chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 9 years old, came in for second dose of moderna Vaccine. Patient was administered a dose of moderna vaccine for 6 months to 5 years of age instead 0.50 mL administered to the left arm. Monitored patient for 15 minutes and no adverse effects.  Second dose of Moderna vaccine administered today. The vaccine bottle was in a bag labeled for 6-11 year old. I looked at the vaccine bottle and it was labeled. 6m-5 years. I went to my charge nurse and informed her that this patient is 9 years old and I took this vaccine bottle out of a the 6-11 year old moderna monovalent bag however it shows 6 month to 5 years. I was informed by my charge nurse that it was the right vaccine to give even though it was labeled 6 months to 5 years. When I sat down to chart unable to find lot number and charge nurse confirmed that I was correct and it was the wrong vaccine for the age group. I called parent and informed her that her daughter received a weaker dose that was suppose to be given for 6 months to 5 years and that there won't be any side effects to be concern of but she will need to come back for another dose in about 1-2 months to receive the correct vaccine for her age. Parent understands.
red, swollen left upper are, hot at injection site, stiff arm, total body aches, on evening of shot.  Day 2 same symptoms plus nausea, exhaustion, diarrhea.  Day 3 same as listed, Day 4 arm still warm and swollen at injection site, nausea gone, still not normal bowel movements, and some aches. Day 5 arm still red and minor selling at site.
Patient presented with half of her left eye red in color. It appears as though a blood vessel ruptured. She states there is no pain associated with the eye. She had been suffering with a migraine the day prior.
pt recvd 1 dose of Engerix-B & w/in 5 minutes of inject became warm all over, diaphoretic, drowsy & dizzy; VS remained stable; recovered in about 1 hr w/o tx; had malaise for 1 day;
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. As per the provider the vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Moderna doses Stored in standard freezer. Date Stored in Standard Freezer 2 degrees F high and minus 1 degrees F low was 30-Nov-2021. No treatment medication was reported.
around 2 hours after the shot I developed a headache. I suffer from chronic migraines but this way way more intense than my normal ones. the pain was all over my head, I had vision changes being very blurry and cloudy. the pain shot all the way down my neck. i had to go to urgent care expecting to get a toradol shot and go home. instead was sent via ambulance to the ER in fear i may have had a bleed. i ended up in the ER on saturday 4/24/21. they never gave me a CAT scan i was sent over there for. instead made me sit there for 2 hours in room before being seen. then came in said here's some meds and made me wait another 2 hours. i was discharged faster than it took them to take my copay for the visit! so for having a blinding headache for 2 days they didnt take it very seriously. on top of the headache i had sever muscle and joint pain to the point i couldnt move. i couldnt keep food down either.
Chills and fever and achey, headache forehead, arms and legs and back and no joint swelling. Immunized with BEXSERO and GARDASIL on 5 days ago. Lt arm was twitchy in area of injection the day after the immunization and has pain at injection site. Reddened area about baseball diameter warm and tender, for 3 days and now not red, nos swelling.
Extreme pain and stiffness migrating from the left shoulder to the back and radiating to the neck and into my head around my left ear. Neck and head pain has cause prolonged episodes of vertigo. Normal functions like sleeping and driving have been difficult since the neck stiffness does not allow me to turn my head. Dr. is sending me to physical therapy. I have not started that yet.
This is a spontaneous report by a contactable nurse. This is second of the three reports. This nurse reported that a patient (age and gender unknown) received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were unknown. Other vaccines given to the patient were not reported. Vaccines taken within the last four weeks were unknown. On an unknown date after vaccination, the patient experienced swelling and redness at the site of injection. Relevant lab data was unknown. Treatment regimen was not reported. At the time of the report the clinical outcome of the above event was unknown. Follow-up (14JUL2011): Follow-up attempts completed. No further information expected.
(L) arm, erythema, swelling, tender to touch. Local Rxn to vaccine.
Information has been received from a pharmacist concerning a 65 year old female with no known allergies who on 12-DEC-2007 was vaccinated SC in the upper arm with a 0.65 ml dose of Zostavax (Oka/Merck) (lot # 658605/1089U).  "About 2 weeks after vaccination" on approximately 26-DEC-2007 the patient developed paresthesia in her feet, shins and one of her lower thighs (side not specified).  The patient saw a neurologist and had a motor/neurologic evaluation.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Patient was given his 2nd Pfizer vaccine 6 days before the recommended time between the 1st and 2nd dose.
Inappropriate Age at Vaccine Administration; Malaise; Headache that "made his hair hurt".; Flu-like symptoms; made his hair hurt; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced malaise, headache, influenza-like symptoms, scalp pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the malaise, headache, influenza-like symptoms and scalp pain were resolved with sequelae and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the malaise, headache, influenza-like symptoms and scalp pain to be related to Shingrix.  Additional details were reported as follows: HCP was self-reporting that he got Shingrix and he was under the age of 50 (estimated that he was 38 years old), which led to inappropriate age at vaccine administration.   The day following vaccination the patient experienced malaise, flu-like symptoms, and a headache that made his hair hurt.   The symptoms lasted 1 day and then subsided the next day. This case has been linked with US2019183216, reported by same reporter.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: PAA165969) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Monocryl stitches" (unspecified if ongoing); "Known allergies: Dermabond glue" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; ETHINYLESTRADIOL. Past drug history included: Zithromax, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.
Patient reported lighted headedness, body tightened and then quickly passed out. Immediately after I called for Dr. and layed patient on back with feet elevated and obtained pulse of 42 and o2 of 100. Patient regained consciousness, drank water, continued to stay laying for 45 mins while watching vitals stay stable. Patient left clinic after provider discharged.
No adverse symptoms were reported; One patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a nurse, concerning a 9 week old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 13-DEC-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route lot # R035673 with expiration date of 19-SEP-2020, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided. The storage temperature of the vaccines was reported as above 9 Celsius degrees (12 Celsius degrees) for a time frame of 12 hours and 14 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse symptoms were reported.
Underage patient receiving vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient receiving vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient receiving vaccine). On 25-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient receiving vaccine) outcome was unknown. 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 medication was reported.  Treatment information was not provided.  Upon in internal review on 18 May 2021, the age was corrected to 14 years.
Information regarding Prevnar was received from a healthcare professional regarding a 7-month-female patient who experienced irritability, low muscle tone/stopped waving, balance was off, tired, stopped babbling and slight fever. The patient received a dose on 24-Jan-2007. Additional suspect vaccine received on the same day included Act-Hib. On 25-Jan-2007, one day post vaccination, the patient's mother called to report her child experienced irritability, low muscle tone/stopped waving, her balance was off, she was tired, stopped babbling and a slight fever. The patient was evaluated by her physician on 29-Jan-2007. The events lasted for two weeks and subsided. The reporter indicated the child appears to be fine now. No additional information was available at the time of this report.
Information has been received from a Nurse Practitioner concerning a 23 year old female with a history of asthma and cow's milk allergy who on 15-JAN-2008 was vaccinated with her 1st dose. IM with Gardasil (lot # not provided). On 15-JAN-2008 the patient developed a "fine red rash all over her face that itched within an hour post injection." Subsequently, the rash lasted for an hour and cleared on its own. The patient sought unspecified medical attention. Additional information has been requested.
patient received flu vaccine and sat down for a few minutes. As patient sttod up and started walking he felt dizzy and fell to the gound. He was alert and knew his name date and where he was. Patient's major complaint was thathe was light headed, pale, and nervous. The EMT was called and reported patients vitals were all within normal limits.
slight swelling to inferior tongue after 15 minutes.  given 50 mg oral Benadryl.
Since Jan 2022 had unintentional weight loss of 45 lb. Then in nov 2022 had shortness of breath. Work up eventually showed stage 4 colon cancer with Mets to lungs and also diagnosed with lymphoma.
This spontaneous report was received from a pharmacist regarding an approximately 61 year old female patient. The information on medical history and concurrent conditions were unknown. She did not have any drug reactions or allergies. On 21-MAR-2015, she was vaccinated with ZOSTAVAX 0.65 milliliter, Product lot # K020185, expiry date reported as 27-JAN-2016, taken subcutaneously. The information on concomitant medications was unknown. On an unknown date in March 2015, after receiving vaccination, she experienced a lump and itching around injection site. No treatment was given for the adverse events. The patient had spoke to pharmacist and sought medical attention. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Patient got Shingrix vaccination at 230pm on 07/28 at Pharmacy.  Patient went home and stated he was sitting in the sun for a short period of time, and noticed three bumps(possibly hives as described by patient) on both his thumbs and one ankle at approximately 345pm.  Patient took 2 capsules of diphenhydramine 25mg at approximately 4pm.  I followed up with patient an hour later, and the bumps had decreased in size; and hadn't spread.  Patient stated he was feeling fine.
10 day status post vaccine equal to macular rash on trunk and extremities, sparing diaper area no vesicules/pustules.
Woke up in the middle of the night after getting vaccine disoriented, unable to stand without help. Loss of balance, little feeling in the right side of my body (legs, hands, arms), babbling/not making sense. Kept falling to the right, unable to keep standing up without help from my fiancé. Had a severe headache, had to take motrin and use an ice pack to fall asleep but was also super out of it/drowsy. I've had a headache and unusual neck pain every day since. Still feeling extremely drowsy 6 days later.
Patient received 0.2mL of undiluted Pfizer pediatric (5-11yrs) COVID vaccine. No adverse reaction noted. Pt was kept extra x30min in observation. Parent informed of dosing administration error and given VIS, sx to observe for, when to seek emergency attention, and VAERS information sheet in case of later reaction.
ON 4/4/21 PT EXPERIENCED SHOULDER PAIN, HEADACHE AND ANKLE PAIN AND NUMBING ON HANDS, ON 4/27 PT WENT TO URGENT CARE MD PRESCRIBED MEDROL DOSE PACK, AND MOTRIN. PT WAS INSTRUCTED TO FOLLOW UP WITH DR  AND  RECOMMENDED TO GET AN MRI 4/29 PT DEVELOPED COUGH
Itchiness, redness on injection arm, shortness of breath within 10 minutes of injection.
This spontaneous report as received from a registered pharmacist refers to a 70 years old male patient with "CHF" (chronic heart failure). The patient was vaccinated IM with dose 1 and dose 2 PNEUMOVAX 23 on 03-JUL-2012 and 05-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that prior to 03-JUL-2012, the patient had already been admitted to the hospital for CHF, and was still in the hospital. On 05-JUL-2012 the patient was found to have decreased oxygen sats. The patient had not recovered. No treatment information was reported. The relatedness for decreased oxygen sats is unknown for PNEUMOVAX 23. Additional information has been requested.
PATIENT REFERS THAT THREE DAYS AFTER ADMINISTRATED THE FIRST DOSE OF COVID-19 VACCINE, PRESENTED INFLAMMATION IN THE AXILLARY GANGLIA.
12 hours after shot - extreme migraine with nausea, sensitivity to all light, noise and movement along with chills, fever, muscle and joint pain - most symptoms gradually decreased over following 24 to  72 hours with acetaminophen (2-500 mg)  taken every six hours over 72 hour period.  Chills and headache lasting entire 72 hour period
Client reported Hx of fainting from needle injections.  After injection, client reported feeling weak. Client was assisted into a gravity chair for 30 minute observation and provided bottled water and cheese cracker snack. Initial blood pressure 94/54 and heart rate 44. After 30 minutes, vitals returned to within normal limits and client reported feeling "almost 100%" and called for a ride home. Client denied any other side-effects. Client was provided education on vaccine and was advised to seek emergency medical services if side-effects return or worsen. Client left facility unassisted and had a steady gait.
administered 0.5 mL, should have been 0.25 mL for booster dose
" Per Agency and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and HA instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes."
Information has been received from a physician concerning an 8 month old black female with no known drug allergies, who on 02-AUG-2007 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant suspect vaccinations included ROTATEQ.  Concomitant vaccinations included PEDIARIX, ACTHIB, and PREVNAR.  On 22-OCT-2007 the patient was seen in the office at 2 months old with complaints of cough, fever, and throwing up for four days.  It was reported that the patient was breast fed and formula fed.  The patient had wet diapers and post tussive was decreasing.  The patient was vomiting small amounts, there was no projectile vomiting and no sick contacts.  The signs and symptoms of dehydration were reviewed and to follow-up with the physician.  The patient was diagnosed with viral syndrome.  On 02-JAN-2008 the patient was brought to the clinic by her mother.  The patient experienced vomiting and cough.  It was reported that the patient would throw up after coughing or feeding.  It was reported that the patient was alert, active, afebrile, not in acute respiratory distress, and no dehydrated.  The patient was diagnosed with an upper respiratory infection.  The instructions were to increase oral fluids kept at room temperature 68-72 degrees F and to follow-up at next appointment on 08-JAN-2008.  The patient was also prescribed CARDEC DM, 0.5 CC by mouth four times a day for 3-5 days, and PEDIALYTE.  On 28-JAN-2008 the patient was brought in by her mother with complaints of cough and cold.  The patient was diagnosed with an upper respiratory infection and phyaryngistis.  The patient was treated with amoxicillin 125mg/5mL by mouth three times a day for 10 days, nasal saline drops, and infant TYLENOL (8mg/0.8mL) 0.8mL by mouth every 6 hours as needed.  The patient was instructed to return to the clinic in 2 weeks.  On 08-FEB-2008 the patient returned to the clinic with her mother with complaints of cold, cough, and fever.  the patient experienced a fever for two days, nasal drip, cough, and post tussive.  The instructions given to the patient were to increase humidification, "VRO", increase fluids, use ball suction with saline, use drops 3 to four times, and return to the clinic in 1 to 2 weeks for physical examination.  On 15-FEB-2007 the patient returned to the clinic and it was noted that the coughing had decreased and the patient had not experienced a fever since the previous weekend.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Started swelling and redness shortly after Varicella immunization. Continued to swell, itch and increased skin temp. Area 12cm x 10.5cm with bruising in area.
Patient is fully vaccinated and boosted on 11/21/2021.  COVID + 1/4/2022 at ED visit.Complains of slight lightheadedness and shortness of breath. States that she has had a cough over the past few days which has worsened. Denies any CP, weakness, nausea, vomiting, fever, chills, diarrhea, constipation.No hx of DVT/PE. No dizziness, no diplopia, no weakness, no difficulty swallowing or speaking. CXR: no convincing acute intrathoracic abnormality evident on single view. No acute intracranial abnormality by noncontrast CT imaging. Negative troponin x2. Discharged from ED.
37 weeks pregnant admitted to the hospital with early appendicitis. Estimated due date: August 23, 2021. Received the first dose of the COVID shot around 5:15pm on 8/4/2021, and woke up around 6:15am on 8/5/2021 with lower right abdominal pain. Went into the hospital, no signs of labor so blood and urine tests were ran. White blood count was at 19.69 so a CT of the abdomen pelvis with IV CONTRAST was performed. Finding were concerning for early acute appendicitis. Received antibiotics of Ceftriaxone 1g IV qd and Flagyl 500 IV TID. After about two days white blood count went down and was released from the hospital. No effects on the pregnancy.
After the vaccine, I developed symptoms similar to COVID-19: fever, slight dry cough, mild headache, mild body aches, and chills, my son had them too. We went to the ER and my temp was 104 and my son's was 102.1. We were tested for COVID-19 and RSV, negative for COVID and positive for RSV, then sent home. Was told to follow up with PCP in a few days, and to take cold medicine to treat symptoms. My son followed up with his pediatrician and they gave him a decongestant/expectorant and told us to use the nebulizer for him if needed. The symptoms for us lasted all week. My cough started getting worse and my body chills started worsening, and when I went to the local clinic to follow up they said I tested positive for Pneumonia. I was given an antibiotic and my symptoms lasted for a few days then got better.
Extreme muscle weakness leading to fall 12 hours after injection.  Unable to walk unaided for another 12 hours.  Muscle weakness lessens but does not cease after 36 hours.