chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates the patient were vaccinated with RECOMBIVAX HB for prophylaxis. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to RECOMBIVAX HB. The reporter considered no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1708USA008033.
Low antibodies post completed series; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 66-year-old male patient who received HBV (Engerix B) (batch number p4dj5, expiry date 15th December 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 19th July 2021, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, less than a month after receiving Engerix B and less than a year after receiving Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided are as follows: Nurse reported that a patient received the complete schedule of the Engerix -B vaccine and tested low antibodies after. The reporter had no further information on the subject. The reporter consented to follow-up.
Migraine; lingering headache; Arm had a red and swollen area; Arm had a red and swollen area; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine), HEADACHE (lingering headache), VACCINATION SITE ERYTHEMA (Arm had a red and swollen area) and VACCINATION SITE SWELLING (Arm had a red and swollen area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (she has migraines).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine) and HEADACHE (lingering headache). an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Arm had a red and swollen area) and VACCINATION SITE SWELLING (Arm had a red and swollen area). At the time of the report, MIGRAINE (Migraine) and HEADACHE (lingering headache) was resolving and VACCINATION SITE ERYTHEMA (Arm had a red and swollen area) and VACCINATION SITE SWELLING (Arm had a red and swollen area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-075578, US-MODERNATX, INC.-MOD-2021-075578 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up contains no new information. On 21-Jul-2021: No new information: When requested to provide additional information about the patient's experience, the responder stated she was unable to provide any further information.; Sender's Comments:  MOD-2021-075578:Same reporter /Different patient US-MODERNATX, INC.-MOD-2021-075578:Same reporter/ Different Patient
The most recent one was slightly more intense; soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Chronic lung disease and Polyneuropathy.    In 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue). At the time of the report, CONDITION AGGRAVATED (The most recent one was slightly more intense), INJECTION SITE PAIN (soreness at the injection site) and FATIGUE (fatigue) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. Patient tolerated all shots well and has not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. Events lasted about 1.5 days before resolving with each dose. The most recent one was slightly more intense, lasting 2 days. Patient had taken another 5 doses of the Moderna COVID-19 vaccine as on 24FEB2021 with lot number 006M20A, 26MAR2021with lot number 026A21A, 9NOV2021 with lot number 004F21N, 3JUN2022 with lot number 05A22A, 28NOV2022 with lot number 016H22A.   This case was linked to MOD-2023-749424, MOD-2023-749425, MOD-2023-749427.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date in April 2014, patient received his or her second dose of GARDASIL (dose, frequency, product lot #, expiration date not specified). On an unknown date in December 2014, the patient was present in the office to receive the third dose. Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Causality was reported as not related to GARDASIL. This is one of several reports from the same source (MARRS # 1412USA013535. Additional information has been requested.
After getting flu shot, numbness in right hand. Then I cannot sleep on my right side because it causes pain.
acute and progressive onset of confusion, agitation, disorientation - no focal neurologic signs or somatic complaints - difficulty wiht attntion, concentration, focusing on conversation - oriented x 3 but confused why she was where she knew where she was 9 her home), aware of people and names,
Subsequent to receiving vax, the pt experienced hives on her arms, legs and abdomen. The physician contacted the board of health and Engerix B was discontinued. The most recent information received reports the pt recovered after 5 days.
We gave 4 doses of expired Moderna Bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine).    At the time of report patient initial and date of birth was not known by the reporter.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 3rd out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730166 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730166:Master Case - Patient 1 Case
soreness in my left arm for about 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my left arm for about 2-3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in my left arm for about 2-3 days). At the time of the report, PAIN IN EXTREMITY (soreness in my left arm for about 2-3 days) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-117219 (Patient Link).
The capsules were not refrigerated for 10 days; A spontaneous report was received from a patient on 06NOV2022. It described a male patient of unknown age who took "the capsules that were not refrigerated for 10 days" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) to vaccinate against typhoid. It was reported that the patient was prescribed four capsules of Vivotif recommended as one capsule every other day. Reportedly, the patient took the first dose of Vivotif on 01NOV2022, and following the second dose, he noticed that it was written on the box to refrigerate it. Furthermore, it was reported that he took the capsules that were not refrigerated for roughly 10 days and were kept at an average temperature of 55 degrees Fahrenheit and to most of 60 degrees, as the room was cold. Additionally, the lot number of the product was provided as 3003785 and 3003783. It was also reported that the capsules were kept in the refrigerator this last Friday (as per reporting) after he got to know about the refrigeration from the box. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  The medical/surgical history of the patient was reported as none and he stated that he also takes other medications (not specified).  No additional information was reported.  Company comment: It was reported that a consumer took the capsules that were not refrigerated for 10 days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the capsules that were not refrigerated for 10 days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
Patient reports development of severe arm pain shortly after administration of the tetanus vaccine.  She reports difficulty with range of motion and is unable to lift the arm above her head. She denies fever, chills, swelling, redness.  Represented to primary care provider on 9/4/13 due to continued pain.
I have a rash on my arm and on my chest and they itch; I have a rash on my arm and on my chest and they itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Aug2021 (Lot number: F08448) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid problems" (unspecified if ongoing), notes: Verbatim: Thyroid problems; "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma; "Osteoporosis" (unspecified if ongoing), notes: Verbatim: Osteoporosis; "Arthritic pains" (unspecified if ongoing); "bones" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; CALCIUM; LOSARTAN POTASSIUM taken for blood pressure abnormal; LEVOTHYROXINE taken for thyroid disorder; LATANOPROST taken for glaucoma; HYDROCHLOROTHIAZIDE; ALENDRONATE SODIUM taken for osteopetrosis; IBUPROFEN taken for arthralgia; DORZOLAMIDE + TIMOLOL taken for glaucoma.  The following information was reported: RASH (non-serious), RASH PRURITIC (non-serious), outcome "unknown" and all described as "I have a rash on my arm and on my chest and they itch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, rash pruritic.  Additional information: Other medication, take general vitamins, I take generic medications like they give for general problems. For lab test go to the doctor and it was done in August around first part of August. Patient will second vaccination on 22Sep2021. Patient received Clobetasol Propionate cream for hands one time. Shot time, "Around 10 am, it was quite a little bit before 10 am, it was like."  No follow-up attempts are possible. No further information is expected.
Patient admitted; patient was persistently in atrial fibrillation with RVR despite oral and IV metoprolol.  She was started on a Cardizem drip, subsequently transition to p.o. Cardizem.  Echocardiogram with EF 45 to 50%. Patient was evaluated PMNR and accepted for inpatient rehabilitation.    Patient was discharged to a local Hospital on 12/27/2021 in stable condition. Hospital admission within 6 weeks of receiving the COVID vaccine.
Temp 97.7. Eyes rolling, arm spasm, non-responsive to talking x < 30 seconds. When episode were over there were dilated pupils, pallor and nausea. Vitals stable - transmitted by EMS to hospital
PERSISTENT NUMBNESS IN RIGHT FOOT; This spontaneous report received from a physician concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, Laboratory data included: Neurological examination (NR: not provided) Decreased sensation on right foot compared to the other one. On 13-AUG-2021, the patient experienced persistent numbness in right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent numbness in right foot. This report was non-serious.
I got my first Covid vaccine dose on Feb 4, 2021. 8 days later, a red welt appeared at the point of injection. My upper arm was hot, itched and had a "ring" with a rash that was inside the "ring", above and below the "ring". The reaction lasted a little over 24 hours.  My husband a physician called it a "delayed cutaneous hypersensitivity."  I am due for the second dose on March 4, 2021. There was no treatment involved.
No symptoms or adverse effects from administration of these vaccines; 4-year-old patient received PROQUAD and VARIVAX concomitantly; This spontaneous report has been received from a medical assistant referring a 4-years-old patient of unknown gender.  The patient's pertinent medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On 03-AUG-2022, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at the dose of 0.5 milliliters (ml), once for prophylaxis, (lot number U031561 had been verified to be a valid number, expiration date was reported and established as 06-APR-2023) (strength, route of administration and anatomical location were not provided). And with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at the dose of 0.5 ml for prophylaxis, (lot number U015687 had been verified to be a valid number, expiration date was reported and establised as 18-MAY-2023) (strength, route of administration and anatomical location were not provided) (drug use for unapproved schedule). Both reconstituted with sterile diluent solution for injection, at a dose of 0.7 ml (lot number T020662 had been verified to be a valid number, expiration date was reported and established as 30-DEC-2022). Patient had no symptoms or adverse effects from administration of these vaccines.
LUPUS TYPE RASH ON FACE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. . The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced lupus type rash on face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lupus type rash on face was not reported. This report was non-serious.
T 100.3. Cellulitis post immunization. Left thigh 10 cm area red, hot, tender; induration. Put on Keflex 250 mg TID for 10 days.
Pt received vaccines (MCV4 & Gardasil) at 1250 at our satellite clinic, waited for copy of immunization record and experienced syncopal episode when walking out of clinic door at approximately 1300. Pt slowly collapsed, and fell approximately 2 feet to the ground from a concrete ramp. Sister was walking in front of pt. when incident occurred.  Two 3" superficial scrapes noted on L lower arm. Sister states she believes pt. hit head on ramp railing and on the ground. Head examined; No hematoma noted; denied head or neck pain. Blood pressure 80/50 @ 1301. Cool cloths to face & neck. Placed in flat position. Opened eyes immediately.  Walked with assist of 2 nurses up ramp and into the office, placed in chair with feet elevated and cool cloths placed on neck & face.  Drank soft drink without nausea or vomiting. Alert & oriented to time, place & person. Moves all extremities without difficulty.  Left office @ 1330 with mother & sister. B/P 110/60.
Information has been received on 14-JUL-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient administered one dose of improperly stored ZOSTAVAX lot # N013289, expiration 04-JUL-2018, 1 DF, subcutaneous for prophylaxis that was reconstituted with one dose of sterile diluent (STERILE DILUENT) lot # L035498 expiration 01-MAY-2018. No adverse effects reported. The vaccine and sterile diluent were stored at a temperature range of 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 24 hours. There was no previous temperature excursion. The call was not because of a data logger. No additional information provided. Additional information has been requested.
After the next day she developed scratchy throat, then congestion then 3 days later fever of 101 x 2 days and then congestion in the chest. She was seen today by us for "influenze" and pulse ox was normal at 99 and it is still only URI sx.
5-8 hours post injection, intense headache, sore arm, dizziness. 12 hours post injection, fever, sweats, neck pain on left side. 15 hours post injection, altered mental state - hallucinations - nausea - weakness - higher fever - intense thirst. 24 hours post injection, altered mental state cleared, weakness, fever, & nausea continued. 30 hours post injection, able to drink clear liquids. Fatigue, weakness, headache, body ache, intermittent fever remained. 48 hours post injection, headache subsided, mental clarity returning, fatigue & intermittent fever remain.
got the flu anyway; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced "got the flu anyway" (influenza) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "got the flu anyway" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported "I stopped taking them after I took it and got the flu anyway. That was 17 years ago. Haven't gotten the flu since."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
pt recv vax 8JUL96 & 10JUL96 pt exp h/a, runny nose & upset stomach;pt noted that a co-worker & a brother w/whom she lived were both sick;19JUL96 pt exp blurred vision & heaviness in arm & legs;
First Vaccine given on 4/1/2021 at local Pharmacy. Moderna Lot # Unknown. Body Site and Administration Route Unknown.
Marked local reaction.  Right 13 x 12 cm thigh swelling, redness, induration.
From initial information received on October 17,2003 from a patient, who is a physician, regarding an adverse event occurring in the USA.  It was reported that he received a dose of Fluzone SV '2003-'2004 USP on October 2, 2003, route and site of administration not reported.  An unspecified time after vaccination, the patient developed brachial plexus neuropathy and skin pain in the chest, neck, and back area. From additional information received on 11/20/2003 through a telephone call to the patient, who is a physician, it was reported that the onset of the symptoms began with a left sided sore throat, ear ache, and tenderness of the skin over the left clavicle and left breast.  The patient developed a "bump" on his left shoulder and was treated with acyclovir.  He was seen by a neurologist and the neurological work-up was within normal limits.  A C-spine and MRI of the spine were performed and were within normal limits for a 60 year old male.  The patient also stated that he fully recovered from these events on 11/11/2003.  No other information was provided. No further information is anticipated, this case is considered closed.
Headache, Myalgia, Fever, BODY ACHES, FEVER, HEADACHE Narrative: