chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccine left my left arm weak for about 6 months... I had no strength to pick anything up it was as if my arm was only working 40 percent. I luckily regain strength but was very limited for months. I didn't bother going to the doctor just hoped whatever nerve affected would heal.
BODY PAINS, MOSTLY JOINT PAIN, TIRED ALL THE TIME, DOES NOT REST/SLEEP AT NIGHT,
Local red swelling at site of injection. 2 inches x 3 inches in size. Taking ZYRTEC 10mg daily, Hydrocortisone cream 1% topically. Shingles vaccine given 10/26/12.
First vaccine was July next was in August. I have not had a period since July. Also following my July vaccine I started experiencing debilitating migraines. They have significantly got worse each month. I am now on migraine meds that don't help me. They were doubled in dosage - still not working. I'm constantly exhausted and have muscle aches throughout my body. I now have to get weekly massages. I have an upcoming appointment for an MRI of my head as well as an appointment with a neurologist. I've had 2 panels of blood taken to find answers and no answers. The migraines are lasting 2-3 days and most days I wake up with a headache. I've had headaches for as long as 8 days straight. I can't work. I can't help my kids. I'm losing a good third of each month to the pain. I'm irritable and can not take another month of this pain I've been enduring.
Patient stated of having a heavy chest and fast heartbeats. Patient denied having difficulty breathing. Advised patient to see doctor immediately. Patient refused to get medical help. Patient stated being diagnosed with anemia.
anxiety, eye swelling. Client left at 2:07 pm feeling tored but well without symptoms.
This spontaneous report as received from a Health care worker pharmacy technician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VAQTA (lot # J000337 exp 25-SEP-2015) 1 adult dose (dose and route not provided). Health care worker (pharmacy technician) stated that one patient may have received vaccine (dose and dose in series unspecified) that were improperly stored on 28-FEB-2014 at 9.5C for 50 minutes. No adverse effects reported. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 31-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced  PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.
One week after receiving the first dose of Moderna, I woke up with a very sore left arm. As the day has gone on, my arm has become swollen around the injection site, has become more sore, and it hot to the touch. There is no rash. The soreness/pain radiates down my arm and up my shoulder.
Large bruise approximately 2 inches in height by 3 inches in length at injection site.
Patient states to be ok but got nauseous and did vomit in bathroom. Then she got a plastic bag in case she needed to vomit again and did. The vomitting did subside and she states to be a little light headed and was considering  going home from work. Her managers allowed her to go home.
pt passed out 20min p/vax & was out about 2-3min;has hx of egg allergies, PCN, amox & many other;
2/12/07 @8:30 pm patient complained of itching all over, no breathing or tachycardia.  Had a "case if hives" that did not progress to welt or wheals.  Mother called urgent care and MD suggested watching him at home for signs of increased allergic reaction.Patient fell asleep about 9:00 pm without distress but still with some itching.  On 2/13/07 at @ 1:00 am, patient started vomiting and continued vomiting intermittently until about 7:00 am.  For the remained of Tuesday, the patient was lethagic with a temp of 100.1 degrees.  Felt better on Wednesday, but still has a decreased energy level and is emotionally fragile.  Parents did not pursue further medical help.
PT RECEIVED THE VACCINE AND APPEARED TO BE TOLERATING UP THE 15 MINUTE MARK WHEN SHE REPORTED THAT SHE FELT LIKING FAINTING.  SUDDENLY PT PASSED OUT COLD. PT STOPPED BREATHING AND  EPIPEN DOSE WAS ADMINISTERED. EMERGENCY SERVICE WAS REQUESTED . PT WAS COGNITIVE UPON ARRIVAL OF EMERGENCY SERVICES.
I started feel a traveling pain in both legs and shortness of breath. I developed blood clots all over my body. I had surgeries to remove some of the clots but they could not remove the clots in my lungs.
Flu shot - redness on 12/09/2015. Prevnar shot - redness on 12/10/2015.
severe vomiting; diarrhea; fever / more severe; arm soreness; trouble lifting the arm that lasted 4-5 days.; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vomiting, diarrhea, fever, pain in arm and mobility decreased. On an unknown date, the outcome of the vomiting, diarrhea, fever, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the vomiting, diarrhea, fever, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: Age at event onset was not reported but it could be 62 or 63 years old. The reporter was a GSK employee reporting an event told to him by the patient who was his sister in law.  The patient had her 1st dose in October 2020 and the symptoms were more severe and included, severe vomiting, diarrhea, fever and the same arm soreness and trouble lifting the arm that lasted 4 to 5 days. The reporter did not consent to follow-up. For tolerance in 2nd dose refer case US2021003151.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003151:same reporter
feeling blah (can't do anything); Blood sugar spiking at night /spike in their blood sugar; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling blah (can't do anything)), BLOOD GLUCOSE FLUCTUATION (Blood sugar spiking at night /spike in their blood sugar) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL for Blood pressure, INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (LISPRO INSULIN) for Blood sugar abnormal, PANTOPRAZOLE and INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (RELION/NOVOLIN) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling blah (can't do anything)), BLOOD GLUCOSE FLUCTUATION (Blood sugar spiking at night /spike in their blood sugar) and FATIGUE (fatigue). The patient was treated with LEVOTHYROXINE ongoing since an unknown date for Thyroid disorder NOS, at a dose of 1 dosage form. At the time of the report, MALAISE (feeling blah (can't do anything)), BLOOD GLUCOSE FLUCTUATION (Blood sugar spiking at night /spike in their blood sugar) and FATIGUE (fatigue) had not resolved.            Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-jun-2021 included reporter details. On 30-Jun-2021: Follow up received on 30-jun-2021 included Dose dates and Batch number, Added Concomitants (Pantaprazole, Lantus, Lispro, Lisinopril and Levothyroxine ), Added events Fatigue, Feeling Blah.
Pt started with  fever, Fatigue and headache at 1/6/2021 @3:00 AM
Headache- 1000 mg of Tylenol, went away 30 minutes after taking Tylenol  Fatigue- all day
Fever; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Tired). At the time of the report, PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-154330.
she went to bed, she woke up a couple time; sharp pain down the whole right arm; sunday the pain moved around her whole neck; pain in the left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sunday the pain moved around her whole neck), POOR QUALITY SLEEP (she went to bed, she woke up a couple time), ARTHRALGIA (pain in the left shoulder) and VACCINATION SITE PAIN (sharp pain down the whole right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010F21A, 012M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (pain in the left shoulder). On 24-Oct-2021, the patient experienced NECK PAIN (sunday the pain moved around her whole neck). On an unknown date, the patient experienced POOR QUALITY SLEEP (she went to bed, she woke up a couple time) and VACCINATION SITE PAIN (sharp pain down the whole right arm). At the time of the report, NECK PAIN (sunday the pain moved around her whole neck), POOR QUALITY SLEEP (she went to bed, she woke up a couple time), ARTHRALGIA (pain in the left shoulder) and VACCINATION SITE PAIN (sharp pain down the whole right arm) outcome was unknown.            The patient was taking other medication also.  The expirations for the doses were not provided.   No treatment information was provided by the reporter.
About a month after my second dose (04/10/2021) I started to have symptoms of fatigue and easy bruising.  I was diagnosed with ITP (Idiopathic thrombocytopenic purpura) on 07/14/2021
administered with 0.5 ml for booster dose instead of 0.25ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (administered with 0.5 ml for booster dose instead of 0.25ml) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 PRODUCT ADMINISTRATION ERROR (administered with 0.5 ml for booster dose instead of 0.25ml). At the time of the report, PRODUCT ADMINISTRATION ERROR (administered with 0.5 ml for booster dose instead of 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
chills; aches; fever.; sore arm; This is a spontaneous report received from a contactable consumer (not patient). A 41-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unwon route on an unknown date for Covid-19 immunization. Medical history included gastrooesophageal reflux disease. Concomitant drugs included omeprazole (PRILOSEC). Patient experienced adverse events chills, aches, fever on an unknown date. The clinical course was reported as follows: Patient experienced sore arm shortly after receiving Covid 19 vaccination. He also woke up in the middle of the night approx 12:30AM with significant chills, aches and fever. Fever was 102 and managed with paracetamol (TYLENOL) until all symptoms subsided at 4PM. Outcome of the events was resolving.  No follow up attempts are needed. No further information is expected.
Arm soreness around injection site, extreme tiredness, ear ache, some dizziness and over all body aches.  These all started around 8 pm the night of the vaccine.  No treatment just slept a lot and 48 hours later felt better.
2 days post vax pt returned w/bilat leg weakness, paresthesias, dx by neurologist w/mild GBS post vax demyelination;pt required IG IV;on d/c needed a walker for safe mobilization;
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 62 years old patient of unknown gender who experienced faint rash about the size of a quarter at the injection site, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 20-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route. On an unknown date, the patient developed a non-serious developed faint rash about the size of a quarter at the injection site (vaccination site rash) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported No itching or burning. It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose. (Other relevant tests included no lab data.) Final diagnosis was 62 year old developed faint rash about the size of a quarter at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for developed faint rash about the size of a quarter at the injection site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC 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.
after getting flublok, patient did not feel good, chest pain and arm pain , dizziness so he went to ER that night. They did ECG and other tests but all came normal.
This spontaneous report has been received from a consumer of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was not certain which vaccine received and reported that received three doses of PNEUMOVAX 23 for prophylaxis, or PREVNAR 13 (strength, dose, frequency, route, lot number and expiration date were not reported). The patient did not experience any reaction.
pt recv vax 28OCT95 & devel numbness & tingling in wrist & hot flashes;sx gradually lessened throughout the day;pt recovered;
an acute covid infection (PCR proven); an acute covid infection (PCR proven); This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 at 10:00 as dose 1, single (Lot number: EK5127), in left arm and on 15Dec2021 at 11:00 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years, in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "recovered" and all described as "an acute covid infection (PCR proven)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Positive, notes: Infected by covid; (23Dec2022) Negative, notes: Upon presentation to (hospital name withheld) 23Dec2022, covid PCR negative.; Sender's Comments: A contributory role of BNT162B2 to event an acute covid infection (PCR proven) cannot be excluded based on temporal association and available information.
Tested positive 7 months after vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive 7 months after vaccination) 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 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced COVID-19 (Tested positive 7 months after vaccination). On 15-Dec-2021, COVID-19 (Tested positive 7 months after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: positive (Positive) tested positive. On 15-Dec-2021, SARS-CoV-2 test: negative (Negative) tested negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Company comment: This is a  spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The events occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The events occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
15x7 cm area of erythema over (L) deltoid. Hot to touch. Treated with antibiotic & Ibuprofen.
Patient received a first and second dose of measles virus vaccine live. Subsequently, following the second dose, a titer done by the hospital lab was <0.9 (>=0.9 was considered positive). The patient sought unspecified medical attention.
This spontaneous report was received from an office manager and medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 17-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, subcutaneously, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015680: US-009507513-1705USA015683: US-009507513-1705USA015682:
"I've got 1st vaccination shot at 11 am 12/21/2020.    Got moderate (3 to 5 on 10-steps scale) pain in left upper arm/shoulder around 9 pm, limited mobility. Took 2 extra-strength Tylenols.    Between 2 and 3 am woke up because of severe headache (7 to 8), couldn't normally sleep because of that. Temperature 99.6 F. Another 2 Tylenols about 4 am. Not effective. Drinking a lot of water.    Decided to stay home. Contacted my supervisors by text and e-mail, left a voice message for EH.   8 am - another 2 Tylenols. Tried to sleep - slept till 1 pm. Headache improved (3-5), 99.3 F. Water and tea, minimal activity.    Received instructions from EH - to stay at home if any symptoms will take place, to get COVID test upon returning to the hospital.    Condition was improving during the day. Low pain and discomfort in the evening (2-3).    Sleeping normally during the night. No symptoms in the morning. No reason to delay returning to work.    Took COVID test at 9 am. Negative.    No symptoms since then"
My left arm was swollen, hard, sore, itchy and red at injection site.   I took Benadryl, Advil and placed an ice pack on it.  The swelling went down by evening  and the red spot gone by Tuesday, January 19.