chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; tired; throat started burning; weak; sores around mouth; chills; sugar dropped; blood pressure dropped; body aches; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills) and BLOOD GLUCOSE DECREASED (sugar dropped) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped) and MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped), MYALGIA (body aches) and PAIN IN EXTREMITY (sore arm) had resolved and FATIGUE (tired) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood glucose fluctuation: 24-feb-2021 abnormal Low. On 24-Feb-2021, Blood pressure measurement: lower abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Consumer declined to provide contact information. No other information was provided
I went in to have a blood panel done and it showed high liver enzyme levels. I have never had this issue before. They think it might be from taking Lexapro and Lipitor at the same time. I am going to continue to have tests done to be sure.
PATIENT BEGAN SLURRED SPEACH AND WEAKNESS IN LEFT SIDE ONE WEEK AFTER VACCINATION. DAUGHTER, WHO IS A NURSE, NOTICED AND MADE PATIENT GO TO ER.  THERE, PATIENT HAD A SCAN DONE THAT REVEALED TWO BLOOD CLOTS, WHICH HAD CAUSED A STROKE, IN THE BACK OF THE BRAIN.  PATIENT WAS KEPT FOR OBSERVATION OVER NIGHT IN THE HOSPITAL AND THEN RELEASED.
Fever 102, chills, body aches, headache, fatigue, nausea, vertigo, weakness, injection site erythema and swelling and pain Fever lasted 24 hours.  Vertigo resolved within 12 hours of onset of symptoms.  Body aches, headache, fatigue improved after 24 hours and resolved by 72 hours. Nausea was intermittent over the first 72 hours. Localized injection site symptoms resolved within 72 hours.
Generalized urticaria developed shortly after leaving clinic. No angioedema. No respiratory difficulty. Was seen 2 days later 8/5/04 with mild ant hives. Given Atarax.
pt devel 10-12 chicken pox lesions p/ exposure to a child who had devel chicken pox following vax;
Patient fainted about 1 minute after receiving the vaccine. She has a history of fainting when having blood drawn but never from receiving a vaccine. Patient woke up on her own before the smell salt was opened.
No energy; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), PAIN (Body aches) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (No energy), PAIN (Body aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Ache, Chills and Energy decreased, at an unspecified dose and frequency. At the time of the report, ASTHENIA (No energy), PAIN (Body aches) and CHILLS (Chills) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Local reaction with cellulitis appearing about 36 hours, post vax, consisting of an area of induration and erythema measuring 2 1/2cm X 7 1/2cm; cellulitis with a 9cm streak going into axilla.
70 yo Female experiencing left leg tingling after vaccination. Otherwise well. No rash, vomiting, swelling, weakness. Patient did state that she was nervous about her vaccine today. Vitals RR 20 HR 94 BP 140/90  Oxygen 97% GCS 15, patient is alert and oriented, lungs clear, heart RRR, no murmur, strength bilaterally 5/5. Patient was observed for a total of 45 min and she felt better, tingling diminished. Patient declined going to hospital. Since patient improved and was feeling well discharged to go home with anticipatory guidance.
Patient developed atrial fibrillation for the first time, later required ablation.  No risk factors for atrial fibrillation.
blurred vision; back pain; pain in her knee and leg; fatigue; pain in her knee; rash on her face and chest; This case was reported by a consumer and described the occurrence of blurred vision in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced blurred vision, back pain, rash, leg pain, fatigue and knee pain. On an unknown date, the outcome of the blurred vision, back pain, leg pain, fatigue and knee pain were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the blurred vision, back pain, rash, leg pain, fatigue and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received the first dose of shingrix three and half weeks ago from the reporting date and had rash on her face and chest that last 3 days. The patient also experienced pain in her knee and leg, back pain, blurred vision and fatigue, she was not recovered till the time of reporting. No address where the vaccine was administrated provided and no exact date of vaccination was provided. The customer had a virtual follow up with her doctor. The reporter did not consent to follow-up.
Headache, dizziness, fever, diarrhea, eyes floating, irritibility, inconsolable.
Extreme chest pain on the left chest around the heart starting on the evening of 2nd dose vaccine and continued into the following day. The doctor at the emergency room conducted an ultra sound to see around the heart. Excess fluid around the heart indicating inflammation of the lining of the heart. Blood test results were elevated so CT scans were conducted to verify if any blood clots around the heart were present. CT scans show no signs of blood clot. Anti-inflammation medication was administer via IV and prescribed for treatment.
Slightly light headed for about 15 minutes.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 13:00 (at age of 70-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, after second shot, the patient became slightly light headed for about 15 minutes. The events 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 slightly light headed for about 15 minutes was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozenand PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozenand PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication  was not provided .
High fever, chills, aches, sick to stomach, head ache, flu like symptoms..
pt states was diagnosed 5 dys ago with COVID @ urgent care clinic; presents to ED with increasing SOB, myalgias, congestion; started on O2 supplementation 4-5 L, remdesivir, dexamethasone; COVID pneumonia and ARF; pt's condition worsened and she required intubation with ventilation; developed shock, AKI and hyperkalemia; was made a DNR by family; pt deteriorated and expired in the hospital
Contracted covid a couple days later; This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced contracted COVID a couple of days later. The event outcome was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient complains of pain, swollen, redness and can not raise arm. Feel sick all days for 1 day.
When I woke up in the morning, pain was gone, but entire body is weak; About 8 hours after receiving the vaccine, i started getting feverish and had a headache.; About 8 hours after receiving the vaccine, i started getting feverish and had a headache.; Slowly started having severe pain in both legs from my waist down to my toes for about 6 hours; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 21Apr2021 at 08:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 08:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 16:00, about 8 hours after receiving the vaccine, the patient started getting feverish and had a headache. Slowly she started having severe pain in both legs from her waist down to her toes for about 6 hours. When the patient woke up in the morning, pain was gone, but entire body was weak and still had a headache. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slowly started having severe pain in both legs from waist down to toes for about 6 hours was resolved the next morning on 22Apr2021. The clinical outcome of the events about 8 hours after receiving the vaccine, started getting feverish and of entire body was weak was resolving, while that of headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Was vaccinated and got shingles twice/Suspected vaccination failure; Shingles not bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Was vaccinated and got shingles twice/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles not bad).The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient's wife via interactive digital media. The patient was vaccinated with shingles vaccine and got shingles twice not bad. The patient was better in less than a week. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Injection Site of Pneumonia Vaccine was hot and swollen, chills, nausea, vomiting, headache, muscle pain, fever rose to 104 but was 102 plus in doctor''s office on 6/19/2014, prescribed Bactrim for 10 days for Celllutis, returned to Dr on 06/20/2014 and was sent to ER because redness, swelling around injection site had spread, ER on Friday eve, 06/20/2014, where given an antibiotic injection (of?) and prescribed a 2d oral antibiotic, Keflex to be taken in conjunction with first prescribed antibiotic, returned to Dr on 06/24/2014, red, swollen area has receded, still hard hot lump about the size of a golf ball, was instructed to finish both courses of antibiotics, Dr said I had symptoms of both an allergic reaction and cellulitis
A report was received from a health care professional on 12/5/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03 the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
11PM CHILLS,TEETH CHATTERING, BODY SHAKING, NAUSEA.   APPROX 2-3 AM 2/18/21 ON WAY TO THE BATHROOM LOSS OF CONSCIOUNESS-FELL HIT HEAD, PASSED OUT 2 X MORE. PARAMEDICS CALLED  ADMITTED TO HOSPITAL EEG, CAT SCAN, NO FEVER, CHILLS 4-5AM SWEATING PROFUSLY, LOW BP, POSTURAL HYPOTENSION, DISCHARGE FRIDAY 2/19/2021 . SATURDAY 2/20/2021 HIGH BP > 170.  BP CURRENTLY UNSTABLE HIGH AND LOW
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA291567 (same reporter). This case involves 2 patients of unknown demographics who received a dose of expired vaccine FLUZONE QUADRIVALENT (lot number and expiration date not reported) via unknown route and unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported that the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
pt recvd vax; swelling of throat & face; to er; DPH injected;
Information has been received from a physician concerning his 8 year old daughter who in approximately 1998, when she was 2 years old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Last week, approximately 04/15/2004, the child got a real bad case of full blown chickenpox.   It was reported that he prescribed his daughter acetaminophen and diphenhydramine hcl for treatment.  Medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Nausea, stomach cramping and vomiting and dry heaving for several hours. Fatigue, body aches, fever of 100.7. Tylenol and ibuprofen given every 4-6 hours. 30 hours or so of feeling unwell.
5 years old male inadvertently administered Pfizer 6 months to 4 years old dose instead of 5 years old to 11 years old for his first dose.
Initial case was received from a healthcare professional on 04 April 2013. A four-year-old female patient received an injection of DAPTACEL, sanofi pasteur Ltd., lot number C4286AA and an injection of IPOL, sanofi pasteur SA, lot number H1452, (routes, sites, sides and dose in series were not reported) on 01 April 2013. The parent reported the child seeing "ghosts and monsters" while awake during the day; but not sure if started day of vaccinations or the day before the child received vaccinations. The parent reported the child asks "when will all these ghosts and monsters go away" during the day. The patient had no fever or any other reaction reported. The patient required a doctor visit. Laboratory or diagnostic testing or treatments were not reported. The patient had no known allergies and no history of medical conditions. The patient had no illness at time of vaccination and did not have any other vaccinations within four weeks of vaccinations. The patient's outcome was reported as not recovered. Documents held by sender: None.
Patient said that after vaccine that within 3 hours she was in tremendous pain and said she felt the site was to high on her arm. She said she was unable to move her arm. She went to ER  and was given pain medication. She said injection site was sore for 3 weeks. She asked to be reimbursed for ER visit.
Pt tested positive for COVID-19 57 days post vaccination. Pt experienced altered mental status.
Swelling and slight redness in left arm began evening of 11/11 Swelling in the lymph nodes in left armpit began overnight. Woke up around 7am and there was a large swelling under left armpit and an egg sized swelling above middle of left collarbone that were painful.  Also have joint pain and fatigue. Still have symptoms on 11/16/2021
Localization of redness, warmth, swelling and fever. Subsequently developed infection requiring IV antibiotics.
Little white pin drops all over; Rash; Breaking out on arms, waist, chest, legs, hands, face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAPULE (Little white pin drops all over), RASH (Rash) and RASH (Breaking out on arms, waist, chest, legs, hands, face) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (on both arms).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAPULE (Little white pin drops all over), RASH (Rash) and RASH (Breaking out on arms, waist, chest, legs, hands, face). At the time of the report, PAPULE (Little white pin drops all over) and RASH (Rash) had not resolved and RASH (Breaking out on arms, waist, chest, legs, hands, face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Inconclusive.         Patient advises that since the rash started she's been to the emergency room twice, to her dermatologist and to her primary care doctor 6 or 7 times.  Patient advises her primary care doctor has been trying to figure out what her rash was and how to get it taken care of. She had blood work done at her primary care doctor. In the middle of all of this dealing with her rash, she's seeing the dermatologist for skin cancer. The dermatologist did send scrapings of the rash off. Advises she doesn't have those results.  No treatment medications were reported.  No concomitant medications were reported.   This case was linked to MOD-2021-109718 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event added On 22-Jun-2021: Possible NNI please confirm
Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia,  and headache
RECEIVED SECOND DOSE TOO EARLY FROM FIRST WHICH WAS ADMINISTERED 09/15/2021.
Moderate shoulder pain, radiating down towards bicep and forearm. Struggles to lift arm over head.
Extremely cold, shivers, nausea, dizziness, sore body, sore arm