chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis since 1999, Arthritis since 1999 and Pollen allergy. Concomitant products included HYALURONIC ACID, CORTICOSTEROID NOS, METOPROLOL, LISINOPRIL, THEOPHYLLINE, FAMOTIDINE, FINASTERIDE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MECLIZINE HCL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). On 14-Jan-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) had resolved.            Concomitant medicines include , epidural injection.   This case was linked to MOD-2021-219907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added patient demographics ,added patient medical history and added concomitant medications
Mother called to report her son had a "bad reaction" to shots and she wants someone to know about it. Friday 6/23, when he woke up his leg was very sore and swollen to twice its normal size.  Later in the day, she noticed a 3-inch circle that was bluish/green surrounded by "flame red."  He also developed a fever.  Not sure exact temp but described as "very warm."  She gave him Motrin and Benadryl.  The fever lasted Friday and all day Saturday.  At 4am Sunday, the fever was gone and he has been afebrile since then. Monday, 6/26/06 the leg is still swollen but normal color and not sore.  He is walking normally.
Headache. Eyes felt like they were swollen. Tongue felt a little swollen.  Ears felt hot on the inside. Dizziness/Light headed. Nauseous.
Low grade fever, headache, head pain, exhaustion, syncope, unresponsive during sleep, tremors, seizure-like episodes, memory loss, dizziness, neck pain, back pain, pelvic pain, sore muscles, chills, swollen glands, loss of appetite, irritability, constipation, dehydration.
Pt vaccinated with DTP late in afternoon day of shot after a nap was whimpering, pale, and limp. l hr later given Tylenol, cried harder & color improved. Took another nap & was back to normal.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 12-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Really painful dead-arm, body got chills then switched to getting hot after a few hours, fatigue.
all the medication went down the patients arm, didn't feel anything go in her arm, no AE; Typhim syringe that started leaking, fault of the syringe, no AE; all the medication went down the patients arm, didn't feel anything go in her arm so readministered the injection, no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old female patient who had exposure via skin contact, Inappropriate dose of vaccine administered and syringe issue while she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2019, the patient received a Dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot R2A26, exp date: May 10, 2021 via intramuscular route in the left deltoid.  On 27-Sep-2019, while administering the vaccine as HCP pressed on the plunger, all the medication went down the patients arm, patient didn't feel anything go in her arm so she readministered the injection (exposure via skin contact). While placing the needle on the syringe she heard a "cracking sound" but nothing leaked out at that time. HCP states that was fault of the syringe. It was stated that the carton did not have any damage upon arrival but the cartons from shipping are opened by their purchasing department and she didn't notice any leaking before the injection nor any damage to the carton the actual syringe was in.  It was case of actual medication error due to Inappropriate dose of vaccine administered.  At the time of the report, 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 holder's 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 the sender: none
On 6/6 at 4pm, pt received 2nd dose of Pfizer COVID vaccine. He felt fine that night, but the next day (Monday) woke up with a headache, which was resolved by ibuprofen 200mg. 5 hrs later, headache returned. In total, he took 3 doses of ibuprofen 200 mg that day. On Tuesday, he went on a field trip for school, during which he walked for a total of 40 min. He also went to football practice, where he did weight training and conditioning for 1 hr. He experienced no chest trauma during practice. He tolerated exercise with no dyspnea on exertion and felt perfectly normal, but when he returned home, his mom felt that he appeared unwell and his face and eyes looked swollen. At 9 pm, headache recurred but responded to ibuprofen 200 mg. This morning (Wednesday), he woke up in the early morning complaining of difficulty breathing and orthopnea. Dyspnea was improved by propping head up on more pillows. He also had headache again and received another ibuprofen 200 mg before going to the ED. Denies fever, malaise, muscle aches, chest pain, syncope, dyspnea on exertion, palpitations, URI symptoms, sore throat, cough, diarrhea, abdominal pain, vision changes, dizziness currently or since receiving the vaccine. He still endorses orthopnea but it has been improving. No recent illnesses, sick contacts, new environmental exposures, or travel recently.  Admitted to Cardiac Step down with concern for troponin leak, peak at 29. Cardiac MRI confirmation of myocarditis
Initial information received from a healthcare professional on 23 SEPTEMBER 2013. A 12-year-old male patient had received first dose of MENACTRA (batch number: U4648AA, expiry date: 25 APRIL 2015, route of administration not reported) in the left deltoid and first dose of ADACEL (batch number C4456AA, expiry date: 10 DECEMBER 2015, route of administration not reported) in the left deltoid, on 21 SEPTEMBER 2013. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical conditions. The patient had not received any other vaccinations within 4 weeks of the present vaccination given on 21 SEPTEMBER 2013. On 21 SEPTEMBER 2013, the same day after vaccination, the patient had enlarged lymph nodes less than 3 centimeter, in the left axilla. The patient also had minimal swelling, less than 1 centimeter round area with minimal redness. There were no other symptoms. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 12 NOVEMBER 2013. The patient had no medical history and no illness at the tine of vaccination. On an unspecified date, the patient recovered.
Patient experienced swelling of the R arm.  Denies any pain or discomfort of the limb.  No decrease in mobility.  Per CDC recommendations, mother is icing and elevating limb.  CDC also recommends follow up with family physician for treatment with NSAIDS if symptoms persist or worsen.
A report has been received from a Health Professional concerning a patient, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres, Lot number: FL2117. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient had received expired FLUMIST (medication error). The outcome of the event of expired FLUMIST (medication error) is unknown. The report was considered to be non-serious by the company physician.
CONTEMPLATING SEPPUKU; SHOOK UNCONTROLLABLY; DID NOT GET TO SLEEP UNTIL LIKE 8 AM; CHILLS; 103 FEVER; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 administration not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, dose number in series 1, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, patient had 103 degrees Fahrenheit fever and chills so bad that patient get shook uncontrollably after moved an inch and touched the cooler part of the sheets (shaking). Patient did not get to sleep until like 8 am (difficulty sleeping) and also stated about contemplated seppuku to be honest (Suicidal ideation) (dose number In Series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 degrees Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 103 fever, chills, shook uncontrollably, did not get to sleep until like 8 am and contemplating seppuku was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211261770-COVID-19 VACCINE AD26.COV2.S-Contemplated seppuku (Suicidal ideation). This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This spontaneous report as received from a consumer (patient's wife) refers to a 68 year old male patient. The patient's drug reactions/allergies included penicillin, sulfa and clindamycin. The patient's medical history included nose polyps. On an unspecified date in 2012, the patient was vaccinated with PNEUMOVAX23 injection of strength 25/0.5 Y lot # H015780 (expiration date, dose number, dose unspecified) route reported as 'injection'. Concomitant therapies included simvastatin (manufacturer unknown) 20 mg. Approximately on 18-APR-2016, unspecified X-ray was done. On 18-APR-2016, the patient was diagnosed with pneumonia. The patient sought medical attention, went to physician. The patient was treated with unspecified steroids, antibiotics, cortisone and breathing treatments. The patient was "still feeling crappy (approximately April 2016), but getting better" / recovering from the events. It was reported that suspect therapy was not discontinued. Product quality complaint was not involved. Causality assessment was not provided. The reporter did not supply the patient's specific demographic data. No further information was provided. Additional information is not expected as no reporter details were provided.
Dizziness; Fever; Chills; Muscle joint pains; Muscle joint pains; Aches; Nausea; An extreme dizzy spells; Super tired; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FA6780), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jun2021 15:00 (at the age of 68-year-old) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 26Jul2021 15:00 (Batch/Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunisation. No other vaccine in four weeks. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELEBREX) taken for arthritis, start and stop date were not reported; docusate sodium (STOOL SOFTENER) taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro [ciprofloxacin] for drug hypersensitivity. It was stated that the patient has been feeling very sick to my stomach. On 29Jun2021 18:00 the patient experienced fever, chills, muscle joint pains, muscle joint pains, aches, nausea, an extreme dizzy spell, super tired. On an unspecified date dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 18Jul2021 Nasal Swab. No covid prior vaccination. The patient had covid tested post vaccination. The outcome of dizziness was unknown, rest of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received MENACTRA vaccine on 8-5-2016 and had facial redness, dizziness, hoarseness and itching at site on the following day 8-6-2016. Pt took BENADRYL and issue resolved.
Information has been received from a registered nurse concerning a 20 year old female patient with drug reactions or allergies reported as none who on 15-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 661530/0575X). On 07-MAR-2009 she received second dose of GARDASIL (lot # 661952/1129X). On 07-JUL-2009 she received third dose of GARDASIL (lot #661952/1129X). Concomitant therapy included YAZ. On 07-JUL-2009 within 3 minutes of given third dose of vaccine, the patient "passed out". The patient claimed she did not eat anything and that was the cause. The patient was given food and cold compresses in the office and watched for 20-30 minutes after she woke up. The patient went home and the next day the mother was upset that the patient was sent home because the patient had another reaction when she came home. The mother took her daughter to the emergency room but the patient was not admitted to the hospital. The emergency room informed the child's mother that the child had a reaction to the GARDASIL. No reaction was reported after first and second doses of GARDASIL were given. On unspecified date the patient recovered. Follow-up information has been received from the registered nurse concerning the 20 year old female with no drug allergies who on 07-JUL-2009 at 16:15 was vaccinated into left deltoid with third dose of GARDASIL (lot # 661952/1129X) without problems or complaints. There was no illness at the time of vaccination. Three minutes after vaccination, patient fainted in the exam room, no injures occurred. Patient complained of dizziness and nausea. The patient was treated with cool compresses. The patient remained in office about 15 minutes due to adverse effects. She left the office ambulating with complaints of "problems. No further information is available.
Parents noticed the vaccine reaction around 03:00 pm at home. Symptoms: redness, swelling and hard on the right thigh from PENTACEL vaccine. 30 x 20 mm.
Bivalent, GRAY cap that was "open for 18 hours" and left at room temperature, in the vial.; Bivalent, GRAY cap that was "open for 18 hours" and left at room temperature, in the vial.; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose number unknown, 0.3 ml single (Lot number: GJ6796, Expiration Date: 31Jan2024), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete; Manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "unknown", described as "Sore arm"; PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 23Dec2022, outcome "unknown" and all described as "Bivalent, GRAY cap that was "open for 18 hours" and left at room temperature, in the vial.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of product administration error, poor quality product administered, pain in extremity.  Additional information: The pharmacist reported that the patient received a dose of Pfizer Covid19 vaccine, Bivalent, Gray cap that was "open for 18 hours" and left at room temperature, in the vial. This happened on Friday, the patient was stable and ok. Created an AE Form because a vaccine was administered 6 hours past the 12 hour period time allowed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (27Dec2022): New information was reported from a contactable Pharmacist. This Pharmacist reported for a patient that: Updated information included: Reporter mailing address and institution, lab test, dosage regimen details and new event.  No follow-up attempts are possible. No further information is expected.
Information has been received from an unspecified reporter via an article about significant mortality decrease after vaccine shortage, referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB or GARDASIL 9, both for prophylaxis (strength, dose, frequency, route, lot #, expiration date and indication were not reported). It was reported that from 2003 to 2017, there was a yearly basis an average of 29 deaths after the use of the RECOMBIVAX HB. In 2018 there were only 6 of 2 which were linked to RECOMBIVAX HB. It was also reported that the recipient of the Merck vaccines, which contained aluminum, could lead to neurological and auto-immunological disorders. The outcome of the events was unknown. The causality assessment was not provided. Upon internal review, auto-immunological disorder was determined to be medically significant.
Really sore arm, very hard to lift. Other vaccines would feel like a "normal" type of sore, but this time my arm was extremely sore for about 2 to 3 days. Also, both armpits were sore. The opposite underarm was only sore for 1 day. However, the underarm of the same injection arm was sore for a week and a half.
After the third dose my flu-like symptoms came on sooner. My Shingles outbreak happened with 24 hours in the same place on my right side near my ribs.. I spiked a fever of 102 and I was tested for Covid-19 and the test was negative. My fever did not break for five days. I also got a rash on my right side which has resolved after ten days. I had headache, fatigue and dizziness and muscle aches for 8 days. My joint pain was more severe on the third shot. My immune system went into overdrive. I did not have any flare up of my Asthma or my allergies. The symptoms were similar to the ones that I got for the second dose but they happened faster and lasted longer. They were also a little more severe.
MMR 21MAY91, 2 wks later mom noticed swollen gland in lt groin; Pt also had monilia type diaper rash @ that time; Gland 1/2in long; Pt also exp swollen neck, jaw & face; To ER & dx "mumps", also had ear infect, & did not want to eat much;
Bumps, dry skin mostly fingers. Stated dry skin post 1st dose JE. After JE #2 exacerbated psoriasis symptoms increase on hands & fingers post 2nd dose - PCP treated with Methylprednisone. 5/17/12 Pt was referred to Rheumatologist by Dermatologist. Jap Encep 2nd dose 11/29/11.
Within a minute of giving the patient her Pfizer booster 0.3ml dose, patient started to pass out.  Patient's mother and immunization pharmacist quickly reacted to hold her up in her chair.  Patient woke up shortly after passing out and her temperature was 97.6, blood pressure of 91/56, pulse was 63.  Patient is 15 years old and her mother was with her in the room the entire time.  Patient was given a bottle of water to drink and was kept in the immunization room for about 30 minutes.  The  immunization pharmacist offered to call the patient an ambulance, patient and her mother refuses.  Various foods and drinks items were offered to help the patient feel better, but the patient refuse them all. The patient felt better and left the pharmacy with both of her parents.  Immunization pharmacist called the patient's mother to check in with the patient at 5:48pm and the patient's mother reported what the patient is doing fine, with no problem.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.