chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID 19 Vaccine EUA Side effects: redness, warm to touch, sore arm,  lymph nodes sore under arm, fatigue, slight headache Side effects began around 3 hours after vaccination dose number one.
Numbness of Rt upper extremities immediately. Later with weakness + numbness of right lower extremities last for about a day. Fever and vomiting the next afternoon. Rt UE numbness resolved 3 hrs later. Still a little weakness in Rt. leg.
Extreme fatigue, body aches, head ache, chills, nausea, dizziness, fever, loss of appetite. Symptoms started 10 hrs after the vaccine. Severe symptoms lasted for 36 hrs. Moderate to mild symptoms lasted for 72 hrs. I rested, drank liquids and took acetaminophen for severe symptoms. Continued to drink plenty of liquids for moderate to mild symptoms took acetaminophen if needed.
red rash on arms, back & abd w/mild itching since this AM dad states pt cut grass PM of 7APR93; immun given 6APR93 in the afternoon;
Patient at check-out area stating "i just don't feel right". Skin clammy patient escorted to exam room, had her lay down, lower extremities raised. Orange juice. Provider.
This spontaneous report as received from a nurse refers to a 18 year old female patient. On 22-AUG-2017, the patient was vaccinated with GARDASIL 9 intramuscularly (dose number, exact dose were not reported; lot # N004798 with the expiration date 31-OCT-2019), for prevention of Human papillomavirus (HPV). Upon sticking the patient with a needle, the patient jerked back and only a partial amount, "barely any", of the GARDASIL 9 was administered.
No adverse event; The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on 5/12/2023 and they stated that it had expired on 5/11/2023).    Vaccine was administered to a resident. It was stored as specified per recommendations until administration.  Concomitant medication was not provided. Treatment information was not reported.
Regarding urgent removal notice of Pediatric Pfizer COVID-19 5-11 yo vaccine- NDC# 59267-1055-04  - lot # FL2757 with manufacturer's expiration date of Sept 30, 22. Information has been received from the manufacturer indicating that stability and efficacy data supports the use of this product through Oct.19, 2022. Per guidelines: doses administered between Oct 1 - Oct 19, revaccination is not indicated, patient notification is not required
This spontaneous report was received from a registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (Lot numbers K026384; expiration date 15-DEC-2016 and L002870; expiration date 17-JAN-2017) dose, route, frequency and anatomical location were not provided. No concomitant medications were specified. No adverse effect was reported. This is one of two cases received from the same source. Additional information has been requested.
Patient reports whole arm is swollen, red, itchy, and hot to the touch at vaccination site.
pt recvd vax; pt stated she fell on back of head & felt very dizzy; mom stated pt fell to the ground & hit back of head;
Some soreness in left arm. Just after midnight, began experiencing flu-like symptoms (achy, felt feverish but no fever) and now feel the way I did when I last had influenza...lethargic and sleepy, and a bit achy.
Onset of retrosternal, nonradiating chest pain on 11 Dec 2017 (5 days after primary smallpox vaccine). Patient sought evaluation at local ER where ECG, labs, and exam essentially normal. Treated with GI cocktail (no impact on pain) and naproxen initiated, which did decrease chest pain. No accompanying symptoms. Pain remained substernal, worse when lying down improved with sitting up, and improved with taking Naprosyn.
There was no adverse event to be reported .  However, the vaccine vial expiration date was on 01/22/2022, and patient received a dosage of expired vaccine.  Patient was contacted on 01/27/2022, and he reported  moderate common cold like symptoms.
Expired dose given to patient; We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where product was administered 28 hours and 5 minutes after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.  Reporter said excursion was seen with the product which was administered 28 hours and 5 minutes after the vial was punctured and the vial was taken out of the freezer and placed in the refrigerator on 1/26/2022 and  was punctured on 1/27/22 at 10:39 AM and remained at room temperature.       No other additional information was available from the customer.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 10 month old patient. On 12-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
General pain in legs, more painful in thighs and left leg muscle near lower shin, trouble with breathing, pain in right shoulder, fatigue. Symptoms have not stopped.  They do not appear to be a 24 hour event, but come and go.
gained 11 lbs with snacking; 20 minutes after shot felt nauseous/Nausea continues off and on all Day/More nausea than relief/feels nauseous in between breakfast and lunch; coolness over the body; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (coolness over the body), WEIGHT INCREASED (gained 11 lbs with snacking) and NAUSEA (20 minutes after shot felt nauseous/Nausea continues off and on all Day/More nausea than relief/feels nauseous in between breakfast and lunch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concurrent medical conditions included Drug allergy (Aspirin.), Penicillin allergy and Allergy to antibiotic (Erythromycin). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal), LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) for Blood pressure, PANTOPRAZOLE and LISINOPRIL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BODY TEMPERATURE DECREASED (coolness over the body). On 12-Feb-2021, the patient experienced NAUSEA (20 minutes after shot felt nauseous/Nausea continues off and on all Day/More nausea than relief/feels nauseous in between breakfast and lunch). On an unknown date, the patient experienced WEIGHT INCREASED (gained 11 lbs with snacking). The patient was treated with CALCIUM CARBONATE (MAALOX [CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE DECREASED (coolness over the body) and WEIGHT INCREASED (gained 11 lbs with snacking) outcome was unknown and NAUSEA (20 minutes after shot felt nauseous/Nausea continues off and on all Day/More nausea than relief/feels nauseous in between breakfast and lunch) had not resolved.            This case was linked to MOD-2021-232193 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up information received on 21-Apr-2021 contains information of  event. The outcome of the event (Nausea )is unknown has been updated. On 23-Jun-2021: Follow up information received on 23-jun-2021 contains significant information. Patient height and body weight and race has been updated. Patient medical history include Drug Allergy to Aspirin and penicillin and erythromycin has been updated. Event (Nausea) with outcome not recovered has been updated. On 13-Aug-2021: Follow up received and added new events.
I became very tired almost immediately after my second dose, and proceeded to take a 3 hour nap. Upon waking up from the nap, I had full body aches, joint pain, a headache, and a low grade fever. Said symptoms have now lasted over 24- hours
Tingling in left hand and left side of face starting aprox 20 min. after injection and subsiding ~1 hr later with no treatment fever and chills starting 2-3 hrs after injection & subsiding 4 days later treated with ibuprofen severe body spasms starting ~7hrs after injection & subsided 2 days later treated with ibuprofen, heat and rest Nausea starting ~7 hrs after injection and subsiding 4 days later with no treatment Migraine starting ~4 hrs after injection, treated with ibuprofen and rest, subsided 2 days later
DRESS syndrome. My father was in the hospital from 8-12-17 through 8-28-17. First hospital 8-12-17 through 8-21-17 then second hospital 8-21-17 through 8-28-17. He suffered severely and almost died due to ARDS. Once the correct diagnosis was made he ultimately recovered by IV methylprednisolone.
Information has been received from the mother of a 4 year old male with a gelatin allergy who on 5/18/04 was vaccinated SC with a second dose of MMR (lot number not reported). On 5/18/04, 5 minutes after the vaccination, the patient began coughing. The mother noted that the patient's face became swollen and he developed hives all over his body, although, were concentrated around the area of injection. At the recommendation of the patient's physician, the mother took the patient for a 15 minute walk. There was no change in the patient's condition when they returned, and the physician administered a steroidal Benadryl injection. The patient's symptoms resolved quickly after the injection, and he was prescribed unspecified steroids for 5 days. Cough, facial swelling and hives were considered to be immediately life-threatening. Additional information has been requested.
Fever  101.5 for about 18 hours Chills for about 18 hours Moderate headache for about 18 hours Body  aches for about 18 hours Fatigue for about 24 hours Mild hallucinations about 24 hours after vaccine and lasting 2-3 hours.
Pt was in monitoring area shortly after vaccination. Notified EMT she was having SOB. Assessed pt. She tearful, c/o chest pressure and difficulty of breathing, HA. Rapid response called and pt transported to ED for further treatment. Pt given Benadryl, Solu-Medrol, Albuterol in ED. Symptoms improved and discharged home. Pt informed she should not receive second dose.  Pt remained in ED approx 2 hours post event.
2 weeks post vax, pt developed a flat rash on face and neck and a large node behind ear.  There was no fever.  A couple of days later the rash was all over body.
vomiting; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and FATIGUE (fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VOMITING (vomiting) and FATIGUE (fatigue). At the time of the report, VOMITING (vomiting) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ADMINISTERED VACCINE AND PT. PT WAS SEATED ON A CHAIR AND COMFORTABLE. 1 OR 2 MINUTES LATER AFTER RECEIVING THE VACCINE PATIENT FAINTED. WE CALLED 911 BUT WHILE ON THE CALL WITH DISPATCH PT CAME TO "WOKE UP". PT WAS OUT FOR ABOUT 1 MIN OR LESS. WE ASKED PT IF NEEDED AND AMBULANCE HE SAID NO. SAID THIS HAPPEN A FEW WEEKS AGO WHEN PT HAD BLOOD DRAWN AT CLINIC. WAS DIAGNOSED WITH A POSSIBLE VASOVAGAL SYNCOPE. PT STAYED, SEATED. WE GAVE HIM WATER AND FOOD. HE FELT COMFORTABLE AND FINE. HE DID NOT NEED TRANSPORTATION. AFTER ABOUT AN HOUR OF MONITORING HE WENT HOME ON HIS OWN.
he was sick; unable to get the second dose because he was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he was sick) and PRODUCT DOSE OMISSION ISSUE (unable to get the second dose because he was sick) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (he was sick) and PRODUCT DOSE OMISSION ISSUE (unable to get the second dose because he was sick). At the time of the report, ILLNESS (he was sick) and PRODUCT DOSE OMISSION ISSUE (unable to get the second dose because he was sick) outcome was unknown.            Patient was taking unspecified concomitant medications. Treatment information was unknown.
information has been received from a manufacturer concerning a 21 year old male who was vaccinated with a does of MMR. Concomitant therapy included a first dose of Hep B in the RA and a dose of tetanus toxoid on 06/17/04 the pt
felt dazed and confused; RSV; Covid-19; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV), COVID-19 (Covid-19) and CONFUSIONAL STATE (felt dazed and confused) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine and MODERNA COVID-19 VACCINE; for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine, MODERNA COVID-19 VACCINE and Moderna COVID-19 vaccine.   On 14-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 04-Nov-2023, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV) and COVID-19 (Covid-19). On an unknown date, the patient experienced CONFUSIONAL STATE (felt dazed and confused). The patient was treated with IBUPROFEN at a dose of 800 milligram every six hours and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV), COVID-19 (Covid-19) and CONFUSIONAL STATE (felt dazed and confused) outcome was unknown.            No concomitant medication was reported. It was reported that patient had to go to the hospital for his wife on 2-NOV-2023. On 3-NOV-2023 he started to have a little runny nose, slight fever, a little cough, fatigue, and felt dazed and confused.
12 hours after administration, awoken with uncontrolled leg spasm and fever of 102 followed by nausea and attempted vomiting. Duration of 4.5 hours and high fatigue the subsequent 24 hours
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 10x1 single dose vial (SDV) injection (lot# K009482, expiry date 06-MAR-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified), lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
The day after the vaccine, I felt my arm and it was lumpy. I had two blisters above and beneath the site of the injection, fluid filled blisters. The dermatologist poked a needle in each of them and drained them. That resolved that. The very first day of my vaccine, I was sore and achy. It all went away except that I am having prolonged and lingering neck discomfort. It's not muscular, it's more nerve ending feeling. I can barely turn my neck right and left. It's interfering with sleep and it's very uncomfortable. No treatment except Motrin every now and then. I had my flu shot Monday, September 20th, I don't have the brand name or lot number. I am not sure which arm it was. I had it at Dr. office.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date:02-OCT-2016 and lot# J015437, expiration date: 09-OCT-2016.  The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 23 months old child patient of unknown gender. On 26-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
HD was notified that the patient tested positive for COVID-19 on 6/22/2021.  She has been asymptomatic.  Patient received Janssen COVID-19 Vaccine 5/18/2021 which was given by Health Department.  No other information is available.
RN called for another client to come to exam room, this client responded and received the following immunizations at the inapproriate age: Hepititis A  (Havrix) Lot # AHAVB103AA  Proquad Lot # 0466F There was no adverse reaction noted at time of situation.  Explained situation to clients mother, answered all appropriate questions.
Pt reported feeling like he was coming down with a cold, including flu-like symptoms such as coughing, runny nose, and swollen glands. Pt states he usually gets swollen glands as a precursor to getting a cold. When patient reported to pharmacy, stated that symptoms were slowly resolving.
Patient fainted shortly after administering Janssen Covid-19 vaccine. Emergency response was called and patient was taken to hospital by ambulance.
Febrile reaction 101.6 started 24 hr after injeciton. Required alternate of Tylenol and Ibuprofen x24 hours. Then 48 hours of Tylenol and Ibuprofen x 24 hours. Then 48 hours of malaise. 99.6 Sx Myalgia, mailaise, slight head ache.
pt recv 1st dose of varicella virus vax plus hep-b vax engerix-B on 3/23/98 then on 3/30  pt exp an unspecified condition described as a ``generalized case''