chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 times) and immunosuppression (undefined immunosuppressed disease). On 22nd June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 23rd June 2018, the patient experienced fever blister, lip blister, chills and oral mucosa blister. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the fever blister, lip blister, chills, fever and oral mucosa blister were unknown. It was unknown if the reporter considered the fever blister, lip blister, chills, fever and oral mucosa blister to be related to SHINGRIX. Additional details were provided as follows: Approximately 1 day after receiving SHINGRIX, the patient developed a blister on her lip, which was described as a fever blister. One day after vaccination, the patient experienced chills and blisters inside her cheeks. The physician prescribed an unknown antiviral and the patient symptoms had improved a bit.
Patient received vaccination at clinic and was in the waiting area for the 15 minute monitoring time. About 5 minutes into the waiting time, patient said he was getting light headed. It was noticed he was taking deep, sharp breaths causing his mask to go in his mouth. We switched him to a chair with arms and asked him to remove his jacket and called 911 as a precautionary as the breathing pattern was not improving.  EMS arrived to ask the patient how he was feeling and he said he had a dry mouth and was thirsty. At this time, it was aout 15 minutes after the vaccination. Patient refused transport and asked for water. I asked EMS if that was advisable now that he declined transport and it was beyond the 15 minutes. EMS was still near the patient. Patient was provided water and was able to remove his mask to drink and was much more coherent afterwards. He stayed in the pharmacy area about 20 minutes. He was asked to have his wife drive, which he refused.
pt recvd vax; 4 hrs later,had fever of 103;was shakey & unable to walk;mom gave apap q 4 hrs for 24 hrs;15dec94 in eve,had t 106.3;to er; adm to hosp for 1 day;
Reports Left Deltoid area soreness/pain with movement, edema, redness, hard lump and tenderness at injection site. Scarring of skin at injection site.
Subsequent to the pt receiving one dose of varicella virus vaccine live in 1995, laboratory values in 1999, indicated that the pt did not seroconvert. Additional information has been requested.
JAN2-HEADACHE, JAN 3 RIGHT SIDE OF TONGUE BECAME NUMB, AND JAN 4 RIGHT SIDE OF MOUTH BECAME NUMB, RIGHT EYE PAIN WITH TEARING,  NOTICABLE DROOPING RIGHT SIDE OF FACE, MINIMAL ACTIVE MOVEMENT, FLUIDS DRIBBLED OUT OF RIGHT SIDE OF MOUTH WHEN DRINKING LIQUIDS, EVALUATED BY PA ON 1/5, DIAGNOSED WITH BELL'S PALSY, STARTED ON VALACYCLOCIR 1 GM THREE TIMES A DAY AND PREDNISONE TAPER BEGINNING WITH 60 MG X 5 DAYS AND TAPERING DOWNWARD
Bells Palsy. numbness in hands and less. no motion in face. eye cant blink. further evaluation is needed.
Skin iritated, shed after a few days(similar to sun poisoning) on wrist of injection arm.; Skin iritated, shed after a few days(similar to sun poisoning) on wrist of injection arm. Specifically where fitbit band is; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Apr2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, moderately high LDL cholesterol, allergy to nutmeg and bell peppers. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and generic multi-vitamins (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. On 28Apr2021 the patient experienced skin irritated, shed after a few days (similar to sun poisoning) on wrist of injection arm specifically where patient's Fitbit band was. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event skin irritated, shed after a few days (similar to sun poisoning) on wrist of injection arm specifically where patient's Fitbit band was, was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Increased frequency of menstrual cycle  and bleeding heavier after completing second dose.  Also experiencing headaches and nausea.
I visited the hospital?s ER for dog bite treatment. They prescribed Tdap vaccine and antibiotics. The first night after the vaccine I woke up several times at night grasping for air, like my body forgot to breath on its own. When I woke up in the morning my chest muscles, back muscles-all muscles around my chest were stiff and hurting like I?ve been lifting bricks all night. It was very scary, I didn?t know if I will make it through the night but I was too weak to get up and drive myself to the hospital again. Next day I felt dizzy and weak and spent most of my day in bed. On the third day symptoms cleared. Soreness in my arm lasted about 5 days.
This is a spontaneous report received from a contactable pharmacist from a sales representative. An 8-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Well-controlled asthma" (unspecified if ongoing); "Constipations" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR oral; MAGNESIUM OXIDE. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; NAUSEA (non-serious), outcome "unknown". Additional Information: Events took place after use of product. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever 103 degrees F about 7-8 hours after flu shot. Patient had shakes, nausea, headache. Patient went to the ER and was released after being given something for fever and Potassium tablets.
Swelling and tenderness on right side of face along jawline in front of the ear. Resolved after 48 hrs Kw/cool compresses.
Patient reports nosebleeds from the left nostril starting the day after vaccination that has became more frequent as the days has went by.
Hard Lump,Lump increased in size; Pain; Redness,Redness became larger; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness,Redness became larger), VACCINATION SITE MASS (Hard Lump,Lump increased in size), SWELLING (Swelling) and PAIN (Pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ERYTHEMA (Redness,Redness became larger) and SWELLING (Swelling). On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Hard Lump,Lump increased in size) and PAIN (Pain). At the time of the report, ERYTHEMA (Redness,Redness became larger), VACCINATION SITE MASS (Hard Lump,Lump increased in size), SWELLING (Swelling) and PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial report received from a consumer (the patient) on 22 August 2013. A 38-year-old female patient had received a dose of Rabies vaccine (manufacturer unknown) (batch number, route of administration was not reported) in the left deltoid on 17 August 2013. On 17 August 2013, the patient had received first dose of IMOGAM vaccine (batch number, route and site of administration not reported). The patient had no illness at the time of vaccination. The patient had medical history of gall stones, varicose veins and sensitivities. Concomitant medications were not reported. On 17 August 2013, after vaccination the patient developed cold sensation up her arm, spread to across chest and teeth was chattering, heart was beating fast, achy muscles in legs and felt more sleepy. On an unspecified date, EKG (Electrocardiography) was done, the results of which was reported as 'ok'. Corrective treatment was not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
vaccine did not work for her because she contracted COVID-19 3-4 weeks after being fully vaccinated; vaccine did not work for her because she contracted COVID-19 3-4 weeks after being fully vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "vaccine did not work for her because she contracted COVID-19 3-4 weeks after being fully vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: If covid tested post vaccination: Yes.  Clinical course: It was unknown if treatment was received. Patient did not had covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Approx 10 min after immunization administration, pt experienced dizziness, pallor, weakness.
Right sided facial pain that resembled sinus infection pain; Lot of bleeding at injection site after the vaccine; Soreness at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of FACIAL PAIN (Right sided facial pain that resembled sinus infection pain), VACCINATION SITE HAEMORRHAGE (Lot of bleeding at injection site after the vaccine) and VACCINATION SITE PAIN (Soreness at injection site) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced FACIAL PAIN (Right sided facial pain that resembled sinus infection pain), VACCINATION SITE HAEMORRHAGE (Lot of bleeding at injection site after the vaccine) and VACCINATION SITE PAIN (Soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FACIAL PAIN (Right sided facial pain that resembled sinus infection pain), VACCINATION SITE HAEMORRHAGE (Lot of bleeding at injection site after the vaccine) and VACCINATION SITE PAIN (Soreness at injection site) 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.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added vaccine information (site of vaccination, expiry date) updated.
pt recv vax 11FEB97 & 21JAN98 pt devel chickenpox described as a number of lesions on the chest & scalp;
Swelling and tenderness to left arm at injection site from injection on 1/12 through to 1/16 causing discomfort preventing him from attending school/function as usual. Swelling was the size "slightly bigger than a golf ball and hard" as per his mother's report.
Local reaction on left arm, pain, swelling, bright brightness, traveling down the arm. Vaccine given on 6/15/16. The patient still has red swollen area around her elbow. The site of injection is better but sore but swelling is traveling down and feels hot and sore.
Sore upper arm. Red ring around injection site. Tender, itchy, raised skin around injection site.
Information has been received from a health professional concerning a 7 yr old Caucasian female, with no known allergies, who on 02Jul98 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 1547E). There was no illness at the time of vaccination. On 03Mar05 the pt experienced rash upon visit consistent with chicken pox. No relevant diagnostic tests or lab studies were performed. Subsequently, on 13Mar05, the pt recovered. No additional information is expected.
Arm pains (wrists, fingers, elbows). SOB when sprinting across street or singing.
This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown) On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (dose, route and lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
12/6, I started having severe diarrhea, continued for 10 days. I went to my local doctor, had several tests, and he referred me to a Gastrologist, and because my sister had died of Pancreas Cancer, he wanted to check my pancreas enzymes, and the result showed that they were very  low; by then we were moving to a specialist, on the 3rd week of February (maybe the middle of February), when I got the results, I was referred to a high risk pancreas clinic, and I will have 5-7 days evaluation .
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 86-year-old female patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. At the time of the report, the outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Client presented at her scheduled appointment time to receive his 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported she developed a rash to her lower left abdomen about 1 week after administration of first Pfizer COVID vaccine. Client reports the rash is still present 2 weeks later. but has decreased in visibility over the last two weeks. Client denies associated itchiness, pain or spread of the rash. Client reports she followed up with PCP.
Swelling on right side of face occurred 24-48 hours after injection. Feelings of anxiety of unknown origins 24 hours after injection. Soreness at the injection site.
Tiredness, body aches, discomfort in lungs, brain fog (15 days, acetaminophen)
Patient states that on 4-10-21 she developed a severe pain in her right knee. Patient states that the pain radiates from her thigh to her knee and sometimes down her leg. Feels a tightness in her leg and knee, No noted swelling of discoloration of the area.
Pt recvd rubella vax on 7AUG91 & on 19AUG91 pt exp pain, tingling & numbness in hands;
11/4/21 Patient was tachypneic and short of breath intially on presentation to the ED. Patient was started on Bipap for increased work of breathing. ABG with Bipap showed 7.46/33/434 and bipap was discontinued. CXR showed biliateral interstial infiltrates with mild increased venous congestion. CTA chest was done that showed no PE, trace right side PE, bilateral interstial infiltrates. Patient taken for cath, no findings of occlusion. elevated troponin found to be 2/2 likely myocarditis.  11/4/21 Cath showed no significant change from previous cath 2016.  Total occlusion of LAD, LCX, RCA.  Patent LIMA to LAD.  Collaterals from LAD to LCX and RCA.LVEDP 33 (Lasix Given) Patient most likely has COVID-vaccine related myocarditis. High dose steroids with Solumedrol IV 500 mg daily for 3 days, followed by Decadron 6 mg daily for 10 days. Tocilizumab 400 mg IV once. Admitted to ICU. 11/10/21 Discharge Summary: 79M PMH ischemic CM, CAD s/p CABG, HTN, HLD, BPH, SSS s/p pacemaker placement, who pressented about 2 days after receiving the moderna booster complaining of SOB and chills. He initially required BIPAP due to increased work of breathing and then improved. Initial troponin 85 but then uptrended to 16000 over the next 12 hours. Pt had no chest pain. EKG with no ischemic changes. Heart cath done which was unchanged from 2016. Pt thought to have a covid vaccine induced myocarditis with elevated inflammatory markers following recent booster for COVID (moderan) he was started on high dose steroids with improvement in his inflammatory markers and troponin. CTA done on admission negative for PE. TTE with LVEF 35-40% adjusted on heart failure therapy. he was weaned from supplemental O2 during hospital course and completed course of antibiotics d/t concern for superimposed PNA. He clinically improved with reduced shortness of breath and increased exertional capacity. He was stable for discharge on medrol dose pack for steroid wean to follow up with primary care and cardiology
pt recv vax 9OCT95 & devel redness & warmth to the inj site;no tx necessary;pt recovered;
Pt received Pfizer booster at 3:03pm, she reports symptoms started 5 mins after injection. C/o swollen soft palate, noted min tongue swelling. Blood pressure and HR elevated (173/106, 144). Epipen administered by COVID RN  to L outer thigh at 3:16pm. Pt transported to ED via wheelchair at 3:18pm.
Patient reported at 1112. Self reported as feeling woozy, "i think it's anxiety, it started as soon as they gave me a shot". 0 CP, 0 SOB, 0 throat tightness. 0 PMH. Allergies to pollen. VS 98%, P 50, BP 144/100, R 16. patient provided water and snack. Patient feeling better and repeated BP at 149/86. Patient had a driver to drive home.
No additional AE; reporting a temperature excursion; This spontaneous report was received from a nurse (also reported as medical assistant) and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 05-FEB-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), recombinant human albumin (rHA) (lot # S015962, expiration date: 23-MAY-2021 and with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025608, expiration date: 18-AUG-2021); (strength, dose, frequency, route of administration and expiration date were not eported for both) both 1 dose for prophylaxis. No adverse effects were reported. According to the reporter, the temperature excursion was 16.7 degrees Fahrenheit for a time frame of 1 hour on 09-NOV-2020 (reported as 09-NOV-2021), with a previous temperature excursion 11.8 degrees Fahrenheit for a time frame of 1 hour on 06-NOV-2020 (reported as 06-NOV-2021), which was not detected by a digital dta logger.
Right arm cellulitis, treated with antibiotics, anti-inflammatory and anti-histamine meds.  Full recovery, went to American Mission on 12/10/99
Information has been received from a health professional concerning a 64 year old white male who on 10/25/00 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent 1531J. It was noted that the pt received a 1st dose of pneumococcal vaccine 23 polyvalent in Oct/1995. On 10/25/00, he also received a 3rd dose of influenza vaccine (Fluzone U0428AA). On 10/27/00, the pt developed right arm cellulitis which extended to the elbow. The pt also experienced right arm swelling, redness and tenderness. The pt was prescribed 875 mg, twice daily of Augmentin. The pt subsequently recovered. The reporter indicated that the pt's experience was considered an "Important Medical Event". Two additional pt's had a similar experience following exposure to pneumococcal vaccine 23 polyvalent 1531J. No further information is available.
Pt received Covid-19 vaccine at 1300. After no reportable symptoms for approximately 2 hours, reported back to immunizations for additional vaccine. After administration of last vaccine, pt leaned head back (pt was seated), eyes rolled in back of head, and appeared pale and diaphoretic. After a few seconds, pt regained consciousness. Pt continued to rest with legs propped up and cold compress on neck. VS were taken following event: BP 115/80. SPO2 93%, T 96.8, R 16. Pt reports hx of "passing out" with blood draws and previous vaccinations. Provider visited with pt and was okay to leave facility.
Some fatigue, muscle stiffness a few hours after injection Swollen, painful lymph nodes under L arm 3 days after injection; gone approximately 11 days later Redness, swelling, itching at injection site 6 days after injection; gone approximately 7 days later Only treatment was applied cold compress to injection site
Moderna COVID-19 Vaccine eua very sore muscle in upper left arm.  injection was very high, almost in shoulder.  can barely raise my arm  It hurts and feels heavy.
Initial report received from a healthcare professional on 25 September 2012. A 52-year-old female patient, whose medical history and concomitant medications were unknown, received a dose of FLUZONE (lot number: UH731AB) intramuscularly in the left arm on 12 September 2012. On 12 September 2012, the patient developed soreness that was radiating down her left arm since the vaccine given. Corrective medications and laboratory investigations were not reported. At the time of this report, the outcome of the event was unknown. Follow-up information was received from a healthcare professional on 26 December 2012. Based upon the new information, this case has been upgraded to serious. Treatment included diclofenac 75mg twice daily and cyclobenzaprine 10mg at bedtime. As of 21 December 2012, the issue was still not resolved. The patient stated it aches like a toothache all the time. Concomitant medications included calcium and aspirin. Outcome was not recovered. List of documents held by sender: none.
Complained of itching at injection site at approximately 2:00PM, hives appeared at approximately 2:30 PM
Event: Low Platelet count. Treatment:  Received radiation therapy and blood infusions  Outcome:  Death
Chills, pain behind eyes, fever, body aches, nausea, vomiting, diarrhea, chest restriction, bloating, fatigue