chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; 2 inch circle around the injection site in red-bluish color; swollen arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE DISCOLOURATION (2 inch circle around the injection site in red-bluish color) and PERIPHERAL SWELLING (swollen arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy NOS. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy NOS, SILODOSIN for BPH, HYDROCHLOROTHIAZIDE for Diuretic therapy, IRBESARTAN for Hypertension, VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ZINC for Immune enhancement therapy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE DISCOLOURATION (2 inch circle around the injection site in red-bluish color) and PERIPHERAL SWELLING (swollen arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and INJECTION SITE DISCOLOURATION (2 inch circle around the injection site in red-bluish color) and PERIPHERAL SWELLING (swollen arm) 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.   Treatment information also provided as aloe vera.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 13 Apr 2021 included adverse event, treatment updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The morning after receiving 1st Pfizer COVID vaccine patient awoke with multiple quart-sized bruises on bilateral medial aspects of thighs.  No pain, tenderness or swelling reported.  She denied personal or family history of bleeding disorder.  She denied a precedent trauma.   CBC was within normal limits on 4/2/2021.  On 4/6/2021, she  denied any further bruising and those present were fading.   patient reports her sister had similar atraumatic bruising on inner thighs after 1st COVID dose as well.
1/16/21 left arm soreness by 18:00 1/16/21 left arm tingling by 20:30, resolved 1/17/21 01:00 1/16/21 chills, sweats, headache, red rash at site of injection  1/17/21 worsened headache, weakness, sleepy, loss of appetite, arm soreness, red rash at site of injection, goosebumps throughout the day  1/18/21 headache, red rash at site of injection larger and more raised, swollen upper lip (right side) and swollen earlobe (right side), appetite and energy improved
Pt received KINRIX, MMR & Varicella yesterday. Today has red, itchy blotches on back of neck armpits trunk. None on arms/legs. No fever. Adv BENADRYL and to contact office if symptoms worsen or change.
I RECEIVED VACCINE BOOSTER 3RD  DOSE 8/31 (7 MONTHS AFTER 2ND)  I AM 67 IMMUNE COMPROMISE, QUALIFIED FOR THE SHOT.   MY URINE WAS COFFEE BROWN FOR A DAY 9/3/2021, NEXT DAY 9/4 ABDOMINAL PAIN ON RIGHT SIDE FOR ONE DAY.  SEPT 7TH, I HAD BLOOD TEST AND URINE NORMAL.    9/8TH SONOGRAM ABDOMINAL AREA NORMAL.   ANOTHER PERSON CLOSE TO ME THAT HAD THE BOOSTER 3RD W PFIZER HAD THE SAME EXACT EVENTS.
Two days post vax, the pt was admitted to hospital for high fever of 101. Dx with viral infection. She was hospitalized again on 9/13 with a temperature of 100.9 at 6 weeks.
Patient passed out for a couple of minutes.  She was moved to a couch and her feet propped up.  After 30 minutes, she  was doing well.
I saw blood in my mouth, I made a appointment with my dentist. Once I got into my dentist, he took x-rays and found that I had infection around the dental implant I had on my left side. He instructed me to use my dental rinse and to make an appointment with my periodontist. The periodontist took more x-rays and advised me that I needed to have surgery to my bite realigned.
PT RECEIVED 2ND DOSE OF COVID 19 VACCINE ON 4-1-21  ,    ON 4-2-21  PT  WAS AT WORK   FELT FLUSH  AND PAIN IN HER CHEST  ,  WAS TAKEN TO HOSPITAL  AND DIAGNOSED WITH EXTREME HIGH BLOOD PRESSURE  ( POT PRESSURE NOMRALLY VERY CONTROLLED)  190/110.    PT WAS KEPT OEVERNIGHT FOR OBSERVATION....... AND  GIOVEN STRESS TEST 4-3-21  PT
We started noticing patient slowing down speech development, which was previously normal, eventually not speaking at all.  She has hearing loss. Patient currently wears hearing aids, and goes to speech therapy 5 days a week.
Woke up morning of 05/26 to room spinning.  Been dealing with vertigo and dizziness every day since. Ear pressure/pain, nausea, diarrhea, vomiting, I've been through 2 courses of antibiotics, 2 courses of steroids, I've seen an after hours dr, my family doctor, an ears nose and throat specialist and I've started vestibular therapy. So far nothing has helped. I go back to ENT dr next month for follow up. He diagnosed me with Vestibular Migraine but admitted he wasn't certain of that diagnosis and that he was treating me as if it was that and then we would re-evaluate again next month at my appt.  I've been working from home and been able to do my job but afraid to drive. The dizziness is constant to some degree but I get spells that are really bad and I have trouble focusing, reading, and nothing makes them better, I just have to wait for them to pass, usually it's no more than an hour, sometimes only 20-30 minutes.  I'm not sure I really think it's related to the vaccine but I can't completely rule it out considering I'm
Patient's mom reported hives starting around the mouth approximately 30 minutes after receiving the vaccine. By 9 pm that evening, she reports that patient had hives over half her body. She was advised by pediatrician to give benadryl and go to the ER if hives didn't resolved. Hives responded to benedryl. Patient reports feeling fatigue the next 48 hours as well. Patient is now doing fine. No further followup at this time.
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age with no pertinent medical history or drug reactions/allergies. On an unknown date in June 2013 ("5 months ago") the patient was vaccinated with first dose of GARDASIL (lot#, expiration date, dose, route not reported). There was no concomitant medication. On an unknown date in 2013 ("immediately after the shot") the patient began to experience "night sweats", irregular menstrual bleeding where previously it was regularly, and joint pain, particularly in her lower back. The patient went to the orthopedist, who performed an MRI. The physician diagnosed the daughter with arthritis and wanted to begin steroid injections, but the mother refused any injections. The patient had not received any treatment at the time of the report. The outcome of the events was reported as not recovered. This is one of several reports received from same source. Additional information is not expected.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No treatment medication information was provided. No temperature excursion was reported. Date place in refrigerator 29-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
during patient's 15 minute observation period after 2nd moderna dose, patient lost consciousness and fainted.  Eyes remained open, she did not fall out of her chair because he fiance was with her and she has a known history of fainting, from after first moderna dose, as well as during her menstrual cycles.  We were able to arouse her through stern shoulder shaking and chest tapping.  She was given water to drink, 2 glucose tablets to take, but patient confirmed that she had eaten breakfast and hydrated that morning.  911 was called, and paramedics came to check on the patient, and patient was taken out with the paramedics to further check on her to confirm that everything was ok outside.
4/21/08 Student came in one week after HPV (GARDASIL) #2 injection on 4/14/08. Reports LUE sore in deltoid and shoulder area. N/ ROM and moves freely. Denies numbness and tingling. No redness, discoloration or swelling. CMST. Rad pulse palp. Color pink, RTC again on 5/01/08 with cont'd pain, with shoulder/arm.
@ 230 pm mother reported pt having @ T of 104 w/ decreased hearing & tremors.Mother to contact MD & call us back.
ACCORDING TO TRIAGE NOTE  Interpreter used. Mom states that pt received vaccines on 3/7. She states that injection site looks swollen and is red. Mom denies fever. Mom is giving Tylenol and ibuprofen for pain and swelling and states that is it helping some. Advised mom that for a local reaction at injection site, she can apply cold packs for 20 mins on and 20 mins off. Continue to dose with Tylenol and ibuprofen for pain. Also advised that patient use his arm like normal and drink lots of fluids. Advised mom to CB if this worsens or does not improve in 24-48hrs.  CALLED PT BACK AND PER PROVIDER INDICATION, ADVISED PT TO GO TO THE ER
Fever, chest pressure, general malaise cough, feeling of impending doom lasting 14 hours
Narrative: PATIENT PASSED AWAY DUE TO COVID-19 PATIENT HAD RECEIVED COVID-19 VACCINE.
Hives the night I received the vaccine, rashes the next day. I took Benadryl (advised by a NP) both times and it subsided.
Hot flashes that continue throughout the day, and at night. Started about week after taking the first dose of the vaccine. Followed by spells of tiredness that lasts from a few minutes to maybe 45 minutes and then goes away.  Also, I missed my period, which was due around 4/22.
Hib vaccine expired on 2/26/22 and was given on 3/1/22.
p/vax pt exp flu-like symptoms; nausea; wet & cold chills; felt feverish; inj site soreness; & had slight reddened rash at site; not tx given
Pt rec'd 12 mo IMM at 10/14/16. Fever (105 degree max) Began 11/03/16 at daycare. Fussy. No cough, no rash, no VI. Seen 11/04/16 for S/S. Positive L-TM = Pink with clear fluid; Tx'ing fever with alt. TYLENOL/MOTRIN. (questionable Roseola).
I95.9 HYPOTENSION 5/20/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 03Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroid disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Acetaminophen, reaction(s): "known allergies: Acetaminophen", notes: known allergies: Acetaminophen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from  25Feb2023 to 01Mar2023.  Clinical course: Covid Rebound after taking Paxlovid five days after the last day of taking the medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12JAN96 AM pt devel a gen raised rash, t102 & swelling around eyes w/o dyspnea; 13JAN96 the rash worsened, t012;15JAN96 rash began to disappear & pt was afeb; swelling remained around the eyes;
pt recvd vax;10 mins p/ vax exp dizziness,pt's BP "bottomed out";subsided;addtly exp hot flashes,loss of focus & ha 10 mins p/vax;ha are recurring & pt has also exp rt upper quadrant pain since day of vax;sxs tx in er w/ epi & dph;released
Just under 24 hours after vaccination, I developed a low fever around 100 for an entire day. I had constant body aches and chills for the day as well. This lasted for approximately 10 hours. I felt fine after that with some ibuprofen. The chills and body aches returned again at approximately 48 hours post vaccination. This last for approximately 6 hours then everything returned to normal.
Patient became dizzy / weak a few minutes after getting the dose.  Had slight flushing on chest and rapid heart rate.  ER physician feels it is likely  vaso vagal response and not a medication reaction. Patient recovered quickly.
MOC called office at 3 PM.  Pt had a seizure and was unresponsive.  They were on there way to ER.
an unspecified patient was administered an expired dose of MMR II; The patient experienced no symptoms; This spontaneous report was received from a nurse, referring to a child patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, vaccination scheme, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prophylaxis (expired product administered). Also, the use of a sterile diluent (DILUENT MRK) was reported. The patient experienced no symptoms.
COVID vaccine breakthrough case. Moderna 3/12/21 044A21A, 4/9/21 018B21A and boosted 12/2/21 FJ8762.
Patient passed out after exiting the exam room. Hit head on floor. Decreased LOC for 10-20 seconds. Disoriented to person and place. Monitored patient in office for 2 1/2 hrs. 3 episodes of vomiting, tiredness, and dizziness. Pt was sent to hospital for further exam. Received IV fluids and cardiac testing at ER. Sent home from ER with Dx of concussion.
Patient stated felt lightheaded after injection, laid down on table had bubbles coming from mouth, arms and legs became rigid, eyes fixed, lasted approx 1-1 1/2 minutes. Member began to respond to verbal cues, was given, crackers, ice pack for neck, given sucker, and soda improved over time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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 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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 19Jun2022, treatment stop date: 20Jun2022, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient and wife came in and wife stated that she wanted us to look at patients arm. The redness started roughly 2-3 inches below injection site. Warm to touch no itching. Patient wife stated it was not there until today. We advised patient to use cold compress, benadryl by mouth and hydrocortisone cream. Advised pt to follow up with doctor as well. Pt was not having any other adverse reactions.
Around 24 hours after the vaccine I developed a headache. The injection site had become swollen and very painful. The next day I developed sinus and chest congestions so I called my doctor. She recommended I take a COVID-19 test so I did and tested negative on 8/15. I developed a high temperature that week. I missed an entire week of work. I called my doctor and she said I may have blood clots in my lungs and recommended I go to the ER so I did. The ER doctor confirmed the suspicion but CT scan did not detect anything. I developed extreme fatigue over the course of the following week. I went back to the ER after developing wheezing and more fatigue. The did an echo which revealed that the left side of my heart was a little enlarged. I followed-up with a lung specialist and heart doctor. I have had COVID-19 three times since the fall of 2020. The most recent was in 6/28. I developed a fever, severe sinus congestion, headache, extreme coughing and extreme fatigue. My doctor sent me for an anti-viral infusion.
COVID-19 Vaccine EUA; Severe pain when moving or raising left arm or laying on left side. This symptom started about 3:20 pm the day of the shot and continues 22 hours later.
This case was reported by a consumer via call center representative and described the occurrence of eyebrow loss of in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included eyebrow loss of (history of eyebrow alopecia, but the condition was improving until she received SHINGRIX). In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced eyebrow loss of, condition aggravated, itchy rash, chronic cough and upset stomach. On an unknown date, the outcome of the eyebrow loss of, condition aggravated and upset stomach were unknown and the outcome of the itchy rash and chronic cough were not recovered/not resolved. It was unknown if the reporter considered the eyebrow loss of, condition aggravated, itchy rash, chronic cough and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient developed itchy spots of rashes on various parts of her body. She also developed a chronic cough that was causing stomach issues. This case linked with US2019GSK054186, reported by same reporter for the same patient.
Arm numbness which progressed to hands, fingers, and legs; Tingling; Weakness; Headache; Feeling poorly; Out of work; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a 40-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   In September 2019, the patient received FluLaval Tetra 2019-2020 season. In September 2019, couple of hours after receiving FluLaval Tetra 2019-2020 season, the patient experienced numbness, tingling, weakness, headache, feels poorly and inability to work. On an unknown date, the outcome of the numbness, tingling, weakness, headache, feels poorly and inability to work were not recovered/not resolved.   It was unknown if the reporter considered the numbness, tingling, weakness, headache, feels poorly and inability to work to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The director of pharmacy reported that the patient received the Flulaval vaccine on unknown deltoid on either 14th September 2019 or 15th September 2019. Within a couple hours of receiving the vaccine, the patient started feeling poorly. The symptoms continued to devolve over the next 5 days, and the patient experienced initial arm numbness which progressed to hands, fingers and legs. 5 days after the injection, the patient presented in the emergency room for evaluation and the neurology consult was unable to diagnose anything at the time. The patient was referred to outpatient neurology for follow up.  The patient was still experiencing headache, numbness, weakness, and was still out of work on leave as of the time of this call. The reporter consented to follow up. No further details available at the time of this call. The pharmacy consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Patient came to ED with generalized weakness, runny nose, chest congestion, cough, and diarrhea.  Patient was admitted to the hospital with Covid and treated with remdesivir.
2-3 minutes after the shots were givenm mom approached my assistant because of change in baby's color. Wfen I came in a few seconds later, baby is awake,limp, pale, dusky but not cyanotic, breathing, clearbreath sounds,  heart rate 100/min. , regular in rhythm, no seizure movement and afebrile. Stimulated baby to cry by patting feet and about 1-2 minutes later, he pinked up,heart rate went up to 180's (crying) and 02 sat was 98%. Baby was observed in the room was observed x 1 hour before he was sent home, was feeding well. A phone follow-up was done in the afternoon and per dad, baby was fine. Anothe phone call was done the following day and per dad, baby had a fever and was advised to give acetaminophen.
Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in the left deltoid.  Per father, patient did not have a reaction to the vaccine.
Headache, SkinRash, Rash, Dyspnea on exertion Narrative:
Patient reports experiencing severe back pain on the lower left side right above his buttocks a couple hours after the shot. He said this continued for a couple days afterward. He did not report that he got any treatment for it.