chrisvoncsefalvay/vaers-outcomes huggingface dataset:
huge knot/tiny knot; burning; shooting pain; red; pain; itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (huge knot/tiny knot), BURNING SENSATION (burning), PAIN (shooting pain), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (huge knot/tiny knot), BURNING SENSATION (burning), PAIN (shooting pain), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (pain) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE MASS (huge knot/tiny knot), BURNING SENSATION (burning), PAIN (shooting pain), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (pain) and VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided. treatment medication was not provided.
Pt. c/o of breathing difficulties after receiving 2nd dose of Covid vaccine. Pt. reports anxiety prior to injection due to recent news reports regarding vaccine. Pt. reports minimal burning sensation to L arm. Symptoms resolved after additional monitoring and patient dc' d home.
Postural orthostatic tachycardia syndrome (POTS); Extreme fatigue; Dizziness; Orthostatic intolerence; autonomic dysfunction; Severe and constant headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), severe and persistent headache, autonomic nervous system imbalance, orthostatic intolerance, dizziness, and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007498: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Local rxn, rt thigh; high pitched abnormal crying last 1/2hr or more @ a time for 24hrs;
Developed chest/throat tightness, flushing, low grade fever, cough within 3-4 hours of receipt of seasonal influenza vaccine.  To ER, albuterol nebulizer given. Diagnosed with vax reaction. Discharged with steroids, benadryl, and nebulizer treatment.
Patient states that she was hospitalized for cellulitis 2 days after the vaccines were given.  Per patient, provider stated that it was related to vaccine administration. Patient was given 10 day course of cephalexin 500mg caps four times daily .
I had a really bad headache, felt really tired, and also had a cough. I did an at home test and was positive for COVID-19 on January 2, 2023. I went to see my doctor, but he didn't do another test. He didn't think I needed any medication for it.
7PM became fussy worsened-cried hard, difficult to console; from 730PM to 3-4AM head/shoulders would jerk, even while sleeping (periodically) not exactly a sz; vomited x 2 next day;
Left leg where immunization given, red, swollen, hard.  Mom called at 14:30 on 03/31/04 to let RN know of symptoms.  RN advised to give Motrin/Tylenol and apply heat on and off.
The morning after receiving his MMR vaccine, my son started having diarrhea. The following day he had a lot of diarrhea and stomach pain with the diarrhea and said it hurt when he urinated. I took him back to the dr and dr said the diarrhea was likely a stomach bug. Dr did a urine test because of the pain with urination and a slight amount of red blood cells showed up in his urine. After about 4 days, thankfully, the diarrhea and stomach cramps stopped. Several days after that, my son got strep throat which was treated with antibiotics. We went back to dr 2 weeks after the first urine test to have my son's urine retested, and it still had some red blood cells in it. Also, his strep throat infection came back and he is now on a different antibiotic. (I'm aware that the strep throat has nothing to do with the MMR, other than that the vaccine may have temporarily lowered his immunity). The dr ordered a standard blood test because of the continued red blood cells in urine, and I just got a call back from the dr that his blood tests all came back normal! I'm so relieved!! Now we just have to go in for a follow up urine test in 2 weeks to see to check again for red blood cells in his urine. This may all be a coincidence but I am reporting it to you in case it is related to the vaccine.
I started experiencing heart palpitations at rest and when in motion on 03/05/23. I continued experiencing the sensation that my heart was racing, both during the day and at nighttime. I visited my PCP on 03/09/23 and again on 03/17/23 . These symptoms have since dissipated (04/04/23) I still felt it necessary to report this change in my medical health.
Patient has long standing COPD and asthma. He has been stable on his home medications for years. No hospitalizations for these issues in the past. During Covid times he has been very restricted to his home with no visitors. Approximately 5 days after receiving the 2nd Moderna Covid-19 vaccine, he started having increased difficulty with breathing. Over the next few weeks he continued to get worse and required home oxygen and an adjustment with his medications. He was started on steroids and antibiotics about 3 weeks after the vaccine and then hospitalized on 3/16/2021 with COPD exacerbation and pneumonia. He tested negative for Covid at that time. He was in the hospital for 9 days and discharged home on steroid taper and home oxygen. A few days after being at home, he had gradual onset of subacute dementia/delirium. All workup has been negative. MRI/MRA normal. He is currently continuing on oxygen and again on steroids and mental status may be starting to improve.     The concern here is that patient was stable and had been stable on his medication regimen for years. He was doing well until approx 5 days after his second Covid vaccine when he started having worsening pulmonary complaints and eventually ended up in the hospital. He continues to be on oxygen at home and was recently started back on steroids. There has been no explanation for his subacute onset of Dementia/Delirium. MRI/MRA normal. This has been discussed with both Pulmonology and Neurology specialists.
Pt had a brief resolved unexplained event early Monday morning in which he was found in bassinet not breathing, mom slapped his back and in a few seconds he recovered
Woke up from a nap with burning/itching/sensitivity in hands "like pain from shingles" about 20 minutes later started experiencing stomach upset. Within an hour began feeling achy and feverish. At 8:45 PM got up to get ready for bed and noticed a rash similar to that experienced in bacterium reaction on arms and chest.  Took diphenhydramine at 9PM and left for emergency room at 9:30.  Arrived at the ER at 10:15 and was in a bed by 11. Given additional dose of diphenhydramine at unknown time and released at 3:00 after observation.
Became ill 11 hours after 1 dose. Fever in excess of 101, body aches, cough and diarrhea. Felt much worse than when I originally had COVID on 1/11/2021.  My COVID was a normal case with no hospitalization but primary doctor care with z-pack and steriod.    Definitely not looking forward to 2nd dose.
Injection site pain on left arm, Pain near the left armpit, Muscle pain, Joint pain, Feeling like pain inside veins
"body aches, chills fever 99.9, extreme fatigue, dizziness followed by nausea and vomiting"
COVID-19 symptoms started on 12/28/2021 with coughing. I went to the Doctor and didn't know I had COVID-19 and then was told I had COVID-19. I felt very fatigued and tired. The fatigue and tiredness symptoms lasted about 3 weeks. I lost my sense of taste and smell briefly, for about 2 days. I had a fever of 102. I feel very spacey and not grounded and I'm seeing a neurologist 04/29/22 about that.
BODY ACHES; HA; DIARRHEA; INJECTION SITE RED, SWOLLEN, HOT, TENDER
Painful blisters in the genital area; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL BLISTER (Painful blisters in the genital area) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 046B21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Herpes infection (Patient had herpes 45 or 50 years ago). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and COLLAGEN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL BLISTER (Painful blisters in the genital area). At the time of the report, GENITAL BLISTER (Painful blisters in the genital area) had not resolved.            Concomitant medications include Blood pressure pills.  No treatment details were reported.  It was reported that patient will visit ER  09-NOV-2021 to consult doctor.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up report received on 12-Nov-2021 contains Non Significant Follow-Up.
Patient presents with a potential reaction to the COVID19 vaccine. Patient-reported vague symptoms of some RUE tingling and R-sided facial tingling after RUE injection along with some neck tightness. The patient also reported mild generalized itching without rash, which he felt may be due to seasonal allergies. He requested 50mg oral Benadryl.  Oral Benadryl given per request. Returned to baseline with monitoring.
Arthralgia, ErythemaMultiform, UrticariaPruritus, lump in arms, swelling in arm, Narrative:
The day following the first dose of the Comirnaty/Pfizer COVID-19 vaccination (10 Oct 21), I began to experience severe low back pain, muscle spasms in low back, SI joint pain, and a dull ache that radiates to my groin and testicles.  I have made two appointments with my primary care physician to discuss and treat these symptoms.  I was given Naproxen, Flexeril, and an X-ray (which came back negative) for kidney stones.  3 weeks post vaccination I am still experiencing low back pain in muscles and joints, the radiating pain to my groin and testicles has subsided but still returns at times.  Patient has no history of back pain, and no injury that would have caused the symptoms.
Chills, nausea and vomiting, painful, red, raised around injection site.
Motor and verbal tics similar to Tourettes without coprolalia.  Tics last for about 3-4 secs involving the shoulders, neck and arms with 1-2 words repeated during tic.  The intervals can range from 1 min to 30 secs.
I had my 3rd dose in October and was low in iron over the summer so I was taking my injections since. I work at a school so I wanted to be vaccinated. I noticed I had dry and red skin soon after the vaccine sometime since the vaccine to be treated for that. After winter break I went back to work and I was starting to feel symptomatic and a bunch of my co workers were positive but my test came back negative. However I was sick. I was extremely fatigued and low energy. The following Monday Jan 17th, I took another test and it was positive. I believe I was sick the entire time. After I recovered the brain fog has not gone away, I keep calling it COVID brain. On March 14th, I taught classes and after 2 meetings I went to the 6th grade basketball game and I felt weird. I decided to go to the parking lot and I felt off and I was tired and dizzy. I had a fitness device for the heart so I checked it and it said I was in A fib. I went to the ER and they shocked my heart back to normal. Right now I am in a 30 day heart monitor. My other vaccines I felt like I had no symptoms other then just a sore arm.
General fatigue; feeling unwell; This non-serious case was reported by a consumer and described the occurrence of fatigability generalized in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigability generalized (Verbatim: General fatigue) and feeling unwell (Verbatim: feeling unwell). The outcome of the fatigability generalized and feeling unwell were resolved (duration 2 days).   The reporter considered the fatigability generalized to be related to Arexvy. It was unknown if the reporter considered the feeling unwell to be related to Arexvy.     The company considered the fatigability generalized to be related to Arexvy. It was unknown if the company considered the feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-OCT-2023 The patient took first dose of Arexvy and experienced general fatigue and felt unwell for 1 to 2 days. Consumer reported seriousness for fatigue as not serious. Arexvy manufacturer, expiry date of Arexvy was unspecified. The reporter denied the consent to follow up.
Flu, severe allergies, nerve damage, sore arm, general weakness, chronic fatigue syndrome, intestinal trouble, diarrhea, cough, wound taking four months to heal.
After my first dose of the Pfizer-BioNtech Vaccine, I experience rashes all over my body. Raised bumps, very itchy, hives. On 4/16/2021, I went to a dermatologist, Dermatology Group She prescribed me Prednisone 20mg Tabs (5), Xyzal (levocetirizine) 5mg, 1 tab in the morning, and 1 tab in the evening. The medicines she prescribed helped for a little, but after I finished the Prednisone my rashes, hives, and itchiness came back. I was not able to get an appointment with the PAC until 5/7/2021. She then prescribed me: Prednisone 20mg tabs (21) take 2 tablets by mouth daily for 7 days then take 1 tablet by mouth daily for 7 days, Hydroxyzine Hcl 25mg take 1 to 2 tablets by mouth every night at bedtime, Xyzal (levocetirizine) 5mg take 1 tab in the morning and 1 tab in the evening, and Pepcid AC. Once again, once I finished the Prednisone my hives, itchiness and rashes returned. on 04/26/2021 I received my second dose of the Pfizer Vaccine. Lot Number EW0167 8/21. I got my the first day of my menstrual cycle was 04/25/2021. My menstrual cycle continued for 3 weeks and still, I have spotting everyday. I made an appointment with my OBGYN on 5/17/2021 for irregular periods. She preformed a Venereal Disease Screening and wrote me prescription for blood work and a US, Pelvis, Transabdominal + Transvaginal. I got my blood taken, and my appointment for US, Pelvis, Transabdominal + Transvaginal is 6/09/2021.  On 05/25/2021 I had a telehealth video appointment to go over my blood work. below are the results.  1. Serum TSH level abnormal Repeat TSH level.  Discussed possible sub-clinical hypothyroid.  Follow up with PCP, however, will contact if any further abnormal findings. ? thyroid panel with TSH ? thyroid antibodies 2. Hyperprolactinemia Obtain fasting prolactin level.  Discussed possible etiologies. If persistent elevation will do further workup. ? prolactin-004465-P 3. Macrocytosis Discussed mildly elevated MCV.  Possible referral to Heme ? vitamin B12 and folate 4. Leukocytosis S/P COVID vaccine. Repeat CBC for evaluation. ? CBC, platelet, no differential  The doctor put a prescription for me to go back to LabCorp and have a complete Panel done of my blood. I have an appointment on 06/01/2021.  Today is Sunday 05/30/2021 and I still experience itchiness, rash, hives, and menstrual bleeding.
developed a sore throat / have a reaction in his mouth and throat; mouth infection; This case was reported by a consumer via call center representative and described the occurrence of throat infection in a 78-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced throat infection and oral infection. On an unknown date, the outcome of the throat infection and oral infection were unknown.   It was unknown if the reporter considered the throat infection and oral infection to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had experienced throat infection after vaccination. The patient asked could a person have a reaction in his mouth and throat from the shingles shot.
Redness, swelling and severe itching to injection site. Numbness and tingling to mouth,lips, gums and toung and severe headache 8 days after injection was given.
Sore arm; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on (29MAR2021), this case now contains all required information to be considered valid.  This is a Spontaneous report from a Pfizer sponsored program. A contactable 80-years-old patient of an unspecified gender reported that received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 27Jan2021 (Batch/Lot Number: EL9265) as SINGLE DOSE, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm (pain in extremity) on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that on an unknown date the facility had a temperature excursion for the Moderna COVID-19 vaccine and the excursion duration was 1 month. And also, the vaccine was stored in an ultra cold freezer at -82 degrees Fahrenheit. On 19-Nov-2021 the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. 70 vials were in the ultra cold freezer, 8 vials were in the refrigerator. The vaccine was never refrozen. Number of vials impacted were 78 and none of the vials were punctured and there were no previous temperature excursions.   This case was linked to MOD-2021-402935 (Patient Link).
patient had a blood work drawn and it showed no immunity for measles, mumps, and rubella; no adverse effects reported; This spontaneous report was received from a registered nurse and refers to herself, a female patient of unknown age with hyperlipidaemia, seasonal allergy and food allergy. Concomitant therapies included sterile diluent, unspecified thyroid medication, unspecified cholesterol medication and unspecified seasonal allergy medication.      On an unknown date (also reported as "unknown vaccination history with MMR II"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), via an unknown route of administration, for prevention of measles, mumps, rubella (strength, dose, frequency, lot number and expiration date were not provided).     On an unknown date, the patient had a blood work-titer drawn for  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and it showed no immunity for measles, mumps, and rubella (measles antibody negative). No adverse effect reported.      At the time of reporting, the outcome of measles antibody negative was unknown, however it was reported that the patient was stable.     The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the reported measles antibody negative was not provided.
Per patient, she started having throat pain and soreness, headache, and right face swelling in the night. She feels it is getting worse.
Patient reported dizziness at 30 min post injection but admitted symptom had started soon after injection. She was given po fluids and allowed to rest in recumbent position until improved.  At time of discharge was ambulating without syncope but still had residual dizziness which family reported will typically persist for 1-2 days.
Within minutes, I felt flushed (sweating, light headed), weak, and arm pain. followed by fatigue, fever, continued pain in my arm, overall weakness, and occasional naseau.
Day of shot around 7:30pm got chills really bad, next morning had fever (high to 101), vomiting, dizzy.  Fever broke around 7:00pm on 4/6/2021.  Next morning, 4/7/2021 the front of my chest and back broken out in a rash. I believe my head also. It was itching.  Called my family doctor and got in. By the time I got there it spread to my arms also. Doctor had given me a shot of DEPO-MEDROL and 2 prescriptions- Triamcinolon cream and Hydroxyzine pills.