chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning her 65 year old male husband with chronic dermatitis on the legs, a lot of medical history but mostly broken bones, sleep apnoea, rapid eye movements (REM) sleep disorder and no drug reactions or allergies, who at the end of 2010 or beginning of 2011, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included clonazepam, clobetasol propionate and triamcinolone. The nurse mentioned that her husband received ZOSTAVAX (Merck) and approximately in June 2011 (in the summer 2011), experienced "lumps with pain and skin rash that was on his head and neck". The husband was in significant pain. The physician (who did not gave the patient ZOSTAVAX (Merck)) diagnosed and treated her husband the patient for shingles. The patient was treated with a new antiviral; the nurse could not remember the name. Sometime in the summer 2011, the patient recovered from shingles; the nurse stated that it took 3-4 weeks to go away (approximately in July 2011). No laboratory tests were performed. The patient sought medical attention by an office visit. Follow up information has been received from a healthcare worker who reported that the patient was placed on VALTREX 1000 mg therapy, three times a day for 7 days, for the shingles. In addition the physician stated in his notes that he felt that the shingles were caused by the stress of the surgical removal (on an unspecified date) of a benign tumor that was located below jaw line on the right. It was diagnosed by other physician. At the time of the report, the patient's outcome for benign neoplasm was not reported. Upon internal review, benign neoplasm was determined to be an other important medical event. Additional information has been requested.
Welt at injection site. Shortness of breath. Itching/nausea.
Employee had hypersensitivity reaction to MMR vaccine.  Employee had large hard lump that measured about 5in x 4in at the injection site with large area of bruising.  EE also stated she had to start using her inhaler 3-4x/day starting the night of the vaccination.  She stated her joints were achy and stiff.  Saw her PMD over telephone. As the week progressed so did the induration with a bump top and red streaks. She had burning pain.  She took Tylenol/Ibuprofen/Benadryl.  Slowly area started to heal and symptoms started to subside.  Spoke to employee today and she still has small induration but is not taking inhaler and does not have any joint discomfort.
Day of vaccine: Headache/migraine with light sensitivity, severe nausea (constant need to throw up for 4-5 hours), vomiting, body aches. Day after: Shakiness, dizziness, slight nausea - unable to work
hives; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via The Agency (Reference number- 00348957) and transmitted to Sanofi on 06-Nov-2020.  This case involves a 2 years old female patient who experienced hives, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment, vaccination and family history were not provided. List of concomitant medication was reported as not applicable.  On 05-Nov-2020 at around 09:30, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7102MA, expiry date: 30-Jun-2021] via an intramuscular route at the left thigh for prophylactic vaccination.  On 05-Nov-2020 at around 15:30, the patient developed a non-serious hives (urticaria) 5 hours 30 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.   Parent was instructed to give the patient Benadryl [DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE] and to closely monitor.  Frequency and product use were reported as once.  First time product used and still using product were reported as no.  At the time of reporting, reporter was questioned regarding egg component in vaccine and if any other measures need to be taken following reaction.  At the time of reporting, the event outcome reported as unknown for hives.
patient felt dizzy one day after she received her vaccine.  Her MD doesn't know whether is from the vaccine or from her medications she is currently taking.  Her MD will check and let patient know whether she should get the 2nd dose or not
Vaccination was adminsitered high, near the top of the shoulder, not in the thickest part of the deltoid. Patient came back to pharmacy next morning stating inability to sleep the night prior due to pain. He tried taking ibubprofen and found some relief, but still in pain and with limited range of motion. Primary care provider Dr aware of incident and asking patient to be seen for evaluation.
flu-like feeling; back pain; major headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (back pain) and HEADACHE (major headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 007C21A) for COVID-19 vaccination.     Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]) and PROBIOTICS NOS for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (back pain) and HEADACHE (major headaches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (back pain) and HEADACHE (major headaches) had resolved. Not Provided          No medical history was reported.  After booster dose the patient took Tylenol in the noon.    This case was linked to MOD-2021-415871 (Patient Link).
Day one thru three pain at injection site and swelling.  Painful arm and shoulder and could not sleep on that side for two nights.  After pain and swelling subsided, had heart palpitations, and some shortness of breath on evening of night four.  Event lasted about 15 minutes.  Was sitting up in chair so stayed put until breathing normalized and palpitations diminished and heartbeat normalized.  No history of heart palpitations before.
Currently pregnant at 17 weeks. I had a headache, fever, chills, fatigue, muscle aches (these 5 side effects last about 24 hours) but the one that is still lingering two days later is swelling and pain in my left armpit, same side that I had the injection.
The day after receiving vaccines (11-4) patient began to experience rash that was warm to touch and itchy.  Followed up with patient 11-11 and still some redness on left arm but symptoms had subsided.
My daughter had a seizure.  She felt it start up her left foot and followed up her left arm.  Her head and chest came forward and she passed out.  Had shaking.  My son witness the shaking and he called 911. She then went to the emergency room by squad and they diagnosed possible seizure. She was also in a postictal state following the event.
Dizziness, Headache, Myalgia, Arthralgia, INJECTION SITE PAIN, LEFT ARM NUMBNESS, WARM FEELING Narrative:
Mild flu like symptoms. Low grade fever, muscle soreness, general fatigue.  Lasted for about 12 hours, woke up felling near 100%.  No medications taken, just rest and slower schedule.
Prior to her second dose of the COVID vaccine, although my daughter had neurological issues that caused her to use orthotics to assist in walking, she was able to stand, walk and navigate stairs relatively easily. Within 48 hours of her second dose of the Pfizer COVID vaccine, she reported pain and weakness in her legs and became no longer able to walk even with the assistance of the orthotics that previously had been helpful. It has been weeks and she still has not regained the ability to walk/stand in spite of physical therapy that she has received. It is possible that her undiagnosed neurological condition is Guillian Barr Syndrome, though her neurologist has not made a definitive diagnosis of this, her symptoms are consistent with that disease and it is possible that the vaccine's adverse effect is a result of that undiagnosed disorder.
patients age range of 59 to 62 received Fluzone High-Dose, no AE; patients age range of 59 to 62 received Fluzone High-Dose, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to cases 2020SA059552 and 2020SA059571 (same reporter).   This case involves a patient (age range of 59 to 62) who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination in the last October to November.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  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.  Information on the batch number was requested.
Per mom, patient received vaccines on Monday, 10/12/2020. He developed symptoms the following morning on 10/13/2020. Patient felt sore and experienced persistent fever-highest 103.9, stiff neck, severe headache, and left arm was hot to touch with localized swelling, and blotchy redness. Per mom, patient developed flu like symptoms that continued through Wednesday morning on 10/14/2020. Symptoms eventually subsided and patient felt as if he had never been sick. Wednesday afternoon around 2-3pm symptoms reappeared. Patient was seen in clinic today, 10/15/2020 ,for response to vaccines. Patient is still unwell and presents with swelling, redness and heat to left arm. Per patient, arm is sore and difficult to lift.
This spontaneous report as received from a pharmacist refers to a 93 year old female patient (at the time of report) with none pertinent medical history and none drug reactions or allergies. On 19-OCT-2012 the patient was vaccinated with ZOSTAVAX, 0.65 ml, injection (lot number # H013018, exp. date 09-OCT-2013, subcutaneously). Concomitant therapies included TRAVATAN, AZOPT, ESTRACE cream, fluoxetine, SYNTHROID, ranitidine, "FERROCITE", metoprolol, furosemide (manufacturer unknown) and losartan potassium (manufacturer unknown). At an unspecified time after receiving ZOSTAVAX the patient developed a lupus. The patient sought medical attention went to her physician on an unspecified date and received prednisone (manufacturer unknown) on 18-JUN-2013 for lupus. The outcome of lupus was reported as not recovered/not resolved. Upon internal review the lupus was considered to be medically significant. Additional information has been requested.
Moderna COVID-19 Vaccine EUA...experienced, fever, chills, body aches, headache, and extreme fatigue after the second vaccine.
Gradual symptoms, abdominal pain, progressive weakness, over several weeks. Dx of Guillain-Barre Syndrome per neurologist on 11/29/2010-11/30/2010.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 23-JUN-2014, patients were vaccinated with (Oka/Merck) VARIVAX, 0.5ml, once, subcutaneous (lot number was not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received (Oka/Merck) VARIVAX (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minute each excursion). Nurse stated vaccines were administered on 23-JUN-2014. No adverse effects reported. This is one of several reports received from the same source.  Additional information has been requested.
Pt recvd 1st dose of Hep B vax & exp episodes of chronic EpsteinBarr virus infect 5 yrso ago; also exp gastrointestinal cramps, upper back pain, rt upper quad gastric pain & diarrhea; sore throat, fatigue, lethargy, joint swelling;
PATIENT LIGHTHEADED, FAINTED (~2 SECONDS).  SYSTEMIC MUSCLE CONTRACTIONS AND DYSPNEA LASTING 30 MINUTES ATER REGAINING CONCIOUSNESS.  BP AND HEART RATE ELEVATED BUT DECREASED WITH TIME. NO MEDICAL INTERVENTION REQUIRED
Near syncopal reaction minutes after vaccination.  Hypotensive + bradycardia immediately after near syncopal episode and cool, pale, diaphoretic. Laid down until BP + HR increase soda + crackers provided as he had not eaten.  Reaction like this with blood drawn earlier this year.  Monitored approximately 50 minutes + he left ambulatory with mother.
fever 100.8 first day, swollen arm, hot arm, lymph nodes swollen under arm in armpit, neck lymp nodes under ear painful, pain in neck, hands tingling and going numb.
I have not had a menstrual period since the first vaccine.   Even though I am 47 years old, I have never skipped a period  yet until now.  I do not have other perimenopausal symptoms.  I do not know if this is related to the vaccine, but it is the only thing different since my last period.
Shingles on June 7th.  Was treated by Doctor on June 8th with antiviral and pain medicine
Unclear! Pt developed chest pain and shortness of breath, progressive with orthopnea. Admitted to the hospital with mild hypoxemia and pericardial effusion.
Patient was administered with an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired vaccine) outcome was unknown.            No concomitant medication were reported.   No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up document contain no new information.
A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinee inadvertently received Fluvirin 0.5ml IM. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/5/03. On 11/5/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.
swelling of eye lids; blotchy rash over trunk, red ears; 10AUG94 pt referred to allergist for future immun; unable to obtian emdical records;
patients have been complaining about not feeling well; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comment: The reporter reported that the patients had been complaining about not feeling well after the 2nd dose. The reporter consented to follow up.
HI FEVER  BODY CRAMPS  INDIGESTION SEVERE HEADACHE HEARTBURN STARTED EARLY EVENING AND RECOVERED BY 6 AM.
About 2 or 3 days after the second Moderna shot, I developed  painful joints/muscles in my shoulders and hip joints
A pediatrician reported via a company representative that an 11 month old male received his third dose of Prevnar along with HIbTITER and Tripedia vaccines on 7/12/02 at 6 months of age. On 12/23/02, the infant developed lethargy and a fever of 104.3 degrees F. On 12/27/02, he was seen by a physician. On examination, his temperature was 101.7 degrees F. He was hospitalized. Laboratory tests results were as follows: CSF WBC 187; CSF and blood cultures positive for pneumococcus (serotype 6B isolated); IgG, IgM, IgA, and CH50 normal; HIV negative. Pneumococcal antibodies by ELISA were as follows: serotype 4, 0.38 mcg/mL; serotype 6B, 0.25 mcg/mL; serotype 9V, 0.56 mcg/mL; serotype 14, 1.36 mcg/mL; serotype 18C, 0.28 mcg/mL; serotype 19F, 1.13 mcg/mL; serotype 23F, 0.14 mcg/mL; interpretation: non-responder. The infant was treated with IV vancomycin and cefotaxime. Vancomycin was discontinued following receipt of sensitivity results (sensitivity to penicillin). Subsequently, the infant developed seizures. An MRI was performed and showed an infarct. Weakness in the left arm was noted, and the infant was not walking or sitting up normally. On 1/9/03, he was transferred to another hospital facility. No further information was available at the date of this report. ON 1/22/03, he was discharged. The physician indicated that the child recovered and noted that the child was crawling and "cruising" but not walking; some weakness in his left upper extremity persisted.
Infant with "milk protein allergy" at 1 month of age, developed diarrhea about 3 weeks after getting only dose of ROTATEQ.  Found to have rotavirus diarrhea that has lasted at least 4 months.  Stool virus confirmed to be vaccine strain in lab.  Child proven later to have SCID due to RAG-1 homozygous deficiency.  7/10/09 Hospital records received DOS 11/10/08 to 2/24/09. Assessment: Severe Combined Immunodeficiency Disease, Persistent Rotavirus Gastroenteritis - strain consistent with vaccine, Pneumothorax resolved, Feeding intolerance. Patient presented with fever, vomiting, increased output of 'mucousy' stools. Floppy, low tone. Hyperpigmentation rash on neck and upper chest. Dehydration, poor feeds and weight loss. Continued diarrhea, tachycardia, tachypnea, abdominal distention. NG tube placed. TPN initiated. PCP pneumonia. Pneumothorax. Difficulty swallowing secretions. Enteral IVIG administered.  ICD-9 Codes: 136.3 Pneumocystic carinii infection  8/20/09 ICD-9 Codes: 279.2 Combined immune deficiency, 999.39 Infection following injection unspecified person, 008.61 Viral enteritis due to Rotavirus, 558.3 Allergic gastroenteritis and colitis, 783.3 Feeding difficulties, 512.8 Pneumothorax other, 5733 unspecified hepatitis, 511.9 Pleural effusion, 789.59 Abdominal tenderness in multiple sites, 423.9 other disease of pericardium unspecified, 263.9 Other protein-caloric malnutrition unspecified, 783.41 Failure to thrive, 783.21 Loss of weight, 781.3 Recurrent dislocation of joint, 996.1 Mechanical complication of other vascular device implant and graft, 276.51 Dehydration, 578.0 Hematemesis.  9/28/09 Hospital records, multiple admissions, consultations, and follow-up visits, received DOS 2/24/09 to 8/6/09. Assessment: SCID, chronic rotovirus infection Rotateq strain, chronic hepatitis, failure to thrive. Patient transferred from another facilty for haplo match BMT from parent donor. Patient presents with tachypnea, feeding intolerance, course breath sounds. Fever and cut Broviac line, mouth pain, emesis, upper airway congestion. Mucous in stools. Oral Ulcer. TPN. IVIG. Hepatosplenomegaly. Epiglottitis. Rhinorrhea. No evidence of BMT engraftment. Iron deficiency anemia. Rectal area - erythematous rash. 2nd BMT preformed. Bloody emesis, bright red blood per rectum, friable/oozing esophagus. PICU. Upper airway obstruction. Respiratory insufficiency. Tachycardic. Icteric. Hepatic veno-occlusive disease. Alopecia. Rotavirus enterocolitis. Massive upper GI bleeding. Gallbladder wall thickening, sludge. Malnutrition. Pre-renal failure. Gingival eruption cyst.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reaction started day after injection and was more severe initially.  Saw provider  Dr due to scheduled appointment who characterized the red swolled arm as an adverse reaction. No treatment given at this time.
Injection site is warm to the touch, raised / swollen and red. It is also a bit itchy. Neck pain and achiness came along with it.
Chest Pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and PYREXIA (Fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PYREXIA (Fever). In July 2021, the patient experienced CHEST PAIN (Chest Pain). At the time of the report, CHEST PAIN (Chest Pain) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported.  No treatment information were reported.  Patient  went to the hospital on 5JUL2021 for the chest pains and he told that everything is fine at this time after routine tests and the patient was referred to a Cardiologist. Patient took second dose of vaccine on 19 Aug 2021(088B21A) intramuscularly and experienced the same side effects.   This case was linked to MOD-2021-308353 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Added reporter's state. Updated action taken and onset date for fever.