chrisvoncsefalvay/vaers-outcomes huggingface dataset:
top of her shoulder hurt a little bit after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (top of her shoulder hurt a little bit after first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METOPROLOL and LOSARTAN for Blood pressure management.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (top of her shoulder hurt a little bit after first dose). At the time of the report, ARTHRALGIA (top of her shoulder hurt a little bit after first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information for dose 1 events was provided.   This case was linked to MOD-2021-254186 (Patient Link).
flu symptoms/ those symptoms; nervous; felt so sick; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced nervous and feeling unwell. On 19th August 2022, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms and nervous were unknown and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the flu symptoms, nervous and feeling unwell to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the first shot two days ago and had flu symptoms one day before reporting date. Less than a week after the vaccination, the patient felt so sick and was nervous about getting the next one but he/she really did not want shingles. The patient asked that there was anything that he/she can do to felt better for the second shot. Additional supportive information: The follow-up could not be possible as no contact details were available.
Soreness on sight, muscle aches,headache and chills into fever. Next day, today, dizzy.
This spontaneous report as received from a physician via other company refers to 15 month old female patient. On 05-AUG-2014 the patient was vaccinated with a dose of MMR II (dose, route and lot # not reported). Other suspect therapies included given on the same date (Oka/Merck) VARIVAX (dose, route and lot # not reported) and PREVENAR (dose, route and lot # not reported. On unspecified date in 2014 the patient experienced fever. The outcome of fever was unknown. The relatedness between fever and MMR II, (Oka/Merck) VARIVAX and PREVNAR was not reported. Additional information has been requested.
I was feeling good until I went to bed and I kept waking up throughout the night, I am feeling sick, chills, ache all over and headache throughout the night, and it's worse this morning. I took some medicine to feel better.
Dose 1: on day 3-4 after injection I noticed supra clavicular lymph nodes swollen and painful, then on day 8 I noticed a 6 inch red, hot, itchy rash on left arm at the site of injection. I went to urgent care they prescribed an anti-inflammatory and an antibiotic. Dose 2: took Benadryl on day of injection and started another 10 days of antibiotics. On day 3-4 after injection I noticed more swollen lymph nodes under both arms, then on day 6-10 I noticed little blisters on my chest, back, and arms. Today is 3 weeks after second injection and I still have supra clavicular lymph nodes swollen but it is getting better.
Headache, Fever, CoughWheeze & NauseaVomiting Narrative: COVID test on 1/5/21 was negative
Later the evening of injection, I began have sharp painful shark of pain in leg toward my knee,  The pain was continually every 2-3 minutes for a course of 48 hrs and now still feel sharp pain in hip like blood is crawling that is painful with sharp sparks at time.  I continue to take tylenol and advil to ease the pain along with muscle/joint pain ointment.  Was unable to walk due to pain.
Right arm started with small amount of redness 9 days after infection. It started to get bigger and splotchy, area was raised and hot.   Flushed, hot face and mild tachycardia.
Anemia, unspecified type. Patient received 3 doses of IV iron therapy and discharged home on PO iron. ED visit to hospital admission within 6 weeks of receiving the COVD vaccine.
8 days after receiving the first Moderna covid shot, I woke up with a red itchy hard dot of about an inch at the injection site.  A bit painful, but I played pickleball that morning outside without any major discomfort.  Around noon the spot started to itch a lot and seemed very sensitive to touch.  It was red and hot and getting bigger.  I changed into a sleeveless shirt and that helped with the itch. By nighttime the spot had grown to5-6 inches, round, red and still more itchy.  It presented like a severe ant bite. I slept fine and by next morning it seemed a bit less hard and red and calming down. Still a sleeveless shirt. One more day and the spot calmed down to near normal and my arm was soft and a bit hot at the site, but quite normal. I thought a bug had bitten me there.
Injection site swollen, red, warm and painful to touch.  Symptoms resolved in 72 hours.
Difficulty breathing lots of asthma attacks. Fever, chills, dizziness, nausea, headache, tiredness, pain in injection site.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from another healthcare professional. This case is linked to case 2018SA290867. This case involves an unknown demographics patient who was vaccinated with FLUZONE QUADRIVALENT with a 5/8th inch needle rather than a 1-inch needle which is recommended for intramuscular administration (lot number not reported via intramuscular route in unknown administration site). The patients past medical history, medical treatments, vaccinations and family history were not provided. It was as actual medication error case due to wrong technique in product usage process. It was unknown whether the patient has any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Indurated erythematous area around injection site. Recommend warm compresses to thigh with antibiotics BACTRIM DS BID x 5 days.
Pt came in at 1:30 pm on 10/21/15 to report local reaction to ZOSTAVAX. He developed a raised, red, warm, and painful bump the size of baseball on injection site. No systemic effects reported. Instructed pt to follow up with PCP.
I had a heart attack, tightness of chest. Pain in my left arm. Intense pain in back underneath my shoulder.
This spontaneous case was reported by a consumer and describes the occurrence of hyperhidrosis (sweating after getting vaccination), chills (little bit chills) and vaccination site pain (second shot never hurt like first but can feel it) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 021B21A and 021E21A) for COVID-19 immunization. The patient's past medical history included open heart surgery. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 4, 2021, patient experienced hyperhidrosis (sweating after getting vaccination), chills (little bit chills) and vaccination site pain (second shot never hurt like first but can feel it). At the time of the report, hyperhidrosis (sweating after getting vaccination), chills (little bit chills) and vaccination site pain (second shot never hurt like first but can feel it) outcome: unknown/not provided. Diagnostic results: On Apr 7, 2021, SARS-CoV-2 test: Positive. The patient tested COVID-19 positive. No concomitant medication or treatment information provided.The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. This case linked to MOD-2021-069943 (patient link).
One week after injection, injection site became inflamed, warm to touch and large rash surrounding the injection.  Slight fever of 99
This spontaneous report was received from a other health professional (medical assistant) refers to a three unspecified patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiry date 25-DEC-2017 (strength, dose and frequency were not reported) intramuscularly for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccines were exposed to a temperature 32 degrees F to 35 degrees F for a time period of 1 hour. There was no previous temperature excursions. Digital data logger was involved. No additional information was provided. Product quality complaint (PQC) was not reported.
Four hours after administration of immunizations this child had a seizure. The paramedics were called to the house, but the child was not transported to the hospital.
Massive headache the night of. Increased difficulty sleeping.  On the 15 of April noticed a massive full body rash had a appeared with what looks like allergy contact dermatitis from the neck down and the injection site had a large circular red scaly rash.
Information has been received from a registered pharmacist concerning her 37 month old daughter with no past medical history and no allergies who on 9/13/02 was vaccinated with a dose of hep A virus vaccine inactivated. There was no concomitant medication. On 9/25/02 the pt developed a low grade fever, swollen feet, and a rash which progressed into a full body rash. It was noted that on 9/29/02 the pt was "able to walk again." The pt sought medical attention and was given diphenhydramine "around the clock from onset of rash." The reporter considered the symptoms to be disabling. Additional info has been requested.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:12 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 11:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.66 for dose administered on 27-Feb-2021 and as 69.74 for dose administered on 27-Mar-2021  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature range at 9 AM: 33, 11AM-2PM: 35, 3PM-4PM: 34, 5PM: 35 Degree Fahrenheit. These vials were moved to fridge on 24-feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00AM to 10:00 AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
Patient received dose #2 of Pfizer vaccine on 6/8/2021 and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Physicians re-administered dose on 6/19/2021 as recommended. No adverse reactions identified on site.
States 8-10 hrs post vaccination of Tdap - L arm became red, hot, swollen in biceps and triceps area, not injection site and developed fever of 101 degrees F and myalgia which persists 2 days later.
Hospitalized fever in patient undergoing chemo for testicular cancer, COVID positive with upper respiratory infection
After the 2nd shot, second day after; I had left arm pain that woke me up in the middle of the night. I also, suffered a terrible headache with chest tightening, shortness of breath, hard time swallowing and a pulsating pain on the back of my head.  This lasted four days before it eased.  Also, I have been feeling run down and headaches since.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and no side effects other than a sore arm.   The reporter consented to follow up. For tolerances of 2nd dose, refer case US2020140274, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140274:same reporter
This spontaneous report was received from a nurse practitioner referring to a 16-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 04-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL (lot # M014929 and expiration date 27-MAY-2017) for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Awoke today with bumps on buttocks, arms, and legs. Consistent with hives, non pruritic, afebrile, no treatment.
SORENESS AT INJECTION SITE FOR A FEW DAYS; This spontaneous report received from a consumer concerned a male of unspecified age.  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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness at injection site for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness at injection site for a few days was not reported. This report was non-serious. This case, from the same reporter is linked to 20220707811.
Awoke about 1:00 a.m. with 101.8 fever (teeth chattering, shivering), bad headache. Took 2 TYLENOL, temperature went back to normal. Also had tachycardia (heart rate in the 120's, took 12mg metoprolol, 50mg flecainide, and heart rate went down to 105 or so and stayed there for about 3 more hours. I used a pulse oximeter to determine heart rate, and oxygen level was also lower than my normal 98% (92-94%) during those 3 hours.
IT KILLED; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer through via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 2 doses (2 shots) of covid-19 vaccine (unspecified manufacturer) (dose number in series: 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series: 1). The patient had previously received first booster of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first booster of covid-19 vaccine ad26.cov2.s (dose number in series: 2) The patient received second booster of covid-19 vaccine ad26.cov2.s (dose number in series: 3) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was off label dosing frequency and revaccination with different covid-19 vaccine (dose number in series: 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter reported that it (vaccine) killed (death) patient on an unspecified date (dose number in series: 3). On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that "It Killed my sister 2 shots & double boosted". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on an unspecified date, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221259495.; Sender's Comments: V0: 20221259488 - It killed. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
swollen, hot, red 5 1/2 inches by 4 1/2 inches from injection site on 4th day from injection.  TREATMENT:  Benadryl and Mortin.
I started having numbness in my feet and tingling in my legs, especially my left leg. I went to the ER and they admitted me. I was in the hospital for 3 days. They ran a bunch of tests and they referred me to a specialist. I was diagnosed with some type of a neuropathy. He advised me not to get the second shot.
17SEP98 8:30 inj given 8:45 pt reported to nursing station rash chest, around inj  & face no itching;rash began to resolve @ approx 9:00;
Normal body aches and fatigue for the first couple of days.  Exactly one week after the vaccine, my arm became red at the injection site.  It started the size of a quarter.  The next morning it was the size of a baseball.  By that afternoon it was swelling and became the size of a softball.
Problem was first noticed in Q2, 2022, I don't remember specifically when. I have long had mild tinnitus in my right ear. Last spring it became much worse and also started in my left ear. I consulted an ENT specialist last week who told asked me when I had my COVID boosters. I had my first booster, from Moderna, on December 22, 2021, and my second booster,  from Pfizer on May 21, 2022. He has had many patients report increased tinnitus correlating with their COVID boosters. I have not test results as tinnitus cannot be measure, as I understand it.
Lump in left neck above collar bone radiating down the  chest.  Very warm to touch about 2 degrees warmer that body temp and sore.
This spontaneous report as received from a nurse refers to a 20 years old female patient. The patient concurrent conditions included Crohn's disease and drug reactions/allergies to aspirin, KEFLEX, ZITHROMAX. On 20-SEP-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J006082, exp. date 12-APR-2014, 0.5 ml, intramuscular, site of administration not reported) for prevention of pneumonia. On an unknown date in 2013, after injection of PNEUMOVAX 23, the patient experienced injection site cellulitis. The patient saw physician. The patient was treated with AUGMENTIN and CHLORTRIMETRON. The outcome of injection site cellulitis was reported as recovered/resolved. Additional information has been requested.
Felt tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and FATIGUE (Felt tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L204 and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Anxiety, Arthritis and Heart block NOS (Left Ventricle Blockage in the heart.). Concomitant products included ALPRAZOLAM for Anxiety, AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced MYALGIA (Sore arm). On 20-Jan-2021, the patient experienced FATIGUE (Felt tired). At the time of the report, MYALGIA (Sore arm) had resolved and FATIGUE (Felt tired) outcome was unknown.      Treatment medication was not provided by the reporter.
Grandmother states child had swelling with a red knot and itching in arm of vaccination. Grandmother states it started the night of when the vaccine was given and had started to get worse. She reported to nurse at Health department two days later on 10/04/2017 at approximately 4:00pm. Nurse instructed to go to clinic. Grandmother states she had made an appointment for 10/05/2017 and would take to emergency if needed.