chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fussy baby; Signs of inflammation; Eye lids are red; got diarrhea all over again; Broke out into a rash all over her face/Rash in abdomen/rash started 6 hours after she(mother) received the vaccine and it got progressively worse as she nurses some more, Rash in bum area; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Fussy baby), INFLAMMATION (Signs of inflammation), ERYTHEMA OF EYELID (Eye lids are red), DIARRHOEA (got diarrhea all over again) and RASH (Broke out into a rash all over her face/Rash in abdomen/rash started 6 hours after she(mother) received the vaccine and it got progressively worse as she nurses some more, Rash in bum area) in a 4-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A and 032H21A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Past Medical History: Inflammatory Arthritis Allergies (medications, food, and other products): Egg, problem with dairy 19-SEPT-2019 patient had COVID + test or diagnosis She does not take medicine/other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     MEDICAL HISTORY (Patient): The patient's past medical history included Maternal exposure during breast feeding on 20-Dec-2021.   On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) 1 dosage form. On 17-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) dosage was changed to 1 dosage form. On 17-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Broke out into a rash all over her face/Rash in abdomen/rash started 6 hours after she(mother) received the vaccine and it got progressively worse as she nurses some more, Rash in bum area). On an unknown date, the patient experienced IRRITABILITY (Fussy baby), INFLAMMATION (Signs of inflammation), ERYTHEMA OF EYELID (Eye lids are red) and DIARRHOEA (got diarrhea all over again). At the time of the report, IRRITABILITY (Fussy baby), INFLAMMATION (Signs of inflammation), ERYTHEMA OF EYELID (Eye lids are red) and DIARRHOEA (got diarrhea all over again) outcome was unknown and RASH (Broke out into a rash all over her face/Rash in abdomen/rash started 6 hours after she(mother) received the vaccine and it got progressively worse as she nurses some more, Rash in bum area) had not resolved.            No concomitant medications were reported. Nursing mom stated that she and her baby are reacting to the Moderna COVID 19 vaccine.  Reporter's baby was 4.5 months old when mother received the vaccine. Topical steroid were used for treatment of rashes, once they stop the steroid for a day, the symptoms came back. Reporter visited the pediatrician and allergist and they prescribed steroid. It was also reported that this was day three that they stopped the steroids and patient was having the symptoms again, that was the third time reporter tried to stop the steroid   This case was linked to MOD-2022-507351 (Parent-Child Link). This case was linked to MOD-2022-506778 (Patient Link).   See case MOD-2022-507351 for details regarding the child case.
Narrative:  Myalgias, SOB, lightheadeness, inability to take care of self soon after COVID shot; likely due to known possible adverse effects from the shot. Also has positive trops and slight rising trend and an episode of chest pain this morning, which is concerning ofr Type I vs Type II NSTEMI. Currently on ASA Transferred to higher level of care. Found to have PE.
Fully vaccinated individual became symptomatic for COVID-19 on 8/9/2021 and tested positive on 8/10/21.
A report has been received from a Health Professional concerning, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter stated that on 10-Dec-2013 there was administration of expired FLUMIST in error to the patient. The outcome of the event of administration is unknown. The report was considered to be non-serious.
Received flu vaccine on 12/9/13 and 12/10/13 started to experience flu-like symptoms - body aches, fever enlarged tender cervical nodes and swollen vagina vulva.
This is a spontaneous report from a contactable consumer reporting for herself. This 90-year-old female patient received a single dose of PREVNAR 13 via an unspecified route of administration in the arm in Aug2016 for immunization. She also had influenza vaccine for immunization in Aug2016 (she was unsure if it was before or after pneumococcal 13-val conj vac). The patient medical history and concomitant medications were not reported. On an unspecified day in Aug2016 the patient all of a sudden for a couple seconds could not move legs, she had hives, very heavy breathing, felt like in a race, maybe she was allergic to vaccine, her immune system was down. She also  fell and broke her left femur on 23Aug2016 due to which she was hospitalized from Aug2016 for 2-3 months and she was having a lot of physical therapy and in rehabilitation. It was reported that when the patient first got home after vaccination with PREVNAR 13 on an unspecified day in Aug2016, all of a sudden for a couple seconds she could not move her legs and then it went away. She then stated that her dog ran away and she ran after it and got very heavy breathing, she felt like in a race. She could not recall if the breathing was the same day as the shot or not. The heavy breathing lasted about 3 months and then went away. She told her heart doctor about it and he thought she maybe was allergic to the vaccine. She also stated she got hives around the same times but no specific time frame was known and that did not last too long and went away. The patient recovered from could not move legs in Aug2016, very heavy breathing and hives on an unspecified date in 2016, outcome of fall, femur fracture, immune system was down and allergy to vaccine was unknown.
Parent/s did not report that patient had an adverse reaction to the vaccine given. Parent/s have been notified of this error and all protocols have been followed.  This is simply an error report to reflect that the error was made and corrected.
Minor presented to pharmacy for Covid vaccination. Pt was accompanied by guardian. Verified correct date birth, but vaccine was still administered although pt is 16 years of age, Followed up with pt guardian via phone. Minor presented no adverse reaction at the time of phone call. Guardian was made aware of the fact that the vaccination has not yet been studied or approved for minors under 18. Will follow up with pt, to make sure no other adverse events are present.
pt states his right leg had pain and tightness from the inner thigh to the knee.  It was painful to touch.  Pt went to his PCP Dr. on 2/22/2021.  He had blood work and ordered a sonogram for legs to check for blood clot. He was told to use a topical cream Voltaren which did not help.  The sonogram showed that he had multiple blood clots on this inside of this leg down to his calf and was prescribed Xarelto.  The blood clots disappeared after a couple of weeks.
I was having stomach problems and I assumed it was my reflux as I have had this happen before except this time it is dragging on and on, more so I have a lingering cough and it feels like something is dripping there and my throat gets sore and it starts hurting behind ears from coughing. I feel like I have to clear my throat often.
While ushering at a church service, I felt clammy and that my heart was racing. I checked my heart rate at 4:27 PM using a smart watch and found that my heart rate was at 148 to 154 BPM that lasted about 2 minutes.  During the episode, I took deep long breaths which reduced my heart rate to normal.    At about 4:37 PM my heart rate went back to about 152 to 156 BPM that lasted about 4 minutes.  I sat down and once again took long deep breaths and my heart rate reduced.  No additional problems after the second occurrence or since.
April 6, Immediate muscle soreness at injection site. April 7 Morning chills. Soreness spreading. Body aches. Headache. Mild tinnitus. Cough. Chills gone by afternoon. April 8, No chills. Overnight sweat. Reduced body aches, headache, soreness. April 9, Reduced body aches, headache, soreness.  All symptoms reducing over next few days. April 14, Symptoms gone. Slight tinnitus remains.
Client complained of nausea, dizziness, and passed out for few seconds after receiving 1st HPV9 immunization
Fatigue (resolved in 24 hours), headache (resolved in 24 hours), muscle aches (resolved in 24 hours), fever (resolved in 8 hours), sore arm (resolved in 48 hours), swollen armpit (resolved in 48 hours)
Information has been received from a physician concerning a 12 month old female with Down's syndrome and congenital heart disease who on 8/10/04 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 647707/1245N). There was no illness at the time of vaccination. On 8/19/04 the patient broke out with a few lesions, but more lesions are expected. The patient also developed a fever of 103. The patient had a CBC done to check her immune system. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 8/17/04 at 11:00AM the patient developed a rash and had lesions which were red in color. The lesions were all over and the next day more showed up. The rash was consistent with atypical varicella. The patient recovered in approximately three days. The reporter also indicated that another patient (WAES0408USA01856) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Soreness at the injection site; Tired; Weird dreams; tossed and turned during the night; Fever; Injection site only feels tender / Arm still tender; Severe body aches; Joint pain; Severely nauseous; Dizzy / Lightheaded; Felt ill; Unable to go to work; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work. On an unknown date, the outcome of the injection site pain, fever and nausea were recovered/resolved and the outcome of the tiredness, pain in arm and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disorder, general body pain, joint pain, malaise and inability to work were unknown.   It was unknown if the reporter considered the injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Less than year after vaccination, the patient experienced tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability. Unable to obtain additional information. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2019AMR190454, reported by the same reporter.
Stroke shortly after the first dose; A spontaneous report was received from a consumer concerning an 81 year old, male patient who experienced stroke shortly after the first dose (cerebrovascular accident).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  It was reported that the patient experienced stroke shortly after the first dose.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event of stroke shortly after the first dose (cerebrovascular accident) was considered unknown.; Reporter's Comments: This is a case of sudden death in a 93-year-old female subject with no medical hx reported who suffered a stroke (unspecified days)  after receiving first dose of vaccine. Very limited information has been provided at this time. Further information will be pursued..
Patient tested positive for COVID 19; Patient tested positive for COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient tested positive for COVID 19. Symptoms mild. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient was vaccinated with Comirnaty and received two boosters. Patient tested positive for COVID 19. Symptoms mild. Patient prescribed Paxlovid and is responding well to therapy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child went to the school nurses office 10/30/19 complaining of injection site itching.  The school nurse pulled the band-aid from 2 days ago off and saw that the child had a 5 1/2 x 3 1/2 red spot that was swollen and warm to the touch.  She called the child's parents to have them come get him from school and take him to the doctor.
CHILLS; MUSCLE ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle ache, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle ache, and chills. This report was non-serious.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment Medications were not provided by the reporter
I had a sore throat, cough, running nose, headache, chills, fever of 101.3. Shakes, and high heart rate. I tested positive for COVID-19 at home. I talked to my doctor, and they said I could have Paxlovid but I decided not to take it. Now I am feeling dizzy.
25 hrs after vaccine given noticed vision changes and dizziness. 2 hrs later noticed right sided facial numbness and tingling, then right arm numbness. Admitted to ER and received IV BENADRYL & IV Droperidol. Sx resolved. Diagnosed with complex migraine caused by inflammatory response.
Patient received IM vaccine, was under observation when felt dizzy and lost consciousness. Spontaneously awoke a few minutes later and was confused, and wasn't able to feel his legs. Confusion resolved after about 5 min but leg numbness/weakness remained. Was taken via EMS to the hospital, with clinical assessment showing no neurological deficit, withdrawing to pain, and patient demonstrated ability to ambulate independently about 12 hours after symptom onset. CBC, CMP, Urinalysis, UDS unremarkable.
Patient developed a rash. It was a petechiae like rash across his chest and stomach. It started 48 hours after I received the shot in the afternoon. After I got the vaccine I was still breastfeeding him. He did not have any new foods that I believe caused the rash. He did receive 3 or 4 of his routine vaccines a week before, but I'm not for sure of the name of those vaccines he received.  He also had covid back in March  of 2021 when he was two weeks old. He was also a premature baby born at 34 weeks. He has also been intermittently having daycare colds.
Parsonage Turner Syndrome. Lt arm weakness and Neuropathy since 2010. On going.
pain in shoulder. Especially at night. Hurts to move. Shooting pain off and on
pt recv vax 22AUG97 & 10FEB98 pt devel 10-12 vesicles w/itching; pt was afeb;
pt under 4 years received Kinrix; Kinrix was third Dtap and IPV dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2PP74, expiry date 10th June 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: This was patient's third Dtap and IPV dose. The reporter did not consent to follow-up. Additional supportive information: The patient received Kinrix under 4 years of age by error, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The dose number was captured as per reported verbatim, 'This was patient's third Dtap and IPV dose.'
I was vaccinated on 2/25/2021 (1st shot Pfizer). 2nd dose Pfizer was given 3/18/2021. "Full immunity" achieved on 4/1/2021. But 13 days later (on Wednesday 4/14/2021 the most severe shooting pains in my right leg(thigh) while walking almost made me collapse from pain(blood clots/unknown). But 2 days later at approximately 1:55pm on Friday 4/16/2021 notice a rapid and arrhythmic heart beat. I was in mostly (almost the entire time) Tachycardia at around 150 bpm for aleast 7 hours before discharging myself. And have battled Tachycardia and afib ever since.
Initial report was received 27 October 2011 from a consumer, who is also the patient's parent. An 11-year-old male patient had received an intramuscular injection of TDAP and MENACTRA vaccines (lot numbers unknown, sites of administration not reported) on 24 October 2011 and 24 hours later, he developed pain in both arms and his arms were sore to move. At 48 hours post vaccination, he experienced a headache, muscle aches, stomach ache, continued soreness of his arms and a rash that was red, raised and hot to touch on both arms located one half inch below the injection site and 4x2 inches extending down his arms. He received BENADRYL as corrective treatment with no change. The reporter contacted the patient's pediatrician but no additional treatment was prescribed. The event required a doctor's visit. Outcome was not recovered. The patient experienced a previous similar event in 2009 after receiving a DTaP vaccination which has been captured in case number 2011-10444.
Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness
mild hangover-like symptoms: headache, stuffy nose, fatigue, light sensitivity stronger symptoms: confusion, dizziness/vertigo, mild paranoia/delusion, anxiety
Patient received his booster shot approximately three months too soon.  His Moderna series (1&2) was completed on 01/07/2022, and he received his booster on 03/11/2022.  He is not immunocompromised, or otherwise eligible for earlier dosing.
For 20 years I've been able to walk 2 - 2.5 miles per day, 6 days a week. And for the 20 years, I've had Afib but I did not run out of breath at all, it was just something I lived with. Nothing to get excited over. Then by the time I got my 2nd shot in Feb. all of a sudden I noticed I couldn't quite get through my walk and would have to cut it short to a mile and a half. Then it slowly but surely got worse and worse. Today I can't walk 2 blocks without being short of breath, for the last couple of months actually. And of course my Doctor as soon as I told him about it he increased my Eliquis to 2, 5mgs twice a day. And I ended up having a TEE in Feb 2021. Then the Dr found out I had a blood clot. 3 months later another TEE was done and I still had the blood clot. Then it was time for me to go back and saw my Primary Dr. there. She did a 3rd TEE and blood clot was still there. The plan was to have an ablation if I got rid of the blood clot. In Sept 2021 I got rid of the blood clot, then I came back to my original Dr. and he set me up with a Cardio electro Doctor. On Feb 16 2022 I will have an ablation where they will go in an tweak the electrically system of my heart to get rid of the Afib. I went to the hospital for the TEE Conversion outpatient produced - note the conversion part was not done due to the blood clot.
Headache, Fever, 6-8 HOURS AFTER INJECTION DEVELOPED HEADACHE, FEVER, CHILLS, AND INJECTION SITE REDNESS/SORENESS. SYMPTOMS LASTED 2 DAYS, RESOLVED ON DAY 3 Narrative:  Other Relevant History:
Approximately 24 hours post vax, this pt developed a fever of 105 F. The pt sought medical attention and subsequently recovered.
received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the nurse reported that the patient received 1 dose of the vaccine past the 6 hour used-by time. The nurse stated that the dose of the vaccine was administered 24 hours after the bottle was opened on 29 Dec 2020.  No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 025L20A.  There were no reported AEs associated with this case of out of specification product use.