chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 86th patient of the total 190 patients.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
pharynx red, cervical nodes, occasional rhonchi, no rales/wheezes, fever, arm pain, cough, sore throat, swollen lips;
Child received his second dose today. He was accidently given an adult 0.3mls of Pfizer vaccine instead of pfizer 5-11 0.2ml dose. Parent was advised to watch out for flu like symptoms and to reach out us if they have any questions or follow up with pediatrician, who was also informed about this.
patient received covid pfizer monovalent vaccine in error was supposed to get pfizer covid bivalent
On 11-2-09 pt was given Imms-KINRIX on L arm and MMR/Varicella on R arm. He was brought into office on 11-4-09 due to redness, heat and swelling of left arm. Evaluated by CFNP -Advised to apply ice to site and take ibuprofen. Redness covered most of upper arm.
Very nauseous and extreme diarrhea 20 minutes after shot. The next day started haviing severe heart palpitations and tightness in my chest. Went to NP and was sent to hospital for EKG and chest Xray. EKG was abnormal and Xray showed small aneurysm.
Client was heard by pharmacy staff in the aisles requesting help. The client was hunched over at shelves with excrutiating lower back pain. Pharmacy staff got a chair for her to sit in while we waited for 911 ambulance to arrive. EMT were able to transfer patient to gurney and patient was taken to local area hospital. We did here from family that hospital did not believe the pain was associated with vaccine but was unsure of cause the pain was subsiding by midafternoon from last report, will followup with patient.
Parents state that 3 days after patient received 1 MMR vaccine, started having episode of first clenching and shaking. Lasts just a couple seconds, then self-resolved. Pt alert and awake with normal alertness after episodes. Occurs 3-5 times per day.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 56-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 26-NOV-2016 to 26-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 26-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
4:30-4:45 pt seen @ ER had 15min sz;eyes deviated & pt unresponsive, clonic;active arms & legs;resolved;
Patient fainted approx 2-3 minutes after admin. She had not eaten all day & had come from working out. Approx 3 pm during the day. Also has phobia of needles.
received error of third dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (primary series completed in 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received error of third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 03-AUG-2023 The reporter reported that he or she had case where patient received error of third dose of Shingrix vaccine. The reporter reported that the patient received single dose now. The reporter asked a question that what were the studies done of patients receiving 3rd dose and recommendations. The follow-up could not be possible as the as no contact details were available. The reporter reported that the patient received 3rd dose of Shingrix, which led to extra dose administered.
During a review of the Department's internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Covid Arm or Moderna arm. Red, itchy, hot to touch. Used perscription steroid/cortizone spray to relieve itching.
she had a nodule at the injection site; arm was so sore she couldn't touch it; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "she had a nodule at the injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was so sore she couldn't touch it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Temp 104 Infection Blood clots in both legs, heart, lungs, right parietal lobe of brain Heart Attack due to emboli Stroke  Coded X 3 Endocarditis Aortic valve abscess Aortic valve replacement
I went to the doctor, and I had swollen lumps in my right breast. I have a check-up in February.
rapid heart beat that resolved after 1- 2 day persistent substernal pain in the lower region, sore no decreased activity or SOB
Erythema 2.5 x 3" in diameter immediately following injection of MMR-V
Reports that 2 days after vaccine, patient noticed L neck pain and warmth with possible rash. Says that while the rash/warmth improved, he noted that a vein was very prominent on that side and he came to my office (I'm his PC doctor) to show me it. I felt a cord, and suspected a superficial neck vein thrombosis L side, which was confirmed on US.
Red rashes developed after 8-10 days smallpox placement rashes - both arms, chest & back, states his rash worsened after wearing a new T-shirt he never washed. Pleased see attached providers notes.
Chronic idiopathic urticaria/itchy under-skin lumps/Also lines and streaks on arms and back; This is a spontaneous report from a contactable consumer reported for herself. This 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Feb2021 02:30 PM (lot number=EN6203) in left arm at single dose for COVID-19 immunization. Medical history included osteoporosis, prolapsed bladder, Polio as a toddler, allergies with food/inhalants, stopped 20 yrs ago. Concomitant medications included tolterodine, raloxifene.  The patient previously experienced allergies with levofloxacin (LEVAQUIN), ciprofloxacin hydrochloride (CIPRO), neomycin, diphenhydramine hydrochloride (BENADRYL), polymyxin b sulfate.  On 02Mar2021 08:00 AM, the patient experienced first itchy under-skin lumps appeared on thigh/buttocks junction on awakening. Since then .5 to 1 inch bumps had appeared in same area, knees, back, torso, arms, and feet. Also lines and streaks on arms and back. Two raised bumps on forehead and 2 inch square on hairline/forehead. All disappear few hours later. Patient took loratadine (CLARITIN), recommended by PCP. Seen by allergist 29April. Diagnosed with chronic idiopathic urticaria. Prescribed fexofenadine hydrochloride (ALLEGRA). Added famotidine (PEPCID AC) twice daily by PCP. Only 5 days without presentation since start. The event resulted in Doctor or other healthcare professional office/clinic visit. Additional treatment included antihistamines, cortisone cream, both OTC. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination, patient has not been tested for COVID-19 since the vaccination. Outcome of event was not recovered.   Follow-up attempts are needed. Further information is expected.
pt recvd vax; began w/ v, d , stomach cramps; dizziness & lightheaded; no soreness/redness at inject site; no c/o any above sxs this am;
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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 unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
ENTIRE BACK IS ITCHING BUT NO RASH OR HIVES; ACHINESS ALL OVER THE BODY; TINGLING TO LEFT HAND; CHILLS; EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not provided medical history and had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1808980,expiry:18-SEP-2021) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, treatment medications included: paracetamol. On 03-SEP-2021, the patient experienced entire back is itching but no rash or hives. On 03-SEP-2021, the patient experienced achiness all over the body. On 03-SEP-2021, the patient experienced tingling to left hand. On 03-SEP-2021, the patient experienced chills. On 03-SEP-2021, the patient experienced extreme fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from entire back is itching but no rash or hives on 04-SEP-2021, was recovering from extreme fatigue, chills, and achiness all over the body, and had not recovered from tingling to left hand. This report was non-serious.
Currently pregnant (due date: 09/03/2021). 5:30 pm felt tingling. 6:15 pm felt chills. 8:30 pm fever (fluctuated, up to 100.0, as of 9:30 pm)
Within a few days (at least by 9/6/2021) patient began to have fever and a cough.  Patient began to progressively decline.  Started with inability to ambulate.  At baseline patient could ambulate independently in her assisted living room.  Within days, she was no longer able to do so, her swelling worsened, and her oral intake declined.  This time period was complicated by an elevated potassium that improved with oral hydration and it was rechecked and improved, but her decline continued.  She was treated for a UTI from a gathered urine sample starting 9/7/21, but there is uncertainty to the extent it was either responsible or contributing to her declining status.  Patient was carried to the office on 9/16/21.  She was found to have an oxygen saturation of 79-81% on room air, she was too weak to hold her head up, and her swelling had increased.  EMS was recommended for transport to the hospital and with some convincing with her son's assistance, she finally agreed.  Patient was transferred from the rural hospital to a tertiary center in city.  She became severely oliguric.  She was given IV furosemide that was not very effective.  Patient was not only volume overloaded but also hypotensive requiring ionotropic treatment.  Renal failure worsened and nephrology opinioned that she was a poor candidate for dialysis given her poor clinical condition and recommended hospice care.  Patient died three days after admission on 9/19/21.  Inpatient team determined that urinary tract infection did not appear to be septic in nature.
Breakthrough case admission after 2 vaccines Moderna 2/23/21 Lot# 031L20a;  Moderna 3/25/21 Lot# 030A21A
Chills; Cold; Having tremors, his hands and his feet were shaking; This is a spontaneous report received from a contactable consumer.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 07Mar2021, outcome "unknown", described as "Having tremors, his hands and his feet were shaking"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe chills shakes and extreme joint pain. Back pain 101 fever fatigue and nausea. Moderate Headaches
Friday evening 11/5 experienced labored breathing, swollen lymph nodes under arms and neck/throat area. Difficulty swallowing, pain with swallowing (even water), dizziness, chills, excessive sweating, extreme pain at injection site area, temperature of 102, extreme body aches that kept me from sleeping, joint pain, dull headache.  Saturday and Sunday all day 11/6 Same symptoms as above but magnified. Sweating was far more excessive, labored breathing throughout the night, trouble swallowing, pain swallowing,dizziness when standing, pain behind eyes.
Pt recvd vax 8OCT92 & 22OCT92 exp flare-up of psoriasis manifested by erythema w/heat & itching on neck, hands, forearms, & feet; pt was seen by dermatologist & treated w/Aclovate cream & fluocinonide cream;
Breakthrough case of covid-19 even though he was vaccinated; Breakthrough case of covid-19 even though he was vaccinated; This is a spontaneous report from a non-contactable consumer (patient's child).  A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Breakthrough case of COVID-19 even though he was vaccinated on an unspecified date. Required hospitalization. Event took place after use of product. Unsure if this patient took the Pfizer vaccine or another vaccine for covid. Reporting just in case. Also this was reported within the required 24hr timeframe. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up at night. learned to train my brain to ignore. two weeks after the 1st vaccine shot, hearing another high-frequency ringing on right ear, louder, on and off, needing more effort to handle.  other reactions: right after the 1st shot, felt face swelling. these symptoms disappeared 4 hours later.  left arm sore for rest of the day, back to normal next day.
I don't get the flu shot, because it makes me sicker than a dog; Initial information received on 24-Nov-2020 along with live follow up on 01-Dec-2020 (both process together) regarding an unsolicited valid non-serious case from a patient via social media (facebook) in the United States.  This case involves an adult patient of an unknown gender who did not get the flu shot, because it made the patient sicker than a dog (illness), while the patient received influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.   On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (with an unknown route, frequency, strength, lot number and expiry date) for prophylactic vaccination.  On an unknown date, the patient reported that when the patient got the flu every time, then the patient got the flu shot. The patient reported that there was popular belief that you could get the flu or get sick. The patient did not get the flu shot in couple of decades and the patient felt just fine.  On an unknown date (latency unknown) after starting the suspect vaccine therapy, the patient did not get the flu shot, because it made the patient sicker than a dog (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Pt reported having stiffness in neck after few hours after receiving flu shot. He said he is taking bed rest & using wet towel helps relieve pain to some extent. Pt said will see a physician if pain continued.
Fever, chills, severe body aches, nausea all night. The next morning, it wasn't as bad, but two days later and I'm still very tired and not myself. I'm usually very active playing tennis or running and don't feel like I could do either one. I just wish I had been warned by the pharmacist. He only told me that my arm would be sore, which it was but I could handle that.
This patient reports being in his normal good state of health other than reporting a viral like symptoms 1 week prior to receipt of the influenza vaccination that had resolved the day he was given his annual influenza vaccine on 10/22/2019.  He reported no adverse reactions until day 2-3 post vaccination when first experienced commonly reported vaccine adverse events of generalized pain, arthralgia, tingling (face, lips, throat, arms, legs, back of throat), bifacial weakness of legs, and tightness in throat, and fatigue.  However the progression of his symptoms over the next 2 weeks of worsening total body pain, paresthesia, headaches, bilateral weakness first to lower then upper extremities (upward progression), tightness in his throat, difficulty swallowing, difficulty with speech, difficulty-inability to stand-walk-run, bowel incontinence, chest pressure and shortness of breath, are not typical vaccine reactions.  A comprehensive medical record review identified on 11/7/2019 a lumbar puncture that showed elevated CSF proteins confirming the diagnosis of axonal Guillain Barre Syndrome for which he received intravenous immunoglobulin (IVIG). Following his initial admission, he spent the next 3 months in rehab, being readmitted to the hospital x3 for relapsing symptoms that required further treatment with IVIG and plasmapheresis. Following each treatment his symptoms markedly improved until he was finally able to return home 20 January 2020 to continue with home physical therapy. In January 2020 he was given a diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) as his symptoms persisted greater than 8 weeks which is the characteristic for this diagnosis.  He has been working under light duty profile since January 2020 and remains under the care of Dr. for plasmapheresis therapy every 3-4 weeks.
ct's mom states tiny red dot day after immun. with a small not, states was not concerned.  states has recently become concerned. Took infant to DR. 9-11-07 due to enlarged reddened area with large knot.  This visualized reddend raised are iwth purplish center approx. 1 cm in dia. with 2 additional redden spots out from original reddened area.  There is dimpling of skin.
cannot raise his vaccine administered arm; pain; Soreness after 2nd dose; Tenderness after 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOBILITY DECREASED (cannot raise his vaccine administered arm), VACCINATION SITE PAIN (pain), MYALGIA (Soreness after 2nd dose) and VACCINATION SITE PAIN (Tenderness after 2nd dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout, Hypertension and Hypercholesterolaemia.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 MOBILITY DECREASED (cannot raise his vaccine administered arm), VACCINATION SITE PAIN (pain), MYALGIA (Soreness after 2nd dose) and VACCINATION SITE PAIN (Tenderness after 2nd dose). At the time of the report, MOBILITY DECREASED (cannot raise his vaccine administered arm), VACCINATION SITE PAIN (pain), MYALGIA (Soreness after 2nd dose) and VACCINATION SITE PAIN (Tenderness after 2nd dose) had not resolved.            Concomitant medications included Unspecified Blood pressure medications, Cholesterol medications and Gout medications.  No treatment medications were reported.