chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient had Allergies with medications, food and other products was reported as unknown.  Patient ever had COVID positive test was reported as unknown.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of Vaccination was reported as unknown.  Previously administered products included for Product used for unknown indication: COVID-19 vaccination (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 vaccination.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome 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 (Last night I administered an expired dose from a red top vial of Moderna Covid-19 vaccine.).    No concomitant drug were reported.   The patient received full dose.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown.  The patient experienced a similar event in the past was reported as unknown.  Symptoms improved or worsened was reported as unknown.  The vial size was 5.5 mL.  The vial was initially stored in the refrigerator was reported as unknown.  The vial did not undergo any temperature excursions.  No treatment drug were reported.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: 1st time getting Pfizer vaccine, Pt has a history of getting the Moderna vaccine. Upon immunization on 05/31, the injection site became red and swollen. The pt was given Benadryl and instructed to take Ibuprofen. On 06/03, the patient presented with redness/warmth at the site and continued to take Benadryl twice daily & Ibuprofen every 4-6 hrs. On 06/06, the site was bruised and yellow, no redness or swelling present.
Red skin, Itchy, Bright Red Blotches on neck, torso and groin, Trouble Breathing
Became ill with headache, nausea and vomiting and high temperature evening after immunizations.  Temperature 103 axillary.  Received Motrin.  Unable to eat due to nausea.  At approximately 5AM, temperature rectally 102.  Received more Motrin and went back to bed.  At 1-2 later pt had seizure.  Ambulance called pt taken to ER.  Diagnosis: Febrile seizure status post vaccination treated with Motrin/Tylenol.
itchiness at injection site/thought something bit her; Quite red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site/thought something bit her) and VACCINATION SITE ERYTHEMA (Quite red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site/thought something bit her) and VACCINATION SITE ERYTHEMA (Quite red). At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site/thought something bit her) and VACCINATION SITE ERYTHEMA (Quite red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment included some cream. The area was still a little red but less itching.
Pain, swelling, heat, redness at injection site, symptomatic right deltoid . Treatment.
Pt states reaction 24 hours later. Left arm red/purple bruised at injection site. No treatment. Pt came to clinic on 11/19/2001. Reaction increased down arm.
Headache, muscle pain, upset stomach, fatigue. Onset the morning after the vaccine, ongoing.
24-26 hrs post vaccine administration, started with sore arm, headache, restless sleep.
Severe sore throat  & loss of voice (result- swollen vocal chords, (hurt when I talked)- saw family doctor and ENT, had to go on steroids, took 6 weeks for pain to go away. Increased seizures- Seen by neurologist, had MRI done showing more gray areas.  Administered neuresta for increased headaches (didn't work) from increased seizures.   Seizures in face -I've never had before! Neuropathy pain increase/facial pain increase Sore arm with large lump
muscle twitching; lack of energy; weight loss; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3248, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 11Jan2021 09:45 (age at vaccination 39 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The had no allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. On an unspecified date the patient experienced uncontrollable muscle twitching, lack of energy, weight loss. The patient underwent lab tests and procedures which included weight was loss. Patient visited doctor or other healthcare professional office/clinic visit for reported events. The patient did not receive any treatment for reported events. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
L 1st phalange MCP joint pain that limits activity. The pain went away within 2 weeks of the first dose however it has been almost 6 weeks since the 2nd dose and it has not gone away. Pain medication (acetaminophen and ibuprofen) has not helped.
Employee reports 10 to 15 minutes after the injection she developed overall body itching and rash. Throughout the day she had wheezing and reported using her inhaler a few times during the day. She also took two doses of BENADRYL. The symptoms lasted a few days and slowly went away.
Pfizer COVID vaccines received on 3/24/2021 and 4/20/2021. Hospitalized at Hospital on 11/2/2021 discharged on 11/8/2021 Diagnosis of Unresponsive, Altered Mental State, initial blood sugar 40, acute respiratory failure with hypoxia, aspiration pneumonia of lower lobe (unspecified side), cystitis without hematuria first positive COVID was 10/12/2021 was patient at hospital discharged on 10/13/2021  extubated on 11/5/2021 and discharged to home with hospice
Coughing on and off for several weeks. At 38 weeks my water broke, legs very swollen, urine test for preeclampsia was negative. 38 weeks and delivered on March 3, 2022. Had so much fluid accumulated that I almost had preeclampsia.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. In 2015, between February 2015 and 13-APR-2015, the patients were vaccinated with a improperly stored doses of ROTATEQ lot # K001198 exp. date 25-OCT-2015 and lot # reported as "K00645", exp. date "09-MAR-2016". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had one episode of syncope after received HPV#1. Pt fall and hit the ground on his left forehead at waiting area. Pt was referred to hospital for head injury as per Dr. Spoke with pt regarding post ER f/u on 6/26. As per pt, he went to ER for head laceration on 06/25/14. Pt got 5 stitches done and discharged home w/o any medication. ER MD suggested for suture removal on next Monday 06/30/14.  Pt is feeling OK. Denies fever/pain/HA. Advised to keep suture site clean and dry. RTC for MD evaluation if fever or redness around suture site. Pt verbalized understanding. ER f/u appt made with PCP on 06/30/14 2:45pm.
Pt was playing at the park the day following her vaccine. It was a very humid and hot day. We were at the park for about an hour when we were getting ready to leave I notice her face was red with a rash. I then checked her stomach, back, and arms. They all were covered with red bumps but only her stomach looked like it was heat rash. After cooling down, her rash did not subside. I contacted her doctor they said to give Benedryl and send photos. I sent photos and was told it was most likely a viral infection and continue Benedryl or do Claritin. We switched to Claritin and after day 5 her rash started to fade.
Frozen shoulder  Parsonage Turner Syndrome COVID booster received in October 2021  Primary care referred me to orthopedics thinking it was most likely a rotator cuff tear.   Ortho has  done many things to try to help, ruling out a rotator cuff tear with X-rays and an MRI of the shoulder.   Ortho has done steroid injections, PT, a nerve block, X-rays of both shoulders and neck and MRI of shoulder
No adverse event -- the pediatric (orange-top) vial was accidentally given to patient for his 2nd adult booster. The vial was not diluted and 0.3mL was given. I spoke with Pfizer directly and based on the undiluted volume and concentration, the patient received a 30mcg dose (the correct Pfizer adult dose).
Clinical Summary Patient is a 57 y.o. female with a history of HTN, DM2, CKDIV who was admitted to hospital from 11/8/22 to 11/13/22 for abdominal pain was diagnosed with H.pylori infection. Re-presented to hospital 11/14/2022 with increased upper abdominal pain and N/V. She was found to have acute cholecystitis, admitted to surgery. Consulted for pre-op evaluation and medical management. Underwent cholecystectomy 11/15/22. Course complicated by acute encephalopathy, likely secondary to delirium and uremia which resolved. Renal function worsened, so dialysis was initiated 11/22/22 with improvement in encephalopathy.  Patent then contracted COVID with hypoxia and required steroids and O2 then completed therapy and discharged to home.    1. COVID-19 infection: Unvaccinated.  Tested positive on 11/24/2022.  Minimal cough, with no phlegm.  Chest x-ray 11/26/2022 with patchy infiltrates at the periphery of the mid and lower lungs. Multifocal pneumonia versus developing pulmonary edema. Small bibasal pleural effusions.  Slightly hypoxic and given 5 days decadron with significant improvement. Stopped steroids early due to significant hyperglycemia with improvement in symptoms. Isolation complete on 12/5/22.   2. Uncontrolled DM2 with neuropathy and nephropathy: A1c 8.1, could use better control outpatient. With significant hyperglycemia >500 with decadron. 12/2/22 is last dose of steroids. Hyperglycemia resolved with stopping steroids.  3. Tooth pain: panorex 12/2/22 pending. Previously evaluted outpatient. Lasting last 6 months. Panorex negative for abscess. Will need outpatient follow up with dentistry 4. AKI on CKD stage IV: Likely ATN after decreased PO intake and vomiting and intra-op/post-op hypotension. Cr baseline 2.5 likely due to diabetic and hypertensive nephropathy. Cr 3.3 on admission, peaked around 6.5. IR HD cath placed 11/21/22, HD initiated 11/22/22, continued per nephrology.  Patient does have an outpatient dialysis chair arranged beginning 12/5/22.  5. Hospital acquired pneumonia: Patient febrile and hypoxic with new productive cough on 11/22/22. CXR with questionable LLL infiltrate. Unable to rule out aspiration given fluctuating mental status.  Blood culture no growth.  Urine antigens negative.  On Levaquin, ended 11/27/2022. 6. Cholelithiasis with acute cholecystitis: presented with RUQ abdominal pain and N/V. Admit US revealed distended GB with sludge/stones, CBD 4mm. S/p cholecystectomy 11/15/22. S/p IV abx. Follow up with surgery in 2-3 weeks. 7. Glaucoma: Patient reported pain and worsening of blurred vision 11/17/22. Ophthalmology evaluated, resumed glaucoma medications, follow up outpatient. 8. H. Pylori infection: Diagnosed 11/1/22. Triple therapy started 11/13/22, continued on admission, ended 11/27/22 9. Uncontrolled HTN: Continued Norvasc and BB. Monitor. Stable.
Patient had MENVEO shot and after 10 minutes he was dizzy. After sitting upright and drinking he was fine and left. I called after a few hours & he was doing good.
Patient received 1st dose Pfizer COVID19 vaccine @ 10:30 AM Around 7PM of the same day she developed irritation on the right side of her tongue followed one hour later by swelling of the right side of the tongue with change in voice and difficulty swallowing.  Presented to the Emergency Department shortly after and symptoms resolved rapidly with administration of Tranexamic acid @ 0001 on 5/23/21.  On the morning of 5/23/21 she had no further symptoms and there was no recurrent tongue edema.
The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) 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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 10 out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:
Information has been received from a 68 year old female referring to herself. The patient's pertinent medical history and concurrent conditions were not reported. On 22-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported). No concomitant medications were reported. The patient reported on 22-FEB-2016, after receiving PNEUMOVAX 233 in her left arm, her arm was "very sore and swollen, hot to the touch, with red blotchy bumbs that looked like hives". Patient also experienced difficulty moving her left arm. Patient sought medical attention by visiting physician's office. The outcome of the events pain in extremity, urticarial, rash macular, peripheral swelling, movement disorder and skin warm was reported as recovered/resolved. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Quarter size area began on 2/5/23 to the outer area of L thigh (SQ) area. Had few "dot" like areas. Tender to touch, red. No fever noted. Still present today.
Lymph nodes swelled up in armpit in 3 days, lasted 2-3 weeks tender noticed when you using deodorant. I did not go to the doctor.
SYMPTOMS: Diaphoretic, Headache, Nausea, Dizziness, Elevated Blood pressure, low heart rate. Sent to ER, they initiated an IV and gave benadryl, pt was there for a number of hours.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with VAQTA (lot #, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received on 07-JUL-2015. This report refers to a 13-month-old patient of unknown gender who on 05-JUN-2015, was vaccinated with improperly stored VAQTA lot # K018181, expiration date: 04-JUN-2017 (dose and route of administration were not provided). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning a 10 year old male who on an unknown date was vaccinated with MMR II (Enders-Edmonson, Jeryl Lynn, Wistar RA 27/3).  The consumer reported that the patient developed autism after getting MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  The caller believes it was "overnight."  Caller reported a "woman in a parent group mentioned everyone she talked to whose kids have autism claimed it happened overnight after they got MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  There was no product quality complaint.  Upon internal review, autism was determined to be an other important medical event.  No further information is expected.
At approx 1025 pt complained of dizziness, to another patient in waiting area who notified staff. On assessment, pt appeared to be holding his breath, and staring straight ahead. He was shaking mildly, VSS-BP 120/90, P-76, R-22, Sat 97%. Gluc 135. EMS was called. Pt began to come back to baseline, reported seizures as a child, but none since. Reported had "odd" feeling, headache, and feeling faint. Patient taken to Medical Center for further eval and treatment.
Per husband. Patient complained of syncope and he is  not sure if wife passed out or if it is was just dizziness. He called 911 and by the time pharmacist was notified emergency personnel had taken over the seen. All accounts are based on husband's recall of events. Attempted to follow up with patient with no luck. Left voicemail for them.
Soreness of facial muscles at the jaw: Started 6/30/2021 at nighttime.  Weakness and pain of facial muscles at the jaw while speaking or eating: Started 7/2/2021 at nighttime. Acute onset of emotional lability: Started 7/3/2021 in morning around 10:00 a.m. I don't believe this adverse effect is due to the bipolar II disorder, as I've been taking all of my medications, including psych meds, as prescribed daily. I have experienced a similar level of intensity of emotional lability, like this current event, when I had occasionally stopped taking my psych meds cold turkey. However, I'm taking my psych meds consistently now. Also, my menstruation is due to start within the next few days, and I tend to be more emotional prior to my period, so that may (or may not) possibly have some sort of effect in combination with the COVID-19 vaccine.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches occasionally.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested Concomitant medications included ibuprofen for headache. On MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID a few days later) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID a few days later) (seriousness criteria medically significant). At the time of the report, COVID-19 (Diagnosed with COVID a few days later) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. 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. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Causality for event COVID-19 is not applicable; Sender's Comments: Causality for event COVID-19 is not applicable.
My shot reacted from a pneumonia shot. I end up in the hospital 5 days. It messed my whole body up.
Patient received a fourth COVID  19 vaccine dose during an office visit to see his primary care provider.
Swollen lymph nodes in right side of neck. In front of ear. Per local Emergency Room, CT scan showed everything ok. Visible swelling and tender to touch for 4 weeks now.