chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, chills, aches, loss of appetite, severe pain and redness on right arm.  Symptoms of fever, chills and loss of appetite lasted from date of vaccine until 10/3/2020. Fatigue and aches is still present. Hives and swelling showed up on my right arm on 10/2/2020. Hives presented as stripes and by 10/3/2020 had combine into one large hive/rash on arm. Swelling and red rash still present on right arm. Rash starts on the outside of my arm and goes to the inside of arm.
Fever 106 degrees F, fever x3d. Febrile seizure. Rochephin 500mg IMx3
Hand was hot to touch; Hand swell; Hand was red; Hand was red; Hand swell; Hand was hot to touch; This spontaneous case was reported by a patient and describes the occurrence of the first episode of ERYTHEMA (Hand was red), the first episode of PERIPHERAL SWELLING (Hand swell), the first episode of FEELING HOT (Hand was hot to touch), the second episode of FEELING HOT (Hand was hot to touch) and the second episode of PERIPHERAL SWELLING (Hand swell) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Thyroid disorder NOS. Concomitant products included LISINOPRIL, NIFEDIPINE and ATORVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced the first episode of ERYTHEMA (Hand was red), the first episode of PERIPHERAL SWELLING (Hand swell) and the first episode of FEELING HOT (Hand was hot to touch). On 19-Mar-2021, the patient experienced the second episode of FEELING HOT (Hand was hot to touch), the second episode of PERIPHERAL SWELLING (Hand swell) and the second episode of ERYTHEMA (Hand was red). At the time of the report, last episode of FEELING HOT (Hand was hot to touch), the last episode of PERIPHERAL SWELLING (Hand swell) and the last episode of ERYTHEMA (Hand was red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified medicines for blood pressure and thyroid.  Patient had the symptoms on11-MAR-2021 which went away but returned again on 19-MAR-2021.  The patient did not receive any treatment.
MEDICATION ERROR; TEMPERATURE EXCURSION EXPOSURE/ NO MORE TEMPERATURE WAS RECORDED FOR ABOUT 3 HOURS AND 20 MINUTES PAST THE LAST RECORDED WITHIN RANGE TEMPERATURE; This spontaneous report received from a pharmacist concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included augmentin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced temperature excursion exposure/ no more temperature was recorded for about 3 hours and 20 minutes past the last recorded within range temperature. On an unspecified date, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion exposure/ no more temperature was recorded for about 3 hours and 20 minutes past the last recorded within range temperature and medication error was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 68 year-old male patient with "sulfa drugs" allergy (the patient noted that, on an unknown date, the head of his penis turned blue and swelled). On 17-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot # J002777, expiry date 07-JUN-2014 (dose not provided). It was reported that, on 19-JUL-2013, the nurse noted that the patient developed a "fever blister on his lip". The patient saw an unspecified physician about the fever blister on his lip persisted. Relatedness for fever blister on his lip was not reported for ZOSTAVAX. Additional information has been requested.
Patient experienced difficulty breathing and her face was flushed.  Patient also felt anxious and had headache.  Pharmacy called EMS and continued to monitor.  Paramedics took over treatment and continued evaluation.
Hives on arm that vaccine was administered in that gradually spread to chest, back and L arm.
Information has been received from a health professional concerning a female who on 29-MAY-2007 was vaccinated, subcutaneously in the right arm, with varicella virus vaccine live (Oka/Merck) (lot# 656821/0174U). Subsequently the patient experienced local reaction around the injection site. "Symptoms included swelling, redness, and "slightly raised" around the injection site. Also, medical chart lists "+/- pink and purple" with the symptoms. BENADRYL and ice packs were instructed for treatment." The patient sought unspecified medical attention. Subsequently, the patient recovered from local reaction around the injection site. This is one of two cases for this physician. Additional information has been requested.
Restlessness, insomnia  I was extremely fidgety all night and unable to settle.  My mind seemed calm but I couldn?t hold still.  I felt a strong need to move my body.  I kept thinking this what be what it?s like to be ?crawling out of your skin.?   It felt like restless leg syndrome but for my whole body.  If I got out of bed and walked around, I was fine.  I took Benadryl, hoping it would make me sleepy.  It did but it didn?t settle the restlessness.  I was so tired but so unable to settle.  As a middle-aged woman, I know insomnia that keeps me awake, thinking and alert.  This was entirely different.  My mind was calm and sleepy but my body wouldn?t settle.  I?ve never had this before.  I have had a few experiences with something I think is similar to restless legs but that was intermittent and never persisted.  Prior to this, 15 and 16 April, I had aches, chills, lethargy, weakness, and burning in my nostrils.  All of this seemed very normal for dose 2.   I was able to work throughout but took a nap one day.
Arm soreness; Temperature of 99 degrees; Mild chills; Severe hives; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PYREXIA (Temperature of 99 degrees), CHILLS (Mild chills) and VACCINATION SITE URTICARIA (Severe hives) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (Arm soreness), PYREXIA (Temperature of 99 degrees), CHILLS (Mild chills) and VACCINATION SITE URTICARIA (Severe hives). At the time of the report, PAIN IN EXTREMITY (Arm soreness), PYREXIA (Temperature of 99 degrees), CHILLS (Mild chills) and VACCINATION SITE URTICARIA (Severe hives) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degree Celsius High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
SEVERELY SWOLLEN AND ITCHY DELTOID AROUND SITE OF INJECTION; SEVERELY SWOLLEN BILATERAL AXILLA; ENLARGED, PAINFUL LYMPH NODES IN AXILLA; ECXEMA BILATERAL AXILLA FOR 5 MONTHS, SEVERE DIARRHEA X4 MONTHS, SEVERE EXCEMA B DORSAL ASPECT OF HANDS, AGGRAVATION OF HASHIMOTO'S HYPOTHYROIDITIS SYMPTOMS
Patient mentioned he was hospitalized with numbness and Guillain - Barre syndrome like symptoms.
pt reports bilat leg pain, weakness, swelling from knees down starting day p/vax given reaching peak 2wk later, gradually improving over next 2-3mo;
Friday July 16, 2021, about 10:30-11:00 pm I started having abdominal pain that radiating through to my back. I could not sleep and was up all night in pain. It felt like I was being sawed in half. At 05:00am Saturday morning I went to the ER, I was given pain medication that did not help with the pain. I had a CT that was "normal". I was discharged home by 10:00am Saturday. Saturday night I started having nausea and vomiting into Sunday morning. My spouse contacted a doctor that suggested I go back to a different ER, which I went to on Sunday 10:00am. At this point I was vomiting blood. I was taken to medical center by ambulance. The CT scan showed pancreatitis. I had labs done showed lipase numbers were high. By 02:00pm Sunday I was admitted to a step-down unit in the hospital. On Tuesday I received an endoscopy to make sure there was nothing else going on in esophagus or stomach. I had a small tear in esophagus that had started to heal itself. My lipase numbers started to come back down. I went home from hospital on Wednesday afternoon. I have not had any symptoms come back since leaving the hospital.
Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021 at 2:30 PM, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine/vaccine vial that was in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. The patient was monitored after Moderna  COVID vaccine was administered for 15 min. Pt was ok and left home after 15 min observation.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Non- Significant Follow-up received on 07-OCT-2021 contains patient condition (patient was monitored after Moderna Covid vaccine was administered for 15 min. Pt was ok and left home after 15 min observation).
fatigue; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "mild nausea".  Additional information: The patient later received her second dose of the vaccine (lot number: ER8735) on 28Apr2021 at 14:00 and reported that twelve hours later, about 2:00, she woke up and felt okay initially but was then hit with severe nausea few minutes later that lasted 24 hours. She stated that she had Pepto Bismol but did not want to take it and instead drank some ginger tea, which did not help. She would like to know if severe nausea lasting 24 hours after the Pfizer BioNTech COVID-19 vaccine would be considered a severe allergic reaction. She would like to know if any nausea meds, such as Pepto Bismol, would be okay to take to treat the severe nausea she experienced after the second dose of the Pfizer BioNTech COVDI-19 vaccine.  No follow-up attempts needed; No further information is expected.
Very confused; Couldn't be stand; Arm Sore; Very weak; Din't feel good; Tired for several days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Feb2021 14:15 (Lot number: EM9810) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid Pneumonia both lungs" (unspecified if ongoing), notes: Covid Pneumonia both lungs, Date-21Dec2020 to 24Dec2020, Result-positive; "ICU", start date: 21Dec2020, stop date: 24Dec2020, notes: Covid Pneumonia both lungs, Date-21Dec2020 to 24Dec2020, Result-positive, Hospitalized ICU 4 days; "covid virus", start date: 09Dec2020, stop date: Jan2021, notes: onset date-09Dec2020, stop date-Jan2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (Time: 2:15 PM, Anatomical site of Injection-Left Arm, Route of Administration-Intramuscular, Lot# -EL3249), administration date: 21Jan2021, for Covid-19 immunization, reaction(s): "Run a 103 fever", "Arm sore", "Tired for several days", "didn't feel good". The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Very confused"; DYSSTASIA (non-serious), outcome "unknown", described as "Couldn't be stand"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Sore"; ASTHENIA (non-serious), outcome "unknown", described as "Very weak"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Din't feel good"; FATIGUE (non-serious), outcome "recovering", described as "Tired for several days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Arm sore-got up around 8AM. by 10:00AM could not stand, very weak. very confused. Thought he had a stroke. he kept trying to get up, walked to kitchen, had to sit down at table. stay there till 4:30 begin to get where he could stand by6:00PM, could walk. next day, tired, but better, didn't feel good for several days.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED FIRST DOSE OF COVID VACCINE AROUND 10 AM ON 4/30/21. DURING THE 15 MINUTE OBSERVATION PERIOD, PATIENT FAINTED IN HIS CAR. BP WAS 88/32, O2 WAS 88, AND PULSE WAS 88. OXYGEN WAS GIVEN AND 911 WAS CALLED. AMBULANCE ARRIVED BUT PATIENT DID NOT REQUIRE TRANSPORTATION TO EMERGENCY ROOM. PATIENT WAS OBSERVED FOR 30 ADDITIONAL MINUTES AND RETURNED TO WORK.
Contracted Covid sometime after the vaccine, about a month after. I believe that I got it from my daughter in law who did test positive about a day after. I am reporting this just to have it documented that I do not believe the vaccine was the cause of it and I do believe that it made my symptoms milder, however I was still able to contract the virus quite easily.
severe fever and chills 12 hours after vaccination, fever was 102, chills were so intense teeth were chattering.
I have an allergic reaction to the flu shot; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Digital Media through social media.  This case is linked to cases 2020SA302080 (same reporter).  This case involves a patient of unknown age who had an allergic reaction to the flu shot (hypersensitivity), while patient was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient had an allergic reaction to the flu shot (hypersensitivity).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
I woke up two weeks after the vaccine to cold symptoms, despite not being around anyone without a mask. I had a cough and an extreme stuffed nose that I had to take Musilex in order to breathe. The cold lasted 11 days, but I still wake up with a cough and stuffed nose. I also have hives on my face. Sometimes I see them and sometimes I just feel itchy. At first I thought it was a side effect to the Atenolol I started taking -- and it might be -- but my face continues to itch despite having stopped taking Atenolol over a week ago. I wonder if these side effects are the vaccine, especially the cold symptoms since the vaccine has a cold virus in it.
About 2 weeks after first injection, I began to smell a sour/rotting type odor like milk gone bad or garbage that needs to go out.; This is a spontaneous report from a contactable consumer. A 69-year-old female non-pregnant patient (consumer) received first dose BNT162B2 (COVID 19, brand: Pfizer, lot number: EL0142, Solution for injection) via an unspecified route of administration in Left arm on 11Jan2021 at 07:45 AM at single dose for COVID-19 immunization. Patient medical history included Asthma, CAD (Coronary artery disease), Hypertension. Concomitant medications were not reported. Patient previously took itraconazole (SPORANOX) and had known allergies. About 2 weeks after first injection, she began to smell a sour/rotting type odor like milk gone bad or garbage that needs to go out on 25Jan2021. It was consistent now. Not sure it was related but curious if any others have noticed this. No treatment AE. No covid-prior to vaccination. No covid tested post vaccination. Outcome of event was not recovered.
Reaction started 2-3 hours post vaccination. Patient developed a severe sore throat with tightening, stomach cramps after eating at8 pm, and later that evening had chills and body aches and could barely move. She was able to sleep but developed severe sweating for part of the night. Patient said she had to have someone carry her to bed. She has a lingering but improving sore roof of her mouth and lethargy.
Patient was given the vaccine by a fellow nursing student at a vaccine clinic.  Patient starting having significant pain in her shoulder and inability to raise or move her shoulder.
burning sensation in both legs; painful in the bone; head feels funny.; both knees hurt; legs had funny pain; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in both legs), BONE PAIN (painful in the bone), ARTHRALGIA (both knees hurt), PAIN IN EXTREMITY (legs had funny pain) and FEELING ABNORMAL (head feels funny.) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced ARTHRALGIA (both knees hurt) and PAIN IN EXTREMITY (legs had funny pain). On 04-May-2021, the patient experienced BURNING SENSATION (burning sensation in both legs), BONE PAIN (painful in the bone) and FEELING ABNORMAL (head feels funny.). At the time of the report, BURNING SENSATION (burning sensation in both legs), BONE PAIN (painful in the bone), ARTHRALGIA (both knees hurt), PAIN IN EXTREMITY (legs had funny pain) and FEELING ABNORMAL (head feels funny.) outcome was unknown.            The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05-May-2021 contains no new information.
PATIENT WAS GIVEN HUMIRA FROM ANOTHER PHARMACY ON 5/12/16. THE NEXT MORNING THE PATIENT WOKE UP WITH AN EGG SIZED RAISED RED AREA ON THE SAME ARM IN THE SAME AREA WHERE HERE PREVNAR AND TWINRIX VACCINES WERE PREVIOUSLY ADMINISTERED.  SHE ALSO HAD WHAT SHE THOUGHT WAS A BASEBALL SIZED ENLARGED LYMPH NODE UNDER THE LEFT ARM.
Arm redness and soreness at injection site 7 days after receiving injection. Also shoulder sourness
redness; Itch; This case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix 6 days ago and still had redness 2 inch by 4 inches. No pain but it did itch.  The pharmacist asked if it was common and the side effect information did list as side effect but did not say how long it should last. The reporter asked should they be concerned. The reporter asked could the patient use over the counter Benadryl or Cortizone for itching.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 08-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
No ADR, timing ERROR only, 2nd dose given 43 days after 1st Narrative:  Timing ERROR only