chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant concerning a male patient of unknown age. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. On 18-JUL-2017, the patient was administered VARIVAX (lot # M049126, expiration date 15-DEC-2018; dose and route unknown) reconstituted with sterile diluent (dose, route, lot # and expiration date unknown) to prevent chickenpox. On 20-JUL-2017, the patient experienced a "full body rash". The medical assistant reported the patient was seen by physician on an unspecified date in 2017, who treated the rash with an unspecified amount of "witch hazel". The medical assistant reported that the unspecified parent of the patient called the office "five days after being seen and stated the rash was gone". The causality between the event and VARIVAX was unknown.
Complained of a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Complained of a headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002521A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Complained of a headache). At the time of the report, HEADACHE (Complained of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment information was not provided.  First Moderna Covid-19 vaccine expiration date is not provided. Patient received the Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle and received her vaccine at a Pharmacy. Patient provided permission for Safety to contact her.  Patient prefered to be contacted via telephone.
Following hpv vaccine (along with meningitis shot) my daughter started having black out episodes later EEG results came back abnormal indicating seizure / epilepsy which she NEVER had before. Other neurological symptoms include: frequency of episodes getting progressively more often, Occasional numbness of face Tingling of arms head aches following seizures
Right arm 2nd shot injection site burning  and throbbing pain and spreads throughout whole arm into arm pits and fingers.  Only goes away with pain medication.  Intermittently happens  and last 30min or more until meds start working. Also increased  standing heart rate. 60 to 84.
in the following order: extreme fatigue--sleep, until 07/19 zinger sensation travelling up both sides of her brain to the point it was frightening her--07/19 resolved vicious headache, heart pounding starting 7pm 07/16 ensuing anxiety, high pressure in head, 07/16 evening swollen hot flash, 4" diameter red rash---feverish, extremely pain
Patient called 02/08/2021 at 0800 and reported a severe rash on his right lower/mid back, appeared within the first 24 hrs. post admin of 1st dose which was at 11:00 AM on 02/05/2021.  Patient stated he noticed that rash began to appear around 0900 on 02/06/2021. described rash as small ?pimple? like bumps, raised, itchy, x 2+ days. Patient forwarded a picture of the rash. Patient states he took no medications (oral or topical) to relieve symptoms. Prior to ending phone call at 0825 on 02/08/2021, patient states rash remains with raised pimple like bumps and that rash seems to be contained to same initial area of right lower mid back.  Stated rash continues to be slightly irritating and slightly itchy. Does not feel that he needs medical attention at this time.
polyarthralgias developed suddenly, shortly after administration of second dose of COVID-19 vaccine. Prior to, had no history of RA or any other autoimmune diseases.   Swelling, arthritis on hands and feet, worsened stiffness in mornings that last 20 minutes and has persisted since 5/15/21.  Pertinent physical exam findings: Tender Joints: Right- 1st cmc  2nd & 3rd mcp  3rd and 4th pip in right Carpi ulnaris tendon pain on right Subtalar joint  Left:  2nd and 4th pip Subtalar joint (L worse than R) esp on inversion. Pes anserinus pain   Swollen: Right: 2nd and 3rd MCP  Left: 3rd and 4th PIP  Subtalar swelling and tenderness. Synovitis Worse on left than right  MTP squeeze negative on left and right foot  Treatments: currently on Ibuprofen 400mg bid prn for pain
an hour after injection dizziness, nausea and numbness in the arm of injection. About an hour and a half after injection left side of face felt tingling and numb. The feeling was similar to the affects of dental numbing. Chills and joint pain started about 2 hours after injection and were relieved by taking Advil. At 7am the next morning I had severe stomach cramping and diarrhea. My whole body ached and my muscles and joints were sore. I had full body chills coming in waves and severe nausea. I had diarrhea throughout the day with severe sharp stabbing burning stomach cramps and pain. These symptoms lasted throughout the day. Everything I ate caused severe stabbing burning cramps in the stomach and lower intestines and immediate diarrhea. I had strong bile diarrhea several times yesterday and I have had bile colored diarrhea several times today 3/25 as well as the same stabbing sharp burning stomach pain. The symptoms of body aches and chills have gone away and lasted about 36 hours after the shot but I still cannot eat, and I have bile just pouring out of me. I had my gallbladder removed 2.5 years ago. The stabbing burning pain after eating or drinking feels like the pain I had prior to removing my gallbladder. I am afraid to eat anything because of the burning pain, cramps and diarrhea.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient came to pharmacy and stated that his doctor looked at his medical history and said he can get a COVID vaccine. Answered questionnaire and stated no allergies to anything. Gave pt the vaccine, and then patient told us that he had history of Guillain-Barre Syndrome. Gave patient cold water. Patient requested some table salts and 2 tabs of 25mg diphenhydramine. Patient refused Epipen and calling 911. He sat for at 45 minutes to an hour before leaving. He said he was feeling okay when leavin
15 minutes after administration of Pfizer Covid19 vaccine, client complaints of slight nausea. Nausea continued. 30 minutes after administration, became very nauseated, chest tightness, tingling lips, tingling tongue, skin pale, and tip of nose purple in color. Assessed by Dr., onsite doctor. Orders received to give Epinephrine and Benadryl 50mg/ml IM and send to Emergency Room for monitoring. Epi-pen given in right thigh. Benadryl 50 mg/ml given left deltoid IM. Informed spouse to take patient to Emergency Room immediately. Phoned patient @ 4:40pm. States she is currently at  Emergency Department. States feels no worse than before, but they were planning to monitor her for at least another hour.
Left ant thigh with 2x3 cm area of erythema. No induration, no warmth, no pain, superficial papular lesions noted. No discharge. Warm compresses, benadryl prn
On the morning after the 2nd injection, about 09:00, I started experiencing flu-like symptoms: muscle aches, then I was feverish and sweated heavily, then I felt lethargic and craved sleep.  I slept heavily. I experienced these symptoms for three days, from 4/20/2021 until 4/22/2021.  Today is 4/23/2021 -I have muscular soreness in left arm / injection site. I also ache and have a low- grade head-ache.
Patient presents with itching skin and red rash to her chest shortly after getting her first dose of Moderna COVID-19 vaccine. She denies a history of allergic reaction to prior immunizations, but has had itching skin and rash with allergy shots.  She denies SOA or swelling in her throat, lips or eyes. Patient was treated with Benadryl, solumedrol and lactated ringers, monitored in office for 2 hours before being sent home. Patient was recovered within 24 hours.
Post vax, symptoms occurred during series of shots and have continued to persist. Symptoms include: fatigue, joint & muscle stiffness & aching (neck, shoulder blades, shoulder /elbow, hip & hamstrings) and an ear ache which I've gone to my doctor 2 times and still persists. First Anthrax was given on 1/30/00 lot #FAV031 (R) arm. Pt adds that sxs are primarily (R) sided. Pt adds that sxs began w/ 1st Anthrax VAx & have worsened w/ each of the following 2. No further Anthrax following the 3/12/00 dose.
Patient is a 65 yo female from home with a history of complicated ESBL E. Coli urinary tract infection, nephrolithiasis, s/p stone basket removal of stone May 2020. DM, HTN, GERD, osteroarthritis, who presented to the ED complaining of AMS.  The night prior to presentation, she went to sleep with a friend staying over, and this morning the friend noted that the patient was not acting appropriately. She then called EMS, and on arrival the patient had a temperature of 101.1F.  She needed 2L NC. This patient was recently evaluated in the ED on 6/06, where she was diagnosed with right-sided pyelonephritis. She was sent home on cefpodoxime and Motrin.  During this current hospitalization, patient was found to be COVID positive on 6/26/21 with RLL pneumonia and E. Coli ESBL complicated UTI. She did not have a prior diagnosis of COVID. Last COVID PCR test on 6/6/21 was negative.
enter a booster for a patient age was not approved by FDA; I spoke with patient mother no reaction no medical condition
No additional AEs; Caller reported expired dose of PROQUAD was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  Information regarding the patient's medical history, concurrent conditions, and past drug allergies or drug reactions were not provided. Concomitant medication included sterile diluent (0.7 milliliter (mL), lot # W025272, expiration date reported and stablished as 04-OCT-2023).  On 19-APR-2023, the patient was vaccinated with an expire dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection 0.5 mL, subcutaneously (lot #U031563 confirmed to be a valid lot number with an expiration date reported and stablished as 06-APR-2023) administered as prophylaxis (strength and anatomical location were not provided) (expired product administered). No additional adverse event (AE's) was reported (no adverse event).
Local rash, hot skin, lump underneath skin, bruising  3 days after, patient stated that it was healing  so no treatment was necessary
still red; itching on injection site.; cluster hives 2" wide on injection site; rash on injection site; A litte sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (still red), VACCINATION SITE PRURITUS (itching on injection site.), INJECTION SITE URTICARIA (cluster hives 2" wide on injection site), VACCINATION SITE PAIN (A litte sore arm) and VACCINATION SITE RASH (rash on injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (A litte sore arm). On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching on injection site.), INJECTION SITE URTICARIA (cluster hives 2" wide on injection site) and VACCINATION SITE RASH (rash on injection site). On 19-Jan-2021, the patient experienced RASH ERYTHEMATOUS (still red). At the time of the report, RASH ERYTHEMATOUS (still red), VACCINATION SITE PRURITUS (itching on injection site.), INJECTION SITE URTICARIA (cluster hives 2" wide on injection site), VACCINATION SITE PAIN (A litte sore arm) and VACCINATION SITE RASH (rash on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information and no relevant concominant medications were reported
Started out with vomiting then became unstable and unsteady while walking and standing. Woke up in at 3 Am screaming and crying saying that there were fish and snakes and bugs on the bedroom floor. Also started to say that there were bugs under his skin biting him. Pupils were huge and it was as if he was on LSD. The hallucinations finally stopped around 4 Pm. But still experiencing the unsteady movements and continues to walk into things and a rash had developed around his mouth and vomiting occasionally.
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips]  with chills on and off. My face became little puffy and  swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night.  All my symptoms resolved by 01/19/2021 noon.
had a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (had a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine.) outcome was unknown.            No concomitant medications were provided by the reporter. It was reported that  the patient and her husband had a sore injection site arm after receiving their primary series of the Moderna Covid-19 vaccine. No treatment information was provided by the reporter.   This case was linked to MOD-2022-559051.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Follow-up received and included no new information.
Patient is complaining of severe pain and swelling in the arm from shoulder to elbow.  Patient has tried icing arm since yesterday evening.  Patient is going to contact PCP to have additional guidance.
The evening of immunizations started with leg warmth and fever to 101 F. Then developed eye crossing and stiffening of arms/legs/back. Admitted to hospital had lumbar puncture, labs, urine done all negative, antibiotics x 48 hours. Symptoms resolved after initial evening. 11/5/07-record received for DOS 10/12-10/18/07-DC DX: Fever episode most porbably due to immunizations. Three days prior to admission developed fever and swelling of left thing, rolling her eyes and question of apnea. Temp in ED 100.4.
tested positive for Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Contact Information Updated
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   Previously administered products included Covid vaccine.   On an unknown date, the patient received RSV vaccine and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving RSV vaccine and FLU VACCINE (NAME UNKNOWN), the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 28-SEP-2023 This case was reported by the patient via interactive digital media. The patient got the RSV shot and Flu shot and had sore arm for a couple of days. Patient felt that it was better to did, then being very sick or in hospitalization, racked up huge medical bills. Patient did not get the new booster shot for Covid. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.
Nasuea , chills, headache, joint pain, site red swollen, fatigue, stomach upset, sinus  issues
Patient received Pfizer Vaccine at approximately 1430 and was in observation area. At approximately 1435  observer stated that patient started to c/o  dizziness and became pal.. Patient maintained LOC. Emergency measures implemented. Patient was place on oxygen,  vital signs taken, EMSA called. EMSA present and evaluated patient. Patient was able to leave clinic site after evaluation.
On Tuesday (07/27/21) 11 hours after vaccination administration patient woke up around 11:00pm with heart racing, weakness and fever of 103. The following morning (Wednesday 07/28/21) her symptoms continued and she contacted her doctor, they instructed her to take ibuprofen alternating with tylenol for the fever. By noon that same day she was having trouble breathing and heart rate was high, between 140-150, her temperature continued to spike, her chest was tight, and she was feeling nauseated and started vomiting. Her oxygen level was in the 80s at that time, according to at  home pulse oximeter. At this time she went to the emergency room. At the ER Dr.  decided to admit her into the hospital. She was then put on oxygen and given breathing treatments 3 times a day. She remained in the hospital until Thursday. She was released at 5:30pm on 07/29/21. She is no longer reporting issues breathing but her oxygen levels variate when she lays down. She also reports a knot at the injection site. All other symptoms, the heart racing, tight chest, and fever have subsided.  She has an appointment with her primary care physician,  today to follow up regarding her adverse reaction.
Very sore left arm.  Headache.  Body aches. Tired.  Lasted 1-1/2 days
2 days post vaccine developed flat blotchy mild red rash to arms/legs and torso. C/O mild itching with some relief with Benadryl. 8/20 - reported rash resolved.
Heavy menstruation/bleeding beginning hours after receiving the second dose of vaccine. This happened in the middle of my cycle AND while on oral contraceptives. I am currently on day 8 of a heavy menstruation and concurrent oral contraceptives.
1900 t103, mom reported jerking like was going to have a sz; put in carseat & had sx enroute to clinic; seen by MD w/ear infect dx; ? temp @ that time;
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced death. The reporter stated that, "Johnson & Johnson Vaccine killed my sister". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220245790 -COVID-19 VACCINE AD26.COV2.S - Death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
testicules crumps; little pain most in sitting position in his both testicules; left side testicule still hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (testicules crumps), TESTICULAR PAIN (little pain most in sitting position in his both testicules) and TESTICULAR PAIN (left side testicule still hurt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE SPASMS (testicules crumps), TESTICULAR PAIN (little pain most in sitting position in his both testicules) and TESTICULAR PAIN (left side testicule still hurt). On 15-Apr-2021, MUSCLE SPASMS (testicules crumps) and TESTICULAR PAIN (little pain most in sitting position in his both testicules) had resolved. At the time of the report, TESTICULAR PAIN (left side testicule still hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. Upon in internal review on 04-AUG-2021, the age was corrected to 35 years
Doesn't find the vaccine effective; Doesn't find the vaccine effective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Doesn't find the vaccine effective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.