chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Muscle pain in leg; Sore arm for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a day and a half), HEADACHE (Headache) and MYALGIA (Muscle pain in leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm for a day and a half). On 17-Apr-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle pain in leg). On 15-Apr-2021, PAIN IN EXTREMITY (Sore arm for a day and a half) had resolved. At the time of the report, HEADACHE (Headache) and MYALGIA (Muscle pain in leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 24 hours unilateral swelling and redness of lower posterior arm and chest with slight pain. Lasted apx 48-72 hours then resolved. (We used BENADRYL x 48 hrs).
Vomiting and diarrhea without fever within 72 hours of immunization lasting approximately 24 hours
On 07/18/2021 abdominal pain and nausea. I went to the ER at midnight on 07/18/2021. As a result of the test: suspicious spot on the kidney, very inflamed gallbladder, suspicious mass on the liver, suspicious mass in the sigmoid colon. I was admitted to the hospital for further test. My white count was elevated. I was admitted to the hospital for 4 days for pain control, IV control and anti nausea medications, IV fluids and antibiotics. On day 3 or 4, I ended up having many more tests, I had another cat scan, 2 ultrasounds, an MRI, a colonoscopy. Every day everything got better and cleared up, and they found out it was not cancerous. They found a spot on my kidney that was the size of a pea, they will continue to observe. The doctors were looking at my liver and colon, and the kidney, and they said everything originally looked suspicious because everything was so inflamed that it caused it to look like it did on the cat scan. They diagnosed me with diverticulitis. I had 3 different types of antibiotics on IV. My liver enzymes were skyrocketed and they took me off the Zosyn. They took me off my simvastatin. They are monitoring my liver enzymes.
Information has been received from an other health professional concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# 667690/1158Z). It was reported that on an unspecified date, the patient experienced soreness and swelling. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. The is one of several reports received from the same source. Additional information has been requested.
Information has been received through the Merck pregnancy registry from a registered nurse concerning a 34-year-old female with no pertinent medical history and no drug reactions/allergies who on 30-AUG-2006 was vaccinated SC in the left arm with a 0.5mL dose of Varivax (Lot # 652664/1033R). Concomitant therapy that day included a dose of MMR. There was no other concomitant medication. It was noted the patient was confirmed to be pregnant through a pregnancy test. LMP=30-AUG-2006. No symptoms were reported. Unspecified medical attention was sought. There was no product quality complaint. No further information was available. Follow up information indicated that on 10-MAY-2007 the patient gave birth to a 7 pound 10 ounce male. The baby was born 2 weeks early. The baby was born without a rectum. The baby then had hyposodiumia secondary to surgery so he was in the ICU for 1 week. Slight hydrocephaly was noted, along with auto temp regulation problems. During pregnancy, it was noted that the mother had high stress. She is a single mom G4P3 prior to delivery. She was in school and worked. Infidelity with husband was noted. No other medications were used during this pregnancy. No additional information is expected.
Patient experienced severe swelling, pain, and redness on arm when spread - patient  had an ultrasound to rule out phlebitis and was then started on an antibiotic as a precaution due to possible infection.
Immediately upon receiving the flu shot, my arm experienced consistent soreness. It has been 3 weeks since getting the shot and my arm is still persistently sore. I have limited range of motion, muscular soreness, and am unable to sleep on my left side due to the pain.
Client has received an inactivated polio vaccine from an opened multi-dose vaccine that had been subjected to temperatures out site of safe storage. The multi-dose polio vaccine vial experienced a temperature above 46 deg. F for 27 minutes on 4/01/2019. The vaccinating nurse was unaware of the temperature excursion at the time of administration on 04/02/2019.
Side effects / aches in my muscles; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The patient was still feeling aches in muscles. The reporter consented to follow up.
Itchiness at the injection site; swelling at the injection site; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA232560, 2020SA229965 and 2020SA231710 (same reporter).  This case involves a female patient (aged 20-30 years) who experienced itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.   On an unknown date, the patient received 0.5 mL dose (once) of suspect INFLUENZA QUADRIVAL A-B VACCINE (Pre-filled syringes) (lot UJ432AB and expiry date 30-Jun-2021) via unknown route in the deltoid(not otherwise specified) for prophylactic vaccination.  On an unknown date, the patient developed non-serious itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was reported as unknown.
Initial and follow up information has been received from a medical assistant and refers to patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 28-SEP-2015, the patient received an improperly stored dose od VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sever pain in my shoulder from the time she stuck the needle in. This pain continued for two more days, slacking off some each day. Later that day, I started getting pains in my joints and muscles. This pain continued for two days, getting worse the second day.
35 weeks pregnant received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia (stable.) on 01-Jan-2021. Concurrent medical conditions included Drug allergy (Allergies to Percodan,Percocet.), Morning sickness, Gestational diabetes, Hyperthyroidism and Shaking. Concomitant products included METFORMIN for Gestational diabetes, LEVOTHYROXINE for Hyperthyroidism, AMITRIPTYLINE HYDROCHLORIDE (AMITRIP) for Shaking.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-May-2020 and the estimated date of delivery was 18-Feb-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Glucose tolerance test: abnormal gestational diabetes. In 2020, Ultrasound foetal: pregnant pregnancy confirmation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Upon internal review on 21-Jul-2021, patient, events, analysis and regulatory reports tabs were updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
I broke out in hives.; My tongue swole up; I became extremely itchy all over the place; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 09Apr2021(at the age of 30-years-old) as a single dose for COVID-19immunisation. The patient's medical history included COVID-19. The patient had no known allergies to medicines, food or other products. The patient did not receive any medication within two weeks of the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021, with in five minutes, the patient reported that she broke out in hives, her tongue swelled up and she became extremely itchy all over the place. The events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events broke out in hives, tongue swelled up and extremely itchy all over which included treatment with BENADRYL. The clinical outcome of the event broke out in hives, swollen tongue and extremely itchy all over the place was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(L) arm-blotchy rash from upper arm to wrist-rash started 12-14-2009-No warm or swelling only on one arm-No fever saw nurse at police academy told him to put antibiotic ointment on it 90% resolved on 12/28/09 per wife.
This case was reported by a healthcare professional (nurse) and described the occurrence of flu-virus in a 30-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included influenza vaccine unspecified; non-GSK manufacturer; CSL Biotherapies; unknown; unknown given in October 2013. Concurrent medications included ALESSE. On 14 November 2013 at 12:00 the subject received 2nd dose of HAVRIX (a "unit dose syringe", unknown details, left arm). On 24 November 2013, 10 days after vaccination with HAVRIX, the subject experienced flu-virus, fever, chills and body pain. The nurse reported that the subject woe up on 24 November 2013 with fever, chills and body aches. The subject "continued to feel worse during 25 November 2013" and sought medical attention at an urgent care facility. Per the nurse "urgent care confirmed the flu" but the nurse was unsure if "that was based upon symptoms or lab tests." The subject was treated with TAMIFLU on 25 November 2013. At the time of reporting the events were worse.
received only  adjuvant portion; received only  adjuvant portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only  adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: received only  adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist reported a patient received only the adjuvant portion of the Shingrix vaccine The reporter consented to follow up.  The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2023AMR056653, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR056653:same reporter
Dose 2#017B21A About two weeks after the vaccine I had one shot of Limoncello and I think I fainted. I have never had a reaction to any food except for Beets once as a child. It has been six months and I have been occasionally have dizzy spells since that incident. It happens about twice a day. I went to my Primary care physician and he noticed recommended I see a Cardiologist due to the dizzy spells.  I wore a Heart Monitor for two weeks. They noticed that I had a Bundle Blockage. I had one incident of dizziness while I was wearing it. I was told once that I had a Medusa Artery. I am scheduled to see the Cardiologist. Dr.
Bilateral Knee Pain, crippling.  Sudden onset.  Pain walking and lying in bed.  Today, 7 days later still have pain, but manageable.  Ice, elevation, Arnica and Advil helped to relieve pain.
Case number PHEH2015US019686, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 25 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
He had no adverse event.  His Pulmonologist  had the patient do a COVID antibody test post vaccination which came back showing no antibodies for COVID.  Patient was taking his CellCept for his Pulmonary Fibrosis and the Pulmonologist wanted him to have the vaccinations repeated and to stop the CellCept medication for 2 weeks before the next immunization & to not start the medication again until 2 weeks after the 2nd injection.  As per this recommendation the patient was given a 2nd series of the COVID Moderna vaccine.
bad joint and muscle pain, diarrhea, nausea,  rash, asthma worsened
Throat swelling; chills; muscle tremors; weak; dizzy; high resting heart rate 135 to 145; elevated BP 168/58; BP fluctuated; heart and BP fluctuated; head ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 10:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history of the patient included GERD, allergy from Oxy family which causes significant respiratory depression. Concomitant/other medications in two weeks included Omeprazole 20 mg, famotidine [PEPCID AC], cannabidiol [CBD oil] taken for unspecified indication. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if patient had COVID prior vaccination. On 11Mar2021, at 10:45 patient experienced Throat swelling, chills, muscle tremors, weak, dizzy, high resting heart rate 135 to 145, elevated BP 168/58. Both heart and BP fluctuated, headache. AE resulted in: Emergency room/department or urgent care. Patient was not for COVID tested post vaccination. Treatment in response to the events were unknown. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. on an unknown date the patient was vaccinated with ROTATEQ (strength, dose and lot number unspecified) orally, which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
An ER MD has reported that several pt's recently have exp large swelling @ the inject site w/pain radiating into  the elbow & fever;
pt recvd a combination of Engerix-B & Recombivax-HB titer 19JUL92 was neg; booster dose given 22JUL91 & titer done 11SEP91 was neg;
I exp joint pain and severe eczema since October 25, 2021. I'm just getting appointments scheduled to go in see the doctor.
Throat felt tight; Softball size swelling at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat felt tight) and INJECTION SITE SWELLING (Softball size swelling at site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (Codeine) and Environmental allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat felt tight) and INJECTION SITE SWELLING (Softball size swelling at site of injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. In March 2021, THROAT TIGHTNESS (Throat felt tight) and INJECTION SITE SWELLING (Softball size swelling at site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Consumer reported that Benadryl resolved her symptoms.
This is a spontaneous report from a non-contactable pharmacist. A female patient of an unspecified age received first dose of PREVNAR 13 on Nov2016 in arm, at 0.5 ml single for immunisation and first dose of  PNEUMOVAX on Jan2017 in arm at 1 DF, single for immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced pretty severe reactions in the same arm when received the second injection: her arm was extremely swollen and so painful that she cannot lift it. She has been all day in bed. Final outcome of the events was unknown. Causality not be probed. No follow-up attempts are possible. No further information expected.
Client reported fatigue and arm pain later on on the date of vaccination.  She reports he was able to play golf and work.  He had Friday off.  Reports over the weekend he became so fatigued he could not get out of bed.  Is feeling a bit better today.
Nasal spray given at achool. Within 12 hours child was sniffing and sneezing. By the next morning he had 1 swollen eye. After 24 hours both eyes were swollen weeping and sore.
Nausea and vomiting started just after midnight, every 30 minutes, then increased to constant every 5 minutes by 0500. 0630 intractable and heart rate in 130s. Taken to ER where 2 boluses of fluids and Zofran given. 1200 she still could not get an ice chip down without vomiting and heart rate remained between 110-140. Admitted to pediatric floor for observation and fluids. About 1600 she was able to hold down spoonful of fluids. By 1900 she was totally back to feeling good and was able to hold down mac-n-cheese, ice cream, crackers with no nausea.
Pt was administered MMRV vaccine instead of MMR, as well as varicella and Hep A vaccines in left thigh at approx. 10AM on 8/2/13. Health Dept. and parents contacted.
Patient received shot on Friday and on Saturday afternoon noticed redness/itching and knot around injection site.
The daughter tested positive last 28May for the COVID-19 Virus; The daughter tested positive last 28May for the COVID-19 Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "unknown" and all described as "The daughter tested positive last 28May for the COVID-19 Virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive.   Clinical course: Reporter stated that she scheduled an appointment for the 2nd booster shot on 04Jun for her daughter and mentioned that the daughter tested positive last 28May for the COVID-19 Virus. Reporter is asking if that matters or does the daughter need to be held in the quarantine facility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.