chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.; The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.) and PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the Moderna Covid-19 vaccine monovalent 6months-5 years which was delivered on 12-Dec-2022 was administered to patients after 12-Jan-2023 with last dose given on 13-Apr-2023.  Treatment medications were not provided.  This case was reported for patient 1 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-721727, US-MODERNATX, INC.-MOD-2023-721731, US-MODERNATX, INC.-MOD-2023-721730, US-MODERNATX, INC.-MOD-2023-721732, US-MODERNATX, INC.-MOD-2023-721729 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721730:04th patient case US-MODERNATX, INC.-MOD-2023-721732:05th patient case US-MODERNATX, INC.-MOD-2023-721729:6th patient case US-MODERNATX, INC.-MOD-2023-721727:2nd patient case US-MODERNATX, INC.-MOD-2023-721731:3rd patient case
Report made within hours of discovering error. Parent will be contacted to notified to monitor for potential side effects or concerns. None reported at the time of this report
reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
24hrs post: injection site tenderness, subclavian swollen and very tender lymph node on same side of injection, mild on/off headache. 48hrs post: extreme fatigue, swollen lymph node, mild on/off headache. Currently 11 days post and lymph node is still swollen.
Patient experiencing minor muscle pain and soreness at the injection site for 3 weeks. No swelling or redness in the area.
First injection: developed low fever, chills, body aches, pain in right shoulder, pain at injection site and swollen glands. Prescribed antibiotics for swollen glands. Second injection: developed fever of 102 for 12 hours, aches, headache, pain in right shoulder intensified and swollen glands in neck intensified. Shoulder pain became so bad after 2 weeks I could not lift my right arm. Seen by orthopedics and told I had bursitis. Received injection in right shoulder. I completed 8 weeks of physical therapy with ongoing should pain today. Also saw doctor for swollen nodes in right-side of neck that continue to cause discomfort. CAT scans and MRI performed. No cause found for continued swelling. Continue to have pain in shoulder and lymph node swelling/discomfort has not subsided since first occurrence. After the first course of antibiotics. I returned to my family doctor about 6 weeks later and told them I continued to have uncomfortable lump in my neck. They performed an X-ray and gave me a referral having found no cause for the swelling. I have another appointment on 11/29/2021 for monitoring of the lymph node.
Patient received a third booster dose of the COVID- 19 vaccination.  Patient came into clinic with vaccination card that was not updated.  Patient later stated that he has 2 and must have brought the wrong one.  Vaccinator reviewed card with him and based off the vaccination card he brought- patient was due for another vaccination.  Patient tolerated dose well, no concerns noted from patient.
CHIEF COMPLAINT: Confusion. HPI: 56-year-old female with chronic lower back pain who has been vaccinated for Covid with Pfizer in May 2021 (has not received her booster shot yet p/w acute onset confusion today. She started having covid 19 symptoms Friday(5 days PTA) with fevers/chills/dry cough/feeling queasy/fatigue/nausea/no appetite/bodyaches in the setting of multiple family members testing positive for covid. She tells me that she has been taking Tylenol every 4-6 hours for fevers along with DayQuil NyQuil for these past few days.  She has been feeling very dizzy and has been in her bed most of the time.  She also reports SOB and intermittent chest tightness for the last few days. She has not been tested for COVID-19 yet. Per EMS, She woke up today perseverating her childhood phone number and therefore her daughter who lives with her called 911. Pt states she does not remember saying that.   Per EMS, BP 75/50 after 500 ml of normal saline. Multiple Tylenol bottles noted in the house per EMS.  In ED, she has temp of 100.8, hypotensive but resolved and normotensive after  2L of LR bolus/stating 98% on RA Rapid covid 19 test positive/flu rsv negative CBC with leukopenia and mild thrombocytopenia (plt of 132) d/t acute viral illness Ddimer of 0.44. BMP K of 3.3/normal Cr/mg/LFTs/Tylenol levels normal/normal lactate/salicylate and etoh negative.  VBG normal pH Portable chest x-ray w/ Nodular opacity right hilum (corresponds to pulmonary infiltrate superimposed on right interlobar artery on CT angio) CT angio negative for PE but notable for minor patchy peripheral ground glass opacities consistent with COVID-19 pneumonia. She was given Toradol x 1 dose for fever/trazodone for sleep and zofran for nausea HOSPITAL COURSE: 56-year-old female with chronic lower back pain who has been vaccinated for Covid with Pfizer in May 2021 (has not received her booster shot) admitted for covid 19 PNA complicated by hypotension and transient confusion resolved after fluid resuscitation.     COVID 19 PNA w/o sepsis w/o hypoxia Leukopenia  Metabolic encephalopathy, resolved Hypotension, resolved CTA w/ b/l infiltrates, no PE. Patient monitored and given IVF, anti emetics, tylenol.  She remained off 02 during her stay.  She was febrile here, but SBP normal. Patient elected to go home as we were only providing her symptomatic relief.  She was instructed to buy a pulse ox and return to the ER if o2 drops below 90%.  Given script for tessalon perles and zofran.
Information has been received from an office staff concerning a female who in June 2008, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported) instead of ZOSTAVAX (Oka/Merck) most likely. The reporter said there was no way to confirm since lot number was not documented on file. No adverse experience reported. Follow-up information was received from the physician noted that he had no idea why VARIVAX (Oka/Merck) was given instead of ZOSTAVAX (Oka/Merck), and that it was at another office. Additional information is not expected.
He notes approx 3hrs after felt transient lightheaded, fatigue, malaise which lasted few hrs and resolved without tx.  2 days later developed bilat otalgia, redness to periauricle, tinging and muffled hearing and fine papular rash posterior ears, mid face, nose.  Small patch to L arm only which resolved.  No airway compromise, respiratory complaints.  .
stroke and MI came in with symptoms of stroke but symptoms for 24 hours so did not receive tPa. MRI showed brainstem infarct. Statin was increased and started on plavix 75 mg daily for 3 weeks due to small stroke with low NIH. Patient came back in 3 days later due to STEMI and went  into cardiac arrest. patient died after 1 hour of resuscitation
Diarrhae; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhae) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 3:00 AM, the patient experienced DIARRHOEA (Diarrhae). At the time of the report, DIARRHOEA (Diarrhae) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated she took some coffee after the event. No other treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhae) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 3:00 AM, the patient experienced DIARRHOEA (Diarrhae). At the time of the report, DIARRHOEA (Diarrhae) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated she took some coffee after the event. No other treatment information was provided.
Increasing low back pain which became severe by 10/3. Started having temp up to 101 on 10/4 with extreme weakness; could not get out of bed. Saw doctor on 10/4 and got urine test which was neg. Temp and severe low back pain and extreme weakness continued. Saw doctor on 10/7 and started on 5 days of 10 mg Prednisone, 6-5-4-3-2-1. Temp back to normal by 10/9 but severe back pain and weakness continues to be a problem as of the date of this submission, 10/11. If it does not improve in a few days will return to doctor.
Within 14 hours of receiving the second injection, I was awakened feeling ill and sweating with flu symptoms and a fever. Within 24 hours, the area around the injection became very red, hot and swollen and it was difficult to move and lift the arm. Glands under the arm became tender and swollen. I had trouble sleeping due to the fever and body aches, despite taking long-acting paracetamol twice daily. These symptoms persisted for 3-4 days.
received less than the full dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Engerix-B liquid leaked during the administration of Engerix-B to a patient.  The patient received less than the full dose of the vaccine, which led to incomplete dose administered. The reporter did not consent to follow-up.
Patient was inadvertantly given 0.3ml of undiluted Pfizer vaccine. Patient was contacted immediately after this was discovered and notified of the error. He was told what adverse effects to watch for and what do if he experienced them. He was given my cell phone number to call if he had any further questions. I will plan on checking in with him later today and several times over the next few days/weeks.
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
Onset of muscle aches 24h after vaccine. All other symptoms started 48h later and have now lasted for an additional 48h. Zofran ODT for N/V (3 doses taken over 2 days). Joint/muscle aches Nausea Hiccups Vomiting Abdominal Pain Fever Headache Dizziness
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931982, 20210932036, 20210932240, 20210931810, 20210932567, 20210931844, 20210931951, 20210932874, 20210933129 and 20210933076.
. He needed help with ADLs, which is currently provided by HHA and family members; Vomiting bile; unable to stand / Imbalance; loss of hearing right ear /Asymmetrical right sensorineural hearing loss; severe vertigo; Labyrinthitis of Right Ear; Dizziness; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 14:15 (Batch/Lot Number: EN 5318) as DOSE 2,SINGLE (at the age of 74 years) for covid-19 immunisation. Medical history included radical prostatectomy removing prostate cancer, appendectomy, tonsillectomy, type 2 diabetes, adhesive tape and Covid-19 in May2020. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); losartan potassium (COZAAR); rosuvastatin calcium (CRESTOR); and dulaglutide (TRULICITY), all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine, codeine and experienced allergy. The patient received the first dose of BNT162b2 (Lot: EL 3248), on an unknown date, given in arm left for Covid-19 immunisation. The patient experienced vomiting bile, unable to stand/ imbalance, loss of hearing right ear /asymmetrical right sensorineural hearing loss, severe vertigo, labyrinthitis of right ear and dizziness on 12Feb2021 at 01:00. It was further reported that patient was transported by an ambulance to emergency department on 12Feb2021, admitted at 11:27AM. Vomiting bile, unable to stand, loss of hearing right ear, severe vertigo. Admitted as inpatient based on ED Disposition Decision. Discharge: 16Feb2021. Referred to rehabilitation, diagnosis was Labyrinthitis of Right Ear, Asymmetrical right sensorineural hearing loss, dizziness, imbalance. As of the date of this report, he have chronic symptoms. He was receiving services of a Home Health Aide(HHA) and require a cane to maintain stability. He needed help with ADLs, which is currently provided by HHA and family members. The patient underwent lab tests and procedures in May2021 which included Covid-19 Antibody positive test via blood test, and on 20Au2021, Covid -19 Antibody, Total Spike was positive (blood test). The outcome of the events was not recovered at the time of the report.
Patient's mother called explaining that within 24 hours of receiving the vaccine, the patient had bright/flashing light in both eyes, numbness in his fingers and toes, chest pain, and stomachache. These events did resolve by June 9th when she called me however he still had a stomachache. I told her that these events would not be expected and that she needed to follow up with his primary care doctor. He received his first shot from us as well with no complaints
1100- Menactra 0.5cc given in error. Immunization Program contacted; discussion ensued regarding the fact that expected reactions would be the same as those noted with other inactivated vaccines; Discussed this with parents; VIS given. Advised to call if any further questions or concerns.
within 15 minutes of vaccine, symptoms of lethargy, pallor, weakness, and tightness in throat.
I got a fever the next morning and shortness of breath. The fever went away after 36 hours but the breathing difficulties continued to get worse. I was admitted to the ICU through the ER at the Hospital on May 25th for a Myasthenia gravis crisis.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to multiple unspecified patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On multiple unknown dates (ranging from December 2014, January 2015, and February 2015), the patients were vaccinated with doses of improperly stored GARDASIL (lot# J009788, with expiration date 17-MAR-2016 and lot# K004205, which expiration date 12-JAN-2017, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
headache, tiredness  nausea ,dizziness ,lethargic, hives on the 4th day in her belly and back and itchy and she also got hives in her face but went away the following day. on 9 day got chills and she had not left the bed for nothing had no energy pt said . the arm and local area of injection was fine no pain no redness to the point that she did not take the band aid off till the day she reported the event on 12/15/20
Vaccine given 930 AM on 3/2/09: with 1 1/2 - 2 hours later cried, high pitch voice; lasted x 4 hours with 15 minutes cat naps. Child would woke up and cry, high pitched voice; cries at feeding decreased appetite.
The shot itself was extremely painful. It felt like I was injected with shards of broken glass and I said this to my husband immediately. I have never had a shot that painful. My first shot in the series was not painful at all and I had no reaction.  I soon developed an extremely painful arm and I developed the covid rash. My arm was very swollen and extremely hot. I was very sick until Thursday when I woke feeling better although my arm was still a mess. The rash and swelling lasted about 6 days although the arm was still sore.  The side effects I experienced I guess were normal but not the feeling of the shot.  The main unexpected feeling was how painful and harsh the shot itself was.  It truly was like nothing I have ever felt before.
26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021; Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021) and PRODUCT ADMINISTRATION ERROR (Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017Z21A and 017Z21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021) and PRODUCT ADMINISTRATION ERROR (Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine). At the time of the report, OFF LABEL USE (26May2021 and got the first dose of the Moderna vaccine,second dose of the Moderna vaccine on 23Jun2021,first dose of the Pfizer vaccine on 22Apr2021) and PRODUCT ADMINISTRATION ERROR (Patient got 2 doses of Moderna vaccine and one dose of Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
On 08/18/2021, right after the injection, I tasted metal in my mouth. On 08/20/2021, I had fever chills. I came down with a sore throat, and cough and it progressively got worse. On Monday, A coworker at work was positive for COVID. I went to urgent care to get tested on, 08/23/2021, for COVID-19 and it was positive, and I started quarantine. On 08/27/2021, I went to urgent care to get the immunotherapy vaccine. It took care of my fever, muscle pain, headache, abdominal pain and I am not as fatigue as I was. I still have the cough. I have mostly recovered from the AEs; the cough still remains.
Narrative: COVID infection following COVID vaccine series 04/06 Janssen, dose #1 08/03 COVID swab, result: detected 08/05 - 08/07 pt cc: loss of taste or smell, chills, cough, diarrhea, rhinorrhea, sore throat exposure: sister +COVID 08/07 clinically resolved
Low platelets on incidental CBC 3/19.  Last injection 01/25/2021.  Repeat CBC on 5/2021 is now normal