chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her daughter who on an unknown date was intramuscularly vaccinated with 0.5 ml of the three doses (0, 2 and 6 months) of GARDASIL (lot # and expiration not reported) series. Consumer reported that her daughter had the three doses of GARDASIL and had HPV 16. It was unspecified if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. No further information is available.
Redness - swelling with itching noted ER and deltoid area. Benadryl - Ibuprofen given, ice packs applied.
After receiving my 2nd dose of the Moderna Covid 19 vaccine, I have developed sexual health issues.  I have developed signs and symptoms of Peyronie's disease.  These symptoms have been persistent since receiving the Moderna vaccination.  I have been experiencing painful erections and also have difficulty maintaining erections.
Rash started on trunk approximately 4 days after receiving one year vaccination.  Rash moved from back and stomach down to legs and arms and to the back of the neck.  Seen by doctor on 02/21/2006, doctor states hives.  Gave Zyrtec which made rash worse - started Zyrtec 02/21.  Stop given Zyrtec on 02/22/.  Rash looks like measles rash.  Fever one day of 101 degrees.  Made appointment to see Allergies.
Had TD vaccine on 5/30/00. Symptoms began at 15:00 on 5/31/00. Pt complained of headache, fever, increased fatigue, pinkness and swelling at injection site and nausea. Referred to his MD on 6/1/00 for exam and antihistamine for swelling.
Initially with left shoulder pain following both influenza quadrivalent vaccine and HPV9 vaccine. Over time he had decreased ability to lift his arm above parallel to the ground. He did not report until 4/24/17 at visit. Has been referred to physiatry, but as yet has not been evaluated.
Fever, 99.9, exhausted, eyes feel tired and burn, lower ribs hurt, she?s feels tight?.have no energy
Moderna COVID-19 vaccine# 1 in series administered. A 56-year-old female completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: Pseudo seizure. Action(s) taken: Epinephrine administered. Allergy to COVID-19 vaccine documented in allergies activity. Patient advised to discuss second dose considerations with a clinician.
Started to have chills, shivering, muscle pain, headaches and restless sleeping. Had to take next day off from work
Morerna 2 vaccine was admitted on Jan. 24  at 3:45 pm from the Hospital. Mild Cheer, muscle, fever and diarrhea on 25th. On 26th, Moderate symptoms abdominal pain.  On 27, Mod localized Abdominal pain developed and 28the 4:30 am entered to ER. Blood work and CT done.  Dx: Appendicitis   . Transferred to higher level of care   OR at 3pm and Surgery was done at 5:00pm with Appendicitis with burst.  Discharged from hospital on 30 th at 2pm
Unexplained bruising started 6 days after receiving vaccine. Bruising to bilateral posterior thighs extending to posterior knee and up to lower back as well. No trauma. No sign of anemia in initial labs.
Patient received 0.5ml of Moderna Booster instead of 0.25ml. Patient did  not have any adverse reaction to vaccination.  Patient is G1 P0 and is 16wks. EDD 07NOV2022
I gave the patient 0.25mL instead of the required 0.5mL. As soon as I realized it, I called her back and asked her to come in. I gave her the rest of the full dose (0.25mL) to make it a complete dose of 0.5mL in her left deltoid, as she requested, (1 inch) from the previous dose given in the morning. The time of this dose: 2 pm.
Body aches starting 6 hours after injection 99 degree fever at 7 hours after injection Fever 100-103 degrees and chills 10 hours to 15 hours after injection  Fever reduced by using Tylenol, continued throughout the next day Fatigue until approximately 45 hours later
Vaccine was administered after the 10 week BUD after receiving vaccine from Department of Health. No reported ADE from patient
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding several nursing home pt's who experienced influenza-like symptoms, after possible accidental exposure to health care workers or family members who received Flumist.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) therapy were not provided. Concomitant medications were not reported.  Several nursing home pt's became sick with "influenza-like symptoms," after possible accidental exposure to health care workers or family members who received Flumist.
Headache - Aleve myalgia - Aleve Diarrhea - Imodium Nausea - Zofran fatigue
Swelling of the face, fever, face pain on cheeks, swelling of lymph glands, redness on face.
Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4,  her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic  reports she coached the client on her breathing  to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.
Red splotches on calf, not raised, resolved within a week, dr was notified, no specific treatments mentioned by pt, did not recieve 2nd dose per dr instructions
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. date of refrigeration 7 May 2021.
On 11/13/2022, I was having a scratchy throat. I tested at home and is was negative. I tested again on the third day, and I was feeling like I get hit by a truck. I had wheezing, earache sore throat, coughing and nasal congestion. I tested on that Friday, and it was positive. I went to a care clinic. I was prescribed Paxlovid. I was weighing the risk of having a rebound because of my age. I took it on Friday evening and through five days into that Wednesday morning. It was a few side effects of very bitter taste, and nausea, diarrhea and headache.  I finished it all and I have no more side effects now. I have very mild symptoms at this point, with a minor cough and headache. It worse at night. The COVID-19 symptoms have gone away.
Started with dizziness and then facial drooping. Hospital was unable to identify so they sent me home. I saw my neurologist, but by then the facial drooping healed. However, I am still dizzy and experiencing nystagmus. My neurologist believes it may be some sort of palsy like Bell's, but it is unknown and we are treating it like it is with steroids. I am unsure if this is related to the vaccine, but thought I should report it anyway.
SHOULDER PAIN; MUSCLE ACHES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and muscle aches. This report was non-serious.
I had a scratchy throat on Sunday night. I woke up sinus pressure. ear pressure and pain, sore throat, non-productive cough, headache, body ache, fatigue, and a low-grade temperature. I had a virtual visit on the March 20, 2023, after I tested positive for COVID-19, which prescribed Paxlovid. I finished it in five days and was feeling pretty good. I started feeling terrible on the March 27, 2023, and tested and was positive again, so I had a second virtual visit, and have been managing with over-the-counter medicine. I have not tested since March 27, 2023
The third dose - My hiccup burps were still there, if I had Covid - like symptoms I think I slept them off, they didn't last as long as the last ones. But in general, my acid reflux has gotten worse. I went to doctor recently for it, because I wasn't sure what was wrong. I also started to have bowel problems, and bloody stool, and white diarrhea, and wasn't sure if they were related. I saw him on 04/04/2022, and she sent out an emergency referral to a GI. On 4/07/2022, I went to the ER and now have an endoscopy and colonoscopy scheduled for next week. I've also been experiencing body pains, and also have a UTI. Dr. has checked my organs, gall bladder, appendix, etc., and they seem to be fine. Regular Dry performed bloodwork; it came back pretty normal. ER also performed some blood work, and they said it was a little whack but wasn't an emergency situation. The last thing I've heard from the ER, one sample had bacteria in my blood but it could be an accidental contamination. My stomach feels like it's on fire a lot of the day, and has become very tender to the touch, I've been having trouble keeping food down. Dr. prescribed a prescription antacid. I have not mentioned to my doctor that I felt this started with the hiccup-burps from my second dose. ER has put down as preliminary diagnosis gastroenteritis acute.
no adverse event; fist dose administered at 15 weeks 0 days, 1 day too late; This spontaneous report was received from a other health professional refers to a 15-week-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-DEC-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters, administered orally, lot # 1684166, expiration date 27-JUN-2021 (strength, was not reported) for prophylaxis. At the time of vaccination, the patient was 15 weeks old (was past 14 weeks 6 days, so the patient received the first dose 1 day too late).
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, strength, lot #, site and route of administration not reported). The reporter stated that ZOSTAVAX doses were exposed to 7F to 10F for a total excursion time of up to 504 hours from 01-DEC-2013 to 08-JAN-2014. The reporter was informed per stability data that this was supported as long as the overall average temperature remained between -5 degrees C and -15 degrees C (-58 degrees F and 5 degrees F). No adverse effects reported. The reporter stated that further evaluation would be needed to determine if overall average temperature remained at the recommended storage temperature of -58 degrees F and 5 degrees F. No adverse effects were reported. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), patient was treated a doctor for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not provided. The lawyer considered shingles to be related to zoster vaccine live(ZOSTAVAX).
Numbness on left arm, tingling down to fingers. Feels like electricity running down to fingers. Lt hand feels cooler than right hand.
I95.89 CHRONIC HYPOTENSION 11/12/2021 ATHEROSCLEROSIS OF AORTA
Sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE, VITAMIN D3, VITAMIN B6 and MAGNESIUM for an unknown indication.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included 5HTP.  No treatment information  was provided by reporter.   This case was linked to MOD-2021-222979 (Patient Link).
pt c/o aches & pains, chills, unable to get up from bed, sick to stomach;
APPROXIMATELY 2 HOURS AFTER VACCINES ADMINISTERED THE PATIENT DEVELOPED FEVER (105 DEGREES), ASSOCIATED VOMITING X 3, AND DIARRHEA X 1.  SOON AFTER ONSET OF FEVER HE DEVELOPED CLONIC SEIZURES X 3, INVOLVING ARMS, LEGS, AND TRUNK.  HIS EYES ROLLED BACK AND HAD ALLEGED CYANOSIS OF LIPS.  THESE LASTED APPROX. 2 MINUTES.  HE AWOKE IMMEDIATELY THEREAFTER.--PER PARENTS.  3/28/07 Received medical records from hospital which reveal patient experienced bilat otitis media w/mucopurulent rhinitis treated w/antibiotics & resolving on the day of vax.  Approx 2 hrs s/p vax, had fever of 105 w/ vomiting/diarrhea & tonic clonic seizures x 3 w/ central cyanosis. Admitted 3/23/07-3/24/07 & progressed well w/only 1 temp spike & associated seizure.  FINAL DX: Febrile seizures s/p vaccination; vomiting/diarrhea, resolved; bilat otitis media, resolved.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: pt stated dizzy feeling faint headache neasuea weakness i sat with her for  around 30 minutes until she felt better
Information has been received from a registered pharmacist concerning a 60 year old caucasian female who on 10/20/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine, subcutaneously in the left arm.  Therapy on 10/13/2004 included influenza virus split virion 3v vaccine inactivated influenza virus split virion 3v vaccine, also in the left arm.  There was no illness at the time of vaccination.  On 10/21/2004 the patient developed minor pain and redness at injection site.  On 10/22/2004 the patient developed swelling and redness 3 inch diameter, 2-3 inches away from the injection site had a patch of redness approximately 2x3.  There was no itching, but a little warm.  There was no treatment given.  It was reported that two days later, the redness disappeared.  No additional information is expected.
RED PIN POINT DOTS ON STOMACH; LATE/ABNORMAL PERIOD; LIGHT PERIOD WHICH WAS USUALLY HEAVY; FELT HORMONAL ANXIETY, PIT IN STOMACH; NAUSEA; FELT DRAINED AND TIRED; TREMENDOUS HEAD PRESSURE; LIFTING DIZZINESS; ATE BUT DID NOT FEEL LIKE EATING; LEG PAIN; FELT OUT OF CONTROL; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A71A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt out of control. Laboratory data included: Blood test (NR: not provided) complete blood count, vitamins and thyroid : Normal. On 13-APR-2021, the subject experienced leg pain. On 16-APR-2021, the subject experienced lifting dizziness. On 16-APR-2021, the subject experienced ate but did not feel like eating. On 16-APR-2021, the subject experienced tremendous head pressure. On 16-APR-2021, the subject experienced felt drained and tired. On 17-APR-2021, the subject experienced felt hormonal anxiety, pit in stomach. On 17-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced late/abnormal period. On 19-APR-2021, the subject experienced light period which was usually heavy. On 21-APR-2021, the subject experienced red pin point dots on stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt drained and tired, lifting dizziness, nausea, ate but did not feel like eating, felt hormonal anxiety, pit in stomach, tremendous head pressure, leg pain, and red pin point dots on stomach, and the outcome of light period which was usually heavy, late/abnormal period and felt out of control was not reported. This report was non-serious.
The pt was limp and had a temperature of 103F which started on 11/21/01. Mom says "there's chickenpox in our family right now too. I called the MD and the receptionist said to give her ibuprofen." Mom was advised by the RN to see her MD or go to ER. On 11/26/01, the mom stated "the child was seen in ER and given Benadryl. She ran a fever for 2 days, but is fine now".
DIARRHEA; BODY ACHES; HEADACHES; This spontaneous report received from a consumer concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1812072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headaches, diarrhea, and body aches. This report was non-serious.
Presented with numbness and weakness in his legs and trunk.  Diagnosed with transverse myelitis by thoracic spine MRI.  Given IV steroids for five days.  Worked up extensively by neurology.
My menstrual period arrived 2 days early, on 12/23/21. It was not due until 12/25/21. I continued to experience menstrual bleeding for 12 days, with my last day of bleeding 1/3/22. My typical period lasts only 3 days. I sent a message to my doctor on 1/3/22 to ask if I should be concerned about the extended bleeding and was reassured that I should not be concerned at this time.
Fever, shivering, rash on thighs, achiness in upper back (like shingles were starting). Fever started first, along with shivering. The rash on thighs started after that, about 3 days after the vaccine. Once that resolved, then the fever in the skin around my spine around my left side started and resolved about 7 days later.
Allergic reaction only to covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jan2022 as dose 2 (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, lot number unknown), administration date: Dec2021, when the patient was 11 years old, for covid-19 immunization, reaction(s): "Allergic reaction only to covid vaccine - previously reported". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergic reaction only to covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309430 same reporter/patient, different dose number/events;
Rhabdomyolysis. Persistent muscle aches persisting from time of vaccine to time of presentation and diagnosis 1 mo later. Muscle weakness started 2 wks after vaccination
PATIENT RECEIVED AN EXPIRED VACCINE - RECONSTITUTED THE EVENING BEFORE. I OFFERED TO REVACCINATE IMMEDIATELY BUT PATIENT DECLINED AND AGREED TO COME THE FOLLOWING DAY FOR REVACCINATION
Expired RotaTeq given to patient. RotaTeq expired on 4/26/2013.