chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
This spontaneous report was received from a nurse and refers to an unspecified 6-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patient received the first and the second dose of ROTATEQ orally (strength, dose, lot # and expiration date were not reported), for prevention of rotavirus. On 10-MAY-2017, the patient choked and then vomited twice, while the administration of third dose of ROTATEQ via oral route (strength, dose, lot # and expiration date were not reported), for prevention of rotavirus. There was no treatment given for the adverse events. The patient did not seek medical attention. The outcome of aforementioned events was unknown at the time of the report. Upon internal review, the event of choking was determined to be medically significant. The causality assessment was not reported. Additional information has been requested.
flu-like symptoms began 6 days after being vaccinated with first dose and have continued through this reporting on 03/24/2021, including: lingering headache slight chills and body aches low-grade fever  fatigue
The veins also ached; all of the veins in my right arm (the one that received the injection) had swollen up and were very prominent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 17:30 (Lot number: ER8735) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prolactinoma" (unspecified if ongoing); "Allergy: Bees" (unspecified if ongoing); "Allergy: cats" (unspecified if ongoing); "Allergy: scorpions" (unspecified if ongoing); "Allergy: spider bites" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: ER8730    , Date of start of drug: 23Mar2021 04:30 PM , Anatomical Location: Arm Left    , Dose Number: 1), administration date: 23Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: VASCULAR PAIN (non-serious) with onset 20Apr2021 17:45, outcome "recovered" (20Apr2021 21:30), described as "The veins also ached"; VARICOSE VEIN (non-serious) with onset 20Apr2021 17:45, outcome "recovered" (20Apr2021 21:30), described as "all of the veins in my right arm (the one that received the injection) had swollen up and were very prominent". Therapeutic measures were not taken as a result of vascular pain, varicose vein.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used). On Oct 25, 2021, product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
I was sick; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (I was sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick). At the time of the report, ILLNESS (I was sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-408953, MOD-2021-408707 (Patient Link).
8 days post injection I have a bad headache, some stomach pain, and I had a random pain in my left leg.
SLIGHT SHORTNESS OF BREATH; BODY ACHES; TINGLING IN INJECTED ARM; FEVER OF 100-102; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight shortness of breath. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced tingling in injected arm. On 13-APR-2021, the subject experienced fever of 100-102. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100-102, body aches, headache, tingling in injected arm, and slight shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
This case was forwarded to Crucell, No: CVAE-026-2012. An initial report was received from a healthcare professional on 26.Jun.2012 and concerns a male patient of unspecified age who, on 20.Apr.2012, received an administration of VIVOTIF (batch no: not reported). The patient's medical history and concomitant medications were not reported. On an unspecified date, at an unspecified time following the HAV-Pur administration, the patient experienced a severely dry mouth. No further information was available. At the time of reporting the patient had not yet recovered. The events were considered non-serious. Follow-up received on 17-Sep-2012: The patient's age was between 30-40 years. The event was short term which the patient recovered from on an unspecified date. The patient stated that he and his primary care doctor concluded that the reaction was not related to VIVOTIF but something else which he does not remember.
HEADACHE,  FEVER, CHILL, NAUSEA, VOMITING, BODY ACHES, FATIGUE
Patient reported waking up with the worst headache she has ever had with chills. Years past patient stated she developed a slight headache and chills, but never anything like this.
When her consent from was evaluated before her injection, it was missed that the patient was 11 days younger than 18.  The Moderna vaccine is indicated for 18 years of age or older.  It was not discovered until after her injection.
When I received the shot it was very painful and I made a comment to the pharmacist that it hurt really bad. Exactly 1 week later (12/6/21) I woke up and had numbness and tingling in my left forearm, top and outside of hand, and pinky and ring finger. It was not painful but worrisome that I could not feel. I went to the doctor and they said they though it could be due to how the shot was administered. On 12/6 I was working and felt sharp and intense radiating pain in my left top hand. That weekend the sharp pain moved to my forearm, but was no longer in my hand. On 12/21 I woke up at 3 am to intense and sharp pain in my upper arm and shoulder pain. I could not lift my arm. I took Advil and this did not help much. The only position I could get comfortable in was childs pose. I called my doctor and they sent me for x-rays which showed nothing wrong (as I knew it would because I did not injure my arm). On 12/22 I again woke up and had intense sharp pain in my shoulder blade at 3 am and could not move my arm. OTC pain meds do not touch the intense sharp pain. During the day the pain is still there but subsides so I can at least use my arm and hands. Meanwhile, I still have numbness and tightness in my left 2 outer fingers and wrist as well as tingling but it is not as intense as it was initially when this began.
Severe muscle pain at injection site requiring high dose over the counter analgesic, development of runny nose and watery eyes within 12 hours, and chills within 4 hours.
Patient had some trouble breathing, fever chills, diarrhea, flu symptoms started 3 hours after vaccination. Lasted a couple of days.
20 minutes after receiving injection developed slight double vision, dizziness and fatigue. Symptoms are mild. Double vision and dizziness resolved after 1 hour, fatigue remains.
Rash, Hives starting at the left eye and then spread to nose and left cheek.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-JUN-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Headache, Arthralgia, Localized pain, itching; chills, fatigue Narrative:
Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.
On Saturday night I started feeling tightness in my chest, and then by Sunday morning around 01:00AM, I was getting up every two hours with chest pains and I was having trouble breathing. I woke up again around 09:00AM and took all my normal medications and then around lunch time I had to take my rescue inhaler. It is supposed to work in a few minutes but it did not so my dad took me to the Emergency Room, when I got there they asked for my pain level and I told them around an 8 or 9.  They gave me three albuteral breathing treatments, a Steriod Shot and Tyelonol for the pain. The also did an EKG and Chest X-Ray to make sure the problem was not in my heart. the Dr. notices that I had a significant reaction to the vaccine, it was red and swollen at the injection site.  He also said that my heart was fine and that my reaction to the booster made my asthma worse.  By the end of the visit I was feeling much better.
swelling; Inflammation; Tenderness left upper arm 10 1/2 cm x 13 cm (see attachment).  Do not know the exact time that reaction begin.  This was on the report already.
2/10/2021 010M20A 3/10/2021 048A21A 10/27/2021 FE3590 5/5/2022 FK9894 10/8/2022 GH9702 Pfizer BiValent  6/9/2023 - 6/13/2023 (4 days) Presents hospital progressively worsening generalized weakness for last 1 week and dyspnea on exertion.
Had pain from her first Shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain after receiving her first Shingrix shot (date of first shot was unknown). No lot or expiry date was available. The patient was offered Shingrix Product Information. The reporter consented to follow-up and recommended follow-up with her health care professional. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR104820.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104820:Same reporter, same suspect, same patient (2nd dose)
Swelling, bruise, pain in arm around injection site. N/V/D x 48hrs. Headache and joint pain. Joint, muscle pain stayed for over 1 wk.
Severe chest pain 24 hour later admitted to ICU with myocarditis Given aspirin, monitored closely for 72 hours Cardiac MRI performed No other treatment
Reported to pharmacy the day after vaccination was administered. Very painful and patient barely could sleep the evening of receiving the influenza vaccination. Swollen, and very painful to move her arm. Patient's husband reported that it was not muscle pain rather than pain in the joint. The pain in shoulder joint is still reported 1 and 1/2 months after the vaccination occurred with inability to use her shoulder. Follow up treatment(s) and care are unknown at this time but it believed to be at least several doctor's office follow up visits.
2 days after small bump on roof of mouth.  Very tender and painful for 6-7 days.  Continued dizzy and balance issues.  No injection site soreness but  5 days post injection shoulder joint in injection arm incredibly sore for 6+ days
Patient has experienced low grade fever, red and itchiness on the left side where the covid vaccine was administered. Patient stated that there were lymph nodes swollen on the left side around the armpit, which was very painful. Symptoms have not gotten better since 4/5/22. Patient has taken tylenol, ibuprofen and benadryl for the symptoms.
seems i have mild case of "Covid Arm"  10 days after injection have the round red rash at injection site and another spot about an inch below it.  NO itch or pain just the "unexpected delayed rash"   still visable 24 hrs later
at 3:45p on 9/22 I received the vaccine. I felt fine until later in the evening where I developed a headache and later extreme fatigue. I went to sleep thinking I would feel better in the AM -- wrong. The next morning, I awakened and felt like i had been run over by a truck, I felt horrible. I was unable to stay awake throughout the day. That went on for about 5 days -- the extreme fatigue really altered my life. My arm was swollen, hot to the touch with a hard knot for about 15 days.  After the initial bout of illness from the vaccine subsided, I then contacted my PCP about this lingering fatigue that comes and goes and coughing when doing anything (like walking up stairs, walking at a fast pace, talking fast, etc.). I seemed to make a causal connection between activity, my heart beating way faster than necessary and the uncontrollable coughing. I decided to wait 1 month post administration to see if whatever was going to subside. It did not subside. 1 month post here is what I have experienced:  1. a period, that is normally averaging 5.9 days, now on its 12th day with no sign of stopping 2. rapid heart beat 3. chronic fatigue 4. insomnia (on days there is no fatigue) 5. inability to do normal things (like mentioned above)  I went to the PCP on 10/22 and was sent to the hospital for testing. There is still no diagnosis.
Redness and swelling below injection site - noticed it first today, but it starting itching two days ago. It?s not itchy today, just red and swollen. The area is about an inch and a half to two inches long and about an inch wide.
Pt recvd HIB/DTP on 21SEP91 & @ 7months of age devel high fever 104.6 & was taken to ER on 17OCT91 & hospitalized for 10 days; LP positive for H. influenza meningitis; tx Rocephin IV, APAP, PEdia Profen; Infant has some hearing loss;
13:50 C/O feeling like her throat is tingling denies SOB/CP, pt able to stick tongue out and move as directed. No swelling noted to pt tongue.  Pt given drink/ cracker to eat.  BP 116/70 Hr 84 Spo2 98%.Pt reassessed after waiting 30mins  ,pt states her throat still feels itchy but denies SOB / CP at time of assessment and pt was able to eat and drink with out issue. Pt D/C  homeand instructed to F/U with PCP if symptoms remains or worsen,ER/EMS
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017; dose and route were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE; A HCP called to report that an expired dose of VAQTA was administered to a patient; This spontaneous report was received from a nurse, referring to a patient with unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were not reported.  On 16-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot number U021561 has been verified to be a valid lot number, expiration date was reported as 14-JAN-2023, dose, route and anatomical location were not provided) for prophylaxis (expired product administered). It has been confirmed no adverse effects were noted. No additional adverse event (AE) reported (no adverse event).   This report was considered as non-valid due to the lack of the patient's identifiers.  Follow up information has been received from the nurse, referring to a 23-year-old female patient on 24-JAN-2023.  The patient had no ill effects from administration. On 16-JAN-2023, the patient was vaccinated with the correct hepatitis a vaccine, inactivated (VAQTA) (anatomical location was reported as left deltoid) via intramuscularly at private doctor's office/hospital. The hepatitis a vaccine, inactivated (VAQTA) expired two days prior to administration. No concerned with the efficacy of the vaccine administered.  This report became to valid.
Developed what we believe was an encephalitis with confusion, memory loss, fever.  MRI with abnormal enhancement of the mesial termporal lobes bilaterally.  No other obvious etiology found.  Slowly over several weeks improve.
The next day was extremely tired. Took EKG with apple Iwatch 6. It was fine. Took O2 sat level and it was 89. Performed several deep breathing exercises then took it again, but it was only 91.   Continued taking O2 readings throughout the day but was always between 88-92. The next morning I was back to normal with readings between 98-100. Even when I had Covid-19 in Nov 2020, my 02 levels stayed between 97-99. So it being down to high 80s and low 90s is unheard of for me. It was most definitely from this vaccine.
Pt recvd vax on 9DEC92 & on 6JAN92 pt seen by MD because of devel of herpes zoster involving the lt naso-labial area & forehead of face w/some eye involvement;
Chills; body eaches; soreness in left arm approx. 2 hours post dose.; Escalation in discomfort throughout the day; This is a spontaneous report from a contactable consumer. A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 10Feb2021 at 09:30 (at the age of 55-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EJ6796) as dose 1, single administered in right arm on 20Jan2021 at 15.30PM for COVID-19 immunization. Concomitant medications included cetirizine hydrochloride (ZYRTEC), curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported other medications received in two weeks. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Patient had no known allergies. No other medical history. Facility type vaccine workplace clinic. On 10Feb2021 at 02:00 PM, patient experienced soreness in left arm approximately 2 hours post dose. Escalation in discomfort throughout the day. Throughout the day on 11Feb2021 Chills around 10pm-12pm and body ashes and chills. No treatment received for the adverse events. COVID tested post vaccination reported as no. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected. Information about Lot/Batch has been requested.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 12-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Patient begin to faint, never loss consciousness, was little out of it.  There started to droll however was able to communicate with other.