chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 41 yoF that was transferred to Medical Center on 4/10/21 after being seen at a free-standing Emergency Department for chest tightness and shortness of breath worsening over the past week. Pt reportedly received both COVID-19 Moderna vaccines (1/24/21 and 2/26/21). Over two weeks prior to admission she was exposed to her brother who was found to be COVID19 positive. The patient stated that her symptoms started 3/30/21 and she was found to be both COVID19 and influenza positive on 4/2/21 prior to admission. She did not take COVID precautions when she was exposed to her brother. Her symptoms started with fever, chills, myalgias, fatigue, nausea, vomiting, and loss of taste/smell.  She also reported her pulse ox revealed O2 sats at 88%.  She was admitted to the hospital 4/10/21 and later discharged on 4/15/21. She was given supplemental oxygen, Remdesivir, Dexamethasone, and convalescent plasma while being admitted.
Throat and mouth swelling severe rash over entire body swelling of feet, hands, face, neck, trouble breathing.
Headache Abdominal pain Irregular menstrual cycle: usually I never have one (IUD), and I had a period the day after the vaccination and it was heavy. Chest pain
Complained of pain in left  arm right after which would be common I thought: gave MOTRIN around  one and nine pm. Woke up from sleep five thirty am with pain. Crying. By nine thirty am had fever of one hundred one point three, big red area that was hot touch.., gave MOTRIN started to form blister..went to urgent care Dx with cellulitis.. took to pediatrician was told that she has chicken pox.. needle didn't go under skin enough. On generic BACTRIM and cream for 10 days.. blister area must stay covered.. pt is contagious now.
Pt recv vax on 3/25/99; post vax pt exp swollen, red, hard, hot to tough left thigh; tx=Ibuprofen, Benadryl
Patient received Anthrax vaccine on 30 Sep 14. She stated that symptoms first developed on 01 Oct 14. She presented to the clinic on 4 Oct 14 with a complaint of adverse reaction to Anthrax vaccine. She had a softball sized, red, swollen patch on her left deltoid that was hot to touch. She denied any other symptoms.
Patient developed a red, hot circular rash about 3 inches in diameter about 6  inches below injection site. No treatment required.
Vaccinations on 1-2-08.  Mother calls 1-4-08 to report redness, swelling & "hot" at L leg (thigh) injection site.  Also reports site turning "sort of black".  Instructed mother to take child to his pediatrician today.  1-7-07 follow up with mom: child on cephalexin since 1-4-08 MD visit.  Feeling better.  Leg looks better.  MD records indicate L upper thigh redness around puncture site, redness, and 3 cm induration around puncture site.
Information has been received from a consumer concerning her 14 month old niece, with no medical history and no allergies, who on 10-DEC-2007 was vaccinated with a dose of PREVNAR (manufacturer unknown).  Concomitant suspect vaccination included PEDVAXHIB.  Other concomitant vaccine included a dose of FLUZONE (unspecified).  Two vaccines were administered in the right thigh region, and the third was administered on her left thigh.  It was reported that, on 10-DEC-2007, "When the nurse administered the vaccine, the needle went through her leg and out the other side".  The area swelled up twice the normal size.  The patient was unable to walk for two days.  The patient also experienced a fever and was crying all evening and night.  At the time of the report the patient was recovering.  It was noted that the patient was checked at a clinic.  There were no laboratory of diagnostic tests performed.  No product quality complaint was involved.  No other information was provided.  Follow-up information was reported by a nurse who stated that the patient received PEDVAXHIB and "the needle went through the other side".  Additional follow-up information was received from a physician and a Medical Assistant who clarified that the patient never received PREVNAR (manufacturer unknown) or PEDVAXHIB.  It was reported that on 10-DEC-2007, the patient received the following vaccinations:  PEDVAXHIB, Lot # 657392/1164U, right thigh, concomitant suspect therapy, PREVNAR (manufacturer Wyeth), Lot # 854015C, left thigh and FLUZONE, (manufacturer Sanofi). Lot # U2512AA, right thigh.  The physician stated that the vaccine that was injected by incorrect technique on 10-DEC-2007 was PREVNAR.  The physician stated that the patient had recovered.  Additional information is not expected.
Case number PHEH2013US016021 is an initial report received from a consumer via patient oriented program (specialty pharmacy) on 26 Jul 2013: This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. This patient was vaccinated with FLUVIRIN (batch number: unknown) on an undetermined date. On an unspecified date after vaccination, the patient experienced Guillain-Barre syndrome. No additional information about outcome, causality and seriousness was reported.
Initial report from the healthcare professional received on 16 Dec 2009: This patient had received inadvertently FLUVIRIN 0.5 ml on 15 Dec 2009 at the age of 2 years considered to be potential off label use. No further information received at the time of the report.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed flu-like symptoms. The reporter did not consent to follow up. This report 3 of 3 reported by the consumer. The consumer did not have any further information, did not consent to follow up.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. The reporter stated that improperly stored (temperature: 15.8 F and time frame: 10 hours and 75 minutes) doses of (Oka/Merck) VARIVAX (lot: L006383, expiration date: 25-FEB-2017; lot# L015048, expiration date: 29-APR-2017; lot# L019124, expiration date: 27-MAY-2017; lot# L019130, expiration date: 27-MAY-2017; lot# L023588, expiration date: 26-JUN-2017 and lot# reported as L29418, expiration date: 06-AUG-2017) (dose and route were not reported) were administered to the patients on unspecified dates. No adverse effects reported. There were no previous excursions. Additional information has been requested.
This spontaneous report as received from a physician via a field employee refers to an unspecified number of patients of unknown age and gender. No information regarding medical history was provided. On an unknown date the patient were vaccinated with GARDASIL. No concomitant medication was reported. The patients have been receiving the vaccine outside of the recommended vaccination schedule. No adverse effects were reported. No outcome ws reported. Additional information is not expected.
Pt. observed for 30 minutes after vaccine. About 1hour after leaving area of vaccine observation she began to feel shortness of breath, tightness I throat, and throat felt full. I was informed about 1 hour after these symptoms had begun to develop. I advised to go to emergency room. Taken to ED by co-worker. Spoke with patient 1-5-2021. Returned to work today. Had severe joint pain, especially in left wrist that evening.. Still has achy joints and states she is exhausted.
Noted to develop ecchymotic area with swelling to R upper thigh with no adverse events noted or reported. X-rays completed 4/13, CBC, CMP, PTT, PT INR completed 4/14. No abnormal results. Daily ASA on hold, eliquis 2.5mg bid started, frequent monitoring in place. Repeat labs 4/16 and 4/19.
Patient received Pfizer (EM9810) vaccine, while in observation for 15 minutes she began to feel paresthesia in LD. Five minutes after that she also began to feel nausea, no vomiting. Patient remained in observation for additional 15mins. Benadryl 25mg P.O was provided and patient stated she began to feel better 10 minutes after taking Benadryl. She noted feeling better when face mask was off.
Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
patient didn't feel well for 2 days after vaccines but on 4th day started developing a rash on the arms and by 6th day rash was spreading to her back and lower body . told patient contact primary care doctor to see if he felt treatment was necessary
Raised rashes after first dose and second dose. Rashes are light red/pink in color and itch.   Rashes are observed all over my body.  Typically, every third day rashes appear all over body.
About 2 minutes after vaccine administration, patient was sitting, mother witnessed her slump forward then suddenly fell forward off exam table, she hit her nose and lip on sink then slumped to the ground face down. Mother called for help, I found patient lying face forward on ground, unresponsive but breathing for about 10 seconds then became alert and able to answer questions. She had small amount of bleeding from the nares, no other signs of injury. She rested on the floor for several minutes then placed on exam table. Monitored for about 20 minutes, able to ambulate, given water and Tylenol PO.
Injection arm numb/tingly down outside of arm and into hand on side of pinky. Feels weak and numb as if coming out of being numbed.
Patient developed allergic, itchy rash with raised bumps, swollen hands and feet on 3-28-08.  Rash did not start around eyes (on Vigamox since 3-26-08).  Mother gave Benadryl.  Rash gone when seen by Dr on 3-31-08 & then recurred through April 6, 2008.
covid arm; Itches; The patiIt got bigger, raised area, and now has another red spot; Raised area; Red spot all the way around the vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (The patiIt got bigger, raised area, and now has another red spot), VACCINATION SITE SWELLING (Raised area) and VACCINATION SITE ERYTHEMA (Red spot all the way around the vaccine site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Allergic reaction to drug, Blood pressure high, Cholesterol, Hot flashes, Drug allergy (Advil - Hives), Drug allergy (Aleve- Hives), Drug allergy (Birth control pill - Pulmonary Embolism) and Drug allergy (Estrogen cream - High blood pressure). Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high, ATORVASTATIN for Cholesterol, VENLAFAXINE for Hot flashes, VITAMIN D3 for an unknown indication.  On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot all the way around the vaccine site). On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (The patiIt got bigger, raised area, and now has another red spot) and VACCINATION SITE SWELLING (Raised area). On 05-Aug-2021, VACCINATION SITE ERYTHEMA (Red spot all the way around the vaccine site) had resolved. At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (The patiIt got bigger, raised area, and now has another red spot) and VACCINATION SITE SWELLING (Raised area) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Patient's concomitant medication also included water pill.   Patient did not took any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received contains updated patient demographic details(race, height, weight), added concomitant drug (Hydrochlorothiazide), and updated other drug dose details, updated event outcomes.
weakness, poor appetite, low grade fever; COVID +; O2 on 2L NC. AKI, gental hydration, decadron. Foley Cath. 2/16 Pt more lethargic, O2 increased to 4L NC. able place pt on RA on 2/18. Failed voiding trial, will dc with foley to SNF.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 026A21A), in left arm and on 05Apr2021 as dose 2, single (Lot number: 032B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing); "Dose 1 and 2: Moderna/ Dose 3: Pfizer BioNTech" (unspecified if ongoing), notes: Dose 1 and 2: Moderna/ Dose 3: Pfizer BioNTech. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient had Anti-viral product Paxlovid (Lot number GA1190) for Treatment of COVID-19 started from 22Jun2022.  No follow-up attempts are possible. No further information is expected.
Vaccinated pt admitted overnight with covid infection. No information available on date, type, or vaccine history. Pt self reported covid vaccination
Hives that had been predominately dormant flared up that night and a week+ later continue on trunk, arms and legs and continue to today.  If not getting better will be put on steroids.
Tired 2 days; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tired for 2 days on an unspecified date. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
mild irritation 7 hyperpigmentation @ inj site on both thighs;increased fine hair growth w/in borders of hyperpigmentation;
Real sore on my joint of my right big toe. really ached. thought i had Gout but have never had that. couldn't walk on it. it was right in the joint. stayed through last night and this morning and now it is completely gone.
pt recvd vax & 2 wks following vax exp severe joint pain & dizziness; consulted a physician; lab eval 4NOV92 revealed ESR of 32mm hr, WBC count 12.6, platelet count of 460, neutrophils 6 & neg RA titer; knee pain & mild effusion; pain
Pain in his right shoulder with weakness down his arm.  Considering possible SIRVA.  He continues to have pain three weeks later, though his weakness is resolving.
Patients got doses after the 30-day beyond use date; Product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Product storage error).    This case included information of patient 13th out of 14 patients.  No concomitant product reported by reporter.  Reporter had no information about previous COVID-19 vaccination doses. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The pharmacist received a Moderna order on 15Nov2022 but accidentally put the expiration date as 10 weeks instead of 30 days. Some patients got doses after the 30-day beyond use date. Vial size was 2.5 ml. Date the vial was initially stored in refrigerator was 15-Nov-2022 and administration dates were 16-Dec-2022, 28-Dec-2022, 04-Jan-2023, 07-Jan-2023, 09-Jan-2023, 11-Jan-2023, 13-Jan-2023 and 18-Jan-2023. Vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:MASTER  CASE
fever; shaking; flu-type soreness all over; This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, tremor and flu-like aching. On an unknown date, the outcome of the fever, tremor and flu-like aching were recovered/resolved.   It was unknown if the reporter considered the fever, tremor and flu-like aching to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received Shingrix and experienced fever, shaking, and flu-type all over soreness.These events fully resolved within 48-72 hours. The vaccine was administered at a pharmacy.  The reporter believes that she was around 82 years old. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (recovered) and the outcome reported in the source document (recovered with sequel).
Apps 3? diameter hot red area on arm at  injection site, very warm to touch and lump under skin
Since having my second vaccine administered on February 3rd of this year. A few weeks after I have had issues with pain in my pinky and joints in my pinky and outer hand. I had never experienced any problems until the vaccine
Patient states that he started having lower back pain after getting 2nd shot of COvid vaccine.  Patient states that the back pain is still the same or little worse even after 4 days. Patient has been taking advil and old oxycodone prescription for management.
Approximately 10 minutes after recieving the vaccine, the patient honked her horn to call a staff member over. RN approached vehicle and the patient stated she didn't feel well. Patient appeared pale. RN sent another staff member to get water, at which time the patient stopped responding to questions. The patient remained in her car, with the seat belt on - her eyes rolled into the back of her head and she began having jerky movements. 911 was called. HR was feint and BP was not able to be felt (too low, even with manual cuff). The patient came to, after about 45 seconds. RN asked the patient her children's names and the patient talked gibberish. About 1 minute later the patient began speaking in clear sentences. 0.5mL of epinephrine were administered. Blood glucose was 123. At 1:50 we were able to get a HR of 80 and a BP of 128/100. Oxygen was 100% with 2L via nasal canula. Patient was transported to Hospital.
w/in 10mins p/vax pt reports exp SOB, h/a, & dizziness;was seen in ER & given DPH IV along w/having blood work & CXR done;was informed had an allergic rxn to MMR;no prev hx of allergic rxn to vax; c/o swelling in rt hand & arm;
Central retinal artery occlusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202200165097 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (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. The following information was reported: RETINAL ARTERY OCCLUSION (medically significant) with onset 15Sep2021, outcome "unknown", described as "Central retinal artery occlusion".  Clinical Course: Reporter stated that patient has not had a history of stroke or blood clot and after the occurrence of this a battery of stroke intervention tests were run and no other clots were found. Could the booster have contributed to the blood clot causing this permanent loss of vision in his right eye?  The lot number for bnt162b2 was not provided and will be requested during follow up.
had a systemic rash; Initial information received on 18-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 66 years old female patient who experienced had a systemic rash while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 03-Oct-2019, the patient received suspect influenza quadrival A-B high dose HV vaccine lot number not reported via unknown route in unknown administration site for immunisation.  On 03-Oct-2019 the patient developed a systemic rash after receiving a fluzone high-dose quadrivalent vaccine (rash) (latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Caller asked if it would be safe to administer a Shingrix vaccine to this patient or if it would be contraindicated based on the reaction to fluzone-high dose quadrivalent.  Action taken: not applicable.  Corrective treatment: not reported  Outcome was Unknown.