests were performed. The outcome of the events was reported as recovering. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Nurse reported that on 25-MAR-2014 the patient was inadvertently administered with an expired PNEUMOVAX 23 (lot # H010916, expiration date 15-FEB-2014) intramuscular which also had underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Severe Fatigue as of 09/18/2021- Continuing to increase daily 09/20/2021- increased fatigue and tachycardia with PVC?s 10/04/2021- Syncope incident with seizure to follow. Overnight hospital monitoring. EKG, echocardiograph, blood tests, 21 day heart monitoring.   Continuing symptoms of- Foggy brain Forgetfulness  Body Achy when I lay down or sit.  PVC?s Continuing  Weight gain Skin itchy/ dry Lower/ left side abdomen cramping  Hair loss Fatigue  Wake up in the middle of the night having to urinate. Having to urinate more often than normal. Inflammation/ painful skin
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In approximately 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 09-NOV-2016, the patient was treated by a physician for a rash, which was diagnosed as shingles, and post herpetic neuritis. The patient was prescribed VALTREX and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
severe chapped lips; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (severe chapped lips) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (severe chapped lips). At the time of the report, CHAPPED LIPS (severe chapped lips) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
AFTER 15 MINUTE WAITING PERIOD PATIENT STATED HER ARM FELT VERY ITCHY AND LIKE IT WAS SWELLING, ALSO FELT A LITTLE LIGHT HEADED. GAVE 25MG BENADRYL AND MONITORED ADDITIONAL 30 MINUTES.  TOOK BLOOD PRESSURE, PULSE, AND HAD PATIENT STAND  WITH ME PRIOR TO LEAVING. BP AND PULSE NORMAL, PATIENT COHERENT AND ABLE TO STAND WITHOUT DIZZINESS, LIGHTHEADED, OR FAINTING.
fever; slept a lot; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a day after receiving Shingles vaccine, the patient experienced fever and sleep excessive. On an unknown date, the outcome of the fever and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the fever and sleep excessive to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received his/her shingles shot 3 days ago.  The patient stated that, need to take easy for 2 days.  The patient had fever the first day, slept a lot and after everything was fine. The patient would receive his/her second shot at the beginning of July. The patient was very happy because he/she received the shot. The patient stated that, he/she needed to protect himself/herself. Additional Supportive Information: The follow up would not possible as no contact details were available.
SOB x 2 weeks -- > presented to ER for evaluation on 3/23/2021 and found to have a PE
Had Pfizer immunization 10/08/21. Had bunionectomy on 12/2/21. Developed Complex Regional Pain Syndrome following the surgery which started 12/4/21.  I had severe burning pain, numbness, tingling, sharp cutting sensation over incision, swelling, purple discoloration, sensation abnormalities, clammy skin, range of motion problems in left foot. Went to Pain Clinic MD and was diagnosed on 2/1/22. Underwent lumbar sympathetic nerve block, high dose Prednisone, physical therapy. Will be having a second nerve block tomorrow and an EMG on 3/4/22. I have seen reports that CRPS can be activated with the COVID vaccine so wanted to report this.
Got the covid booster and flu shot on 10/13/2021 at 11am and by 8pm was in ER diagnosed with heart attack.
Initial soreness at injection site, rash/redness developed on 3/6/21 (2 inch radius around injection site--initially itchy which has subsided--but redness continues).
I had pretty severe pain in my left arm a few hours after the vaccine. I started to take TYLENOL and it did not relieve the pain immediately. I ended up not sleeping at all. I continued taking the TYLENOL and it started to get better. My arm remained sore about a week. I have completely recovered from the pain at this time.
DTAP administered in left deltoid; on 09/27/2003-the upper arm was hot to the touch, swollen; tender; on 09/28/2003, it had spread down to the elbow, more swollen, hot. A follow up report received 10/31/2003 adds: On 9/28/03 we went to ER, received IM antibiotics which within 12 hours decreased swelling, redness.
Patient said that the evening after receiving the vaccination he started feeling very anxious, having shortness of breath from time to time as well as sweating profusely. This is his first covid vaccine he has received. This came and went over the next few days. on 10/16/22 he visited the emergency room for his symptoms and was prescribed hydroxyzine 25mg. Even after the hydroxyzine he is still having the same bouts of anxiety. Today 10/18/22 he came to the pharmacy to report his symptoms. He also contacted his primary care physician to let them know as well.
The day after the 2nd vaccine, I began having an unusual period only 15 days into my cycle.  It lasted 5 days.  Then, on my normal menstrual cycle schedule, 12 days later, I began having another period which is again unusual in length and amount.
A non-serious spontaneous report of administration of FLUMIST to an 18-month-old was received from a registered nurse in a country concerning an 18-month-old subsequent to the administration of FLUMIST. This case is submitted accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Relevant medical history and concomitant medications were not reported. On 02-Nov-2009, the patient was administered FLUMIST. There was no adverse event associated with this vaccination administration at an inappropriate age, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  18-Feb-2010.
Pt developed cellulitis. Went to see doctor and was started on antibiotics. If no improvement pt may need to be giving iv antibiotics.
Severe Headache, body aches, fever, tiredness  starting about 4am 4/3.  most symptoms gone by 4pm same day. headache lasted until going to sleep that night about 8pm. Symptom free when i woke up 4/4 at 7am.
See attached. Chills, itching, nausea, sweats, diarrhea, bil. UE swelling.
About one day from first injection, I am having headaches I would describe as mildly sharp intermittent pains in right temple.  I may add more information to VAERS to the extent that I exhibit further adverse effects.  I am self reporting for the purpose of accurately memorializing adverse effects.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Diagnosed with Kawasaki Disease 6.15.07 after hospitalization.  09/24/2007 MR received for DOS 6/15-18/2007 for DX of Persistant fever elevated for > than 7 days.  Erythema Multiforme.  Kawasaki Disease. Infant presented with 5 day hx of fever, irritability, rash on arms and legs, exudative pharyngitis Strep (-), and poor po intake with decreased UO. Admitted for dx of Erythema multiforme and dehydration.    Tx with IVIG and ASA.  D/C home afebrile with improved po intake.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain at left arm) 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 MYALGIA (muscle pain at left arm). At the time of the report, MYALGIA (muscle pain at left arm) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Relevant concomitant medications were not provided. Treatment information was not provided.
itching a lot at injection site; arm is sore; arm is swollen; red/big round circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching a lot at injection site), VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (red/big round circle) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ZINC and DAPAGLIFLOZIN for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching a lot at injection site), VACCINATION SITE PAIN (arm is sore), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (red/big round circle). At the time of the report, VACCINATION SITE PRURITUS (itching a lot at injection site) and VACCINATION SITE PAIN (arm is sore) outcome was unknown, VACCINATION SITE SWELLING (arm is swollen) had not resolved and VACCINATION SITE ERYTHEMA (red/big round circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include, blood pressure medications, and pill for swelling in the legs. Treatment information included application of alcohol to affected area.
4-5" erythematous rash around inj site, warm to touch, little induration, no fever