chrisvoncsefalvay/vaers-outcomes huggingface dataset:
99.8 fever; Body chills; Bodyaches; Nausea; Shortness of breath; throwing up; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; Er8733) via an unspecified route of administration in left arm on 26Mar2021 at 16:00 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history was reported as "I'm in very good health". The patient did not have allergies to medications, food, or other products. Concomitant medication included unspecified HRT (hormone replacement therapy). Prior to 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 4 weeks prior to the COVID vaccine. On 27Mar2021 at 08:00, the patient experienced 99.8 (units unspecified) fever, body chills, body aches, nausea, throwing up, and shortness of breath. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes of the events 99.8 (units unspecified) fever, body chills, body aches, nausea, throwing up, and shortness of breath were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient left clinic and returned approximately 30 min after vaccination with reports of nausea, shakiness, and fatigue. Vital signs report as following 156/95, 36.4 C, 88 HR, 99%, 18 RR.  Patient monitored for an additional 15 minutes with resolution of symptoms.  No rescue medications administered.
Vaccine administered 12:30, adverse event began 12:35 same day. Patient had itchy throat, denied swelling of tongue or SOB. Given Benadryl 25mg/50mg PO (dose unspecified on reporting form). Patient stable, released from vaccination site.
She was paralyzed; had bad reactions to it; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's medical history included poliomyelitis, previous drug reactions or allergies and concomitant medications were not reported.     In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported).         On an unknown date, the patient had bad reactions to vaccine (vaccination complication) and she was paralyzed (paralysis).   The outcome of paralysis and vaccination complication was not reported. The causality assessment between Zoster Vaccine Live (ZOSTAVAX) and vaccination complication was considered related, and for paralysis was not reported.       Upon internal review, paralysis was considered disable and medically significant event.
patient stated recent eye exam showed corneal ulcer; This is a spontaneous report from a contactable other health professional. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, the patient stated recent eye exam showed corneal ulcer. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product information, the causal relationship between the reported ulcerative keratitis and use of BNT162B2 cannot be fully excluded. However, the medical history of rheumatoid arthritis may confound the reported drug event pair. The limited information precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees and Investigators, as appropriate.
accidentally administered a dose of Arexvy using a shorter than recommended needle; Probable subcutaneous administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (subcutaneous). On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong technique in product usage process (Verbatim: accidentally administered a dose of Arexvy using a shorter than recommended needle) and intramuscular formulation administered by other route (Verbatim: Probable subcutaneous administration).  The outcome of the wrong technique in product usage process and intramuscular formulation administered by other route were unknown.   Additional Information: GSK receipt date: 9-Oct-2023 A pharmacist called in to report that an intern accidentally administered a dose of Arexvy using a shorter than recommended needle and wanted to know how to proceed.  The reporter gave partial information about the event and patient but consented to receive follow-up calls. The reporter consented to follow up. An intern accidentally administered a dose of Arexvy using a shorter than recommended needle probably subcutaneously, which led wrong technique in product usage process and intramuscular formulation administered by other route.
3 Days after first vaccine (2/6/21) I had ringing in ears.    Also, had slight loss of hearing 6 days after first vaccine.  Ringing in ears has gotten worse after 2nd vaccine (2/27/21).
Immediate symptom- head swollen, eyes swollen, face extremely flush like a tomato. Doctor claimed serotonin reaction. Dr. Had patient stay in clinic for 30 minutes to ensure no anaphylaxis. Episode occurred again on Day 3 coupled with uncontrollable crying for 1 hour. Patient now has permanent ezcema on cheeks that is sore and painful.
Approx 1 min after vaccination, pt standing, fell to ground and hit head on floor. Pt began seizure like activity including convulsing and eyes rolling back. Ammonia inhalant administered with no response. Episode lasted approx 30-45 seconds. Pt vitals were stable following event and pt was alert and oriented. EMS arrived and pt was transported to local hospital for evaluation.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:23 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.  The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured.  No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report was received from a nurse referring unspecified number of patients of unknown ages and genders. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB injection, one dose intramuscularly (lot # M001813, expiration date 14-OCT-2018). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
I started exp pain in lower abdomen and mild nausea went to GI on 3/23 thinking with GI problem.The doctor wasn't able to pin point was in going on so I have a follow up for a CT scan.
After approximately 12 hours of receiving the vaccine shot my entire body ached. Every muscle in my body was tight, making it difficult to move. I also experienced a strong headache behind the eyes, and difficulty urinating.
Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after vaccine. Some tingling on face and left had   Resting to see if it goes away.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 10th September 2018, the patient received the 2nd dose of SHINGRIX. On 10th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell were recovering/resolving. It was unknown if the reporter considered the pain in arm, weakness, headache, stomach pain, influenza-like symptoms, chills and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a sore arm, stomach hurting and general feeling of unwell. The events experienced by the patient were slightly improving at the time of reporting. The patient had denied permission to contact their physician. At the time of reporting the event experienced by the patient was slightly improving. This case was linked with US2018167128 (1st dose), reported by the same reporter for the same patient.
REDNESS, ITCHING, HIVES AND SPREAD UP AND DOWN LEFT ARM, FACE AND NECK AREA approx. 20 min after receiving vaccine
SWOLLEN FACE; This spontaneous report received from a consumer concerned a 56 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen face was not reported. This report was non-serious.
On 11/27/00, pt developed a fever and was fussy. On 11/28/00, she was dx'd with bilateral otitis media and URI. Rx'd with amoxicillin according to parent. On 11/29/00, she was seen by MD at ER with fever. On 12/01/00, the pt was seen by SLP and dx'd with Roseola. Rashes eventually resolved as did the fever.
pt recv vax in mid to late afternoon;mom related that about 4hrs later pt became fussy & leg was very swollen (lt thigh were DTP/HIB was placed) rash on face & head receded as pt calmed down,per mom;gave pediaprophen;mild clear rhinorrhea
Patient hasn't received 2nd dose because she was sick; Patient hasn't received 2nd dose because she was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient hasn't received 2nd dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because she was sick) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Patient hasn't received 2nd dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because she was sick). At the time of the report, ILLNESS (Patient hasn't received 2nd dose because she was sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because she was sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medication was reported.  No Treatment medication was reported.
On March 4th, I had a routine check in because I have a history of breast cancer so I was in for an MRI. I had a mammogram on 11/16/2021 and it was normal. On this MRI, they saw a suspicious lymph node. They wanted to do a biopsy that day but we were unable to do so at that time so I came back a month later and we did biopsy it but it came back as benign. My health care provider and I discussed this and we came to the conclusion that it could be related to the vaccine as it appeared after the booster and the mammograms close to the shot did not show anything present. I do have a procedure coming up and am holding off on the second booster at this time.
No available appointment for second dose of vaccine; Sore arm; A spontaneous report was received from a 58 year old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and there was no available appointment for second dose of vaccine and developed a sore arm.   The patient's medical history included hypertension. Concomitant medications reported included unspecified hypertension medications.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, after vaccine administration, the patient was a little sore for a day and a half.  On 31 Dec 2020, the patient reported that her second dose of the vaccine should be on 25 Jan 2021 and that there was no available appointment for her. It had been recommended to the patient that she receive her second dose within 36 days of the first dose. No treatment was administered for the events.  Action taken with mRNA-1273 in response to the events was unknown.  The event, developed a sore arm, was considered resolved on 29 Dec 2020. The event, no available appointment for second dose of vaccine was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 58 year-old female, who experienced a non-serious expected event of pain in extremity and Inappropriate schedule of Product administration. The event occurred soon after the first dose of mRNA-1273, lot # 025J20-2A. Based on the current available information and temporal association between the use of the product and the start date of the event, for the event of pain in extremity a causal relationship cannot be excluded. There was no reported AE associated with this case of Inappropriate schedule of Product administration.
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing  Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
Information has been received from a physician concerning a 13 year old patient with obesity and had no known allergies who on 15-MAR-2010 was vaccinated subcutaneously in left arm with the second 0.5 mL dose of VARIVAX (Merck) (LOT# 665692/1297Y). The office was contacted on 16-MAR-2010 regarding patient and examined the patient in office on 17-MAR-2010 and 19-MAR-2010. The patient was diagnosed with localized vasculitis with topical infection. The area was 12cm of dark pink and 5cm of deep red in the center. The area was swollen and warm. Patient was treated with BACTRIM DS one tablet daily for 10 days. Patient did seem to be improving. No serious intervention needed. This is one of the two reports from the same source. Additional information has been requested.
Patient was found dead at home 1/26/07.  5/1/07 Received Autopsy Report which reveals COD as probable SIDS.
The day after receiving the vaccine arm had large swollen area with red whelping. The area inflamed was to the side of the site of injection and about a 2 inch circumference.  Skin was fevered and itchy.  Day 3 itching and rash traveled down to wrist.  By day 5 or 6 arm appeared almost back to normal.  Today, on day 9, there is a re-occurrence of a large inflamed  itchy area which is once again fevered.
Severe muscle spasms in the bicep of arm he got the vaccine/now it is (muscle spasms) spread to other muscle groups; He could not sleep; This is a spontaneous report from a contactable physician (patient's wife). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in Arm Left on 03May2021 at 11:00 (at an age of 45-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported and had no problems with vaccines in past. Concomitant medications were not reported. The patient had no other vaccines given the same day or 4 weeks prior. On 03May2021, approximately 3-4 hours after the injection (dose 1), he developed a severe muscle spasm in the bicep of the same arm of the injection. Physician saw the contraction of the head of the bicep muscle. The first night was very frequent, overnight, and he could not sleep. He had not had that before the vaccine and did not do any exercises that could have caused it. After 5-6 days, it had improved but now spasms had spread in other muscle groups (at the time of report), like the quadriceps and on the back, but less severe compared to the arm. Spasms have continued, although improved and it was mainly at night now (at the time of report). The reporter was concerned if this could happen to anywhere in the body. Wonders if this could happen to any other part of body for the rest of his life. The reporter asked if patient should get his second dose if he has developed severe muscle spasms after the first dose. Physician did not feel that it was medically significant. On 03May2021, patient recovered from event could not sleep, the patient had not yet recovered from severe muscle spasm.  Information on lot/batch number has been requested.
This spontaneous report as received from a para legal refers to a patient of unknown age and gender. The para legal stated in her conversation with MNSC representative that she had a client who, on an unknown date, was vaccinated with a dose of ROTATEQ (lot#, dose, frequency and route unspecified). On an unknown date the patient had a reaction to the ROTATEQ vaccine. The outcome of the event was unknown. The patient looked for the legal contact information in order to file a claim. Para legal was not prepared to participate in the report at this time. Additional information has been requested.
COUGH, CONGESTION. FEVER, SOB. FATIGUE. LOSE OF TASTE AND SMELL
Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a Nurse Practitioner concerning a 26 year old female with anemia and a history of cutaneous intraepitheleal neoplasia who on 02-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #658100/0525U.  Concomitant therapy included hormonal contraceptives (unspecified), prenatal vitamins, PROMETRIUM, and SLOW FE.  Last menstrual period was the end of JUN-2007.  Estimated delivery date was 05-APR-2008.  Subsequently, the patient became pregnant and it was confirmed by a home pregnancy test.  She was not experiencing any known symptoms.  Unspecified medical attention was sought by the patient.  There were no reported complications during the pregnancy.  On 15-MAR-2008, the patient delivered a normal set of twins, one male 6 pounds and 4 ounces, and one female 6 pounds 1 ounce.  There were no congenital anomalies and no reported complications or abnormalities.  No additional information is expected.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of ROTATEQ (lot number, expiry date and dose were not reported), route default to oral that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.