chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on her arm). At the time of the report, PAIN IN EXTREMITY (Pain on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on her arm). At the time of the report, PAIN IN EXTREMITY (Pain on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
He had a 8cm x 10cm size redness, no induration, pt. states it is sore at times, it was warm to touch.  This started the night pt. received vaccination and continued to swell, no other signs or symptoms.
10 minutes after vaccination my left arm started tingling and my left hand started getting stiff. My blood pressure was 144/100. The EMS arrived and they completed an EKG and waited for my pressure to come down. I did not go to the hospital.
Headache chills body-aches generally unwell couldn?t get out of bed. No energy. Felt like a really bad flu.
chills; body aches; general fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CIMETIDINE (ongoing). Vaccination history included: Bnt162b2 (first dose), administration date: 16Jan2021, when the patient was 72 years old, for COVID-19 Immunisation, reaction(s): "Body aches/ body and leg aches", "Body aches/ body and leg aches", "Joint pain", "Fatigues", "Chills", "A lot of nausea", "Cold sweat". The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "general fatigue". Therapeutic measures were taken as a result of chills, pain, fatigue.  Additional information: Tylenol was taken as treatment for the events. It was reported that the side effects were not as bad and lasted 3 days. It was also reported that the patient never had fever or arm pain with either dose. The patient has no family medical history relevant to adverse events and no relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, red blotchy rash, low fever, extreme fever, itchy over entire body. Treated with ice packs and Advil.
4 year old was administered Kinrix and Infanrix at the same clinic visit / only supposed to receive Kinrix; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered Kinrix and Infanrix at the same clinic visit, which led to accidental overdose. The patient was only supposed to receive Kinrix, which led to wrong vaccine administered. No further information available. The reporter consent to follow up.
RED LACERATION ON ARM WITH SLIGHT BRUISING; MASS IN THE ARM AND HARD TO TOUCH; PAIN IN THE ARM THAT PREVENTED HER FROM SLEEPING; EXTREME TIREDNESS; PERSISTENT HEADACHES IN MIDDLE OF HEAD; ITCHINESS IN INJECTION SITE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient had no known allergies and no medical issues.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced itchiness in injection site. On 26-APR-2021, the subject experienced mass in the arm and hard to touch. On 26-APR-2021, the subject experienced pain in the arm that prevented her from sleeping. On 26-APR-2021, the subject experienced extreme tiredness. On 26-APR-2021, the subject experienced persistent headaches in middle of head. On 27-APR-2021, the subject experienced red laceration on arm with slight bruising. The action taken with covid-19 vaccine  was not applicable. The patient recovered from red laceration on arm with slight bruising on 02-MAY-2021, mass in the arm and hard to touch on 01-MAY-2021, pain in the arm that prevented her from sleeping on 07-MAY-2021, and extreme tiredness on 29-APR-2021, was recovering from itchiness in injection site, and had not recovered from persistent headaches in middle of head. This report was non-serious.
pt recv vax 29MAR96 & devel rash & itching @ site;stated that felt like throat was closing w/in 15mins of receiving vax;given EPI;seen by MD
Sever Headache, body aches, chills, Joint pain, Exhaustion, nausea for approximately 2 days. Still feeling extremely tired and rundown.  I was told not to take Tylonel because my "immune system" needs to do its job. I have an Immune Deficiency (CVID) and infuse gamma globulin 2x weekly.. I believe that if I was able to take Tylonel at the onset my reactions wouldn't have been so severe. Immune Deficiency cannot fight off viruses.
Red rash (erythema) at the shot area on the left leg, groin and abdomin. Given Benadryl.
About 6 hours after administration, patient developed severe muscle pain, bone pain, soreness at sight of vaccine. She did not experience this with the first dose of Shingrix. Lasted for 3 to 4 days. Patient reports similar feelings on the skin as poison ivy pustules, but there were no visible pustules. She reports a hard lump still present in the area today 9/27/23, but is no longer hurting her.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 14:30 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Dairy sensitivity" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left), administration date: 06Nov2021, when the patient was 9 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 13:00, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 28Nov2021 13:00, outcome "recovering", described as "sore left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  No follow-up attempts are possible. No further information is expected.
tongue was swollen; choking; couldn't breath; This is a spontaneous report from a contactable consumer, reported for herself.  A 65-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The next day, late in the day she got up off the couch and she couldn't breathe. She felt like she was choking. She felt like her tongue was swollen. She also take endomethacin 100mg.  Information on the lot/Batch number has been requested.
This spontaneous report as received from a nurse refers to a patient of unkown age and gender. On 01-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (strength, dosage, route and lot# not reported). Other doses of GARDASIL were administered on 05-OCT-2012 (second dose) and 21-DEC-2012 (third dose). The nurse reported the patient received dose 3 of GARDASIL early. No symptoms reported. Additional information has been requested.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with 9 doses of improperly stored doses of PROQUAD (Merck) (lot# and expiration date reported as L016393, 08-NOV-2016) (dose, route of administration and frequency were unspecified). No adverse effects reported. Concomitant medications were not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 17 years old patient. The patient was vaccinated with a dose of GARDASIL (lot # H012973; exp date 05-MAR-2015) on 12-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that GARDASIL was exposed to 72 degrees Fahrenheit for 120 hours and the vaccine was administered to the patient after the temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Left arm, shoulder and neck swelling and severe pain for 9 days. On day 9, area vaccinated swelling  (lump) and draining (weeping).
Chills followed by fever, bad headache, dizziness causing vomiting. These symptoms lasted 2 full days before I could sit up without getting dizzy. Stayed in bed and took ibuprofen the second day.  Too sick to eat first and most of second day.
No adverse event; Bivalent dose administered before 2nd dose of primary series; Bivalent dose administered before 2nd dose of primary series; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series), WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 vaccination.     No other vaccines were given within 1 month prior to Moderna COVID-19 Vaccine.     On 04-Nov-2022, 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 04-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series) and WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series), WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent dose administered before 2nd dose of primary series) and WRONG PRODUCT ADMINISTERED (Bivalent dose administered before 2nd dose of primary series).    The reported stated that the patient was not under any concomitant or regular medication.  Patient had only received a first dose from primary series of Moderna COVID-19 vaccination on 19-Jul-2021. Patient then received Moderna bivalent booster dose before receiving second dose.  No adverse events were reported  No treatment details was reported.
PATIENT IS AN 11 YEAR OLD MALE WHO INCORRECTLY RECEIVED THE ADULT DOSE OF THE COVID 19 VACCINE FOR HIS FIRST DOSE AND THE PEDIATRIC DOSE ON HIS SECOND INOCULATION.  PATIENT REPORTS NO UNUSUAL SIDE EFFECTS AT THIS TIME OTHER THAN THAT HIS ARM WAS SORE FOR APPROXIMATELY 24 TO 36 HOURS AND THAT HE WAS A LITTLE MORE LETHARGIC THAN NORMAL.
Chills Headache Joint pains Muscle or body aches Fatigue or tiredness Nausea Headaches started evening of 5/3/22; full symptoms next morning.  Lasted 4-5 days, began tapering on day 3. Bed rest for 3 days.  Took Tylenol.
This case was reported by a lawyer and described the occurrence of mercury poisoning in a five year old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and pertussis vaccine absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified this report. At an unknown time after receiving Hepatitis B vaccine, DTP/DTaP vaccine, Haemophilus vaccine, and/or MMR II vaccine, the patient experienced neurotoxic effects resulting in severe neurodevelopmental injuries. The events were attributed to mercury overdose and poisoning resulting from the thimerosal component of the vaccines. The multiple symptoms of the patient's injuries occurred and were first manifest no later than 1/1/01. According to the attorney, the patient incurred medical expenses and will continue to incur medical expenses in the future as a result of his injuries. The attorney also alleged that the patient suffered significant impairments in his ability to enjoy life, faces significant obstacles to performing the tasks and activities of every day living, and suffers ongoing physical and mental distress. This case was assessed as medically serious (OMIC).
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administered by vaccine nurse.  NO ADVERSE REACTION, just reporting medication error.  Our Vaccine Task Force, after speaking with CDC and DOH, decided to offer the employee an additional COVID-19 vaccine dose.   Thanks.
A physician reported the occurrence of arthralgia in a 52 year old male who was vaccinated with Lyme disease vaccine recombinant OsaA (Lymerix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The subject received injections of Lymerix on 05/03/00, 06/08/00 and 10/03/00.  The third injection was administered five months after the first injection, rather than the recommended interval of 12 months.  In approximately March 2002, he began to experience arthralgia of the knees and ankels.  He was seen  by the physician.  Testing for the HLA-DR4 gene was positive.  The physician considered the arthralgia to be possibly related to Lymerix administration.  As of 03/28/03, the arthralgia persisted.
Guardian filled out consent form.  Listed child's age  as 12 on consent form.  Upon reviewing paperwork, child's date of birth was listed as 9/10/2009, making him 11 years and 10.5 months; not required age of 12 for vaccine.
A ringing in my ears and pressure in my sinuses that has been occurring for weeks since the vaccine.
Most shockingly, I developed labial ulcers; I received my 2nd vaccine around 7 am. At midnight, I woke up with a fever and chills.; I received my 2nd vaccine around 7 am. At midnight, I woke up with a fever and chills; I was very exhausted for the following days.; The lymph nodes in my right axilla got very swollen and sore - probably to the size of half an orange; This is a spontaneous report from a contactable Nurse (Patient). A 26-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation solution for injection, Batch/Lot number: EK9231), via an unspecified route of administration, administered in right arm on 26Jan2021 07:00 AM as 2nd dose single for COVID-19 immunization. The patient medical history includes Seasonal allergies, cats and Mild asthma. The patient concomitant medications included in two weeks was Microgestin 120, multivitamin, Claritin, melatonin. Patient received, first dose of BNT162B2 (Batch/Lot number: EK5730) via unspecified route of administration, administrated in right arm, on o4Jan2021 at 07:00 AM for COVID-19 immunization. On 27Jan2021 at 12:00AM at midnight, patient woke up with a fever and chills. Patient was very exhausted for the following days. The lymph nodes in my right axilla got very swollen and sore - probably to the size of half an orange. Most shockingly, patient developed labial ulcers. patient called her OBGYN and patient stated this was most likely caused from a viral overload and it was a way her body was responding to the vaccine. patient never had any sort of genital ulcers in the past and have had the same partner for 7 years. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Faint, both arms tingling, nausea, sweating profusely. Evaluated by EMS-Cleared
pt. received TDAP,HPV,VZV and MENING on 3/7/07. Within a week, one of the injections sites swelled,became painful and red. The doctor's office was notified of this reaction. Within two weeks of injections, both lips swelled for one day. Within 4 weeks of injection, lips cracked and by the fith week after injection pt was hospitalized for severe stomatitis. Please note, the pt has never suffered these symptoms before, nor has she seeked care for this problem prior to this outbreak. Pt became dehydrated and needed i.v. care. Pt had blister type lesions that started on the outside of the lips and continued to spread to the back of the throat. Pt has improved greatly and should have a full recovery. 6/27/07-records received from facility. Oral lesion, virus culture positive for herpes simplex virus. Blood culture no growth. No documentation to support hospitalization.  Stomatitis outhreahs regularly meds needed daily, possibly for life.  Altered life illness.  The doctor wants her to get the other two shots.  I think that is negligent!  This shot never should have been given with all the others!
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date during 2016, the patient was treated at a medical center for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Petechiae , Facial rash and swollen lips.   Still the same after hydration, Tylenol and Benadryl.
sore arm; tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a few days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Steroid dependant.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a few days). On 06-Mar-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-090324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090324:2st dose
Local erythema + induration 3X2 cm on L - Deltoid arm. Complained L-arm pain.  Plan warm compression.
JOINT INFLAMMATION (KNUCKLES  AND ANKLES); PAINS IN NECK AND SHOULDERS; PROGRESSIVE MUSCULAR ACHES/MUSCLE ACHES AND PAINS WHICH  INCREASED OVER TIME; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced joint inflammation (knuckles and ankles). On MAR-2021, the subject experienced pains in neck and shoulders. On MAR-2021, the subject experienced progressive muscular aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the progressive muscular aches, pains in neck and shoulders and joint inflammation (knuckles and ankles) was not reported. This report was non-serious.
noticed a swollen lymph node  in neck, left side.  Noticed 4 days after injection.   still present 5 days later
While in seated observation area, pt reported feeling faint. Brief loss of consciousness, while supported by pharmacist, legs stiff, arm twitch then relax as regained consciousness, lasting few seconds. Feet elevated, called 911 for care. Evaluated by paramedics in parkinglot, returned back to pharmacy after recovery for checkout.