chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding her medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with RECOMBIVAX HB. Nurse reported that the patient had negative titers on an unspecified date. It was unspecified if the patient required medical attention or not. Outcome of the event was unknown. Reporting nurse had not assessed the causality of the event with respect to vaccination with RECOMBIVAX HB. Additional information has been requested.
I had the sensations of facial tingling; eye swelling; lip swelling; This is a spontaneous report from a contactable Nurse. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on the right arm on 20Jan2021 08:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa  and allergy to animal (cats) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021 08:45 AM, the patient stated, "I had no symptoms during the 15 minute observation after the vaccine. After leaving the site, about 30 minutes after the shot I had the sensations of facial tingling, eye swelling and lip swelling (nothing visible on a photograph). My pulse remained stable and I had no throat symptoms or trouble breathing. This all resolved spontaneously within an hour after the shot. I am allergic to cats and sulfa but have never had anaphylaxis. I plan to stay in observation for a little longer after the 2nd shot. Any other recommendations?" No treatment was received for the events. The outcome of the events was recovered on 20Jan2021.
swelling and Nodules in all locations she was treated in Jul; nodules in her chin area; everywhere she had treatment she had bumps/ Nodules in all locations she was treated in Jul; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): GL-090821-21582.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling and Nodules in all locations she was treated in Jul"; NODULE (non-serious) with onset 2021, outcome "unknown", described as "nodules in her chin area"; INJECTION SITE NODULE (non-serious) with onset 2021, outcome "unknown", described as "everywhere she had treatment she had bumps/ Nodules in all locations she was treated in Jul". The events "swelling and nodules in all locations she was treated in Jul", "nodules in her chin area" and "everywhere she had treatment she had bumps/ nodules in all locations she was treated in Jul" were evaluated at the physician office visit. Therapeutic measures were taken as a result of injection site swelling, nodule, injection site nodule.  Additional Information: It was stated that, the caller had a patient that was treated by her practice many times over the years. She was treated in Jul by her PA with all these syringes in one treatment. The patient called on 31Aug and stated everywhere she had treatment she had bumps. When she came in to the office we saw nodules in chin area only. We treated with some medication at that visit. The patient came back this weekend and had swelling and Nodules in all locations she was treated in Jul. Note the patient did have the Pfizer vaccine earlier in the year and the product she was treated with in Jul.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & approx 4 months later was dx w/thrombocytopenia; exp bruising-blood blisters in mouth;
Vaccine was given 10/9 at local grocery store.  Developed left arm pain 10/10 with swelling,myalgia, fever (started10/11) and left side trunk and left leg pain.  Seen 10/13 with persistent symptoms.
Fever; Chills; Aches; Injection site pain; Headache; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and penicillin allergy. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and Amlodipine-Benazepril (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 01:00, the patient experienced fever, chills, aches, injection site pain, headache and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events fever, chills, aches, injection site pain, headache and feeling unwell was not recovered.   No follow-up attempts are needed. No further information is expected.
Pt recv vax on 6/30/80; in 7/80 pt exp welts on body & legs w/ fever
Received 2nd COVID shot (Moderna) on Satuday, March 13th at 2:40pm. By 8:00am the next morning (Sunday, March 14th) I experienced the following symptions: extreme fatigue, dizziness, massive headache, sharp back pains in lower back, and nausea. The symptoms did not subside until late Monday (March 15th).
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse event. This report was non-serious.
Large patch of redness at Shingrix injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group  was not reported however captured as adult as per vaccine indication. The patient experienced large patch of redness at Shingrix injection site.
Felt weird; Headache; Did not sleep well; Shivering; Had Nightmares; Legs hurt/Arm hurts; Whole body hurts; Does not feel well; This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023 10:30, the patient received the 1st dose of Shingrix. On 1st February 2023, less than a day after receiving Shingrix, the patient experienced weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell. On an unknown date, the outcome of the weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell were unknown.   It was unknown if the reporter considered the weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: The patient self-reported this case. The patient received Shingrix vaccine on left arm at about 10:30 am. The patient stated that she was okay all the day after received Shingrix vaccine, but on the same night when she was laid down to go to sleep, she felt weird, headache, did not sleep well, shivering, nightmares, her legs, arms and whole body hurts, she did not felt well. The reporter did consent to follow up.
Dizziness Narrative: Reports dizziness today. Recieved 2 doses of Pfizer > 6 mo ago and booster recieved is moderna
On 7/12/2021 patient was given Moderna 1 ml instead of 0.5 ml. Outcome: Follow up call on 7/16/2021. Patient stated she had bodyaches on 7/12/2021 after the injection. She took Ibuprofen 600 mg and rested. No symptoms the following day. No need for an ER visit. Doing well.
Headache, Myalgia, Fever, Arm sore x 3 days, fever was "mild", HA & fatigue Narrative:  resolved without treatment  Other Relevant History:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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: "Coronary Artery Disease" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Attention deficit hyperactivity disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Midazolam, reaction(s): "Known allergies : Midazolam". 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: (unspecified date) Positive, notes: COVID-19 Treatment; (13Sep2022) Positive, notes: throat on 13Sep, re-tested and it was positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient started Paxlovid on 01Sep2022 and completed Paxlovid treatment on 05Sep2022, indication was Treatment of COVID-19, orally and felt well enough to go out again 08Sep. She then developed a bad sore throat on 13Sep, re-tested and it was positive for Covid. Symptoms are mild. She received other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE)  and Covid 19 cannot be ruled out.
The pt received his vaccines on 4/13/00 and returned to the MD's office on 4/17/00 with an urticarial rash, and was placed on Benadryl and Prednisone. He returned to the office on 4/18/00 at which time there was no rash, but he now had arthralgias of his knees, hips, elbows and shoulders. He was diagnosed with serum sickness and increased his Prednisone and added Ibuprofen. On 4/20/00 his joints were normal, but he again had urticaria. Meds were continued. On 4/22/00 the Prednisone was discontinued and on 4/24/00 he developed joint pain. The Prednisone was resumed. On 4/25/00 an urticarial rash was still present but his joint exam was normal. Prednisone will be tapered off over the next 3-4 days. By 5/12/00 the pt had developed a fever, vomiting and night sweats, URI symptoms.  The pt is having further evaluation by another MD. At this time it is not clear whether his medical problems were caused by any of the vaccines.
Patient received both the FLUZONE QUAD and PNEUMOVAX in the same arm on the same day. Patient had a local reaction of redness, swelling, and warmth at injection site and also a low grade fever. MD prescribed AUGMENTIN 875 po BID x 10 days.
Feeling abnormal; Weakness; Nausea; Appetite lost; Confused; Chills; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal), PAIN IN EXTREMITY (Pain in arm), DECREASED APPETITE (Appetite lost), ASTHENIA (Weakness ) and CONFUSIONAL STATE (Confused) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 29-Dec-2020 to 19-Jan-2021.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and CHILLS (Chills). On 27-Mar-2021, the patient experienced DECREASED APPETITE (Appetite lost) and CONFUSIONAL STATE (Confused). On 28-Mar-2021, the patient experienced NAUSEA (Nausea). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal) and ASTHENIA (Weakness ). At the time of the report, FEELING ABNORMAL (Feeling abnormal), PAIN IN EXTREMITY (Pain in arm), DECREASED APPETITE (Appetite lost), ASTHENIA (Weakness ), CONFUSIONAL STATE (Confused), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case created for 2nd dose. The action taken with mRNA-1273 in response to the events changed (from Unknown to No change).
High fever up to 103.8 which lasted 4 days. Developed RLL pneumonia.
Patient felt dizzy. Patient stayed at pharmacy for about 30 minutes. Patient said he felt better and left pharmacy.
vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle joints hurt; flu like symptoms; head pounding; this may have been a bad batch or something; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3302 , via an unspecified route of administration on 22Jan2021 10:00 (at the age of 59-years-old) as a SINGLE DOSE in the left arm for COVID-19 vaccination.  Medical history included potentially had Covid prior to receiving the vaccine from an unknown date and unknown if ongoing, he had antibodies prior to the vaccine from an unknown date and unknown if ongoing. The consumer reported he must have had Covid in the Spring because he got sick, took a Sudafed and had Afrin nose spray and was fine after that. The patient previously took pseudoephedrine hydrochloride (SUDAFED) for he got sick, oxymetazoline hydrochloride (AFRIN) nasal decongestant for he got sick.  They were giving shots out. The patient  did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Jan2021, the patient experienced flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool. The consumer reported that this may have been a bad batch or something in Jan2021. The consumer reported that the body aches started at 8AM and resolved at 6PM. The consumer reported that he recovered from all other events late afternoon on Saturday. The consumer reported he vomited from noon-1PM. The consumer reported had body aches at 08:00, muscle joints hurt at 08:00, felt like he was beat with a baseball bat 08:00, felt sick at 10:00, vomited 12:00, loose stool 09:00 and fever 08:00 .The events did not require a visit to the emergency room or physician office. No treatment was received for the events. Outcome of the events flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool was recovered on 23Jan2021. Outcome of the event this may have been a bad batch or something was unknown.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 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: "Pacemaker" (unspecified if ongoing), notes: Pacemaker. The patient's concomitant medications were not reported. There were no other medications received in 2weeks. There were no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient experienced rebound Covid infection. The patient tested positive on 04Jul2022, started Paxlovid on 05Jul2022 and again tested positive with mild symptoms on 16Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive; (16Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
fainting vitals checked Patient reported history of fainting after recovery, Patient also reported history of low HR after recovery lie flat feet elevated, candy, Gatorade
No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (concentration, dose number and vaccination scheme frequency were not reported; lot number T033812, was verified to be a valid lot number with an expiration date reported and established as 29-DEC-2021) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported. It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002597:
I?ve got diagnosed with Brain Tumor (grade 4) in the brainstem, on 06/23/2021 at hospital. Then confirmed after a biopsy surgery, with Grade 4 Difuse Midlining Glioma in the brainstem. All the symptoms started after the vaccine. Please contact me regarding that
pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which vax was injected;this is 1 of 5 pt from this facility to exp this event p/vax;
Immunized 10/15/16, called at 10PM C/O arm red, hot and very painful.
Developed fever 102-104, vomiting, diarrhea, severe muscle aches and pains. 1 episode of chest pain. Treatment of symptoms with Tylenol and Ibuprofen. Private MD notified at 5 days post symptoms.
Pt reported symptoms began with swelling, redness, pain at injection site with increasing swelling progressing to today and accompanied by general feeling of illness.  Instructed patient to seek medical treatment at their private physician immediately.
COUGHING, THEN SYNCOPE, DIAPHORETIC. CODE GREEN CALLED, PARAMEDICS CAME. PROVIDE WATER, SX RESOLVED, NO TRANSPORT.
Extreme fatigue; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 01Mar2021 at 13:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), cholecalciferol (VITAMIN D3), ascorbic acid (VITAMIN C) and sertraline (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 07Mar2021, on 6th day after the first dose of vaccination, the patient experienced extreme fatigue and muscle pain that lasted for 24 hours. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.  No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue and muscle pain were recovered on 08Mar2021 after the duration of 24 hours.   No follow-up attempts are needed. No further information is expected.
On 9/9/99, the pt experienced a local reaction of redness the size of a half dollar.
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014, unspecified patients were vaccinated with 3 doses of ROTATEQ (strength, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that on an unknown date, these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA011843, Case # 1405USA014111, Case # 1405USA014113 via the same reporter link. Additional information has been requested.