chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Near syncopal episode after COVID19 vaccination. On direct questioning patient does not recall the episode, he does remember receiving the vaccination, but has no recall of later events. Patient was being observed after administration of COVID19 vaccination, and while being observed, he became less responsive, and he was noted with a decrease in his heart rate, and decreased strength of pulsations, a rapid response was initiated and he was transported to the Emergency Department (ED).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 048L219) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) Negative; (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 16Dec2022 to 21Dec2022.
pt recv vax MAY96 & 1mo later pt exp hyperglycemia w/blood sugar levels in the three hundreds;No further details were provided;
punding headache, fever, chest pain, dizziness, body and joint pains of stabbing type
SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fatigue. This report was non-serious.
RN ATTEMPTED TO VACCINATE PT ON THE LEFT DELTOID, BUT MET RESISTANCE UPON ADMINISTRATION AND DID NOT INJECT. RN WITHDREW THE NEEDLE/SYRINGE AND USED A NEW NEEDLE/SYRINGE ON THE PATIENT
Patient felt really tired, body aches, large area on her arm the became red, hot and painful that is lasting  over the past 4 day along with hot and cold flashes.
Patient received additional dose of moderna from primary series stock instead of moderna bivalent booster. Patient already completed primary series and had received one booster dose prior. Per visit patient should have been given second booster of moderna bivalent stock.
4" swollen sore circle at injection site lump in arm, total body muscle & joint pain, eye lids swelled from brows to eyelashes & sagged heavy on lashes 2 days. Slowly went away over several days.
approx 12 hours woke up to left knee swelling/stiffness/ could barely bend knee/great difficulty walking. Also fever to 100.4 for about 24 hours.  Knee pain/swelling persisted  Seen by urgent care physician on 2/5 am regarding knee who prescribed prednisone; x ray of knee showed small to moderate knee effusion. Prescribed Prednisone 50mg daily for 4 days.  I took 50mg on Friday evening, 25mg on Saturday and Sunday.  Swelling reduced after first dose of prednisone.  Physician at Urgent care did not believe that swelling to knee was related to vaccine.  Saw orthopedic doctor by Tuesday and received steroid injection to knee.  I have a history of left knee issues with some swelling but never to that extent and have had no issues since.
cough; runny nose; sore throat; chills; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (in the fall). Previously administered products included for Product used for unknown indication: Pfizer vaccine in January 2023. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concurrent medical conditions included Blood pressure high and Hypercholesterolaemia.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In November 2023, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, COUGH (cough), RHINORRHOEA (runny nose) and CHILLS (chills) had not resolved.            Patient had Pfizer vaccine last January as she could not get it in the fall because she had pneumonia.  Concomitant medication included unspecified medication for blood pressure and cholesterol.  It was reported that patient was not sure if it was her third or fourth dose.  It was reported that patient had Spikevax vaccine on Monday afternoon. On the same night, patient started with cough, Sore throat, Chills. Symptoms were ongoing at the time of reporting. Patient still had coughing but did not had sore throat anymore, but she had a runny nose and a cough at the time of reporting.  Patient was treated with Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2023-750647 (E2B Linked Report). This case was linked to MOD-2023-750647 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750647:Same patient, different product
Fever 103, urticaria, sore throat, joint pain devel same day p/immun;
Information has been received from an unspecified reporter referring to an 13 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
I started feeling nauseous right away, so I had to wait for 30 min. Later that night I started throwing up. I was sick for almost 3 days. I rested a lot because I couldn't move because I was so tired, achy, really cold and I threw up everything I happened. I waited to contact my doctor in hopes that it would go away, but I couldn't stop vomiting. By that Monday, I decided to get help. I was told to go to the hospital to get rehydrated. They did a CT Scan and they didn't find anything. I am waiting to follow up with my doctor since I am still throwing up.
On 09/13/12 patient (pt.) reported experiencing nausea & sweating (all over "wringing wet") within 8-9 hrs. & lasting 4-5 hrs after receipt of Hepatitis B #1 dose of vaccine. No additional vaccinations were received on 07-13-12. Pt. did not seek medical care.
Per patient- She had a rash + fever @ time of ER visit. On 3/3/09 zero rash zero fever-body-aches.  Per patient.
Pt recvd vax 17FEB92 exp viral gastroenteritis; FEB20 ataxia & lateral nystagmus, 26FEB92 dx = viral cerebellitis;
Back very sore; ankle ache, back, knees and hips sore; Headache; Fatigue/exhausted,Weakness; injection arm, thigh and calfs sore / body aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back very sore), ARTHRALGIA (ankle ache, back, knees and hips sore), HEADACHE (Headache), FATIGUE (Fatigue/exhausted,Weakness) and MYALGIA (injection arm, thigh and calfs sore / body aches) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced BACK PAIN (Back very sore). 04-Jan-2021, the patient experienced ARTHRALGIA (ankle ache, back, knees and hips sore), HEADACHE (Headache), FATIGUE (Fatigue/exhausted,Weakness) and MYALGIA (injection arm, thigh and calfs sore / body aches). On 08-Jan-2021, BACK PAIN (Back very sore), ARTHRALGIA (ankle ache, back, knees and hips sore), HEADACHE (Headache), FATIGUE (Fatigue/exhausted,Weakness) and MYALGIA (injection arm, thigh and calfs sore / body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medication were reported  Treatment was not reported  The vaccine recipient stated that " On Sunday I moved many heavy bags up the 3 flights of stairs to my apartment and took several trips so my legs may have been slightly sore before that and the shot just exacerbated the soreness."     Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received and reporter information updated, patient demographics updated, vaccine information updated, new event added, and event outcome updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
death: At 1745 staff alerted writer to come into resident's room because he was not doing well. resident's vitals as follows; Temp 97.3, BP 114/71, HR 141, RR 42, O2 saturation 35%. Resident was ashen in color and was unresponsive. Hospice was called. The DON was updated on resident's change in condition and a confidential message was left for the professional guardian,
Pt recv vax on 2/19/99; on 2/21/99 pt exp fatigue, myalgias, arthralgias, unsteady gait, right eye nystagmus; dx=obsiclonus
HA, chills, fever, body aches, swelling at injection site.  Symptoms resolved after 48 hrs
Chills, fever and intense headache.  Started at 9:30 PM and lasted through the night.  8:00 Am next day felt much better but did have the upper teeth sensitive to cold and heat.  This lasted half a day.
Headache, Myalgia & Diarrhea Narrative:  HAD TO TAKE DAY OFF WORK,  PROBABLY 2
Approx 20-25 mins p/vax admin pt became unresponsive head fell forward in car seat eye rolled back; mom attempted to arouse but pt woudl just open eyes for a few seconds; attempted to get pt to stand;
Pfizer Dose 1 1/14/21 (NA) Pfizer Dose 2 2/4/21 (NA) Pfizer Dose 3 10/27/21 (FF2593) COVID Positive 1/15/22 COVID positive 2/6/22  2/5/22: Patient is a 101-year-old female with past medical history of arthritis, osteopenia, hypertension, and atrial fibrillation.  She presented to the emergency department on 02/05/2022 with chief complaint of loose stools and lower extremity edema.  Patient is extremely hard of hearing /essentially deaf and is also a poor historian.  Therefore, history is limited to my discussion with the ED provider. Patient's only complaint when I attempted to talk with her was generalized weakness.  She kept asking repeatedly why it was difficult for her to stand on her legs anymore. In the emergency department, her vital signs were normal and stable with the exception of some mildly low blood pressures.  Her lowest recorded blood pressure was 89/73 but this did improve.  X-rays of her lumbar spine were notable for osteopenia and unchanged compression deformities with no acute findings.  Chest x-ray was notable for bibasilar atelectasis or infiltrate.  CT abdomen and pelvis with contrast was most notable for fecal impaction creating colonic and small-bowel obstruction and pneumatosis of the cecum and ascending colon.  There were multiple other incidental findings as well.    Her lab work was otherwise unremarkable.  General surgery was consulted from the ED.  They recommended conservative management with laxative and enemas.  In the ED, the patient was administered ertapenem for possible colitis given the pneumatosis was mentioned on CT.  She was also administered a Fleet enema and 500 cc of NS.  She was admitted for further monitoring and management due to her old age, frail condition, and borderline hypotension.  2/6/22: Pt was admitted and was started on bowel protocol  She subsequently successfully had a large bowel movement  She remains vitally stable and voiced readiness to discharge back to the nursing home  Antibiotics for UTI  Discussed with her daughter over telephone  Code status DNR  f/u pcp within 3-5d  CBC, CMP post discharge
mom called couple hr p/vax & stated pt was shaking the hands & head for mins.- called ambulance, but when they arrived pt was OK
Rash on top of hands within 1 hour  Peeling skin on the back of wrists within 2 hours, rash is still there  Rash around neck, back of ears and the side of neck   Threw up 9 times one day and was severely dehydrated, had motion sickness and could not keep water down. A nurse had suggested IV to stay hydrated but a herbalist suggested homeopathic medicine for nausea and motion sickness instead
pain to inj site w/in 8hr of inj;swelling & redness to upper lt arm 2/3 of arm circumference & approx 10cm length, starting next day 12FEB98, diminishing by 13FEB98;
Accidently used a wasted extra dose  that left in a COVID vial  and mixed it  with 1.8 ml  Normal Saline. Thinking I was mixing an intact vial. A dose was withdrawn from the affected vial and administered to the patient.
On the afternoon after the vaccine I noticed extreme fatigue. It lasted all that afternoon and through the next couple of days. It lasted about four or five days in total.
Information has been received from the authors of a published literature article, titled as stated above, regarding a male patient of unknown age.  The patient's current condition included eczema, microthrombocytopenia and wiskott-aldrich syndrome.   On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (route and dosage information was unknown) as prophyaxis.  The patient developed bacille CalmetteGuérin lymphadenitis.  On an unspecified date the patient underwent a hematopoietic stem cell transplantation.   The outcome of lymphadenitis was unknown. The authors considered lymphadenitis was associated to bcg live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience  This is one of two reports from the same literature article (2206USA004823)
Suspected vaccination failure; Have had shingles 3 times; 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.  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) 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.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles 3 times. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
I woke up on the 31 of January with general symptoms of malaise, head congestion, fever late that night into the next day that was over 100F., diarrhea that lingered for a month. I stayed in bed for a couple of days trying to get in touch with my doctor after I had taken a home COVID-19 test that came back positive. I was unable to reach my doctor as it was the New Year holiday until the middle of the week, I was advised that it was too late to take the antiviral. I had received an MRNA influenza shot in November, I am a part of a study. I was tested to make sure I had not gotten the flu that was also negative. I do still have a lingering cough.
Hives, redness and itching to face. Cold compress applies and anti-histamine taken. Symptoms resolved within 10 minutes.  Symptoms occurred again on 2/17/21.
This spontaneous report was received from a nurse referring a patient of an unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 07-JUN-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 5/0.5 mcrg/ml, once, intramuscular (lot # K008986, expiration date 01-APR-2016). No adverse effects were reported. Also was reported that the nurse called to inquire about the stability of expired RECOMBIVAX HB and informed that they had data to support the potency of the vaccine. No product quality complaint was reported. Additional information has been requested.
Injection site rash warm to touch; injection site swelling; Injection site red; Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site rash warm to touch), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site rash warm to touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE WARMTH (Injection site rash warm to touch), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site red) 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 provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Patient received vaccine (HPV9) and within seconds he start feeling dizzy and complaining of headache and blurry vision - as minutes passed his face color change and became pale and headache was worsening - patient was alert and responding to questions but in pain. Blood pressure drop from ~126/69 to 87/38 - decision was made to use EpiPen due to concerns for anaphylaxis - patient started to recovering from symptoms slowly within minutes after EpiPen - blood pressure back to 100/57
Administration after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA570A, expiry date 30th June 2022) for prophylaxis.   On 12th July 2022, the patient received Menveo. On 12th July 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: Medical assistant called to report that that 16 years old patient was vaccinated with an expired Menveo vaccine one day before the reporting date. The reporter stated that the vaccine was already discarded so no expiry date was available, but upon Lot provided expiration date shown on SFS was 30th June 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo vaccine, which led to expired vaccine used.
shingles; Left side broke out in rash; raised rash; Itching; White raised areas, hives; painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles, itchy rash, raised rash, pruritus, hives and pain. On an unknown date, the outcome of the shingles, itchy rash, raised rash, pruritus, hives and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, itchy rash, raised rash, pruritus, hives and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient went and took vaccine shot as patient doctors said. 3 days later patient left side broke out in rash and itching. The patients experienced white raised areas that turned into hives. The patient was fighting this for almost a month. The patient said very painful and nothing gives relief. The patient did not had shingles before. The reporter said before taking vaccine talked to your doctor and hoped he/she never go through this again.
Diffuse rash, tongue, itch, shortness of breath/wheezing (?urticaria) rash on arm, trunk.
Covid-19 booster dose of Moderna given from a vial that expired 03/18/2022.   Medication error reported to Moderna . Notification received August 29, 2022 stating, "Analysis of the vials associated with your storage excursion is complete.  The vaccine administered on August 23,2022 from lot number 012H21B maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
1. Muscle twitching on the left side of my head  2. Soreness/tenderness on the injection site of the left arm  3. Body aches, fatigue, lack of appetite, inability to sleep 4. Decreased left shoulder range of motion, pain on the anterior shoulder/ left pectoralis region 5. Fever