chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours; Patient received dose from a vial greater than 12hrs at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial greater than 12hrs at room temperature) and PRODUCT STORAGE ERROR (Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial greater than 12hrs at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial greater than 12hrs at room temperature) and PRODUCT STORAGE ERROR (Patient received dose from a vial greater than 12hrs at room temperature/ Moderna vaccine that has been sitting at room temperature greater than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received her Moderna booster dose and previous vaccination history was unavailable. The vial was initially stored in the refrigerator on 14-Apr-2022. On 06-May-2022 around 9:30 AM the vial was first punctured. The vial stored at room temperature post puncture. 4 doses were given on 07-May-2022 at 11:20 AM, 11:49 AM, 12:05 PM and 12:30 PM. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as 29 hours. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received contains non significant information.
total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C reported with no adverse  event; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 46 years old and unknown gender patient who was administered with influenza quadrival A-B vaccine [Fluzone Qiv] which was having total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c reported with no adverse  event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Nov-2021, the patient received a  dose of suspect influenza quadrival A-B vaccine, suspension for injection (strength and formulation: unknown) (lot UT7325JA; Expiration Date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date it was reported that total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c reported with no adverse  event (product storage error) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c reported with no 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 the 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.
weakness; rash on neck/skin on neck got red; rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash); tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), RASH ERYTHEMATOUS (rash on neck/skin on neck got red), RASH (rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash)) and FATIGUE (tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C(2/Z)1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), SPIRONOLACTONE, ATENOLOL and ROSUVASTATIN for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), RASH ERYTHEMATOUS (rash on neck/skin on neck got red), RASH (rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash)) and FATIGUE (tiredness). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), RASH ERYTHEMATOUS (rash on neck/skin on neck got red), RASH (rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash)) and FATIGUE (tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included tea tree body wash.   This case was linked to MOD-2021-240508 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received: contains no new information
6-20-14 vaccination given - pt noticed Rt arm swollen at injection site 6/22/14, also pt did not feel well. 6/23/14 reported to pharmacy more swollen 3" diameter and arm hurting. Recommended BENADRYL orally and topically. Notify pharmacy and MD if not improved 24h. MD called.
Shortness of breath/I also felt short of breath; Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath; It felt like I was going to pass out; I had a sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath/I also felt short of breath), CHEST PAIN (Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath), DIZZINESS (It felt like I was going to pass out) and PAIN IN EXTREMITY (I had a sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021 at 4:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 16-Nov-2021, the patient experienced DYSPNOEA (Shortness of breath/I also felt short of breath), CHEST PAIN (Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath) and DIZZINESS (It felt like I was going to pass out). At the time of the report, DYSPNOEA (Shortness of breath/I also felt short of breath), CHEST PAIN (Chest pain/a sharp pain in middle of my chest/Felt it more while leaning forward or taking a deep breath), DIZZINESS (It felt like I was going to pass out) and PAIN IN EXTREMITY (I had a sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitants were not provided.  Treatment was not given.  Patient have these events sometimes, it is not uncommon for patient when patient  go up stairs or something like that.   This case was linked to MOD-2021-388374 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received included product details and additional event.
Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Pt received varicella (Varivax) vaccination at 10am on 11/14/07. Approximately 5 hours later, she developed cough, itching, swelling and redness at injection site. On 11/15 am awoke with bilateral eye swelling, on pm of 11/15, developed hives on bilateral lower legs.
Pt stated his arm begin to swell the day after the vaccination on 17 AUG 2022 and turned red with a 50 cent size mark on his R ARM/SHOLDER. He stated it was sore to the touch but no itching was reported.  Pt. also stated he was experiencing a sore throat as well as swollen lymph nodes in his neck lesions in is mouth and a fever (which as subsided since he reported it) , lastly the patient stated he has a rash all over his body but mainly on his trunk and legs. Pt stated he has no rashes on his face at this time.     While the patient and I were on the phone, Dr. called the pt. to inform him of his appointment day and time, which will be on Friday 02 SEPT 2022 at 9:20am at Clinic. The patient left me on the line while speaking with Dr. and after a few minutres the call was ended by the patient.  The patient was called back and did not answer the phone, so I left a vm informing the patient that I would call again tomorrow to follow-up with him.  No further informaton is needed from the patient at this time.
12:30pm presented self in observation w/ c/o abd. discomfort.  Stated took vaccination w/o eating today.  B/P 184/47, HR 62, O2Sat 97%.  Provided w/ bottled water and allowed to wait in observation.  12:50pm verbalized feeling better.  left observation.
One hour after vaccine administered child had a 3 1/2 hour episode of high pitched, inconsolable crying.
1/20- 5 pm headache 1/21- runny nose - body aches/ fatique 1/22-  congestion-chills- body aches , Mailase 1/23- all of the above plus Vomiting and Diarhea that awakend me from sleep
Patient received 2 shots. The Prevnar caused quarter size local reaction at site of injection. The Boostrix a dime size local reaction at site of injection. Both arms sore. Told to apply cool compress and if worsens or does not improve see doctor.
Chief Complaint: CRAMPS, STOMACH ACHES, INDIGESTION, CHILLS & WEAK1ST COVID SHOT 1/182ND = 2/18.  Onset of symptoms: JAN 18TH. Additional information: HAD BOTTOM TEETH REMOVED - JANUARY 5 & COULDN'T EAT SOLIDS UNTIL LAST WEEK, LOST LOTS OF WEIGHT(WEIGHT TODAY INCLUDES HEAVY BOOTS)DARK YELLOW URINE ON 'BAD DAYS'. History of Present Illness -- Patient is seen today, really has not felt well for a while.  This is been especially the last month or more.  Has had several things going on this winter, actually contracted COVID-19 illness in December.  Says this was pretty much like having the flu but I think at the time felt.
Joint and nerve pain throughout body. Reports got flu and was sick for weeks. Symptoms of pain persist.
Breakthrough case admission after 3 vaccines MOderna 4/6/21 Lot# 016B21A;  Moderna 5/4/21 Lot# 009C21A;  Moderna 12/29/21 Lot# 059H21A
The day after my second injection my arm began to itch. Two days after injection, my shoulder swelled up and I had a red patch 2" x 6". The swelling has continued for the last three days.  I do NOT feel sick in any way, just redness and swelling on shoulder.
Patient with left arm pain starting after injections of Hepatitis A. No improvement after 2 months.
When titer testing was done in 1999 the pt was found to be a non-responder and was given 2 more Hep B shots. Approximately 1-2 weeks later she began tripping on her right foot. By 12/16/1999 her foot was noticeably flopping, and by the first of the year she couldn't lift her foot. He right calf muscle weakened and began to shrink. This weakness and atrophy moved up her leg into her thigh. She saw her PMD who referred her to an internal medicine MD who referred her to an orthopedic surgeon who then referred her to a neurologist. He diagnosed her with a viral infection and referred her to a Medical Center. Following an EMG she was diagnosed with ALS. The pt continues to have muscle weakness and atrophy in both legs. She has done some research and feels her problem may be related to the vaccine she received.
12/14/21 presents to ED for "left leg weakness". PMHx of "T2DM, HTN, HLD and gastric bypass"
4 days after vaccination, burning, itching right middle back and front torso, transient burning patches on left thigh at top and top of left foot: side of neck and ear
Diaphoresis; Drop in blood pressure; Feeling of dizziness; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6Q02), via an unspecified route of administration in the left arm on 25Mar2021 at 15:45 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient had allergies to cephalosporin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:45, the patient experienced diaphoresis, drop in blood pressure and feeling of dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events diaphoresis, drop in blood pressure and feeling of dizziness was resolved on an unknown date in Mar2021.  No follow up attempts are needed. No further information is expected.
Pt given 5th PCV7 instead of Hept A vaccine. Hept A vaccine then administered.  MTR notified of event.
11 year old patient received Infanrix insted of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that a 11-years-old patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Tinnitus greatly worsened within a day after receiving vaccine....so loud and unable to drown out the ringing.  In the past two weeks, I have had six bouts of vertigo/dizziness. I did go for hearing test/saw a specialist (March 17th and March 18th)  for tinnitus after it worsened immediately after receiving vaccine.  In the past two weeks, I have had bouts of dizziness that have come on suddenly (enough that I feel like I could fall over) as well as nauseas brought on by the dizziness. I have an appointment with my doctor for the vertigo tomorrow.
had been given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 8th October 2021, the patient received the 2nd dose of Shingrix. On 8th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On 8th October 2021, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received an expired dose of the Shingrix vaccine, which led to expired vaccine used. According to the nurse only the powder portion had expired. There was no specific information for the vaccine nor patient information aside from gender. Nurse did confirm that patient had not experienced any reaction or side effect at time of the call. The reporter agreed to follow-up by email.
Patient received her COVID vaccine booster of Pfizer at 12:12. At 12:25, during the observation, patient began shaking and became unresponsive. She was slouched down in her chair, then lowered to the ground by staff, while staff held her head for safety. The shaking lasted approximately 2 minutes and patient began to become responsive about 3 minutes after the shaking began.  VS: 207/115 HR 122 99% on RA. Patient reported chest pain 5/10 after the vaccine. Patient and her friend reported that she had serum syndrome with joint swelling and N/V after previous doses. Patient was very anxious and upset about getting the vaccine but told the LVN injector that the doctor would not give her a medical clearance for the booster. VS at 12:36 222/128 HR 124 98% on RA. Report given to paramedic for transport to the emergency department.
Arthritis type pain in all joints that has persisted since the day of the vaccine. Ibuprofen does not help.  Sporadic periods of rapid and irregular heartbeat  since vaccine  Swelling in lower legs since vaccine
have no feeling down my left arm at all and it's getting weaker; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (have no feeling down my left arm at all and it's getting weaker) 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)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2023, 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 20-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced HYPOAESTHESIA (have no feeling down my left arm at all and it's getting weaker). At the time of the report, HYPOAESTHESIA (have no feeling down my left arm at all and it's getting weaker) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2023: Live follow-up received on 08-Oct-23: reference numbers were added.
Child developed pain in her left leg at 10pm 4/29/19. She was unable t bear weight and ay 3am developed achiness all over and diarrhea.
I got shots of Moderna 1 and 2.  I had NO effects. Two weeks ago I got the Moderna booster shot. It knocked me down. I had extreme fatigue for two days. The fatigue slowly diminished but continued until, now, day 16, I feel like I have recovered.
Rash to face and stomach diagnosed with viral exanthema most likely a reaction to the Rubeola vaccine.
1) Within 10 minutes of the injection, my upper lip and area between lip and nose became numb. I took some benedryl and the numbness went away within 5 hours.  My arm was sore for 5 days.  2) During the evening of March 12, seven  days post-injection, an annoyingly itchy 2x2" red, bumpy rash appeared at the injection site. I used cortisone cream on it which relieved it but had to reapply it multiple times over the next couple of days when the itch  finally stopped. The redness/rash remained until 2 days ago on March 25. It has faded but is now a 2x2 inch brown spot on my arm. Will it go away?  3) I've suffered with headaches and neck pain (6 on the pain scale) ever since the vaccine until yesterday, March 26. I tried taking ibuprofen and Advil but nothing helped until  it  all just suddenly disappeared overnight,
NOSE BLEED; LOSS OF APPETITE; DIARRHEA; LOW GRADE FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and samter's triad disease, and other pre-existing medical conditions included patient have allergies . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, cetirizine hydrochloride, estradiol, fluticasone propionate, guaifenesin, hydroxyzine, ibuprofen, lansoprazole, levothyroxine sodium, montelukast sodium, omalizumab, and pseudoephedrine.  From 20-MAR-2021 the subject experienced a low grade fever, extreme fatigue, diarrhea, headache, and nose bleed till 29-MAR-2021. On 23-APR-2021, the subject again experienced nose bleed,  loss of appetite, diarrhea and low grade fever ,her fever reduced to a low grade on 27-APR-2021.  On 23-APR-2021, the subject experienced headache, extreme fatigue.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) over 100 degree, and COVID-19 (NR: not provided) Negative (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, diarrhea, headache, extreme fatigue, nose bleed, and loss of appetite. This report was non-serious.
Pt vaccinated with meruvax II developed swelling of joints, pain & swelling in all joints.
Pediatric Pfizer was undiluted and 0.2 ml was administered to patient. Patient report no adverse reactions after administration. Will follow up.
200 pm pt started to cry & all 4 extremities shake /w quivering of mouth, felt warm & /p 1-2 min went to sleep,went to MD's ofc-T 104.7.Given Tylenol ggts kept there until T went down to 102.Rest of day slept,T controlled /w meds,next am ok