chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; HCP reported VARIVAX was administered after a temperature excursion. No additional AE or PQC reported. No additional information  ?    Names of vaccines involved (including lot/exp): VARIVAX  Lot W025273, Exp 10AUG2024        ?    Temperature: 34; This spontaneous report has been received a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml), lot number W025273 verified as valid, expiration date reported and upon internal review established as 10-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion with a temperature of 34.7 degree Fahrenheit for 13 hours and 15 minutes (product storage error). No additional adverse event reported.
Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. This occurred on 3/31/21 and 4/8/21.
My pregnancy has been going perfect. Symptoms since the shot -pain where the shot was given -redness and swelling where the shot was given -itchy at application site -tiredness (more than usual for being pregnant) -feels hot and hard underneath the skin of application site.
11/12/03: per phone call request from father: rash on back noticed 11/9/03 red, slightly raised, small round areas, increased after bath 11/10/03. Few spots on chest. Redness at left arm injection site, not raised that has subsided. No fever (11/20/03). PC: no response, message left. 11/24/03: per father: had intermittent rash on arms, episodes of sweating, now reports T 100.5 Ax on 11/25, 11/26. Symptoms subsided. Now has bruises on left leg. 11/24/03: possible injury/bump (unreadable).
1509 pt received imms x3 listed above as inpatient prior to discharge home 1513 moc called nurse back to bedside per MD / Rapid response note: child unresponsive, good pulses, non-responsive to sternal rub, eyes open but not tracking, heart and lung exam WNL  Narcan was administered in case related to narcotics- no change in LOC after admin Ativan was administerd in event of possible new onset seizure- no change in LOC after admin
Pt received the Johnson and Johnson covid vaccine on 4/1/21 at 1330 and started having  body aches, rash, fatigue and angioedema on 4/2/21 at noon.
Presents to the ED c/o AMS Altered Mental Status (Since last night. Febrile upon arrival with N/V, emesis x 2 upon arrival .  COVID 19 pneumonia.  V steroids/singular/nebs.  Received 1 dose of meropenem in ED. Continue empiric antibiotics with ceftriaxone.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Date of refrigeration: 07-May-2021.
IIV 4 given right anterior lateral thigh 12/3/14 at 1600. 1800 that same day noted whelps on back. BENADRYL oral given. No respiratory problems. No feeding problems. Small erythema macular rash trunk, face persistent to 12/4/14. ATARAX 2 mg/kg/day q6hr, consult allergist.
Patient states that a few hours after injection, her left deltoid became swollen, sore and hot, and she had body aches. She states that lasted a few days, but now the swelling has gone down and her arm is itching. There is not any signs of rash, and she did not experience any breathing difficulties.  Her pain was moderate, but was relieved by TYLENOL. Patient states that she does not want the second shot in this series.
Atrial fibrillation; Thyroid hormone (TSH) goes down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood thyroid stimulating hormone: low (Low) Low. On 21-Mar-2021, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. On 21-Mar-2021, Stress echocardiogram: atrial fibrillation (abnormal) Atrial fibrillation.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient was in emergency room for few hours and was given 3 doses of apixaban (Eliquis) for treatment for the events. The patient was on holter monitor for 3 days.  The patient reported, his thyroid level comes near normal after one and half weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. He is pilot and kept off the duty for Atrial fibrillation.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PATIENT WAS GIVEN AN EXPIRED PREVNAR 13 VACCINE - NO ADVERSE REACTION.
Day 7 - Left Upper Arm became itchy then developed what looked like hives.....got worse throughout the day and night....by next morning the area was itchy, red, swollen, hard, and painful
Swollen lymph node above collarbone for about 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BM6955), via an unspecified route of administration in the left arm on an unspecified date (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced swollen lymph node above collarbone for about two weeks. It was unknown if the patient received treatment for the adverse event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of swollen lymph nodes was unknown.  No follow-up attempts are needed. No further information is expected.
The area where I received the injection became itchy.  Yesterday, the 18th, it felt very warm to the touch and a little painful.  The area also looked a little red.  Today, the 19th, it feels the same as yesterday.
Vial was at room temperature for 25 hours; No Adverse event; Bivalent vaccine given to patient from a vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, 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 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours).    No concomitant medication was reported. The size of the vial was 5.5ml. The vial was initially stored in the refrigerator on 12-Oct-2022. The date and time vial was first punctured on19-Oct-2022 at 10:00am. The vial was administered to 3 different patients on 20-Oct-2022 at 10:13,10:15 and 11:00 respectively. The vial was stored at room temperature post puncture. The vial did not underwent any temperature excursions. The total amount of time the vial was exposed to room temperature range was just over 25 hours. This case was for 2nd patient out of 3 patient which reported by reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661788, US-MODERNATX, INC.-MOD-2022-661793 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661788:patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-661793:patient 3 (same reporter)
Swollen lymph nodes under left arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had previous allergy to codeine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 11:45 as 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 COVID vaccine. On 10Apr2021 at 08:00, the patient experienced swollen lymph nodes under left arm. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes was recovering.   No follow-up attempts are needed. No further information is expected.
10cm erythema, myalgia, malaise, fever to 102, clinical appearance of serum sickness reaction;
Patient with previously stable autoimmune inner ear disease noticed L > R hearing loss after 1st dose of vaccine. Undergoing intertympanic steroid injections.
BACK FEELS LIKE SANDPAPER; BACK FEELS LIKE A BAD SUNBURN; MENTALLY TIRED; STOMACH PAIN AND UP THROUGH THE NIGHT WITH IT; DIARRHEA AND UP THROUGH THE NIGHT WITH IT; SHOT HURT LIKE HELL; FEVER ON AND OFF; HEADACHE; PHYSICALLY TIRED; WORSENING NEUROPATHY OF LEFT HAND/FINGERTIPS/LEGS/KNEES/TOPS OF FEET; This spontaneous report received from a patient concerned a 62 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: systemic lupus (SLE), neuropathy on bottoms of feet, and fibromyalgia. The patient never had another vaccine in life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included gabapentin for neuropathy in feet.  After vaccination on an unspecified date in AUG-2021, the patient experienced constant diarrhea and up through the night with it. The patient also experienced bad and ridiculous pain in the legs and knees, which started first in knees and then spread and sometimes felt like legs would buckle due to knees. Further the patient had stomach pain and it was not relieved and up through the night with it. The patient felt like sand paper on her back and also felt like a bad sunburn, the patient lifted her shirt but nothing was visible. Initially the patient had neuropathy only in the bottom of feet but it spread to left hand and fingertips and tops of feet. The patient had severe pain and she was tired of hurting, also she had pain at the shot site and headache. The patient experienced fever on and off and took acetyl salicylic acid (ASA). The patient became mentally and physically tired due to her side effects. The patient visited MD twice for the symptoms but the doctor nothing mentioned about the shot. The patient was previously taken gabapentin (90 capsules per month) and at the time of reporting 270 capsules per month for neuropathy in feet, but it did not help patient. The patient also stated that Nurse practitioner also did not advise about the vaccine and its risks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea and up through the night with it, back feels like a bad sunburn, worsening neuropathy of left hand/fingertips/legs/knees/tops of feet, stomach pain and up through the night with it, and back feels like sandpaper, and the outcome of shot hurt like hell, fever on and off, headache, mentally tired and physically tired was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210855258-Covid-19 vaccine ad26.cov2.s-WORSENING NEUROPATHY OF LEFT HAND/FINGERTIPS/LEGS/KNEES/TOPS OF FEET. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Chest pains on left side of chest started after I took the first vaccine pill. They continued for 4 hours every 5 minutes or so. 6 days later I visited my general practitioner doctor and my blood pressure was 134/78. Usually, it is 118/80.
Moderate to severe inflammatory arthropathy involving knees, Lt>Rt, neck and right elbow.
0-6 hours: no side effects at all 7 hours: pain at injection site begins 14 hours: arm pain increases; woke up 6+ times during the night; difficultly sleeping 20 hours: ping pong sized lump at injection site; continual pain in arm 30 hours: chills and body aches begin; lump in arm continues to swell to hard boil egg size. was in bed by 8pm and stayed in bed for 16+ hours 30 - 48 hours: continual chills and flu like symptoms get worse (note: no fever); made it from bed to couch. 48 - 72 hours: flu like symptoms slowly subside, but pain in arm continues and upper arm still swollen Days 3 - 10: arm pain and egg sized lump *slowly* subside. Lump finally gone by day 10.
I had sinus drainage, mild fever, body ache, chills, headache and slight confusion.  These lasted for about 3 days. On Jan 19th, I tested positive for Covid-19.
Pfizer-BioNTech VOCID-19 Vaccine EUA 3 days after the injective, I had a bout of diarrhea. Since them I had had increasing bowel movements each day.  Yesterday I had 6 bowel movements, stomach gurgling, acid reflux.  I am getting worse each day.  I need to know what to  do and if I should avoid the second shot.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Migraines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Topamax, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid (lot 2815225) from 27Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
ADMINISTRATION ERROR : Pt.'s wife states that Pt. received the 3rd Booster of Moderna 12/03/2021 3 months from the 2nd initial dose of Moderna 08/08/2021 (Reported fatigue as noted Symptom) No noted Primary visit/communications.
about hour later was rushed to hospital with seizure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Nov-2023 and was forwarded to Moderna on 06-Nov-2023.      This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (about hour later was rushed to hospital with seizure) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2022, the patient experienced SEIZURE (about hour later was rushed to hospital with seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in January 2022 due to SEIZURE. At the time of the report, SEIZURE (about hour later was rushed to hospital with seizure) outcome was unknown.            No concomitant medications were reported.  It was reported that about a year ago patient had vaccine and about hour later was rushed to hospital with seizure. Had 4 seizures in a month after the vaccine. Patient states it was the Moderna vaccine and patient was afraid to get another vaccine because of that. Patient was in the hospital for 5 days and they did tests on Went to the emergency room a couple times. Patient states got the vaccine some time in Jan-2022 and had 4 seizures early Feb-2022 also patient had same shot and had no problem.  No treatment medications were reported.  Company comment:  This spontaneous case concerns a patient (unknown gender and unknown age), with no medical history reported, who experienced the unexpected, serious (medically significant and hospitalization) AESI seizure. The event was described as occurring "about one hour" after an unspecified dose number of Spikevax NOS (COVID-19 Vaccine, mRNA). The report stated that the patient was hospitalized for 5 days and that the patient also had 4 seizures in the month after the vaccine which required going to the emergency room a couple times No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax NOS (COVID-19 Vaccine, mRNA) is not affected by this report.
This spontaneous report was received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient's were vaccinated with a dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported). The healthcare worker reported that an improperly stored GARDASIL, "may" have been administered. The reporter stated that the GARDASIL, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additional information has been requested.
Patient stated that she has persistent left upper arm/shoulder pain and difficulty lifting her arm. She said she has nerve pain and tingling/numbness in her left hand.  She has not been treated for her symptoms at all.
Localized reaction, induration of 4.5cm with warmth and tenderness and erythema. Near syncope after taking Ultram (?) and Zyrtec. Pt also received Ultram 20 minutes prior to symptoms. Lethargy.
Extreme chest tightness, SOB, numbness of mouth and tongue - facial itching Placed on combination of Ativan, Benedryl + Zyrtec for 3 days to calm symptoms Out of work x3D
1 of 2 pts vaxed in SEP93 who exp flu (types A & B) in DEC93;no further clinical details available
On day 4 I started feeling itchy all over.  On day 7 a rash appeared on my right arm, on day 8 the rash looked worse-  I put eucerin itch relief calming lotion on arm and took a dose of Benadryl.  This morning day 9 the area looks much better.
Has had symptoms off and on since SHINGRIX vax 7.2.18, feeling well at that time. 7/4, see notes, symptoms: severe chills, body aches, fever, emesis, severe HA with photophobia. Resolved after 2 days. On 7/9, recurrent sx, fever, chills, emesis. Better next day. Recurrence early 7/13/18 same sx, started with chills. Each time used ibuprofen or TYLENOL; ibuprofen this morning and usual meds.
Day after immunization 6cm no lesion notes at site of injection, induration, redness and heat (left arm).