chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant concerning a patient from another office who on an unspecified date was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient developed a rash or rash like reaction. No other information was available. This is one of several reports from the same reporter. Additional information has been requested.
Myalgia, NauseaVomiting, injection site reaction, fatigue Narrative: Employee reports injection site pain/discomfort/redness/itching, headaches (mild), joint pain, "severe" body aches, "head feels spacey" , fatigue, and nausea. Reports is feeling ok as of date of repot, but noted that after her first dose, her symptoms worsened about one week after receiving the vaccine, therefore unsure whether this is the worst of her current symptoms or not. Reports taking Aleve (naproxen) every 12 hours x 2 doses.
received only the MenCYW-135 liquid conjugate vaccine component of the Menveo vaccine without the the MenA lyophilized conjugate vaccine component; patient received only  diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On 29th July 2022, the patient received Menveo. On 29th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: It was reported that patient received only the MenCYW-135 liquid conjugate vaccine component of the Menveo vaccine without the the MenA lyophilized conjugate vaccine component. The Vaccine Administration Facility is the same as Primary Reporter. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of only the liquid conjugate vaccine component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
No adverse symptoms occurred no treatment required. On 6/23/03 at 12pm it was discovered during follow-up exam that child had inappropriate dose.
"Not feeling well" prior to administration. BP: 122/28 (unsure of accuracy in reporting diastolic value), Pulse:90, Resp:16, O2: 98%, Temp: OK. Patient was given Tylenol and went home from work (explains possible inaccurate recording of BP). No other issues noted.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Information about concomitant medication and medical history was not provided. On 07-OCT-2016, the patient was vaccinated with GARDASIL 9 (lot # M009378, expiry date: 23-APR-2018) for prophylaxis (vaccine exposure during pregnancy). On 22-FEB-2017, the patient performed ultrasound due to vaginal bleeding which was started from an unknown date. The ultrasound showed that the patient was pregnant "25 weeks and 1 day". The patient became pregnant with last menstrual date: 16-AUG-2016 (estimate due date: 23-MAY-2017).  The outcome of vaginal bleeding was unknown. The causality between vaginal bleeding and GARDASIL 9 was unknown. Additional information has been requested.
This spontaneous report was received from the registered nurse and refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was given oral, ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning his 2 year old son with allergies to oats, gluten, wheat, eggs and dairy who on unspecified dates since 2002 was vaccainted with dosed os MMR (lot 0038M), Pneumococcal vaccine, polyval (Lot 0813M), Varicella virus vaccine live (lot 644087/0975M), Hib conj vaccine (lot 0652M and 1527K) and Prevnar, in addition to unspecified other childhood vaccines. Subsequently, in approx 2004, he was diagnosed with autism with high mercury levels. Medical attention was sought, a CT of the pts head was performed (results not provided). At the time of the report, at the age of 4, the pt was being treated by a Naturopathic doctor to help increase the immune system and then reduce the mercury levels. No further information was provided. There was no product quality complaint involved. Upon internal review autism was determined to be an other important medical event (OMIC). Additional information has been requested. 1/4/10 Autism and mercury poisoning.
Itching  arm, foot, head, and back. Itching/ burning on face around the jaw, mouth, and nose, Muscle/ joint pain, Raw tender skin, pain in arm at the injection, slight fever 99-100, faster heart rate, chest pain and some shortness of breath.  Took Tylenol for pain and fever. Took Antihistamine (Loratadine) for itching. Pain lessened however itching has not stopped.
Information has been received from a nurse practitioner concerning a 67 year old male patient with sleep apnoea and a history of head injury recovered (patient fully mentally alert) with no drug reactions/allergies, who on 12-SEP-2008 was vaccinated subcutaneously with a 0.7 mL dose of ZOSTATVAX (Oka/Merck) (Lot # 658859/0411X).  Concomitant therapy included LIPITOR.  On approximately 26-SEP-2008, 2 weeks post vaccination, the patient developed joint and muscle pain, and had been taking PREDNISONE for the joint and muscle pain but the pain still persisted.  It was unknown when started on PREDNISONE.  The patient sought unspecified medical attention.  At the time of reporting, the patient had not recovered.  On 12-DEC-2008 follow-up information was received from a phone call from the patient.  The pain began in his left shoulder and then moved to his right shoulder and later included the joints in his left hand.  The patient did not remember which arm he received the vaccination in.  On an unspecified date, his sedimentation rate was initially 77 and later 7.  He had a PREDNISONE injection in his right shoulder.  No further information is available.
Admitted to hospital. Pt experienced apnea the night of receiving immunizations. 3/31/06 Received medical records from hosptial.  Pt born 1/25/06 as preemie twin & not d/c until 3/20/06.  Mother was smoker w/incompetent cervix & PPROM who had yeast infection 2 wks prior to delivery.  Born w/RDS, sepsis, anemia, extremely low birth weight, PDA, apnea of preemie & hyperbilirubinemia.  Received vax on 3/27/06 & was readmitted to hospital 3/28/06 w/dx preemie apnea. D/C home 3/31/06/ss
Site: Pain at Injection Site-Medium, Additional Details: Patient states his right arm is still sore after getting his flu shot on 9/9/22. I asked him to lift arm and he said it starts to ache when he lifts it up. He does have full range of motion - he can lift it up; however, it aches as he lifts it. He will be following up with his primary care physician.
Congestion, sore throat, cough, low grade fever starting on 8/23/2021
This non-serious spontaneous case, was initially received from other healthcare professional (nurse) on 22-Sep-2017, concerns a patient of unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (lot number: 644623A (as reported), expiry date: 30-Jun-2018, dose, route of administration, anatomical location: not reported). On an unspecified date, the patient developed six-inch circle that looked like cellulitis. it was reported that, the patient was immunocompromised, had developed raised, bumpy, very red, circular area that was about 5 to 6 inches in diameter and looked like cellulitis. The patient's reaction had persisted for the past 6 days. The outcome of the event was not reported. Non-significant case correction received 22-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
no adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.   This case was linked (Patient Link).
after received patient waited for 15 mins and was ok when leaving. next day patient call pharmacy stating that she has red bump/rash and her whole body was itching inside and outside. pharmacist suggest patient to buy otc Benadryl. patient been taking Benadryl but is still experience itching for 20 days now.  can't sleep at night due to itchy. no more rash but still very itchy
SWOLLEN INJECTION SITE WITH REDNESS. ORAL ANTIHISTAMINE PRESCRIBED.
Pt has had vasovagal episodes after immunizations in past.  She had two again last night.  She recovered fine after resting and some juice and crackers.  Blood pressure checked twice and was at her normal range when leaving.  she was doing fine when she left
Patient presented to hospital for repeat low transverse cesarean delivery and right salpingectomy via pfannenstiel skin incision on 12/25. Patient delivered healthy baby and was in stable condition after surgery. On 12/26, patient presented with left lower extremity swelling and erythema from toes to groin. Patient also complained of left shin tenderness and tenderness from right side from abdomen up toward her shoulder. Patient was diagnosed with acute deep vein thrombosis in the external iliac, common femoral, profunda, femoral, popliteal and peroneal veins of the left lower extremity and acute superficial vein thrombosis in the left great saphenous vein from saphenofemoral junction to mid thigh. Patient was transferred to higher level of care at another hospital for treatment. Patient received anticoagulation and had a catheter thrombectomy on 12/27. Patient was then started on eliquis.
From a telephone call received on 08/13/2002, it was reported that a five year old male patient was vaccinated on 08/08/02 with Daptacel and IPOl/ On 08/09/02, developed fever (no temperature documented), redness and pain at the injection site. The physician prescribed Tylenol and ice packs to the site. The patient was seen in physician's office for follow-up. The symptoms resolved. Case linked linked with reports U2002-006632 & U20002-00634. The follow up info received on 11/14/02, it was reported that the pt had no illnesses or pre-existing condition at the time of vaccination. No other medications were take at the time of vaccination. Lot number for IPOL is U1275-2. Physician's info has been updated.
By noon, soreness and warm to touch. Pt exercised arm throughout day. By 1630, site swollen to size of dime. Took OTC ADVIL, but increased soreness. Could not sleep on arm. Morning after, swelling size of quarter and hot to touch. Drew circle around erythema, increased redness exceeded circle. Swelling and soreness manageable by 9Mar15.
Few minutes after Pfizer 1st dose injection, patient felt lightheaded and fainted.
he could not sleep all night; has a deep pain where the sciatic nerve begins, in the lower back towards the belly, he can't sit, he has been standing for hours, walking, if he sits or lies down, the pain worsens; has a deep pain where the sciatic nerve begins, in the lower back towards the belly, he can't sit, he has been standing for hours, walking, if he sits or lies down, the pain worsens; vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious) with onset 2021, outcome "unknown", described as "he could not sleep all night"; PAIN (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "has a deep pain where the sciatic nerve begins, in the lower back towards the belly, he can't sit, he has been standing for hours, walking, if he sits or lies down, the pain worsens"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomited".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have had tinnitus--ringing in both ears since about 4 days after I had my second vaccine.
I had a little soreness at the injection site for a day. I tested positive for COVID-19 via a home test on 08/19/2022. I had body aches, fever of 102 degrees and a lot of congestion. I contacted my doctor and got the prescription for PAXLOVID. By day three, I started feeling better and I tested again and it was negative. In a day or two, I felt bad again and tested positive again. I drank a lot of fluids, consumed soups, for the body aches and fever I took ibuprofen and I also took DAYQUIL and NYQUIL.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 5:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 5:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month.  No treatment medication was reported by reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Bigeminy.  Atenolol 50mg orally.  Resolved by morning.
Patient has a fear of shots, needles, and blood.. She got light headed . We had her lay down and got her a cold compress. We continued to talk to her and observe.  She was awake and coherent mainly embarrassed.  Approximately after 15 to 20 mins we helped her to a chair. We continued to observe and  noticed nothing more.  She was not having breathing or communication issues, we asked if she would like a water and got her one.
Within 10 minutes:  anxiety, dizziness   Within 1 hour: diarrhea, anxiety, mild trouble breathing   2 days later: trouble breathing, mild fever
Received false information that pfizer was approved for children ages 5-11 , Later found out it was leaked to the media by pfizer before the CDC recommendations. No reactions since vaccine no fever, headaches, body aches, sore throat, vomiting or diarrhea.
Pain at injection site next day leading to pins/needles shooting down arm and numbness to thumb/pointer finger.
localized redness to the injection site.; puffiness to the injection site; itchy rash to the upper legs on the thighs; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 67 years old female patient who experienced localized redness and puffiness to the injection site (Erythema), (Swelling) and itchy rash to the upper legs on the thighs (Rash pruritic), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], lot UJ004AB  and expiration date: 30-MAR-2019 via an intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious localized redness and puffiness to the injection site (Erythema), (Swelling) and itchy rash to the upper legs on the thighs (Rash pruritic) 3 days later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  (Other relevant tests included no lab data.)  Final diagnosis was itchy rash to the upper legs on the thighs, localized redness and puffiness to the injection site.   It was not reported if the patient received a corrective treatment.  The outcome was reported as not recovered for localized redness and puffiness to the injection site and as resolving for itchy rash to the upper legs on the thighs on an unknown date.
Approximately 5 minutes after receiving the 2nd dose of Moderna, pt came by the drop off window to let me know that she was experiencing some severe light-headedness and headache as part of her required 15 minute stay post-vaccination to ensure no ADEs. I took her over to the vaccine area and had her sit down and try to relax. She said her throat was feeling a little bit itchy/closing up and it was hard for her to breathe. I suspected possible anaphylaxis in early stages. During this whole time of questioning, pt was still conscious and able to speak to me, albeit a bit short of breath. I took her blood pressure and the initial reading was around 69/40s. She also reported a very heavy feeling on back of her neck. I suspected anaphylaxis at this point, therefore I quickly grabbed an adult EpiPen and administered it into her left thigh. Pt said she started to feel a bit better but was still feeling very bad and her hands were very cold/clammy. During all this, I had a technician call emergency services and we were on the phone with paramedics. About 5 minutes after the initial EpiPen administration, I checked her BP again and it raised up to 80/64, better but still below 90/60. Pt was still alert/conscious and able to converse with me and answer questions emergency services operator was asking her over the phone.  By that time, EMS arrived and took over the situation without me having to administer a 2nd EpiPen dose within that 5-15 min timeframe for anaphylaxis.
Pt complained of left arm swelling / red/ warm to touch at injection site that measured 18cm x 12cm on 8/26/09. Pt given Benadryl, Motrin and ice.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 08:00 (Lot number: Ff8839) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EL9265,, prev dose lot unknown=False,, prev dose administration date=10Feb2021,, prev dose administration time=08:30 AM, prev dose dose number=2,, prev dose vaccine location=Right arm), administration date: 10Feb2021, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Obscured by other product labelling, prev dose administration date=21Jan2021,, prev dose administration time=08:45 AM, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 21Jan2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 01Oct2021, outcome "not recovered", described as "Tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient had no COVID prior to vaccination and post vaccination patient has not been tested for COVID.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2023) Positive, notes: After finishing a 5 day course of Paxlovid (from 10Feb2023 to 15Feb2023), patient tested positive for Covid 7 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.