chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated improperly stored VAQTA lot # K005958, expiration date reported as 09-FEB-2017 (dose, route and site of vaccination were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 56.8 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
swollen joints (knees & feet), elevated temp w/in 1 wk of shot;
C5-C6 transverse myelitis. Information from medical records states numbness, paralysis, Urinary retention and neurogenic bowel.
Tightness in throat, increased heart rate, decreased O2.  Information received from Discharge summary states pharyngitis. msv
Child developed low grade fever of 99.4 on 01-05-11 around 9 pm - medicated with BENADRYL and fever subsided. Hives developed thru the night on sides, back, abdomen, legs, then face. Child was taken to pediatrician on 01-06-11 and treated with BENADRYL and steroid.
Pt recvd 1 dose of Engerix-B & devel lymphadenopathy & stiffness in the neck which has resolved;
I began fine on the day of injection, towards the night I started to run a fever around 99.9 body aches, chills, severe headaches, fatigued. These symptoms lasted about a week after receiving the vaccine symptoms caused work to become challenging, I had a lot of brain fog, continued fatigue. I have had increased levels of issues with insomnia, I found myself after the second week getting winded after just getting dressed or walking to my kitchen, walking upstairs, Body aches continued to become more persistent.  I found myself struggling to work normal hours. My memory seems to be affected as well. It feels like as if I'm walking under water. When I saw my physician June 7th, 2021, she stated that people who are immunocompromised and look at the covid-19 vaccine as a threat to the body and react to it like the real virus causing a severe, prolonged adverse reaction. I am still experiencing chest pain and chest palpitations since vaccination. I began to work towards a more holistic approach towards bettering the health.
Got SIRVA(Shoulder Injury Related to Vaccine); This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced got SIRVA (shoulder injury related to vaccine on 27Feb2021 with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (24Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. .
Heart skip beats; Red up into the shoulder; 100.4 F each day and after 4 days went down to 99 F; Neck aches and sore/Achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRASYSTOLES (Heart skip beats), ERYTHEMA (Red up into the shoulder), PYREXIA (100.4 F each day and after 4 days went down to 99 F) and MYALGIA (Neck aches and sore/Achy) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced EXTRASYSTOLES (Heart skip beats), ERYTHEMA (Red up into the shoulder), PYREXIA (100.4 F each day and after 4 days went down to 99 F) and MYALGIA (Neck aches and sore/Achy). At the time of the report, EXTRASYSTOLES (Heart skip beats), ERYTHEMA (Red up into the shoulder), PYREXIA (100.4 F each day and after 4 days went down to 99 F) and MYALGIA (Neck aches and sore/Achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Body temperature: 100.4 °F High. On 22-Jan-2021, Body temperature: 99 °F High.     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 reported. No treatment related information has been reported.    Reporter did not allow further contact
The patient had completed the GARDASIL 9 series and has now undergone a splenectomy; This spontaneous report was received from a pharmacist technician/student referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions and allergies were unknown by reporter.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular for prophylaxis (strength, dose, frequency, anatomical location, lot number and expiration date were not reported).         The reporter stated that, on an unspecified date, the patient had completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series. On an unknown date, the patient sought medical attention and was admitted to the hospital, as he underwent a splenectomy at the reporter's facility. It was unknown if laboratory diagnostics/studies were performed or if treatment was given for the event. The outcome of splenectomy was unknown.      The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned event was not reported.
Got the vaccine and had shingles/Suspected vaccination failure; Had shingles again; Such pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and had the shingles again, such pain. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 26-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
I was positive for COVID 19 on 29DEC2022, I was didn't have symptoms at the time but after I got cold like symptoms such as fever, runny nose and congested. I called the nurse and she prescribed Molnupiravir.
DTAP-IPV was administered to the patient, the powdered ActHIB was never mixed/ No AE; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who was administered second 0.5 ml dose of DTAP-IPV from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] the powdered ACT-HIB was never mixed lot UJ084AA via intramuscular route in the left thigh on 30-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and HIB VACCINE (HIB) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event occured.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Subsequently post vax, the pt was determined to be pregnant at the time of vaccination. LMP was 6/13/99. The estimated date of delivery was 3/20/00. The physician reported no complications at the time. The pt took a prenatal vitamin during the pregnancy. She also took Colace to prevent constipation. The pt gave birth to a normal male on 3/17/00. The pt experienced severe postpartum hemorrhage. The severe postpartum hemorrhage was considered a significant medical event. The infant experienced transient jaundice.
third dose of Shingrix was administer; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter called to report a third dose of Shingrix was administered to a patient. The reporter did not have any information about the event, said he was out of office.  The reporter agreed to follow up to gather information. The reporter consented to follow up. Additional Supportive Information: The reporter called to report a third dose of Shingrix was administered to a patient, which led to extra dose administered.
Note:  I am a physician myself, and do not require medical care now for what I am about to describe.    Twenty-four hours after the injection, when I woke up on 2/1 I could not eat breakfast and had profound malaise, so I went back to bed util 1 PM, when I got up.  I was very weak.  I was going to take my dogs for a walk, but realized I was too weak to do so.  I didn't have much muscle pain, and no fever or headache, just extreme malaise and weakness.  Mid-afternoon, I ingested a sugar load, and felt somewhat better.  I woke up on 2/2 completely recovered.  I certainly would not have been able to work had I been scheduled to work
moments after receiving the vaccination, patient became dizzy, was sweating all over (arms and face/neck were damp with sweat). I checked the patients blood pressure, it was low at 70/45. Patient was given water to drink followed by orange juice to drink. Over about 15 minutes time, patent began feeling better, and blood pressure increased to a normal reading of 120/72. She stood up and sat back down a couple of times, then felt well enough to leave. She was escorted to her vehicle by a member of management. She was contacted 2 hours later, she was feeling much better.
I experienced an approximate 6 inch area of redness around the vaccination site.  My skin was hot to the touch.  This lasted for approximately one week.  The soreness lasted for approximately 2 weeks.  I noticed weakness in my left arm and a general sense of feeling tired as of the date of filing this document.
Burning sensation that "goes right down though my body" gesturing neck to knees. Flushed face 12:15 132/40  Hadn't eaten yet and history of anxiety. Had a granola bar and cranberry juice.  Laid supine 12:40 felt better 12:50 ambulatory
Patient called the office and stated that 2-3 days after 1st HOV vaccine she experienced bilateral leg fatigue and some SOB, noticed more at night. Symptoms resolved after 5 days - will report, advised no further vaccines.
feeling tired/started feeling really, really, tired on Friday (19Mar2021), Saturday (20Mar2021), and Sunday (21Mar2021), but paid no attention to her tiredness.; got her second COVID-19 Vaccine on 16Mar2021, and had been sick ever since then.; not feeling well; chills; cold; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that a 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:30 (78-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included depression (Stated she was diagnosed with depression back in the 1990s, and had been on medication for years) from an unspecified date in 1990 and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6205), via intramuscular administered in Arm Left on 25Feb2021 as dose 1, single for COVID-19 immunization. The patient had not received any vaccine within four weeks. No additional vaccines were administered on same date of the Pfizer Suspect. On 16Mar2021, the patient experienced illness. On 19Mar2021, the patient experienced fatigue. On an unspecified date in Mar2021, the patient experienced malaise, chills and cold. The patient reported she got her second COVID-19 Vaccine on 16Mar2021, and had been sick ever since then. She said she started feeling really, really, tired on Friday (19Mar2021), Saturday (20Mar2021), and Sunday (21Mar2021), but paid no attention to her tiredness. She said as time went on, she was very tired feeling, not feeling good, was cold, and had chills. The patient wanted to know how long the side effects can last. Therapeutic measures were taken as a result of chills (chills), cold(nasopharyngitis) using Naprosyn Sodium 220mg tablets (Lot Number: 1AE2412A, Expiration Date: Jul2022). The patient reported she put a sweater on when she was cold and had chills, and took some Tylenol (clarified as Naprosyn Sodium). She said she did not think there was anything else she could do for her symptoms. She said she told her friend about her symptoms, and her friend told her to report her symptoms to Pfizer. The patient reported sometimes she may take 2 Naprosyn Sodium 220mg tablets a day, and other days not take any at all. The patient reported her symptoms were no worse, but about the same. The patient asked if there was anything she can do for her symptoms. Adverse event did not require a visit to emergency room or physician office. The outcome of the event Illness was unknown while other events was not recovered.   No follow-up attempts are possible. No further information is expected.
ASTHMA FLARED UP A LITTLE AND PROGRESSIVELY WORSENED IN THE NEXT 24-48 HRS.  THE NEXT DAY, MONDAY,  I CONTACTED MY ALLERGIST AND WAS TOLD TO START 4 BREATHING TREATMENTS DAILY.  THE ASTHMA SYMPTOMS LESSENED OVER THE NEXT SEVERAL DAYS. I ALSO EXPERIENCED THE EXPECTED SYMPTOMS FROM THE SHOT, SUCH AS CHILLS WITH SEVERE SHAKING, FEVER 101.7, HEADACHE, MUSCLE ACHES, AND THE INJECTION SITE WAS RED AND SWOLLEN FOR A WEEK IN ADDITION TO 17 DAYS LATER THE INJECTION SITE IS  LIGHTLY DISCOLORED. IN OCT 2020,  I WAS HOSPITALIZED WITH COVID FOR 2 WEEKS WITH ASTHMA,  PNEUMONIA, AND ON OXYGEN.
Anxiety, panic attacks, heart palpation, strange taste in mouth, tingling throughout body right after shot, strange sensation with tongue, shakiness, pale cold hands, dry mouth.  Blood pressure was fine, elevated heartbeat.   Discharged but had rolling panic attacks throughout the day. Muscle and joint pain, headache
A spontaneous, non-serious report of FLUMIST given to 59-year-old was received from a nurse. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Fever between 101-102.1 for about 18 hours starting about 12-13 hours after the vaccination. I think I was given information about VAERS because I reported my symptoms to the v-check site. If this is not a real adverse event, please forgive my filling our this form.
Stomach pain one month; stomach is severe inflame; Severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTRITIS (stomach is severe inflame), ABDOMINAL PAIN UPPER (Severe stomach pain) and ABDOMINAL PAIN UPPER (Stomach pain one month) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041b21a) for COVID-19 vaccination.     Concurrent medical conditions included Heartburn, GERD since August 2011 and Iodine allergy. Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX), MAGNESIUM and CALCIUM for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced GASTRITIS (stomach is severe inflame). 10-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain). On 10-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain one month). At the time of the report, GASTRITIS (stomach is severe inflame) and ABDOMINAL PAIN UPPER (Severe stomach pain) had resolved and ABDOMINAL PAIN UPPER (Stomach pain one month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. the patient race was reported as Middle Eastern.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up information was received wherein events, medical history and batch number was added. On 09-Aug-2021: Follow up  received which contains no new information.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Tendinitis (In her elbow) and CIDP (Diagnosed for 20 years). Concomitant products included LEVOTHYROXINE, ALPRAZOLAM and OMEPRAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            patient got a steroid shot for the tendinitis in her elbow2 hours before getting the second dose of vaccine. Concomitant medications include Supplements. No treatment medication were provided.   This case was linked to MOD-2021-286520 (Patient Link).
Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator; No adverse event; They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator) 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 (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May) and PRODUCT STORAGE ERROR (Expiry date was 17-May-2023 and on 12-Jun-2023 the vial was initially stored in the refrigerator).    Concomitant medications were not reported.  The vial size was of 2.5 mL.  On 12-Jun-2023, the vial was initially stored in the refrigerator and was administered on same date.  12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date.  The vial did not undergo any temperature excursions.  Treatment information was not reported.  This case contains information for the 10th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live follow up received is Significant. Reporter, Patient details, Batch number, Expiry date, Event and Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Patient 1
SEVERE SWELLING AT INJECTION SITE, VERY PAINFUL, VERY RED AND HOT TO THE TOUCH. HEADACHE AND TIREDNESS. LASTED 3 DAYS.
arm pain @ inject site, nausea & intestinal cramping; approx 36 hrs later devel redness & itching of hands & forearms; later same day also devel redness, itching & swelling of feet; tx DPH;
Pinched nerve pain, dizziness, swelling of throat, numbness/tingling right arm, nausea, difficulty swallowing. Arrived nauseous and listed symptoms -- verbalized improvement. Stable, released from vaccination site.