chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 patients 16-17 years of age were administered from the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 039K20A) for COVID-19 vaccination.     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, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported as 4 doses were given to 4 patients (ages 16-17 years).  No treatment medications were reported.   This case was linked to MOD-2022-554595, MOD-2022-554700 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information.
After getting the vaccine on Monday afternoon, that evening  around 10:30 pm I started feeling achy all over. This  achiness got worse throughout the night and in the morning I had a fever of 100.5, chills, body aches,sore arm at injection site, severe nasal congestion, and bad cough. Temp rose to 100.8 that afternoon and congestion and cough were much worse. This continued until Thursday, that's when my fever broke. I felt a little better but was weak and had bad cough and congestion. On Friday( day 5), I felt better but still had  a little runny nose and congestion. Cough had subsided. I see my doctor this Mon, Oct 17, and will explain the issue I had with the vaccine. I have had the original 2 vaccines and 2 boosters and never had a problem other than sore arm with them All have been Moderna. I truly feel like I had COVID! Just wanted to let you know.
Left lower extremity DVT- symptoms within days of vaccination, did not present for diagnosis for about 3 weeks.
Mild case of shingles. I had 5 (1 millimeter) small clear puss filled bumps form on my chest creating a 1/2 circle shape edge about the size and shape of a nickel edge. The shingles lasted two full week before drying up and leaving a scar. For about one week I had  burning pain and sensitivity where the bumps appeared.  The scars still remain 3months later (5/9/2021-8/8/2021). I had chicken pox as a child.
Knocked on butt; Intense headache; 100 fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 21-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Knocked on butt), HEADACHE (Intense headache), PYREXIA (100 fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MALAISE (Knocked on butt), HEADACHE (Intense headache), PYREXIA (100 fever) and CHILLS (Chills). At the time of the report, MALAISE (Knocked on butt), HEADACHE (Intense headache), PYREXIA (100 fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pyrexia: 100 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment included Advil.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of headache, fever and chills, and the non-serious unlisted event of Malaise.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
The vaccine was administered at 12:30 pm on Saturday, March 6, 2021. That night around 7:00 pm he called to tell me that his arm was hurting. That was the last time anyone heard from him. Two days later on the evening of Monday, March 8, 2021, he was found unresponsive in his home. When the ambulance arrived they found he had a temperature of 115 degrees. He was taken to the emergency room and placed in the critical care unit. It was determined that he suffered an anoxic brain injury and would never recover. He passed away on March 21, 2021.
Pt says she felt fine the day of the shot, but starting the next day, she experienced fever/chills, nausea, diarrhea, headache, and pain/swelling at the injection site. She missed a day of work due to these symptoms.
Within 30 minutes of receiving 3 vaccinations, pts ears became very red and swollen, began breaking out into hives all over back and neck received adrenaline shot at the doctors office and then received a Benadryl and Decadron shot at the ER.
have now had 4 days of hards rigors and chills that come on each afternoon but occurred today in the AM seemingly getting worse.  No fever.  Started 2 days after shot with only other symptoms being the return of sore muscle and fatigue that I had with a Covid infection in mid-Nov.  Shot reaction has been more drastic than the Covid illness for me which was fairly mild.
a little lump under her armpit on the side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (a little lump under her armpit on the side of the injection) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced AXILLARY MASS (a little lump under her armpit on the side of the injection). At the time of the report, AXILLARY MASS (a little lump under her armpit on the side of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 30-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the second time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the third time was 296 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the fourth time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
130PM pt recvd vax;pt stayed in clinic x 20mins;nurse reported no adverse rxn @ that time;mom called 445PM to ask if pt was having rxn;mom reported pt was shaking sl as if were shivering, felt pt was breathing harder than usual, hands cold
he feels like he started having more rapid afib episodes about a month after his 2nd moderna vaccine
Patient was given the Pfizer COVID 19 vaccine from a vial that was reconstituted yesterday (11.2.21 at 4:45pm) and given today (11.3.21 at 2:35pm). The vial should have been discarded last night after we closed the pharmacy, but this was missed. The vial was labeled as 4:45pm and that was interpreted by another pharmacist as it was good until 4:45pm on 11.3.21. We talked to a Pfizer representative and they do have excursion data stating a reconstituted vial is stable for up to 24 hours.
Complained of swollen glands, difficulty swallowing and had pursed lip breathing. Vitals= 140/83, Pulse= 69, no O2 obtained. 2nd set of vitals= 136/71, P 67. Gave 50 mg of Benadryl, IM, right deltoid by S. Lisman, RN. Pt took one dose of albuterol inhaler (RX'd to her by PMD). EMS was called and arrived on scene to assess patient. Patient refused transport. Observed patient in observation area of an additional 30 minutes. 1:30-1:45 pm. S. Lisman educated patient on signs and symptoms of worsening condition and when to call 911. Pt advised to accept transport if,  signs and symptoms return post Benadryl is no longer in her system.
Day following injection pt experienced very runny nose and eyes swollen shut (8/20/11) lasted about 1 day.
Rash at injection site appeared 8 days after first vaccine. Red, itchy, sore, hard lump 2 inches in diameter. Disappeared after 1 week.
This is a spontaneous report from a contactable physician. A 3-year-old child was administered PREVNAR 13 via an unknown route of administration, in the left thigh, on 21Sep2010. Relevant medical history, concomitant medications and past product history were not reported. On 23Sep2010, the patient returned to the physician's office exhibiting local hives and substantial swelling and redness (onset date not reported). The parent reported having administered BENADRYL to the child. The physician examined the patient. Following examination of the patient, the physician administered ORAPRED to the child. Subsequently, the parent contacted the physician and stated that it took "about a week" for the redness and swelling to subside. The outcome of the hives was not reported.
Client came to clinic to get all required and recommended vaccines at 1630. Client was at clinic with mother and younger sibling who was also getting vaccinations. Called patient back to room with mother and brother to administer vaccines together. I, RN, prepared immunizations to give to client and asked mom which child wanted to be immunized first. Clients mother stated that she wanted client to get immunizations first because she was the most nervous. Client stated that she "does not like needles and gets very nervous with shots". I informed client and mother of what immunizations we recommended and they get verbal consent along with written consent to proceed. I had client sit down in chair and told her that I was going to give her two vaccines in each arm. I had patient pull her hair back behind her shoulders because it was draping on her shoulders. I cleaned the sites left arm and administered her TDaP and Hep A. Client handled procedure very well we proceeded to clean the right arm to administer final two immunizations. After cleaning right deltoid I administered the Menactra and HPV and put bandaids on immunization sites. Client stated that the "shots were not as bad as they normally were and I usually scream but I didn't this time". 3 minutes after finishing administering final immunization patient was still sitting in chair and put her head in her hands between her knees. I asked client if she was feeling okay and she stated "no". I had got client a cool rag for her neck and had her lean back in her chair. Client stated "I am nauseous" and then lost consciousness for 30 seconds. Client woke up and stated she was still feeling nauseous and I got her a garbage can to vomit in. Patient vomited twice and in the mean time another RN in the facility went and got a fan for some cool air in the room. Got patient a cup of water and a snack of mini cookies. Patient stated that she was starting to feel better started eating the cookies and drank the entire 8oz class of water. Patient then stated she had a headache but was feeling better otherwise. I instructed patient to remain in the room for as long as she needed before leaving. Patient remained in room for 20 min before leaving clinic. Patient was no longer nauseous or feeling light headed when she left. Will call and follow up on 08/31/2020 to ensure patient is feeling better and did not have any other adverse events.
Mom states child c/o swollen right arm at site of injection, redness and slight itchy.
Fever 101, chills, pain both arms (flu in left, Covid in right. Precipitated flare of RA, pain in feet, hands, sharp pains in left upper back.
Both arms and back was very painful. Later on in the week I started to feel pain in my legs. Its mostly at night when I'm not moving. In May I started to feeling body shaking. One day the shaking lasted about 3 hours. I went to the hospital on May 24th beacause I was shaking for about 12 hours.
Information has been received from a physician concerning a 49 year old female with allergies to iodine/betadine, quinolones, penicillins, nitrofurantoin (Macrodantin), albuterol sulfate (Proventil), morphine and sulfa and history of cervical cancer, hysterectomy and kidney stones who on 27-FEB-2007 was vaccinated with the first dose of RECOMBIVAX HB IM into the left deltoid (Lot # 654018/ 0904F). It was noted by the reporting physician that the patient had urinary tract infection "coming on' at the time of vaccination. On 30 MAR 2007 a urine culture was collected, which noted >100,000 CFU/mL Escherichia coli. A second dose of RECOMBIVAX HB was administered on 26-MAR-2007. Concomitant therapy included UROCIT-K, SYNTHROID and ACTONEL. On 29-MAR-2007 the patient experienced fever that ranged from 100.5 to 101 degrees, and headache. The physician instructed the patient to take Tylenol. The patient recovered on 03 APR 2007. Additional information is not expected.
Noticed swelling and redness around injection site (approx size of 50 cent piece) within 24 hours. Had headache and nausea about 48 hours following injection which lasted for 24 hours. Feels completely fine today (10/20). No treatment required.
he blows his nose it does "smell pretty bad, like an infection"; sneezing and has a runny nose; sneezing and has a runny nose; if it was really diarrhea or just early morning coffee or something; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 17Jul2021 at 15:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history of the patient were not reported. Patient was not taking any other products/concomitant. Patient did not receive any prior Vaccination (within four weeks). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL10196, it what's that appears to be as per reporter, EW10196 [not clarified]) via an unspecified route of administration on 26Jun2021 (at the age of 60-year-old) at around 12-13:00 as single dose for COVID-19 immunization. Reportedly, after receiving second dose of vaccination, on an unspecified date in 2021, patient experienced sneezing and has a runny nose and when he blows his nose it does "smell pretty bad, like an infection" [as per reporter may be there was some type of sinus infection]. Patient was sitting on the toilet and did not knew if it was really diarrhea or just early morning coffee or something. Patient wondered if it was something common with the second shot or not. Patient took off from work today (report day) and was looking for compensation. Patient asked if he has to take Tylenol on work, how does that work, will patient be compensated for that, if that's related." Patient did not receive any treatment in response to the event. Outcome of the events were not resolved [consumer stated events to be persisting and that was really worse].  Information on the lot/ batch number has been requested.
Feb 12: vaccine Mid- feb: noticed lesion Mar 1: had grown, started treating with tolnaftate Mar 12: no change, emailed doc Mar 12: vaccine Mar 20: received terbinifine  End of March: more lesions Apr 11: emailed doc no changes Apr 15: started clobetasol Week of Apr 20: started seeing changes in color Sun exposure while working in yard, approximately 8-10 new lesions. Cleared up in about a week with clobetasol Sun exposure the next week: 5-6 more lesions. Cleared up in about 3 days with clobetasol  Bloodwork & Biopsy: Erythema multiforme
Sudden onset of high fever (104 degrees F), fussy, acute otitis media diagnosed the next day and started on amoxicillin. Still having high fevers 3 days later.
A consumer report has been received. The report concerns a 34 year old, Female consumer, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 21-JAN-2015. The patient experienced vomiting and sickness which started on 21-JAN-2015. The outcome of the event of  vomiting and sickness is unknown. The report was considered to be non-serious.
Client presented to vaccination site on 01/10/22 for 1st dose of Moderna. After client completed observation period and left facility, RN reported to lead RN that client had received Moderna 0.25 mL (lot #066H21A) instead of 0.5 mL. Lead RN attempted to call client 3 times, unable to leave voicemail, email sent to client with no response.
10 pm: Severe chills, body aches Midnight: same as above plus vomited on time Following morning: body aches, lethargic, head ache
No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 01-SEP-2017, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date:15-DEC-2018, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).   Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved.    This is one of several reports from the same reporter.  All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful.  Follow up information has been received from an other reporter concerning a 12 month old patient. On 08-SEP-2017, the patient vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA002098:
TO ED ON 02/12 WITH KIDNEY STONE.  ON LABWORK, PLATELETS NOTED TO BE LOW AT 85,000.  I WAS NOTIFIED ON 02/16 BY THE UROLOGIST OF LOW PLATELETS WITH NO KNOWN CAUSE AND PATIENT/EMPLOYEE S/P COVID VACCINATION.  ADMITTED TO HOSPITAL--DISCHARGED ON 02/14 AND PLATELETS 74,000 AT DISCHARGE.  TO FOLLOW-UP OUTPT WITH PROVIDER TO RECHECK LABS.
Left deltoid area swollen and reddened with bluish induration noted around injection site. Advised mother to alternate warm and cold packs to arm. See physician if the symptoms persists. Child stated he bumped his arm on his head. No other symptoms noted.
Something hit his shoulder,It's a pretty hard hit; there is a little red on the top of his shoulder; there is a little swelling on the top of his shoulder; Turned red around the skin area where he got the vaccine; something hit his chest; His right hand feels very heavy; He could hardly lift it up to his head level; This spontaneous case was reported by a consumer and describes the occurrence of CHEST INJURY (something hit his chest) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced LIMB DISCOMFORT (His right hand feels very heavy) and MOBILITY DECREASED (He could hardly lift it up to his head level). On an unknown date, the patient experienced CHEST INJURY (something hit his chest) (seriousness criterion medically significant), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine). At the time of the report, CHEST INJURY (something hit his chest), LIMB DISCOMFORT (His right hand feels very heavy), MOBILITY DECREASED (He could hardly lift it up to his head level), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
The injection was a bit painful at the time given. It felt like liquid dispersed throuhout the muscle. After, the area has had increasing achiness and now some stiffness up the neck and around the arm to the shoulder blade.
12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent  1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs  12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek,  new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint  12/30- tingling sensation persist, fatigue is gone.  Chills- 1-3 min duartion, intermittent.  left ear pain, left headache, "pings " of left cheek, tingling  back pain persists  (left)  12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided  tingling persists with intermittent headache, ear pain, teeth pain  sought care of PCP  tx of early onset bells palsy with steroid taper + PPI  Began prednisone 40 mg PO 1/1/2021 left sided back pain persists