chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no titers present in blood work; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis, Hib (Hiberix) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix, the 2nd dose of Hiberix, the 3rd dose of Hiberix and the 4th dose of Hiberix. On an unknown date, unknown after receiving Hiberix, Hiberix, Hiberix and Hiberix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hiberix, Hiberix, Hiberix and Hiberix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional calling to report that patient completed the entire Hiberix series and had blood work completed and showed no titers present in their blood work for the Hiberix. The reporter consented to follow up. The health care professional calling did not have any patient information or vaccine information available. She said you can mail or email her a questionnaire.      Lab Comments: lab test performed on unknown date
Child passed out after receiving the Hep A and P13 vaccines. The child's father was holding the child in his lap during vaccine administration.  The vaccines were given at 9:20 AM, and he passed out at 9:25 AM. The child was walking around the room after the vaccines were given. Child was standing at the desk looking at stickers, and fell backwards and hit his head on the floor.  EMS was called at 9:26 AM, and EMS arrived at 9:36 AM. The mom picked the child up and put him in her lap. The child remained conscious, and was back to normal within a couple minutes after the fall. EMS was called, but the child was not taken to the hospital. Vital signs were normal after the fall. No medicine or CPR needed. Mom was educated by EMS about signs of a concussion to monitor her child at home, and to bring to the ER if any signs of a concussion occur.
Extreme migraine began within 4 hours of vaccination. Migraine lasted about three more hours, affected sight. Sight completely lost for two hours. Migraine and difficulty seeing have come and gone ever since. Head all over body pain for all day the next day and the following day. Still experiencing side effects such as fever and all over body pain. Can't walk very much without extreme pain and joints still. Fever comes and goes around the clock.
some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes; on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes;  0.6 degrees Celsius above for a maximum of 22 hours and 56 minutes; and 0.6 degrees Celsis above for 22 hours and 56 minutes (Incorrect product storage). There was previous temperature excursion however it was not reported.
pt rcvd vax & was unable to wake; pt taken to hosp & adm to ER then ICU; t 104; hospitalized 3 days; pt normal when released;
Body aches and joint pain head to toe, headache for 12days straight then a few days off now headache again nausea. I?m taking flexoril meloxicam magoxide ibuprofen will start gabapentin  Status of event is ongoing since July 5  FYI my second dose was taken at a facility on April 15 around 845am.
1/14/21 ED note: Received first dose of Moderna vaccine on Saturday 1/9/21 w/o immediate RXN. Did not take any premeds in preparation for vaccine. By Tues 1/12/21 noted the development of a mildly pruritic rash over torso and extremities. No oral lesion or bleeding. No epistaxis. No fever. Came to ER for evaluation of rash and noted to have plt count of 123K. SARS COVID-19 nasal swab test negative. Started on Dexamethasone for rash. PE: Diffuse dry blanching papular rash on UE, LE, torso and face. No petechia, vesicles or bullae. No rashes in mucus membranes of mouth, pharynx or eyelids/conjunctiva. No rashes to palms or soles. H&P: 1/14/21- Started on dexamethasone 4mg pot id, Benadryl 25mg po q8h, Pepcid 20mg IV daily. 1/15/21: Clinical impression: Drug-induced skin rash, other eosinophilia, thrombocytopenia. Hematology note- No known COVID exposure. States rash is improving since admission. 1. Non-petechial rash and thrombocytopenia. No oral purpura or external bleeding. 2. The thrombocytopenia by pt. report is pre-existent, long standing and mild. 3. No evidence of DIC or TTP. Follow plt count. 4. Rash may be temporally related to vaccination. Internal Medicine- Hematology consult = cleared for DC after CBC for today platelet stable. Discharged 1/15/21.
2 months later. Pain at right thumb joints, stiff, weak, strength loss. Started July 7 to present. Also one and a half month after had seasonal allergy attack,  never had one in all my life. Late June for 2 straight weeks.
Slight, painless discoloration at site of injection, onset ~7-8 days after vaccination. The discoloration is oblong and rounded with an irregular border and is about 2" x 2".  Comparing a photo of the injection site with the rash, it seems that the injection site is at the top of the rash, not in the center.  Arm was sore on the day of the vaccination, and the soreness lasted ~1 day.
about 1 week after first shot, develop hard lumps on clavicle (same side as shot given).  site very painful and tender.  determined to be swollen lymph nodes caused by vaccine..  Currently lumps have decreased in size and no pain.
A couple days after tetanus booster severe pain in collar bone and shoulder blade area. No pain in the injection site or when the injection was given. Throbbing pain and it is hard to lift arm up. It has been almost 2 weeks now.
High fever (103.1 F) for 18 hours, extreme weakness,  fatigue and headache
sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever.   On 24-May-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). The patient was treated with PARACETAMOL (TYLENOL) (oral) from 22-Jun-2021 to 26-Jun-2021 for Pain relief, at a dose of 800 mg. On 28-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  Painful  sore throat treated cough medicines and cough drops and sore throat sprays.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow up contain reporter contact details, patient demographics, Allergies and event outcome are updated.
booster; All issues after booster Full blown rheumatoid flare after years of no issues; Cold sore on upper lip within 10 days after 15+ years of no issues. Currently 2nd cold sore upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 13:00 (Lot number: EL8982) as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "CLL observation 20+ yrs." (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Rheumatoid arthritis 8 yrs." (unspecified if ongoing); "Non smoker" (unspecified if ongoing); "Non diabetic" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; TIMOLOL; PREDNISONE. Vaccination history included: Bnt162b2 (Dose 2; Lot Number: EL9269;at 11:00 AM in right arm), administration date: 09Feb2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose1 lot number=FF2590 at 10:00am in Left arm), administration date: 19Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021 1300, outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant) with onset Nov2021, outcome "recovering", described as "All issues after booster Full blown rheumatoid flare after years of no issues"; ORAL HERPES (non-serious) with onset Nov2021, outcome "recovering", described as "Cold sore on upper lip within 10 days after 15+ years of no issues. Currently 2nd cold sore upper lip". The events "all issues after booster full blown rheumatoid flare after years of no issues" and "cold sore on upper lip within 10 days after 15+ years of no issues. currently 2nd cold sore upper lip" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body mass index: 25.1. Therapeutic measures were not taken as a result of rheumatoid arthritis, oral herpes.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, Rash, NauseaVomiting Fatigue Narrative:  Able to to to work. Hx of COVID 9/18/2020.
Red rash around the injection site, itchy becoming more significant in presentation appearance of Delayed Cutaneious Hyper-sensitivity  . Responded to Benadryl and warm compress.
Case number PHEH2015US03127, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 17 years old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 06 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error.
SWEATS PROFUSELY; ABDOMEN PAIN; CHILLS; HEADACHE; FEVER; NAUSEA; VERY TIRED; This spontaneous report received from a patient concerned a 59 year old male. 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: 203A21A and expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced sweats profusely. On AUG-2021, the patient experienced abdomen pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fever, sweats profusely, nausea, abdomen pain and very tired was not reported. This report was non-serious.
patient use to take FLUZONE HD QIV every year but her arm would swell up each time; Initial information received  on 18-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2022SA477113(CLUSTER).  This case involves Adult female patient who used to take influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] every year but her arm would swell up each time.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Egg allergy.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (with an unknown dose, strength, route) (lot number and expiry date: not reported) in unknown administration site for immunization, every year but her arm would swell up each time (vaccination site swelling) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Itching occasionally; Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itching occasionally) and RASH (Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 017F21A, 028L20A and 025J20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to excipient (Past reaction to polysorbate.) and Epilepsy.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching occasionally) and RASH (Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines). At the time of the report, PRURITUS (Itching occasionally) and RASH (Patient had a rash off and on since receiving the most recent dose of the Moderna COVID-19 vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  She had been taking something to stop the itching occasionally.
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation.  Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021.  She doesn't know if the dehydration made it worse.  His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved.  When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
Mother called clinic ~22 hours after vaccine was administered and reports softball size redness and warmth on patients arm around vaccination site and reports child denies any pain or other symptoms at this time.  ~48 hours after vaccine was administered spoke with mother again; softball size redness and warmth continues, child now complains of pain and itching at site. Mother gave child OTC ibuprofen and Benadryl, plans to alternate cold and warm compress
At time of shot pharmacist told me there were side effects, especially diarrhea & nausea in my age group. Severe diarrhea began next day, 2 medical appts. 1 ER, colonoscopy, Feb 26th. Stomach pain continues. Can only eat soft foods, lots of H2O, diarrhea continues every 2-3 days. Taking Imodium as needed. Biopsy showed ulcerative colitis. My life has been very difficult since Feb. 6th. My left arm was swollen, bruised and painful for 3 weeks but the gut issues are with me everyday after eating.
The patient's mother warned pharmacy staff that she often passes out from vaccinations. Immediately after receiving the vaccine, the patient became pale and unresponsive which lasted ~5-10 seconds. Patient then opened her eyes and said her stomach and head hurt. The patient was laid down and placed a damp towel on her head and back of neck. She drank water and had crackers. Pharmacist monitored her for responsiveness and improvement in symptoms for 25 minutes. She remained in the exam room for ~30 minutes until she felt better and was able to safely stand up.
Woke up this morning with debilitating pain across middle of back; Every breath caused severe pain; low grade fever (100.7); chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 10:30 (age at vaccination 42 years old) (Batch/Lot Number: EN6203) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. Historical Vaccine BNT162B2 product=COVID 19, lot unknown=False, dose number=1 age at vaccination 42 years old, for COVID-19 immunisation. on 09Mar2021 01:00 The patient experienced woke up this morning with debilitating pain across middle of back Every breath caused severe pain. Went to ER and received Toradol. Came home and developed low grade fever (100.7) and chills. AE treatment with Toradol and Tylenol.  The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on 09Mar2021 developed low grade fever (100.7), chest x-ray: negative on 09Mar2021 Chest X-rays negative. Therapeutic measures were taken as a result of woke up this morning with debilitating pain across middle of back (back pain), every breath caused severe pain (chest pain), low grade fever (100.7) (pyrexia), chills (chills). Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
On 1/3/2021 (4 days after first dose). I have 2 vesicular lesions on right hand, 3/4 digits, very similar to HSV type finding.  Round, red, fluid filled lesions, 2-4mm, non pruritic and slightly tender. Not a adverse event, but a strange skin finding that I wonder could be due to Covid  vaccine?  Definitely resembles Covid toes/fingers but very mild. I?ve never had before so very strange. Thought I would report it.  I have pictures should want.  Otherwise I?m fine! Not even a sore arm!
Pt came to PCP with site reaction to Left mid upper arm and severe muscle stiffness of neck and shoulder muscles, mild fever post vaccination on 10/7/18.
Pulmonary embolism - significant drop in pulse ox, short of breath, pain in chest Thrombectomy - six clots removed, remained in hospital four days
Patient was showing no symptoms and was in good mood until right before he went unconscious. After the incident the patient reported "feeling weird", but did not share information with his father or me. After his syncopal episode his father moved him into a chair in the immunization room. The ASM immediately called 911 and I talked to the patient and asked how he felt and whether he was having difficulty breathing. There were no signs of SOB or anaphylactic reaction. I check pupil dilation and asked what other symptoms the patient had. His only complaints were "being tired, and mild head and neck pain". I stayed with him until EMS arrived and turned over the lead to them. At that point 4 minutes had passed
moderna clinic - Patient sat for a bit after vaccine - fainted when got up to leave. I heard the commotion from the pharmacy while i was giving a vaccine. Patient had signed up online for the vaccine with the date of birth 6-20-2001 (showing 19 years of age). Patient came to quickly after fainting - felt dizzy, nauseated, warm and blurred vision (seeing spots). Patient did not hit her head during fall. EMS came to check her out. Took blood pressure and pulse - within normal limits for patients age.  Being that she's 14 and received Moderna instead of Pfizer that could have been the reason. Patient faulted age during online sign up stating she was 19.  I checked with the mom the day after the incident - patient feels fine - no flu like symptoms or feeling dizzy, nauseated or blurred vision.
FULL DEVELOPMENT OF SHINGLES:  2.5 days after the Left Deltoid IM administration of Shingrix, the patient noticed a small patch of rash on Left Torso, associated with burning pain and then progressing to enlarge  in size and dermatomal spread, characterized as classic  maculopapular, vesicular rash of herpes zoster.  Treatment with Valacyclovir 1,000mg po TID begun immediately on Day 1 of presenting with first evidence of rash Adjunctive therapy with OTC NSAIDS 400 mg QID prn Adjunctive Therapy of Prednisone (tapering dosage) begun on Day 4 due to worsening symptoms