chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLIGHT FEVER; patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature; patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature; Soreness; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature), POOR QUALITY PRODUCT ADMINISTERED (patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature), PAIN (Soreness), HEADACHE (Headache) and PYREXIA (SLIGHT FEVER) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature), POOR QUALITY PRODUCT ADMINISTERED (patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature), PAIN (Soreness) and HEADACHE (Headache). On an unknown date, the patient experienced PYREXIA (SLIGHT FEVER). At the time of the report, PRODUCT STORAGE ERROR (patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose in right arm on 29 Apr2021 in morning and which was prefilled syringe outside from 26Apr2021 to 29Apr2021 in room temperature) outcome was unknown and PAIN (Soreness), HEADACHE (Headache) and PYREXIA (SLIGHT FEVER) had resolved.        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.   No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098155 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow up received on 13-Jun-2021. The events headache and soreness was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098155:
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  STATUS EPILEPTICUS 6/30/2022 HX OF FALL  STATUS EPILEPTICUS 6/30/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE
Large fluid filled blister over injection site with numerous small blisters that encompass large area around large blister. Cellulitis that extends from lower deltoid to elbow and inner arm.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
I was lethargic for a day or 2 after injection; Arm soreness at injection site; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness at injection site), FATIGUE (Extreme fatigue) and LETHARGY (I was lethargic for a day or 2 after injection) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy, Allergy to molds and Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R), SODIUM CHLORIDE, XYLITOL (SALINASE MAX) and MULTIVITAMINS [VITAMINS NOS] for Product used for unknown indication, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA), VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], ZINC and BARLEY for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness at injection site) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced LETHARGY (I was lethargic for a day or 2 after injection). At the time of the report, VACCINATION SITE PAIN (Arm soreness at injection site), FATIGUE (Extreme fatigue) and LETHARGY (I was lethargic for a day or 2 after injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: positive (Positive) positive for covid 19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Green with varying strength is used by patient as concomitant drug Treatment information was not provided On 15th July 2021 patient done his rapid and PCR test   This case was linked to MOD-2021-254109 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant Follow Up Appended- Event added
local rxn of 2cm of  redness @ inj site & 6-7cm around that area;
This spontaneous report was received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified) lasting for 152 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.55 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving the vaccine it was about 10 or 12 hours later when I developed chills, a fever of 103.6 degrees, a headache, body aches, weakness, and fatigue. It lasted for about 48 hours. I'm still experiencing shortness of breath with exertion, fatigue on exertion, and low oxygen saturation of 88% to 94%.
she experienced redness on her arm and the redness had already gone down to her elbow/His wife's arm is pink from where she got the shot down to her elbow.; It is a little bit tender; This is a spontaneous report from a contactable consumer. A 90-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (age at vaccination 90-years-old) (Batch/Lot Number: EN9581) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (age at vaccination 90-years-old) (Batch/Lot Number: EL3249) as dose 1, single for covid-19 immunization. In Feb2021, the patient experienced redness on her arm and the redness had already gone down to her elbow/his wife's arm was pink from where she got the shot down to her elbow and little bit tenderness. It was reported that the patient got the second dose of the COVID-19 vaccine on 04Feb2021. After 1 week, the patient experienced redness on her arm and the redness had already gone down to her elbow and arm is now pink, it kept getting worse as it came down and tender. Reporter wanted to know if the color will diminish and will it go away. The events were not treated. The outcome of the event little bit tenderness was unknown, and patient not recovered from another event.  Follow-up attempts completed. No further information expected.
The patient was to receive the second dose of the series on 1/25/21 and received it on 1/19/21. The patient experienced injection site soreness for a period of about 24 hours.
Case number PHEH2016US025915, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to an 86-year-old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (lot number: 1618521) at a dose of 1 ml intramuscularly. Nurse reported that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported following this medication error.
The child received the first dose of Moderna vaccine at 17 years of age by providing a false date of birth. Then the child went for a second dose to a different facility, without notifying them of the first dose of Moderna.  At this second facility, the child received Pfizer, Lot # ER8735 as the second dose.  As such, this VAERS report is being competed due to an error type of Mixed Series.
Myalgia for about 24 h. injection site pain and swelling. Lymphadenopathy on the underarm of injection site (left arm) that lasted for about 5 days
mom reported pt had temp 103.7 @ 210PM;mom states temp started 14MAY in the PM;temp inc to 104.3 but pt still playing;no other problems;advised further fever meds;call if any other sx;
Swollen (R) thigh, abnormal gait told, ambulates freely noticed today by mother. Brother age 4 yo stated pt fell off a chair, crying- mom noticed the leg swelling. NSAIDS given, warm compress continue resolving 7-18-2013.
SUSPECTED CLINICAL VACCINATION FAILURE; VERY ILL WITH COVID; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients of an unspecified age, sex, race and ethnicity. Initial information was processed along with additional information received on 20-DEC-2021. 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 administration, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination (dose series in number 1). The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On an unspecified date, the reported stated that, "I know too many that were vaccinated and hospitalized and very ill with covid" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very ill with covid and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000207767. The suspected product quality complaint has been confirmed to be the reporter complaint description, general notes, and source documents were merged into 90000207716. This record will be voided as a duplicate. therefore, only this complaint (90000207767) will be submitted for void and 90000207716 will be processed as a CI based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20211240566.; Sender's Comments: V0: 20211243153 -covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure. 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: SPECIAL SITUATIONS. V0 20211243153 -covid-19 vaccine ad26.cov2.s - very ill with covid . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Motorcycle accident-Passed out while driving motorcycle and fell off bike, hit head onto ground. was seen by ER. Subsuquent visits with Physicians; 12/17/09, 1/11/10. Was told passed out due to H1N1 vaccine.
Fever; throwing up; heart rate was going up/heart rate from 80 to 150; Shivers; This is a spontaneous report from a contactable consumer or other non-Health Professional. A 25-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 at 01 pm (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021, 1 day after vaccination at 1 am the patient woke up with a fever, and she was throwing up until 1 o clock today, heart rate was going up/heart rate from 80 to 150, shivers. The patient underwent lab tests and procedures which included body temperature as going up, heart rate as 80 to 150, heart rate going up on 04Feb2021. She gave her Tylenol because her fever was going up. She was wondering she could take a Xanax. That way she can see if it is her anxiety or the vaccine that is raising her heart rate. The outcome of events was not recovered.   Follow-up attempts are completed. Information on the lot/batch number has been requested.
What appears to be a heat rash on my right arm near elbow pit, also on my left forearm, my neck, legs.
I was exposed to Covid-19 from my husband who tested positive on 5/13/22, and my son who tested positive 5/11/22. A few days later I woke up around four in the morning with extremely itchy eyes. They felt dry and irritated. As the day went on I started to have nasal congestion, and a sore throat. I developed night sweats but I never had a fever. The roof of my mouth felt like the same sensation as if I would have burned it eating hot food. On 5/16/22 I had a telephone visit with my Provider and was prescribed Paxlovid. I am still having symptoms at this time.
She received the second vaccine in the VZV series on the Left Tricep on 7/12/2010 at approximately 10:00 by the Employee Health Nurse.  She states that the site began itching, and started swelling since right after the injection was given.  This morning, 7/14/2010, the employee approached me and asked regarding the swelling, the swelling - in diameter, is approximately the size of a tennis ball.  It is red, and hot to touch.  The client also received Hepatitis B, according to documentation, on the Left Deltoid.  She states that the first time she received the VZV vaccine on 06/02/2010, she had a few "bumps" throughout her skin, but they went away in 2 days, and was not sure what had caused them.  Currently she is not experiencing any other symptoms.
About 10 minutes after receiving vaccine, patient states she feels like her heart is beating fast. I took her blood pressure and was high 187/114, then took two more times and went down almost immediately. Last reading was 128/79 about 15 minutes after first reading. She was feeling good when she left. Observed the patient for a total of 40 minutes after vaccine administed. Her pulse was slightly high 110, 103. Slight headache, but had this before receiving vaccine.
Patient only received 0.25ml for a dose.  Patient  returned on 9-16-22 and received the full 0.5ml dose.
Menstrual irregularities. Light spotting for at least one full week (never experienced). Heavy bleeding and clotting (currently happening). This is day 16 of this. I have experienced heavy bleeding in the past but it only lasts 2-3 days at the most (usually only 2 days). Clotting is heavy unlike anything I've ever experienced. Minor soreness of nipples shortly after 1st vaccine, which was constant for 4 weeks but has since stopped (this has never happened).
High fever 101.5 to 104.4 for 24 hours; body aches; joint pain; hives; headache; fatigue. Stopped at 24 hours but 3 days later, lips swelled.  Took Benadryl and it stopped. Went to see Dr. who determined I was allergic to the vaccine and was prescribed a steriod pac.
Woke up the morning following my vaccine shot to find my right eye swollen.; Right eye swollen and discolored under the eye, with a darker, swollen area extending from under the tear duct along the bottom of eye socket to eye's outer edge; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 10:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, osteoarthritis, high blood pressure, diabetes and psoriatic arthritis (PsA). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) 800 mg tablet, gabapentin (MANUFACTURER UNKNOWN), and empagliflozin (JARDIANCE) 25mg tablet; all for an unknown indications from an unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since having the vaccine. On 23Mar2021 at 05:00, the woke up the morning following his vaccine shot and found his right eye was swollen and discoloured under the eye, with a darker, swollen area extending from under the tear duct along the bottom of eye socket to eye's outer edge. The patient did not receive any treatment for the events. The clinical outcome of the events right eye swollen and discoloured under the eye was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Per verbal order by MD client received a 4th dose Moderna COVID vaccine LOT 014F21A.  Client's previous doses are as follows:  1st Dose Pfizer COVID vaccine: 01/31/2021 LOT EL9262  2nd Dose Pfizer COVID vaccine: 02/21/2021 LOT EN6198 3rd Dose Janssen COVID vaccine: 08/11/2021 LOT 201A21A Client remained for a 30 minute observation without incidence and left the vaccine site on his own accord and with a steady gait.
Fist day on 12/24/20 when I got the vaccine about 30min after I started feeling a lot of chills & nauseas on the second day on 12/25/2020 my arm was swollen on the area of the injection It was affecting the movement of my arm. Then on 12/26/2020 around 3am I got a horrible pain that started in the front on my abdominal then it went to the back from my neck & my spine all the way to my butt I was like paralyzed due to the pain. I felt like they where squeezing my bones.  We had to call the ambulance because I could not move by the time I got to the hospital the pain was gone but my whole body was sore because of the pain I went through.
On the after post receiving flu vaccine, pt began feeling dizzy. By 3-4 hours later pt woke up and eyes were swollen shut. By am, pt was feeling generalized fatigue, neck was stiff, arm where shot was administered was very sore.
having some bumps that are starting to come up; This is a spontaneous report from a contactable consumer for her husband. A male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history was not reported. The concomitant medications was none. Patient have some bumps that are starting to come up as well on an unknown date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
redness, swelling, knot and pain in arm following injection, pt perceives it to be worsening
Having issue with my arm. It is painful to lift/raise. From my shoulder to my elbow. I never had any issues with my arm prior to the vaccine shot. (Pain is in the same arm shot was done on)
The day after vaccine I had a lump on my arm and under my arm at my arm pit. On the 3rd day I had a rash on my whole left arm (non-itchy). This morning I no longer have a rash but still have some slight inflammation at my armpit and injection site, with some discomfort if pressed on.
Patient broke out in a rash over chest, back and arms and experienced muscle weakness in legs and arms and was unable to move out of the bed at 3:00 am on Saturday 5/21/2022.  Patient also had a fever of 101 degrees Fahrenheit.  Patient's wife called EMS where the rescue squad came to evaluate.  He was told to take Tylenol and did take two Tylenol.  Patient's wife states that EMS told her it was a reaction to the COVID vaccine.  As of Sunday at roughly 12:15 pm, the patient's wife reported that the rash was gone and that he can now move arms and legs with no issue.