chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local injection site reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Shingrix (had 1st dose, refe case US2019230531).   On an unknown date, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's wife. The patient receive dose of Shingrix and high dose of flu vaccine and experienced local injection site reaction that resolved. This case has been linked with cases US2019230531 and US2019AMR231140.
Had fever that rose to 103.5. Had febrile seizure that lasted about 5 minutes. Was transported by ambulance to hospital. Fever was 104.0 at hospital. Was released when 101.5. Developed chicken pox.
Information has been received from a pharmacist concerning a 64 year old female patient who on 05-NOV-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664668/0153Z). There was no concomitant medication. On 06-NOV-2010 the patient noted a single, large, red bump at the injection site, which was inflamed and sore. The pharmacist note it was not a rash or pus-filled, and it did not look like chickenpox or shingles. Currently it has decreased in size and the area was irritated, red and itchy. At the time of this report, the patient was recovering from the adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Headache, Myalgia,  tired, chills Narrative:  Other Relevant History:
This spontaneous report was received from a physician referring to 11-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
~ 1 month after booster dose I began having tinnitus ( ringing) and pulsatile tinnitus both ears.  Never had previously, had full ENT workup including CT, CTA, carotid studies.  All of which were negative.  Physical exam , lab work  , vitals all normal
Generalize Body itch; Wired sensation on her lips; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalize Body itch) and PARAESTHESIA ORAL (Wired sensation on her lips) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Generalize Body itch) and PARAESTHESIA ORAL (Wired sensation on her lips). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (Generalize Body itch) and PARAESTHESIA ORAL (Wired sensation on her lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Naseau, stomach pain, chills. Fatigue , lack of appetite, pain in joints
She has hives all over her body with swelling and swollen lips and tight throat and swollen eyes, headache and shortness of breath which she woke up with approx 2 weeks after her first (and only) covid 19 vaccination
SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no changes to diet or medication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180522, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on right arm for prophylactic vaccination.  No concomitant medications were reported.  On 02-APR-2021, the subject experienced soreness at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site. This report was non-serious.
Hives on trunk 3 days after vaccine given. No breathing difficulty. somewhat fussy. resolved by the following day, 2/23/21.
Two days after PNEUMOVAX injection, patient developed redness and swelling on the left arm above the elbow, which appears to be a gravity dependent continuation of the upper elbow swelling. That started the day of the shot.
Pt received 2 vaccines on 09/12/2017 (FLUZONE HD on left arm and PNEUMOVAX 23 on right arm). Pt felt fatigue/flu like symptoms 2 hours after vaccination. She called her PCP, her PCP instructed her to go ER. ER visit(9/14)- there was redness and swelling on the right arm (upper arm to elbow in range) -provide pt with discharge instructions of apply BACTROBAN and TYLENOL/ice PRN- ER MD not sure if cellulitis vs. post injection site reaction. She called today to inform us of the events, she is doing better and swelling/redness is decreasing but still present. Apologized to the pt and asked if any further assistance or concerns are needed to let me know. Filed a VAERS report. Pt has receive pneumonia vaccine before but this reaction is first time. Lot: N004564 Exp:10/22/2018.
Patient was to receive Pediatric Pfizer but was given Adult Pfizer in error. Patient via mother is reporting severe sore arm and numbness at the wrist
REPORTS LIGHT HEADED FOR A FEW SECOND AND WAS FINE AFTER DRINKING WATER
This spontaneous report as received from a 79 year old male consumer referring on himself with hypertension, cholesterol, enlarged prostate. On 22-JAN-2013, 6 week ago, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # H011426 expiration date, 12-SEP-2013), injected in the left arm. The patient's drug reactions/allergies include allergy to VICODIN and mercury. The patient did not want to provide concomitant medications. On 22-JAN-2013 (also reported as a week after injection), the patient noticed that he had a dime sized patch that had crusted over and had not gone away. The patient also stated that the patch was very itchy and was asking for medication he can take for the itching. No treatment was reported. The patient did not seek medical attention. Additional information has been requested.
Individual came to walk -in  clinic  on morning of 5/3/2022 to get her Covid booster shot. She had received 1st vaccine of J & J  on 3/22/2022 and she was receptive to getting MRNA vaccine for booster.  Moderna booster dose was given too early. This was brought to PHN's attention on 5/4/22  after dose was entered into the system and came up as "invalid" . When checked guidelines for actions to take,  the recommendation stated not repeat the vaccination.
pt recv vax & c/o pt shaking uncontrollably;denies fever;advised to take pt to ER & tell them pt had immun;was very sore;started about 6:30 blotchy skin;t101 later on;shook x 20min;
Patient presented with burning chest pains, found to have ST elevations on EKG, Trop peak 17 and cath with clean coronaries. Transferred to center for cardiac MRI and treatment for Myocarditis. No other preceding inciting triggers found including negative utox/preceding illness. Echo with wall motion abnormality but quasi normal EF (50%).  Improved with colchicine and NSIADs for perimyocarditis.
INJECTION SITE ITCHING; rash around the injection site, getting worse, around 3-4 inches in size; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), LEVOTHYROXINE SODIUM (SYNTHROID), FAMOTIDINE, CLONIDINE, MACROGOL 3350 (MIRALAX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size). At the time of the report, INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Benadryl ointment
Left arm from shoulder to elbow red, warm, swollen. Fussy/irritable. No fever. Still with symptoms.
Redness, swelling, hot to the touch; Redness, swelling, hot to the touch; Redness, swelling, hot to the touch; Route of administration: Intravenous; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness, swelling, hot to the touch), SWELLING (Redness, swelling, hot to the touch), SKIN WARM (Redness, swelling, hot to the touch) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Route of administration: Intravenous) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Route of administration: Intravenous). On an unknown date, the patient experienced ERYTHEMA (Redness, swelling, hot to the touch), SWELLING (Redness, swelling, hot to the touch) and SKIN WARM (Redness, swelling, hot to the touch). On 16-Jun-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Route of administration: Intravenous) had resolved. At the time of the report, ERYTHEMA (Redness, swelling, hot to the touch), SWELLING (Redness, swelling, hot to the touch) and SKIN WARM (Redness, swelling, hot to the touch) had not resolved.            No relevant concomitant medications reported. No treatment was provided by the reporter.
blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
The vaccine was taken sometime in April, and then two months later. The symptoms were: Fever, headache, muscle ache, as well as local swelling/pain. The first vaccine, I didn't know what the side effects would be, so it took me 36 hours to look it up and take some ibuprofen (I thought I had a virus). The second time I was prepared, but still got just as ill, even though I started ibuprofen right away.
Patient seen as walk-in prior to his Holter appt with c/o left shoulder/arm/chest edema and pain after receiving his PNEUMOVAX vaccine yesterday, patient reports edema did not start until 1800 last night when his shoulder became quite large and painful, he reports this swelling gradually his chest and upper arm, on inspection left shoulder and upper arm reddened, very warm to touch, painful, slight edematous, BP elevated 177/122, 98 seen by PCP will medication with CATAPRES 0.1 mg po x 1 and BENADRYL 25 mg PO x 1 will perform serial BP checks 144/107, 90, 143/106, 92, 148/99, 108 after one hour, patient feels much better, calmer, rash greatly reduced less red and less edema, patient is liable. Rash, hypertension and shoulder edema and pain. Clonidine 0.1 mg once, diphenhydramine 25 mg once.
patient was given 1 cc instead of 0.5 cc patient was monitored for 15 mins with no adverse events or symptoms patient was called after 3 days to check on symptoms but unable to reach pt
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 an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:46 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 medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.
Rash at injection site, then increase heart beat. Call 911 Paramedic, patient still alert. Took patient to ER and release patient couple hours later.
fever; night sweats; chills; headache; nausea; administration date=21/01/2021. dose number=2/administration date=04Jan2021. dose number=1; This is a spontaneous report from a contactable physician (patient). A 34-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular on 21Jan2021 11:30 at SINGLE DOSE at left arm for covid-19 immunisation.  The patient received the first dose of bnt162b2 on 04Jan2021 for covid-19 immunisation. Medical history included gastrooesophageal reflux disease, allergy to Sulfa.  Concomitant medication included pantoprazole, spironolactone, and multivitamin.  The patient experienced fever, night sweats, chills, headache, nausea on 22Jan2021 02:30.  The patient received ibuprofen and acetaminophen for fever, night sweats, chills, headache, nausea. The outcome of events was recovering.
I got tinnitus three days after second shot.   It will not go away.   I am presently on prednisone
flu like symptoms decribed as feeling achy; Feeling achy.; redness at the site of the injection into the right arm; sore right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, pain in arm and pain. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, pain in arm, influenza-like symptoms and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm, influenza-like symptoms and pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that patient received dose of Shingrix and on that evening patient reported that redness at the site of the injection into the right arm, a sore right arm, and flu like symptoms described as feeling achy.     It was reported that all events has been resolved. The reporter consented to follow up.
Stabbing pain in left rib- sudden - followed by chills - went to bed and arose 4 am to complete head to toe/arms and legs spasms. Complete loss of motor controls - thought it was an MS attack. Visit to Emergency Room CT scan of organs for liver/kidney/pancreas etc all negative.  - Electrocardiogram  done- all ok Given large dose of pain medication and a nerve pain reducer - after 3 hrs of so spasms calmed down
I was told that upon receiving the shot the Nurse kept talking to me and then she saw my skin color change and I was slurring my speech and then I knocked out. When I woke up, 911 was there and I was surrounded by nurses which had put me on oxygen. They checked my pressure and said it dropped immensely and then it went way high. The ambulance wanted to rush me to the hospital saying I had a mild stroke. I was extremely thirsty  and dizzy. I did not go to the hospital and stayed at the clinic until I felt strong enough to go home. I did not go because I was scared of going into the hospital and not leaving.
Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 23rd July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a below freezing temperature excursion on 23rd July 2021.  No adverse event was reported The reporter consented to follow up. This case is one of 28 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164789: US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter.
pt recvd vax;exp soreness in neck;gen aching & felt lousy;devel T 101,lasted 24 hrs;felt ill;7jul94 had fine red rash on stomach,chest,back,neck,sl on face;8jul94 pt recovered;
Patient presented to the ED and was subsequently hospitalized for C. difficile diarrhea within 6 weeks of receiving COVID vaccination.
My father received the Flu vaccine on December 27, 2017. Per his verbalization, he did not get a vaccine information sheet nor was he given the option to decline the vaccine. On December 30, 2017, he states he developed a generalized rash, had an internal generalized burning sensation, voided urine that was red in color, and developed generalized skin peeling which has now worsened in his hands and his feet. He went to the ER on December 30, 2017 and they administered benadryl through injection. They prescribed him antihistamines and he followed up with his primary medical doctor a few days later. After seeing his primary medical doctor, he was referred to a dermatologist who prescribed him medications for the skin peeling. Per his verbalization, his doctor had him get blood work done recently and the results are pending.
This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Redness and swelling of arm above and below on 7-13 cm of RUE vaccination site.