chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash in the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE RASH (rash in the injection site). At the time of the report, VACCINATION SITE RASH (rash in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included diabetes medication. No treatment medications provided
dizzy and light headed; she is in her third trimester of pregnancy 32-33 weeks; tired; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (pregnant) received BNT162B2 (COMIRNATY), administration date 10Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 10Nov2021, outcome "unknown", described as "tired"; HEADACHE (non-serious) with onset 10Nov2021, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 12Nov2021, outcome "unknown", described as "dizzy and light headed"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 10Nov2021, outcome "unknown", described as "she is in her third trimester of pregnancy 32-33 weeks".  Additional information: Clinical course: After receiving the Pfizer COVID-19 vaccine booster dose 10Nov2021, patient stated she was very tired, headache on Wednesday after the dose and this morning dizzy and light headed and just tired. Patient also stated she was in her third trimester of pregnancy 32-33 weeks.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was here today for a flu shot. Within 5 minutes, while driving away from the office she complained of sore throat and began to cough, within another 5 minutes her eyes were puffy, she became itchy and agitated, mom turned car around and returned to the office. Constitutional: General appearance: Mildly distressed., truckal itching, frequent harsh cough; Eyes: Conjunctativa/Lids: Conjunctival edema bilaterally. Upper lids red and quite puffy; Ears, nose, mouth and throat: Ears Tympanic membranes shiny without retraction, Canals unremarkable. Hearing grossly normal. Oral: Inspection of gums, lips, palate, and teeth normal. No scars, lesions, or masses. Oral mucosa unremarkable with non-inflamed posterior pharynx. Uvula midline.;Respiratory: Mild expiratory wheeze heard throughout both lung fields; Cardiovascular: Cardiac: Regular rhythm. No murmurs, rubs, or gallops. PMI not displaced. No thrill. HR 100; Skin: Eyes edematous, generalized itching but no generalized hives or angioedema; Assessment/Plan: E949.9-Adverse effect, vaccine NEC Treatment: 0.15 cc sq Epinephrine 1:100, Oral Benadryl 1 1/2 tsp, and nebulization treatment of 0.375 Albuterol. Treated, and vital signs monitored closely over a 40 minute period, she improved gradually, less eye redness, no more pruritis, and improved chest exam, and was discharged from office care, with instructions to give more Benadryl dose 4 hours after office dose, and to RTC for any exacerbation of symptoms. 1700 spoke w/Mom regarding how patient was doing. Per mom swelling of eyes have resolved as well as sore throat, cough and itching. Mom did give second dose of Benadryl as advised by doctor. I did advise mom should any sx appear such as swelling of eyes, sob, dib, sore throat, coughing to contact on call doctor immediately/911. Asked mom to call w/update tomorrow.
chills,gone sweats,gone vomiting,gone diarrhea,gone muscle aches,gone mouth sores,ongoing
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Patient's aunt reported she has had arm soreness, tender, redness that has spread as well as "not feeling well", dizziness, and loss of appetite.
On Day 5, after receiving the 2nd Moderna Covid vaccine, I began getting small red bumps on both arms. These bumps are very itchy and the bumps are in the same places on both arms. Also have itchy red bumps on abdomen, back and tops of both feet. Benadryl isn't helping.  Also had 100 degree fever, body aches and burning skin 22 hours after the second vaccine. Those symptoms lasted 15 hours.  The itchy bumps are still itching and this is Day 5.
Dizziness and Vertigo. Began upon waking and has continued throughout the day.
1544 Patient c/o sweating, difficulty talking, "lips feel taped", fingertips numb. Patient instructed to lay down, offered water, Vital signs taken, given 02 6 liters at 100%. Patient symptoms improved. VSS. Patient observed ambulating with husband at 1609
Felt like patient had the flu; swollen neck; swollen clavicle; fever; under each axillary swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like patient had the flu), SWELLING (swollen neck), BONE SWELLING (swollen clavicle), PYREXIA (fever) and LYMPHADENOPATHY (under each axillary swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like patient had the flu), SWELLING (swollen neck), BONE SWELLING (swollen clavicle), PYREXIA (fever) and LYMPHADENOPATHY (under each axillary swollen lymph nodes). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like patient had the flu) and PYREXIA (fever) outcome was unknown and SWELLING (swollen neck), BONE SWELLING (swollen clavicle) and LYMPHADENOPATHY (under each axillary swollen lymph nodes) had not resolved.            No concomitant medications were reported It was reported that after receiving the 2nd booster dose patient had fever, felt like patient had the flu. Patient had ongoing swollen neck, clavicle and under each axillary swollen lymph nodes which was ongoing. It was stated that the patient had to get a biopsy and stated it will cost a fortune. No treatment drugs were reported
anxious; emotionally fragile; fearful but not suicidal; nightmares; vivid dreams that does not go away; also has short term memory black out; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxious), AFFECT LABILITY (emotionally fragile), FEAR (fearful but not suicidal), NIGHTMARE (nightmares) and ABNORMAL DREAMS (vivid dreams that does not go away) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN HCL, Zolpidem titrate, Buproprion, AMLODIPINE BESYLATE, OXYBUTYNIN, HYDRALAZINE HCL, INSULIN GLARGINE, Earoxetine HCL, LISINOPRIL, DORZOLAMIDE, lantanoprost, GABAPENTIN, Novolin, Momethasone, Metoprolo titrate, Albuterol, DEXTROSE, DESONIDE, MULTIVITAMIN [VITAMINS NOS], Fishoil omega3, PARACETAMOL (TYLENOL), Metamusil, ACETYLSALICYLIC ACID (ASPIRINE), Tylenol simly sleep, Veequil and IBUPROFEN for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 09-Feb-2021, the patient experienced ANXIETY (anxious), AFFECT LABILITY (emotionally fragile), FEAR (fearful but not suicidal), NIGHTMARE (nightmares), ABNORMAL DREAMS (vivid dreams that does not go away) and AMNESIA (also has short term memory black out). At the time of the report, ANXIETY (anxious), AFFECT LABILITY (emotionally fragile), FEAR (fearful but not suicidal), NIGHTMARE (nightmares), ABNORMAL DREAMS (vivid dreams that does not go away) and AMNESIA (also has short term memory black out) outcome was unknown and PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Immunizations given at 10 AM. At 1005, mother complained of sight getting red. Site of MMR and Varicella; both areas around sight, red with whelp noted above site of MMR. 1025 AM Whelp gone; some redness noted at MMR site; none at Varicella site. No treatment done; just observed.
~12-18 hours after injection pt began to feel itchy with steadily worsened over the next ~36 hours.  At that point he began to have angioedema and bilateral hand swelling  and large generalized wheals. He never had difficulty breathing or swallowing. He was seen by another provider and given a solu-medrol injection followed by high, tapered dose of prednisone.   3 days after treatment pt returned to clinic and was seen by me. Swelling has resolved though he continues to have generalized urticaria. He is taking his prescription as instructed. No difficulty breathing or swallowing. Pt instructed to keep cool, continue his medication, and to f/u immediately for any worsening symptoms or concerns.
7 days following vax fever (dec 102) noted; no rash; on 27SAEP93 fever is less but still present there are no other sx of illness;
This spontaneous report was received from a physician, via a company representative, referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, frequency, lot/batch # and expiration date were not reported). On approximately May 2016, reported as "about a year ago", the patient experienced "at the injection site, vesicles (injection site vesicles) indicative of shingles (herpes zoster) that would come and go and come and go for quite some time" (unspecified dates).  The outcome of injection site vesicles and herpes zoster was unknown.   The causality between injection site vesicles and herpes zoster with ZOSTAVAX was not reported. Additional information has been requested.
heart palpitations; SOB; nausea; intermittent dry cough; headache; runny nose; extreme fatigue; Joint tenderness; malaise; muscle aches; This is a spontaneous report from a contactable other hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:30 as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6202) as an unspecified dose for covid-19 immunisation. Patient received dose for CETIRIZINE HCL via an unspecified route of administration, administered in unspecified location of administration as an unspecified dose for unspecified indication. List of any other medications the patient received within 2 weeks of vaccination: Cetirizine HCl, Olly Multi-vitamin, joint supplements. Medical history included hypersensitivity from an unknown date and unknown if ongoing known allergies: Codeine. Information was available for Vaccine Facility, Ethnicity and Race. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. On 28Mar2021 the patient experienced joint tenderness, malaise, muscle aches, extreme fatigue on 30Mar2021, heart palpitations on 03Apr2021, sob on 03Apr2021, on 01Apr2021 intermittent dry cough, headache, runny nose, nausea on 02Apr2021. The patient underwent lab tests and procedures which included echocardiogram: normal, sars-cov-2 test: negative on 02Apr2021, sars-cov-2 test: negative on 06Apr2021. He said was probably a neurological response to vaccine and prescribed a beta blocker (propanolol) to help with heart palpitations. Extreme fatigue and muscle aches lasted through 4/10, still experiencing slight SOB and heart palpitations upon exertion. Therapeutic measures were taken as Covid test, EKG, zofran, propanolol as a result of the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
tested positive for COVID-19 3 -5 days after; This is a spontaneous report from a contactable Physician. The patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot and batch number not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications and past drug history were not reported. A patient received the 1st dose, tested positive for COVID-19; 3 -5 days after, received the bamlinivimab antibody treatment, then got the 2nd vaccine dose 3 weeks after the 1st dose. It is usually recommended to wait 90 days to get the vaccine after monoclonal antibody treatment. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine, there is no temporal relation between the onset of Covid-19 and administration of vaccine.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I experienced multiple symptoms. First one very acute headache which would not go away with OTC medication. Acute joint pain in the right knee and right leg, sharp shooting pain and never had this pain before.  I also had a sore arm and turned red on my right arm, worst than normal.  Third symptoms, extreme fatigue, worse over 72 hours. In the first 24 hours, chills, like I never had before and a temperature of 97.3F. My mouth was very dry and no matter how much fluid I drank, this lasted 24  hours. I also had very awful metallic taste in my mouth.  For a 2 hour period I also had tightness in my chest in the first evening when I received the vaccine also stomach pain and no other GI symptoms.  The symptoms of longest duration, was fatigue, joint pain and acute headache which lasted 72 hours.   I consulted with my PCP the first 48 hours, advised to take extra strength Tylenol and Advil.  After 48 hours my PCP checked on me and monitored my symptoms.   I am probably 80% back to normal, my headache is still of and on and the fatigue is still there to some degree and the other symptoms have disappeared.
The patient felt feverish right after her shot, but it passed. Then about 8 hours later she became very feverish, difficulty breathing, fast heart beat, and hives. The patient felt okay by the next morning.
Within 30 sec of HPV vaccine given, pt turned pale and fainted. Pt reports she was feeling "shaking". After about 10-15 min, pt recovered completely.
Chills, body shakes, fever, fatigue- 14 hours starting 1030pm-1230pm after 415 vaccine Headache- 48 hours (starting at 1030pm after 415pm vaccine)- more severe In first 24 hours
(L) arm - red, sore, hot to touch. Width: 12 cm. Height: 10 cm.
Soreness for the next 2-3 days, then shoulder pain around injection site started to get worse, mainly at night, it has progressed considerably to almost unbearable and has been effecting my sleep, pain is now constant, reported to my PCP and was told to take ibuprofen/NSAID.  Followed up 2 weeks later and received a cortisone steroid injection, still no relief.  As of today (4/12/2021) it has not gotten any better, scheduled another visit for 4/14/2021
Improper balance; Inner ear issue like improper balance; Nausea; Dizziness; Hard time moving; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Improper balance), DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving), EAR DISORDER (Inner ear issue like improper balance) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Walker user (Using a walker to prevent risk of fall) and Contrast media allergy (Contrast dye). Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), SOTALOL, WARFARIN, CALCIUM and MAGNESIUM for an unknown indication.    On 07-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 DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving) and NAUSEA (Nausea). On 16-Jan-2021, the patient experienced BALANCE DISORDER (Improper balance) and EAR DISORDER (Inner ear issue like improper balance). On 16-Jan-2021, DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving) and NAUSEA (Nausea) had resolved. At the time of the report, BALANCE DISORDER (Improper balance) and EAR DISORDER (Inner ear issue like improper balance) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include OTC Meclizine 35 mg: on empty stomach in AM of 10th January then after 25 mg on empty stomach in AM (changed dosage 5 days ago)   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
Patient was given the bivalent booster as her first shot and should have been given the monovalent as her dose 1.
Patient was given 1st Hep B 3/9/08 and given another Hep B 3/14/08 - mother did not have paperwork that stated she had vaccines and was unsure if received any vaccines.
Numbness to right side neck and face. Swollen right side of tounge. Observation for an hour. Numbness and swelling were mostly resolved within the hour.
pt presented with drug overdose alter mental status and covid. Pt was intubated and self extubated. Pt was discharged home.
5-10 min. post FLUMIST / Varicella developed agitation, hives, flushing, lip/nose swelling Sat's stable 98-100% no resp distress required EPIPEN, BENADRYL, Prednisolone.
Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. Patients' concurrent and historical conditions were not reported. The reporter stated that unspecified patients received doses of improperly stored GARDASIL (dose, frequency, route, lot# and expiration date were unknown) on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I woke up lightheaded. I had dizzy spells throughout the entire day, starting at 6AM. I went into work late and at work I got so dizzy, I saw spots and had to rest my head for 20 minutes. This continued into the evening. If I was moving around too much, I got lightheaded. I have had continuous headaches since the 12 hours after the injection on 1/20. Around 4PM on 1/21, my chest started to feel tight. My chest has continued to feel tight since. Drinking water has seemed to help and I was actually able to sleep through the night last night. The first evening, I woke up every hour or so. Throughout the day on 1/21 I had the chills and hot flashes. I was achy all day. As far as my arm goes, it is a little sore now, but the tetanus shot was worse for soreness. Immediately after the shot, I had a shooting pain/numbness go down my left arm to my fingertips. That went away in a few hours. My shoulder/arm throbbed throughout the first night. I have had little abdominal pain in the evenings before bed.
PT. FULLY VACCINATED 2/22/21 LOT EM9810; 3/15/2021 LOT EN6198. TESTED + 8/22/2021
Information has been received from a physician concerning an 18 month old male who, post vax, on 5/9/2000, the pt experienced twitching and a temperature of 101F. He was taken to the ER. He also, kept "screaming out". It was thought to be due to the fever and the pt was treated with antipyretics and was sent home. On the car ride home, he experienced a generalized tonic-clonic seizure that lasted approximately 60 seconds. The physician "felt the child was afebrile at the time". The pt was taken back to the hospital and was admitted. At that time, the pt had no fever. He was treated with anti-seizure medication. A CT scan was performed (results not reported). It was reported "this morning the medication had worn off, and the pt had not had another seizure". The pt also experienced a generalized rash with erythematous macular that the physician noted was similar to the rash he seen after vaccination. There was no known exposure to wild-type varicella. The pt was discharged on 5/10/2000, although he had a fever of 102-103F. No further information is available.