chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her face was swollen; This is a spontaneous report from a contactable consumer or other non hcp (parent) via pfizer-sponsored program. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unknown date, the patient's face was swollen. Going to doctor office as we speak. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  Health care professional mentioned that there was incident because of miscommunication as a coworker said that there were some lot numbers whose expirations dates had been extended.  On 05-Apr-2022, the patient received 2nd booster expired dose from the lot number 031H21A.  Treatment information was not provided.   This case was linked to MOD-2022-549134 (Patient Link).
Information has been received from a nurse concerning a 30 year old female patient who on an unspecified date was vaccinated with MMR II (lot # not reported). Subsequently the patient failed to produce immunity to the mumps and measles, but had immunity to rubella. No treatment was given to the patient. Blood work tests were performed but no results.
Shot received at 7:15 am.  That night at 2 am I awoke after developing rigors that lasted for 1 hour then resolved.  I took 600mg Motrin at 2 am and 1g of Tylenol at 2:15 am.  I was able to go back to sleep around 3 am.  I woke up for work at 7am feeling sweaty but temperature was normal at 97.3.  Overnight temperature at time of rigors was also normal.  It is now 9:15 am and I feel better with mild residual symptoms.
burning sensation on skin over entire body, no rash (yet), when in sunlight or when sweating.  gums and roof of mouth feel like they are on fire.  Warm/hot water sensitive.
Received tetanus vaccine on 1/13/05 in Right deltoid. Stated that on 1/19/06 she developed edema, tenderness and warmth to touch of right upper arm and erythema at injection site. Referred to hospital on 1/20/06 for further evaluation and was prescribed Augmentin 875 mg. PO BID x 10 days and advised to apply cool compresses PRN.
Not severe, normal for me to have sickness following shots.  With this one I was extremely tired, and had a slight headache.  Everyone else I know that has had it has not had any side effects at all.  Completely better 100% the next morning 3/20/2021  I am just providing this information so you can make note of it in your data, and for no other reason as I am well at this time.
After vaccine I was told to wait 30 minutes and I started feeling woozy/a mild nausea and broke out into cold sweats a few minutes later. I got up and told the nurses at Medical Center (site in which I received vaccine) that I felt like I was going to faint. I was instructed to lay down on floor and they put my legs on a pillow. I next recall being blood pressure cuffed and them saying my BP was rather low. I was also very thirsty. I was told I wasn't responding for a few (smelling salts were used) I then was instructed to sit up but my BP was low and I felt dizzy. It was then decided I should be wheeled to the ER for observation. I was in a room where they took my EKG which turned out fine and I was given an IV flush and hydrated. I had blood work done and all was well so I was released a few hours later.
little sore arm in arm of injection; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient had very little problem with either dose of the Shingrix vaccine; a little sore arm in arm of injection, but minimal problems. For tolerance of 2nd dose of Shingrix, refer case US2020AMR135183. The reporter desclined consent to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135183:same reporter
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 22-FEB-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB lot # J008570, expiry date 05-FEB-2016 (dose, strength and route of administration were not reported). No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
felt bad; she had fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt bad) and PYREXIA (she had fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and PYREXIA (she had fever). At the time of the report, FEELING ABNORMAL (felt bad) and PYREXIA (she had fever) outcome was unknown.            Patient stated that she was healthy and did not take any medications.  Treatment information was not provided by the reporter.  This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious event of feeling abnormal and the expected, non-serious event of pyrexia after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-396434, MOD-2021-395617, MOD-2021-395805, MOD-2021-395824 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious event of feeling abnormal and the expected, non-serious event of pyrexia after administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
No adverse event; 1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (monovalent) was administered on 07Feb2023 BUD).    Concomitant medication was not reported. Treatment medication was not reported.
muscle weakness; arm soreness; headaches; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Latex allergy (allergic to morphine and flagyl also), Drug allergy, Allergy to antibiotic, Autoimmune disorder NOS (attacks her joints especially the right foot, ankle and calf.) and Breast implant user. Concomitant products included ESTRADIOL (ESTRING) for Estradiol abnormal, TESTOSTERONE for Hormone therapy, ESTRADIOL (ESTRADIOL TRANSDERMAL) for Hysterectomy, LEVOTHYROXINE SODIUM (UNITHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder NOS.   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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not use any treatment medication.
patient received 2nd moderna shot june 2021. it was at a pharmacy.  within two months, her liver transaminases and alkaline phosphatase were elvated and she started losing weight. she developed a cyst on her pancreas, barrett's esophagus, and was evantually diagnosed with autoimmune hepatitis
Initial health care professional (medical assistant) report received on 15 Nov 2010: This patient with an unknown medical history was vaccinated with MENVEO (batch number: 100023) 0.5 ml intramuscularly on 15 Nov 2010. During vaccination the patient received only Men CWY liquid conjugate component of MENVEO without being reconstituted with the Men A conjugate component. No adverse event was reported following this drug administration error.
Suffered a stroke due to high blood pressure.  Hospitalized 2 nights at Hospital.
Patient reports while driving home she began experiencing pain pens and needles type sensation all over her body, including pain behind her eye and in feet.  The symptoms lasted about an hour, patient took two aspirins.  The pains were improving when patient contacted the pharmacy. Patient was advised to take benadryl and seek medical attention if symptoms persisted.
Has been having seizures for 3 months, since DPT shot in Nov.  The MDs think it is Epilepsy but don't know.
facial flushing; increased blood pressure; scratchy throat; felt heavy; rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUSHING (facial flushing), BLOOD PRESSURE INCREASED (increased blood pressure), THROAT IRRITATION (scratchy throat), HEAD DISCOMFORT (felt heavy) and RASH (rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FLUSHING (facial flushing), BLOOD PRESSURE INCREASED (increased blood pressure), THROAT IRRITATION (scratchy throat), HEAD DISCOMFORT (felt heavy) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. In January 2021, FLUSHING (facial flushing), BLOOD PRESSURE INCREASED (increased blood pressure), THROAT IRRITATION (scratchy throat), HEAD DISCOMFORT (felt heavy) and RASH (rash) 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.   She received her vaccine at a hospital and stayed about 1 hour after the vaccine was given due to her reaction. Relevant concomitant medication was not reported.
Tired and unbelievably fatigued; Little difficult to breathe; Burning in left arm that went into chest; Tightening in chest; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration in the Injected in upper left shoulder (unable to confirm if in the intramuscular) on 25Jan2021 (at the age of 70-years-old) as a single dose for Prevention. Medical history reported was diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: BMI is up spring of 2020. Prediabetic Nov2020. Allergy to Penicillin, No manufacturer, lot, or expiration. This was in the 1970's. She has not had any since. Bad reactions to Imitrex and Topamax because she is a migraine sufferer. She tried and they made her sick. She does not have a lot or expiration for either. This was a year and a half ago for Topamax, and the Imitrex was 5 years ago. Family medical history as reported as None. Concomitant medications were not reported. No other vaccine patient received within 4 weeks prior to the vaccine. On an unspecified date, received call from consumer regarding the Pfizer Covid vaccine. She had it on 25Jan2021, and was listed in high-risk area so she had to wait 30 minutes after receiving. About 10 minutes into it, at 10:15-10:30, she experienced burning in left arm and it went into her chest. It radiated out and she had tightening in her chest at 10:15-10:30. She had heart issues in the past. At 10:30, it was also a little bit difficult to breathe. It lasted about 15 minutes or so. The other thing was that when she got home, at 12:30 she was so tired, that the fatigue was overwhelming for 2 days. It felt like when she had chemo treatment in the past. She has not had chemo since 2011. Her fatigue lasted 3 years. She did not provide the names of any of the Chemo that caused fatigue and did not have a lot or expiration. The fatigue after receiving the vaccine lasted 3 days. There was no prescriber. She provided the number from another card she received, but later said it was not the same card as the vaccine lot information and had # on it. That card also had a barcode on it. This injection seems to have been higher than where she got the flu shot. Her next dose was due on 22Feb2021. Time the vaccination was given as between 10:00 to 10:15. Patient was not immunization with the Pfizer vaccine considered as suspect earlier. There were no other medicines administered on the same day of Pfizer Suspect. Outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
About 18 hours after getting the vaccine I started to feel very tired and just ?off.? I wasn?t moving from the couch, but my heart rate became very elevated. My smart Watch began alerting me that my heart rate was extremely high for at-rest. My heart rate at rest averages around 64 (per my smart Watch for Sept/October), on 11/25/21 it averaged 98 bpm at rest. Looking through old data, around 4:30 I received an alert while sitting at dinner (no alcohol consumption) that my heart rate was 120 at rest  and that I should seek medical attention.  I did not, as I was with several relevancies who are home health care providers, who took my blood pressure (it was high, I believe around 140/90), temp (around 99.5), and hooked me up to a pulseox (I don?t recall this being abnormal. Perhaps around 98?). I was monitored overnight by a home health care provider and felt generally okay the next day.  I ended up getting Covid in mid-Jan. In Mid-Feb, I started feeling extremely nauseous and started once again getting alerts about my heart on my watch. I went to primary care, EKG was normal, but they sent me to ER out of fear of a pulmonary embolism.  It ended up being a bad UTI. But that was the only other time I?ve ever experienced tachycardia to my knowledge.
Patient called 2 days after receiving vaccine. Concerned about redness, swelling, knot at injection site. Also had low grade fever. Redness about 3" diameter - small know. Suggested ice & anti inflammatory.
Day after vaccines, woke up feeling weak and faint. Sat down, and passed out. He had generalized seizure activity > 20-30 sec. He was tired but not confused afterwards. Parent took to E.D. Where woke-up was negative.
This case was reported by a healthcare professional and described the occurrence of injection site atrophy in a 5-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent medical conditions included seasonal allergy.  On 13 July 2010 at 15:00 the subject received 1st dose of HAVRIX (.5 ml, unknown route, left thigh).  On an unspecified date in July 2010, less than one month after vaccination with HAVRIX, the subject experienced injection site skin atrophy, injection site rash and "dimple" (indentation) at injection site.  This case was assessed as medically serious by GSK.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with HAVRIX.  Three weeks prior to a doctor's office visit date of 10 August 2010 the subject's mother called to report a rash and what looked like a dimple on her thigh.  No exact date was given for onset.
Participant stated his symptoms began yesterday at 12:00 noon. His wife noticed his lips swelling. Got worse throughout the day by the evening his lip was 3x the normal size and both palms itched and stated he had a mild headache. The swelling in his lip went down by the morning, but not to normal. Was instructed to be seen by his physician. 11:15 AM, follow-up with phone call from participant. He was seen by his physician and given prednisone. His lip continued to improve.
RSV vaccine was given to a patient at age 59.  Per patient, no major adverse reaction besides soreness around injection site.
Injection site pain, General Malaise.  Injection site pain persists on 12/30/2020.  General malaise disappeared by 6pm 12/29/2020 after self treatment with acetaminophen.   Note:  took azelastine nasal spray 45 minutes prior to injection on the advice of my allergist. Also took acetaminophen 1 hour prior to injection.
Induration right upper arm from elbow to shoulder within 24 hours of vaccine.  Treatment: Ice packs, Motrin, Benadryl as occasion requires for itchiness.
High fever to 101.9 (ax) 2 days after vaccine Given. No identified source of fever.
Patient sitting on exam table. Appeared very pale, leaning to his right side. Writer assisted to lay down. Not responsive for 4 seconds. Observed jerking of arms, legs. Became responsive stating "what just happened?" BP 120 /70  HR 84.  After 5 min sitting up-drinking soda.
Covid19 vaccine clinic at pharmacy. Patient was listed as requiring her second dose, with her first given 1/29/21. Upon completion of the clinic, when the pharmacist returned to pharmacy to input all of the vaccines for the day, she noticed that the patient received her first dose on 1/8/21 and her second on 1/29/21 making the shot on 2/19/21 her third dose in a two dose series.
small rash that is red where got the vaccine; small rash that is red where got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (small rash that is red where got the vaccine) and INJECTION SITE ERYTHEMA (small rash that is red where got the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE RASH (small rash that is red where got the vaccine) and INJECTION SITE ERYTHEMA (small rash that is red where got the vaccine). At the time of the report, INJECTION SITE RASH (small rash that is red where got the vaccine) and INJECTION SITE ERYTHEMA (small rash that is red where got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cold rag.
Patient had received 2 doses of Moderna and accidently received a dose of 3rd dose of pfizer when she wanted moderna.  At the time Moderna is not approved for a 3rd dose for the patients category.  Pharmacist was mistaken.  Thought the patient had already received 2 doses of Pfizer and was here for a 3rd and she would have been eligible at that time.
stomach upset; bodyaches; fever; nauseated; episodes of vomiting; tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), PAIN (bodyaches), PYREXIA (fever), NAUSEA (nauseated) and VOMITING (episodes of vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), PAIN (bodyaches), PYREXIA (fever), NAUSEA (nauseated), VOMITING (episodes of vomiting) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, ABDOMINAL DISCOMFORT (stomach upset), PAIN (bodyaches), PYREXIA (fever), NAUSEA (nauseated), VOMITING (episodes of vomiting) and FATIGUE (tired) 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.   Other relevant concomitant medication included Diabetes and Emphysema.
Hands & feet looked bluish within a few hours after 3rd Gardasil vaccine. Was seen at ER and Hosp. Labs normal. Prescibed steroids but took only 1 dose.