chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a healthy 48-year-old male with a history of adverse reaction characterized by severe myalgia and malaise with onset 3 hours after receipt of anthrax #4 on May 18 2016. He reports symptoms included headache nausea, vomiting and increased in severity over the next several hours and were very severe for 3 days and had a total duration of 5 days when symptoms resolved. He had difficulty performing required tasks for his pre deployment. He was seen in ER on 19 and 22 May. He had no previous issues with any vaccines or other doses of anthrax vaccine. He reports he had no immediate reaction and does not recall any urticaria, pruritus, oral facial throat or tongue swelling, flushing or watery eyes. ER note 19 May state dehydration and treated with Tylenol Motrin doxycycline zofran  ER note May 22 diagnosis pharyngitis, negative strep mild temperature elevation at 99.5 heart rate 96. Rx added cepacol.
This 26 year old male took the first capsule of Vivotif (Ty21a oral typhoid vaccine, batch no. 3000341) on  07/19/2004 and concomitantly he was vaccinated with Twinrix i.m. and polio s.c.. One day later, on 07/20/2004 he developed redness, puffiness amd itching to the shaft of the penis, on 07/21/2004 he developed further blisters around the mouth. In spite of the symptoms he took the second Vivotif capsule on 07/21/2004. The symptoms continued  and additionally he developed oedema of the medial part of the eyes, nose, and mouth. He continued the vaccination and took the 3rd capsule on 07/23/2004 and the last capsule on 07/25/2004. The same day after the last  dose he noticed a rash on knuckles. At the time of reporting the outcome was not known and the patient did not yet contact his primary care physician. Pharmacovigilance Comments: The patient was concomitantly vaccinated against polio, hepatitis A/ B, and typhus: the symptoms can not be specifically assigned to one of the administered vaccines. However, the close time relationship , the continuation and the increasing intensity of the symptoms over time is a strong argument for a possible causality for Vivotif. Hypersensitivity reactions are known to occur following oral typhus immunization and hypersensitivity reactions are therefore  labeled for Vivotif. The case is assessed as expected, non-serious and causality possible. Further information on the outcome and possibly performed allergy test had been requested.
No adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    Concomitant medication was not reported. Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
fatigue; arm soreness; injection site soreness in the arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6204) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness in the arm soreness".  Additional information: Caller wanted to know if the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was wearing off and the shelf life for the Pfizer COVID-19 Bivalent Vaccine and if there was safety information for the Pfizer COVID-19 Bivalent Vaccine administered after its beyond use date. if the side effects he experienced with the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was working and if the Pfizer COVID-19 Bivalent Vaccine is different from the Monovalent. Caller got 4 covid vaccines, primary dose, 2 boosters, and bivalent booster, all of them from Pfizer. He mentioned that he usually felt fatigue and arm soreness. He wanted to know if someone else has experienced this for this long and what to do to feel better. If there was a difference in the formulation that could have caused this. He also mentioned that he didn't have any COVID-19 symptoms, but that if one could get the vaccine with a previous infection of COVID-19 in case he had the infection without being aware. He also wanted to know why sometimes the expiry was placed as 6 months and other times as 10 weeks, given that his vaccine expires on 14May2023. He also wanted to know if his side effects meant that the vaccine was working and if the fact that we're constantly needing boosters means that the vaccine is wearing off. Typically with the other injections, a few hours later, he started feeling fatigue and then later in the evening injection site soreness in the arm soreness. Fatigue lasting into the next day which happened with prior shots. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300164781 same patient, different vaccine dose/event;US-PFIZER INC-202300164778 same patient/event, different vaccine dose;US-PFIZER INC-202300164780 same patient/event, different vaccine dose;US-PFIZER INC-202300164779 same patient/event, different vaccine dose;
Narrative: She reports having developed mild nausea that started about 6-8 hours after the first vaccination, which lasted for about 24 hours. She was able to eat and drink during that time and did not experience any diarrhea, vomiting, or abdominal cramping. Only other reported adverse effect was tenderness to the injection site that lasted about 1.5 days (not associated with rash or erythema).
Patient waiting after second vaccine and stated slight scratchy throat and asked to watch HR due to first increase in side effect. Pt. Premedicated with Zyrtex prior to vaccine this am. 0903am BP 141/83, HR 57 and 02 sat 98%. 0932am BP 127/66,changed to larger cuff ,HR64 and sat 98%. Patient talking appropriately and stating that she is feeling better than her first dose experience, does have c/o HA. 0940am BP 153/65, HR 59 and sat 98%, patient having conversation during BP being obtained. 0950am BP 132/81, HR 62 and sat 96%. 0959am BP 129/80, HR 58 and sat 98%. Patient and husband state feel safe and comfortable going home and attribute increase in BP to some anxiety and HA.
High fever; confused state; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his 70's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (hospitalization), outcome "unknown", described as "High fever"; CONFUSIONAL STATE (hospitalization), outcome "unknown", described as "confused state". The patient underwent the following laboratory tests and procedures: Body temperature: High fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The recipient felt dizzy, had a headache, and was very pale immediately following receiving the vaccine.
Cramping but it feels more like period thing and I am not on my period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: ER8734, Expiration Date: 31Jul2021) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing). Concomitant medication(s) included: LORATADINE taken for hypersensitivity; SPIRONOLACTONE; GLYCOPYRROLATE [GLYCOPYRRONIUM]. Vaccination history included: Bnt162b2 (Dose 1, LOT(first dose) ER8730, Expiration date(first dose): 31Jul2021, left arm), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "Cramping but it feels more like period thing and I am not on my period".  Additional information: Patient stated that patient was getting like cramping but it feels more like period thing and patient was not on period and it started like a day after second dose."  No follow-up attempts are possible. No further information is expected.
Info has been received from a consumer concerning her daughter who in 9/01 was vaccinated with a dose of Hep-B. On 11/30/01, the pt was vaccinated with 1 dose each of DPT and IPOL and Hib-Titer. On 12/01, the pt developed hives at the injection site and all over her body. Unspecified medical attention was sought. Follow-up info was received from an RN who indicated that Hep-B vaccine was not the suspected product since the hives were following the other products, not the Hep-B vaccine, which was administered 2 months prior to the event. The outcome of the hives was not reported. No further info is expected.
This spontaneous report as received from a consumer refers to two patients of unknown age and gender. On an unknown dates both patients were vaccinated with ZOSTAVAX (dose, strength and route of administration not reported). On an unknown date both patients got shingles. The outcome of shingles for both patients was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Narrative: Patient is a 63-year-old female, she reports a history of significant spinal stenosis. She states from time to time her legs just feel wobbly and give out on her. She was in the cafeteria, actually bought her lunch and felt like her legs got weak. She tried to sit down and missed the chair. Although she endorses some lightheadedness, there was no history of syncope, and she was brought to the ER from the canteen. She does report some lightheadedness, which she attributes to not having eaten anything today yet, she also received her second coronavirus vaccination with Moderna vaccine about an hour ago. She denies any traumatic complaints, no headache or fever, no chest pain, cough or shortness of breath. She denies palpitations, abdominal pain, vomiting or diarrhea. She does endorse chronic back pain, which is unchanged. After observation she was sent home
Approximately 3-4 minutes after administering the COVID-19 vaccine to the employee she became nauseated, hot, and dizzy.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 74 year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 74, in right arm, on Mar 4, 2021, at 16:30, single dose, for COVID-19 immunisation. No medical history. There were no concomitant medications. Vaccination history included the 1st dose of BNT162B2 (COVID-19 vaccine, batch/lot# unknown, expiry date: unknown), at the age of 74, intramuscularly, left arm, on Jan 30, 2021, single dose, for COVID-19 immunization; and experienced no reaction(s)/no ill effects. The patient reported fatigue (her husband instantly came down with unbelievable fatigue), somnolence (she and her husband wanted to sleep a lot), onset Mar 5, 2021, with outcome of recovering; asthenia (she and her husband had no energy at all), onset Mar 5, 2021, with outcome of not recovered; and myalgia (her husband's achiness was more specific to his right calf muscle), onset Mar 5, 2021, with outcome of recovered (Mar 2021). She said her husband said his right calf muscle was very painful. Additional information: The reporter said her husband was a very active person before getting his second COVID-19 Vaccine and was in pretty good health. No additional vaccines administered on same date of the Pfizer suspect. Her husband did not take any Tylenol, as suggested by the pharmacist. Her husband did not go to the emergency room or his doctor for treatment of his symptoms. Her husband had not received any other vaccines during the time period within 4 weeks of his COVID-19 vaccine doses or at the same time as his COVID-19 vaccine doses. The patient received second COVID-19 vaccine almost 5 weeks apart from the first COVID-19 vaccine dose. No relevant tests performed. Vaccination Facility Type: Pharmacy/Drug store. The adverse event did not result in emergency room/doctor or other healthcare professional office/clinic visit. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021296207 same reporter, drug and events, different patient.
Pt with right deltoid swollen, red, and hot at sight. provider advised cold compress and to use benadryl every 8 hours for adverse reaction.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm 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's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing), notes: other medical history: Type 1 Diabetes; "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension; "Kidney Disease" (unspecified if ongoing), notes: other medical history: Kidney Disease; "Anemia" (unspecified if ongoing), notes: other medical history: Anemia; "Gastroparesis" (unspecified if ongoing), notes: other medical history: Gastroparesis. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: after 2 days. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received flu shot on 9/3.  Patient called pharmacy on 9/8 stating that 1 day after the flu shot she had a swollen lymph node and 4 days after the flu shot her hands started to itch and she started to get a rash on her hands and her arms. She reported having no fever.
Fatigue; involuntary muscle movement on left middle forearm on the pinkie side down by his wrist, felt like a thump thump (not muscle but nerve); diarrhea; felt cold; nerve reaction; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DYSKINESIA (involuntary muscle movement on left middle forearm on the pinkie side down by his wrist, felt like a thump thump (not muscle but nerve)), DIARRHOEA (diarrhea), FEELING COLD (felt cold) and NEUROLOGICAL SYMPTOM (nerve reaction) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), ACETYLSALICYLIC ACID (ASPIRIN 81) and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.    On 08-Mar-2021 at 6:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE (Fatigue), DYSKINESIA (involuntary muscle movement on left middle forearm on the pinkie side down by his wrist, felt like a thump thump (not muscle but nerve)), DIARRHOEA (diarrhea), FEELING COLD (felt cold) and NEUROLOGICAL SYMPTOM (nerve reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, FATIGUE (Fatigue), DIARRHOEA (diarrhea) and FEELING COLD (felt cold) had resolved. On 09-Mar-2021, DYSKINESIA (involuntary muscle movement on left middle forearm on the pinkie side down by his wrist, felt like a thump thump (not muscle but nerve)) and NEUROLOGICAL SYMPTOM (nerve reaction) had resolved. Not Provided
Patient fainted for less than 1 minute after becoming dizzy and nauseous within 5 minutes of receiving the vaccine.
pt recvd vax;devel 1cm lesion red-2 on 15OCT95 rt leg-spread up legs & thighs x2-3days;pruritic;pt had rash 1wk;inflammatory papules sl eczematous;poss allerg dermatitis-erythema multiforme-diarrhea-vasculitis-CHF;exp tremors;meds given
Diagnosed with Triple Negative Breast Cancer Sept 2021.  Diagnoses with malignant neoplasms November 2021.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a 0.5 dose of 9/9/08-GARDASIL IM. Secondary suspect therapy included VARIVAX. About one week later, the patient was hospitalized with severe abdominal pain. She has since been released. The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested. On the evening of 13-AUG-2008 the patient started to vomit.  The next day on 14-AUG-2008, the patient was complaining of abdominal pain and vomiting. She was taken to the ER that night. The patient was not admitted to the hospital at that time.  The patient was sent home on the night of 14-AUG-2008.  On 15-AUG-2008 the patient developed diarrhea and complaint of abdominal pain and vomiting. The patient was admitted to the hospital on 16-AUG-2008 and discharged on 18-AUG-2008  (diagnosis not provided).    12/22/08-records received for ED visit 8/14/08 C/O abdominal pain, vomiting waxing and waning, began day of presentation to ED. Difficulty moving bowels. Dizzy when has pain. Constipation.  DX: Gastritis.
Patient presented with redness and heat on the (L) deltoid measuring 4.5 inches in width and 5 inches in length. There was swelling and minimal pain.
Approximately one hour after the injection he developed hives on his face and ear, and felt a little irritation in his throat, noticed some difference when swallowing.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JAN-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting.  Causality assessment was related. Additional information has been requested.
Dizziness, nausea, muscle aches, joint pain, exhaustion, difficulty staying hydrated, fever, chills, migraine, sensitivity to light, diarrhea, muscle cramping, soreness at injection site, weakness, vertigo when standing up or sitting down, lack of appetite, brief numbness in hand on same side as injection site
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were not reported). Concomitant medication was not reported. On an unknown date also reported as "shortly after receiving ZOSTAVAX", the patient experienced V1 eruption. Product quality complaint (PQC) was not involved. The outcome of V1 eruption shortly after receiving ZOSTAVAX was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
- initial chills, fever - same leg "freezed" as first shot reported - 4 days later, anaphylactic event - ER 3/15/2021 - continued fatigue and nausea   Chills, Fever, nausea leg stiffness as in first shot ( 2/11/21)  4 days later - ER - anaphylactic event (epipen used) 3/15/21 - continued fatigue and nausea persists as well as leg limp 3/23/21
Malaise - started 6 hours after the injection and lasted 36 hours. Fever - started 8 hours after the injection as a subfebrile fever, caused chills at post-injection 13 hours, peaked between post-injection 14-20th hours, continued subfebrile another 24 hours.  Headache - Mild, accompanying the fever and malaise.
High heart rate even while resting. 120s-130s most of the day. It got up to 150 at least once.
Post vax, the pt's throat started itching and swelling; he had slight shortness of breath. Treated with Epinephrine and Benadryl.
2SEP97 pt looked like broke out w/mumps;pt exp tiredness, irritability, devel T102-104 & swollen glands;mom reported pt devel diarrhea x 1-2d on 29AUG97;warm to touch w/swollen fluids in neck,exudate & mouth ulcers;dx pharyngitis & adenitis
Lymph node under arm pit swelled, then entire left arm swelled.  feels hot to the touch.  Small rash around the injection site.  Going from day 4 to 12 (today).  Hurts to lift arm but today (Day 12) swelling seems to be going down.
Abdominal pain beginning the night of Sunday December 19. Didn?t go away with any type of OTC painkiller. Was diagnosed with acute pancreatitis.
This spontaneous report was received from a health professional refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored dose of (Merck) VARIVAX (lot# L010146, expiration date 24-MAR-2017, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received ZOSTAVAX 9/13/16. Called 9/14/16 complaining of redness on injection site. Told to mark area and note progression. After 1 week, mostly resolved.