chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, chills, body aches, nausea started about 1 day after 3rd dose of modern. Arm pain started same day as injection but is less severe than other symptoms being experienced.
3rd dose of Pfizer COVID vaccine given 11/18/21, #30135ba; 4th dose of Pfizer COVID vaccine given 5/13/22, #fm7553; 10/14/22 pt to hospital and found to be positive for COVID; sepsis, respiratory failure; "received appropriate medical therapy" per medical records, specifics not known; pt aspirated during hospital stay; ICU; high flow NC; PICC line for TPN; alternated between BiPAP and OptiFlow therapy; pt's condition worsened; drops in O2 saturations and episodes of hypotension; DNR/DNI; transitioned to hospice and to GIP service; pt passed away in the hospital
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID after being vaccinated". Clinical information: The patient wife did not realize that getting COVID after being vaccinated was considered an adverse event until she received the postcard that was sent to colleagues. After that she reported immediately. The same situation occurred with her husband and son for which she reported and could gather all the relevant info (VX dates and lots) from them. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed practical nurse concerning a 12 month old patient who within the last two weeks (in August 2010) was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided). The nurse reported that the patient experienced normal redness around the injection area (in August 2010). The nurse reported that BENADRYL took care of the redness. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Immediately following the injection, patients left hand went numb and tingling. Five hours after  injection, pinky and ring finger remain numb, with a tingling sensation in the rest of the hand.
On the day of the injection, my arm was bruised and developed a hard knot on the site. Within 24 hours I had a red hot rash from my elbow to my shoulder. This healed in about 10 days. 7-10 days after the injection, I developed muscle and joint pain in both legs, knees and ankles. A sharp pain in the left foot on the side. 14 days after the injection I noticed red raised sores on my neck, then my face, by 16 days I had 6-8 itching oozing sores on my face, neck arm head and stomach. The Co health dept assured me I was contagious and my nurse practitioner at my doctor's office examined me and both concluded chicken pox. I was given Acyclovir to take 4x a day for 7 days. I have not returned to work in an elementary school because of the warning of contagious.
Approximately 5 minutes after vaccine patient felt lightheaded. Pharmacist immediately checked on patient who was beginning  to become incoherent.  He had a mild seizure and ems was called.  Patient was sweating and pale.  He remained onsite with EMS and later left with a family memeber.
rigors/chills; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "rigors/chills". It was unknown if therapeutic measures were taken as a result of chills. Additional information: The pharmacist reported that her husband experienced rigors/chills after the first dose of Pfizer COVID-19 vaccine, but tolerated the second dose without reaction. Other vaccine in four weeks was unknown. Other medications in two weeks was unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Allergies to medications, food, or other products was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
the patient did not experience any other adverse event; The caller said the patient received an expired dose of VARIVAX on 4/26/2023; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #u012222, expiration date: 16-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). Confirmed with caller the patient did not experience any other adverse event.
Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especially back hips neck . Itchy rash at end of fever andafter fever subsided lasted for five days. I typically with fever get a rash.  Nausea, body aches all over swollen neck glands
Gave child vaccine (Flu was the only vaccine he received) within 1 minute parents came running out of room yelling child was not breathing. Picked child from parents he took a big breath then began coughing turning bluish, purple Dr.  administered Epipen Jr and placed on 2 liters of oxygen. Child began perking up. 911 was called and child went to ER.
pt recvd vax; experiencing severe bone marrow depression,w/ fatigue,anemia abd thrombocytopenia;to date no drugs used;series has been discontinued;reporter feels events are possibly related to vax;
the second one I had hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (dealt with shingles 3 times before the first shot came out) and chickenpox (at 7 year old). Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date) and Shingles vaccine (had the 1st shingle shot when it came out).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   The reporter considered the hives to be possibly related to Shingrix.     Additional Information: GSK receipt date: 29-NOV-2022 Reporters comment: This case was reported by consumer via interactive digital media The patient he/she sated that had the 1st shingle shot when it came out,he/she had chickenpox when 7 year old,for 1shot of shinrix he/she was ok,before first shot had shingles three times,but the second one experinced hives.
After 1 hour:  Muscle soreness to area of injection. After 7 hours:  chills After 12 hours:  tired, fever After 24 hours:  headache, continued
Head spasms, headache, fever lasting 15 hours (100--103 degrees), fatigue, very, swollen arm from shoulder to elbow with fever in it.
Patient called 11/10/10 to report area of injection is still sore after 3 weeks and she has difficulty moving arm because of that. There is no redness or rash at site, nor swelling visible.
a swollen, lump and hot to touch irritation on the injection site; a swollen, lump and hot to touch irritation on the injection site; a swollen, lump and hot to touch irritation on the injection site; a swollen, lump and hot to touch irritation on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE IRRITATION (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE MASS (a swollen, lump and hot to touch irritation on the injection site) and VACCINATION SITE SWELLING (a swollen, lump and hot to touch irritation on the injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts.    On 05-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE IRRITATION (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE MASS (a swollen, lump and hot to touch irritation on the injection site) and VACCINATION SITE SWELLING (a swollen, lump and hot to touch irritation on the injection site). At the time of the report, VACCINATION SITE WARMTH (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE IRRITATION (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE MASS (a swollen, lump and hot to touch irritation on the injection site) and VACCINATION SITE SWELLING (a swollen, lump and hot to touch irritation on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information were not provided by reporter.  The patient was in an urgent care.  The patient had no known allergy with medications.  The patient had no known medical history.  Lot number and expiration date couldn't provide by the reporter.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age with macrolide antibiotics allergy. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # 669260/0152AA, expiration date 01-MAY-2012) (dose and route unspecified). On an unknown date the patient now had shingles. The reporter stated a physician reported this to the pharmacy. The reporter stated the physician received a shipment of ZOSTAVAX that was shipped out from the pharmacy on June 2011 and given to the patient at an unspecified date. The physician was requesting a lot check to see if other reports of shingles had occurred with this lot number. Physician would like this information sent to him directly. The patient had sought medical attention via office visit. Treatment was given. The event outcome was reported as recovering/resolving. Additional information has been requested.
Sunday 4/20 presented with a slightly raised area with an area of redness smaller than the size of palm. Patient was told to watch area for any signs of worsening symptoms and evaluate on 4/21. On 4/21 patient went to Urgent Care even though symptoms had not gotten worse. She will also follow up with primary doctor. On prednisone and BENADRYL.
Left deltoid are warm to touch, red and minimal swelling. Reddened area was about 3 inches diameter circle. Treated with Zyrtec for 10 days and Biaxin for 10 days. (reacted to previous Hep B per pt.)
Within 5 minutes of the injection recipient complained of headache, slight shortness of breath and sweaty palms. She was evaluated by an on-site EMT and refused transportation to the hospital.
Delayed urticaria (hives). I?ve been suffering from itchy red rashes all over my body for about 7 weeks now. The reaction didn?t start until 16 days after my booster shot, but it hasn?t let up since. It only flares up at night around 10pm each night. It used to be an all day battle. Itching mostly occurs on my legs, feet and hands.
The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) 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 ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.).    No concomitant medications were reported. No treatment details were reported.  Patient received underdose of 0.25 ml Moderna Bivalent Booster.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Pressure, pain in brain, top of skull radiating to eyes and down spine to lower back. Went away 9/16/2012.  9/17/2012 woke with severe dizziness, eyes darting back and forth, nausea and vomiting. Severe dizziness subsided 9/18/2012 but still weakness and slight dizziness 2 days later.
terrible reaction to COVID 19 vaccine; Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.; Swelling &inflammation of my arm; Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present; Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.), INFLAMMATION (Swelling &inflammation of my arm), CHEST PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present), NECK PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) and VACCINATION COMPLICATION (terrible reaction to COVID 19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PERIPHERAL SWELLING (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.), INFLAMMATION (Swelling &inflammation of my arm), CHEST PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) and NECK PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present). On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible reaction to COVID 19 vaccine). At the time of the report, PERIPHERAL SWELLING (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.), INFLAMMATION (Swelling &inflammation of my arm), CHEST PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) and NECK PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) had not resolved and VACCINATION COMPLICATION (terrible reaction to COVID 19 vaccine) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Additional Information received included newevent was added.
Patient fainted for a few seconds after administration. Skin became clammy and pale. Patient felt nauseous but did not vomit. She was placed on floor with legs elevated until complete recovery. Shots given at 11:45AM-patient had not eaten any food today.
Headache, Fever & NauseaVomiting Narrative:  Fever 100.3 1/20/2021, 99.9 1/21/2021: Mild headache 1/19/2021, moderate headache 1/20/2021, mild headache 1/21/2021; mild nausea 1/19/2021. Resulted in unable to work 1/20/2021 and 1/21/2021.
Diarrhea; headache; chills; Extreme fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 25-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 19Dec2020 at 12:00, at single dose, for COVID-19 immunisation. Medical history was none. Patient was not pregnant and was not pregnant at time of vaccination. Concomitant medications included cannabidiol (CBD OIL) and unspecified birth control. The patient experienced diarrhea, headache, chills and extreme fatigue all on 09Jan2021 at 16:00 with outcome of recovered in Jan2021. Extreme fatigue recovered after 36 hours. Patient did not have COVID-19 prior vaccination and was not tested for COVID-19 after vaccination.  The information on the lot/batch number has been requested.
SOB 15 minutes prior to EMS arrival, duoneb at home with no improvement. Pt COVID positive
Had the red splotch and itchiness around the injection site at 8 days after.  Still there slightly, but not a big bother.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 6/04/21 and 7/02/21 Covid + 1/19/22. Presented to ED 1/24/22 for DKA and acute hypoxemic resp failure 2/2 COVID intubated in ED 2/2 altered mental status c/b 2 episodes of V-fib/PEA arrest. ROSC achieved both times, admitted to ICU. Febrile on 1/29. BAL 1/29 shows MRSA, enterococcus, G- rods. Extubated on 01/31 to HFNC with increasing O2 requirments.  Altered on 2/4, reintubated for airway protection. HD catheter placed 2/6, started dialysis. Afib with RVR noted 2/6, s/p DCCV x2. PEA arrest 2/13 after transport for a CT PE, findings of LUL PE. ROSC achieved but then went into VTach, the asystole. Treated with remdesivir and dexamethasone.  Expired 02/13/22.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/15/2021 COVID-19 PNEUMONIA R09.02 HYPOXEMIA 12/15/2021 COVID-19 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/15/2021 BACTEREMIA R09.02 HYPOXEMIA 12/15/2021 BACTEREMIA
Woke up in early morning with chills, fever, muscle ache, sore left arm.  Throughout the day when I wasn't sleeping chills, fever increased to 102.8, noticed headache, nausea, and metallic taste.  Into the night and early Jan 24, same symptoms intermittent fever.  Jan 25 symptoms more tolerable, but fatigue and arm continues to hurt, firmness, redness, swelling with blotchy, swollen lymph note all noted.  Treated at home with Tylenol, Aleve, ice, rest and sleep.  Fever ranged from 100.5-102.8
Information has been received from a physician concerning a 10-year-old male with no medical history or allergies who on 09-MAY-2006 was vaccinated SC with a 0.5 mL dose of Varivax (Lot #652081/0942R). There was no concomitant therapy. The physician reported that on approximately 11-MAY-2006 the patient developed an approximately 10 cm rash in diameter at the injection site. No other symptoms were noted. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. Additional information has been requested.
I received a Moderna booster at 7:15 pm at 6:45 pm, I had premedicated with 25 mg of Benadryl. because I have a mast cell disorder and have reacted to some vaccines in the past. I did not have an allergic reaction to the J7J vaccine I received on 04/09/2021. I waited the 15 minutes post-vaccination and felt fine. My husband was with me, and we headed out on our drive home. About 10 minutes into the drive, my tongue started tingling. It quickly escalated into my tongue feeling like it was swelling and I became short of breath. We were nearly home, and I ask my husband to drive instead to the fire station up the road. I was evaluated by medical personnel at the station. I had tachycardia, high blood pressure and was short of breath. I was transported by ambulance to Hospital's ER. There I was evaluated, given more Benadryl and placed under observation for a few hours. I was released to go home and told to continue taking the Benadryl until my symptoms completely subsided. My diagnosis was an allergic reaction to the vaccine. I sought follow-up care today with my internist.
Information has been received from a pharmacist refers to a patient of unknown age. On 24-JUN-2016 the patient was vaccinated with the first dose of GARDASIL which was expired on August 2015, dose, route and frequency was not reported. There was no adverse event reported. Additional information has been requested.
Expired use beyond date from when removed from freezer which was on 11/16/21 No adverse S/S no treatment needed
Redness & induration 2 7/8" x 3 1/3", warm @ site, pain @ site;
Left thigh became swollen and red, 24 hours after injections. Was treated with Keflex. Pt recovered.
Given at 18 month check-up on 10/18/00 at 17:30, Prevnar in right anterior thigh-3cm X 3cm. DTAP and IPV given in left anterior thigh with 4cm X 6cm large, local reactions. Red and slightly raised and warm to the touch. Improved within 48 hours.
Delayed Localized Hypersensitivity Reaction in the left arm, at site of the vaccination. In under 48 hours a lump appeared under the skin at vaccination site on left arm. The area was swollen, hot to the touch, and there was a red rash on the skin above the lump. The swollen lump under the skin was treated with Zyrtec  10 mg- once per day; and Aleve 220 mg- twice per day. An ice pack was applied as needed. Cortizone cream was applied topically to the rash as needed. Within four days these symptoms had lessened significantly. Within seven days the lump under the skin, as well as the rash, were gone and treatments  were terminated.   Unexpected, unusual menstrual bleeding began 14 days after receiving first Moderna COVID-19 Vaccination. This unusual menstrual bleeding lasted a full 2 weeks before it ended.
Pt. Deceased - Cant confirm in system.   Johnson and Johnson Dose 3/31/2021  042a21a
I experienced symptoms commonly indicated as possible side effects: arm soreness, headache, low-grade fever, chills, and nausea. I also experienced an intensification of my chronic back pain. In addition I experienced about 20 hours of intense heart pounding with moderate labored breathing/shortness of breath. This is what I am identifying as the adverse event.