chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurt; arm swelled up; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-SEP-2023, the patient received Shingrix. On 18-SEP-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm hurt) and swelling arm (Verbatim: arm swelled up).  The outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.     It was unknown if the company considered the pain in arm and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The nurse practitioner reported that after administration of shingrix vaccine patients arm got hurted a lot and was swelled up. The reporter consented to follow up with healthcare profession on afternoon hours on voice mail box, if necessary, to collect additional details about AE. No additional details were provided on the afterhours voice mail box regarding adverse event.
My shoulder was very stiff and I could barely move it that night. The next day it was just sore. The days that followed, the soreness never went away and I felt pain if I moved my shoulder in certain ways, i.e. when pulling a shirt off over my head or swinging a sweater or jacket around my body to put it on. I went to see my doctor about 6 weeks later and she suggested 'wall crawls' and 'pendulum swings' to stretch out my shoulder. I tried to continue my weights routine at my gym, but any weight exercises done with my left arm left it sore and in pain most of the time. It has currently been about 7 weeks since I was given the vaccine and I am still having the same symptoms.
ON Jan 16 complained of lightheadedness then felt better after supper and nap. Next day ok On Jan 22 did not get up, had stroke, taken by ambulance to hospital and transferred to medical facility.
root canal; facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of ROOT CANAL INFECTION (root canal) and SWELLING FACE (facial swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ROOT CANAL INFECTION (root canal) and SWELLING FACE (facial swelling). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ROOT CANAL INFECTION (root canal) and SWELLING FACE (facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. The patient was treated with antibiotics(ongoing).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 26-NOV-2014 the patient was vaccinated with an improperly stored VAQTA (lot # J000366, expiry date 22-AUG-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sometime over the summer, I started feeling some ankle pain and my whole ankle was swollen. I went to the doctor. I was given a steroid treatment. I had the fluid aspirated and was diagnosed with large Ganglion Tenosynovitis. I have surgery scheduled next month.
Patient developed clear vesicular rash with red band on trunk, extremities and scalp- some were crusted on exam. Positive for itch. Consistent with varicella.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's other concurrent or historical condition was not provided. On 12-APR-2016 the patient received dose 1 of GARDASIL (strength, dose, frequency, route and lot # unknown). Then on 17-JUN-2016 the patient received a dose of GARDASIL 9 (strength, dose, frequency, route and lot # unknown). No symptoms reported. Additional information has been requested.
2 days after 2nd woke up with uncontrollable anger; upper arm ached inside bones; felt like electric wire laid against bone; shoulder blade up side of neck; This is a spontaneous report from a contactable Other HCP for herself. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 09:00 (Batch/Lot Number: EL3248) as dose 2, single (age at vaccination 61-year-old) for covid-19 immunisation. Medical history included type 2 Obese, hypertension, Low Blood Platelets from an unknown date and unknown if ongoing. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC); azilsartan kamedoxomil (EDARBI); alprazolam (ALPRAZOLAM); vitamin b complex (VITAMINE B COMPLEX); ascorbic acid (VITAMINE C); colecalciferol (VITAMINE D) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on 06Jan2021, administered at 10:00 AMAM, lot number EK4176 for Covid-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 07:00, the patient experienced 2 days after 2nd woke up with uncontrollable anger, upper arm ached inside bones, felt like electric wire laid against bone, shoulder blade upside of neck. It was reported that 2 days after 2nd woke up with uncontrollable anger and upper arm ached inside bone, next week pain moved to outside bone felt like electric wire laid against bone. Pain moved up and down by 3rd week under right shoulder blade up side of neck. Started taking Tylenol Called doctor thinks maybe nerve got nicked but advise to report as possible side effect. Started taking Methylprednisolne. Pain is less but still aches every day. Can't sleep. Pain still moving around now going around to arm pit. The patient underwent lab tests and procedures which included platelet count: low on an unknown date. Therapeutic measures were taken as a result of events includes Tylenol and Methylprednisolne. The outcome for all events was recovering.   No follow-up attempts are needed. No further information is expected.
Pt given pneumovac on 10/15/03 with her Influenza on different arms. Later the same afternoon c/o redness, swelling and pain at the site of pneumovac. Was instructed to take Tylenol, Benadryl and apply warm compress to site. On 10/16/03 pt went to ER. Site marked per ER doctor, to return to clinic in AM, was given Rx for Tylenol 650mg. Pt came in to clinic on 10/17/03 to see NP, Dx local reaction to pneumovac. No change in site marked per ER doctor. On 10/23/03 called pt for follow up, no redness, doing fine.
pt recvd vax approx 1975 & w/in 7 to 10 days following vax pt devel a rash, lethargy, & a fever of 104 or greater; pt recovered;
This case was reported by a consumer (also the subject) and described the occurrence of hearing loss (l. ear) in a 47-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included stapes implant prosthesis (left ear) in 2003. On 22 October 2008 the subject received a dose of FLUARIX (unknown, left arm). On an unspecified date in December 2008, approximately 2 months after vaccination with FLUARIX, the subject experienced stomach pain and diarrhea for which she was hospitalized for 4 days. On an unspecified date in March 2009, approximately 5 months after vaccination with FLUARIX, the subject experienced hearing loss (l. ear). The subject reported that her main complaint was the total hearing loss, left ear which was being treated at her physician's office. At the time of reporting, all the events were unresolved. The subject reported that she and her physician believed that her hearing loss was from the FLUARIX. The subject believed that the stomach pain and diarrhea were from the FLUARIX.
I woke up with what I thought was light cold. I had a scratchy throat with a little congestion. About 6:15 PM, I was running a fever 99.0. I tested myself the next night and was positive. I retested because my kit was expired so I tested with a new kit, and it was also positive. I contacted my doctor on February 23, 2023. They advised me to take water and other fluids and over the counter. My cough lasted all the way. My cough had gotten so bad that I thought I had pneumonia. I had a strong pain in my lower left lung. I had a cough the whole 10 days. The chest x-ray was clear. I was given a steroid shot. I felt significantly better the next morning. The chest tightness had gone away. I briefly got the tightness which lasted up until Wednesday or Thursday.
missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he missed second dose because he was in the hospital. No concomitant medications were reported.  No treatment information was reported.
Suspected vaccination failure; Shingles/ Everyone I know who got the shot had Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patient's who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's got the shingle shot had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter. Invalid-Hearsay case. US-GLAXOSMITHKLINE-US2021AMR166325:Same reporter. US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter. US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter. US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter. US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter. US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
I had vaccination on 11/12/2022. On 12/25/2022 I started to experience an irritated throat and started not feeling well. I was fatigued achy loss of taste and smell. I tested COVID-19 Positive on 12/26/2022. I was prescribed Paxlovid. I presently feel pretty good on 05/15/2023.
RED AREA WITH HARD KNOT UNDERNEATH    EXTREMELY NAUSEOUS FOR LAST 2 DAYS
Huge migraine; Super sore all over; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Huge migraine) and MYALGIA (Super sore all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Huge migraine) and MYALGIA (Super sore all over). At the time of the report, MIGRAINE (Huge migraine) and MYALGIA (Super sore all over) had resolved.  No concomitant medication was reported. No treatment information was provided. Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-220651 (Patient Link).
chills; soreness in my arm; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, soreness in my arm on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt recv vax on 10/14/98; on same day pt exp red, swelling, warmth, & pain at vax site
form of dermatitis; skin rash on the neck, back and the forearms; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (form of dermatitis) and RASH (skin rash on the neck, back and the forearms) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], PRAVASTATIN and PLANTAGO OVATA (METAMUCIL FIBRE THERAPY) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH (skin rash on the neck, back and the forearms). On 01-Apr-2021, the patient experienced DERMATITIS (form of dermatitis). The patient was treated with TRIAMCINOLONE for Itching, at an unspecified dose and frequency. At the time of the report, DERMATITIS (form of dermatitis) and RASH (skin rash on the neck, back and the forearms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101951 (Patient Link).
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture), PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022) and NO ADVERSE EVENT (No Adverse Event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2022 at 9:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture), PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022) 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 EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022). No concomitant medication was provided. Number of doses were 2 Doses. It was reported that vial was initially stored in the refrigerator on 16 Sep 22 in the morning. Vial was first punctured on 19 Sep 22 at 15:15 (3:15pm). Post punctured vial was stored at room temperature. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius equals to 46 degree to 77 degree Fahrenheit) was approximately 18 hours. The patient had received Moderna vaccine first dose on 02 Feb 21, second dose  on 03 Mar 21, first booster dose on 15 Nov 21 and second booster dose on 21 Apr 22, Moderna bivalent booster 1 on 20 Sep 2022. No treatment medication was provided. This case was linked to MOD-2022-648558 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2022: Significant follow up- patient details, dose number and narrative updated.
12/11/22 I was real tired, had a sore throat and headache. I thought it was a cold. The next day I had the same symptoms. On 12/13/22 I tested at the pharmacy for COVID. Both home tests and the PCR test from the pharmacy were positive. I called my doctor on 12/14/22 and he prescribed PAXLOVID, azithromycin, benzoinated, montelukast and ADVAIR for after I finished PAXLOVID, but only took it for a day. I had a telehealth after I finished my PAXLOVID and was feeling pretty good and the doctor told me just to call if I got worse. On 12/25/22 I tested negative with a home COVID test. I walked today, not my normal walk, but I feel pretty good.
Initial report was received on 21 January 2011 from a consumer who is also the patient. A 49 year-old female patient with a history of asthma, GERD and an allergy to Amytriptyline had received a first dose intramuscular right arm injection of ADACEL, lot number C3487AA on 30 November 2010 and later that night, experienced a mild headache, tense muscles, restless legs and ringing in the left ear. The patient had also received the "Flu vaccine" (manufacturer, lot number, route and site of administration were not reported) in October 2010. Concomitant medications were NEXIUM and SYNTHROID. The patient was evaluated by a physician however treatments were not reported. No further information was available at the time of the report. The reporter stated that "all symptoms except for the ringing in the ear have resolved". Documents held by sender: none.
Developed both Vulvar Lichen Planus and Oral Lichen Planus
Vaccine-1/7 Covid positive-1/10 Hospitalized-1/17 Deceased-1/25
pt recv vax MAR96 & exp pain & swelling @ inj site;pt did not exp inflammation or fever;pt recovered;
Per COVID-19 vaccination card, Moderna dose #1 (lot# 011M20A) administered on 07/20/2021 and Moderna dose #2 (lot# 003A21A) administered on 08/03/2021 at inappropriate interval (14 days between doses).  Further investigation revealed concern for 1st dose lot# 011M20A having been expired at time vaccination received.
Passed out immediately, but awoke after several seconds. Had cold clammy skin. Blood pressure would not regulate. After half an hour began vomiting. Small red spots began to develop on lower abdomen. Spots developed higher and higher until they reached the midpoint of my neck, and then began to recede. Was rushed to the hospital where it took me roughly 3 hours before my blood pressure reached a level deemed safe to for discharge. Over the next two nights, trying to sleep, I found it difficult to breathe. In the weeks following this event I became forgetful and rather simple minded. It was abnormal for me, because I have a very analytical mind and frequently find myself thinking of all sorts of things. I wish I knew the extend of how that shot affected me.
Her right thigh was bright red, hot-to-touch, very swollen with a large, hard knot under the injection site within 15 hours. It has now been 48 hours, the redness, swelling, and fever has spread further out. I have tried cold compresses, topical BENADRYL, and TYLENOL. I have contacted the Dr's office 2 times with concerns and provided a picture. They have told me it is a normal reaction and should clear up in 5-7 days. I have talked to other medical professionals and after seeing her leg, they do not think it is normal.
still has pain; This case was reported by a consumer and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had pain. The reporter requested medical advice for pain relief. The medical disclaimer was provided and HCP consultation was recommended. The customer disconnected abruptly because wanted medical advice. No additional information was collected.
This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The pt received a dose of Engerix-B (lot ENG2597A2) on an unspecified date. On 12/10/2003, the pt's attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.
The pt received his 1st flu shot on 12/20/01. That PM, he had a fever to 102F and a febrile seizure. The next day, he continued to have a fever plus a headache, stiff neck and vomiting. He also had neck pain and chills. At the ER, the doctor gave him an antibiotic shot and told us he did not have meningitis since his WBC was over twice the normal amount.
12 hours after shot i started having bad chills.  I had a high fever, not sure, but well over 100 as it came down to 100 by morning.  I was hallucinating and had terrible body aches and chills all night long. I was achy and tired all next day and fever stayed over 100 all next day, and that night fever broke and i soaked through my sheets and pajamas.  Was fine 36 hours later, just tired.
Received the Pfizer booster on October 21, 2021. Shingles blisters first appeared on Monday morning, November 8, 2021. Diagnosed with shingles on Monday, November 15, 2021, after visiting PCP and enduring terrible pain November 13-14, 2021.
Arm pain for 2 days and a very bad headache for 2 days and extreme fatigue.