chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/21/04- received primary spv- "flu-like symptoms" for the next few days. 5/28/04- noticed "redness" on the left side of his face, corner of his left eye, and around the groin area- redness had gotten worse throughout the day. 5/30/04- notice a rash on his chest down to his waist, both ears ("inside and out"), chin, neck and around his left eye- "scattered and itchy"-"looked like poison ivy"- his left eye started to "get swollen". 5/31/04- rashes have now spread to his right arm- pruritus worsened and his left eye became more swollen- went to the ER- given Benadryl. 6/1/04- sxs worsening- the patient was told by his Case Manager to go to the ER immediately and to obtain an emergent ophthalmology consult for his left eye.  He was also instructed to contact his Case Manager from the ER and notify his CM of the name/contact number of the healthcare practitioners who were participating in his care- in the following few hours, no calls received from the patient- multiple attempts were made to contact this patient but no calls were returned- according to the healthcare practitioner who was present during the patient visit, the patient mentioned to the physician about his hiking trip on 5/28/04 and the patient also stated that he may have been exposed to poison ivy during hiking- the Medical Director of the HC has spoken with the physician who managed this patient- according to the Medical Director, the physician stated that he (the physician) "was comfortable that this patient had no ocular involvement."  On that basis, it maybe safe to assume that this is not a case of ocular vaccinia and that the patient's symptoms are not temporally associated with the receipt of the smallpox vaccine.
Severe cold with stuffed nose  Started Dec 20 @8:00 pm Meds started on 12/24 Mucinex DM (2 tablets per day)  PseudoEphedrine Hydrochloride (6 tabs per day) All Medication stopped on 12/27
Pt received vaccine on 1/4/21 and then that night had a fever of 101.3 She found out she was a close contact to a Covid pt & tested post on 1/6/21
At the time of receiving my Booster shot, nothing happened right away. My arm was a little bit sore for a day or two, but that was it. About 4 days after my shot, I developed a sore throat which lasted for over a week. I had no other symptoms at this time, and there's a chance that the sore throat was unrelated or from the dry air. However, a few days after it ended, I started getting these horrible hives all over my body. They start as just itchy spots that seem to be caused by pressure (if I lean against something, I get itchy there). If I resist the urge to scratch them, the itchiness goes away, but if I do scratch them then it develops into raised bumps resembling hives or bug bites. This has gone on for over a week now, and allergy medication doesn't seem to help very much. I'm at a loss as to what to do.
This spontaneous report as received from a physician refers to a 64 year old female patient with hypertension and asplenia and no drug allergies or reactions. In approximately 2007, 7 years ago, the patient was vaccinated with PNEUMOVAX 23 dose 1 (lot# not reported) 0.5 ml, intramuscular in right arm. On 30-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # K010466, Expiration date March 2016) dose 2, 0.5 ml, intramuscular in right arm. Other suspect therapy included unspecified influenza vaccine administered in left arm (lot#, route and dose not reported) on 30-OCT-2014. On 31-OCT-2014 the patient called the office and stated that she experienced stiffness from the shoulder extending to the elbow of the left arm. The patient was unable to move her left arm. Reflexes were intact and no other neurological damage was noted by the physician. No treatment was given for the events. No lab diagnostics studies were performed. The patient would see a physical therapist on 03-NOV-2014 and she would also be following up with a neurologist. The physician had recommended passive range of motion exercises to the patient. The outcome of the events was not recovered. The event unable to move arm was considered by the reporter. Additional information has been requested.
pt recvd vax; exp severe swelling of arm & redness, warmth & pain & soreness at inject site;
Client reported an onset of "feeling lightheaded" while ambulating from vaccination area to observation area. The client subsequently developed nausea and dizziness following the receiving the 1st COVID vaccine Pfizer. The client notified personnel in the observation area of symptoms and laid down. She states she also developed mild chest tightness which resolved a few hours later. The client was provided a juice in the observation area. The client stated she tried to drink the juice, but spit it up immediately after. No medications were provided at the vaccination site. The client states she sought care at an urgent care immediately following departure from the vaccination site. The client states they obtained "vitals and checked my lungs" at the urgent care. The client also stated "my blood pressure was a little high." The client did not take any medication following the initial episode of feeling lightheaded and dizziness. She states her symptoms resolved about 24 hours after onset. The client stated she reported her initial reaction to her PCP and her PCP gave approval to receive the 2nd COVID Pfizer dose. Vitals obtained by RN Barberan were obtained by RN Barberan at 7:56PM were as follows HR 78 and BP 115/90. A medical consult was submitted via text message. Approval to proceed with 2nd COVID vaccine Pfizer was obtained by Summer Leal, Vaccine Operations via telephone. Client received the 2nd COVID vaccine Pfizer Lot# EW0191 at 8:24PM in the anti-gravity chair. RN Withers educated the client on s/s of anaphylaxis, when to seek EMS, 30 minute observation recommendation, and V-safe. The client voiced understanding of this. At 8:32PM the client reported nausea to EMT Bustamonte. RN Withers responded. Vitals obtained at 8:36PM were as follows: HR 78 and BP 144/100. The client denied SOB or dizziness at the time. The client removed their mask and RN Withers noted pallor on the client's face. At 8:39PM the client denied any dizziness or feeling lightheaded. Vitals obtained at 08:44PM were as follows: BP 140/98 and HR 74. The client noted mild improvement of her nausea at that time. Repeat vitals obtained at 08:54PM were as follows 142/92 and HR 78. The client reported her nausea was "a little better." At 08:59 PM RN Withers offered to call EMS to evaluate the patient. The client denied EMS. RN Withers let the client know she could seek care at an urgent care, emergency department, or monitor her symptoms at home. The client elected to monitor her symptoms at home. RN Withers reiterated when to seek EMS and s/s of anaphylaxis. The client voiced understanding of this. The client stood up from the anti gravity chair without assistance, ambulated with a steady gait unassisted, and was visualized getting into a person vehicle driven by her husband at 9:03PM.
After first dose; chills, aches, sore throat, congestion, fatigue, loss of smell and taste
Fever, temperature of 100.0 degrees blurred vision lasting three days. Only lights out lying in bed gave me relief.
Localized reaction, swelling, redness to area. Appears to be allegic reaction, mild fever.
Seen 9/3/02 had had 6-8 weeks of joint pain. He believes is related to Hep A vaccine and myalgias. Now waxs and wanes.
A nurse reported that a 45 year old female received an injection of influenza virus vaccine (manuf unk). Subsequently, the pt developed paralysis which lasted for three days. No further info was available at the date of this report. Paralysis is considered medically important (OMIC).
I got the shot my left arm. When I raised my left arm to look in the mirror, I had a black and blue line down to my arm pit. The next day, the left side of my left breast looked modeled with red and white kinda looking. THen two days later, the line that was red under my arm turned black and blue. and the model on my breast turned black and blue. The line is now gone, but the left side of my breast is now black and blue.  I see some yellowing and I think it's starting to go away.
Within the week after 2nd shot, I got very painful jaw tmj like symptoms that are not yet fully resolved and I never had before.  Pain, loss of mobility.  I also had new eye twitching in right eye that persists.
fever 101 rectal given APAP;had 2 sz approx 230AM 19SEP96 taken to ER;2wk later had 2 sz then 2wk p/that had another sz;
Case number PHEH2012US009634 is an initial spontaneous report received from a pharmacist on 04 May 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 04 May 2012, he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: A10123) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported.
Fever (98F); headache; pain on injection site on the very same night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (98F)), HEADACHE (headache) and VACCINATION SITE PAIN (pain on injection site on the very same night) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0ALLD073121) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever (98F)), HEADACHE (headache) and VACCINATION SITE PAIN (pain on injection site on the very same night). The patient was treated with PARACETAMOL (TYLENOL) on 02-Mar-2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN on 02-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever (98F)), HEADACHE (headache) and VACCINATION SITE PAIN (pain on injection site on the very same night) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 98f (Inconclusive) 98F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.
Broke out in shingles in 2 separate areas, different sides of the body. Never broke out 2 places at same time before. Areas of lesion: right buttocks and left labial. Severe pain from sciatica down both legs making walking or even standing very difficult.
At the exact moment I received the injection my vision immediately blurred and remained blurred for about 30 seconds. I thought maybe I was becoming light headed (even though never have before). I blinked  a few times and sat there for a about another 30 seconds after the blurriness stopped. I was able to walk and waited about 10 minutes before leaving the site - until the blurry feeling stopped. About a week later I started noticing my right eye would go blurry when doing everyday activities.  My left eye slightly- but always my right eye. I tried wearing blue light glasses and such until I finally decided to go to the doctor. I am a very healthy person and have never had vision problems since surgery  about 10 years ago.
Given at Dr. office Left upper arm red, swollen and painful for about 2 weeks. headaches and nausea for 1 day. After that there was and still is a deficit between triceps and deltoid muscles that looks like and indentation between the muscles. Strength and range of motion are intact. 2nd injection given 2/5/2019. Arm soreness, light headed and facial flushing that next morning 2/6/19 at pharmacy. Right deltoid. Lot#353S5. Exp:5-29-21.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient's arm had a large red circle where the vaccine was given and some bruising.  She said she wasnt having any difficulty breathing or bad pain or itching.  I recommended a cool compress, antihistamine and to monitor the area to see if it shrinks or enlarges.
Transfer from clinic where patient was attempting to receive monoclonal antibody infusion when found to be hypoxic with  SPO2 in low 80s. Upon arrival to our hospital vomited and underwent seizure like activity and lost pulse. CPR initiated with v tach.  Defibrillated, intubated, started on amiodarone drip. Developed shock and started on levophed and propofol drips.  STAT EKG showed ST elevation, code STEMI was called. Ejection fraction 15%. Started on remdesevir for covid pneumonia but stopped due to liver failure. Given dexamethasone. Developed right sided pneumothorax and developed renal failure requiring CRRT. Increasing respiratory failure with max vent settings and flolan. Family decided to transition to comfort care.
Right deltoid sore, tender to touch with a large reddened area, area 11x8cm
rash; SORE ARM; JOINT PAIN; CHILLS; COLD HANDS AND SHAKING VIOLENTLY; HEADACHE; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of RASH (rash), BONE PAIN (SORE ARM), ARTHRALGIA (JOINT PAIN), CHILLS (CHILLS) and TREMOR (COLD HANDS AND SHAKING VIOLENTLY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Food allergy (Wheat allergy), Food allergy (Barley allergy), Food allergy (Rye allergy) and Gluten intolerance.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced RASH (rash), BONE PAIN (SORE ARM), ARTHRALGIA (JOINT PAIN), CHILLS (CHILLS), TREMOR (COLD HANDS AND SHAKING VIOLENTLY), HEADACHE (HEADACHE) and PAIN IN EXTREMITY (sore arm). At the time of the report, RASH (rash), BONE PAIN (SORE ARM), ARTHRALGIA (JOINT PAIN), CHILLS (CHILLS), TREMOR (COLD HANDS AND SHAKING VIOLENTLY), HEADACHE (HEADACHE) and PAIN IN EXTREMITY (sore arm) had resolved.            No concomitant medications provided. Treatment included Naproxen and antihistamines.    This case was linked to mod-2021-029396 (Patient Link).
approx 30 mins post receiving Td pt began to exp cold, clammy sweaty sensation; became nauseated & vomited repeatedly; also blurred vision & sx of orthostasis; ? low grade temp
I received my second Pfizer/Biontech vaccine on May 1 (the first vaccine appointment was late April). After the 2. vaccine which I received in the morning around 9:30 am I started feeling extreme fatigue, muscle pain/soreness, strong headache, dizziness and my left arm hurt slightly (the arm where I received the injection. The same symptoms lastet the entire following day. The symptoms have been continuing today, Monday, and I had in addition temperature and felt nausea. I went to a pharmacy and got Advil for the headache as I am working which did not help much.
No additional AE; HCP called to report an expired dose of MMR-II that was inadvertently administered to a patient.; This spontaneous report was received from a medical assistance and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 15-JUL-2023, administered for prophylaxis (strength, lot #, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
COVID breakthrough. Patient says she tested positive at an urgent care on 2/27/22 and presented to the hospital. She has cough and sore throat.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified date in June 2017, two doses of improperly stored (due to defrost cycle) VARIVAX lot # L034372 and expiration date 08-SEP-2017 (strength, dose, route and anatomical location were not provided), were administered to the patients for prophylaxis. On unspecified date in August-2017, were administered 2 doses of improperly stored (due to defrost cycle) VARIVAX lot # M017290, expiration date 07-APR-2018 (strength, dose, route and anatomical location were not provided), were administered to the patients for prophylaxis. The temperature ranges and time frames were not provided. A data logger was involved, and no previous temperature ranges were reported. No adverse effects were reported.
Varicella rash, generalized, approx. 30 lesions developed on 12/30/00.
Period/cycle came 5 days after the second dose.  Cramping started within 48 hours of the shot along with irritability.
Pfizer COVID-19 Vaccine EUA: presents with shortness of breath for two weeks, hypoxic necessitating supplemental oxygen, found to be COVID-19 positive. Was treated with steroids and remdesivir. Discharged  to home charge medically stable.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2016, the patient was inoculated in her right arm with ZOSTAVAX (lot #, dosage and route of administration not provided) at a pharmacy, for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient presented to a physician with complaints of headaches and a raised, painful injection site, in conjunction with feelings of numbness and tingling in her right arm. The patient's complaints did not improve. Accordingly, on 12-DEC-2016, the patient returned to the physician with complaints of decreased strength, weakness, and numbness/paresthesias in her right arm. She was evaluated and diagnosed as suffering from neuralgia and neuritis of an unspecified origin. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Mother states child had seizure one time when they got home and then another seizure that afternoon. Mother called ambulance. Child was transported to hospital; child had another seizure at hospital. Mother states child is fine now and is home; was given medicines to use of another seizure occurred.
Slight pressure in  middle of  chest, slight pain that comes and goes.  Felt when sitting or laying down.
severe varicella type rash, DIC, electrolyte, abnormality;air lift to PICU @ clinic;Annual follow-up dated 02/27/01 provided no additional data
ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION; ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION; PAIN IN THE SHOULDER; FEET AND HANDS WERE SWOLLEN; FINGER TIPS STILL NUMB; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (FEET AND HANDS WERE SWOLLEN), INFLAMMATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION), SKIN DISCOLOURATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION), HYPOAESTHESIA (FINGER TIPS STILL NUMB) and ARTHRALGIA (PAIN IN THE SHOULDER) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis aggravated.   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In August 2022, the patient experienced PERIPHERAL SWELLING (FEET AND HANDS WERE SWOLLEN) and HYPOAESTHESIA (FINGER TIPS STILL NUMB). On an unknown date, the patient experienced INFLAMMATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION), SKIN DISCOLOURATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION) and ARTHRALGIA (PAIN IN THE SHOULDER). At the time of the report, PERIPHERAL SWELLING (FEET AND HANDS WERE SWOLLEN), HYPOAESTHESIA (FINGER TIPS STILL NUMB) and ARTHRALGIA (PAIN IN THE SHOULDER) outcome was unknown and INFLAMMATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION) and SKIN DISCOLOURATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION) had not resolved.            Concomitant product use was not provided by the reporter.  It was reported that Humira was not improving the symptoms. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.   The Moderna MPID was 4782589.  The reporter's causality for the events of arm, face and lips were turning purple due to too much inflammation. feet and hands were swollen, finger tips still numb, Humira was not improving symptoms, pain in the shoulder Adalimumab Solution for Injection was not provided  Treatment information was not provided.
Patient received the Pfizer monovalent vaccine when she was meant to receive the Pfizer bivalent vaccine. Pfizer drug safety report reference number: D3VH0R6L
LOW GRADE FEVER; KNOTS IN STOMACH; SORE ARM; SWEATING PROFUSELY; LIGHTHEADED; FEELING TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sweating profusely. On 08-APR-2021, the subject experienced lightheaded. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced feeling tired. On 09-APR-2021 17:00, the subject experienced knots in stomach. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100 degrees. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating profusely, and lightheaded on 08-APR-2021, and knots in stomach on 09-APR-2021, was recovering from sore arm, and low grade fever, and had not recovered from feeling tired. This report was non-serious.
Received first dose of Pfizer COVID vaccine the evening of Thursday, 16Sep2021 with no issues. Friday afternoon/evening (17Sep 2021) ankles swollen (L>R) and legs felt heavy. Elevated legs with pillow. Saturday, 18Sep2021 ankles slightly swollen (L>R) but now notice calves/lower legs are swollen. Legs feel heavy and tight.
swelling & itching from shoulder to elbow; also low grade t100; tx as cellulitis w/warm compresses;