chrisvoncsefalvay/vaers-outcomes huggingface dataset:
whole body ached, could barely move; major headache; rash; throat got strectchy and kind of irritated; congested and runny nose; fever; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose), PYREXIA (fever), PAIN (whole body ached, could barely move) and HEADACHE (major headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03720KA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Cancer and Hypertension. Concomitant products included TAMOXIFEN for Cancer.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose) and PYREXIA (fever). On 16-Jan-2021, the patient experienced PAIN (whole body ached, could barely move), HEADACHE (major headache) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose), PYREXIA (fever), PAIN (whole body ached, could barely move), HEADACHE (major headache) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
APPROXIMATELY 10 MINUTES AFTER THE VACCINE WAS ADMINISTERED TO THE PATIENT,  THE  PATIENT BEGAN SWEATING AND FEELING LIGHTHEADED/DIZZY AND WAS THIRSTY AND APPEARED PALE IN COLOR.  THE PATIENT WAS GIVEN 50MG OF LIQUID DIPHENHYDRAMINE BY MOUTH AND BEGAN TO HAVE IMPROVEMENT IN SYMPTOMS APPROXIMATELY 5 MINUTES LATER.  THE PATIENT WAS OBSERVED FOR 30 MINUTES AFTER, AND WAS GIVEN WATER TO SIP.
A report has been received from a physician concerning, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started during Oct-2013. The patient experienced positive influenza B test which started during 2013. The outcome of the event of positive influenza B test is unknown. The report was considered to be non-serious. Corrected report 25-Nov-2013: Drug and event started dated added. Reporter details and patient details updated.
Approx 45 min after injection pt c/o weakness in knees and heaviness in arms and legs with lightness in chest. Vs 90/68 R 90/64 L P84 Reg lung cl, hx asthma, used Alupent Inhaler, relieved chest tightness, rested approx 1 hr sx decreased and stopped.
Viral meningitis due to reactivation of the Varicella Zoster Virus.; Viral meningitis due to reactivation of the Varicella Zoster Virus.; This is a spontaneous report received from a contactable consumer(patient). This 58-year old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EW0161) at single dose on 16Apr2021 09:30 via an unknown route in left arm for Covid-19 immunization. Medical history included known allergies. No other vaccine in four weeks, no covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient received other medications in two weeks. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER2613) at single dose on 26Mar2021 11:00 AM, via an unknown route in right arm for Covid-19 immunization. Patient experienced adverse event of viral meningitis due to reactivation of the Varicella Zoster Virus on 16Apr2021 04:00 PM. The event resulted in Emergency room/department or urgent care. Treatment included intravenous Acyclovir every 8 hours from 20Apr2021- 21May2021. Outcome of the events was resolving. Since the vaccination, the patient had been tested for COVID-19. The report was assessed as non-serious.
hematoma noted with overlie edema to L thigh, area hard when palpated. Reported on 11/16 by Dr.
Pt devel erythema, swelling, & warmth @ the inject site p/recvd DT (ped)/MMR/OPV; The area involved was approx 2" in diameter;
08Oct90 pt vax w/ Hepta B; 6 hrs later exp sore red arm.  deltoid area was edematous from shoulder to elbow.  2-3 days sx resolved. 13Nov90 pt vax 2nd hepta B; no adverse reaction as of 12Dec90.
Client reported that about 5 minutes after receiving the first dose of Moderna COVID vaccine, he experienced and ?anxiety attack.? The client stated ?I felt like I couldn't breathe and like I was going to faint. Also, I was coughing to get air.? The client reported the symptoms lasted one hour and resolved after ?talking with my friends.? The client did not alert staff on site of his symptoms at the time. The client denied any dizziness. The client reported that no medications administered on site or at home. The client didn't follow up with his primary care physician. The client stated he did follow up with psychologist who stated, ?it was my mind tricking me.? The client reported a history of anxiety and is prescribed medications but hasn't taken them in 6 months. The client reported a history of experiencing anxiety attacks with feeling ?worry.? The client stated all the symptoms he experienced after the first Moderna COVID vaccine were normal for his anxiety attacks. The client denied development of any rash, pain in chest, or swelling of throat or tongue after the first dose Moderna COVID vaccine.
Malaise; myalgia; fatigue; injection site pain; injection site erythema; painful lymph nodes in right armpit; fine red rash all over trunk, abdomen, and back. I don't see that rash has been reported previously. It's not in the package insert and not in Clinical Pharmacology.
This spontaneous report as received from a physician refers to a patient of unknown age (gender unspecified). Physician reported that a patient received 1st GARDASIL dose on an unspecified date about a year ago (in 2012) and was on 22-MAR-2013 back in the physician's office to continue series of GARDASIL. Lot # was not reported. Outcome and action taken was unspecified. Additional information has been requested.
STERILE WATER FOR INJECTION MIXED IN AS DILUENT NO ADVERSE REACTION REPORTED BACK TO PHARMACY AT TIME OF THIS REPORT.
Patient and mother return to vaccination site approx. 20 minutes following vaccine administration. Pt. reports pain behind her right eye, stating it began 10 minutes following vaccination and has remained constant since. Pt presents covering her right eye with hand. Demeanor appears calm. Normal rate of speech. Alert and oriented with no indications of alteration to LOC. Vitals within normal range (HR 102, BP 124/67 w/ adult cuff, 02 98%, RR 13). Pt. reports no alterations to vision in affected eye, except that colors appear slightly ?warmer? in unaffected eye. PERRLA. Tracks finger in all directions with both affected and unaffected eyes. Pt. and mother remain at site under observation for 30 minutes. After approx. 20 minutes of observation, pt. states pain behind eye has resolved. Pt and mother instructed to report to ER if symptoms return or new symptoms develop. Pt.?s mother given list of emergent symptoms to monitor for. Observation ended at mother?s request.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Painful swollen lymph node), LYMPHADENOPATHY (swollen lymph node on the left side of the neck - same side as the injection site /swollen lymph node, 3.5 cm in diameter, on the neck, left side) and VACCINATION SITE SWELLING (Swollen site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The patient's past medical history included Kidney disorder. Concurrent medical conditions included Hypertension. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Swollen site of injection). On 09-Jul-2021, the patient experienced LYMPH NODE PAIN (Painful swollen lymph node) and LYMPHADENOPATHY (swollen lymph node on the left side of the neck - same side as the injection site /swollen lymph node, 3.5 cm in diameter, on the neck, left side). On 12-Jul-2021, VACCINATION SITE SWELLING (Swollen site of injection) had resolved. At the time of the report, LYMPH NODE PAIN (Painful swollen lymph node) and LYMPHADENOPATHY (swollen lymph node on the left side of the neck - same side as the injection site /swollen lymph node, 3.5 cm in diameter, on the neck, left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were  reported.  No treatment information  was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information added on 12JUL2021 contains significant information. New events updated, medical history updated, dosage information updated.
right eye lid swelling; Initial information was received on 09-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a two-year-old female patient who experienced right eye lid swelling (swelling of eyelid), after she received vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, past vaccination and concomitant medications family history were not provided.  On 02-Nov-2020, the patient received a dose of 0.5 ml suspect IPV (VERO) (lot P1F54, expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination.  On 02-Nov-2020, the patient developed non-serious right eye lid swelling (swelling of eyelid) within 3 hours following the administration of IPV (VERO).  Details of laboratory data were not reported.  On 03-Nov-2020 in the morning the patient recovered from the event after treating with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).
Fatigue; some swelling between clavicle and neck for first couple days; Intermittent pain which was just uncomfortable/just sore mostly in upper body; Little bit of sore arm; Really bad shoulder pain and joint pain; little bit nausea; little bit chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (some swelling between clavicle and neck for first couple days), PAIN (Intermittent pain which was just uncomfortable/just sore mostly in upper body), PAIN IN EXTREMITY (Little bit of sore arm), ARTHRALGIA (Really bad shoulder pain and joint pain) and NAUSEA (little bit nausea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Anxiety.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced SWELLING (some swelling between clavicle and neck for first couple days), PAIN (Intermittent pain which was just uncomfortable/just sore mostly in upper body), PAIN IN EXTREMITY (Little bit of sore arm), ARTHRALGIA (Really bad shoulder pain and joint pain), NAUSEA (little bit nausea) and CHILLS (little bit chills). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, SWELLING (some swelling between clavicle and neck for first couple days), PAIN (Intermittent pain which was just uncomfortable/just sore mostly in upper body), PAIN IN EXTREMITY (Little bit of sore arm), ARTHRALGIA (Really bad shoulder pain and joint pain), NAUSEA (little bit nausea), CHILLS (little bit chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone) and FATIGUE (feeling tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone) and FATIGUE (feeling tired). On 03-Mar-2021, PAIN IN EXTREMITY (arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone) and FATIGUE (feeling tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-366456, MOD-2021-366464 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-Nov-2021, anatomical site added. Narrative updated.
Information has been received from a physician and a consumer concerning her 11-year-old daughter who had a reaction to albuterol and no pertinent medical history who on 26-MAR-1997 at 10:30AM was vaccinated IM with a first dose of Varivax (Lot # 620625/1343D). There was no illness at the time of vaccination. There was no concomitant medication. On 11-JUN-2006 the patient experienced "100-200 lesions" all over her body.  The lesions were fluid filled, but not breaking open and scabbing. No other information was provided. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. The patient's lesions persisted. Follow up information received from a physician indicated that on 12-JUN-2006 at 9:15AM, the physician received a phone call from the mother indicating that the child was exposed to varicella one month prior, and now had red bumps that were itchy. The physician questioned if this was chickenpox, and advised symptomatic treatment. He advised to be seen if concerned. No further information was available. The outcome was unknown. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or siblings. The outcome was unknown. Additional information has been requested.
Patient developed a rash around the injection site immediately following the injection 1/5/2021. Patient was given Benadryl 25 mg po 1/6/2021 @ 0729 am, and rash subsided.
Fatigue one day after. Rash/lesion on my arm at the site of the injection approximately 7 or 8 days later that I still have. It's a red splotch about two inches in diameter is very itchy.
lt leg upper thigh red w/hardness @ site;pt crying greater than 3hr;ice applied to site w/1tsp Ibuprofen given in clinic;pt observed over 30min, crying ceased & drinking bottle;pt sent home w/instructions of care;
I woke up the next day feeling the way you feel when you have the flu.  Achy, crappy, sore.  And my injection spot was very sore all day and some of the next day.  Later that night I also got a sore throat.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included ectopic pregnancy and three normal full-term live births.      On 1 September 2011 the subject received a dose of Boostrix (.5 unknown units, intramuscular, unknown route), and experienced vaccine exposure during pregnancy.  The subejct was vaccinated at approximately 37 weeks gestation.  Date of last menstrual period was 09 December 2010 and estimated delivery date was 22 September 2011.  The subject had not been using contraception prior to becoming pregnant.  The conception was normal.  Prenatal testing revealed no evidence of a defect, including 4 ultrasounds.  Maternal serum alfa-fetoprotein was positive on 07 April 2011.  Quad screen was positive, but scans revealed normal anatomy.  The subject declined an amniocentesis.  The subject had one abnormal value on 3 hour glucose tolerance test, but was negative for gestational diabetes mellitus.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds performed on 07 April, 22 April, 08 June and 17 August 2011, with no evidence of fetal defect. Amniocentesis was not performed. One abnormal value on 3 hour glucose tolerance test (not gestational diabetes mellitus). Quad screen positive; normal anatomy scan.
1yr. after receiving initial vaccine (LYMErix) joint pain, shooting pains in legs, diagnosed with arthritis, (knees) given Celebrex.
Low grade fever, body ache, feeling chilly, fatigue, no appeptite, headache.  Felt like worst flu symptoms.     Lasted 36 hours.  Drank lots of water, stayed in bed, eventually took extra strength Tylenol for relief.
I am 66, received the PNEUMOVAX 23 vaccine on 10-10-2018 and have been in bed with a fever, weakness, fatigue and extreme redness with a radius of 4" at injection site since receiving this terrible vaccine. My symptoms do not seem to be dissipating.
administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature; 7 patients were administered booster doses from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was kept in the refrigerator at normal room temperature. The vial was initially stored in the refrigerator on 12 Apr 2022. The vial was first punctured on 13 Apr 2022 at 8:00 am. Post puncture the vials were refrigerated at 4-5 degree Celsius. The vials did not undergo any temperature excursion.  Total amount of time the vial was exposed to room temperature range  was 30 min or less. The patient did not have any symptoms.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up was received and contains no new information
Given after 30 days in the fridge. Given on day 34 of being in the fridge
Lethargy and convulsion about 24 hours, post vax. Required intubation due to shallow, irregular breathing after seizure. Diagnosed with Status epilepticus.
There was no Adverse event with this error. Pt had no reaction from  the expired vaccine left out over the weekend since 1/28/2022.
Patient signed up to receive the updated COVID19 (Pfizer) bivalent booster, but the pharmacist mistakenly drew up a dose from a COVID19 (Pfizer) vial that was not the bivalent but was for the original series. Patient did not have any adverse reactions and no treatment was necessary. The patient was informed about the error and will return to get the bivalent booster in 8 weeks.
Patient began experiencing difficulty swallowing the morning after receiving the influenza vaccine. No shortness of breath or difficulty breathing, no other reactions noted.
"My shoulder was a little sore when I went to bed. I woke up in the middle of the night with intense pain in the shoulder - I couldn't sleep on that side. I also had chills. My teeth were chattering, and I felt feverish, but my temp was normal. I took acetaminophen. The pain subsided enough so I could get back to sleep, and the chills stopped. When I woke up this morning, I had some pain in my shoulder, but no other symptoms. I took another dose of acetaminophen, which is controlling the shoulder pain. The pain seems to be subsiding, so I'm thinking I probably won't need any more analgesics."
This spontaneous report was received from an administrator referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # L024993 and expiry date: 17-OCT-2017, (dosing details not provided). The vaccine was exposed to temperature of 45.5 degree Fahrenheit for 3 hours and 30 minutes. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of the three reports received from the same reporter. Additional information has been requested.
pt recv vax 9MAY95 11AM & pt started crying 1PM described as screaming;no consoling;mom called MD;MD prescribed Motrin & stated pt should not have pertussis again; leg was swollen, red & warm; pt cried from 1PM until 20mins p/given Motrin
NauseaVomiting chiills, fatigue, nausea Narrative: phone call.