chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.). At the time of the report, MENSTRUAL DISORDER (a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720348 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720348:daughter's friend's mother
Presented with productive cough, SOB, fatigue; + Covid in ED; admit to medical with Covid PNA ; TX with steroids, out of range for remdesivir. 2 L of oxygen for SATS greater than 91%. Home with home oxygen.
Pain at site of injection so severe that it woke me up the evening after I received the injection. I had to take naproxen it was so painful. The pain has diminished but 6 days later it is still tender. In addition I had a red and swollen patch about 3 inches in diameter. That subsided  morning, six days post-dose but was still present yesterday.
Pt recvd 1st dose of Hep B vax in approx 1990; & subsequently devel a local allergic rxn w/redness, hives & itching; Pt will not be receiving the remaining vax;
Patient presented with chest pain 48 hours after received dose #1 of Pfizer vaccines. Found to have transiently elevated troponins. Diagnosed with myopericarditis.
Immediatley after the administration she described a burning sensation, as she never had it before. It Improved. Later that day she developed a frontal headache lasting many hours, that needed NSAIDs to improve. Next morning while taking a shower, she felt dizzy and fainted. Was assisted by family member and later transfered to an ER department, where all tests were considered normal and she was stable. Second day after the shot, she come complaining of malaise, feeling "wobbly", with decreased lower extremities strength and genealized body aches, like "when the flu is starting".
Approx. 12:45am 12/31/22 awakened in fetal position with clenched hands on rt. side with severe shaking, excruciating headache involving entire head and neck. Unable to speak to awaken husband or roll over cried myself back to sleep.  Husband reached over to touch me about 30minute to 1 hour later and was found to be burning up with fever and moaning in sleep.   He started bathing me in  Rubbing Alcohol unable to completely awaken me.  He stated I would eventually awaken for 5 to 10 minutes drink water then return to deep sleep for 2 to 3 hours at a time without being able to awaken me.  This lasted for 24 hours.   Headache continued with added dizziness and severe fatigue.  I am 31 days past the initial episode.  I still have headaches and neck pain varying in severity and length of episode.  Fatigue is mild to moderate depending on activity.
A report has been received from a Health Professional. It was reported that a 17 month old child inadvertently administered FLUMIST (intranasal). It was quickly realized and only half the dose was administered (0.1 mL). The outcome of the event of inadvertent administration to a 17 month old is unknown. The reporter's description of the event(s) was as follows: Child has history of asthma. He received the IM injection last year. Father is an infection control practitioner. Mother is a nurse. There was concern as well re: mother as she is pregnant and they were worried about viral shedding. The report was considered to be non-serious.
sleepiness; arm swelled; arm red; body aches; muscle and joint aches; fever -not confirmed but she had chills and shaking; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), MYALGIA (body aches) and ARTHRALGIA (muscle and joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Cancer surgery (kidney cancer surgery). Concomitant products included OMEPRAZOLE, LOSARTAN, EZETIMIBE, MONTELUKAST, COLECALCIFEROL (VIT D [COLECALCIFEROL]), CALCIUM and UBIDECARENONE (COQ) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (sleepiness), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), MYALGIA (body aches), ARTHRALGIA (muscle and joint aches), CHILLS (fever -not confirmed but she had chills and shaking) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 13-Mar-2021, MYALGIA (body aches), ARTHRALGIA (muscle and joint aches), CHILLS (fever -not confirmed but she had chills and shaking) and HEADACHE (headache) had resolved. On 14-Mar-2021, PERIPHERAL SWELLING (arm swelled) and ERYTHEMA (arm red) had resolved. On 16-Mar-2021, SOMNOLENCE (sleepiness) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-053303 (Patient Link).
Event occurred after 2nd vaccine. First vaccine was on 3/26/21 and the second one on 4/26/21.Pt tested positive for COVID-19 on  11/21/21.
Patient given repeat first dose, 6 days after first dose at a different vaccination clinic.  Patient stated he "forgot" he received the dose elsewhere and on self attestation he had never received another dose.  We discovered the error when entering the administration in our state vaccine database.
By this time (two days later), it became obvious that the pain in my lymph nodes was due to the flu shot. I always get a tender node near my collar bone but this was much more. The area under my arm where I received the shot was the most painful, but also at the collar bone, neck, and at the elbow of that arm were tender to touch and very painful to use that arm. The entire arm was throbbing and nerve pain extended down to my hand.
arm at the inejction site was slightly sore, swollen and reddish; arm at the inejction site was slightly sore, swollen and reddish; arm at the inejction site was slightly sore, swollen and reddish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE PAIN (arm at the inejction site was slightly sore, swollen and reddish), VACCINATION SITE SWELLING (arm at the inejction site was slightly sore, swollen and reddish) and VACCINATION SITE ERYTHEMA (arm at the inejction site was slightly sore, swollen and reddish) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 (arm at the inejction site was slightly sore, swollen and reddish), VACCINATION SITE SWELLING (arm at the inejction site was slightly sore, swollen and reddish) and VACCINATION SITE ERYTHEMA (arm at the inejction site was slightly sore, swollen and reddish). At the time of the report, VACCINATION SITE PAIN (arm at the inejction site was slightly sore, swollen and reddish) and VACCINATION SITE SWELLING (arm at the inejction site was slightly sore, swollen and reddish) outcome was unknown and VACCINATION SITE ERYTHEMA (arm at the inejction site was slightly sore, swollen and reddish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information provided about any concomitant and treatment medications.
This spontaneous report as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored oral, (ROTATEQ) lot # K005273, expiration date 23-FEB-2016. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This infant had rosey pink non pruritic rash appear after DTaP / Hib administration in his right thigh. The rash began to spread upward to the right groin and abdomen. He was started on Keflex and a short course of Prelone on 05/02/01.
Really sore arm, bump resembling a mosquito bite. She continued to experience stiffness in her arm up to her neck. The sore arm persisted even after a cold compress. Doctor prescribed voltaren to help with possible inflamed bursa.
Swelling, redness, tenderness prox (R) arm around inj site 10 x 18 cm.
At approximately 7:30pm patient spiked a temperature of 103.3. Sure was writhing in pain and screamed when touched. Her right thigh had a 1/4" red lump at the injection site that was hot to the touch. The fever was reduced through essential oil adminstration to the soles of her feet. The fever returned after approximately 6 hours and continued for 48 hours, but stayed below 102. The red lump in the right thigh got as large as a quarter in size, before falling into a large bruise after 72 hours. While the lump was large patient reacted very strongly to get leg being touched or bumped. She refused to crawl or to roll into her stomach putting pressure on that thigh.
Could not control any of his body; very floppy baby. Diagnosed with Microencephaly and ataxic CP. Per 60 day follow up. Pt has not recovered. Mother reports that her son is mentally retarded as a result of the vaccination. The annual follow up received on 9/3/03 states pt is profoundly mentally retarded his condition has not changed.
This spontaneous report as received from a Licensed Practical Nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored RECOMBIVAX HB (lot # L020157,expiration date: 12-MAR-2018) (dose, route and site of administration were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On an unknown date the patients received impropelry stoerd GARDASIL (incorrect product storage). No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered product the event to be not related to GARDASIL. This is one of several reports from the same reporter (MARRS # 1504USA004227 and MARRS # 1504USA004228). Additional information has been requested.
"Patient up to date on COVID vaccinations who admitted with COVID complications and subsequently died.  Provider discharge note below:  "68-year-old male history hypothyroidism who initially presented to the ED on 2/11 for chest pain and progressive short of breath.  He was recently admitted to the hospital for COVID pneumonia requiring high-flow nasal cannula and eventually was discharged on 6 L nasal cannula.  In the ED, CTA pulmonary revealed right-sided segmental pulmonary embolism without signs of right heart strain. Dr. (Privacy) (Interventional Radiologist) performed catheter directed tPA thrombectomy on 2/11 due to concern of right heart strain seen on Echo on 2/11 and patient was subsequently transferred to the ICU.  He remained in the ICU from 2/11-2/13 and was transferred to the general floors still requiring high-flow nasal cannula.  Oxygen requirements waxed/waned and did not make significant improvements.    Repeat chest CT on 2/22 revealed bilateral ground-glass opacities, pneumomediastinum with interval progression, and emphysema. Hospitalist team notified ICU on 2/24 that patient's hypoxia continued to worsen and was not ameliorated by maximal HFNC and Pt was transferred to ICU on 2/24.  Pulmonology has been following patient. He was started on bactrim on 2/23 given concern for PJP given high dose steroids, and had fungal coverage 2/20-2/23. Pt got intubated on 2/25. On 2/26, Pt's family discussed with Dr. (Privacy) and decided to change his code status to NO CPR Aggressive Care, as Pt would not have wanted Full Code given his poor prognosis. In the afternoon, Pt's wife and his children made the decision to terminally extubate him and he died on 2/26 at 2:01 PM"
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2016 (reported as since March 2016), patients were vaccinated with improperly stored VARIVAX (lot number, expiration date, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
From the moment I woke up the day after the shot, I have had a high pitched ringing in my ears. It has now been over 24 hours since the shot.  I haven't done anything about this.  I have not sought medical care.
Chills and fever started at 2:00 am almost after 11 hrs of taking the vaccine.  Chills subsided after 20-30 minutes and fever was around 100.2 F.  Heart Rate slightly elevated at night but in normal rane i.e below 100 BPM. Right arm soreness constant. Extreme headache and leg pain in the morning around 9:30 am.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm 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: "Stage 2 liver diseases" (unspecified if ongoing); "migraine headache" (unspecified if ongoing); "Known allergy : Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; PROPRANOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including received Paxlovid from 02Aug2022 to 07Aug022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediate itching (pruritic) then erythematous from injection site extending down to the left elbow.
This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored COMVAX, lot/batch # J013884; expiry date: 19-AUG-2016. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
A red rash developed at the injection site 8 days after the injection.  The rash is slightly itchy.
Got flu shot at facility Saturday 11/12/22 - had redness, firmness, tenderness at site of injection in subsequent days which spread over those days but then eases up at times (mom has pictures); when shot went in he felt a fire-like sensation; after shower and ball practice at night it swells ; less red and swollen this AM (now more of a bruised look) Skin: General: dull purplish-red areas right upper arm - no warmth , mild tenderness (he said 8/10 but was not wincing or pulling his arm away with fairly deep palpation) , no edema. 1. Cellulitis of right upper limb - concern over possible infection in the skin, muscle or even deeper -- xray to rule out bony changes ; start oral clindamycin (plan 4 week course
2 days after second shot (Nov13, 2021) I experienced sudden onset of tinnitus.  Today is 20Nov, 2021 and it?s still there.  It is 24/7 ringing in my ears.  It?s messing with my mental health.  I can?t sleep and triggering a lot of anxiety.
Patient developed erythematous, edematous reaction on L thigh. Area was warm to the touch. Reaction was first noticed 24 hours after injection, and worsened by 48 hours after injection. Parent pre-treated patient with Tylenol before injections and ibuprofen following injection on the same day.  Patient seen in clinic 48 hours after injection. Site was marked and parent instructed to use cool compresses and ibuprofen for relief. Follow up instructions included seek care if site becomes indurated, erythema/edema spreads beyond marked borders, or if patient develops systemic symptoms.
Employee reported redness, swelling, pain, and heat a few hours after administration of vaccine on 3/3/21
Patient was in the office for an annual well child check with immunization update - father did not have yellow immunization card nor any previous records with him.  Medical Assistant accidentally gave patient a Hepatitis A vaccine as well as a MMR vaccine - patient is only 5 months old.  Too soon for these vaccines to be given.
Patient given Pfizer vaccine instead of Moderna. Interval correct and CDC guideline says series is considered complete. No adverse reaction.
Pain in injected arm (bad reaction/ painful); Moving arm caused a great pain; Almost couldn't move arm; Fever; Diarrhea (gastrointestinal symptoms); GI symptoms, horrible gas pains, in bed due to this; gastrointestinal symptoms (diarrhea + abdominal gas pain); Swelling in the injected arm (bad reaction); This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 1st dose of Shingrix (intramuscular). In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, pain in arm, pain upon movement, fever and diarrhea were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the gas pain and abdominal pain were not recovered/not resolved.   The reporter considered the swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after received Shingrix vaccine the patient experienced bad reaction on injected arm, patient experienced left arm was swollen and hurt painful, patient almost could not move it because even when she moved it the slightest bit it caused her great pain.  Patient stated that she wishes she would have strapped it down so that she wouldn't had moved it. The patient had a fever for the first 2-3 days after received Shingrix vaccine. The reporter reported that after received Shingrix vaccine on day 3 patient began experiencing gastrointestinal symptoms including horrible gas pains in her abdomen. Patient stated nothing relieves the gas pain, the pain was not relieved even if she passes gas because the pain comes right back. She had been used a heating pad on her stomach/abdomen. She had been in bed due to this. She was feeling a little better because she was out of bed on the day of reporting but these symptoms had not resolved. Patient had diarrhea as well. Her last episode of diarrhea was on 11th September 2022. Reporter stated patient GI(gastrointestinal) symptoms had not resolved yet she was not back to normal yet. The reporter did consent to follow up
sever swelling of the right axillary lymph node lasting 7 days,  fatigue and body aches lasting 48 hours
DIZZINESS, HEADACHE, FATIGUE, WEAKNESS, CHEST PAIN, SYMPTOMS STILL ONGOING
Pt had 2 complete series of Hep-B vax & has not seroconverted;
A report was received from a health professional on 11/1/01, concerning a 63 year old female pt who experienced cellulitis, 2 days after receiving the FluVirin vaccine on 10/30/01. On 11/1/01, the pt experienced cellulitis of the entire right arm. The FluVirin was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The pt had not recovered at the time of this report. The reporter has assessed the relationship of the study medication to the event as possible. This was considered an "Other Important Medical Event".
Felt very sick with fever and chills; Felt very sick with fever and chills; felt very sick with fever and chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick with fever and chills), PYREXIA (Felt very sick with fever and chills) and CHILLS (felt very sick with fever and chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (Felt very sick with fever and chills), PYREXIA (Felt very sick with fever and chills) and CHILLS (felt very sick with fever and chills). On 19-Jan-2021, MALAISE (Felt very sick with fever and chills), PYREXIA (Felt very sick with fever and chills) and CHILLS (felt very sick with fever and chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ?No treatment information was provided.
Sx developed a few hours after injection of abdominal pain/spasms, nausea, and loose stool. Sx are still persisting now. Tm states the sx are worse at night. Set TM up for testing on 2/12 from 830-930 at BMCJ negative. TM has been working this whole time. MD follow up for sx, MD gave meds that relieved sx, did not advise against second dose