chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; Fever reaching 102 degrees Fahrenheit; Injection site was sore; Injection site warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), VACCINATION SITE WARMTH (Injection site warm to touch), PYREXIA (Fever reaching 102 degrees Fahrenheit) and VACCINATION SITE PAIN (Injection site was sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney failure, COVID-19 and Dialysis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch) and VACCINATION SITE PAIN (Injection site was sore). On 25-Feb-2021, the patient experienced PYREXIA (Fever reaching 102 degrees Fahrenheit). On 26-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia). On 25-Feb-2021, PYREXIA (Fever reaching 102 degrees Fahrenheit) had resolved. On 28-Feb-2021, VACCINATION SITE WARMTH (Injection site warm to touch) and VACCINATION SITE PAIN (Injection site was sore) had resolved. On 05-Mar-2021, TACHYCARDIA (Tachycardia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees fahrenheit (Inconclusive) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  2 CAT scans performed (result not reported). No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Rash at the injection site. Rash has become larger in size. Daughter has also had a mild case of chicken pox.
Headache, Sedation, Myalgia, Arthralgia, Fever,  NauseaVomiting, Chills, Pain/Swelling @ injection site Narrative:   Other Relevant History:
24 hours after vaccine patient had an episode of pallor. She became limp and hyporesponsive. Parents report the episode as lasting less than an hour. They also report she did not have a fever at the time of the event. This was a solitary episode. No further symptoms noted.
This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 40-year-old) as a single dose for COVID-19 immunization. The medical history and concomitant medications were reported as none. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the most recent dose of COVID 19 vaccine in a pharmacy or drugstore. On 29Mar2021 at 16:00, the patient experienced headache Grade 2. Therapeutic measures were taken as a result of the event headache and included treatment with ibuprofen PO (per oral). The clinical outcome of the event headache was resolved on an unknown date at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Less painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Less painful) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Quadruple vessel bypass graft in May 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Less painful). At the time of the report, VACCINATION SITE PAIN (Less painful) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-032413 (Patient Link).
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with RECOMBIVAX HB (dose, lot number and route was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of the several reports received from the same source. No further information provided. Additional information has been requested.
no adverse event; total of 47 patients that received the vaccines after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date.).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023.  On 28 Jun 2023, 9 doses were administered at administration site 1.  No treatment medication reported.   The case corresponds to 5th out of 47 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccination date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
Woke up with alarm. Palms of hands were red, tingling, slightly swollen. After being awake for a half hour, I realized the soles of my feet had similar symptoms but not as pronounced.
heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer.  Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 23rd May 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site mass, injection site discoloration, injection site induration and injection site warmth. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the injection site mass, injection site discoloration, injection site induration and injection site warmth were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site mass, injection site discoloration, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were received as follows: The patient developed a large, hard knot at the injection site that was hot to the touch the day after receiving the first dose of SHINGRIX. The patient also said there was a jagged border with a purplish color around the knot. This lasted for 2 weeks and then the reactions resolved. The patient was also past the 6 month point for the second dose of the SHINGRIX series, which led to drug dose administration interval too long. The reporter did not have vaccine information available.
difficult breathing; high blood pressure; tachycardia; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficult breathing), HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CHILLS (chills) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (difficult breathing), HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (difficult breathing), HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Blood pressure measurement (80-120 mmHg): 171/117 mmHg (High) 171/117. On 01-Mar-2021, Heart rate: 110 (High) 110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a consumer via patient support programs and described the occurrence of chills in a 68-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever and general body pain. On an unknown date, the outcome of the chills, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the chills, fever and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. But it could be 67 or 68 years old. The patient experienced body ache. The patient did not have any seriousness criteria (hospitalized, life threatening, disability, death, surgical or medical intervention or congenital anomaly). For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK119861.
problem breathing; problem swallowing; upward pressure on the base of throat and under sternum "like a fist"; laryngitis-type state; severe hoarseness; throat real sensitive; couldn't lay down; sickness "generalized feeling of not being myself for the last two weeks"; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (problem breathing), DYSPHAGIA (problem swallowing), OROPHARYNGEAL DISCOMFORT (upward pressure on the base of throat and under sternum "like a fist"), LARYNGITIS (laryngitis-type state) and DYSPHONIA (severe hoarseness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD since an unknown date, Emphysema since an unknown date, Fibrosis since an unknown date, Bronchiectasis since an unknown date and Nodule (nodule on lung.) since an unknown date. Concurrent medical conditions included Allergy (allergies to multiple prescription medications).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (problem breathing), DYSPHAGIA (problem swallowing), OROPHARYNGEAL DISCOMFORT (upward pressure on the base of throat and under sternum "like a fist"), LARYNGITIS (laryngitis-type state), DYSPHONIA (severe hoarseness), THROAT IRRITATION (throat real sensitive), ORTHOPNOEA (couldn't lay down) and ILLNESS (sickness "generalized feeling of not being myself for the last two weeks"). At the time of the report, DYSPNOEA (problem breathing), DYSPHAGIA (problem swallowing), OROPHARYNGEAL DISCOMFORT (upward pressure on the base of throat and under sternum "like a fist"), LARYNGITIS (laryngitis-type state), DYSPHONIA (severe hoarseness), THROAT IRRITATION (throat real sensitive), ORTHOPNOEA (couldn't lay down) and ILLNESS (sickness "generalized feeling of not being myself for the last two weeks") outcome was unknown. Not Provided      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
Nausea and dry heave, diarrhea once, epigastric pain. 18 hours post injection. Treated with Maalox 60 ml single dose. Symptoms resolved.
Child is over 12 and should have been given adult dose of Pfizer.  Parent signed up for pediatric dose.  Child is very small for his age and this wasn't noticed until after dose was given.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in an unspecified number of patients who received ENGERIX B adult (batch number C3TY3, expiry date 13th April 2018). On an unknown date, the patients received ENGERIX B adult 1 ml. On an unknown date, immediately after receiving ENGERIX B adult, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to ENGERIX B adult. Additional details were received as follows: The unknown number of patients received a dose of ENGERIX B vaccine and experienced pain and pressure while the vaccine got pushed through. Patient's details were not provided. The reporter stated that, there were more than one batch number and expiry dates for ENGERIX B received by patients but they were not provided.
Patient has P.O.T.S.  Patient was driving and had a episode and blacked out. Patient had a high fever.
On February 22, 2006 at 11:50am after being interview by immunization clinic staff, nurse interviewed student per protocol. He stated that he understood all the questions, answered no to all questions and signed the consent form. MMR vaccine was administered. In approximately ten seconds, student was noted to be pale, torso, arms and legs became rigid, neck stiffened and turning to left side, his legs began to tremor. I instructed staff member to call 911. Two clinic staff members and nurse lowered him to the floor. Approximately one minute, he began to respond. He was oriented to person, place and time. Orange juice with sugar was given and student got from floor onto couch unassisted. Campus security arrived. Nurse attempted to take BP when student's body became rigid, pale, cold and clammy with tremors to both arms and legs. 12 noon, Nurse immediately gave Epi-pen 0.3mg into upper thigh muscle. Student immediately relaxed and began responding, oriented, to person, place, time and situation. BP 98/50 P88. Health clinic staff arrived. Student instructed to call parent. Approximately 12:10 PM EMS arrived and report was given to them. Student was responding appropriately. Student left via wheelchair with EMS to Coney Island Hospital.
pt seen 28APR95 in ER for poss spider bite in rt hand; c/o swelling, heat, pain redness in rt hand; recv TD & told to return to surgery clinic 1MAY95; reported exp fever, swelling/pain in arm-cont to have problems;
I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chills. At 2am, I woke with more chills and a splitting headache. I took Tylenol which decreased the symptoms. All day on Sunday, I had a horrible headache, a fever of 101F, body aches (muscles and joints), cramping, nausea, terrible fatigue. I took Tylenol every 4 hours which did help some. Today, I feel fatigued, fever is gone, I feel nauseated.
Patient stated that a day after her vaccine she got extremely sick with a fever of 102.5, chills, aching all over, and bad headache. Arm became red, swollen and hot to the touch for several days. On 12/19/21, patient started having bad dizziness and episodes of forgetfulness. On 12/20/21, she had her blood pressure checked and it was 164/114. On 12/21/21 she went to her doctor and they did started propranolol and performed an EKG (which came back ok). On 12/22/21 continued having dizziness and forgetfulness and had a bad headache and blood pressure up to 145/103. On 12/23/21 continued having horrible brain fog and BP ran around 164/105 the entire day. She reports constantly feeling her heart racing and BP being higher upon waking. As of 12/27/21, still reporting having dizziness and forgetfulness. Also reports very little appetite and altered food taste.
Lightheadedness, chest tightness, body ache, fatigue, weakness,flu-like symptoms but without fever
After leaving, I instantly felt nauseous with onset headache. It went away later. The next day I was extremely tired and fatigued. There was weakness in my legs and I was super congested. The worst headaches I have ever had. One headache was so bad I even threw up. It was worse than a migraine. Everything like sinus related, sinus pressure, ear pressure. The doctor gave me some antibiotics and a new ENT referral. I gave it a couple of days because I was able to go until Friday. The ENT gave me antibiotics, spray, steroids, and a probiotic. She also did a blood allergy test, which came back normal.
Patient reports feeling ill, nausea, pain in left arm and pale, 5 minutes after receiving vaccination.  Remained under observation until 12:27, patient reports feeling better, doesn't report nausea or pale skin. Patient stable, walking and leaving the facility with legal guardian.
On 02/28/2000, the pt developed a breakthrough case of shingles on his right leg, below his knee and down to his foot. The pt sought medical attention and was treated with calamine lotion for the itching. At the time of the report he had dried scabs on his leg. No further information is available.
Erythema, swelling, pain at injection site, limitation of movement of arm. Pt was given dexamethasone 10mg IM, ibuprofen for pain, and BENADRYL.
Extreme tiredness throughout the body; Throbbing pain on the side of head and behind eyes; Lightheadedness; Cough; Occasional sneeze; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced extreme tiredness throughout the body, throbbing pain on the side of the head and behind eyes, lightheadedness, cough and the occasional sneeze. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events extreme tiredness throughout the body, throbbing pain on the side of the head and behind eyes, lightheadedness, cough and occasional sneeze was resolving at the time of the report.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained. No further information is expected.
pt recv vax 11SEP96 & 17SEP96 pt exp dizziness, a total lack of energy (effort to take step), nausea, & diarrhea;missed 3 days of school;pt was seen by MD;tx APAP;MD stated that gastrointestinal sx would subside on their own;
One month old female pt received 2nd dose of Heb B vaccine and few hours later her eyelids became very erythematous and edematous. No other possible allergens encountered.
The area where I received a tuberculosis vaccine when I was 1 year old nd the muscle around and below it became inflamed (slight swelling, redness, itchiness, hot to the touch) 2 days after my covid vaccination in the same arm.
Within 2 days after administration of Prevnar, child had apprx. 7cm diameter erythema and induration around injection site with pain to touch from elbow to shoulder.