chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches; pain; This case was reported by a pharmacist via sales rep and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced muscle pain and pain. On an unknown date, the outcome of the muscle pain and pain were recovered/resolved.   It was unknown if the reporter considered the muscle pain and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter mentioned that, she experienced muscle aches and pain for several days week after having received a Shingrix dose. The reporter did not agrees to follow up from GlaxoSmithKline Additional supportive information: The reporter did not agree to follow up from GlaxoSmithKline
Metal Mouth, sour salty taste in mouth, dry mouth,loss of appetite, weight loss, exhaustion, chills, nausea
dull, static sound in Right ear only. Very annoying.  Began 2 days after booster
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased. Concomitant products included simvastatin. On 5th March 2018, the patient received the 1st dose of SHINGRIX. On 5th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2018, the patient experienced nausea. In March 2018, the patient experienced shivers, leg cramps, generalized muscle aches and fever. On 6th March 2018, the outcome of the shivers and leg cramps were recovered/resolved. In March 2018, the outcome of the generalized muscle aches, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain, shivers, leg cramps, generalized muscle aches, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The reporter did not have the lot number, expiration date, or exact dosage details. The reporter noted at approximately midnight of 6th March 2018 he had chills and shivers that lasted for about half an hour and then completely resolved. Less than a day after receiving SHINGRIX, at approximately 2 AM, the patient had a fever. He described the fever as a temperature of 100. The fever resolved the next day, no exact date provided. The rest of the night, which he described as after midnight on 6th March 2018, he had leg and foot cramps and muscle spasms. The cramps and spasms completely resolved by 6 AM on 6th March 2018. He had muscle soreness in his entire body for approximately 24 to 36 hours and then completely resolved within 24 hours, no additional details provided. He described nausea as intermittent. The patient experienced pain at the injection site that began immediately after the injection, worsened approximately six hours later, and began improving on 7th March 2018. The soreness was still present but had improved. No start date for high cholesterol provided. The patient denied hospitalization to treat any of the events provided. The vaccine administration facility was a pharmacy. The reporter did not know the name of the Pharmacist that administered the vaccine.
rash up in leg; Quadracel was administered to a 14 months old patient; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 14 months old female patient who experienced rash up in leg while she received vaccine 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5222AA, expiration date- 20-Jun-2019 via intramuscular route in the thigh nos on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On an unknown date, the patient experienced a non-serious rash up in leg (rash) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  It was an actual medication error due to inappropriate age at vaccine administration. Quadracel was administered to a 14 months old patient.   (Other relevant tests included no lab data.)  Final diagnosis was rash up in leg.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported for rash up in leg.  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 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.
Information has been received from a pharmacist for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1 0.5 ml GARDASIL (lot # was unknown) 15 months ago in October 2010 and dose 2 12 months ago in January 2011. No concomitant medications were reported. Subsequently, 3 months after the second dose the patient became pregnant with an LMP of April 2012. It was reported that the patient delivered a healthy baby with no complications at an unspecified hospital on an unspecified date recently. The patient sought unspecified medical attention. Additional information has been requested.
Gen: Alert, normal mental status and interaction, no visible distress, non- toxic appearance. OP : patent Resp : no wheezing or respiratory distress noted. skin: diffuse erythematous macular rash on b/l arms Assessment: L50.0 : Allergic urticaria prednisone 20mg : take 2 tab PO once for 5 days. take with food and drink plenty of water. 2. Discussed precautions. 3. avoid washing affected area with hot water.avoid scratching.apply local cool compresses.apply topical calamine lotion or aloe vera.can take Benadryl 25mg PO 3 times a day as needed for itching.
Information has been received from a certified pharmacy technician (CPhT) concerning a patient who on 05-JUN-2012, "yesterday" was vaccinated with a dose of exposed MMR II (Lot#666834/0284Z, Exp Date: 12-FEB-2012). No adverse effects reported. Follow up information has been received from a health care professional concerning a 5 year old male patient who on 05-JUN-2012 at 16:45, was vaccinated with the first dose of MMR II that was outdated (12-FEB-2012), subcutaneously in the left thigh. No further information is available.
Client came to facility on 4/28/21 for his second dose of Moderna COVID vaccine. He reported that he had arm pain and chest pain. His vital signs were stable. Oxygen was 99%.  Dr. examined the pt.  No medication was given and he was released after 20 minutes.
Tdap given IM Lt deltoid, client came in today with c/o pain and swelling in arm 5-11-07 (started yesterday 5-10-07) also started having muscle spasms, Lt arm very warm to touch area of shot swollen, 12 cm also noted below shot area red patch areas x3, did apply cold compress
Vaccine was stored on 2Jun2022 and administered on 6Jul2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; second dose 10-Feb-22 and booster dose 6-Jul-22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10-Feb-22 and booster dose 6-Jul-22) and PRODUCT STORAGE ERROR (Vaccine was stored on 2Jun2022 and administered on 6Jul2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 068H21A and 066H21A) for COVID-19 prophylaxis.     Patient had no known allergies.    On 13-Jan-2022 at 8:34 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Feb-2022 at 8:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10-Feb-22 and booster dose 6-Jul-22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on 2Jun2022 and administered on 6Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 10-Feb-22 and booster dose 6-Jul-22) and PRODUCT STORAGE ERROR (Vaccine was stored on 2Jun2022 and administered on 6Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  The patient had never been diagnosed with/ tested positive for COVID 19.  Acute illness at the time of vaccination and up to one month before was reported as none. Patient received a booster dose of vaccine from a vial that had exceeded its 30 day working expiration. No adverse events noted at the time of reporting. Number of doses and vials were reported as 15 doses and 3 red cap vials.  Vial was initially stored in the refrigerator on 02-JUN-2022  The vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.
Information has been received from a nurse practitioner concerning a 11 year old female patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot number not provided), at school. Concomitant therapy included Tdap (manufacturer unspecified). The nurse stated that on 25-FEB-2011 the patient came to see her due to an injection site reaction of cellulitis. The patient sought unspecified medical attention. It was unspecified if any treatment was given or any lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
vomiting, fever, diarrhea hospitalized 3/14-3/17.  04/23/2007 MR received from hospital stayof 4 days 03/14-17/2007 for c/o emesis x7 in the previous 24 hours and fever.  Infant had a large, loose, watery stool in the ED.  PE: WNL. Occasional emesis during hospital stay.  IV hydration.  Discharge DX:  Rotavirus (-) acute gastroenteritis vs. post vaccine reaction.
INJURIES IN DIFFERENT PART OF BODY; CRAB FINGERS; JOINT PAIN  IN HANDS, KNEES, WRIST AND FINGERS; NAUSEA; JOINT STIFFNESS IN ANKLES, KNEES, WRIST AND FINGERS; SINUS HEADACHE; SLIGHT CHILLS; FEVER OF 100.1F; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported.  The patient's past medical history included dental work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sinus headache. On 07-APR-2021, the subject experienced slight chills. On 07-APR-2021, the subject experienced fever of 100.1f. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 08-APR-2021, the subject experienced joint stiffness in ankles, knees, wrist and fingers. On 08-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced injuries in different part of body, crab fingers, and joint pain in hands, knees, wrist and fingers.  Treatment medications (dates unspecified) included: paracetamol, acetylsalicylic acid, tramadol, and fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus headache on 08-APR-2021, was recovering from fever of 100.1f, had not recovered from slight chills, nausea, and joint pain in hands, knees, wrist and fingers, and the outcome of joint stiffness in ankles, knees, wrist and fingers, injuries in different part of body and crab fingers was not reported. This report was non-serious.
pt let out cry, eyes rolled back, went limp-diff to awaken;mom called rescue squad;pt never cyanotic, no resp distress, by time pt seen in office had a nl exam
elevated TPO antibodies and elevated TSH. TPO antibodies, TSH, T4 and T3 were completely normal prior to COVID inoculation. Within 6 months, TPO antibodies elevated over 400 and TSH elevated over normal.
After receiving a flu shot into my left arm, the next morning I was unable to move my arm without experiencing excruciating pain. This chronic pain lasted for two months. At three months I have not regained full motion of my left arm. I treated the pain with Ibuprofen.
Reports fever, chills, cough that is productive with clear/white sputum, reports rash to both hands similar to bruising, reports swelling of hands. Rash and swelling of hands still present today.
Fever, chills, rigors, muscle aches, headache, insomnia, sore arm beginning 12 hours after dose and resolving 24 hours after beginning. Sweating for 4-6 hours after this. Fatigue and headache following.
I received the COVID-19 Moderna second dose vaccine on May 5, 2021, at around 1 pm. The night after the vaccine, I had the typical side effects from the vaccine, which are chills, arm pain, severe fatigue, headache, slight fever. By the second day, chills were subsiding but I still feel very fatigued until the afternoon. Then by the third day, which was May 7, 2021, at around 2 am, I started feeling some chest tightness, which at first I associated with back pain.  However, as the day progresses, I started feeling short of breath, on and off chest pain, and palpitations. I decided to go to the ED around 10:15 pm, due to shortness of breath, and chest pain was more pronounced. Upon my arrival in the ED, I was tachycardic at 110. I was triaged and the ED physician ordered did blood work including D-Dimer, EKG. EKG reveals sinus tachycardia. The blood work reveals an elevated D-Dimer which was 1.06. And due to elevated dimer, the physician ordered a CT scan chest which was negative for PE. Since I was still having some shortness of breath and chest pain, I was admitted as observation, for telemetry monitoring and repeat EKG. The following day, I was discharged since the chest pain was resolving. However, I continued to have palpitations for at least a week after the vaccination. At that time, the ED physicians were not sure if my symptoms and elevated dimer were related to the vaccination. I followed up with a cardiologist and my PCP a few days after the hospitalization. I followed up with the cardiologists because of my history of pulmonary hypertension 5 years ago which I believe was resolved, however, it was a concern for the ED physician, because at the time they were not sure of what is the cause of my symptoms. During my visit with the cardiologists, he believed that my elevated dimer was due to the vaccination (possibly due to the inflammatory response), as well as the symptoms I have which was pericardial pain. I did my echo last week, and I will need to do another blood test this week, to check my dimer, and cardiac enzymes.   And now, since I had the vaccination, I have not had my period for 18 days, which is very uncommon to me. I had my period a few days after the vaccine. All my pregnancy tests are negative. So I am scheduled to follow up with my OB-GYN. I believe that my delayed period is also related to the vaccine, but of course, I cannot conclude that until I see my physician and conduct all the tests needed.
49 y/o male within 12 hours had extreme fatigue, nausea, vomiting, diarrhea, fever,  body aches/chills, mental fog, sore throat, cough,just an over all feeling of being very sick.   10 days post vaccine patient continues to feel ill with some increase of function sporadically.  Patient has self medicated with OTCs: Nyquil, Tylenol, etc.    10/20 - treated with zpack, Vit C 1000 mg TID, Vit D 50,000 units weekly, ASA 325 for 5 days.  See patient back in one week.
received Shingrix 50 mcg/0.5ml inj glax. Twelve hours later experienced headache, shivering, upset stomach.
Client reports that approx. 20 min after receiving the vaccine she developed muscle spasms in her right shoulder. Client states that her arm is now swollen and 3 of her right fingers are numb. States she was seen at Urgent Care and was told to massage and apply heat to right arm. In our phone conversation today client states blood clots run in her family and she is concerned. I advised patient to go to the ER.
I woke up on Dec. 1st with severe itching all over and it lasted throughout the day every day , I took Liquid Benadryl at night so I could sleep, I still have itching but it is less severe now and I stopped the Benadryl on 12/25.
Red, swollen, warm to touch, to Right vast. lateral. Immunizations given were PCV, MMR, Hib.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L050907, expiration date: 14-JUN-2017, dose was unknown) which was improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
10/21/2022-Presents to ED, c/o Cp x 2 days. EKG NSR R BBB. 02 Sat WNL. Trop 0.017. Covid + test. CXR-mod increased pulm markings, may r/t mod bronchitis/developing pulm infection. Relief with nitro. 10/22 /2022-Trop0.019 EKG- no change. No SOB or cough, remdesivir held. Solumedrol.  10/24/2022-echo showed CMP with LVOT obs, gradient in 60-70's. unchanged from previous. Start BB. VSS 10/25/2022- Known LV OT, lw dose metoprolol, follow with cardio, D/C home.
itchy area on the lower inside of her eye lid; not sure if its a hive or welt; Patient optometrist thinks it was an allergic reaction.; This is a spontaneous report received from a contactable consumer or other non-health professional (patient).A 57-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via an unspecified route of administration on an unknown date in Jul2021 as dose 1 single for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. It was reported that patient who got her first dose,two days later on an unknown date on Jul2021, patient got a really itchy area on the lower inside of her eye lid like an allergic reaction. If she pulled the lid down on the inside tissue of her eyelid it looked like a pimple. She was not sure if it was a hive or welt.It was almost like a pus-filled canker sore like one can get on the lip.She was not sure if it was a reaction to the vaccine. Her optometrist thinks it was an allergic reaction.Seriousness was reported as no. She has been using antibiotic ointment to prevent infection as treatment for which she donot want to get an infection and it seems to be resolving. Investigation Assessment was not provided. Patient was asking if she can get the second dose and wanted to know anyone else reported anything else like this. Outcome of the events was reported as resolving/recovering.  No follow-up attempts are needed. No further information is expected.
psoriasis plaque; This case was reported by a pharmacist via call center representative and described the occurrence of psoriatic plaque in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number l24m5, expiry date 1st July 2023) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced psoriatic plaque. On an unknown date, the outcome of the psoriatic plaque was not recovered/not resolved.   It was unknown if the reporter considered the psoriatic plaque to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's comment: The patient experienced a psoriasis plaque on her arm after getting her dose of Shingrix vaccine. The patient stated that the plaque was small and had been slowly growing. The reporter did not consent to follow-up.
The patient received her second dose of the Modern COVID-19 vaccine at approximately 7:20pm on Tuesday, March 23, 2021. Patient stated after receiving the vaccine that she had a "very long time ago passed out after a blood draw". The patient remained in the chair with her nurse for approximately 2 minutes, her color was good, skin was dry and had normal respiration. The patient then stated "I'm not feeling so well". Patient aware, assisted to floor, lying prone, lost consciousness (called EMS), proceeded to have a seizure, bilateral upper arm postured wrists out, lets still, body tremors. Episode lasted approximately 1 minute. During the episode, airway patent, head protected, respirations spontaneous, pulse regular 90-110. Patient awoke spontaneously, stated was somewhat confused, but making sense was able to voice event leading to episode. Patient spoke with her mother, nurse spoke with her mother to advise patient to be evaluated at the hospital due to seizure. Client and mother agreeable, report to paramedic, client transferred to Hospital by Ambulance with wallet, keys, and phone.
red spot on lt arm in the triceps area where pt recv vax 6 days ago;pt noticed the day a/that it was red & had warmth where recv vax;
She began exhibiting seizure like activity, admitted to hospital and observation and since has returned to  the facility.
Throbbing in injected arm for 2 days which then quit. Reports pain in left arm when lifted over head, shoulder.
Patient called pharmacy about 6 hours after her vaccination, stating she was having chest pain and discomfort and shortness of breath. Pharmacist recommended patient seek emergency care to get checked out and patient agreed.
Pt. had a Syncope episode within 20 min. of getting immunization. BP dropped to 80's - Systolic. , and HR dropped to the 40's. Pt. placed on Ground-Legs elevated. Provided PO H2O, Rest, Cool packs and recovered well within 30 min. Left Hospital without incident.
Received pfizer covid vaccine on 6/4 and developed hallucinations/diplopia 1.5 weeks later.  Developed BLE paresthesias first and she developed falls . Had bilateral hand paresthesias start about 5 days later, , likely most consistent with guillain Barre. +cyclic vomiting  x3 weeks. Facial edema also noted on 6/24.  Continued to have BLE and BUE paresthesias, as well as tachypnea. Ultimately had cardiac arrest on 8/8.