chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine) outcome was unknown.        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.
Dose 1 on 1/4/2021:   Mild fever (99.1 - 99.5) from1/4/2021 to 1/17/2021 Red, swollen, itchy spot covering most of upper arm (between injection site and elbow) beginning 1/11/2021.  Mostly faded by 1/15/2021.  Did not feel like exercising, but otherwise able to do normal daily activities. Consulted my doctor for advise on getting second dose.  She advised OK to get second vaccine and to take antihistamine for 2 weeks and ice after injection. Dose 2 on 2/1/2021: Took antihistamine and iced as directed by my doctor.  Also took Tylenol as recommended by vaccination nurse.  Mild fever (99.5 - 100.7) from 2/1/2021 to 2/5/2021 Red, swollen, itchy spot covering most of upper arm (between injection site and elbow) beginning 2/2/2021.  Mostly faded by 2/7/2021.  Did not feel like exercising or doing light housework, but otherwise able to do normal daily activities.
56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-701125:Master case
Arm red, swollen, painful still after 2 days. Patient did not seek medical attention.
About 6 hours after 1st shot, pt woke up with irritated GI tract. Felt like severe stomach ache from reflux. Had diarrhea for 3 days. GI tract irritation and stomach pain persisted for the 3 days. Did not take anything for symptoms.
Pt called 09/21/16 and spoke with triage R.N. Pt states she had an allergic reaction to pneumonia vaccine, given 09/19/16. Pt reported redness, warm to touch, pain, shoulder pain, and stiffness in right arm. Pt reported having sx of chills and headache (09/19/16). Time of call 9/21/16 at 2:22 pm. PCP notified. PCP returned phone call to patient at 4:06 pm 9/21/16.
Patient started to feel very ill 8 days after receiving her first vaccination. Symptoms were nausea, dizziness, BP was 200/100. She went to the ED and was admitted for stroke protocol. Her blood pressure remained high for a few days and was started on Norvsac in the hospital. She has been following up with a cardiologist.
05/12/2021 tested for COVID due to labor & delivery, "This is a 24y.o. at 39w5d by c/o contractions getting progressively more frequent/stronger"; D/C'd home 5/13/2021.
Suspected vaccination failure; Very mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got both shingles shots. The patient got a very mild case of shingles.  The patient was grateful for the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Two weeks and six days after the first shot, my left arm became swollen, as if it was lymphedema, something I don't get, or perhaps gout.  After the second shot, the arm swelled more, with the hand looking like a balloon and a few days of tiredness.  I put on a few pounds.  Dr wanted to rule out a recurrence of breast cancer so she sent me for ultrasound, mammograms, and CT scans, with a week gap to take antibiotics for a UTI.  At a coincidental checkup with my glaucoma doctor, he said the intraocular pressure had shot up and added 0.5% Timolol eyedrops, a beta blocker.  In a few days, the swelling is less and the extra weight gone.
Left lower leg pain started on 3/9/2021. Doctor appointment on 3/12/2021 for worsening leg pain. Ultrasound - diagnosed with DVT. 3/12/2021 started on Eliquis.
1st dose on 14Feb2022, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments:  The patient self-reported this case. The patient stated that she had her 1st dose of Shingrix vaccine. The patient explained during the call that she was not received the 2nd dose yet. The reporter refused to provide name DOB or demographics.  The patient inquired if she should start again the 1st dose of Shingrix or continue and get the 2nd dose even after almost a year.  No additional information was provided for adverse event report.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
many people get sick after getting it; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via Social Media.  This case involves patients (unknown demographics) who got sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patients had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patients received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patients got sick (illness, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "No thanks seen too many people get sick after getting it and has baby Parts in it I looked it up a long time ago and it did"  It was unknown if the patients experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patients received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headache. A few hours later was dizzy and had difficulty swallowing and throat was becoming increasingly uncomfortable. Took Benadryl  again and headed to hospital. Blood pressure was extremely elevated upon exam. Throat tightness became somewhat improved after Benadryl. Blood pressure improved some after taking BP med. Doctor ruled it allergic reaction to vaccine and sent me home after 5 hours  with instructions to take Benadryl every 6 hours as needed.
Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included HRT since 2000 and Thyroid disorder NOS since 2010. Concomitant products included PROGESTERONE for HRT.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.). On 28-May-2021, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that NP- Thyroid 60mg  was used for thyroid and was given as concomitant medication. Treatment Information was not provided by the reporter.   This case was linked to MOD-2021-276129, MOD-2021-276128, MOD-2021-276130, MOD-2021-276103 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-Jul-2021 and contains NNI. Reporter stated there were no Adverse Events following this batch product's administration. On 03-Aug-2021: Significant follow-up received, patient demographics were added, dose numbers were added.
"Pain.  Severe pain that included the entire arm including the fingers, shoulder, axilla and the entire side of the body from the axilla to the waist.  Pain so severa tha with Ibuprofen and Tylenol it would wake me up at night if I  moved in my sleep.  Duration of pain. Severe pain for 4 days. Pain gradually subsided. The injected arm hurt for six weeks although not with that severity. Fever.  High fever and chills for about 4 - 5 days. Lower grade fever lasted for four weeks. Malaize. Severe for a few days. I started feeling ill on Saturday and was not able to get out of bed until Tuesday. Could not eat and forced myself to drink during those days. Malaise lasted for four weeks, like the fever. Pain gradually subsided after the first days. Each day was slightly better than the previous one. Malaise and fever subsided some and plateaued for weeks until quickly went away."
Itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 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 injection site itching. On an unknown date, the outcome of the injection site itching was recovering/resolving.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st Shingrix vaccination at an unspecified time and stated that it was a little itchy. The reporter declined to provide further demographic information.
pt was given 2 doses of the HIB by mistake due to combo vaccine. pt develped high temperature, lethargy and increased fussiness
Patient received vaccine 8/28/12. She is having symptoms of redness 3 by 5" swelling and hot to touch. NP prescribed ice packs and BENADRYL. If continues or gets worse got to ER.
PSA level went down(per graph of PSA); but after getting the vaccines his levels went down at least 40%. PSA went down for no other reason of why it happened twice and it was weird to him since he had the vaccine; A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 30Dec2020 (Lot number: Pfizer 1284) as dose 1, single and intramuscular, administered in arm, administration date 20Jan2021 (Lot number: EL8982) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (ongoing); "prostate cancer", start date: Dec2018 (ongoing); "Hypercholesterolemia", start date: Dec2018 (ongoing); "Weakened immune system" (unspecified if ongoing); "chemotherapy" (unspecified if ongoing). Concomitant medication(s) included: ABIRATERONE taken for prostate cancer (ongoing); LIPITOR taken for blood cholesterol (ongoing); DEXAMETHASONE taken for prostate cancer (ongoing); LOSARTAN taken for hypertension (ongoing). The following information was reported: PROSTATIC SPECIFIC ANTIGEN DECREASED (non-serious), outcome "unknown", described as "PSA level went down(per graph of PSA)"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "but after getting the vaccines his levels went down at least 40%. PSA went down for no other reason of why it happened twice and it was weird to him since he had the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states he has had prostate cancer and has been on treatment on that. Wants to report an unusual thing the Pfizer covid shot. His PSA was going up when on treatment and he stopped that because it kept going up. He was on a chemotherapy treatment and had stopped it because it wasnt working, not for a period of time, but after he got the vaccines his levels went down at least 40%. He noticed the levels going down twice when he got the initial Covid dose and the booster dose, his PSA level went down substantially for no other reason. Clarifies he had prostate cancer prior, way before getting the vaccine. This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.   No follow-up attempts are possible. No further information is expected.
Narrative: 44 YO male with PMH of anxiety, HTN, GERD, DM2, HLD, and PTSD reported abdominal twitching - started 48 hours after Pfizer COVID vaccine, first dose. Pt received first dose on 4/7/2021. At the time of reporting, pt received his second dose on 4/27/21. Both vaccine were administered without complications.
Urticarial reaction to pneumococcal vaccine. Treated with antihistamines.
The pt came in the following morning c/o redness, warmth and swelling about 5 inches below where she got the flu shot.  I suggested she be seen by mad and was do with cellulitis and given cephalexin.   To be followed up in 2 days
My son fainted 1 min after receiving his annual flu vaccine.  He was not injured when he fainted.  He recovered quickly and his BP and heart rate were within. normal limits 5 min after
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 1 DF. Other suspect therapies included RECOMBIVAX HB, ROTATEQ and VAQTA. On an unknown date the patient experienced were administered doses of improperly stored doses and no adverse events were reported. The outcome of were administered doses of improperly stored doses and no adverse events were reported is unknown. No further information was provided. Additional information is not expected.
Headache, nausea, body aches, fatique  these symptoms lasted about 48 hours Pain at injection site lasted about 4 days
09:35 pt fell forward after receiving vaccines pt proceeded to jerk back. Right side stiffened, eyes rolled back, color pale. Pt lowered to stretcher. Event lasted 30 sec. B/P 90/62. Pt had no recollection of the event. Medic called.
LEFT HAND SWOLLEN, MILD BODY ACHES, FATIGUE, CHILLS, 99.5 TEMPERATURE.  ALL OCCURRED ONE DAY AFTER SHOT AND ONLY LASTED FOR ONE DAY.  EVERYTHING BACK TO NORMAL 2 DAYS AFTER SHOT.
malaise, pain, slight fever; reaction much worse than experienced with gardasil doses 1 & 2. think it may be due to menactra vaccine given on same day; treatment rest, ibuprofen
The patient had his vaccine at 5:15PM and was fine all night. Woke up in the AM and had scratchy throat and was tired. Kept him home from school and at 10:40 AM 12/02 he reported his lips felt funny and his lips were swelling, and so I brought him to urgent care, and they checked his vitals and he ended up being fine and it didn't effect tongue or throat and that was the only thing that he experienced and he ended up being fine. The urgent care asked what he had eaten but it wasn't anything out of ordinary and just sort of felt like it was reaction to vaccine, and they checked vitals and didn't give him anything and the Doctor prescribed Epi pen but I haven't filled yet and so I don't know but they felt like it was a reaction to vaccine. Lip swelling lasted about 24 hours and it wasn't just his lips- it was area around his lips too like a circle around the lips starting at bottom of nose and all the way around.
TC from pt approx 1 1/2 hours after given Td injection and pt c/o "burning in stomach", "numbness in tongue", "lump in throat". Denies SOB, rash, advised to see PMD or be seen in ER. At 1435 TC to pt, pt states she didn't go to ER and she is feeling much better now, advised to go to ER or PMD immediately if problems persist or worsen.
Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
An error was made in administering this vaccine to a patient who is younger than 18 years of age. This vaccine is indicated for those 18 years and older.
I got a allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (I got a allergic reaction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ALLERGY TO VACCINE (I got a allergic reaction). At the time of the report, ALLERGY TO VACCINE (I got a allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID Diagnosis.         No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
pt recv vax 13OCT98 & 14OCT98 pt committed suicide gun shot wound to head;
Redness and swelling at the injection site as well as soreness when raising arm in both deltoid and tricep.
trouble sleeping, rashes on face 48 hours after vax, rashes are puss, went to urgent care and dr said they think it is contact dermatitis
n/a - a 10 ml single dose vial of saline was used for 2 vials of covid vaccine
How long do the side effects last from the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long do the side effects last from the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do the side effects last from the second shot). At the time of the report, VACCINATION COMPLICATION (How long do the side effects last from the second shot) outcome was unknown.                Concomitant medication use was unknown Treatment information was unknown
Facial edema (notable lips & (L) eye), SOB. BENADRYL & SOLUMEDROL given.