chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of rhinorrhea (a runny nose), oropharyngeal pain (really bad sore throat), got COVID-19, general symptoms (pretty mild symptoms) and really bad headache in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 02SJ202A) for COVID-19 immunization. No medical history reported. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 28, 2021, patient experienced rhinorrhea (a runny nose), oropharyngeal pain (really bad sore throat), got COVID-19, general symptom (pretty mild symptoms) and really bad headache. On Feb 4, 2021, rhinorrhea (a runny nose), oropharyngeal pain (really bad sore throat), got COVID-19, general symptoms (pretty mild symptoms) and really bad headache resolved. Diagnostic results: On Jan 28, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-089411 (patient link).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild, Additional Details: Patient received vaccination around 12:35 pm and fainted within 1 minute of administration. Pharmacist remained with patient throughout entire episode. Patient first fainted, then began mild stiffness and mild epileptic episode that lasted about 30 seconds. She complained of lightheadedness after recovering conciousness, and remained under pharmacist supervision for 1 hour prior to going home.
paralysis of left side of face which is symptomatic of Bells' Palsy. This lasted three days. Main question now is should she receive the second dose on May 2 ?
Information has been received from a licensed nurse practitioner referring to a 24 year old female patient. There were no drug reactions/allergies reported. The patient's medical history and concurrent conditions were not provided. On 18-APR-2016, the patient was vaccinated with MMR II, intramuscular (dose, frequency, lot number and indication not provided). There were no concomitant medications reported. On an unknown date in April 2016, the patient was found to have low rebeola titers. She also had blood test and result was not reported. The outcome of viral titre decreased was unknown. There was no product quality issue (PQC) involved. Additional information has been requested.
Approximately 5 minutes post immunization, the patient reported feeling dizzy and faint.  We made sure the patient was sitting and provided water for hydration.  I monitored her breathing throughout the process.  Breathing was never fully labored, but the patient asked to lay down as she became more progressively faint.  EMS was called to evaluate the patient.  Epi was never needed by the patient.  Her blood pressure dropped to 80/60 per the EMS reading.  The patient refused transport to the hospital and regained her senses.  The patient's husband was called and he arrived to provide transportation.
Outcome :  patient died  Cause :  cardio respiratory arrest  Had previously tested for any heart problem but his heart was in excellent conditions
Redness and swelling of entire upper arm. Continued to enlarge, was treated for skin infection after 3 days.
This spontaneous report was received from a 66 year old male patient with coronary heart disease regarding himself. Patient had no drug reactions/allergies. On 03-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route unspecified). There was no concomitant therapy. On 04-DEC-2012, after receiving ZOSTAVAX, the patient experienced muscle/joint pain. He did not seek any medical attention. No treatment was provided. No laboratory tests were performed. The outcome of muscle/joint pain was unknown. The relatedness for muscle/joint pain was unknown for ZOSTAVAX. Additional information is not expected.
6 days after receiving the vaccine, I had pretty crazy itching at the injection site. The site then became red, inflamed and warm to the touch.. The itching went away after about 36 hours. The redness and swelling lasted about 5 days.
Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022; HCP was not aware of any symptoms for any patient after the vaccine was given; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022).    No concomitant medication was reported.  On 08-Jul-2022, the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medication was reported.
Undergone several temperature excursions and may have been administered to patient; No adverse event; vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Undergone several temperature excursions and may have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 2:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 22-Sep-2022 at 2:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Undergone several temperature excursions and may have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Undergone several temperature excursions and may have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patient).    Concomitant medication information was not provided.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No treatment information was provided.
no additional AE information provided; the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 10-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot number: 1660112, expiration date: 18-OCT-2020 (strength, exact dose and frequency were not provided) orally for prophylaxis. The suspect vaccine was exposed to a temperature above 47 degrees Fahrenheit (52.1 degrees Fahrenheit) for a duration of 15 minutes. There was a previous temperature excursion reported, at a temperature above 47 degrees Fahrenheit (55 degrees Fahrenheit) for a duration of 21 minutes. Data logger was involved. No additional adverse event information was provided.
Information has been received from a 64 year old male with high blood pressure and shingles with post herpetic neuralgia (PHN) and a history of stent placement "2 stents for 3 years" who in approximately October 2007, was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included NORVASC and PLAVIX. The report was as follows: when patient was 28 years old he developed the shingles and then the shingles came back after that. He then developed PHN after developing the shingles and extreme back pain. Approximately 14 months ago after receiving the vaccine, his back pain went away, and then for the last two weeks his lower back pain started to come back. No further information is available.
Facial rash (it appeared like eczema); Irritable; This non-serious spontaneous safety report was received by a partner on 22-JUL-2021 and forwarded on 26-JUL-2021 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event of facial rash (it appeared like eczema), however assessed the event of irritable as related to Vaxelis.   Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 22-JUL-2021 and forwarded to UBC on 29-JUL-2021 and on 22-JUL-2021 and forwarded to UBC on 02-AUG-2021.   No new safety information was provided. Both reports had a different GPV number.  Further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by a partner on 12-AUG-2021 and forwarded to UBC on 13-AUG-2021.  No new safety information was provided.  Further information is expected.
Site of vaccine became red, warm to touch, with pain and itching on 2/21/2021 about 8:00PM. Took Tylenol and applied cold compress.  Woke from sleep about 3:00 AM the next morning itching in  all over both arms (all over), face, and eyes. Took 1/4 of a 25mg Benidryl tab and maybe 30 min later went back to sleep. Symptoms were still present the next day and I did not feel well. Took more Benadryl 25mg tab every 4 hrs and symptoms were gone the next day (Tuesday).  Monday, 2/22/2021, had a virtual appointment with a physician and spoke with her about this reaction.
After the second vaccine only there were the following symptoms: ? injection site pain ? tiredness ? severe headache ? severe muscle pain ? chills ? severe joint pain ? fever (101F) ? nausea ? feeling unwell ? arm pain (first 10 hours)  All symptoms stopped at 5 am on Sunday (in 30 hours after they'd started). No treatments were taken, except for fasting, water, and sleeping. Information about painkiller (ibuprofen or acetaminophen) was controversial and no painkiller was not taken, as I was scared to lose the effect of the vaccination.
reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; drunk/dizzy feeling; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced large golf ball or softball sized welt, hot to touch, swollen at the injection site. The patient experienced drunk and dizzy feeling. This case is 1 of the 4 linked cases, reported by the same reporter.
Headache, dizziness, sweats,  could not eat,  could not get off couch.
It is unknown if the patient received the full vaccine.  At the end of the box, it was discovered that there was a single vial of diluent left over.  This indicates that one of the dry components was not reconstituted with the correct diluent.
Pt recvd vax 25JUL92 & approx 11 days later pt devel generalized erythematous vesicular eruption on the buccal mucosa; pt also exp nausea, myalgia, malaise & posterior auricular adenopathy;
Information has been received from a nurse concerning a female who was vaccinated with a dose of GARDASIL (lot # not available).  The reporter stated that the patient had not eaten prior to receiving the vaccination, and fainted for 3 minutes after receiving the shot.  The patient sought medical attention and saw the physician.  At time of report, the patient was recovered.  Additional information has been requested.
pain started in shoulder, didnt go away and started radiating to back and fingers. hands get numb even when holding the phone. steroids did not help
This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced low grade fever. On an unknown date, the patient's body temperature was recorded as 102 degree F. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter and also linked to the case US2018GSK186373, reported for the same event. Lab Comments: On an unknown date, the patient's body temperature was recorded as 102 degree F.
This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetting things at work/ Foggy brain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interrupted her daily activities), LYMPHADENOPATHY (Swollen lymph nodes in the neck and groin area), CHILLS (Bad chills) and FATIGUE (Very tired) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 059E21A) for COVID-19 vaccination.     The patient's past medical history included Hormone replacement therapy (Patient currently is on hormonal replacement therapy.) since an unknown date. Concurrent medical conditions included Endometriosis, Chronic UTI, Chronic migraine and Sulfonamide allergy (Sulfa allergy).   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetting things at work/ Foggy brain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interrupted her daily activities), LYMPHADENOPATHY (Swollen lymph nodes in the neck and groin area), CHILLS (Bad chills) and FATIGUE (Very tired). At the time of the report, MEMORY IMPAIRMENT (Forgetting things at work/ Foggy brain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interrupted her daily activities), LYMPHADENOPATHY (Swollen lymph nodes in the neck and groin area), CHILLS (Bad chills) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were reported.  After second dose, patient started to forgetting things at work and have foggy brain which interrupted daily activities. The patient had bad chills, very tired, swollen lymph nodes in the neck and groin area.
took flu shot once and got very I'll! Never took it again; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who experienced took flu shot once and got very i'll! never took it again while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious took flu shot once and got very i'll! never took it again (illness) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (took flu shot once and got very I'll! Never took it again).  At time of reporting, the outcome was Unknown for the event took flu shot once and got very i'll! never took it again.
Shortly after the vaccination I got chills, a fever, body aches and developed a rash on my face, neck and abdomen area which caused the skin on my face to peel and was very itchy.  I visited my PCP on 1/7 who prescribed  a dose pack of prednisone for the symptoms which the symptoms lasted about another 10 days out. I took a COVID test on 1/12 which was negative. And Im having this constant little nagging headache that is just consistent and wont seem to ease up.
sterile abscess pain & edema, erythema day p/inject 20MAY92; ATB given;
right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE for Thyroid disorder NOS, ROSUVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm soreness). At the time of the report, PAIN IN EXTREMITY (right arm soreness) had resolved. Not Provided      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.
FEVER, CHILLS, NAUSEA SEVERLY SWOLLEN ARM 2ND DAY, WENT TO DR AS ARM VERY SWOLLEN FROM SHOULDER TO ELBOW & WAS RED...WAS GIVEN SHOT  3RD DAY STILL VERY SWOLLEN & RED, WAS GIVEN 3 MORE SHOTS, BENEDRYL 50 MG, EPINEPHRINE SELUMEDROL 125
Immun @ 11AM screaming started @ 2PM lasted 3 hr, hyperventilated p/fell asleep; t101 AX, very sensitive, irritable next day; Given APAP prior to immun & several time p/immun, also tepid bath;
approx 3 hrs p/vax pt became irritable; parents could not console; cried about 3 hrs 730 to 1030PM; last 1/2 hrs for approx 20-30min had some strange eye movement & body trembles or twitching; appetite returned;
TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
FEVER; STRONG HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose was not reported, administered  on 02-APR-2021 14:56 to right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced strong headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and strong headache. This report was non-serious.
Mom and baby (patient) came in for a 2mo WCC. Pt well and healthy was due for 2mo immunizations. Dr. approved and ordered 2mo Vaccinations which are Pediarix, Hib, PCV13, and Rotavirus. I prepared immunizations and went into the room to begin administering them. I had mom hold baby in arms upright and began to administer Rota virus orally. Patient was taking vaccine well but, then began to cough then I instructed mom to turn baby baby prone and lightly tap his back. Patient began to cry. I went for Dr.  and she came in to assess the we observed red dots on baby's bilat legs. Mom stated baby was putting his weight on mom. Dr. evaluated patient. He was alert and stable . No more immunizations  given at this visit. Patient waited 20mins in clinic and Dr. re evaluated baby again He was alert and stable. Mom sent home with instructed to watch for signs of lethargy, dehydration or any new spots on legs to take baby immediately  to ER . Patient will get the rest of 2mo Vaccines at next WCC.
I was receiving headaches, and I've never had this problems. I had an issue with fatigue. I haven't had no taste. I've mentioned it to my doctor, but no result. I took medicine, and for the fatigue I just attempt to sleep. I haven't been active.