chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vertigo" (unspecified if ongoing), notes: I suffer from vertigo pre covid and it got worse during early 2020; "It got worse" (unspecified if ongoing), notes: it got worse during early 2020. Concomitant medication(s) included: MECLIZINE [MECLOZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 Booster), for COVID-19 immunization; Bnt162b2 (DOSE 4 Booster), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: Hi ,  I had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if theres any links to case studies or general information about it. I suffer from vertigo pre covid and it got worse during early 2020. I noticed every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had. Meclizine 25mg has had no impact anymore it feels like, I had 5 shots already of Callback attempt #1 01Nov2022 2:46PM: to leave voice message with callback number and INT. Sent "further discussion" letter. Hi , I had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there's any links to case studies or general information about it. I suffer from vertigo pre COVID and it got worse during early 2020. I noticed every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had. Meclizine 25mg has had no impact anymore it feels like, I had 5 shots already of.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428 with expiration date 30-JUL-2017, lot # L036245 with expiration date 09-FEB-2017, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received dose #1 of Moderna vaccine 1/25/21 approx 5:04pm, planned observation of 30 minutes followed due to multiple allergies. RN #1 was the observer in the lobby at this time. RN #2 is patient's niece. She also sat with patient in the lobby. At approx 5:40 pm RN #1 was ending her shift and reported to another RN that patient was having symptoms of tongue itching and swelling. RN went to assess the patient. RN then notified supervisor before she left. RN ensured that the supervisor was aware of the situation and both also came to the lobby to assess pt. was escorted to facility room for privacy. She reported phlegm in her throat, difficult to clear with a cough, tongue swelling a bit more in the back of her throat, and starting to lose her voice. Client remained alert and calm, denied trouble breathing or generalized itching. No hives observed. At 5:45 pm RN administered one .3 mg dose from an EPI pen injector to pt's right thigh. RN supervisor advised pt that we would be calling 911 to transport her to a local hospital for further evaluation. RN supervisor also advised that patient should not get dose #2 of Moderna. Secretary called 911. Called patient's daughter. By 5:50pm patient's voice had improved and she also spoke on the phone to her daughter. She remained calm, with no difficulty breathing and no hives or generalized itching. By 5:55pm pt was able to maintain conversations with staff. Discussed her hx of DM and daily schedule for meals and snacks. At 6pm officer was present to assess pt. Oxygen saturation 100%, BP 196/77, HR 88. Client then shared that she was recently diagnosed with hypertension, and was waiting for the dr to fill her prescription. Approx 6:05pm ambulance crew was present to assist pt.
Patient developed redness and itching in left arm, upper left chest and neck. Patient declined diphenhydramine due to increased risk of drowsiness, and declined observation. Patient declined care of EMS as well. Patient states she will go home and take benadryl at home.
Hives,  given Prednisone by physician a week later could not get appt same week, after tkaing prednisone  Hives diminished.  I not have the hives back periodically.  I have had hives before due to the  Auto Immune but they were under control for 3 years.  Now I am back to where i was years ago
11 days after Covid dose #3, patient developed left sided facial weakness and numbness.  Presented for evaluation 1/21 and prednisone prescribed.  F/U scheduled in 1 week.
Patient describes injection as "excruciating" pain -- she has never had pain with previous flu shots.  She also reports that she felt "freezing cold" during the administration and for the next day and a half, but does not thing she had a fever.
The patient received the COVID vaccine first in the left arm and had no symptoms. Then when giving the flu shot secondly the patient fainted after 30 seconds of administration. Patient woke up shortly after fainting and was instructed to sit and be monitored for 15 minutes after the event.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 05-DEC-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Rash to (L) upper arm began after immunization. Progressed to 13cm x 11cm. Warm, edematous, erythematous rash over 36 hrs until patient sought care. Pt denied any SOB/wheeze, tongue or lip swelling. Cutaneous reaction only.
Information has been received from a physician concerning a 62 year old male who on approximately 26-JAN-2007 was vaccinated with a dose of Varicella. Concomitant therapy included multivitamins (unspecified). Three days later, on approximately 29-JAN-2007, the patient returned to the physician's office with a "bad case of shingles." The physician gave the patient valacyclovir hydrochloride (VALTREX) and the patient is still in pain. At the time of the report, the patient had not recovered. A product quality complaint was not involved.
Visible depression of skin over injection site of left deltoid measuring approximately 1 in. x 1.5 in. with 2-3 lesions resembling pimples that appeared over time.
Pt erroneously received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if this batch of Pfizer Adult purple top vaccines were still viable at the time of vaccination provided that the vaccines were thawed on 11/23/21 at 1:43pm .  Determine pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing data.
Vaccine administered 9/13/12. Patient has continued to have soreness and possible tendonitis in arm since that time. MD feels shot may have been administered into tendon.
Sharp squeezing frontal headache about 3am. Woke around 6am with headache and light sensitivity, sore body.  Went back to bed about 8am, woke at 9am vomiting, headache, slow moving. Took ibuprofen went back to bed. Woke at 11:30am vomiting again. Back to sleep shortly after.
Chills; Itching rash on arms, back, neck and chest; Diarrhea; nauseated; stomach started turning like she had a strong laxative and cramping real bad; stomach started turning like she had a strong laxative and cramping real bad / Stomach pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number), via intramuscular route of administration in arm left on 01Apr2021 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included compromised immune status, gentic/ chromosomal abnormalities, endocrine abnormalities, obesity, asthma and respiratory illness all from an unknown date and unknown if ongoing. The patient is allergic to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, Clindamycin, Food allergies to Gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, Broccoli, Cauliflower, Cabbage, Brussel Sprouts, Asparagus, all percifirous (transcribed as provided) vegetables, allergic to pollen, trees, grass, ragweed, mold, mildew, dust and allergic to cats. The concomitant medications of the patient were not reported. The Family medical history was reported as none. On 01Apr2021, the patient experienced chills, itching rash on arms, back, neck and chest, diarrhea, nauseated, stomach started turning like she had a strong laxative and cramping real bad. The patient reported that she got second shot on 01 Apr 2021, and felt good and was excited. She did not feel the weakness previous day, but what she did feel was the stomach started turning like she had a strong laxative and cramping real bad. She ended up with diarrhea like she never had before and it was persistent. She was having very bad stomach pains and on the sides of stomach where large intestines are on left side. She was also nauseated but can't seem to throw up. The nausea had been from previous night. It was hard to eat when you are nauseated and the diarrhea was still going on. She had been taking the same prescription medications for years. She did not felt they were relevant. She wanted to know what to do to help her feel better and with the stomach thing, what would they recommend for severe pain and diarrhea. Therapeutic measures were taken as a result of diarrhea, stomach started turning like she had a strong laxative and cramping real bad / stomach pain that included Tylenol and Pepto Bismol. The outcome of the events chills, diarrhea, nauseated, stomach started turning like she had a strong laxative and cramping real bad was reported as not recovered and the outcome of the event itching rash on arms, back, neck and chest was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Quarter sized red mark. Swelling at the injection site. Entire right arm triceps pain. Pain to the touch of the right triceps.
Following vax pt felt numbness in lt biceps area, felt dizzy, became stiffened, eyes rolled back, color pale, &did not respond; Pt stated had lot of visual dreams while out;
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/2/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.   This case contains information for the 22nd of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
Patient developed vertigo, nausea and vomiting a day after she received the vaccination. Because of the symptoms she couldn't eat anything and she was being hospitalized for 3 days.
This spontaneous report as received from a pharmacist refers to some patients felt "uncomfortable" with injection of ZOSTAVAX (route, dose and lot # were not reported) with 25 gauge with 5/8 length needle and she called to inquire if any higher gauge needle or shorter needle can be used to minimize pain. Specific number of patients unknown. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome of event was unknown. It was unknown if the patients sought medical attention. Additional information has been requested.
Loud tinnitus - right greater than left ear, affecting hearing acuity.  I have had intermittent tinnitus in the past of a mild degree, this is constant and loud
Pt with 5 x 4 cm2 area redness, warmth, and mild tenderness at injection site (R) deltoid; no fluctuance.
Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke.
After both vaccines (12/30 and 1/18) I got itchiness on my scalp and body. Tiny lesions developed and disappeared and looked like mini blisters. Treated with Benadryl. Following-up with dermatologist on 1/26.
I woke up Monday morning feeling off balance, fatigued, foggy and had  a headache. I had to go back to bed. I slept till noon. Still didn't feel right the rest of the day. Balance felt wrong. Extreme fatigue Monday night so went to bed early and slept till the next day. Felt better but still not right. No headache on Tuesday but fatigue and balance felt weird. Today I have no headache. Fatigue less. My orientation feels abnormal and I still feel very foggy.
Mom reported that child received FLUMIST in school on 9/30/2013 given by health dept. 10/1/13 he awoke with croupy cough.
GENERALIZED DISCRETE PUSTULES W/SURROUNDING MILD ERYTHEMA, NONPAINFUL, NONPRURITIC OVER TRUNK AND EXTREMITIES.
Rash (L) deltoid at injection site, achey all over body, chills.
Chills, achiness, headaches, blistering on the left arm, and swelling.
positive for covid on 14Mar2021; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that patient already have first dose Pfizer vaccine since 05Mar2021 and tested positive for covid on 14Mar2021, patient second dose should be 26Mar2021. On 14Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.  Information about lot/batch number has been requested.
Rash, fever, nausea, jitters, heart palpitations, headache AM next morning
No additional AE; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 03-FEB-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W032150, expiration date: 07-APR-2024, (strength, vaccination scheme, anatomical location and route of administration were not provided) administered for prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -3.6 degrees Celsius (C). Time frame was unknown. There was previous temperature excursion. No additional adverse event was reported.
Moderna use for COVID-19 under Emergency Use Authorization (EUA): Booster vaccine intended dose 0.25mL however 2.5mL was administered IM. The ancillary kit that was provided contain a label indicating 1cc or 3cc syringes however the box only contained 3cc syringes.
Tested positive from COVID; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the upper right arm on 15Apr2021 at 15:00 (batch/lot number: ER8731) as a single dose for COVID-19 immunization. Medical history included high blood pressure and diabetes. Concomitant medications included metformin taken for diabetes and losartan taken for high blood pressure; both start and stop dates were not reported. The patient stated he had the vaccine Thursday at 3 o'clock (15Apr2021 at 15:00) and its symptoms were going on but for some reason that night he woke up with fever and chills. So his employee advised him to go and get tested. He went to get tested on Friday noon (16Apr2021) and now he was tested positive from COVID. He asked was that expected with the (incomplete sentence). Even if he was exhibiting some symptoms, he has some body aches and it has already been 4 days since he had the vaccine, he asked if that was normal. On 15Apr2021, he stated probably that evening, so he took the vaccine at 3, he woke up in the middle of the night with chills and fever. He had just a little bit of congestion, body ache, fever. He had a blood work, urine test on Friday (16Apr2021) with unknown results. He stated for treatment, he had one of his coworkers bring him some Tylenol and some Multivitamins high in zinc and vitamin C and D. One of his coworkers brought him some Tylenol, Multivitamin with zinc and vitamin C and vitamin D. He just asked whether this was possible, that it came from the vaccine or maybe it's a false positive or if he does have COVID or he doesn't know what to do. The outcome of the event was unknown.  No follow-up attempts are needed. Information related to batch/lot number was obtained.
This spontaneous report was received from a nurse concerning a 1-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 26-NOV-2018 at 03:38, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R010466 with expiration date 10-APR-2020, (frequency, strength, anatomical location or route of administration were not provided), administered subcutaneously for prophylaxis. The storage temperatures of the VARIVAX were reported as between -14 and -10 degrees Celcius for a time frame of 30 minutes. There was no previous temperature excursion. The call was due to a data logger. No adverse effects were reported.
Vaccine was administered at 1430 Headache was noticed immediately. I kept myself hydrated with water. At 1830, I started getting chest pains and shortness of breath. I put on a pulse ox, sat still for five minutes and my pulse was fluctuating after that. It was irregular for hours. To treat sob, I used my inhaler and kept my head elevated.  I couldn?t sleep at night. Around 100 on 11/3/2021, I started experiencing a mild fever and chills. I wasn?t able to sleep so I treated myself with Theraflu. Fever and chills went away by 11/3. Today (11/5/2021), I was still experiencing chest pains.
a little discoloration of the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (a little discoloration of the skin ) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (a little discoloration of the skin ). At the time of the report, SKIN DISCOLOURATION (a little discoloration of the skin ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient stated that the discoloration was not located where the vaccine was given. The patient described the discoloration as chalk white circular skin blotches the size of a pencil eraser head and did not match his body skin color.  Treatment information was not provided.
R UF Local skin reaction 2cm dia from injection site with extension of 2cm beyond site. Rx with Keflex.
After shots on Thursday 9/20/18 she ran fever of 101 then began to break-out in rash. Rash started on back went to face and toes. Rash started on Friday morning.