chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very hungry; Swelling at the injection site; Pain at the injection site; Muscle pain; Tiredness or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Very hungry), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue). On 07-Mar-2021, the patient experienced HUNGER (Very hungry). On 06-Mar-2021, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle pain) and FATIGUE (Tiredness or fatigue) had resolved. At the time of the report, HUNGER (Very hungry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment medications were reported
Information has been received from a physician concerning a 10 year old male with asthma, seasonal allergy and no drug allergies who on 24-MAR-2008 was vaccinated with MMR II. Concomitant therapy included SINGULAIR and "HYSOL". On 26-MAR-2008 the patient complained of "not feeling". On 27-MAR-2008 the patient was sent home from school with complaints of a stomach ache and a fever of 104. The physician noted that the fever has been sustained at 100 to 104F since onset, despite alternating treatment of MOTRIN and TYLENOL. The patient was seen by physician who ruled out strep throat, flu and pneumonia. The reporter felt that "not feeling good", stomach ache and fever of 104 were related to therapy with MMR II. At the time of reporting the patient was recovering. No lab diagnostic studies were preformed. There was no product quality complaint. Additional information has been requested.
On 2/12/18, Patient reported still having pain and soreness at the injection site. Patient described pain as numbness and tingling at the injection site and hurts when lifting the arm and while moving and sleeping at the injection site arm. Suggested patient to consult with the doctor.
For at least 3 days after immunization. Felt extremely weak, cold-could not keep warm. Unable to leave home, -> felt like she had the flu.
nausea, vomiting started 2-2 1/2 hours after vaccine administered - continued with nausea through next day - poor appetite. Treated fever with Tylenol. Was very nervous for injections (reported by mother of pt).
Deltoid swelling, feverish feeling, redness, hard lump, hot to the touch, pain.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was sitting in chair, as she was getting up, experienced lightheadedness and thought she was going to faint.
8-28-05 - Broke out in hives on trunk and arms.  Ongoing hives/pruritis continue to be present today (9-6-05).  8-29 and 8-30-05 fever.  Pt will visit doctor today (9-6-05).
Information has been received from a healthcare worker (immunization official) referring to a 12 month old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K010440(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Tightness of chest and throat. Difficulty breathing. Started after 20 minutes of receiving the injection and lasted for two hours. Got better with antihistamines.
one low reading blood pressure 93/70; fatigue; trouble with sleep night; Rapid heart rate for about 48 hours after vaccine (around 100) (resting heart rate usually 67-70); Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 09:00 (Lot number: FE3590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes; "osteoporosis" (unspecified if ongoing); "food poisoning" (unspecified if ongoing); "low sodium level", start date: 27Oct2021, stop date: 2021, notes: 27Oct2021 hospitalized for low sodium level (recovered) after food poisoning. Concomitant medication(s) included: ALENDRONATE; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 19Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 29Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Booster"; HEART RATE INCREASED (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "Rapid heart rate for about 48 hours after vaccine (around 100) (resting heart rate usually 67-70)"; HYPOTENSION (non-serious) with onset 20Nov2021 09:00, outcome "recovered" (Nov2021), described as "one low reading blood pressure 93/70"; FATIGUE (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "fatigue"; SLEEP DISORDER (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "trouble with sleep night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypotension, fatigue, sleep disorder.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination:  multivitamin. Since the vaccination, has the patient been tested for COVID-19: No. No known allergies.   Follow-up attempts completed. No further information expected.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were pneumonia, A-fib and hyponatremia. Patient died on 4/21/2021
a little dizziness; feeling confused; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a little dizziness) and CONFUSIONAL STATE (feeling confused) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Dizziness. Concomitant products included MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for Dizziness, TACROLIMUS for Liver transplant, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, ZOLPIDEM, LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM, MAGNESIUM OXIDE, TAMSULOSIN and VALGANCICLOVIR for an unknown indication.    On 08-Apr-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 DIZZINESS (a little dizziness) and CONFUSIONAL STATE (feeling confused). At the time of the report, DIZZINESS (a little dizziness) and CONFUSIONAL STATE (feeling confused) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was provided.   This case was linked to MOD-2021-122615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: No new  information was received.
Thrombophlebitis of superficial thoracic vein (mondor?s) within one week of shot and no underlying predispositions. Remained for several months so far. Was informed by hematologist that it likely will not go away completely at this point.
Fluid on her arm (droplet); Didn't receive the entire dose; A spontaneous report, was received from a consumer (patient), a 61 years-old white female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced fluid on her arm (droplet) (vaccination site extravasation), and didn't receive the entire dose (incorrect dose administered).  The patient's current conditions included hypertension and allergies. Concomitant medications reported included lisinopril and unspecified allergy tablet.   On 09 Feb 2021, prior to the onset of the events, the patient received their second planned doses of mRNA-1273 (lot number: 010M20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021, after the vaccination, the patient experienced that there was fluid on arm (droplet), and the nurse wiped it off. The patient stated that the nurse also attempted to place a band aid over the injection area, but the site was moist, and the band aid wouldn't stick. The patient was concerned if she didn't receive the entire dose. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the event, fluid on her arm (droplet) was unknown, and didn't receive the entire dose was considered as recovered on 09 Feb 2021.; Reporter's Comments: This report refers to a case of a 61-year-old female with Vaccination site extravasation and Incorrect dose administered for the second dose of mRNA-1273 (lot # 010M20A) with no associated adverse events.  Events considered resolved.
Undiluted Pfizer BioNTech vaccine was administered.  No adverse events were observed at the time of administration and 15 minutes afterwards
Breakthrough case after Covid vaccination. Dose # 1 5/26/2021. C/O loss of taste/smell, fatigue, cough, and nausea/vomiting. Onset 8/26/2021.
vials were not refrigerated; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient received Shingrix adjuvant and antigen vials from another pharmacy. The reporter stated that, vials were not refrigerated by patient before patient brought vials to her for administration, which led to incorrect storage of drug. The reporter inquired about vaccine stability and if still okay to reconstitute and administer vaccine. No additional details were provided by the reporter. The reporter did not consent to follow up.
Dtap 0.5cc given IM to Left deltoid on 5/17/05. Left deltoid swollen and red measuring 7 1/2 cm x 9 cm area. Bactrim 40 mg 15ml prescribed 2 tsp BID x 10 days.
if the 2nd dose is given 8 months after the first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date 8 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient enquired if the vaccine would still be effective if second dose received after 6 months.
77 YEAR OLD FEMALE COMPLAINED OF A FUNNY BACK AND NECK AFTER SHE RECEIVED THE VACCINE. ONSITE EMS AND PHYSICIAN RESPONDED. IT WAS RECOMMENDED THAT SHE GO TO THE E.R AND SHE REFUSED AND WENT HOME
swelling, pain, inflammation rt arm @ site inj 2x p/inj;fever 101.9;
Administered HPV to (L) arm, pt reacted, pt eyes rolled back and body became limp, jerky movement to upper body for about 5 seconds then regained control of body. She then became alert, let her sit for 15 min, pt was okay and left with mother.
Initial misuse report received from a healthcare professional on 11 June 2013. A patient had received dose of MENACTRA at age of 11 years, 16 years and eight months later, again on 11 June 2013. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Started noticing hair loss approximately 4 months after first dose. Saw long-time hairdresser in July, she noticed hair loss. Dr prescribed Clobetasol Propionate topical solution. Used it for 2 months without results.  Saw hairdresser again in September and she noticed significant hair loss.  Dr is sending me to see a dermatologist
Patient called on 02/22/2021 and states that she got her vaccine on 02/19/2021. On 02/21/2021 when she woke up in the morning realized that she was itching all over and had a pink splotchy rash all over. She took Benadryl. Advised her to call her PCP. She called PA and was advised to take Pepcid and Claritin for possible allergic reaction to the vaccine. She states that she had no other side effects other than a sore arm. She has had renal failure for quite a few years, not yet on dialysis. She states that she talked to her nephrologist and they encouraged her to not get a second vaccine. She states that she has reacted to illnesses like this in the past and thinks that it is just her body flaring up trying to fight off the immune response. When talking to her today 02/24/2021 she states that she is doing much better. Rash is almost gone and itching is less.
Dose given 8/6/2020 around 12:30 pm; by about 7:00 pm arm was quite painful to move; later in evening I noticed redness and bumpy surface; by next day I could hardly move the arm due to the pain and arm was slightly swollen; this continued for the third day; by August 9 the symptoms were done except that my arm was still somewhat red.
HYPOXIC RESPIRATORY FAILURE COVID-19, SEPSIS COVID-19, PNEUMONIA COVID-19
Pt c/o arm swelling and soreness in same arm that she said vaccine was given. Upon evaluation, (L) arm (outer and inner) was edematous, erythematous approx 4" wide and 6" long approximately 3" below (L) deltoid. No redness or swelling was noted on deltoid area. Area warm to touch.
supposed to give Fluarix accidentally grabbed and administered Fluzone High Dose Quadrivalent, with no AE; Initial information regarding an unsolicited valid non-serious case received via an other health professional on 13-Nov-2020.  This case involves a 44 year old female patient who was supposed to take fluarix, however grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] accidentally (wrong product administered) (batch number: UJ552AA and expiration date: 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) family history and concomitant medications were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
After shot, arm was tender at inject site, 2 days later tenderness spread and into arm pit.  For the last week, tenderness has moved down patients r/side to about breast level.
Started to feel muscle soreness. Got worse and worse, started shivering and feeling really cold but when I touched my skin it felt hot. Shivering went away for a little while and I was able to sleep but then I woke up around 1:45am and started to shiver uncontrollably. My husband checked to see if I had a fever and I didn't.
Nauseous; Headache; Diarrhea; Super exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Super exhausted), NAUSEA (Nauseous) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Super exhausted) and HEADACHE (Headache). On an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Super exhausted), NAUSEA (Nauseous) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
104.4 fever  Chills Body aches  Muscle cramps  Confusion  Sweats
Vaccine was administered after the 30 day BUD date of December 1, 2022.
Approximately 15 min post injection - "Feeling hot all over like I had dye for a CT scan. " No other c/o/ symptoms. Elevated HR of 93 and  elevated  BP of 164/93. Stayed an additional 15 minutes. Able to take water. After additional 15 minutes  VS taken again and stable, but BP 155/97.No further complaints. Denies need to stay longer. Instructions given to call physician or 911 if symptoms change or worsen.
CoughWheeze, chest tightness, shortness of breath Narrative: Employee had cough, chest tightness, and developed shortness of breath after the vaccine and required Emergency Department visit. He had ancillary labs, EKG and discharged home.
Child was sitting in exam room chair to receive vaccines. Immediately after receiving second injection (ADACEL), child became diaphoretic, pale, and stated he did not feel well. RN escorted him to exam table, where he lay down. EMS was called. At no point did child lose consciousness. At no point did child fall or hit any part of his body on any surface. At no point did the child become short of breath. There was no visible or palpable local reaction at the vaccine site. Child was assessed by EMS, sat up, sipped water, stated he felt better. Child was taken by EMS to local ER for further evaluation, his father accompanied him.
Cousin got the shot and got shingles from it./ Suspect vaccination Failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's cousin. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles from it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
12AUG92 turned white; lips blue; head dropped chin to chest; pt staring; extremities limp; did not respond to stimulus; lasted 10-15 mins; seemed sleepy;
patient presented to ed on 5/1/2021 with acute stroke, no family history of stroke. P