chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Evening of the 19th pain both shoulders at the injection location. Continued pain along with a rash on the 11/21/18 on both shoulders. In order to treat this the patient took TYLENOL 2-500mg that night(11/19 and 11/20) and 2-500 mg the next morning (11/21). Patient took BENADRYL (11/20, 11/21 ,and 11/22, 11/23, 11/24, 11/25 and 11/26). Rash resolved on the morning of 11/25. Pain has resolved on 11/26.
11 y.o. F with rashes of bilateral deltoids, pruritic, warm to touch. Dx: Prob reaction to vaccine preservatives.
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.  Tested for covid antibodies.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 12:30 (Batch/Lot number: unknown) 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: HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Headache".  Additional Information: The reporter reported on behalf of patient (daughter) that, the patient had vaccine (Covid Vaccine) and had some headache, little bit of headache. The reporter wanted to know that can the patient could be given Tylenol or Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to email/fax form back), DIZZINESS (lightheaded and constant dizzinesss), VACCINATION SITE PAIN (soreness of the injection arm) and NAUSEA (a little nauseated) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma and Blood pressure. Concomitant products included MESALAZINE (MESALAMINE) for Ulcerative colitis, MULTIVITAMINS [VITAMINS NOS] and HYDROCHLOROTHIAZIDE for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness of the injection arm). On 03-Feb-2021, the patient experienced DIZZINESS (lightheaded and constant dizzinesss) and NAUSEA (a little nauseated). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to email/fax form back). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to email/fax form back), DIZZINESS (lightheaded and constant dizzinesss), VACCINATION SITE PAIN (soreness of the injection arm) and NAUSEA (a little nauseated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were Blood Pressure medicine, Eye drops for glaucoma, Allergy medicine and Medicine for his prostate. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-June-21. No new information provided. According to the information  provided by the CC agent and confirmed by caller there is no previous case corresponding to provided names, telephone number or address. On 13-Jul-2021: Follow up received on 13 JUL 2021 and added concomitant medication. added newevent.
Site: Redness at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient says node is getting bit better and will keep and eye out on it. He says will go to urgent care if anything.
About 10 hours post injection my shoulder joint become extremely painful.  So much so that I couldn't move it in any direction.  It took almost 3 days before I was able to truly use the extremity again.  Ever since I have had loss of strength and sharp pain in the shoulder joint with movement.
Post Menopause for 22 months.  I Have had not bleeding or spotting in those 22 months.   2 hours after the shot I started bleeding heavily with large size blood clots.  I have been bleeding  for 21 days straight.
Severe left deltoid restriction in complete range of motion. This gradually improved over the next day but 10 days post vaccine I  am still having left AC joint pain with internal rotation and full overhead extension. The pain often stops me from completing tasks such as taking off my shirt or extending my arm in front of me with any type of weight in it (even a water bottle).
Approx 15 minutes post vaccine patient sts he feels flushed with no other symptoms. 25 minutes post vaccine pt sts feels like it's hard to swallow, tongue is swollen and throat itches. Alert, oriented. No rash or swelling to face or neck noted. Tongue did not appear swollen. No shortness of breath. Pt appears anxious. Reports no pain. BP 110/palpation, HR 73, RR 20 oxygen sat 96%. EMS notified. Pt declined transport but may have been transported to the local hospital,  of the . Unknown if wife drove him. Pt stated he wanted to go home to take some Benadryl which he takes for seasonal allergies.
Red spots(circles) appearing on different sections of my body, itchy! Today is 6/14/2021 and I have some that appear yesterday on my left arm and chest area.
Corneal ulcer in her left eye; A spontaneous report was received from a  consumer concerning a 58-year-old, White female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced corneal ulcer in her left eye/ulcerative keratitis.  The patient's medical history, as provided by the reporter, included dry eye, kidney stones and osteoporosis. Concomitant medications reported included indapamide, alendronate sodium, ciclosporin.  On 9 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment details included erythromycin and desivance eye drops.  On 9 Jan 2021, at noon the patient experienced a corneal ulcer in her left eye a medically significant event.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event corneal ulcer in her left eye was not reported.; Reporter's Comments: This case concerns a 58-year-old, White female patient, who experienced ulcerative keratitis in her left eye, the day the first dose of mRNA-1273 was received. Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The patient's medical history of dry eyes remains a confounder.
Painful itchy rash on legs, back, front torso and arms. Has persisted for over 2 months. As of 8-22-2018 my lower arms are still inflamed and painful. Took steroids when it became too bad for me to go to work. Will not get 2nd dose as recommended.
About 12 hours after vaccination, patient reports TMAX 103 from 10pm to 7am when it broke and declined to about 101 degrees, bodyaches and headache. Patient reports a low grade fever entire day of 8/9 until about 4pm when it finally broke. Currently has been afebrile since 4pm on 8/9.  Left arm injection side erythematous and edematous and firm. Dimension of redness 5.5 in x 2 in and outlined to continue to monitor spread of redness. Patient reports onset of Migraine about 12 hours after vaccination as well.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies drug reactions, allergies  or medical history provided. On unknown dates, the patient received the three-dose vaccination series of RECOMBIVAX HB (route and site of administration, lot # and expiration date were not reported) for prevention of Hepatitis B. The patient was vaccinated at the appropriate age and interval, as stated in the prescribing information. On an unknown date, the patient had Hepatitis B serologic testing done and it was showing reduced antibody response. On an unknown date, the patient sought medical attention by going to pharmacy and did not receive any treatment for the event. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Swollen lymph nodes right armpit 03/10/2021, still visible 4/13/2021. Swollen lymph nodes under left eye 03/09/2021 to 3/11/2021 gone.
Dose received: 3; Chills; Fever of 101.9; Vomiting; Can't stay awake; This is a spontaneous report from non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 14:30 (Lot number: FE3594) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0162, Anatomical location: Left arm), administration date: 13Apr2021, when the patient was 31 years old, and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0172, Anatomical location: Left arm), administration date: 04May2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Fever of 101.9"; VOMITING (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Vomiting"; SOMNOLENCE (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Can't stay awake". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, vomiting and somnolence. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Approximately 5-10 minutes after receiving the vaccine patient fainted and slid out of chair onto floor. Patient regained consciousness within a 1 minute of event occurring. After patient was hot, pale, and sweaty. Patient DID NOT complain of nausea, vomiting or visual changes.
Starting the second day after the vaccination, the patient's body aches and she has a fever of 103.5F. These symptoms lasted until 6 days after the vaccination.
Three inch diameter swelling, erythema and pain surrounding injection site x 1 week, resembling arthus type reaction.
Generally feeling ill, body aches, headache, raised red area at injection site, painful arm, fatigue
Sore arm, very thirsty, not hungry, diarrhea, dizziness, fatigue, lack of strength, uncoordinated and jerky motions.  Needed assistance to move around at home.  Even to sit and stand. All of these symptoms for 2 days.
On Saturday (2 days after receiving vaccine) patient noticed a rash on her arm. The rash was itchy and continued to spread across her entire upper arm until she reported to the pharmacy on Monday morning. The rash was warm to the touch.
Headache, extreme arm swelling and redness in entire arm. Painful sleeping due to arm swelling and pain.
I26.09 ACUTE COR PULMONALE 12/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 12/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 1/10/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
no adverse event; The patient inadvertently received a dose of PROQUAD instead of MMR II and/or VARIVAX; This spontaneous report as received from a medical assistant refers to a 15 year old patient. The patient received his/her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) in May of 2022 (exact date was unknown). The medical assistant stated the patient was receiving "catch up vaccinations". The patient inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot # W004030 exp date 02-AUG-2023) on 08-JUL-2022.and did not receive a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and/or varicella virus vaccine live (oka/merck) (VARIVAX) wrong product administered). The patient had never received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the past. No adverse effects were reported.
Saturday Fever of 100.4 Body aches  Severe headache  Fatigue Arm pain and swelling.
Information has been received from a Registered Nurse concerning a patient who on 14-APR-2009 was mistakenly vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect was reported. No further information is available.
still have pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (still have pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, 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 PAIN (still have pain at the injection site). At the time of the report, VACCINATION SITE PAIN (still have pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Hardened bump two inches below injection site; Red; Itchy; Headache; Flushed Face; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Flushed Face), VACCINATION SITE MASS (Hardened bump two inches below injection site), ERYTHEMA (Red), PRURITUS (Itchy) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa) and Drug allergy (thimerosal).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FLUSHING (Flushed Face) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced VACCINATION SITE MASS (Hardened bump two inches below injection site), ERYTHEMA (Red) and PRURITUS (Itchy). At the time of the report, FLUSHING (Flushed Face) and HEADACHE (Headache) had resolved and VACCINATION SITE MASS (Hardened bump two inches below injection site), ERYTHEMA (Red) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant Follow-up Information received on 23-JUN-2021; Reporter contact details are updated.
No adverse event; patient received vaccine beyond its use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine beyond its use by date) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-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 25-May-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 (patient received vaccine beyond its use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine beyond its use by date) 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 (patient received vaccine beyond its use by date).    It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. No treatment medication was reported.
Arm was swollen, painful, feverish, rash like in a 5 inch radius circle.  Patient put ice on red area, and took ibuprofen, Benadryl and hydroxyzine.  As of 9/30/15, red, painful, swollen area is decreasing in size and discomfort.
Burning in my chest, Immediately throat  tightness, episodes of  shortness of breathe lasting for hours about about 4 hours after receiving Moderna  my breathing pattern was so bad I considered ER.    Also I developed a cough about 20 minutes after the vaccine. In fact it has been a week later and I still have coughing.
Developed a fever- mostly moderated but up to 103 for 2-3 days.
This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On unknown date, the patient was vaccinated with less than a full dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). The vaccine leaked out of the syringe during administration. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Day of injection pt experienced "severe burning and itching" at injection site for next 36 hours. Pt reports edema. During today's office visit pt's right deltoid area had minimal erythema, no signs and symptoms of infection, no edema.
On 2/11/02, the pt had a fever 100.8F and a headache. Saw PCP on 2/16/02 and was given azithromycin for symptoms. No abatement; pt then given Avalox after increase in severity of fever and headache. Admitted on 2/24/02 with fever of 104F to 105F. He also had myalgia. Discharged on 2/28/02. This is most compatible with a viral illness, probable enteroviral disease. However, cannot rule out a relationship to the recent Yellow Fever vaccine. Will discontinue Tamiflu without further evidence to suggest influenza and add doxycycline empirically.
Moderna Covid Vaccine EUA I got numbness in my throat. I had a bad taste in my throat coming from my sinus area. The taste is like a bottle of nasal spray has been poured down my throat. This is the third day and I am still tasting this shot.
8 days after getting the first dose of Moderna Vaccine I woke to a hot swollen left arm with a huge red, itchy patch and pain in my arm.  It is now 7 days later and I still have redness and a bit of heat.  I read all about Covid Arm and I am assuming that is what it is.
Patient with tachycardia and elevated BP about 20 min following vaccination; O2 sat okay; sat down for 15 min and symptoms resolved without treatment
pt recvd vax & exp fever 100-101, pain in rt arm extending to fingertips;arm was ore several days;pt nauseated; had gen aching; pt is a diabetic
PRIMARY (1st episode) of Shingles. Had Shingrex vaccine series 2019
Patient fainted after 15 minutes from the shot and had a bump on the head from fainting.
Patient 2 hours after receiving injection started to have hives on hands feet and face.  Provider advised to give benadryl.
Client complaint left arm hurts.  Left arm warm to touch at injection site. Client Afebrile 97.4, site swollen, circular shaped like 50 cent size. Parent instructed to use compresses on swollen area.
DEATH; LOW BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: 30-OCT-2021) dose was not reported, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021,  the patient experienced low blood pressure issues since vaccination, was known visited on 02-OCT- 2021. Laboratory data included: Blood pressure (NR: not provided) low. On 04-OCT-2021 after an appointment was missed patient friends went to patient house where patient was found on floor beside bed. The patient died from unknown cause of death. An autopsy was not performed at time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 04-OCT-2021, and the outcome of low blood pressure was not reported. This report was serious (Death).; Sender's Comments: V0: 20211011543-COVID-19 VACCINE AD26.COV2.S-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH