chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a 26 year old female patient.  The patient had no pertinent medical history nor known allergies. In approximately June 2016 (reported as "about 6 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot#, dose and expire date were unknown) for prophylaxis. Concomitant medication was unknown. After the vaccination, on an unspecified date of 2016, the patient developed "a renal disease that causes hypertension". The patient had sought for medical attention. The patient was currently prescribed an unspecified dose of prednisone (manufacture unknown) and unspecified blood pressure medication for this condition. The outcome of the events was unknown. The physician reported that this condition did not appear to be linked to GARDASIL 9. Additional information has been requested.
False positive for HIV; This spontaneous case was reported by a nurse and describes the occurrence of HIV TEST FALSE POSITIVE (False positive for HIV) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIV TEST FALSE POSITIVE (False positive for HIV). At the time of the report, HIV TEST FALSE POSITIVE (False positive for HIV) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HIV test: negative (Negative) false positive test for HIV.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications were not provided.  It was reported that patient had  initially tested positive for HIV1 and HIV2 reactive, the final interpretation was negative. The organization then notified her that they could not accept her blood donation.   `
Fever and night sweats 3 days after vaccine admin. Muscle fatigue and numbness bilat. arms. PMD referred him to a neurologist r/o Guillain-Barre syndrome.
Post vax, the patient's mother called and stated the patient "feels very hot", has little red dots all over her body and red blotches. The rash is most prominent on the right arm and shoulder. The patient complained of arm pain 08/01/2001 in the P.M. The patient was treated with Tylenol and Benadryl. On 08/02/2001 the physician diagnosed the patient with acute exanthem.
The morning after the shot extreme pain above my temples that moved also to the upper part of the left side of my head. Only could ease the pain be keeping eyes closed for a day and a half. When got out of bed after very dizzy for a day.
patient had administred Pentacel and ACT Hib on same time with no adverse event; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from an Other Health Professional via Media Information (under reference 00837120).  This case involves a 6-months-old and unknown gender patient who was administered with HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], which was double dose of the HIB vaccine (extra dose administered).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  Medical history,medical treatment, vaccination and family history were not provided.   On 01-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ494AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination.  On 01-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ522AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported that ''a child was administered ACTHIB and PENTACEL on the same date. Are there any side effects that they need to look out for?''  At the time of reporting no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
THE PATIENT HAD A FEBRILE REACTION WITH LOCAL SWELLING AND ERYTHEMA AT THE INJECTION SITE.  THE PAITENT ALSO COMPLAINED OF MYALGIA AND DARKENED URINE. THESE RESOLVED ABOUT 72 HOURS AFTER ONSET.
pt with ATLE with cyanosis approximately 2 hrs after receiving immunization Hospitalized with observation for 2 hr- 05/23/07-records received from facility-Episode apparent breath holding or vasovagal event occurred about an hour and half after immunization.  Assessment:reflux possible account for symptoms since patient has had reflux documented previously. Breath holding spells are also a possible explanation.
Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia
Within 24 hours, the pt experienced flu-like symptoms. Reportedly, the pt's sister also was home with flu-like symptoms. The pt's sister and nephew had the flu last week. The son started vomiting at 20:00 last night and the pt at 3:00. The nurse felt that the pt's symptoms were not related to Havrix. As of 11/14/00, the outcome of the events is ongoing.
shortness of breath, chest tightness, itching to throat and tongue, tightness, swelling in throat. Given epinephrine and benadryl at physician office with relief for about 8 hours. The symptoms returned and came to ER. Was given epinephrine, Benadryl, and steroid. Given history of anaphylactic shock in past patient admitted for observation.
fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (two years ago).    On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742771, US-MODERNATX, INC.-MOD-2023-742800 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742771:Master case (Spikevax 2023-2024 (same patient)) US-MODERNATX, INC.-MOD-2023-742800:
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 23-AUG-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
The vial was initially stored in the refrigerator on 27-Feb-2023; No adverse event; Dose administered after manufacturer date of expiry(12-Mar-2023); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023).    Concomitant medication was not provided.  It was reported that the vial was 1 dose. The vial was initially stored in refrigerator on 27-Feb-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.   Reporter did not allow further contact
A report has been received from a Study Investigator concerning a 35 year old, female subject, Weight: 124.0 pounds, enrolled in study MA-VA-MEDI3250-1115; A Postmarketing Safety Study of Q/LAV in Subjects 2 Through 49 Years of Age. The patient's medical and concurrent history was not provided at the time of reporting. FLUMSIT (intranasal) started on 22-Oct-2013 for influenza. The patient experienced pregnancy. Action taken with FLUMIST was unknown at the time of reporting. The outcome of pregnancy was abnormal outcome. The investigator assessed the event of pregnancy to be non-serious.
Patient received 0.5 ml of Moderna in left arm at 18:27. Patient stated she has idiopathic anaphylaxis and took 10 ml of oral Benadryl at 1700 prophylactically. Nurse advised patient to wait for 30 minutes for observation. Patient at 30 minutes stated "my throat is sore a little bit and my eyes feel heavy. It's a little bit harder to breath but I'm ok. I had this reaction with my Xolair shot." Nurse notified pharmacist and administered 75mg Benadryl IM at 1914. Observed patient for 15 minutes. Patient stated symptoms subsided. Blood pressure 124/104, HR 82, Resp 20. Pt stable and was discharged home to partner.
Broken right elbow; left side arm pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4469622-00.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER LIMB FRACTURE (medically significant), outcome "recovering", described as "Broken right elbow"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "left side arm pain". The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced left side arm pain due to COVID-19 vaccine and broken right elbow. The reporter's causality for the events of left side arm pain and broken right elbow was not provided with Humira (Adalimumab). The reporter's causality for the events of left side arm pain was possible while for broken right elbow was not reported with BNT162b2.  The reporter's assessment of the causal relationship of "broken right elbow" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "left side arm pain" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
High fever, chills, weakness, muscle aches, insomnia, sore throat for two days.
Rash developed on elbow area (B), 8/26/07, rash spread to rest arms, legs, trunk 8/27/07. Macular-papular rash, no pustules, no vesicles. Injection site intact - mild pruritus. Low grade temp 100.4. Derm biopsy lesion - few petechiae. No new lesions 30 Aug 07 - skin completely cleared 26 Sept 07. Anthrax #2 given 26 Sept 07. F/U 10 Oct 07 - no sx.
ON THE NIGHT OF THE IMMUNIZATION -  FEVER STARTED. NEXT DAY HOT AND COLD SWEATS AND THEN  DIARRHEA AND NAUSEA STARTED..
Patient said that night after the flu shot she started losing her hearing.  It got worse the next day.  She went to the doctor and said she now has a viral infection in the ear damaging
Mild pain in upper arm lasting months. Continuous from injection (10/24/21) to this report (4/7/2022). Sharp twinge when arm is moved.
From faxed correspondence received from reporting health professional stated that a 29 year old female patient received a Rabies Imovax vaccine intradermal in the left deltoid during the early evening of 05/25/01. Later that evening, the patient developed tingling and pain from the injection site to fingers of her left arm. Treatment of Ibuprofen which helped with headache but no effect for arm pain and tingling. As of 06/01/01, the symptoms are still occurring. From mailed correspondence received on 08/28/01 it was reported, "Patient's recovery status; As of 08/20/01, patient reported pain and tingling in the left arm went away approximately week of 06/11/01; 06/15/01. (Patient) stated no occurrence of symptoms with the follow-up rabies vaccine. Patient recovered. This case is closed.
Received vaccine at around 1:25 PM and by the time they reached home, hives were evident starting at site of injection (left arm) up her neck to face down chest and back: Rash also evident behind ears not much on face. Lips sl. swollen save BENADRYL to daughter and called child's pediatrician - no respiratory problems.
Pfizer COVID vaccine received on 8/26/2021 Hospitalized at Hospital on 9/12/2021-9/13/2021, tested positive for COVID 19 for 13 days UTI, hypoxia, weakness, confusion, bacterial pneumonia
warm (not hot) red swelling at administration site (Right deltoid) about 3 to 4 inches in diameter
aches; Chills; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number- UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Additional information: Patient experienced chills, aches, headache and nausea after second COVID vaccine dose. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PER NURSES NOTES   AT APPROX 10:15 PM, THE NURSING ASSISTANT WAS MAKING ROUNDS AND NOTICED THE RESIDENT DID NOT LOOK "LIKE HIMSELF". RESIDENT WAS SWEATING/VERY WARM. SPO2 64-70% ON ROOM AIR. BLOOD SUGAR READING "HI". TUBE FEEDING TURNED OFF, PLACED RESIDENT ON 5L O2, SPO2 INCREASED TO 71%.  RESIDENT TAKEN TO THE HOSPITAL. VITAL SIGNS AT TRANSFER: BP 98/59, PULSE 132, RESP 36, TEMP 101.9, SPO2 66% (STATED ON ROOM AIR). HCP AT FACILITY STATES HE IS NOW IN THE INTENSIVE CARE UNIT.
Uncontrollable shaking for hours, migrane, nausea, diziness, chills, extreme joint, low back and muslce pain, pain at injection sight, a painful swelling /lump on the under arm area of the arm that received the injection.  Extreme fatigue.  Sinus pain and pressure around eyes, earache and felt in my teeth.  Dry throat, runny nose,  cough developed.   The most of these adverse reactions last 2 days where I could not get out of bed.  With 5 days in from vacciation date still experiencing much joint and back pain, fatigue and overall not feeling well but better than a 3 days ago for sure.
interchange of vaccine products; Caller states she has a rare auto-immune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 74-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose number unknown, single), for COVID-19 Immunisation, reaction(s): "she can not take the Moderna at all and she is allergic to everything in it,". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Caller states she has a rare auto-immune disease". Clinical course: Reporter called for the new omicron vaccine. She had the bivalent 1 year ago last Nov. She had a rare auto-immune disease and stated they need to adjust medication before she takes the shot. She could not take the Moderna at all and she was allergic to everything in it, and Pfizer had been wonderful as it was the only safe brand she could take. Her allergy Doctor at privacy clinic only wanted her to had Pfizer.  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.
Employee states that within 6-hours of injection began to spike fever, headache, and body aches.  States that temperature topped out at 101'F during the night but is getting lower today.
enlarged lymph nodes, abdominal pain that sent her to the ED, fever for 10 days, body aches
Seizure; Cough; Sore Right Arm; physical ability to do things has worsened, he is really tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures; physical ability to do things has worsened, he is really tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures; This is a spontaneous report from a contactable consumer (reporter's boyfriend). A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. There were no medical history and concomitant medications reported. It was reported that, seizure (within the 15-minute wait time he experienced a seizure), cough, sore right arm, physical ability to do things has worsened, he is tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures on 07Apr2021. No therapeutic measures were taken. The outcome of the event was unknown for seizure, for cough and physical ability to do things has worsened, he is really tired, states she has no good words to describe it, but he is physically not able to do things after the two seizures outcome of the event was not recovered/not resolved and for sore right arm outcome of the event was recovering/resolving.  Information about lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient was reporter's boyfriend or partner. The patient experienced the injection site reaction. This case has been linked with case US2018055921, reported by the same reporter.
Immediately after the vaccine: less than 24 hours, I got flu like symptoms for 8-10 hours - chills, body aches, really bad headache. The next day, I had a little headache but I was feeling much better. August 1, 2021 - I had a bout of diverticulitis. I hadn't had one in 2 1/2 years. I had a CT scan and got antibiotics. I thought I had recovered from it. Had a follow up with the doctor. And now I'm having another GI episode. Diverticulitis issues are flaring up. That happened last Tuesday, October 26. No testing. It's hard to get in to the doctor. I'm in contact with my doctor but have not been seen - can't get in into November 16th. I am doing some OTC things to help with symptoms.
Developed diffuse erythema over arms and trunk, 10 days after Smallpox vaccine. Mostly papular in nature with 2 pustules (1 on chest and 1 on small of back). No fever. A single post cervical node (L).
Sparse and itchy hives developed around both forearm, both knees, and both ankles. Injection site has a not-so-itchy small red bump.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting of 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.