chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient inadvertenly recieved the thir dose; interchange of vaccine products; wrong product administered; no adverse event; This spontaneous report as received from a the patient's grandfather, and refers to an approximately 12 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.          It was reported that the patient received on 24-AUG-2020, either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) which have a valid lot # S020254 with expiration date on 09-DEC-2021, (formulations, exact doses, routes of administration, vaccination scheme frequency, anatomical locations were not reported). The reporter states a second dose was administered on 25-MAY-2021, and a third dose was administered today, 25-JUN-2021.  The patient was supposed to receive only two doses but the pediatrician's office who administered the vaccine did not record the administration of the 2nd dose, and therefore the patient inadvertently received a third dose only one month after administration of the second dose. No additional adverse events or product quality complaints were reported.  Lot number S020254 is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Tachycardia, elevated BP. Monitored patient and he felt better. Did recommend that he go to the ER for follow-up and escorted him there.
Pt was given Fluviron 0.25 cc instead of Fluzone 0.25, Fluviron recommended to be given over age 4. Department of public health notified. Has not been approved over age 4. No ill effects. Revaccinated in 25D with Fluzone. Immune response may not be effective.
Client states she was feeling flushed and light-headed.  EMT assessed and BP 104/56; 112/62, O2Sat 98%, HR 82 ACC check 132.
APPROXIMATELY 30-45 MINUTES AFTER THE VACCINE COMPLAINED OF FEELING LIKE SOMEONE WAS TRYING TO SUFFOCATE HER.  APPEARED IN MY OFFICE ABOUT 45 MINUTES AFTER VACCINE, RESP EVEN AND UNLABORED, APPEARED TO HAVE BEEN CRYING, WAS ALSO SWEATY, ( WORKS IN CAFETERIA).  COMPLAINS OF BEING EXTREMELY WEAK. WAS TAKEN TO ER FOR FOLLOW UP.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 3/26/2023 CKD STAGE 3A (GFR 45-59) ACUTE DVT, UNSPECIFIED VEIN 3/19/2023 CKD STAGE 3A (GFR 45-59) ACUTE DVT OF LEFT FEMORAL VEIN 3/28/2023 CKD STAGE 3A (GFR 45-59)
Sore, swollen arm with a 4-5" inch diameter erythema around injection site. Warm to touch. Mild body aches lasting 3 days. TX included cold packs to site, an NSAID prn for pain and swelling.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Ten days after third Covid-19 Moderna vaccine (booster), I had spontaneous dermatographia. Nothing had changed in my environment, diet, bathing routine or otherwise notable. After unsuccessfully trying to treat with Benadryl for a week, I found that Zyrtec helped suppress, but not fully eliminate the condition. If I stop taking the Zyrtec, the hives return within 48 hours. I have seen that many people on the internet report similar issues.
rt arm pain-unable to lift above shoulder off from work for 3 days; contact w/MD; ice gave no relief-flu shot in rt arm;
The day after the vaccine, I developed a hot, red, itchy patch, about 10 X 6 cm, about 5cm distal to the injection site. The redness/itchiness got worse for 3 or 4 days, then subsided. The spot remained discolored for several weeks, but the itchiness resolved after 5 or 6 days.  I also experienced left supraclavicular lymph node swelling. I had had one lymph node pop up after my influenza vaccine, 1-2 weeks prior. That node had resolved (or was at least no longer palpable). During the 1-2 days after my covid booster, I developed 3 swollen left supraclavicular nodes. Somewhat tender (not as tender as the initial influenza node) and mobile. At their largest, between 1-2 cm each. Those have gradually shrunk, and are no longer tender, but they are still present. Maybe the size of a BB pellet or a little larger.
Pt. had pain in back, didn't feel good at work.  Had shaking, cold sweat, fatigue and fever of 101.0 degrees F.
I have developed dermatograpghia 11 days after getting the booster shot. It's been 5 days so far that I've had this condition. I did not have this with my first two shots. Symptoms include: skin (anywhere on whole body) that turns red with raised bumps after light touch, itchy skin after that happens. Goes away within 30 minutes if not touched. No other symptoms. Zyrtec taken daily does not help. No treatment has not helped so far.
MILD SORE THROAT; NOT FEELING WELL/ ICKY; FEELING EXTRA RUN DOWN; MILD HEADACHES; HER STOMACH FELT FUNNY; NAUSEOUS; This spontaneous case report (PVX2019-2632) was received from a consumer on 22-Oct-2019. It described a female consumer who "felt nauseous" (PT: Nausea), had been feeling extra run down (PT: Fatigue), not feeling well/icky (PT: Malaise), had mild sore throat (PT: Oropharyngeal pain), her stomach felt funny (PT: abdominal discomfort) and had mild headaches (PT: Headache) while being on oral Vivotif (company suspect) in every other day.  Case report: The consumer completed all four doses of Vivotif either on 14-Oct-2019 or 15-Oct-2019. She stated that she felt nauseous only during the day of her second dose and fourth dose. Since then, had been feeling extra run down, not feeling well and icky and just wanted to sit down and take a nap. The consumer also reported a mild sore throat, but she was not coughing, and it was not unbearable. She was not eating a lot and not eating heavily, since her stomach felt funny. She also had mild headaches for which she was not worried about and thought maybe she just needed more sleep. She would take Aleve for her headache.  The consumer's medical history included occasional back aches and takes muscle relaxer.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: In this case, it was reported that a female consumer "felt nauseous", had been feeling extra run down, not feeling well/icky, her stomach felt funny and had mild headaches while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Owing to the nature of the event the causality of the event "had mild sore throat" has been assessed as unlikely.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer "felt nauseous", had been feeling extra run down, not feeling well/icky, her stomach felt funny and had mild headaches while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Owing to the nature of the event, the causality of the event "had mild sore throat" has been assessed as unlikely.
Symptoms started as pain and swelling - place injection given - began 03/23 post shower at 5:00 AM. Upon exam, right arm with edema, erythema, induration 4x5 cm, fever and 1-5 cm swollen axillary lymph node. Treated with antihistamine and steroid. Pt reported that symptoms resolved on 03/27.
Pt had no reaction to vaccine after administration but the next morning had a lot of soreness.  Later that afternoon developed redness on the whole shoulder. Soreness has gone down over the past day but redness is still there. It is warm to the touch.
received vaccine at 9:30am.  30 min later I started feeling ill and tingling in my neck that moved up into my face causing it to feel numb.  The numbness lasted for 2 hours.
18FEB92 pt to clinic t99.3 lump on rt side of neck; rt tonsil enlarged; erythema inject site; 19FEB92 phone call to SHC c/o red spots on face neck & chest otherwise pt feel OK; tx comm hlth precautions until rash clears;
Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.
Noted rash next to injection site approx. 1 1/2 inch in dimater.  Rash extremely itchy and has persisted for 2 1/2 weeks.  Client applied Cortaid to site and has noted some improvement last 1-2 days.  She questions if rash was due to vaccine or band-aid??
Congestion; Not feeling great; Fatigue; feel achy; Arm soreness about 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness about 2-3 days), NASAL CONGESTION (Congestion), MALAISE (Not feeling great), FATIGUE (Fatigue) and PAIN (feel achy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness about 2-3 days). On 10-Mar-2021, the patient experienced NASAL CONGESTION (Congestion), MALAISE (Not feeling great), FATIGUE (Fatigue) and PAIN (feel achy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm soreness about 2-3 days), NASAL CONGESTION (Congestion), MALAISE (Not feeling great), FATIGUE (Fatigue) and PAIN (feel achy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Advil
Swelling and redness with major itching at injection site occurred suddenly 8 days after injection. No other symptoms occurred at any time.
has not received a second dose of the vaccine.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and PRODUCT DOSE OMISSION ISSUE (has not received a second dose of the vaccine.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced MYALGIA (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received a second dose of the vaccine.). On 29-Apr-2021, MYALGIA (Sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received a second dose of the vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Headache, Myalgia & Arthralgia  Narrative: Arm was extremely sore and hard at injection site the day after injection
stiff neck; throwing up; could barely walk; weak in pain; felt high; feeling pains all over my body; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:30 (Lot number: 30145BA) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; ZINC. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No:  FD8448, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Sep2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 06Oct2021, outcome "not recovered", described as "stiff neck"; EUPHORIC MOOD (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "felt high"; PAIN (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "feeling pains all over my body"; CHILLS (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "headache"; VOMITING (non-serious) with onset 05Oct2021, outcome "not recovered", described as "throwing up"; GAIT DISTURBANCE (non-serious) with onset 05Oct2021, outcome "not recovered", described as "could barely walk"; ASTHENIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "weak in pain". Therapeutic measures were not taken as a result of musculoskeletal stiffness, euphoric mood, pain, chills, headache, vomiting, gait disturbance, asthenia.  Additional information: After the shot at Monday night, she felt high then she started feeling pains all over my body, then chills and headache. Patient started throwing up on Tuesday all day along with the pains and headache, she could barely walk, still she was weak in pain and now have headache and stiff neck. No treatment received for the adverse events, patient did not receive any other vaccinations prior to covid vaccines, she was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and a registered nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 30-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 for prophylaxis, lot # M027552, expiry date: 04-FEB-2018 (dose and route were unknown). No adverse effects were reported. The temperature and time frame were as follows: 0°C to 1°C (1.4°C) for 17 hours and 21 minutes.  A previous temperature excursion was reported from 0°C to 1°C for 1 hour and 12 minutes. The call was because "data logger": Yes. On 07-NOV-2017, the registered nurse reported she had notified the manufactory about the temperature variation and they deemed that the vaccine was still viable.
An adult patient received pediatric doses, no AE; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a patient (unknown demographics, adult) who received pediatric doses of suspect DIPHTHERIA AND TETANUS TOXOIDS (product administered to patient of inappropriate age).  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a pediatric dose of suspect DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  It was reported that "I explained to the customer that it had to be reported and I transferred the call to the Medical call queue. The customer was short on time so I do not know if she stayed on the phone to speak to someone."  It is unknown if the patient experienced any additional symptoms/events.  It was a case of actual medication error due to Inappropriate age at vaccine administration (latency same day).  At time of reporting, no adverse events were 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 the 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.  There will be no information available on the batch number for this case.
Ringing, buzzing, chirping , humming in both ears  general practitioner prescribed allergy medicine,  still have this side effect Dizziness - no treatment Ear ache , ears burning  - no treatment   Flushed  feeling in head  - no treatment Anxiety and stress  - went to  ER with chest pains, found nothing wrong with heart
Severe muscle cramping, right calf and foot: about 8 hours after vaccination, resolved on its own within 2 hours. Severe chills, shivering and shaking: about 11 hours after vaccination, lasted about 3 hours; hot shower helped to resolve. Fatigue: began following day, morning of 03/07/2019, and lasted about 36 hours, resolved on its own.
two shots and Still got them/Suspected vaccination failure; Still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated with the 2 Shingles shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
My left shoulder became sore immediately after receiving the vaccine. Shivering began about 3am the day after the vaccine. In the late morning, I began to feel tired and light-headed, and developed a mild cough.
This spontaneous report as received from a Medical Assistant refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) lot # K021935 expiration date 10-NOV-2016 and lot # K005178 expiration date 10-APR-2016 (dose was not reported). The patients received a dose of VARIVAX (Merck) that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Pt here for assessment of red rash, localized warmth and soreness on left upper arm just below inj. site that started about Monday or Tuesday a.m. pt reported fever/chills Tuesday and Wednesday, but none today. Pt seen and examined. Agree with nursing note. Tmax 103-temp this am at home was 99. Was having chills, feels weak, arm painful, red swollen. Also has had 4 tick bites a day or two prior to vaccine. No other symptoms. Likely cellulitis due to PNEUMOVAX but will start doxy and get tick titers to make sure.
A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 26-Oct-2013. It was reported that they inadvertently administered FLUMIST QUADRIVALENT to a 12 month old on 26-Oct-2013. FLUMIST QUADRIVALENT was discontinued on 26-Oct-2013. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST QUADRIVALENT TO A 12 MONTH OLD is unknown. The report was considered to be non-serious.
Pt has chicken pox on 12/21/04 received Varivax on 10/1/98
Menactra vaccination administered on July 20, 2006. Patient's father called 8/2/06 to describe acute onset severe arthralgias in the bilateral feet and ankles.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 22-APR-2014, the patient was vaccinated with the first dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot# unknown). On 05-MAY-2014 the patient was vaccinated with the second dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot# unknown). Pharmacist stated patient might have received 2 doses of ZOSTAVAX. Pharmacist stated upon entry into "MICR" (Immunization records) in the last few days, an entry was noted for patient that ZOSTAVAX was administered at an unspecified location on 22-APR-2014 by an unspecified clinician. Pharmacist stated patient received ZOSTAVAX on 05-MAY-2014 at a store from a pharmacist. No adverse effects reported. Pharmacist stated there might have been a language barrier when patient communicated she needed as "shot for shingles". The patient did not seek for medical attention. Additional information has been requested.
PATIENT WAS ADMINISTERED AN OUTDATED VIAL OF INFLUENZA VACCINE: FLUZONE QUADRIVALENT NO PRESERVATIVE 2021-2022 FORMULA. IT OUTDATED ON 6/30/2022. LOT NUMBER IS U7328DA. PATIENT AND CAREGIVER WERE ALERTED OF THE ERROR IMMEDIATELY FOLLOWING IT'S DISCOVERY. AT LAST CORRESPONDENCE WITH PATIENT SHE WAS NOT EXPERIENCING ANY UNUSUAL SIGNS OR SYMPTOMS.
Patient came in to let us know she had a Reaction to the vaccine she was given. Her arm was swollen, inflamed and painful. She went to her doctor who prescribed her an antibiotic for cellulitis. I also advised her to take Ibuprofen and use a cold compress on her arm.