chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is still pink; arm became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm is still pink) and VACCINATION SITE ERYTHEMA (arm became red) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 26-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 SITE DISCOLOURATION (arm is still pink) and VACCINATION SITE ERYTHEMA (arm became red). At the time of the report, VACCINATION SITE DISCOLOURATION (arm is still pink) and VACCINATION SITE ERYTHEMA (arm became red) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Post exposure prophylaxis after raccoon bite. 24 hours after dose one: client vomited. Went to ER : nothing done. 24 hours after dose two client reported upset stomach. 48 hours after dose 2: generalized urticaria, itching and malaise. No difficulty breathing. Recommended Benadryl q 6 hours until rash disappeared. To seek medical care if rash progressed or child had difficulty breathing. Went to ER: rash progressed. Atarax IM given. Given reaction for Atarax PO. Rash improved, no itching on day 5.
Information has been received from a pharmacist concerning an 82 yr old white female hospital inpt with a penicillin allergy who on 20Oct05 at 14:30pm was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). Concomitant vaccination at the same time included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated (Fluarix) (lotAFLUA123BC). Concomitant therapy included levothyroxine Na (Synthroid), Mg oxide (Mag ox 400 tablets), excitalopram oxalate (Lexapro). Salcatonin (Miacalcin), sucralfate (Carafate), colestipol HC1 (Colestid), ranitidine hc1 (Zantac), zolpidem tartrate (Ambien), iron (unspecified),  pantoprazole sodium (Protonix), loperamide HC1 (Loperamid), Fluticasone propionate (+) salmeterol xinafoate (Advair diskus), potassium chloride (Klor-con), furosemide (Lasix), ondansetron hydrochloride (Zofran), nitroglycerin (Nitrostat), aluminum hydroxide (+) magnesium hydroxide (Maalox), acetaminophen (Tylenol extra strength), escitalopram oxalate (Lexapro), ferrous sulfate, magnesium hydroxide (Phillips Milk of Magnesia) and lorazepam (Ativan). Illness at the time of vaccination included a rectal bleed, low hemoglobin and hermatocrit, and congestive heart failure. On 21Oct05, the pt developed a local reaction at the injection site on her left arm. She experienced warmth, redness, and a raised area at the injection site. She also had a fever of 102.5 deg F. A chest x-ray and urinalysis were performed (results not provided). Unspecified medical attention was sought. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Follow up information was received from the pharmacist who reported that on 21Oct05 at 8:00AM, the pt had a fever of 102.5 deg, swelling, hardness, redness, tenderness, and warmth at the injection site. The area was noted to be the size of a baseball. The reaction improved daily up until discharge on 25Oct05. The reaction was treated with acetaminophen (Tylenol) 650 mg PO and warm compresses. It was unk if the pt recovered. See lab section for all diagnostic results including a chest x-ray and urinalysis. No further information is expected.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient came down with shingles. The reporter stated that, after 10k dollar in holistic detoxing, still not the same. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (Messed up my arm bad, bad/I can't use my right arm ever since you gave me that shot) in a female patient of an unknown age 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 HYPOKINESIA (Messed up my arm bad, bad/I can't use my right arm ever since you gave me that shot). At the time of the report, HYPOKINESIA (Messed up my arm bad, bad/I can't use my right arm ever since you gave me that shot) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Patient reported that vaccine messed up her arm bad, bad. Patient could not use her right arm ever since patient got the vaccine.  The treatment medication was not reported by reporter.   Reporter did not allow further contact
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 24-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Syncope 15 hours after administration of COVID-19 vaccine. Started with nausea, chills, sweating for several minutes. Sat for several minutes until thought I was better. Stood up and walked a few steps, then passed-out.
10  minutes  after vaccines  was given patient  started   sweating  and stated  she feels  sick in her stomach. We called 911  and lowered her to the floor  and monitored  her blood pressure. she was  breathing  fine . she vomited    before ambulance came. she told them  she is fine . she later started feeling flushing  and ambulance came and too her to hospital.
ERYTHEMA; SWELLING Narrative:  Patient received flu shot on 10/07/2020 in right deltoid. Patient was seen in clinic on 11/02/2020 and reported first experiencing symptoms approximately one week prior. Patient reported on 11/02/2020 that he had a history of a reaction to the flu shot 20 years ago and on 11/02/2020 that he had a history of  reaction to the flu shot 20 years ago and also has an egg allergy. Patient also reports that his previous adverse reaction to the influenza vaccine was a delayed reaction. Previous adverse reaction to the influenza vaccine does not appear to have been documented. Records show the following previous influenza vaccination: FLU,3 YRS 06/17/2004. Of note patient reported symptoms in LEFT arm while immunization was given in RIGHT arm.
This spontaneous case reported by a consumer, describes the occurrence of cough and pain in extremity (arm pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21H) for COVID-19 immunization. No medical history reported. Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 2, 2021, patient experienced cough and pain in extremity (arm pain). The patient treated with Coricidin (oxymetazoline hydrochloride), at an unspecified dose and frequency. At the time of the report, cough and pain in extremity (arm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; unknown. No concomitant medications reported. Treatment for the events included unspecified cough medicines and hot tea.
Pt received second COVID-19 vaccine on 4/9/21 (unknown LOT).    Admitted 5/18/21 with isolated severe thromboctyopenia (plt=1) with otherwise normal cell counts and differential, labs otherwise reassuring against hemolysis and peripheral smear reviewed without evidence of MAHA or platelet clumping overnight by attending. No clear new drug exposures or recent infectious symptoms pointing toward a possible precipitant although patient did receive his second COVID vaccine on 4/9.
I have a frozen shoulder. My doctor prescribed physical therapy for 10 weeks. I saw three doctors and the physical therapist feels that the MRI will show soft tissues or rotor cup injury pending the outcome of the MRI.
Severe local swelling, redness, pain @ inject site (lt deltoid); c/o chills, fever & generalized body ache; cold compress & APAP every 4 hrs given & despite-fever recorded @ 104F orally; s&s started day p/shot was given & persisted 5 days;
Pt received Fluzone .5ml 10/29/2003 and had a 1st time afebrile seizure 11/8/03. Developed fever 11/9/03. CT neg, EEG neg. Received DTaP/ MMR 5/27/04 and had 2nd afebrile seizure 6/10/04. MRI neg. Started on Depallete. No further seizures. Follow Up: Seizure, No fever at time of event. Now on Depakote.
Patient arrived Home from office a few hours after immunization. She noticed a small red bump. 2  days later, in the evening, she noticed it had gotten larger, more red, and started to itch. She was prescribed cetirizine today.
Rash on arm muscle and side of forearm where injection given (left arm) Felt like glass shavings in arm with raised blisters.
I tested positive for COVID-19 01/27/2022, I took a home PC test. My symptoms to began with was moderate, I didn't have to go to the hospital but it knock me for a loop. I had fever, cough, body ache, sore throat, a bad taste in my mouth. I couldn't taste anything. I couldn't taste anything spicy, just sweets. My symptoms last for about 3 weeks, my fever would come and go at night. I still have a dry cough that wont go away. I took a round of Anti-viral Paxlovid pills.
began with extreme tiredness, followed by light chills. I went to bed and woke up around 6:30 a.m. with a headache which became very intense. At times both ears would feel like they were going to explode. Pain not like a migraine, much worse. Lasted about 24 hours.
Seen in ED 2 days after vaccines.  Received w/ pruritic rash & joint achiness.  Dx'd with "allergic reaction" and given diphenhydramine & prednisone.
THE NEXT DAY PATIENT REPORTED RASH LOCALIZED TO THE AREA WHERE SHOT WAS GIVEN AND SEVERE ITCHING ALL OVER BODY EXCEPT FACE AND FEET.
Had my shot on 1/15 in NYC and the rash/itching reaction started in the evening of 1/22 (7 days later). Felt a small pain in my armpit yesterday but coach/play basketball so thought it was related to that. Now realize it probably related. Have had a small bump at the injection site since day of and that has remained the same but no pain, fever, etc. Rash and itch started and spread fast to a large circle with hives (wihin minutes). I did not have COVID and have been tested regularly for months for both antibodies and active virus near weekly so confident I was not an asymptomatic case. Hopeful it passes in a few days but this is to be expected with a new vaccine with limited testing.
Patient received MMRV via IM and DTaP/IPV via sub Q, no adverse events reported.
Rotating unconsciousness, violent seizures, facial palsy, involuntary twitching, deadly high blood pressure?3 weeks hospitalization, vision problems, unable to walk many other issues
Post puncture vial was stored in the Fridge; vaccine administered to patient greater than 12 hours (14 hours) post puncture; patient was called and reported having a sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (patient was called and reported having a sore arm), EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient greater than 12 hours (14 hours) post puncture) and PRODUCT STORAGE ERROR (Post puncture vial was stored in the Fridge) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jun-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced PAIN IN EXTREMITY (patient was called and reported having a sore arm). On 17-Jun-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient greater than 12 hours (14 hours) post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Post puncture vial was stored in the Fridge). At the time of the report, PAIN IN EXTREMITY (patient was called and reported having a sore arm), EXPIRED PRODUCT ADMINISTERED (vaccine administered to patient greater than 12 hours (14 hours) post puncture) and PRODUCT STORAGE ERROR (Post puncture vial was stored in the Fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was over 55 years of age.  Concomitant medications details were not reported by the reporter.  Reporter confirmed that the patient completed their Moderna vaccine series, however lot numbers were no known.  On 16 Jun 2022 vial was initially stored in the refrigerator and was first punctured on 16 Jun 2022 at 10:30 am and a booster dose was administered to patient on 17 Jun 2022 at 2PM from the vial.  post puncture Vial was returned to the Fridge.vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 5-10 min maximum.  No temperature excursions.  Treatment details was not reported by the reporter.
Breakthrough case admission after 4 vaccines Moderna 2/26/21 Lot# 010A21A;  Moderna 3/26/21 Lot# 018B21A;  Moderna 11/29/21 Lot# 012H21B;  Moderna 5/5/22 Lot# 057M21A
Really loud tinnitus in my right ear. Ever since the shop. About a week after the shot it started.  At first the ringing was intermittent it would come and go but now it?s all the time.
no additional AEs; HCP calling to report that GARDASIL 9 was inadvertently administered to 47 year old patient on 3/10/23. No further information available at time of call, no additional AEs, no PQCs.; This spontaneous report was received from a pharmacist, referring to a 47-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 10-MAR-2023, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AEs).
Patient received moderna vaccine on 2/4/21, 3/4/21, and 10/29/21. Presented to ER on 7/25/22 and found to be COVID positive. admitted on 7/25/2022 for COVID infection, hypoxemic respiratory failure, metabolic encephalopathy.              Sepsis present on admission, altered mental status, tachy, hypoxic with mild lactic acidosis.  CT chest no pneumonia however showing bronchitis, V/Q low probability of PE.              Patient was vaccinated against COVID. Was on dexamethasone and remdesivir.  AKI on CKD 3B, received gentle IV fluid given H/O diastolic CHF.  Lasix remain on hold.               Clinically improving, maintaining saturation on room air.  Neck exam medicine, remdesivir discontinued. Patient is medically stable to be discharge Skilled Nursing Facility on 7/28/22 on doxycycline
Hives and rashes for over a month now. I have tried daily zyrtec, benadyrl, hydrocortisone and even prednisone for 5 days after seeking medical attention. I still have not found a cure for the rashes caused by this booster shot. I have never had allergies or a reaction to a shot before.
The Patient felt dizzy and fell to the floor. The Patient's legs were raised above his head and he promptly felt better. He did not hit his head or suffer and bruises from the fall. He rested at the pharmacy for another 30 minutes, then was evaluated again. He then left with his girlfriend.
Initial information regarding an unsolicited valid non-serious case was received on 31-Jul-2018 from a consumer/non-healthcare professional. This case is linked to case 2018SA212231 (same reporter). This case involves a female patient (age not reported) who was vaccinated with 0.5 ml dose of RABIES (HDC) VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients past medical history, medical treatment, vaccination and family history were not provided. It was an actual medication error due to incomplete course of vaccination. It was reported that return home their preferred medical facilities did not have IMOVAX to finish their series. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Approximately 12 days after 2nd dose of Moderna vaccine was given, patient was found down on floor around 01:30 a.m. by husband. Husband states she was unable to move her left side and had slurred speech. Patient was brought to Hospital by EMS. Upon arrival she was unable to move her left side and is drowsy. She is oriented and complains of left sided headache. Stroke protocol was initiated. After stroke work up, patient was transferred by another Hospital.
Complaint of severe pain (6 out of 10) in Left arm where vaccination was given for 10 days following vaccine administration.
Patient reported redness extending down the left arm from the injection site to just above the elbow from a few hours after injection on 5/16/19 to 5/21/19.  There was slight swelling and warmth around the injection site from 5/16/19 to 5/18/19. The patient reports that the reaction is getting better, there is no swelling and the redness is reduced.
Kept the vaccines in ice packs while traveling but the ice got melted by the time, she reach the destination; A spontaneous report was received from the nurse and patient's husband on 11JUL2022. It described a 51-year-old female patient who "kept the vaccines in ice packs while traveling but the ice got melted by the time, she reaches the destination" (PT: Product storage error). The patient received the oral Vivotif capsule (typhoid vaccine live oral Ty21A) for travelling. It was reported that the patient got the oral 8-day typhoid vaccine recommended as one pill every other day. Furthermore, it was reported that while traveling she kept the vaccines in the insulated pack with ice, but the ice got melted by the time she reached the destination, and she did not note the exact temperature reading and thought it was still cool. It was mentioned that the vaccine within icepacks was not completely defrosted. Additionally, it was reported that the patient did not develop any side effects after consuming the Vivotif dose on an unknown date. The outcome of the reported event was unknown.  Lot number was unknown as threw away the packaging.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: A 51-year-old  consumer kept the vaccines in ice packs while traveling but the ice got melted by the time, she reached the destination (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.; Sender's Comments: A 51-year-old  consumer kept the vaccines in ice packs while traveling but the ice got melted by the time, she reached the destination (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.
Covid 19  Pfizer vaccine second dose given 14 days early (7 days after dose 1) No adverse S/S, Patient denies S/S, SOB, dizziness. Patient states he feels good.
3/16/21, initially  I felt a mild soreness at the ejection site  for 2 days.  By 3/22/21 , I noticed the ejection site was slightly swollen  by  5.2 cm  in diameter, slightly raised , red,  warm and tender to touch, firm and itchy.  There is no treatment yet.
Pain in (R) deltoid that radiates to shoulder, neck and head. Diarrhea, nausea.
Injected the shot, patient responded saying "I don't feel so good." His eyes roll back a little bit, Patient slumped over. Jerked his arms and legs once. I called "patient, patient?" and he woke up saying "What's going on?" Dr. came in asked him where he was and he responded "At the doctors." He was fine in a matter of minutes.
Received COVID vaccines (Moderna) on 3/16/21 and 1/19/21.  Vaccines not administered, but found via immunization query.    Presented to ED with leg pain and chest pain.   CXR showed worsening heart failure.    Because of tachycardia, tachypnea, keukocytotis, and lactic acidosis received 5 days of vancomycin and zosyn for possible sepsis.  CPR prior to discharge positive for COVID.   Currently not on any supplemental oxygen.
pt was extremely anxious about getting the vaccine. pt was fine during the administration. 5 minutes after pt sat in the observation area he felt light headed and clammy . we eased him down to the floor before he passed out. We them put ice packs around his neck and hand. he came too and after resting for 15 minutes in a supine postion he had some water and seemed to feel better and left on his on accord.
Severe swelling,soreness,bruising to lt elbow, & nausea w/i 24 hrs of injection.Seen by MD & tx w/ Solu-Medrol w/ fair relief.On 11/22/99,pt still experiencing a moderate degree of swelling.
Reports since having dose 2 of Moderna vaccine: feels flushed, anxious, nausea, off/on body aches, light headedness, and off/on diaphoresis that occurs daily. She has not seeked treatment/evaluation as of today 3/22/2021. She reported to provider today and scheduled her to f/u with physician 3/22/2021 at 1:40pm.