chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Insomnia, starting on night of vaccination. Persisting until last night (6/20-6/21). I did not have serious insomnia issues prior to vaccination, and I haven't been able to sleep more than a few hours per evening since.
As the vaccine provider removed the syringe, a drop of clear liquid on arm; As the vaccine provider removed the syringe, a drop of clear liquid on arm; A spontaneous report was received from a consumer, concerning a 30-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and as the vaccine provider removed the syringe, a drop of clear liquid was on her arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 and as the vaccine provider removed the syringe, a drop of clear liquid was on her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The events, as the vaccine provider removed the syringe a drop of clear liquid was on her arm, was considered resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 30-year-old female who experienced a NS unexpected event of Incomplete dose administered after a drop from the syringe dripped onto her arm.  The event occurred with the first dose of mRNA-1273. No associated adverse events were reported. Event considered resolved. This report refers to a case of PT Incorrect dose administered for mRNA-1273 (lot # unknown) with no associated adverse events.
This spontaneous report was received from an other health professional referring to a 61-year-old female patient. Her concurrent conditions included hypertension, migraine, gastritis, insomnia, nephropathy, rheumatoid arthritis, osteoporosis, gastrooesophageal reflux disease, asthma, sjogren's syndrome, raynaud's phenomenon, sensorineural hearing loss, depression, hypersensitivity, drug hypersensitivity and immunisation. The patient's medical history included pneumonia, colon polyps, constipation, varicose vein, spinal fracture and haemorrhoids. Concomitant therapies included zolpidem, omeprazole, sumatriptan, fluticasone furoate (+) vilanterol trifenatate (BREO ELLIPTA), citalopram, epinephrine, methotrexate, cyclosporine (RESTASIS), montelukast sodium (SINGULAIR), albuterol (VENTOLIN INHALER), cetirizine hydrochloride (ZYRTEC), valacyclovir hydrochloride (VALTREX), fluorometholone (FLUCASON), naproxen, promethazine, albuterol sulfate inhaler, linaclotide (LINZESS), prednisone, ondansetron, aclidinium bromide (TUDORZA PRESSAIR), omalizumab (XOLAIR), calcium supplements, magnesium oxide supplements, multi vitamin supplements, cholecalciferol (VITAMIN D3) supplements and omega-3 marine triglycerides (FISH OIL) supplements. On 13-MAR-2019, the patient was vaccinated with PNEUMOVAX 23, lot # R011632 and expiry date: 02-FEB-2020, intramuscularly for immunization (dose, unit, dose number, anatomical location was not reported). On 15-MAR-2019, the patient experienced left arm pain (pain in extremity), swelling from the injection site to the elbow (injection site swelling and peripheral swelling), lightheadedness (dizziness) and vomiting. The patient sought medical attention and was treated for the events. No lab diagnostics/ studies were performed. The outcome of pain in extremity, vomiting, injection site swelling, peripheral swelling and dizziness was reported as recovering/resolving. Causality assessment of the events was not reported. No product quality complaint (PQC) was involved.
Client passed out in the elevator, on her way out. Pallor noted. Mother stated she "blacked out" but denied hitting her head on the wall as she was holding her daughter's arm. Placed client flat on her back with legs elevated by a foam wedge. She recovered completely and answered questions coherently. Pulse rate was regular and strong. A pouch of juice was given. Assisted by the RN supervisor to stand up and walk to the wheelchair to transport her to her vehicle. Steady gait noted. Sent home in stable condition, accompanied by her mother.
The patient is not complaining of an adverse event or any symptoms or signs of toxicity. This VAERS report is being filed because a 4th dose (a second booster) was given to the patient outside of the standing order protocol as of the 5/4/2022 CDC Guideline.  The patient is a 37yo female and therefore was not eligible for a 2nd booster (not over 50yo) even though she is a worker in a healthcare facility.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 07Nov2023 to 12Nov2023. Known allergies: No, Other medical history: No.  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-202300384794 same patient, different drug/AE;
Patient came in to get a flu shot and he felt pain and burning immediately; after he left, he noticed that the immunizing pharmacist gave it less than 2 finger-widths from his shoulder (he was a paramedic and knows how vaccines should be given); he said it was injected around the ball joint and he believes it may have hit bone; later that night he couldn't sleep from the pain, it radiated down to his elbow and then further affecting his wrists and fingertips (he said he felt pain in his fingertips); he got a 2nd opinion while at the md office and the nurse concurred that it was given too high
more tired and achy that night; more tired and achy that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CARVEDILOL for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night). At the time of the report, PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-237314 (Patient Link).
Itchy throat and skin approx 10 min after injection. After another 3 minutes, felt tightness in chest. No trouble speaking or breathing. Chest tightness resolved spontaneously and itchiness improved upon discharge. No treatment necessary.
Death - Mom discovered infant's head wedged between pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive asphyxia. Compressive markings of skin of chest, shoulders and sides of face. Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic junctions, right more than left.
Case number PHEH2015US026981, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 29-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Lymphedema in the upper left arm and left breast. Several weeks later a soft mass was felt near the breast areola area. Contacted primary care Dr. Adverse condition worsened.  Examined by primary care Dr. and was referred to Breast Oncologist for examination.  Treated with medications (topical and oral antibiotics), symptoms/swelling subsided. Then had a recurrence.
PATIENT STATED WHILE WAITING IN PHRMACY WAITING SEATED IN  ROOM  HE WAS FEELING  SWEATY /CLAMMY , LIGHT HEADED  ABOUT 10 MINUTES  AFTER  2ND DOSE OF PFIZER COVID 19 VACCINATION GIVIN  AT APPROX 3PM .PATIENT THEN SAID HE STOOD UP TO GET ATTENTION FROM PHARMACY PERSONNELL AND FEINTED . BOTH PHARMACIST AND CLERK SAW PATIENT  PASSING OUT AND LOWERED PATIENT TO THE FLOOR. A  FEW MINUTES LATER PATIENT REGAINED CONCIOUSNESS. PARAMEDICS WERE CALLED AND WAS TAKEN TO HOSPITAL FOR CHECK UP
Dizziness, Visual change, Fatigue, Postural hypotension (10-15 min); Lay down until symptoms resolved.
Same day onset of fever, right arm pain, tingling in fingers of right hand and gait instability.
Vaccinated on 06/13/2005.  On 06/15/2005 Mother noted scattered rash on patients head at 09:00AM.  By 02:00PM rash progressed to buttocks.  Patient seen at 3PM by a pediatrician.  Other symptoms include "running nose and cranky".
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information included ample water, and Gatorade on 16 Apr 2021.
Sore Throat, fever of 103.8, body aches, headache, body chills, fatigue
Patient received booster dose of Moderna vaccine on 3/7/2022 at 1439 using an expired dose with beyond use date of 3/7/2022 at 0430. No harm to patient or monitoring provided. Per CDC guidelines, Moderna manufacturer has been contacted for information on the stability of the vaccine and whether the dose needs to be repeated. The patient will be contacted for follow-up once this information is available.
Ringing in the right ear, which progressed to numbness of the inner and outer ear, and then progressed to hearing loss in the right ear.  This progressed over 2 hours and has not resolved as of now, 10 hours post the second dose of the vaccine.
achiness all over the body; extremely painful injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness all over the body) and VACCINATION SITE PAIN (extremely painful injection arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (achiness all over the body) and VACCINATION SITE PAIN (extremely painful injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, PAIN (achiness all over the body) and VACCINATION SITE PAIN (extremely painful injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-066667 (Patient Link).
Patient presents with red arm starting 2 inches below where she received the injection. She also had been using an eye drop "she forgot she was allergic to". So also presented with red inflamed eye. I think the fact that she used a medication she was allergic to and got the shot in the same day, may have made the reaction to the vaccine worse. She said she noticed her red arm on the 5th day. This was 3 days after she stopped the eye drop she was allergic to.
Information has been received from a registered nurse concerning a female in her "mid 60's" who on 17-MAY-200 was vaccinated with Zostavax and on that same day developed redness and burning around the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Received vaccine dose #2 1/21/2021 around 3:30pm. Woke up Friday with headache, nausea and progressive chills and fever throughout the day. By the end of the day was feeling back to baseline. Felt normal all day Saturday and Sunday morning. Sunday afternoon around 1pm left upper lip tingling started and progressed to lip swelling and development of 3 hives to right forearm. Took diphenhydramine, famotidine, ibuprofen and cetirizine at home. Hives did not progress and lip swelling seemed to subside a little. Woke in the night around 3:30am with itching. Eyelids were swollen, hands very swollen with painful palms, new hives to groin, axilla, buttocks. Sought care at ED. No other identifiable cause for reaction, no new food, soap, detergent, exposure etc.
Pt. received Pfizer Bivalent booster dose two weeks early to the scheduled dose. Pt. only complained of right arm soreness for two days and denied other symptoms.
Headache, Myalgia, Arthralgia, Pain/Discomfort and redness at injection site, fatigue Narrative:
I received my Dose 2, J and J, on 12/09/2021, Lot 1855191. Approximately two months later I stated to have water fill blisters on the left side of my body. They appeared below the bicep, up the arm, down to the lower arm top and bottom then the wrist. March 28, 2022 went my primary who prescribed Gastro Chom Cromolyn Sodium 100mg per 5ml 4 anfills a day, new medication and not associated with her pre-existing issue with hives. I still under nurse practitioner who is my primary care. April 4, 2022, I saw my allergist results was shared with the allergist. The results concluded that I was in the normal limits for metal. The Nedian test showed not free floating nedian in the system. I am still under insurance for this new condition of water fill blisters, with primary and issue not been resolved.
It was a dull constant pain in my left side. I thought it was period cramps. It persisted for about a week. Pregnancy was ruled out. They advised me to get a urinalysis and an ultrasound. With a specialist it was confirmed to be an ovarian cyst. They also found a polyp. I'm having surgery to have the polyp removed. For the cyst, I have a f/u appointment to monitor the size.
Brain fog/felt like she was poisoned; Dizziness; Not feeling well; uneasiness; 99 Temp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well) and DISCOMFORT (uneasiness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and FEELING ABNORMAL (Brain fog/felt like she was poisoned), DIZZINESS (Dizziness), VACCINATION COMPLICATION (Not feeling well), DISCOMFORT (uneasiness) and PYREXIA (99 Temp) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f (Low) temperature-99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided
Woke up the morning after my 2nd COVID-19 vaccine with shingles on my right side.
Patient was given a Influenza preservative free 3 and up vaccine. No adverse reactions that I know of.
Severe rash on breast itching nonstop raw and tender.  Swollen ankles and feet and toes all since the Moderna vaccine.  Extreme throwing up and diarrhea since vaccine and not going away .
Vaccine given on the afternoon of the 27th. No symptoms initial day other than a little fussy and redness at injection site. The following day, infant was fussy, feverish (nothing over 103*), lethargic, and not breastfeeding as much as normal (I had to pump). Continued for the entire day and into the next. Third day, he began having convulsions/seizures. They lasted anywhere from 10-20 secs., sporadically but in clusters of 2-3 at a time, spread out over a 5-10 minute window. He would stiffen from head to toe and convulse. Sometimes he would cry immediately after, other times he did not. This went on for two more days, slowly dwindling down, before the seizures suddenly stopped.   I called the nurse line, panicked, but was told his reaction was normal and not related to vaccine. He had never shaken like this before. And otherwise was a very healthy baby.
Headache, Fatigue, Body Aches, Lightheaded onset day after vaccine
Information has been received concerning a pt who post vaccination of varicella developed a severe case of chicken pox and high fever that resulted in being absent from school for 1 week and loss of work for his parents. The pt sought unspecified medical attention. The pt recovered.
2nd dose administered more than 35 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 042l20a) for COVID-19 vaccination.     Concurrent medical conditions included Low back pain (No change in current condition) since 1992, Hypercholesterolemia (No change in current condition) since 2010, Prostatic hypertrophy (No change in current condition) since 2018, Reflux esophagitis (No change in current condition) since 2015, Asthma (mild asthma since childhood, untreated) and Drug allergy (The patient had allergy to unknown past drug). Concomitant products included SIMVASTATIN from January 2010 to an unknown date for Hypercholesterolaemia, CELECOXIB (CELEBREX) from January 2012 to an unknown date for Low back pain, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) from January 2018 to an unknown date for Prostatic hypertrophy, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from January 2015 to an unknown date for Reflux esophagitis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were provided   This case was linked to MOD-2022-570652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2022: Follow-up recieved contains significant information, Concomitant drug information (start date and dosage text) updated.
break through case after first dose; Tested positive for COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (break through case after first dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (break through case after first dose) (seriousness criterion medically significant) and COVID-19 (Tested positive for COVID). At the time of the report, VACCINE BREAKTHROUGH INFECTION (break through case after first dose) and COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The patient worked in a school system.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 test positive and mRNA-1273 is assessed as not applicable. Vaccine breakthrough infection was reported. However, the patient tested positive for COVID19 after the first dose of the vaccine prior to complete schedule of vaccination, thus it is not considered as such.
Patient just had a sore arm initially. 2 weeks after injection she had redness and swelling that occured at the injection site (crescent moon shape) a lot of swelling in her lymph nodes in neck on the side of vaccination. Redness and swelling at injection site has gone down after a few days, lymph nodes are still swollen but are starting to decrease.
Redness, warm to touch, slight swelling under vaccine site approximately 5"x2". No fever approximately 24 hours within injection.
Pt turned 12 on 7/24/22 and was given an 11y/o dose...?..Please advise re: further dosing....