chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health professional concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-NOV-2018, the patient was inadvertently vaccinated with an expired dose of ROTATEQ lot # N009963, expiry date: 17-NOV-2018, orally for prophylaxis (strength, dose and dosage schedule were not provided) (expired product administered). No adverse effects reported.
Pt. received Tdap on 7-20-12 on right arm. Slight swelling. Pt given hydroxyzine tablet.
This non-serious initial spontaneous case was received from other health professional (nurse) on 18-Oct-2017, concerns a patient of an unspecified age and gender. This is 3 out of 24 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, via was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be conclude that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received and significant case correction received on 21-Nov-2017: added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
2 inch by 1 1/4 inch erythema can area. Edema and warm to touch. All at the right deltoid area.
About 24 hrs after vacc. noted itchy + erythema distal to injection site decreased about 5 x 7 cm
Patient notified us today that he has been experiencing pain in the arm since the administration, pain is mainly noted upon arm movement. Pain is a scale of 8 (on a 1-10 rating with 10 being the worst). Patient also claims some muscle weakness in the affected arm. No redness, swelling, or irritations was noticeable, patient has not had a fever.
Patient was given Janssen covid-19 vaccine on 5-2-2021, when doing Alert data entry after vaccination it was discovered that the patient had received Moderna Covid-19 Vaccine in Jan/Feb of 2021.
This spontaneous report as received from a pharmacist (R. Ph) refers to unknown number of patients who on an unknown date were vaccinated with zoster vaccine live which was improperly stored (exposed to 50 degrees F for unknown duration). No adverse effect reported. The outcome of received improperly stored zoster vaccine live was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
24 hours or so after I received my second dose of the Pfizer Covid-19, I experienced severe chest pain and tightness. The chest pain made it unbearable to move and lasted about 2 minutes. As my husband and I were ready to go to the hospital, the pain subsided. It did not come back for the remainder of the night or the next two days, but I still have minor chest soreness lingering.
approx 1/3 of the pts treated w/Engerix-B failed to respond or had borderline titers levels produced p/3rd dose; 60 to 70 pts have been treated to date;
Caller states her client has broken out in hives and welts on her scalp and the only thng they have done different in 3 years is her client got her Pfizer Covid vaccine.; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613, Expiration date was not reported), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 67-years-old) as single dose for covid-19 immunisation.Medical history included stroke and blood pressure. Concomitant medication included ongoing alendronate sodium at 70 mg for bone density and ongoing unspecified blood pressure medication and calcium for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6200) on 25Feb2021 for COVID-19 immunization. On 20Apr2021, the patient experienced dates for hives and welts on scalp during hair coloring. It was reported that caller wants to know if there have been any reports of after the vaccine of someone having an allergic reaction to hair color. It was stated that her client has broken out in hives and welts on her scalp and the only thing they have done different in 3 years is her client got her Pfizer Covid vaccine on 20Apr2021. It was stated that she tried to send an email, but it would not let her. It was stated that she was an EMT in her 20s. It was stated that the patient gets her hair colored every four weeks, has been doing this for 3 years and has not changed anything. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
5 hours later began soreness, stillness, and aching which only got worse and lasted about 36 hours heavy bruising on left arm about 8 inches below site of injection (showed up next day Oct 9) about 8 hours later, began extremely shaking due to intense feeling chills/freezing
started having a lot of muscle soreness in her neck and shoulders and it has not subsided; started having a lot of muscle soreness in her neck and shoulders and it has not subsided; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208; Expiration Date: Jul2021),  via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:45 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation.  Medical history included corrective lens user from an unknown date and unknown if ongoing she needs a magnifying glass to read the lot number maybe and placed her husband on the line to read the lot number. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced started having a lot of muscle soreness in her neck and shoulders and it has not subsided. Patient received the second dose after reaction with first dose. The events did not result in emergency room or physician office visit. No treatment was received as a result of events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pulmonary arterial hypertension, blood pressure high, multiple allergies and asthma. Concomitant products included Aspirin, CRESTOR, Cetirizine, gabapentin, Levothyroxine, ATIVAN, Metformin, vitamin D, Clonidine Patch, dorzolamide, hydrochlorothiazide, latanoprost, lisinopril, Mag Oxide, metoprolol, PRILOSEC and lorazepam. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache were unchanged. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, pain, chills, flushing, upset stomach and headache to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient stated she received the shot of SHINGRIX 50 mcg/mg on Monday at around 10:30 AM on right arm. The patient experienced redness and swelling at the injection site which was spreading up to her arm and down to the elbow. It was covering area which was 10 by 8 inches in size and was hot to touch. The patient had paperwork from the pharmacy that stated she was given the vaccine intramuscularly, but she thought it was given to her on the outside of her arm on the flabby part which she described as the fatty area. The patient had a follow up appointment with her doctor on the reporting day. The patient gave permission to contact her healthcare provider and provided contact details for the same. No further information was provided.
Started  later in the evening  with achy muscles, fever, and cold or flu like symptoms.  Middle of the night stomach cramps and feeling of nausea.  Lasted about 3 days and then progressed to an earache in the left ear.  Ear became badly infected and had to go back to the doctor for tests and Rx antibiotic oral medication and ear drops.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FF2584), in left arm and on 16Jun2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (not ongoing); "Anxiety" (not ongoing); "sleep apnea" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (start date: 10May2023 and stop date: 15May2023.
Nausea, headache, body aches, chills, tiredness starting 20 hours after second dose of Shingrix vaccine. Acute response lasted 4 hours,  total response lasted 28 hours.
PATIENT WAS NERVOUS UPON ARRIVING. TOOK SOME CALMING DOWN AND DEEP BREATHS. GAVE THE VACCINE. PT IMMEDIATELY BECAME HOT, LIGHT HEADED, DIZZY. I TURNED ON A FAN AND GAVE WATER AS REQUESTED. BLOOD PRESSURE SEEMED TO DROP SHE WAS NAUSEATED AND HER ARM/HANDS STARTED TO GO KNUMB. GAVE IT 5-10 MINUTES THEN CALLED EMTS TO COME CHECK HER OUT BECAUSE SHE DID NOT IMPROVE. PT BEGAN TO IMPROVE JUST BEFORE EMTS ARRIVED. AT 1:25 SHE WAS RETURNED TO NORMAL AND DECLINED FURTHER CARE. PROBABLE VASOVAGAL RESPONSE ACCORDING TO EMT.
Jolting shocks through body randomly for two weeks now.  Happens multiple times per day.
Pt recvd vax on 27JUL92 & 12 hrs p/vax devel nausea, h/a, profuse sweating, fever of 102, bad h/a, t101, delirious, was eating again, flu-like sx;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE HYPOXIA
approx 4yrs p/vax pt exp itching, by 15feb99 area became red & looked like a rash. within several hours pt began to exp moderate to severe pain, herpes zoster dx. treated w/tylenol w/codeine. 1wk later pt recovered, lesions healed.
The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023; No adverse event; Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023) 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 (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023).    No concomitant medication details was reported. Individual vials was used and vial size was 2.5ml. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-722188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722188:
Anxiety attack; Normal temporary side effects; Rapid heart beat; Sweating; Chills; Fatigue; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), HYPERHIDROSIS (Sweating), ANXIETY (Anxiety attack), ADVERSE REACTION (Normal temporary side effects) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Weight loss. Concurrent medical conditions included Blood pressure high and Anxiety disorder. Concomitant products included BUSPIRONE for Anxiety disorder, METOPROLOL for Blood pressure high.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue). On 14-May-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat). On an unknown date, the patient experienced ANXIETY (Anxiety attack) and ADVERSE REACTION (Normal temporary side effects). At the time of the report, HEART RATE INCREASED (Rapid heart beat), HYPERHIDROSIS (Sweating), ANXIETY (Anxiety attack), ADVERSE REACTION (Normal temporary side effects), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            The patient reported receiving the Moderna vaccine series (exact date of second dose not provided) and experienced adverse events with symptoms of rapid heart beat, chills, sweating, and fatigue. He reported he would be seeking immediate medical attention and would update Moderna following his hospital visit. Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow up
12 hrs later noticed redness, swelling and pain at injection site. 24 hrs later whole upper arm swollen.
Pt devel weakness in lt upper & lower arm p/recvd flu vax; weakness persists as of 4DEC91 although some imporvement was noted; MFR unable to obtain addtl info regarding this adverse event;
This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
I received my second dose of Pfizer COVID19 in my left arm . It was administered just under the acromion process.  I am currently experiencing posterior shoulder pain with pain radiating  down my arm to my fingers.   I have been seen by my primary provider and have been prescribed gabapentin and Tylenol 3. I will follow up with my provider on 01-10-21.
has received two does of the Covid vaccine, and tested positive; has received two does of the Covid vaccine, and tested positive; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date in Apr2021 (Lot number was not reported) as single dose and first dose via an unspecified route of administration on an unknown date in Apr2021 (Lot number was not reported) as single dose, both for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had received two doses of the Covid vaccine in Apr2021 and tested positive for Covid on 22Aug2021 (reported as yesterday 8/22) through a rapid test waiting on. Outcome of the event was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a nurse concerning a patient who was vaccinated with RECOMBIVAX HB on an unspecified date. Subsequently the patient now has a negative hepatitis b surface antibody titer. Additional information has been requested.
This spontaneous report has been received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot# dose and route unknown). The LIQUID PEDVAXHIB was exposed to 33F for 20 days. The outcome and causality were not provided. This is one of several reports from the same source. Additional information has been requested.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Previously administered products included for Tetanus: Tetanus (104 fever 1 week). Past adverse reactions to the above products included Fever with Tetanus. Concurrent medical conditions included Hay fever.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient visited emergency room on 18-Mar-2021 and was prescribed a cream and was given a shot. It was also reported that by 20-Mar-2021 the symptom was worse and the patient was back to emergency room on 21-Mar-2021 and was prescribed with Proctozone pills. Patient had no medical conditions like anaphylaxis reaction, asthma and hypersensitivity reactions. Patient had received a call to get third booster and she stated that she was going to ask her GP about this.   This case was linked to MOD-2021-385778 (Patient Link).
Patient vaccinated on 3/24/21 and then tested positive for COVID-19 on 8/30/21
SOB, tingling, itching in throat - rash - BENADRYL, SOLUMEDROL.
Shortly after being vaccinated felt dizzy and developed a headache.  Headache got progressively worse throughout the day.   By that evening, headache evolved into a migraine and needed bed rest.  Also started to develop a fever.  About 99.5 deg.  Around that time, several hours after vaccination, heart began to race and had mild chest pains.  Chest pain subsided a couple of hours later.  Headache/ migraine persisted until the next day.  The following day, 24 hours after vaccination, headache subsided but I developed fever 101.5 deg. and chills.  This lasted about 24 hours.  All symptoms subsided after about 48 hours.
In a local clinic, patient presented for Fluzone-HD vaccination.  While in preparation to give her the vaccination, I had patient to repeat what vaccines she was going to received that day. She said that she wanted the Flu vaccine. Then, I processed to vaccinate her. When processing her content form, that when I realize that she had a previous Fluzone-HD several days ago... When trying to contact the patient, I finally reach their daughter (name unknown).  She said that her parents can appear to be very lucid. But, their are not.