chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt exp upper arm pain @ deltoid area w/an erythema approx 6cm wide;appeared to be there inflammation response;
received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first dose) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant product included 'unknown'  No treatment information was provided.
pt recv vax 31DEC96 & 9JAN97 pt had sz;no temp;eyes rolled back in head & had jerking of all extremities lasted 1min;adm to hosp;had CT scan;no meds @ this time;23FEB97 had sz in noc;24FEB97 saw MD given ATB for ear infect;had sz;staring
For the first 48 hours after the shot, I felt dizzy and flu like. After those 48 hours, I was left with moderate to severe dizziness that has not subsided. At times, it has seemed almost like vertigo, but mostly it has been just a constant feeling of things being off balance and that things are moving when I shift my eyes from place to place. I have also had a lot of headaches (which was a very rare occurrence for me prior to the vaccine).
Patient explained he does not like needles but had previously received flu and other vaccines in the past with no proble. He was given the Tdap shot first in the LEFT arm, he was ok and even verbally said "that wasn't so bad, ok, one down", I proceeded to the right arm and gave him the flu vaccine at which point he said, "that one got me a little". At this point he started to top over to the left side. I asked several times if he was ok but he could not verbally respond at this point. I was holding onto his arm and securing him in the chair so that he would NOT topple over to the front. At this point his eyes were rolling into the back of his head and he was shaking profusely. He came back to it about a minute later and said he was fine- at which point I said no he was not and to remain seated for a while longer, after about 30 seconds the same reaction started to happen again- his eyes rolled into the back of his head he slumped to the back and started shaking and could not speak. After about a minute again he came back to it. I asked if he would like me to call an ambulance but the patient declined and said for us to call his wife or another family member- we called his wife and left a message and the patient called his mother to come pick him up. We gave the patient water and had him remain seated in the consultation room until he had someone to come pick him up. After the patient was able to speak again he seemed to have temporary memory loss as to what happened. He said he could hear me asking if he was ok but could not respond and that he felt as though he was sleeping for about 30 minutes during that time. He also did not remember whether he had the vaccinations or not. We advised the patient to follow up with his doctor and take it easy the remaining of the day.
Loss of hearing; Tinnitus; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced deafness/hearing loss and tinnitus.   The patient's medical history, was not  provided. Concomitant medications reported included prednisone.   On 21 Jan 2021, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in an unknown location for prophylaxis of COVID-19 infection.  Approximately two days after vaccination the patient developed hearing loss in his left ear. He consulted doctor but was unable to find the medical reason for his loss of hearing. Also, the patient reported tinnitus. The patient has another appointment with ENT on 06 Apr 2021. The patient is going for a blood work for to confirm for the antibodies after the vaccination.  The event deafness was considered as serious and medically significant.  The treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, loss of hearing and tinnitus was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 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 VACCINATION SITE PAIN (vaccination site pain). On 13-Mar-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  The patient received her first Moderna Covid-19 vaccination in early February and reported no adverse reactions.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD21-072277 (E2B Linked Report).; Sender's Comments:  MOD21-072277:
A report has been received from a physician concerning a 12 year old, male subject, who had been receiving FLUMIST QUADRIVALEN (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 31-Dec-2014. The reporter stated that the patient experienced inadvertently administered expired FLUMIST QUADRIVALENT to four patients on 31-Dec-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to four patients is unknown. The report was considered to be non-serious.
get shingles after had the shots /suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, some get shingles even after had the shots for it. The reporter stated that, causes lots of serious side effects too. The reporter stated that, it seems to be hitting lots of people recently, as so many got them this year. The reporter thought, ongoing stress was a primary cause of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR198913, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198913:same reporter
Very lethargic for 3 days followed by headache, dizziness and shortness of breath.   Has continued up to today but the symptoms have lessen each week.  Most common is headache and dizziness.  Went to emergency in May thinking I was having a heart attack but they could find nothing wrong.
I was being treated for severe mitral stenosis prior to vaccination.  The day of vaccination my condition significantly worsened and I was readmitted to hospital.  Diagnosed with AFib.  I had been AFib negative since a valve replacement two years prior in conjunction with MAZE procedure.
pt seen in ER w/ very hot/ red 2-3 cm area of swelling rt proximal lateral thigh- refused to move/ walk on leg. Admitted to hosp. pt had hip pain r/o septic hip on admit. discharged w/ activity as tolerated. synovitis 2ndary to viral infec
Pt. was given vaccine on 3/4/11, came back in to office 3/8/11 with approximately 4in x 4in circular - warm area to L thigh Mom said gradually got bigger over past few day. Tx with AUGMENTIN for cellulitis.
Tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. Patient reported that they was testing positive for Covid and was not contagious. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected non-serious event of (AESI) Covid-19. The exact date of administration of the second and third dose of mRNA-1273 was not specified, hence latency could not be assessed. Patient tested positive for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637093, US-MODERNATX, INC.-MOD-2022-637094, US-MODERNATX, INC.-MOD-2022-637095 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected non-serious event of (AESI) Covid-19. The exact date of administration of the second and third dose of mRNA-1273 was not specified, hence latency could not be assessed. Patient tested positive for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. US-MODERNATX, INC.-MOD-2022-637094:Patient 2 US-MODERNATX, INC.-MOD-2022-637093:Patient 1 US-MODERNATX, INC.-MOD-2022-637095:Patient 3
After 12 hrs from vaccination I developed 103 fever, abdominal pain underneath left ribs, muscle aches in back beneath the Scapula, severe headache and frontal sinus pressure. Milder symptoms continue - now 6:34 am
had chills; back was a little achy; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back was a little achy) and CHILLS (had chills) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced BACK PAIN (back was a little achy). On 05-Oct-2022 at 4:00 AM, the patient experienced CHILLS (had chills). At the time of the report, BACK PAIN (back was a little achy) and CHILLS (had chills) outcome was unknown.            No concomitant medication were reported.             No treatment information was provided by the reporter.   This case was linked to MOD-2022-655857, MOD-2022-655858 (Patient Link).
DTaP dose 5 was given to an 18 month old when it is not supposed to be given until the child is between 4 to 6 years old and given less than 3 months after dose 4. Hep A was given 30 days early, dose does not count and will need to be re-given in 6 months.
This is the half-dose booster shot. Two days after the shot, I now have numbness on the left side of my face, mostly on the upper half all around the eye socket
Pt began vomiting 8 hrs after shots and had fever (not taken). Vomited 15 times. Had headache. Was seen by MD on 11/12. No stiff neck. Temp 99.2. Zofran was given for nausea.
Patient was admitted to observation level of care on 1-28 -22through 2-5-22 with marked jaundice and complaint of weakness. Receiving treatment for likely alcoholic hepatitis with liver failure. It is noted that the patient tested positive for covid on admission.   Readmitted on 2/12/22 ---he reports feeling very weak and tired.
Client presented to the vaccination site on 01/14/22. The client notified RN that 30 minutes after receiving his 2nd dose of Pfizer on 06/12/2021, he experienced an onset of left sided pulsing chest pain that lasted 15 seconds. Client states he was sitting eating during onset of pain. Client denied shortness of breath, swelling in throat or face, dizziness, weakness or any other concerning symptoms.  Client denies known allergies and reports a past medical history of prediabetes and high cholesterol. Client reports he was taking Rosuvastatin 10 mg daily and reports he stopped taking it for 2 months because he ran out and has followed up with his PCP. Client did not follow up with PCP following onset of chest pain.
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 13-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Temperature , chills, body aches, headache Took 1 Tylenol,Symptoms improved . Only a light headache is left .
patient reports getting dizzy about 1/2 hour after administration.  He also complained of dizziness the next morning. He fell and hit his head on the shower. He went to hospital where he was treated for head injury (stitches) and a urinary tract infection
CARPAL TUNNEL FLARE IN VACCINATED AREA Narrative:  Other Relevant History:
Day 1 pain in left arm vaccine site, fatigue. Day 4 pain in left arm grew to more intense pain and spread up left shoulder to neck and left side of face and around eye area. Same exact feeling as Bell's Palsy.  Day 5 - I took Valtrex I already had 1 gm Day 6-13 doctor prescribed Prednisone 60 mg + Valtrez 1 gm for first day (adjusted to 50 mg Prednisone days 7-12 due to Prednisone side effects, then 20 mg on day 13).   After day 7 facial palsy began to decrease in eye area. Overall Bell's Palsy symptoms after full course of treatment have finally subsided after day  20, for now.  Hoping they will not return.  Very scary and intense experience.  Exercise and PT helpful.
Patient came today to pharmacy and reported she experienced rashes, redness, swelling & a little inflammation on her top left arm where she got her Fluzone HD shot. and after a few days, the redness were increased in size around 5 inches, but the swelling had subsided. Pt was advised to notify her regular PCP since she mentioned she always get redness/rash whenever she gets her annual flu shots.
Itchy eyes and hives on most of body that started 2 hours after injection.  I took 50mg of Benadryl and that put me to sleep. When I woke the hives were gone but I still itches another day. I took Claritin which did not help. When I got home from work I took 25mg of Benadryl which took care of symptoms. Eyes have been itchy off and on still.
Had 3 hours of high pitched insonsolable crying post vaccine at 2 month visit.
Ear infection; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 EAR INFECTION (Ear infection). At the time of the report, EAR INFECTION (Ear infection) outcome was unknown.        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.   No relevant concomitant medications reported.  Treatment medication including Antibiotics.  The caller returned the call stating MOD21-037044 was not referred to her. Her case number was MOD21-047472.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received on 12-JUL-2021 contains no significant information
Pt reports induration that is red aprox 8x4cm,  tender and itchy x 2 days now, the redness appears to be spreading, it used to be smaller. No fever, chills, feels fine otherwise. No Resp. symptoms. Advised its local rxn to the shot, can do benadryl or claritin daily, ibuprofen 400mg tid prn take with food, ice application may be helfpful as well. s/s infection discussed.
Significant swelling of the upper arm where vaccine was placed. Arm was hot to touch and caused a low grade fever of around 100 degrees. Treated with 800mg of Motrin. Pain and swelling continued through 9 July 2011, continued to treat with Motrin. Spent all of 8 July in bed with fever.
Patient received only the liquid component; Patient received only the liquid component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 18-AUG-2022 Reporter's comments: The patient received only the liquid component of the Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported.  The reporter consented to follow up via email.
Intermittent weakness of hands and legs. Intermittent numbness of arms and legs. Fasiculations predominately of bilateral gastrocnemius region, but also in other muscle groups. Has persisted for >10 days now.
Pt developed significant neurological deficits ("couldn't walk straight", per her response) on November 10, 2020.  She is currently hospitalized (day one: November 11) for suspected acute onset of Guillain-Barre syndrome and is undergoing treatment with IV immunoglobulin therapy.    Significant prior history: She was diagnosed with pneumonia on October 9, 2020 and treated with PO antibiotics prior to her influenza vaccination.  Her influenza vaccination was delayed until well after her last dose of PO antibiotics and she presented asymptomatic to me on October 27.  She denied prior history of severe allergic reaction to the influenza vaccine and denied a history of Guillain-Barre.  She was vaccinated for influenza last fall with no adverse effects.  She remains hospitalized at the time of this reporting and is expected to undergo physical therapy to address lower extremity weakness.  I don't have information on other signs/symptoms at this time.
Received TDAP in right deltoid on 5-12-10. First day after had red circle and pain around injection site. Third day 2 circular path of blisters appeared with itching. Then redness spread to entire right arm for 4 days. Could not move right arm for 4 days. Felt nauseated 3 days. Started improving 9 and 10th day. Is able to move arm now and is less sore. Took BENADRYL and MOTRIN.
Woke up in the morning with several hives under armpits and shoulder/neck area about 8 total with injection site red and swollen about 2.5" long. Patient complained of itchiness. Gave patient 5 mg of ODT cetirizine BID as well as hydrocortisone 2.5% ointment BID for 2 days. Sunday, patient used ice pack for itchiness throughout the day.  Monday night: injection site has almost return to normal. hives are still present with complaint of itchiness.
Information has been received from a certified medical assistant concerning a 10 month old patient who on 22-APR-2008 was vaccinated with the third dose of ROTATEQ. No adverse symptoms were reported. It was also noted that the patient received the first and second doses on time (dates unspecified). No other information available. There was no product quality complaint. Additional information has been requested.
Tachycardia at seconds after receiving influenza vaccine, patient's heart rate became very rapid went up to 1600's to 1800's. BP was lower 90/60 from 110/70 but he was asymptomatic. Provider was notified