chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022; patient  got a dose after the use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient  got a dose after the use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient  got a dose after the use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient  got a dose after the use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not provided by the reporter. The hcp wanted to know if the dose was considered as viable or do they need to re-dose. One doses vials administered after 30-day use By date. On 22-Mar-2022, the vial was initially stored in the refrigerator.  On 10-May-2022, the vaccine was administered. The vial does not undergone any temperature excursions.
Within 15 minutes post vax, the pt complained of lightheadedness. BP was 140/100, Pulse 80, Blood pressure increased to 160/100. Coloring was pink with a wave of nausea. The pt was taken to her primary care physician.
Patient reported, 10/11/08. Chills, body ache and fever 10/12/08  and Monday seemed to get worse. Left arm sore under arm, right hip pain, said can't get out of bed or move. Has hives on her face. Instructed her to contact her Doctor and requested that she contact me with update of her status. 11/15/08,11/17/08,11/19/08 and 11/21/08 attempted to contact her, left ,messages but without any response.
Patient received 2nd dose of Pfizer covid vaccine. Began to complain of dizziness and tingling in extremities.  1234- 166/95 hr 72 98%  1239- 146/106;  1242- 180/103 1247- 160/98 1317- 168/96 1325- 142/97   1255- Called Dr. Patient given 25mg benadryl PO per MD orders.    Patient transported to ED by wheelchair
Injection site is red, swollen,  warm and itchy, Benadryl cream was used, but hasn't helped much. I have body aches, just like the flu. Ibuprofen didn't seem to help, but Norco does. These are still occurring.
Client's right arm became swollen and red and tender later in the evening on 5/28/2015.  Client's sister noticed the arm had not reduced in size of redness and was also tender to touch on Friday, May 1, 2015. Sister took client to the hospital ED where client was seen and oral ATB was prescribed (client does not remember the name of the ATB).  When client came in to the health department 5/11/2015 for a TB skin test read, I checked her upper right arm and it was still noticeably warm and slightly swollen larger than upper left arm. Noted in immunization charting client had both MMR and V subcutaneous vaccines in the upper right arm.
COVID arm; Rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) and RASH (Rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 SITE REACTION (COVID arm) and RASH (Rash on the arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) and RASH (Rash on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided. Lab details were not provided.   Reporter did not allow further contact
Pt received vaccine on 3/8/00. Pt experienced soreness near the injection site of right arm and on 3/13/00 redness, warmth, induration at the site and itching was experienced. There was a 7" circle at the site that has spread to inner part of arm.  Pt saw a family MD and was given antibiotics and Benadryl. By 3/18/00, redness is fading and the itching is currently where the last spreading occurred.
About 8 hours, post vax, left leg became red, swollen, hot and painful; effects noted on thigh overall, not specifically at injection site. Seen in office next morning. Treated with Benadryl and observe. Symptoms are ongoing.
pt revd vax & mom described as hoarseness; when asked if pt had difficulty breathing mom was not sure; PHN instructed mom to notify MD of sx; pt seen in MD office due to inc distress;
Joint discomfort, slight fever, swelling and puffiness in the right eyelids and a feeling of numbness or tingling in fingertips
Pt was mistakenly administered ZOSTAVAX instead of varicella. She experienced a minimal localized reaction at the injection site, which was relieved by childrens pain relief and topical BENADRYL.
Pt had DTAP #5 given in right deltoid. She developed a golfball-sized red reaction. It was later dx'd as cellulitis and Rx'd with Keflex for 10 days.
On 9/19/22 I felt a sore throat and went to Urgent Care.  Rapid Test was positive.  PCR test was positive. UC gave me a letter to take to Medical Center Emergency Room requesting monoclonal antibody treatment, which I received the same day. I had symptoms of a mild cold.  I quarantined at home for a week and wore an N95 mask for another week.  I felt fine after 1 week.
Slightly over a month after receiving my second COVID vaccination (1st vaccination January 29, 2nd vaccination February 26) I awoke with markedly worse tinnitus in my left ear and noticeable hearing loss.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th June 2020). Concurrent medical conditions included blood pressure abnormal. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient was takin medication for blood pressure issues. The pharmacist who administered the injection called and reported that the patient experienced pain and soreness immediately after the injection in the right upper arm. No additional information was available at the time of the call. This case was linked to case US2018071876, as reported by the same reporter. The reporter gave permission to contact her and would like to received follow-up in relation to this adverse event.
For three days, i had difficulty lifting my arm from severe burning pain. Ever since the first shot, my arm has been numb, tingling, and burning.
Presumed cellulitis near deltoid muscle on right arm (unsure if my 1st or 2nd was in my right arm) right sided neck and shoulder pain during this infection as well.
Myalgias; cephalgia; nausea; diarrhea; abdominal pain; Fatigue; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284), via an unspecified route of administration on 04Jan2021 16:00 at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history included Anxiety and Allergic Rhinitis. There were no known drug allergies. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) via an unspecified route of administration (Vaccine location: Left arm) on 15Dec2020 15:30 at single dose for COVID-19 immunization. There were no other vaccines received in four weeks. Concomitant medication included fexofenadine, sertraline. The patient did not have Covid-19 prior vaccination and did not have Covid-19 tested post vaccination. The patient experienced Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue on 05Jan2021 08:00. No treatment received for the reported events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue. The outcome of the events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue was recovered in Jan2021.
1st dose hurt like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, the 1st dose for him/her hurt like crazy for over a week. The reporter also stated that, he/she knew he/she was interested in the second shot. The follow-up would not possible as no contact details were available.
Chills, fever, nausea, diarrhea, body aches horrible headache. Began on 12/28. Still continuing but improving
Moderna COVID?19 Vaccine EUA. Soreness as injection site, then chills, 102.7 degree fever approximately 16 hours after the injection.  Lethargy and moderate body aches through the night and into morning.
post vax h/a & fatigue;the next am 99.6 & SOB, burning in shins, calves & forearms, nausea, nerve pain shoot in the thoracic area  back to front;stools pasty lt brn; loss sensation calf, tongue, nerve pain, had to work at breathing; arthral
lymph node was swollen; Rash on my both sides and on my both arm; Not feeling well; Pain on lower left side of back; Muscle spasms; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 71-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry: Unknown, Age at vaccination: 71 years) via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and there were no concomitant medications. The patient previously received bnt162b2 (lot number: E18982 or EL8982, Expiry: Unknown) as dose 1 on 20Jan2021 for COVID-19 immunisation. On 11Feb2021 the patient experienced muscle spasms, headache, on 13Feb2021 the patient experienced not feeling well, pain on lower left side of back, on 17Feb2021 it was reported that rash on my both sides and on my both arm and on unspecified date patient experienced lymph node was swollen. Patient went to see primary care and was prescribed a couple of medicines for the rash and pain in his back. Last Wednesday, patient got the vaccination, his second dose and then Thursday he had headache and muscle spasm, Friday he was not feeling right and also he had his lymph node were swollen and then on Saturday he started getting dead skin on his lower left side but he still had and this morning when he look at his skin, he thought rash on his both sides and on his both arm. The patient underwent lab tests and procedures which included platelet count: unknown results. Therapeutic measures were taken as a result of pain on lower left side of back and rash on my both sides and on my both arms. The seriousness of the events was non-serious. The outcome of the event not feeling well, pain on lower left side of back and rash on my both sides and on my both arms was not recovered and all other events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; Information on lot number, batch number could not be obtained.
Other than a sore arm that evening(Monday), on Tuesday I did not leave my bed except to run to the bathroom for diarrhea and I had a fever and did not have the strength to even get up to feed myself. on Wednesday and Thursday I still diarrhea. 3 days of body aches and pains as well.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 11th of 24 patients described by the reporter.  Concomitant medication was not provided. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
28 minutes after PT. received vaccine she told RN on duty she felt funny"heart fluttery", , light headed, dizzy B/P 190/110 HR 70-80,98-99% RA per facility RN. 0932 182/105, HR 60-70, 99% RA per RN 0945 Continue to monitor  180/95, HR 60-72, 99%RA blood glucose 90( PT ate breakfast) RN @ bedside chair 0954 119/91, 99% RA , 60-73 HR feels better but has headache 10:00 ambulance called10:08 208/96,  68-76 HR 99.24% 10:13 Ambulance arrives,report given  40 Medic 10:20 210/112 per EMS monitor HR80 100% RA  10:28 Loaded onto stretcher left with EMS
Tinnitus, vision disturbances, dizziness, light headed I went to the optometrist and had my vision tested. As I was thinking this was attributed to needing a new prescription. Got a new eyeglass prescription in July. My vision continues to fluctuate wearing new glasses and contacts. My dizziness continues and tinnitus is worsening. Intermittent ear pain followed by bouts of vertigo. Tried to treat with Meclezine and Benedryl.   I will be trying to get a referral to an ent today.
Approx. 13 hours after vaccination the symptoms began: chills, body aches, nausea, restless leg, headache, and fatigue.  The symptoms stopped approximately 24 hours after they started.
developed sx including congestion, stuffy nose, small headache early in the am on 1/5/2022- tested positive on binax rapid antigen test- has had 2 doses of Pfizer plus Pfizer booster as listed above
1/2 hr after inj felt a terrible deep pain travel down left arm. With days after pain radiated across shoulder, had pins and needles in both hands shot was given very high up on tip of shoulder. Left hand discoloration. Felt weak, Went to employee health. Said I got a tendonitis.
About 45 min after vaccine, developed anterior chest pain, worse with deep breath. Shortness of breath with dyspnea on exertion. Heart racing with mild palpitation. Monitored in ER and given Benadryl , Solumedrol , Pepcid , No relief, Hyperventilated, anxious. Epinephrine given , Xopenex, SVN tx, Ativan. No relief. Tele + O2; IV fluids , pain medication. Admitted and developed costochondritis.
Child came to clinic with red rash on both inner arms, thigh (L) and abdominal area. Afebrile. No resp. distress noted lungs clear. 10cc of BENADRYL was given PO. Mom called: child has been of school for the past 3 days with an illness.
Administration Error: Patient is received, which comes to administer his 2nd dose of Moderna, which must have received 0.5ml, however the nurse administered 0.25ml as if it were a booster dose. The patient is notified that he must be inoculated again with 0.25ml to complete the dose that the patient was supposed to receive.
the following day after the vaccine patient developed paralysis of legs 2 days in row causing patient to fall, legs like wet noodle, very weak upper body strength (Guillame Barre syndrome), fever, profuse diarrhea for at least 2 days, urinary incontinence, bowel incontinence, fever for 2-3 days, extreme weakness, nausea, nonstop gagging and choking on saliva in throat for 2 weeks
Patient vaccinated with first COVID vaccine late august - I am unsure of exact date. She suffered an intrauterine fetal demise diagnosed 9/18 by myself in the hospital. She underwent standard testing in setting of IUFD and no issues noted. Autopsy performed and only pertinent info was small for gestational age placenta. No other cause of stillbirth identified.
Headaches; Nausea; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), HEADACHE (Headaches) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, PRURITUS (Itching), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved.            concomitant products were not provided treatment information were not provided   This case was linked to MOD-2021-163877 (Patient Link).
lost of vision; history of vision issues / after receiving SHINGRIX make it worst; Head ache; This case was reported by a other health professional via call center representative and described the occurrence of loss of vision in a 54-year-old female patient who received SHINGRIX for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included abnormal vision.   On 17th August 2020, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced loss of vision (serious criteria GSK medically significant), vision abnormal aggravated and headache. SHINGRIX was discontinued. On an unknown date, the outcome of the loss of vision and vision abnormal aggravated were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the loss of vision, vision abnormal aggravated and headache to be related to SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient experienced head ache and lost of vision after vaccination. The patient had history of vision issues but after receiving SHINGRIX made it worst. The patient also received a dose of a Flu vaccine on the same day of SHINGRIX vaccination. The patient refused to receive the second dose of SHINGRIX. The reporter did not provided lot number and expiration date of the first dose of SHINGRIX. The reporter consented to follow-up.
Pt recv vax on 8/21/97; on 8/22/97 pt exp fatigue, fever, anorexia, nausea, left upper quadrant pain, elevated liver function, splenomegaly, vomit,headache,stiffness,neck pain,gen swelling; dx=cytomegalovirus &Epstein Barr virus
very pale & grunty for 3-4 hrs-started @ 3hrs p/vax; also shaking of hands & quivering of lips for 3-4 hrs;
Presented with a large bullar blister behind R knee o 10/27/2021, rash on back evolving from 10/30/2021 and by 11/1/2021 1/3 of resident's back was covered with a blister that erupted. Leaving area appearing like a burn. Multiple other bullae developed on limbs and trunk.   Digoxin; Morphine sulfate, Eliquis, Acetaminophen, Glycolax Powder, Loperamide PRN. The booster was administered L deltoid. o Previous unknown events; Patient female age 91 expired 11/3/2021. Date of booster was 10/27/2021. 1st dose 12/30/2020, 2nd 1/27/2021 Moderna. Long term care facility resident - is currently on hospice. osteomyelofibrosis, anemia, thrombocytopenia, anorexia, non-hodgekinslymphoma, atrial fibrillation, hypertension, rheumatoid arthritis, moderate protein calorie malnutruition, hyperlipidemia, asthma Allergies: amoxicillin, ibuprofen, penicillin, Zithromax
Completed based on review of ER note from 29 November 2018: Patient's father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father's report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.