chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        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 used was not provided by the reporter.  The reporting physician states the vial was needle punctured at 10:45 AM and expired at 4:45 pm. This patient was administered the vaccine from this vial at 5:20 pm. No additional details were provided.  Treatment information was not provided by the reporter.
I got the second dose at ~1:10 and I started getting a small rash on my arms, neck, and face  at 11:00 that night. I could not sleep that night because I was shivering so much. I felt regular fever symptoms the day after like many people but even though those symptoms disappeared by the end of the day my rash got worse. I got the shot on my right arm because I am left handed but the rash is the most severe on my left arm. The rashes go all along from the back of my hand to above my elbows and are mostly crowded around the underside of my arm. I have had this rash for over a week now and it is still painfully itchy and sensitive. Only recently the swelling and itchiness around my left eye got better but my arms are still the same and look as if its still slowly spreading.
Body aches, pain at injection site, fever, chills. Unable to engage in normal daily activities for about 12 hours. Did not feel 100% during the next 48 hours, although symptoms improved and ibuprofen lessened the severity. I did not have these symptoms with the 1st dose with the exception of pain at the injection site.
I received my flu shot on 10/4/2023 in my left arm and noticed the next day I developed a knot/lump in my left armpit with soreness. also,  my left hand now have numbness and tingling sensation that have lasted over three weeks and this is very concerning to me.
Pt. had reaction in left arm after PNEUMOVAX-23 immunization was administered. Pt. reports that left arm was very red and painful from shoulder all the way to elbow for 3 days after the immunization was administered. Pt. was advised to seek medical attention after he reported reaction but decided not to seek treatment as he thought it was improving. Pt. reported taking benadryl and ibuprofen for the pain.
Patient with fever (102 - 103 deg. F), decrease with Tylenol approximately 9 - 10 days after immunization. ? x 1 day, no rash - all signs and symptoms resolved in 48 hours.
Pain, redness, and swelling occurring >7 days. Redness and swelling around vaccination site increased after day 7. Health care provider was notified. Currently 9 days post vaccination and redness and swelling have not decreased.
Received varicella, TDAP, MCV4 on 081809.  Returns to clinic 082009 with edema, inflammation,hot to touch, pain at varicella injection site on right arm. Onset of symptoms 081909 am size of a "quarter" at onset. Edema and inflammation now 6cm x 5cm. Rub site with alcohol yesterday.
Called pt mom told mom what mistake was done. Ask mom how baby was doing. Mom states baby is fine, no complaints.
Many years ago my left ear would break out, starting with an itch and progressing into an open wound.  My doctor told be that if I had chicken pox as a child that was more than likely have residual effects from the pox.  This would happen once or twice a year.  Ever since my second shot not both ears break out weekly including enlarged nymph nodes.  I have also am experience allergic reactions that have been dormant since my early 30's.  Both of my ears become inflamed and then break out into an open sore/
pt recvd vax; screaming & irritability > 12 hrs; T 101.9;
Admission Date: 7/14/2022 Discharge Date: 7/23/2022  PRESENTING PROBLEM: COPD exacerbation (HCC) [J44.1] COPD with acute exacerbation (HCC) [J44.1] Acute respiratory failure with hypercapnia (HCC) [J96.02] Respiratory tract infection due to COVID-19 virus [U07.1, J98.8] COVID-19 [U07.1] Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC) [J96.21, J96.22]  Patient is a 73-year-old woman admitted for COPD exacerbation w/ resultant acute on chronic respiratory failure with hypercapnia and hypoxia post recent COVID19 infection.  She has a PMH of very severe COPD on 2-3L NC at baseline, chronic systolic heart failure with recovered EF 2/2 NICM,AFIB, depression and anxiety.     Patient presented w/ dyspnea and developed confusion w/ severe hypercapnia noted with blood gas showing PH 7.04 with pCO2 of 130. She was admitted to the intensive care unit with BiPAP.  She underwent an infectious workup with negative strep pneumo and Legionella antigens.  She was not felt to have bacterial superinfection. She improved and IV steroids were transitioned to PO taper.   She completed remdesivir.  She was discharged to SAR when back to baseline respiratory status.
Muscle aches and muscle weakness, slight fever with headache, lack of energy. Felt better by the second day after the shot.
5 m. erythema, swelling L upper arm, pain, tenderness, low fever, hallucination at nights, belly ache- no vomiting or diarrhea.
Symptoms: pain, redness and swelling. Treatment: Ibuprofen and warm compress.
Patient had a self reported rash/hives  break  about 5-10 minutes after vaccine administration, upon presentation patient was given 2 tablets of diphenhydramine 25mg.  Visual appearance was a flushing of the cheeks but no swelling or raised "hives" visibly noteable. At about the 45 minute mark the customer was still upright, conscious and talking to her family group. Patient rejected use of epi-pen or 911 involvement. At 1 hour from injection patient was still conscious and coherent, upon offering further treatment once more the patient declined and her mother drover her home. Patient had redness of cheeks at time of departure
Within a few seconds of receiving IM vaccine, from a sitting position patient slumped forward, had a dazed look, did not respond, then body jerked X 1-2.  Within 30 seconds, she began answering questions appropriately, was able to sit up and independently ambulate.
Patient seen in the ED on 12/2/22 for weakness. Patient has been feeling ill for the past several days, and on 11/28/22 tested positive for COVID. She does wear 2L home oxygen. She has been getting progressively weaker, and reports cough and shortness of breath. COVID PCR test done in the ED also resulted positive. Ultimately she was admitted 12/2/22 - 12/7/22 for COVID-19 infection, acute bronchitis, acute on chronic respiratory failure, and COPD.
Period arrived 11 days late; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Sep2021 at 00:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 08Sep2021, the patient's period arrived 11 days late. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period arrived 11 days late was resolved on an unknown date in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 40 year old female. 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, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210958806, 20210959351, 20210958321, 20210958348, 20210958371, 20210958425, 20210958977, 20210959620, 20210958525, 20210959581 and 20210959909.
pt recvd vax & 11MAY93 & 13 days later (24MAY93) pt went home sick; 26MAY93 noted was recvd in which MD stated that pt was debilitated as a result of receiving Hep B inject; pt become ill; direct react of vax & obtain acute viral infect
Developed rash on face and chest within hours after vaccines administered. Emesis x 1. Hadd also eaten eggs same day. Full resolution of symptoms in 3-4 hours.
No other AE; reports administration of vaccine following temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 28-APR-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) route of administration defaulted to oral, 2 milliliter, lot #1821247, expiration date: 23-JUL-2022 (strength was not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the vaccination, the sample of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion at 11.4 Celsius degrees (C) for 4 hours and 45 minutes. Previous temperature excursion at 10.7C for 1 our and 15 minutes was also reported.
Body temperature decreased; Myalgia; Atrial fibrillation; Alopecia; Nasopharyngitis; Vision blurred; Vasculitis; Dizziness; This case was received via FDA VAERS (Reference number: 1124402) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine, hydrocodone and tramadol.) and Autoimmune disorder.    On 10-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 ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness) and MYALGIA (Myalgia). On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (Body temperature decreased). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved and ALOPECIA (Alopecia), NASOPHARYNGITIS (Nasopharyngitis), VISION BLURRED (Vision blurred), VASCULITIS (Vasculitis), DIZZINESS (Dizziness), BODY TEMPERATURE DECREASED (Body temperature decreased) and MYALGIA (Myalgia) 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.   Concomitant product was not provided by the reporter.  Patient vaccine administration arm coldness and temperature drop. Patient reported the symptoms to her doctors and they recommended she get the second shot.  Treatment information was not provided.  Company comment: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding autoimmune disorder and concomitant medications are required for further evaluation.
Menstrual spotting; Irregular menstrual cycle; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via an unspecified route of administration in the right arm on 19Apr2021 at 11:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol/ levonorgestrel (AVIANE) for an unknown indication from an unknown date and unknown if ongoing. On 21Apr2021, the patient experienced menstrual spotting and irregular menstrual cycle. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual spotting and irregular menstrual cycle were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
3RD DOSE PFIZER COVID VACCINE GIVEN 10/13/21, #EW0169; 8/7/22 pt initially taken to hospital with CP and SOB; reports had a positive COVID test approximately 1 month earlier; no O2 needed or hospitalization with COVID; "had a head cold"; pt still testing positive for COVID at hospital; sent to cath lab where discovered he had multivessel disease; balloon pump placed; transferred to other hospital; CAB x3; ICU; recovered and able to be dc'd to home on 8/17/22; pt passed away at home on 9/12/22
Chest pains for 10 days now, swelling in my throat, migraines,  dizzy stomach pains vomiting
She had a fever, and we gave her TYLENOL through the night. Then, I started to hear a croup sound when she coughed. I took her to the doctor, and they gave her dexamethasone. She still has some congestion and coughing but she is starting to feel better.
DIAGNOSED WITH COVID ARM, REDNESS, SWELLING ITCHINESS SIZE UP TO 6 INCHES. ON LEFT ARM THE INJECTION SITE. REACTION STARTED ON DAY 8 BECAME WORST AND BIG ON DAY 10, TREATMENT GIVEN WAS TRIAMCINOLON CREAM 2X DAILY AND CEPHALEXIN 500 MG 3X DAY FOR 10 DAYS
Patient came a week early for second dose of COVID19 vaccine. Patient had similar name to another patient when verifying information. 2nd dose was administered 14 days after 1st dose.
On October 18, 2021, lilac and bright red spots of 0.5 centimeters - 7 centimeters appeared in the abdomen, under the arms, and between the legs. I began to feel unwell, dizziness and weakness appeared. I went to the doctors and was diagnosed with Scleroderma. I am sure that the immediate development of this dangerous disease was provoked by the Pfizer Covid19 vaccine. I am ready to undergo an examination to clarify the disease caused by the Pfizer Covid19 vaccine.
refused to take bottle;ends up in ICU;unk dx;  Annual follow-up received on 10/18/00 provided no additional data.
I had a right eye occlusion. Cause is unknown. I don't have afib at this point. I have a heart monitor in place.
nausea; vomiting/Severe bout of vomiting this morning; vertigo; This is a spontaneous report from a contactable consumer, the patient.  A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right deltoid on 30Dec2020 at 15:00 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 02Jan2021 at 05:00, the patient experienced nausea, vomiting/severe bout of vomiting, and vertigo. The patient experienced these same symptoms again on 02Jan2021 at 20:00.  The clinical outcomes of nausea, vomiting, and vertigo were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Day of the shot (in the afternoon) I felt began feeling ?off?.    Day after the shot I had pretty severe body aches and exhaustion that lasted for two full days and lingered for a third day although not as severe.  It?s now a week since the last vaccination shot and I went for my first run since the vaccination.  I regularly run about 5 miles 3x a week in the mornings.  On this run,; which was at about 75% of my normal pace,  my lungs felt very heavy with very labored breathing, having to stop and catch my breath periodically.  I eventually had to stop at mile 3.
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) 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 (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
Varicella vaccine break through. Seen in our office 11/18/05 by Dr. and diagnosed with varicella rash started 11/17/05. No fever. Had approximately 50 lesions scattered over trunk, face, and legs.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was accidentally vaccinated with a dose of VARIVAX (lot number not provided) subcutaneous instead of ZOSTAVAX on 02-AUG-2012 by the physician's nurse. No other co-suspects were reported. No concomitant medications were reported. No by the physician's nurse. Additional information has been requested.
Yesterday patient received the LAIV Intranasal Flu Vaccine at School. Today patient started complaining of stomach pain at school and then threw up, no fever!
Pt recvd Hep B vax on 12MAY92; On 14MAY92 devel a severe sore throat; 15MAY92 devel a cough which was productive of bright yellow sputum, chest cold, fever; 20MAY92 c/o intermittent cough, greenish-gray sputum;
Day of vaccine: flu like symptoms with chest tightness, pain, severe shortness of breath and 101 fever 6-8 hours after receiving.    December 24th delayed reaction began. Day 1-3 hives jumping from one place to another randomly all over body. Zyrtec calmed it down. Day 4 low grade fever, chest tightness, racing heart, chest pain, shortness of breath, sore throat, large joint inflammation, blood pressure low, bpm 100-110 resting and 110-147 upon standing in place. Nasal drainage and fluid in ears.  This went on until day 7 of delayed reaction.  Cardiac symptoms manageable by day 7.  Days 7-10 ears very full feeling with pressure. Awful ear ache. Decongestants not working, prednisone helping, but not working well, pulsating tinnitus causing insomnia, Tylenol for intense ear pain. Left eye very red without irritation. Asthma attacks began day 9-10. Using albuterol inhaler prescribed for exercise induced asthma.  Lymph nodes in neck and jaw very large and full. Very painful.
No adverse events noted - did run a fever in the night but received a total of 6 vaccines at visit.
Patient developed nasal congestion within 5 minutes of receiving the influenza vaccine. Prior immunizations of flu vaccine had been well tolerated. Patient was treated in the emergency room with Benadryl, Solumedrol, Albuterol and Ranitidine. After treatment in the emergency room patient improved and was discharged home. Manufacturer: Sanofi Pasteur Lot # U2249AA Expiration date: 6/30/07 Symptoms: 1. Headache, 2. Anaphylaxis, 3. Hypertension (4) swelling, shortness of breath.
Redness, itchiness, pain at injection site. Achiness, low grade fever.
Started as rash under armpits and torso.  It has progressed to include arms, sides, elbows, crotch area, upper thighs & hips.  It is slowly spreading farther away from my torso and seems to be aggravated by heat and rubbing against skin/clothes.
Fever of 100 to 101.3 lasted about 26 hours. Achiness and tiredness corresponded with fever and took one day off of work. Headaches off and on have occurred periodically the entire time, including still on 10/23 and10/24. Headaches have been mild but uncomfortable and noticeable. Still a bit more tired than normal also.
Mother reports child crying and screaming. Started about 4 hours after shots, had fever of 102. Says child vomited X 1, had diarrhea X 2 this AM. Says child has fever 103, now cries and creams when touched. Mother requested to received 1 shot on 08-21-08. Reported infant now moody, was fussy and cried a lot for 2 hours post first set, came back on 8-26-08 requested Hib & PREVNAR both be given; no problem with vaccine given 8-21/08.
Extreme screaming, redness and extreme soreness on both legs. Called 911 then cancelled. Sought nurse help line but could not find one. Administered Tylenol, baby improved, then projectile vomited. 9:36PM baby is feeding and calming down. Will monitor closely.