chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX  (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache were recovered/resolved. The reporter considered the pain in arm, swelling arm, erythema of extremities, myalgia, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The patient's age was over 70 years. The patient received immunization at a local retail pharmacy. The patient had a lot of arm swelling and pain. Other symptoms were everything referencing safety profile in SHINGRIX Visual Aid except for shivering, fever and gastrointestinal issue. Symptoms lasted for 2 weeks. The reporter did not agree to follow up from GlaxoSmithKline. The healthcare professional strongly encouraged patient to get 2nd dose of SHINGRIX even in light of experienced side effects.
Patient came to the pharmacy on 07/20/2018. She complained of a swelling, painful and redness at the injection site. The size  of the redness area is about 2 inches around the injection site. She also complained that her left hand and fingers are weaker. She could not hold an object tightly.
Swollen lymph node left underarm the size of a golf ball. Remained 5 days so far and hasn't gotten smaller. Loss of taste (especially of sweet foods) and diminished smell.
I started having a fever at about 3AM. I was experiencing pretty intense chills to the point I was shaking. I was up and down until about 7AM with the same thing. I didn?t feel good enough to get out of bed and take my temperature until then and it was 101.1. I  had a headache and puked a few times throughout the day. The worst part has been the body pain though. I hurt all over yesterday. I?ve been exhausted as well. I don?t take naps ever, and that?s all I did yesterday. I tried to go to work this morning, but was sent home. I puked when I got home and took a 3 hour nap after sleeping 10.5 hours last night. My back and neck have been hurting really bad though. Like little shooting pain, and it hurts to turn my head from side to side. I felt like my lymph nodes were really swollen when I got up yesterday. I talked to my local pharmacist, and she said to alternate ibuprofen & Tylenol every 3 hours. It seems to be helping. I think the Tylenol is doing more for me though than the ibuprofen.
Information has been received from a pharmacist concerning a 24 year old female with no pertinent medical history or known allergies, who on approximately 14-OCT-2008, was vaccinated with the second dose of GARDASIL (route and site not reported). Concomitant therapy included ALESSE. On approximately 19-OCT-2008, (five days after vaccination), the patient experienced localized urticaria in the left arm. As of 21-OCT-2008, the urticaria has extended from the injection site to the forearm. No laboratory test was performed. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. Additional information was received from a physician which reported that in August 2008 the patient received her first dose of GARDASIL vaccine (route and site not reported) and two days later the patient noticed a rash at the injection site, the rash was itchy and resolved within a week. The physician reported that in October 2008, two days after second dose of GARDASIL vaccine given in the left deltoid, the patient noticed a purple rash (same as before but more severe) on her left arm (from the injection site down to the wrist). The rash was itchy and resolved in approximately 10 days but left scars on patient's arm. The physician stated that the patient will not received her last and final GARDASIL shot. There was no illness at the time of vaccination. No additional information is expected.
Limp body, whole body jerking, color draining from face, lips turning blue, lethargic.
Left ear pain, unilateral. Burning sensation on left aspect of scalp with redness, unilateral. Symptoms began on day 7 after administration of vaccine. Seen by PCP. Being treated for presumptive shingles.
86 y/o male,  immediately post vaccine the patient became nauseated, pale and diaphoretic.  MD called to eval, patient stated he had Hemodialysis yesterday.   HD new since Oct 2019.  No vomiting, no shortness of breath, no rash, no allergic symptoms.  BP initially once back to medical area, 113/77, HR 103, RR 16, Po2 99.  His blood pressure continued to drop  to a point of 77/51 and a decision was made to transport via EMS to the ED .  Time in medical area  55 minutes.  During that time patient did not develop any rash, difficulty breathing or other allergic symptoms.
Rash on back of right arm, left arm, left thigh, right thigh, both feet and arms.
A month after my second vaccine I started having Sinus tachycardia. My cardiologist put me on Metoprolol. On 5/7/21 I went to the local Health ER with SVT's. I ended up having Adenosine (which stopped my heart). Normal sinus rhythm returned.
Pt recv vax on 10/7/98; on same day pt exp chills&fever; tx=aspirin. On 10/8/98 pt imp but injection site & shoulder tender;on 10/9/98 pt exp red streaking of LA w/ rash on abdomen.
Roughly 24 hours after administration of vaccines, infant developed significant swelling of lower right extremity with tightness of skin where PREVNAR and HIB vaccines were given. Swelling extends from just above knee to hip (not just located at administration sites), with some nodularity noted at administration sites. Infant with some discomfort, easily treated by tylenol. No signs of cellulitis or infection at the site.
Information has been received from a health professional concerning a male who on 12 Jul 2002 was vaccinated with a dose Varivax. Subsequently the patient experienced mild, typical varicella. It was reported that the patient had recovered. Unspecified medial attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt presented with pustular lesions. The pts polymerase chain reaction results were positive for betaglobin and negative for VzV. Pt developed 50-75 lesions on upper extremities. Pt was exposed to varicella for 1-2 hours in his household one week prior to the beginning of symptoms. Pt was seen by a dermatologist who diagnosed the pt with bug bites. Additional information has been requested.
Rash started on 4/7/01 with a few on trunk and arms. No itching. Temperature 99F (oral). Seen in office on 4/9/01 with 30 varicella lesions.
Red itchy rash at point of injection started around 6 am on 4-4-21.   Put topical benedryl on.  Fine right now.  Migraine on 4-5-21 started at 9:45 am.  Slept and took 2 Advil.  Headache on 4-6-21 and feeling congestion in head.  Took 2 Advil.  I wanted to report this because I tested positive for Covid on 10-21-20 and thought you should have this information on file.  I had the Moderna COVID-19 Vaccine EUA.
Pt recv vax on 10/21/98; on 10/23/98 pt exp fever, induration/ tender vax site
This spontaneous report as received from a nurse refers to a 7 year old male patient. On an unknown date the patient was vaccinated with PROQUAD (lot # and expiry date unspecified) injection (dose, route and anatomical location unspecified). Other suspect therapies included MMR II. It was also reported that the patient received a dose of VARIVAX (lot # and expiry date unspecified) (dose, route and anatomical location unspecified) administered on an unknown date. The nurse reported that patient had only received a single dose of both VARIVAX and PROQUAD on an unspecified date. Additional information has been requested. This is a corrected report. Therapy of VARIVAX was removed from therapy tab and was replaced for MMR II. The event of inappropriate schedule was added. Narrative was updated.
Vaccine administered in left arm. This is area affected. Soreness along side of left foreman, soreness in finger joints of left hand. Rashes on upper arm and forearm near elbow of left arm. Area is sensitive. Blisters on fingers and fingertips of left hand.
After receiving the injection, after 5 minutes I felt my heart racing.  I took deep breathes and it went back to normal.  I waited the 15 minutes.  At 25 minutes after receiving, I was driving home and all of a sudden I felt my muscles in my neck/shoulders and back tighten up.  Other than a sore arm, all was okay.  That evening I started running a temp, chills, fatigue, shortness of breath, could barely walk, headache, as if I had Covid all over again.  I called my doctor on Monday.  I stayed home in bed Monday and Tuesday and possibly Wednesday after the first injection.  I worked at home the rest of the week as I was too fatigued to get dressed and drive into town.
Information has been received from a nurse concerning a 14 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1703USA002792: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1612USA007442: US-009507513-1702USA010448:
I notices a change in my platelets they were first 198 to 99 then I got my shot then it dropped 149. Oct. 18 2021, 127 then I got the booster Dec 7, 2021 then I had blood work in Feb 23, 2022 the numbers dropped to 98. April 14, I had blood work again and it dropped to 82. June 8,2022, I had a platelet of 77 and they appear clumped. I have another doctor appoint. August 1, 2022 but I do have another appoint for blood work in July.
TERRIBLE NERVE ISSUES; BRUISES ALL OVER MY LEGS AND ARMS; PAIN ALL OVER MY LEGS AND ARMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced terrible nerve issues. On MAR-2021, the subject experienced bruises all over my legs and arms. On MAR-2021, the subject experienced pain all over my legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible nerve issues, pain all over my legs and arms and bruises all over my legs and arms was not reported. This report was non-serious.
Pt reports that he developed a rash on both arms going to his back approximately 2 days after receiving the influenza vaccine. Started w/small red spots, then become bigger, inflamed, bumpy too. Methylprednisolone take by mouth as directed.
Information has been received from the mother of the patient concerning a 14 year old female who on an unspecified day in February 2007 was vaccinated with the first dose, on an unspecified date the patient received her second dose and approximately in August 2007 third dose of GARDASIL (routes and lot numbers unspecified). Concomitant vaccine therapy included a dose of MENACTRA (dose, route and lot number not reported). The parent reported "the patient began experiencing chronic nausea 2 months after receiving her third dose of GARDASIL (October 2007). The patient went to the emergency room but was not admitted to the hospital (date unspecified). The patient started taking unspecified medication for chronic nausea. At the time of the report the outcome of the patient was recovered. Additional information has been requested.
A non-serious spontaneous report of inadvertently given expired FLUMIST was received from a health professional concerning a 37-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. On 27-Jan-2012, expired FLUMIST was inadvertently administered to the patient. There was no adverse event associated with this medication, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 58 months of age.
BACK PAIN; STOMACH ACHE; MALAISE; CHILLS; MUSCLE PAIN; INTENSE DIARRHEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced intense diarrhea. On 27-MAR-2021, the subject experienced malaise. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced muscle pain. On 28-MAR-2021, treatment medications included: ibuprofen. On 31-MAR-2021, the subject experienced stomach ache. On 31-MAR-2021 08:15, treatment medications included: bismuth subsalicylate. On an unspecified date, the subject experienced back pain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. Additional treatment medications (dates unspecified) included: cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense diarrhea, and the outcome of malaise, chills, muscle pain, back pain and stomach ache was not reported. This report was non-serious.
Patient developed symptoms of muscle aches, slight headache, and diarrhea. Tested for Covid 19 5/14/21 and PCR results came back positive 5/15/21.
Information has been received from a physician concerning a five year old female patient who was vaccinated once, at the age of one year (approximately July 2001) with a 0.5 ml SC dose of varicella virus vaccine live. The physician reported that last week (approximately 7/7/2005) (also reported as recently) the patient came into the office with a severe case of chicken pox. The patients body was covered with lesions. It was reported that the patient also had a cough. A chest X ray was done and the results were normal. The physician prescribed Keflex for the patient. At the time the event was reported, the patient was recovering. There was no product quality complaint reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K011325, expiry date: 08-APR-2017). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Patient was hospitalized on 1/4/22 for 4 days with positive Covid-19. The patient had SOB and fatigue and developed ARDS.
The patient received  the Johnson and Johnson Covid-19 vaccine as the primary dose   The Patient was given the monovalent mRNA COVID-19 vaccine as a booster on 09/12/2022. This was done after the FDA?s authorization of bivalent boosters on 08/31/22. Our clinic was not aware that the monovalent formulation could no longer be given as a booster at that time. The patient suffered NO adverse reaction.
Facial, mouth, tongue swelling (angioedema). Patient went to local Emergency Room, was treated with Prednisone 50mg PO QD x 4 days, Benadryl 25mg Q6 hours x 24 hours & Famotidine  PO BID.  Symptoms were reduced until the following evening (7/29/2021) when the patient developed significant Hives on her face, head, neck, arms, & chest.  She then went back to the local Emergency Room where the Prednisone was increased to 60mg  PO QD x 7 days, benadryl increased to 50mg PO Q6 hours & continue with Famotidine BID.
Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 14:00 (at the age of 82-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report.   Information on the lot/batch number has been requested.
This is a COVID+  82y.o. female w/ PMH of HTN, suspected Takotsubo's cardiomyopathy, HFrEF EF 35% on 2L home O2, prior breast cancer s/p R mastectomy 2002, newly diangosed pancreatic adenocarcinoma cancer with diffuse metastasis, and SBO on TPN who presented to HCF on 10/02 with shortness of breath. Pt has had increasing O2 requirement at home for the past 2 weeks, and was found collapsed and unconscious on bathroom floor by her husband. In the ED, pt was tachypneic RR 25, otherwise vitals WNL. Stroke team was activated due to slight left facial droop and subtle left arm weakness, however this was later reported as chronic and baseline for  her, initial stroke workup was negative, brain MRI still needed to be needed to be completed.  Labs notable for positive COVID test.  Lactic acid 1.4.  WBC elevated at 18.5.  Hgb 8.5 (appears to be at baseline). BMP remarkable for BUN of 36, calcium 7.6, hyperglycemia 216. D-dimer elevated to 2107, however CT-PE was negative. UA negative for infection. CT head showed no acute intracranial process, prominence of the CSF spaces with progression and periventricular white matter changes. EKG NSR with possible Left atrial enlargement . Chest Xray showed worsening pulmonary edema. She was started on 15 L nonrebreather and weaned to 5L. Medical team was consulted, pt received Decadron for 10 days. On physical exam patient was fluid overloaded (pulmonary B lines on bedside echo and 2+ b/l LE edema) and had signs of pleural effusion, ascites. She was also started on Lasix 40 mg BID. IR was consulted for paracentesis, it was attempted but they were unable to remove any fluid. Throughout the remainder of her hospital stay, she she remained on 4-5L of oxygen. Pt's ascites, increased oxygen demand, BLE edema were determined likely 2/2 pancreatic cancer metastasis to her pelvis, liver  and small bowel. Oncology was consulted and determined that the pt had a poor prognosis and she was not a candidate for aggressive chemotherapy
pt recv vax 27JUL(5 & 10APR97 pt devel chickenpox fever & cough;pt recovered by 17APR97;
Patient has excessive bruising around injection site as well as a hard nodule at site of injection. Minor pain but no decrease in range of motion.
At time of injection, patient felt needle as if it hit something (possibly bone). About an hour later the pain escalated, and has not gotten any better since. Patient started taking Tylenol Extra Strength that same day. Tylenol has not relieved pain even a little bit. Patient has not contacted primary care yet. Today on Day 5, pain hasn't gotten any better, patient came to see us in pharmacy. She was hoping after a couple days pain would subside but it has not.
23 y/o male with generalized mildly pruritic maculopapulae eruption of the arms, sides, flanks/ lower back, legs, feet and hands approx. 2 weeks after vaccination for ANTHRAX, SMALL POX, and TYPHOID.  Treated with PREDNISONE 60 mg.
Information has been received from an employee in a physician's office concerning a 75 year old Caucasian female pt with allergies to penicillin, sulfa and azithromycin (Z-PAK) who on 9/6/01 was vaccinated IM in the right deltoid muscle, with a dose of pneumococcal vaccine 23 polyvalent (lot 637095/0946K). On the evening of 9/6/01, the pt went to an ER with a right deltoid induration measuring approx. 15cm which was hard and warm. No cellulitis was noted. The pt also had complaints of fever and chills and was dx'd with a UTI. The pt was treated with Levaquin and Medrol Dosepak). The pt improved the next day and recovered 1 week later. Additional information is not expected.
Kidney infection; kidney function effect; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) and RENAL IMPAIRMENT (kidney function effect) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant) and RENAL IMPAIRMENT (kidney function effect) (seriousness criterion medically significant). At the time of the report, KIDNEY INFECTION (Kidney infection) and RENAL IMPAIRMENT (kidney function effect) outcome was unknown.            The concomitant medications were not provided. The Treatment information includes antibiotics.  Company Comment : This case concerns a 54-year-old, male with unknown medical history, who experienced the unexpected events of kidney infection and renal impairment. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no precise onset date. The rechallenge was unknown/since no information regarding the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old, male with unknown medical history, who experienced the unexpected events of kidney infection and renal impairment. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no precise onset date. The rechallenge was unknown/since no information regarding the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.