chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can't sleep at night; Anxiety; Acid Reflux; 2nd Dose Missed; Feeling tired; Tight feeling in her throat like someone is chocking,Pressure on throat; Arm was little sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tight feeling in her throat like someone is chocking,Pressure on throat), PAIN IN EXTREMITY (Arm was little sore), INSOMNIA (Can't sleep at night), ANXIETY (Anxiety) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was little sore). On an unknown date, the patient experienced THROAT TIGHTNESS (Tight feeling in her throat like someone is chocking,Pressure on throat), INSOMNIA (Can't sleep at night), ANXIETY (Anxiety), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), PRODUCT DOSE OMISSION ISSUE (2nd Dose Missed) and FATIGUE (Feeling tired). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of UNK dosage form. At the time of the report, THROAT TIGHTNESS (Tight feeling in her throat like someone is chocking,Pressure on throat), PAIN IN EXTREMITY (Arm was little sore), INSOMNIA (Can't sleep at night), ANXIETY (Anxiety), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), PRODUCT DOSE OMISSION ISSUE (2nd Dose Missed) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Itching; Red for two days 2" by 2" at injection site; little pink a week later but not itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy) in a female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy). At the time of the report, PRURITUS (Itching), INJECTION SITE ERYTHEMA (Red for two days 2" by 2" at injection site) and SKIN DISCOLOURATION (little pink a week later but not itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
HPV vaccine given in error. Client had 3 doses prior that were not noted. No adverse reactions noted.
Agitation, Headache, Myalgia, Arthralgia, Fever, Loss of appetite and fatigue Narrative:  Other Relevant History:
Regressed to no longer speaking, head banging, loss of eye contact, sensory issues, obsessive tendencies.
Mom reported headache, chills, leg pain, lethargy, and sore throat, runny and stuffy nose.
Mild fever and fatigue, headache, strong (but not severe) body ache, took acetaminophen
sore in the arms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 24Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for covid-19 immunization. Relevant medical history included: "arthritis" (ongoing). Family history included: "Ovarian cancer" (unspecified if ongoing), notes: mother; "mother died of Ovarian cancer" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE taken for arthritis. Vaccination history included: Flu shot (maybe in her 30s or 20s), for Immunization, reaction(s): "had a severe reaction". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore in the arms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccine within four weeks of Pfizer vaccine. The patient had Colonoscopy done in Jan2021 resulted negative. Her mother died of Ovarian cancer. Her mother had chemo induced diarrhea.   No follow-up attempts are possible. No further information is expected.
Was admitted from local Urgent Care Clinic on 11/12/2021 because of acute hypoxic respiratory failure, gastroenteritis, dehydration due to COVID-19 virus and pneumonia.  Patient was admitted to telemetry bed initiated on high-dose Decadron which was weaned down to 6 mg daily, she received 5 days of Remdisivir and also 13 days of Baricitinib.  Patient was able to slowly wean off oxygen to room air at rest but required 2 L nasal cannula with ambulation after home oxygen evaluation was performed on day of discharge.
ACHY; SWEATING; CHILLS; SORE LEFT ARM; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 100 pounds, and height was 63 inches. The patient's concurrent conditions included auto immune disease, no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies reported. no drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26/MAY/2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for auto immune disease. On 2021, Laboratory data included: Antibody test (NR: not provided) SARS-CO-2 IGG Antibody result 0.2 (negative per doctor). On an unspecified date, the subject experienced achy, sweating, chills, sore left arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, sweating, chills, sore left arm, and headache on 17-MAR-2021. This report was non-serious.
The patient received the first dose of vaccine on March the 1st and the 2nd dose of the vaccine on March 28th. Patient had difficulty breathing with swelling feet and ankles that did not begin until April 12th. Patient had no history of breathing problems. Cardiovascular history is unknown at the pharmacy as we had only ever performed vaccinations on the patient. Patient was discovered in his house deceased. Exact date is unknown. The pharmacy was contacted by the patient's prescriber which requested we file this report. I apologize for the lack of precise information.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017, dose and route were not reported) that  has experienced an excursion. On 14_DEC-2015, the patient was vaccinated with another dose of GARDASIL (lot # L010596; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
w/in 60-100sec post vax pt appeared to lose consciousness, skin became pale & moist, muscles contracted w/arms drawn toward body, head drawn down toward lt shoulder, face became contorted, muscle twitching in face & arms;sz
Severe chills; mild headache; Arm and pain all over; Arm and pain all over; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and expiration date: not provided) in arm left on 16Feb2021, 07:30 AM as a single dose for COVID-19 immunisation. Patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date: not provided), via an unspecified route of administration in arm left on 26Jan2021, 07:30 AM as a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced arm and pain all over, severe chills and mild headache on 16Feb2021, 08:00 PM. No treatment received for the events. Outcome of the events were recovered.
Pt was sent to ER with another employee in private car. Pt check out swollen arm from shoulder to finger tips, right arm. Pt stated that as a child, she had an allergy to mayonnaise, no egg allergy as an adult. Arm began swelling one hour after shot resolved two hours later.
Swollen lymph node Lt Supraclavicular (trapezoid) Similar Sxs with past flu shot 2 years ago.
Swelling & pain in leg around site of inject; cried many hrs; swelling & induration lasting 5+ days;
Patient received both COVID vaccines.  On 5/21/21 she presented to the ED with COVID symptoms.  She was tested on  5/21/2021 and was positive for COVID-19.  She died on 6/7/2021 in hospital from complications of COVID-19
2:30PM pt. was administered 2 vaccines influenza and pneumonia. No symptoms before she left the clinic. 3:00PM pt. experienced her lips swelling & airway closing. Pt. was instructed to go to the nearest ER. Was administered EPI PEN & oxygen at ER.
Three hours after vax: extreme fatigue, flu symptoms, nausea, dizziness, extreme headache, vomiting lasting 24 hours. One month after vax:  viral infection/bronchial infection. Coughing, phlegm, swollen glands lasting one month.
Patient received this vaccine by accident. When I checked in with the patients mom on 11/27 she reported that her daughter was feeling fine and was not experiencing fever, headaches, chills or body aches. She was acting as her usual self
Systemic: Dizziness / Lightheadness-Mild, Additional Details: we elevated his legs and he sat down and rested. wiped his face with a cold paper towel. he was fine. he also drank some juice before he left.
Just noticed a small rash on my right forearm and itching on my back. Lasted for like an hour on and off
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), ATENOLOL, LISINOPRIL and TAMSULOSIN for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Experiencing hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine approximately 10 days ago and now he/she was experiencing hives. The patient asked if this was possibly related. Additional supportive information: The follow-up would not possible, as no contact, details were available.
The patient was given the Janssen vaccine around 12pm. After about 15 minutes he left the pharmacy area to find his siblings in the store. He returned and stated that he felt dizzy and fell. He cut his elbow from the fall. He stated that dizziness is all that he experienced. I advise him to sit in the waiting area for about 30 minutes so that we could continue to monitor him.
The first dose that I had the Pfizer I got really sick; I really thought that it might be the last time in my life; My blood pressure went sky high; I didn''t suffer with high blood pressure but my blood pressure went so high; shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "The first dose that I had the Pfizer I got really sick; I really thought that it might be the last time in my life"; HYPERTENSION (non-serious), outcome "unknown", described as "My blood pressure went sky high; I didn''t suffer with high blood pressure but my blood pressure went so high"; TREMOR (non-serious), outcome "unknown", described as "shaking". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Raised rash back, chest, legs (+) itchy.  Elevated temperature 99-102 degrees.  Mom used Calamine lotion.
New occurrence of gross hematuria 2 days after vaccination. Required hospitalization. Found to be related to papillary tumor of bladder via cystoscopy procedure.
Two hours later almost passed out. Everything black with sparks, nausea, weak, bowel movement, felt like vomiting. Cold compresses applied, drank a coke, continued to feel weak and uneasy. Left work, rested at home. Vomited during the night about 6 times (a lot!). Slept and read the next day. Up and about the 2nd day after.
Swelling of face, difficulty breathing, fast heart beat, dizziness and weakness 20 minutes after vaccination.The weakness and dizziness
Unexpected therapeutic effect - patient suffers from autonomic CNS disregulation, which was significantly better for several days following both 2nd and 3rd dose of Pfizer covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Apr2021 11:00 (Lot number: ER8729) as dose 2, single and intramuscular, administered in arm right, administration date 21Oct2021 14:00 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autonomic nervous system dysregulation" (unspecified if ongoing), notes: Autonomic nervous system dysregulation; "Interstitial Cystitis", start date: 2010 (ongoing); "Autonomic Dysfunction", start date: 2019 (ongoing); "Small fiber muscle issue", start date: 2019 (ongoing); "Nerve/Muscle issue" (unspecified if ongoing); "Beta Blocker/heart" (unspecified if ongoing). Concomitant medication(s) included: NEURONTIN taken for muscle disorder, start date: 2018 (ongoing); ATENOLOL taken for cardiac disorder, start date: 2021. Vaccination history included: Bnt162b2 (Dose 1, Time (24hr): 11 am, Anatomical Site: Rt. Arm, Route: Intramuscular, Batch/Lot number: Lot # ER8727), administration date: 25Mar2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Oct2021, outcome "unknown", described as "Unexpected therapeutic effect - patient suffers from autonomic CNS disregulation, which was significantly better for several days following both 2nd and 3rd dose of Pfizer covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: I had a reduction of any daily chronic illness symptoms after taking vax 2 and 3. I felt more normal for 3-4 days after the vax. I had less shaking, nausea, muscle weakness, headache. I have a general diagnosis of an autonomic nervous system dysfunction and small fiber muscle issue after a cosmetic botox injection in my forehead in 2018. Illness/AE: Autonomic Dysfunction and Small fiber muscle issue. Pertinent Details: Chronic headaches, Internal Tremors, Muscle Weakness, Numb of skin, Muscle twitching, Heart palpitation.   No follow-up attempts are possible. No further information is expected.
DISTENDED STOMACH, BODY ACHE, FEVER, INJECTION SITE REACTION ERYTHEMA, SWELLING, WARMTH.
vomiting, diarrhea, fever, fatigue p/Recombivax; sx began a few hr post administration of vax & lasted a few days; tx rest & fluids only;
so sick; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "so sick". Additional information: The patient had the first dose of COVID vaccine but was unable to keep second dose appointment. She had it rescheduled but it was 2 hours away. Someone suggested to call Pfizer if she misses the 2nd dose she will have to start series all over again. The patient stated that she does not really care if she gets the second dose cause she was so sick after the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Reports that within 24 hours after receiving vaccination had a splitting headache, fatigue and was barely able to lift or move his arm that the injection was administered. The injection site was red and hot to touch, very painful and swollen. After 24 hours the pain started to radiate into that side of his neck as well. He then felt feverish with chills and was very fatigued and unable to get out of bed for 2 days. Also developed diarrhea in that time frame.
Concurrent medical conditions included Fibromyalgia and Thyroid disorder. Concomitant products included GABAPENTIN for Fibromyalgia.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DISORIENTATION ("out of it"), DECREASED APPETITE (loss of appetite), INSOMNIA (difficulty sleeping), FATIGUE (extremely tired), NAUSEA (nauseous) and MYALGIA (body aches). On 02-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DISORIENTATION ("out of it"), DECREASED APPETITE (loss of appetite), INSOMNIA (difficulty sleeping), DIARRHOEA (diarrhea), FATIGUE (extremely tired), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided as thyroid medication and gabapentin.  Treatment information was provided as paracetamol.
Received COVID booster in right arm and then the flu shot (same arm) about 30 seconds later. About a minute after the lat injection I felt both dizzy and nauseous and had to sit down or felt like I was going to pass out. I was light headed and my vision began to get blurry. Paramedics were called and my blood pressure dropped to 60 over 40 and my lips and hands were blue. My hands were cold but the rest of my body was heating up/sweating.  My blood sugar was normal. I started to feel better in about 15 minutes after drinking some water and it was recommended that I go to the hospital for fluids. I declined since I was feeling much better st that point and could stand without getting dizzy. I had never had a reaction like that to any vaccine before, including the first 2 covid shots.
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 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, 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 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). On 23-May-2021, 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) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Outbreak of varicella and MMR? on chest and back. No fever, (+) vomiting x 1 day, TX no. Tx symptoms-fever with Tylenol/ Motrin. Recovering a few days.
lightheaded "felt drunk", dry throat. Evaluated by EMS-Refusal to transport.
This spontaneous report as received from a physician refers to a male patient of unknown age. The physician reported that he had a male patient who on an unspecified date experienced break through varicella after the second 0.5 ml dose of subcutaneous VARIVAX (Merck). The rep had very little information about this patient. No treatment was given. The patient sought medical attention; he was seen by the health care professional. The outcome of break through varicella after the second dose of VARIVAX was unknown. The relatedness for break through varicella after the second dose of VARIVAX was unknown for VARIVAX (Merck). Additional information has been requested.