chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius; No adverse event; Patient had been administered dose post excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius), POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AS7188B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: VAXIGRIP TETRA (Sanofi IIV4-Free, Lot number: UT7752NA, route of administration, intramuscular and vaccination site: left deltoid.) on 10-Jan-2023. Past adverse reactions to the above products included No adverse event with VAXIGRIP TETRA.    On 27-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 27-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius), POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 (The refrigerator door was open for 5 min and the temp rose to 8.4 degrees Celsius) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose post excursion).    No concomitant drug information was provided. It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19. On 26-Jan-2023, the refrigerator door was open for 5 min and the temperature rose to 8.4 degrees Celsius. Patient had not experienced adverse reaction to the vaccine. Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716571 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716571:same reporter
I started having AFIB about one hour after receiving the vaccine. I was not able to eat, dizzy, stomach upset/pain and  very weak. Due to having AFIB, I have anxiety too. I continue to feel very weak. I feel some better but not 100%.
Evaluated at ED on 11 19 21 secondary to malaise body aches, mild cough and runny nose.  She was found to be Covid positive on 11/19/21.  She was told to return to the ED if she had worsening cough, runny nose, frontal headaches, chills, fatigue, no chest pain, shortness of breath or hypoxia noted on oxygen saturation monitoring device.  Re-presented 11/21 - Initial oxygen sats reported as 83% on room air with COVID Pneumonia.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-06-10.
Syringe/Needle Malfunction. The Aiou Needle retractable safety syringe malfunctioned causing the leakage of vaccination dose from the syringe around the needle. This syringe/needle device comes as an all in one device so there is no assembly of the needle to the syringe.
Worst hang over I ever experienced. Could not move my arm. Terrible headache, extreme fatigue, nausea, diarrhea. The next morning I slept all  morning. I went to work the next day but didn't feel well.  That Friday I was feeling better.  I took Tylenol to relieve headache and muscle pain.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Apr-2021. On 11-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 11-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was received by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on included no new information.
Felt achey and flu like all day, starting at about 5pm I noticed a change in the symptoms. I suddenly couldnt catch my breath, couldnt stand up without feeling dizzy. I put on my apple watch to see if my heart rate was elevated, it was reading 147bpm while I was sitting down. experienced tightness in chest, could not walk without stopping every couple steps to catch my breath and steady myself. could not talk out loud without running out of breath after several words. attempted to relax and just sit on the couch, drinking fluids. after about 3 hours it started to fade. had shortness of breath and dizziness for several days, but it was steadily improving.
Acute hypoxic respiratory failure MV 9-21-21 severe COVID 19 pneumonia septic shock right-sided pneumothorax s/p chest tube 14 F pigtail 9-21-21 pulseless electrical activity of the heart diastolic heart failure acute kidney injury lactic acidosis-improved hyperkalemia
Information has been received from a health care professional concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus  vaccine live (+) varicella virus vaccine live.  On 12-Jun-2006 it was reported that in the "past few weeks" the patient was vaccinated.  The day after the patient developed a reaction and broke out in generalized redness that spontaneously resolved.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients, names and other demographics unknown, who on multiple unspecified dates were vaccinated with improperly stored GARDASIL 9 (lot # and expiration date were unknown), or VAQTA (lot # and expiration date were unknown), or RECOMBIVAX HB (lot # and expiration date were unknown), or M-M-R II (lot # and expiration date were unknown) that were reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date unknown). The vaccines involved: GARDASIL 9, VAQTA, RECOMBIVAX HB and M-M-R II  were stored at temperatures in the range of 0 degrees Celsius to 1 degrees Celsius for 98 hours, 9 degrees Celsius to 25 degrees Celsius for 19 hours for a time frame of 0 degrees Celsius to 1 degrees Celsius for 98 hours, 9 degrees Celsius to 25 degrees Celsius for 19 hours as identified by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No further information was provided.  Additional information has been requested.
1.  numbness in the left forearm and hand about 9 hours after the vaccination with paralysis of the left hand 3rd through 5th fingers flexed and index finger outstretched) .  this lasted for approximately 14 hours.  2.  fever started about 10 hours after the vaccination and lasted about 20 hours 3.  chest pain and shortness of breath and fatigue with exercise approximately 1 week after the vaccination and continues now for over 4 months.  4.  tachycardia and dizziness with standing (POTS  symptoms)
Patient was scheduled for a second covid dose on 2-21-22 (was not scheduled to see a provider), and the dose was administered without an order being placed by an authorizing provider. The earliest the vaccine should have been given was the 28th, but was given on the 21st.
About 6 hours after injection my arm started to hurt, I became very fatigued. 8 hours after injection I was experiencing radiating pain from injection site, body aches and chills, headache and low grade fever. This lasted until 35 hours post vaccination. Minor bruising around injection site
soreness; bad headache; chills; This is a spontaneous report from a contactable Other Health care Professional reported for herself. A 40-year-old non-pregnant female patient received (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number: EL9265, Expiration date: Not reported) 1ST dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 17:00 as SINGLE DOSE for covid-19 immunization. There is no specific Medical history reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 03Feb2021 at 06:00 AM she started experiencing soreness, bad headache, and chills. The outcome of events are of recovering.
This spontaneous report as received from a Doctor of pharmacy refers to a 78 year old female patient with no pertinent medical history and no drug reactions or allergies. On 11-OCT-2013, the patient was vaccinated with a first 0.5 ml dose of PNEUMOVAX23 (Lot # J004747, expiration date 20-JUL-2014) intramuscularly in the right arm and a dose of FLUVIRIN administered in the left arm. Concomitant therapies included RESTASIS, fluorometholone, omeprazole (manufacturer unknown), atorvastatin and diazepam. The pharmacist reported that on 11-OCT-2013, the patient experienced warmness and soreness at the injection site. The pharmacist stated that she also vaccinated three or four other people with this vaccine, PNEUMOVAX23 on 11-OCT-2013 but nobody else developed any adverse experiences. The patient was treated with TYLENOL. The outcome of warmness and soreness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
pt recvd vax 8DEC95 about 10mins p/vax pt devel a rxn @ the site of inj-red raised area about the size of a quarter;states arm felt like it would pop open & had a h/a;called MD told take DPH & observe x 1hr;c/o h/a, flushed, diff breathing
Fully vaccinated with COVID infection breakthrough asymptomatic.   Inpatient hospital stay for non COVID reason.
Patient received vaccine on 9-28 around 4:30pm. Mother noticed rash on 9-29 around 6pm. Patient states that his arm was warm and painful. Mom states that it still has not started to go down.
No adverse event; Administered a Moderna booster that expired on June12,2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a Moderna booster that expired on June12,2023) and NO ADVERSE EVENT (No adverse event) in a 6-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a Moderna booster that expired on June12,2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a Moderna booster that expired on June12,2023) 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 (Administered a Moderna booster that expired on June12,2023).    This case was created for female patient of the 2 patients involved.  Patients age was reported as 50s. Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-736628 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736628:Male patient case
received the flu shot without incident but 20 minutes later, noticed swelling and pain to L arm and unable to raise arm
pt recv vax & devel an inj site rxn characterized by pain & redness;also exp limited motion;
Redness, minimal swelling at site of injection. No burning, bruising, pain reported by patient
Erythema, swelling, warm to touch,  around injection site. "tingling down arm to metacarpals per patient"
Symptoms of HA, blurry vision, body aches, dizziness, vomiting
Patient presents headache, lower backache, chills, N/V, photophobia, weakness x 7 hours. Patient reports symptoms have been worsening after being sent home from work at 1430. Received J&J COVID vaccine at 0800.
Intense 'pinching' pain at injection site 2nd day after vaccine (first day after vaccine had stiffness/fatigue). Pain persisted for a few days, then went away.  Notably, it returns every so often-- once or twice a week. Usually triggered by muscle movement (stretching, gentle massage) or prolonged pressure (sleeping/resting on side). 5/28/2021 it returned and is much more severe-- pain triggered by any arm movement/muscle tension, varies in intensity. Not incapacitating, but distracting and compels me to vocalize discomfort. No redness/swelling at injection site.
Nausea, Weakness, Headache, Hallucinating, Loss of appetite, Metallic taste in mouth and Chills & Fever.
Chills, dizziness, weakness, unable to tolerate PO intake for 4 days (11/8/21) and occasional vomiting
Within 48 hrs of administration pt had redness and swelling and warmth of arm from shoulder to antecubital fossa
I woke up at 2am, with a fever, flu like symptoms, and a bad headache.  I took a nap from 8-10am that morning and woke up at 10am with repeating, recurring chest pain every 2-3 minutes, the pain would only last a second then go away.  My BP and pulse were very high.  This all continued through out the day.  I went to a walk-in urgent care clinic around 4PM, and then to the ER around 6PM.
Violent chills, headache, abdominal pain especially on the right side and vomiting.   Muscular aches all over the body. Fatigue.  1/10/21:  Still experiencing headache and muscle pain, occasional chills.
Mother called day after immunization given. Reported widespread hives on child's arms, legs and cheeks. Not making child itch much. Diminishing quickly. PHN suggested MOC contact physician if they reoccur.
Syncope 3/24/2021, ER visit 3/24/2021, Syncope in 4/2021, 5/2021, 6/2021  Syncope on 7/22/2021, 7/26/2021, 7/27/2021 ER visit with Cardiac Arrest and Syncope on 7/29/2021 . Admit to hosp. From 7/29/2021-8/03/2021. Implanted loop recorder with monitor by heart clinic on 8/2/2021. On 10/20/2021 had episode and diagnosed   with polymorphic ventricular tachycardia related to Clovid 19 vaccine and had immediate Heart Catheterization and no blockage found so was immediately taken to have an Implantable cardioverter defibrillator and loop recorder removed. Have to take medication [toporol and amiodarone].
PATIENT STATES HE HAS BEEN HAVING PAIN IN BOTH ELBOWS (MORE PAIN IN THE RIGHT) AND RIGHT ANKLE SINCE RECEIVING THE SECOND DOSE. HAS TAKEN IBUPROFEN AND THAT HELPS. PAIN IS SUBSIDING A LITTLE BIT. PATIENT WILL SEE DOCTOR WHEN HIS INSURANCE BECOMES ACTIVE
ha/fever/chills/bodyaches/n/v; started developing a gradual onset of fevers and chills, throbbing headache, epigastric and right upper quadrant abdominal pain as well as a squeezing chest pain.  She has vomited several times.
T101 ax, crankiness, staring episodes, quest sz, irritable, fever x 3 days;
vaccine administered to 17 yr old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 17 yr old patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 17 yr old patient). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 17 yr old patient) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information for the event was provided.  This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
@ days after injection of pneumococcal vaccine, she developed a reddened area about 3" in diameter, some soreness, and slight swelling of area.  She is to use ice to area and Tylenol.
Extreme pain under armpit; same arm as injection site. Started after day 1 from getting the shot and ispersistent. By day 3, affecting sleep. The pain from under arm is also extending to hands and fingers, but not as pain but feels slightly swollen.
After taking shingles vaccine, at 11pm I had a fever, shivering, and pain on my right arm where the shot was made.  It was hard to sleep and I had to get up frequently for the  bathroom. The next day I was very tired and still feverish
Initial report received from a Health care professional on 28 April 2014. A 35 years old female patient had received subcutaneously a third dose of Yellow fever vaccine (Lot number UH673AA) in the left arm on 21 April 2014 at 9 AM. The patient had seasonal allergy and hypertension as medical history and the patient had received the first 2 doses of Yellow fever vaccine- lot number, route and site of vaccination in 2004 on an unspecified dates. On 26 April 2014 at 12.00 PM developed with red raised warm and thick area on left arm of the size of a tennis ball 7cmX 4cm. The patient had also received HCTZ 25 mg TOD, NORVASC 10mg TOD and Centrum daily. The patient had denied providing the illness at the time of vaccination. The laboratory details and corrective treatment were unknown. At the time of this report the patient was recovered. Documents held by sender: none.
for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 27-AUG-2011, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on 02-FEB-2015, the patient was treated by a physician, for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
My heart skipping and jumping, then pounding and it won't stop. Been doing this for almost an hour now. I think I may go to the hospital. I am home by myself right now, but if this keeps up, when my husband gets home, we'll go get checked-out. I took 2 aspirin to try to help it stop.
Loss of appetite several hours after vaccination; nausea; insomnia; extreme fatigue; muscle aches.  Lasted from approximately 5:00 p.m. on 11/01/2019 through 11/03/2019.  Stayed in bed and slept intermittently all day 11/02/2019 and 11/03/2019.  All symptoms resolved 11/04/2019.
cataract; Flare up asthma; cold; dizzy; weight gain; This is a spontaneous report from non-contactable consumer (patient) by Pfizer. A  78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included ongoing severe asthma, high cholesterol, high blood pressure, inflammation, fluid around heart, depression, forgetfulness, headaches and reflux. Concomitant medications included omalizumab (XOLAIR), prednisone, montelukast, atorvastatin, azelastine (AZELASTINE HCL), albuterol sulfate, fluticasone propionate, salmeterol (WIXELA INHUB), hydrochlorothiazide, tiotropium bromide (SPIRIVA RESPIMAT), theophylline, amlodipine, pantoprazole all taken for an unspecified indication and start and stop date were not reported. On an unspecified date, the patient experienced cataract, flare up asthma, cold, dizzy and weight gain. The outcome of the reported events was unknown.  No further information was reported. Information on the lot/ batch number has been requested.
NEUROLOGICAL: MEMORY LOSS, CONFUSION, BLANK STARE, HEAD WILL TURN, EYES WILL GO FROM SIDE TO SIDE QUICKLY. CHEMICAL TASTE IN MOUTH. PATIENT HAS BEEN TREATING WITH PEDIATRICIAN. ONSET SYMPTOMS WERE AS IF THOUGH PATIENT HAD BEEN POISONED. CHILD CANNOT PUT ON HIS SHOES OR PANTS WITHOUT ASSISTANCE.
Tightness in forehead and chest, mild headache, heavy breathing, heart pumping, fatigue, lethargy, weakness. insomnia, constipation. After weekly self-injections of methotrexate, symptoms worsen; after about ten days, signs of imminent shingles outbreak begin. Doctor has prescribed course of acyclovir and has advised postponement of upcoming Actemra infusion.
Pt recvd 2 Engerix-B vax 3MAY91 & 12SEP91 & pt exp rash on chest & back of neck next day; itching inc during the day; pt seen in ER & recvd DPH;
Local erythema & induration, intense pruritus (L) upper arm. Rx antihistamines.
Information has been received anonymously regarding a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced redness at injection site.  No further information is available.
Patient received Moderna full dose of 0.5 ml instead of 0.25 ml. Talked to Moderna on 10/26 to get information on the vaccine and talked to patient on 10/30 in person. She said that she did not experience any side effects from receiving the vaccine.
Patient reported feeling lightheaded within 15 minutes of vaccination.  BP decreased and patient was transported by EMS to ER.