chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and erythematous rash. On an unknown date, the outcome of the injection site erythema and erythematous rash were unknown. It was unknown if the reporter considered the injection site erythema and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced palm sized red area around the injection site and bilateral red band from back to abdomen. The health care professional stated that affected areas look like bad sunburn. The health care professional who reported the adverse event did not have patient or vaccine information. The health care professional was reporting information for another health care professional.
Pt recv vax on 5/10/97; on 5/23/97 pt exp red/swollen/ bruised vax site, headache, fever, rapid heart beat, 15 lb weight loss, shaky, uncoordinated, shortness of breath; tx=ice application
Sore arm (4-5 hrs); flu like symptoms (6-7 hrs) - full on flu symptoms, pain in muscles, joints, headache, fever (102 F) chills, insomnia (7-15 hrs).
Numbing in lips after 30 mins that spread to whole mouth.  Loss of taste, hives in arm that got the shot.
Woke up in middle of night after vaccination, feeling like she had the flu.  Patient had aches all over body.  Sweating.  Nausea  Pain in arm of vaccination was extreme and deep "like bone pain", pain radiated up to neck and therefore caused headache.
Patient reports intermittent sometimes severe headaches that began in the days after vaccination and have since resolved. On 12/8/21 patient was having a left temporal headache when she had sudden temporary loss of vision in both eyes. Patient states this lasted approximately 1 minute and resolved.  Since this episode patient has noticed progressively worsening weakness, numbness and tingling in all extremities.  Symptoms seem to be worse in the right upper and lower extremities.  Patient was evaluated by neurology and had an MRI of brain ordered by PCP.  No acute disease was found on the MRI however there were some small questionable T2 hyperdensities over pontine and periventricular regions.  Patient was referred to ED after her neurology appointment for concern of TIA versus Guillain-Barré syndrome versus temporal arteritis.  Labs are unremarkable including normal CRP and sed rate.  Head CT as well as CTA of head and neck did not demonstrate any blockage or leakage of contrast through.  Patient will be given admitted to the internal medicine service for further evaluation.
12/24/22 presents to ED for "SOB". PMHx of "thrombocytopenia, hyperlipidemia, and hypertension"
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 57 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number: UJ00AB and expiry date not reported) instead of FLUZONE QUADRIVALENT on an unknown date. The patient's medical history, previous medications and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No AEs have been reported by the patient. 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.
Fever, very swollen lymph nodes under arm of shot.  Pain under arm. Pain in joints of arm, left breast pain. Painful skin. Headache. Fatigue. Body pain.
Flu like symptoms uniquely, I developed a persistent productive cough with yellow colored sputum that quickly resolved once  the other flu like symptoms of myalgia, fevers of 101.3f and terrible headache resolved.
Approximately 7 days after vaccination, the skin on my left deltoid became warm to the touch and a rash appeared. During the first day of the rash it was tender to the touch, but since then the tenderness has subsided. The rash has grown in size and become more red in the past few days. The rash will itch intermittently throughout the day. Currently the rash takes up most of my deltoid. I will be starting topical corticosteroids ASAP.
Redness and Swelling on both thighs. Hard lump under skin on right thigh. Fever. Cried from 3 pm same day to 4:20 until Tylenol was given.
fever, chills,  body aches to right side of body,  Tenderness under arm, Right buttock soreness, Lump near right side of neck, next to clavicle.  Ibuprofen for body aches taken sunday , Monday.  Today Tuesday 1-26-21 continues with soreness to right underarm, injection site and lump on neck.
On 03/29/2021 I had my second vaccine in the afternoon, and a few hours later I became extremely ill. I was sick to my stomach with diarrhea and vomiting throughout the night and was attempting to keep my blood sugar up by eating cookies and drinking 7-UP. I spent the entire night fighting either high or low blood sugar levels. The next morning my husband left for an hour for work. He returned home to find me in bed and unconscious. He immediately called the paramedics. They could not bring me back to consciousness with a dextrose IV. As a result I was taken to the hospital intensive care unit where I remained in a coma for 4 days and spent another week in the hospital attempting to recover Since I have regained consciousness, I have no consistent sense of smell or taste, I also have a severe vitamin B deficiency, pernicious anemia and neuropathy in my face, before going into the coma. I have met with a neurologist on several occasions and completed therapy sessions.
C/o stiff neck, jaw tightness, difficulty swallowing, lump (L) arm.
Nausea, diaphoretic, lethargy,  sweating  Treatment. Ginger ale, fluids, rest.
patient complained of intermittent fevers since the first administration of the Moderna vaccine on 4/7/21.  fevers continued intermittently until second moderna dose on 5/5/21.  Patient developed lymphadenopathy and eventually was hospitalized on 6/6/21 for sepsis symptoms.  Patient was intubated and found to have an acute lymphoproliferative disorder that caused cardiac arrest and the patient expired on 6/8/21.  She has no lab abnormalities suggesting a lymphoproliferative disorder prior to these events.
33 year old female presents to the emergency department for allergic reaction after receiving 1st COVID-19 Pfizer vaccination.  Patient notes she received vaccination at approximately 15:30 and within 15 minutes developed an urticarial rash.  No swelling of lips, tongue or throat.  No difficulty swallowing.  No shortness of breath, wheeze or stridor. Benadryl  Pepcid  Solu-Medrol  Normal saline 1 L bolus 17:30 patient re-evaluated and subjectively feeling much better.  Rash has resolved.  No pruritus.  No respiratory complaints.  Patient in no acute distress, comfortable, vital signs stable.   18:30 patient re-evaluated and notes minimal pruritus.  Rash resolved.  No respiratory issues.  No oral edema.  No acute distress.  Vital signs stable.   Patient cleared for home disposition
Shingles after 1st dose; Defused rash on left chest; This case was reported by a physician via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix. On 2nd October 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: No Batch Number or Expiration Date was reported. The patient was vaccinated with dose of Shingrix. The 2 day after vaccination patient had a defused rash on the left chest. The patient also had Shingles. No further clarifications. The reporter consent to follow up.
swollen tongue, felt like she was going to have seizure, 105 fever for 5 days, coughing, sneezing, headache, couldn't move arm, felt fluish,
Light headedness; Dizziness; No appetite; Drinking the entire time; Muscle achiness; Joint pain (right foot, ankle and calf); Extreme headache; Nausea and vomiting; Vomiting; Fever of 103.7F; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Light headedness), DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), THIRST (Drinking the entire time) and MYALGIA (Muscle achiness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Iodine allergy, Drug allergy, Latex allergy, Allergy to antibiotic, Autoimmune disorder NOS (breast implant surgery that attacks her joints especially the right foot, ankle and calf.) and Breast implant user. Concomitant products included TESTOSTERONE for Hormone therapy, LIOTHYRONINE SODIUM (CYTOMEL) and LEVOTHYROXINE SODIUM (UNITHROID) for Thyroid disorder NOS, ESTRADIOL and ESTRADIOL (ESTRING) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DECREASED APPETITE (No appetite), THIRST (Drinking the entire time), MYALGIA (Muscle achiness), ARTHRALGIA (Joint pain (right foot, ankle and calf)), HEADACHE (Extreme headache), NAUSEA (Nausea and vomiting), VOMITING (Vomiting) and PYREXIA (Fever of 103.7F). On 12-Feb-2021, the patient experienced DIZZINESS (Light headedness) and DIZZINESS (Dizziness). The patient was treated with VITAMINS NOS (intravenous) on 30-Jan-2021 for Adverse event, at a dose of UNK dosage form; KETOROLAC TROMETHAMINE (TORADOL) for Adverse event, at a dose of UNK dosage form (for inflammation) and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK (for stomach). On 30-Jan-2021, DECREASED APPETITE (No appetite), THIRST (Drinking the entire time), MYALGIA (Muscle achiness), ARTHRALGIA (Joint pain (right foot, ankle and calf)), HEADACHE (Extreme headache), NAUSEA (Nausea and vomiting), VOMITING (Vomiting) and PYREXIA (Fever of 103.7F) had resolved. At the time of the report, DIZZINESS (Light headedness) and DIZZINESS (Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7 (High) 103.7 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included  Toradol for inflammation (given same time) Advil 800 mg and Zofran for stomach. The patient felt better right after treatment with IV Vitamin. After 15 days on 12-Feb-2021 the patient felt dizziness and light headedness until the day of report.
No additional AE; HCP reported that vaccine was administered after it experienced a temperature excursion.          ?    Names of vaccines involved (including lot/exp): VARIVAX (Lot: W031813, Expiration: 10/5/2024)        ?    Temperature: -7.93 C         ?    T; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 29-JUN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031813 and expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was -7.93 degrees Celsius, and the time frame was 0 hours, 15 minutes, 0 seconds. There were no previous temperature excursions.
Atrial Fibrillation Episode; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation Episode) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Cardiac ablation on 03-Jun-2021. Concomitant products included APIXABAN (ELIQUIS), LOSARTAN, LEVOTHYROXINE, LOVASTATIN, CHLORTALIDONE (CHLORTHALIDONE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation Episode) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 01-Jun-2021 to 04-Jun-2021 due to ATRIAL FIBRILLATION. The patient was treated with METOPROLOL ongoing since an unknown date for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation Episode) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included Balance of Nature Supplement.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No significant symptoms to be reported on the days following the 1st and 2nd doses of Moderna vaccine. On 4/14 (one month post second dose) suffered very strong cramps, followed by an very heavy menstrual period. The menstruation too place 11 days after the last one, which was within a regular 22 day cycle. I have always had a very regular cycle and never one that started 11 days after the previous one. Bleeding was so heavy, I had to stay in bed for 2 afternoons and even considered a trip to the ER.
Case number PHEH2011US06998, is an initial spontaneous report received from a nurse on 14 Oct 2011: This report refers to an adult male patient. He was vaccinated with MENVEO (batch number A10131), 0.5 ml, intramuscularly, on 30 Sep 2011. He was also vaccinated with TDAP. Minutes after vaccination, he experienced syncope. Episode was short and event was resolved.
Pt. was given KINRIX then given Polio. Pt. given 2 doses of Polio at once.
Received vaccine, 5 minutes later c/o itching at injection site. Area became red, swollen, warm to touch and itchy from shoulder to elbow. Cheeks became red. No SOB, V/S stable, swelling slowly resolved over 3 hours. Itching and redness of arm and cheeks continued until 8pm per child. Completely resolved by this am.
34 hours (2:00 am on 2/19/21) after injection I woke up with stomaching cramping and nasuea. At 3:00 a.m. I was dizzy and had uncontrollable shaking over entire body for approximately 45 minutes. The nausea continued throughout the entire day on 2/19/21.  I contacted the Department of Health today, but whomever I spoke to did not seem interesed in hearing about it and did not ask any questions or for any information.
2 weeks after my booster I started to have random itching that just came on. I have seen an allergist for dermographia, and without the medications that were prescribed I would be constantly scratching. The medications are helping tremendously with controlling the symptoms severity however there are days when it does come on.
fever 104 degree, trouble breathing, swelling on arm ,upper neck, chest, feeling weak and dizzy , fast heartbeat, blood pressure 200/110 lasted for 24 hours
The patient came to the pharmacy and reported she had a local reaction to her flu vaccine. The patient's left arm was red, slightly swollen, and according to the patient, itchy. I recommended the patient take Benadryl to help with the inflammation and redness. I recommended that the patient go to urgent care if the redness and itchiness doesn't go away in a day or two. The patient was happy with the recommendation and purchased  a box.
This was the new Grey top vial of Covid 19 vaccine, that does not get diluent added to it, but our MA added Diluent, and then gave the 0.3ml dose.  We discovered it when an RN went to give a dose to another patient and there was a note filled out with the time diluent added and how long the vial would be valid.  Patient had no adverse events while in our office after receiving the vaccine.  We attempted to call the parent but did not receive an answer.   Attempted to call again today 2-22-2022 but still no answer on cell number and home number.  Sent email to rep for the vaccine program, no reply as of yet.
Pt has chills and weakness. She has a cough and sore throat. She is a insulin-dependent diabetic. She is admitted with symptomatic COVID-19 and sepsis.
numbness on lt side top of head to waist arm;no loss of motor control x/face;felt hot/cold temps ok;problems in face have gotten worse arm is getting better;centered @ site of inj;
Fever, chills, tiredness, swollen lymph node (under armpit), upset stomach. This all occured after 10pm the day of the shot
Head was hurting; fever; stomach really hurts; heartburn; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date (reported as on the 15th) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced head was hurting on an unspecified date. The patient took paracetamol (TYLENOL) as treatment for the event head was hurting. On an unspecified date, after taking Tylenol, the patient experienced fever, stomach really hurts and heartburn. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8-17-12 at 09:40 patient received tdap and MCV-4, after receiving vaccine pt. alert & oriented. Walked approx. 65 ft. to front office and was talking to staff. At approx. 9:45 father reports pt's eyes rolled back into head, Pt. felt after becoming unconscious hitting head on floor, B/P 107/55 BS=104, HR-55, Pt. regained consciousness - talking oriented. C/O headache and tingling to neck. Transported via ambulance to hospital.
On 3/15/2021 around 8 am noticed a red rash around the injection site on the upper left Arm
Slight fever (99.4); Fatigue; Aches; shoulder where shot was administered ached; This is a spontaneous report from a contactable consumer reported for himself.   A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route at left arm on 26Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included Covid-19 infection. Since the vaccination the patient has not been tested for COVID-19. Concomitant medications were not reported. On 26Jan2021 at 20:00 the patient experienced slight fever (99.4),fFatigue, ache and shoulder where shot was administered ached. The outcome of the events was recovered on unknown date. The patient did not receive any treatment.   Information on the lot/batch number has been requested.
Pt recvd vax 5JAN93 & following the vax pt exp nausea & vomiting;
Patient admitted with RUQ pain and lab and clinical findings consistent with acute cholecystitis. She was taken to the OR. She required LOA and was found to have gangrenous changes to her gallbladder. She did well Post op and was discharged on hospital day 2. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Spoke to nurse the following day and nurse noted that patient was not eating or sleeping the entire night. She had a red welt where the PNEUMOVAX 23 was given. The following day nurse stated patient felt better and was up eating and playing bingo.
Patient woke up Wednesday 4/15/04, covered with red swollen blotches everywhere. Her temperature was 101 degrees. She was taken to see the doctor. He felt she may have been having a drug reaction to the penicillin shot she received 16 days earlier on 3/31/04. She was given a steroid to take at night and Zyrtec. Thursday morning, when she awoke, she was much worse. Her eyes, face, hands, and feet were extremely swollen. Her legs were blue and cold. Her temp was 102 degrees. Mom was told to stop her steroid and just take Zyrtec. By Thursday evening, her temp was 104 degrees and she traveled 80 miles to the ER. The staff there felt it was not a reaction to penicillin. Some of the staff felt it could be a side effect to the MMR she had on 4/6. Their next diagnosis was erythema multiforma. They sent her home with Benadryl only. On Friday, she started vomiting blood. She was extremely dehydrated and very lethargic. She again was taken to the ER and was given IV's and sent home. Saturday around 1 PM, she still hadn't eaten or drank any fluids. She was then admitted to the hospital and given IV's along with Zithromax, Benadryl, and a different steroid. By Sunday afternoon she was finally feeling better--drinking and eating. Monday her rash was gone and she was back to normal. Nurse follow up on 06/03/04 states: Complete. Nurse follow up on 05/17/04 states: " ADD: Urticaria, Dermatitis."
pt recvd vax;15 mins later, rt leg swelling/redness;size of quarter;DPH, advil given; ice pack to rt leg;
pt exp severe joint pains & was unable to work x 3 days; 18SEP95 h/a, achey joints, intermittent muscle twitching; 19JUN & 20SEP95 very severe joint pains, fever 102, nausea; 21SEP95 dec joint discomfort, inc local rxn-pain, edema
skipped the second dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (skipped the second dose of vaccination) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 PRODUCT DOSE OMISSION ISSUE (skipped the second dose of vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (skipped the second dose of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, COVID-19: positive (Positive) tested positive for corona.         No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.  patient received a plasma infusion therapy on 13 February 2021.
Fatigue on Day 1, Day 2 after vaccine Temp 99.1 on Day2 after vaccine
I had no issues around the injection site. I started having leg pain in 07/10/2022. I went to my doctor and was referred to a hospital where I had a ultrasound and diagnosed deep vein thrombosis. They admitted me to the emergency room for four hours.