chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Saturday may 15 2021 I noticed a small cluster of bumps close to the site but I don?t think it was exactly at the site. Today may 19, I Went to dermatologist because the bumps got red, the site was sore, and dermatologist said I had shingles. Possibly brought on by stress.
pt recvd vax 6NOV95 & presented to the hosp on 8DEC95 w/recent hx of fever to 103 R;pt noted to have redness & edema on the floor of the mouth w/tongue pushed up against hard palate;drooling resulting in airway obstruction;dx cellulitis
I was sick for a day in a half; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "respiratory issues" (unspecified if ongoing); "weak immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was sick for a day in a half".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient came is after speaking to a friend who told her she should report what had happened to her. She stated that immediately after the shot her arm was painful and hurt, unlike other times that she has had a flu shot, it almost instantly turned red and hot and ended up traveling to about her elbow and started to bruise at the site. She came in on 10/9/17 and I saw no redness but there was still a yellowish bruising about 2x2 inch area at the site of injection (not perfectly round though) - PT ACTUALLY STOPPED AT ANOTHER PHARMACY AND SHOWED HER REACTION.
Within 20 minutes of receiving his routine vaccines, the patient began to cough and wheeze, became fussy, and then developed hives and facial swelling. His symptoms resolved after admnistering IM Epinephrine, Diphenhydramine, and oral Atenolol.
At injection site, 2" circular, red, slightly swollen, very itchy rash that lasted for three days and slowly extended toward my lower arm as time went on.
erythema at injection site; warmth at the injection site; induration at the injection site; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 2LL97, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In September 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site warmth, injection site induration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site induration were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site induration to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that, the vaccine was not injected into the deltoid muscle, which led to  vaccine administered at inappropriate site. The vaccine was injected in the left arm below the deltoid.  The patient developed erythema and induration at the injection site and the injection site is warm to the touch. The erythematous area was approximately 8 cm x 5 cm in size. The reporter did not provide any additional details.
The patient had a temperature of 102. beginning 12/15, aches, denied headache; did not take Tylenol. Called his PMD explained, side effect of the yellow fever vaccine, possible response to that particular vaccine. Also side effect to inactivated vaccines he received. Instructed to take Tylenol and call PMD again.
Requested to check on pt due to her feeling her HR was elevated after vaccine. Approx 5 min after vaccine, she felt a "rush" and then a warm/flushed feeling, followed by the elevated HR that she checked on her Apple watch of 117bpm. Assessed pt approx 5 min after that, she was stable and felt better. See ROS, PE,  and VS info for more data. patient also states she is allergic to bees (anaphylaxis to bee sting) which was not indicated on her consent checklists prior to vaccine.  Additional post-vaccine screening: pt states (after VS checked) that she has history of elevated BP in the past, with systolic as high as 170s, however has not been dx formally with hypertension or been put on meds.  Observed pt for 20 more minutes (total of 35 minutes) and her HR remained in the 80s and no further sxs. Released to go back to work, where she has a number of co-workers. Advised to observe that would prompt to go to ER or UC in the coming hours or days. Ok to receive the next dose of covid vaccine and would need a 30 minute observation due to history of  allergy to bee stings. Patient verbalizes understanding and agreement with plan of care.  Also advised pt to f/u with her provider regarding the history of elevated BP with BP also elevated today
Felt on some shortness of breath on exertion for several months after receiving vaccine.  Had a heart attack with large clot in R coronary artery which was 100% blocked on July 9th, went to ER on July 10th and was diagnosed w NSTEMI.
42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, 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. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    Concomitant product use was not provided by the reporter.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.   Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more.  Vaccine was given within current guidelines except seven were under 65.   Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.   No adverse reactions occurred.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:
arm was in pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: The patient was a reporter's daughter. The reporter stated that, the patient received Bexsero injection before going to college and her arm was in pain for about 3 weeks afterwards. The reporter mentioned, he/she knew the second dose could be given 1 month after the first dose but how far past one month could it be given. The reporter just wanted to know if they could wait longer than a month to get the second dose. The consent to follow-up was requested.
Received the shot on the afternoon of the 26th. Upon waking the next morning the right cheek of his face and right thigh near the injection site were covered in a handful of red, blotchy reaction spots. His physician was called, and the parent was given the instruction to bring him in the next morning and otherwise go to the ER. He was taken to the ER that afternoon, the 27th, where emergency staff examined the reaction spots. Those near the injection site were light in the middle with a darker ring around the edges by the time he was examined. The doctor diagnosed the patient with an adverse effect of the DTaP vaccine he had received the day prior and then prescribed BENADRYL and TYLENOL to be given immediately before being discharged. The reaction spots faded slightly by the time he was seen the next morning, the 28th, by his pediatrician. He was given a referral to an allergist to determine the cause of the reaction within the vaccine since there is a family history of autoimmune disorders and ingredient sensitivities. The reaction spots lasted about two weeks before completely fading.
Sever pain in left leg upper joint. Similar to Sciatic Nerve pain the shoots down from hip to knee  at any position.
She got her vaccine, and started feeling real dizzy and stumbling around and cold not do anything, and has had no energy and was in a wheelchair for a little while.  She went to her PCP and he told her that she had an infection from the Covid shot, and gave her some antibiotics and some prednisone.  This did not help.   She was able to walk with her rolling walker before but since then she has had this problem.  Her hands hurt, burn, turn red.  She drops things steadily.  When she gets up in the morning she is not able to do much as she drops things.  She still has the same symptoms, and still having no energy and not herself.  Her son has now moved in with her to help her as she is not able to take care of herself anymore.
Information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with no pertinent medical history and allergy to pork who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, IM. On 29-MAY-2008, the patient received the second dose of GARDASIL 0.5 mL, IM. It was reported that the patient received the third dose of GARDASIL (lot# 665266/1378Y) 0.5 mL, IM into her right arm on 26-FEB-2010 and was pregnant. Concomitant vaccination included the first dose of HAVRIX given on 26-FEB-2010. It was reported that the patient had a urine pregnancy test which came back positive on the same day of vaccination. The patient's last menstrual period was on 02-FEB-2010 and the estimated delivery date is 09-NOV-2010. Follow up information was received from a physician. It was reported that the patient had no significant past medical history or concurrent conditions and had no previous pregnancies. On 26-FEB-2010, the patient was vaccinated IM with third 0.5mL dose of GARDASIL (lot number 665266/1378Y). There was no other concomitant medication used in this pregnancy. The patient's LMP was on 02-FEB-2010 with an EDD of 09-NOV-2010. Follow up information was received via telephone call from the medical assistant who stated that the patient reported that on an unspecified date she had a possible miscarriage (no HCP confirmation) and had bled profusely. The medical assistant also reported that on an unspecified date the patient's ultrasound revealed an empty uterine sac, however her blood work confirmed pregnancy. The medical assistant reported "it may had been too early to see the baby with the ultrasound". The medical assistant reported it was noted in the chart "the patient possibly had a miscarriage and then the patient got pregnant again. It was not clear if the patient's first pregnancy ended as a miscarriage, and then the patient became pregnant again". The medical assistant went on to report that the patient was referred to OB/GYN. At 40 weeks gestation on 21-DEC-2010 the patient had a healthy male baby (WAES# 1103USA03674). Upon internal review possible miscarriage was considered to be an other important medical event. Additional information has been requested.
Am a long hauler - symptoms were almost like a recurrurance of Covid- fever, chills, diarrhea, headaches immediately that subsided  after a couple of days but shortness of breath and tightness of chest continues, as does painful joints and blurry vision
Light headedness, headache and visual changes. Hypotension. Pt placed supine and provided with water. Observation for 30min, symptoms resolved and pt sent home.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment was received by the patient
I have tinnitus. One day after I received my COVID booster my tinnitus disappeared; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have tinnitus. One day after I received my COVID booster my tinnitus disappeared".  Additional Information: It was reported that the second day after receiving the booster, the tinnitus came back and the reporter wanted to know if there could be anything that the COVID booster helped the tinnitus.  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.
Patient experienced: vaccine for COVID is not working; Patient experienced: vaccine for COVID is not working; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4345021.  A 59 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. Past drug history included: Amoxicillin allergy, reaction(s): "amoxicillin allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient experienced: vaccine for COVID is not working".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On 30-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (vaccine scheme, route of administration and anatomical location were not reported; lot number T035409 has been verified to be a valid number, expiration date reported and established as 14-APR-2022), as prophylaxis after the vaccine had undergone a temperature excursion (product storage error). The vaccine was stored for the time frame of 1 hours 16 minutes in the temperature of 8.6 Fahrenheit (F). There was no previous temperature excursion. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Flu like symptoms 2 days after injection.  Lethargy, headaches, sore arm at the injection site.  Fever, but no chills
A 38 year old female received injection of Pnu-Imune 23 and Fluzone (PMC USA) on 10/26/99. On 10/27/99, she developed warmth at the site of Pnu-Imune administration that was described as "extremely hot", arthralgia, body aches and an increased heart rate. She recovered.
1st day much arm pain at shot site .  2nd day severe indegestion, stomach cramp, nausea , very painful to touch stomach , 3rd day fatigue, slept all day
11:02am headaches and dizziness when sitting. Bedrest BP 140/90 P 60 R 14. 11:30am headache still dizziness gone Tylenol 325mg two tabs. 11:45 headache decreased BP 110/80 P 60 R 12. Returned to work and lunch.
A 12 year old was given a dose of Moderna vaccine which is only approved for use in 18 yrs and above.  Mother was informed and child will finish out the series with Moderna.
Severe lower back cramping, ongoing ever since 7/2/2021  Period bleeding, unable to get out of bed, during the length of periods   Hormonal imbalances, ongoing ever since 7/2/2021
Patient developed weakness in his left hand the following morning, with inability to move or manipulate with hand such as pick up utensils starting morning of 3/5/2021.  This did slowly improve and pt underwent PT for this.  He has had changes in energy and cognition as well.
EE developed Covid months after completing 2 dose series.  She actually received her 3rd "booster" on 9/30/21.  She turned Covid positive on 10/5/21 after symptoms developed on 10/1/21
pt recvd vax;fever of 103 p/ shot;also d;knot on lt thigh,size of silver $ , red,hard;MD recommend holding pertussis;
About 7 hours after the injection I woke up with intense chills.  I was awake for 6 hours in the night with intense chills, sweating, and a temperature of at least 102.  I was unable to take Tylenol until having the chills for 9 hours.  Tylenol helped.  I slept about 20 hours the first day with a fever all day.  I had a fever for about 24 hours.  The following week I was completely exhausted and slept about 12 hours a day.  I am 38 years old and this was the sickest I have been in probably 20 years.  It was bad and that's why I am reporting it.  I am very thankful to have had the vaccine though.  Thank you all for what you do!
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 60-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. On 01-JUL-2016, the patient suffered shingles (herpes zoster). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of shingles was considered to be a disabling event.
Severe muscle pain, stiffness in shoulders, hips and knees; ibuprophen; slowly improving 6 weeks after
Sx onset 7/22/21 with cough, runny nose, sore throat, nasal congestion, fever, chills, headache, loss of smell & loss of taste. Traveled 7/20 to 7/22 Tested on 7/25 which resulted as positive.
Hospitalized with COVID pneumonia (diagnosed 10/12)  10/15 monoclonal antibody therapy in with fever and severe weakness. Remdesivir IV to complete 5 day course, first dose on 10/15.  Monitoring labs per orders.  - Dexamethasone 6 mg daily for up to 10 days, first dose on 10/15.