chrisvoncsefalvay/vaers-outcomes huggingface dataset:
daily migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (daily migraine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine since 1956. Concomitant products included FLUOXETINE from 2000 to an unknown date and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) from 2005 to an unknown date for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (daily migraine). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at a dose of 1 dosage form. On 30-Apr-2021, MIGRAINE (daily migraine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Opthalmic Herpes Zoster outbreak requiring treatment in ED. Symptoms are ongoing for 8 months.
upper arm is very red; CHILLS; ACHES; HEADACHES; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper arm is very red), CHILLS (CHILLS), MYALGIA (ACHES) and HEADACHE (HEADACHES) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (upper arm is very red), CHILLS (CHILLS), MYALGIA (ACHES) and HEADACHE (HEADACHES). At the time of the report, ERYTHEMA (upper arm is very red), CHILLS (CHILLS), MYALGIA (ACHES) and HEADACHE (HEADACHES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported. No treatment information was provided.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. On 19-APR-2018 the patient was inadvertently vaccinated with expired dose of VAQTA (dose, units and frequency unknown) (lot# N005605 and expiration date 08-APR-2018) (expired product administered). No adverse effects were reported. No product quality complaint was reported.
Patient observed for 15 minutes in the clinic after vaccine with no issues.  Patient is a NP and left clinic.  10 min after leaving, was in physician lounge and had tachycardia, dizziness, flushing.  Hospitalist in lounge recorded pulse as 180 normal rhythm.  Patient taken to ED.  In SVT - heart rate eventually reduced.  Patient released on cardiac monitor to home.   Later that night, patient had increased heart rate again - 160's - while in bed.  Admitted to hospital.
Information has been received from a physician concerning a 17 year old female with a history of fainting when given vaccines and when blood was drawn and asthmas who on 14-AUG-2007 was vaccinated intramuscularly in the right arm with a 0.5 mL first dose of GARDASIL (lot 655849/0263U). There was no concomitant medication. On 14-AUG-2007, post vaccination, the patient experienced shaking of her upper extremities, her eyes rolled back, and her head was shaking for a couple of seconds. The patient had a loss of consciousness for a couple of seconds. Loss of urine and post ictal were both negative. The patient sought unspecified medical attention. After a few minutes, the patient recovered. The patient had an EEG. Additional information has been requested.
Chest pain and difficulty breathing.  Felt pressure in chest that lasted for approximately 24 hours.  Thought it might be indigestion and took an antacid but that didn't do anything to change the feeling and it continued to get worse until I went to bed.  Woke up the next morning with continued chest pain and pressure.   Pressure in the chest started to diminish as the day went on and had subsided approximately 24 hours after it started.
Patient states she received 1st dose of Pfizer vaccine oon 3/29; had an allergic reaction with whole body itching,  numbness  on mouth and lips, facial swelling (left eye).  She was given Benadryl and observed for 1.5 hours and sent home.  (at vaccine clinic 3/29/21) Patient reports she is still having some mild  itching, throat is a bit hoarse.  She is using allergy eye drops.  Patient was advised to see her PCP.  She was told that she should not get 2nd dose of the vaccine.
Note: hx and exam below carried out by medical resident on my service. I did not directly interview pt nor examine him in order to minimize the risk of transmission of COVID to myself and others. Idid carefully review the chart and discuss with other physician providers as appropriate   Patient is a 68y.o. year old male with PMH of HFpEF, COPD on 3L at home, chronic suprapubic catheter, legally blind who presnets for shortness of breath. Patient states that he has had to have his suprapubic catheter changed mutiple times at home d/t his continual penile leakage of urine. He states that his catheter site has been fine, but that he has been having urine leak out of his penis which is abnormal for him. Patient states that he has not been in to see his urologist recently though. Patient also explains that he has been short of breath more recently. Patient was vaccinated in April and does not recall any sick contacts. However, patient does live with two grandchildren and is unsure their vaccination status. Patient states he has been experiencing a worsening cough with increased sputum production. Patient has also required 4L, increased from his 3L baseline. Patient denies fevers, chills. Denies new muscle aches. Patient denies loss of taste, smell.    FULLY VACCINATED (Moderna in 4/2021)   ED course- BP- 123/70, HR 97, Temp- 100.1F, SpO2 89% on 3L, improved on 4L to 90s SpO2. CXR showed no acute changes COVID +
sneezing; stuffiness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021, as the first single dose, for COVID-19 immunisation. The patient woke up on 31Aug2021 sneezing and with stuffiness. The patient got exposed to a positive Covid-19 patient in school. She was due to have the second dose of the vaccine on 31Aug2021. The reporter wanted to know if her daughter could take the second dose on 31Aug2021 or if she needed to be tested first before taking the second dose.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, fever with severe chills, fatigue - these began 01/20/2021 and lasted until 01/24/2021,  arm red  and fevered from shoulder to elbow - 01/20/2021 to 01/22/2021, then same area very itchy - still continues.
Sudden fatigue, fever, chills and nausea. Lasted about 7 hours.
pain, and soreness in the injection site arm; fatigue; chills; Soreness in the Injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain, and soreness in the injection site arm), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Soreness in the Injection site arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced MYALGIA (pain, and soreness in the injection site arm), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Soreness in the Injection site arm). On 02-Jun-2021, MYALGIA (pain, and soreness in the injection site arm), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Soreness in the Injection site arm) had resolved.        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 drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-242276 (Patient Link).
IM injection upper arm. Sore shoulder 12 days, undergoing PT therapy, patient suspects injection into bursa.
Patient was given an expired dose of COVID-19 vaccine. The vial of Moderna 034C21A had been refrigerated and had a 'use by' sticker on the box, hand-written with the date 9/15/21. I (the vaccinator) did not register the date as being in the past until after having administered the vaccination. All other safety precautions were adhered to.
Ataxia, inability to walk. Head CT, MRI both normal. Symptoms improved over 1 week.
I developed a postnasal drip about 48 hours later. Then 24 hours later, I developed an abdominal cramp, back pain, and nausea. I did experience an allergic reaction, a burning sensation on my skin starting from my back to my head. I took Benadryl and Tylenol to deal with the discomfort and fever. I saw a doctor on the 15th and 16th, I got Afrin as needed but no more after 3 days, Flonase prescribed, and an Antiemetic called Zofran 3x a day as needed.
Patient vaccinated with Fluzone HD, which experienced a delay in transit/no AE; vaccinated with Fluzone HD, which experienced a delay in transit/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA309821 (same reporter).  This case involves an 80 years old female patient who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB, expiry date- 09-06-2020 via intramuscular route in the left deltoid on 04-Nov-2019, the vaccine had a delay in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and delay in transit.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), 2 doses, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.   The patient's concomitant medications were not reported. The reporter is a pharmacist who took the 2 doses of Pfizer vaccine two months ago but unfortunately, she tested positive for corona now, and was really really sick. The patient was one of the first ones to receive the vaccine because he/she believed in it ,but the patient don't think the vaccine is 95% effective as you mentioned, and it did not even decrease the disease severity by 92%. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
expired Moderna Covid-19 vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided.,.     On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up document contains updated reporter contact details
Symptoms reported were headache, chills, fever with a temperature of 102 degrees, and lungs hurt when taking a deep breathe. Lasted for 24 hrs and then gone the next day. Was not assessed and evaluated by a medical provider and returned to work.
Existing tinitus became "more prominate" 45 minuets after injection and remained at an elevated state for 3 days.
allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had an allergic reaction to the first Shingrix shot. The patient asked if they should have the second dose.
Swollen red right leg (around injection site) 8cm area erythema, induration 3 cm.
On March 26 started to develop what was a sore arm muscle and what looked like bed bug bites. Kept spreading and pain increased so went to urgent care and was diagnosed with shingles
From patient discharge summary: "Patient is a 63 year old female with a past medical history of lichen planus, and asthma that mostly was problematic as a child.  She presented to the emergency department with increasing shortness of breath.  She reports her symptoms began about 2 weeks ago.  At this time she was working at her brother's house who had recently passed. She was busy cleaning out the house in preparation to listed on the market.  She noticed being a little more short of breath than usual, when going up stairs.  At times she would have to sit and rest a little.  She did not think much of it at that time.  The house was very dusty, she felt like maybe her shortness of breath was being triggered by the dust or mold in the air.  She does have a history of asthma but has not had recent triggers, it was mostly as a child.  She traveled back to town, and contacted her primary care to get a refill on her albuterol inhaler, thinking that that may help her symptoms.  She said it did help her breathing some.  She went to visit her daughter, and noticed that she was much more short of breath going up the stairs there.  She traveled back to home on Saturday 1/22 to continue to clean out her brother's house.  She states on 1/24 when she was brushing the snow off her car, she felt extremely winded and started to feel "dizzy", she had to sit in the car for a while because she felt like she could pass out.  She then decided to be seen in the ED.    She reports even with her driving back and forth from town to town recently, she makes frequent stops along the way and gets out and walks.  She does not live a very sedentary life.  She reports no history of lower leg or calf swelling, no pain.  She has had no personal history of clots, there is no family history of clotting disorder that she is aware of.  She reports her brother who had recently passed away had clots in the past, but he was also wheelchair-bound.  She recently had her annual appointment with her primary care provider, she has had recent mammograms with no abnormal findings, Pap smears have all been normal, she has had colon cancer screening with a benign polyp found, she is due for repeat colonoscopy in the next couple of years.  She does use a topical estrogen cream for her lichen planus, but does not use it frequently, and has not used it recently. She has family members who are currently sick with covid but she has not been around them recently, she received her most recent covid vaccine in November.    CTA was performed, findings of acute bilateral pulmonary emboli and right heart strain, as described above. Treated with heparin drip, with switch to Eliquis. She had resolution in her shortness of breath, was not requiring oxygen. RT performed a home O2 evaluation, she did not require at home oxygen. Will need to continue Eliquis for at least 3 months. Recommend coagulation studies at future follow up with PCP. "
Information has been received from a pharmacist concerning a 63 year old female patient with no pertinent medical history and no allergies who on 10-AUG-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot#665525/0695Z). Concomitant therapy included low dose aspirin. It was reported that the patient developed an injection site reaction after getting ZOSTAVAX (Merck). It was red, warm and round. It was initially itchy but not anymore. The size of the reaction was about the size of a "quarter" but now it's the size of a silver dollar. The patient saw the pharmacist to seek medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient was recovering. Additional information has been requested.
tender at injection site; dull headache; warmth at injection site; hardness at injection site; felt tiredness (3 hours after initial administration); Discomfort at the injection site (3 hours after initial administration); This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)), INJECTION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), FATIGUE (felt tiredness (3 hours after initial administration)) and INJECTION SITE PAIN (tender at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)) and FATIGUE (felt tiredness (3 hours after initial administration)). On 17-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth at injection site) and VACCINATION SITE INDURATION (hardness at injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (tender at injection site) and HEADACHE (dull headache). On 12-Feb-2021, INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)) and FATIGUE (felt tiredness (3 hours after initial administration)) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), INJECTION SITE PAIN (tender at injection site) and HEADACHE (dull headache) 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 medications reported. No treatment information provided.
This was not an adverse event. Patient was given a dose of Pfizer in error that was expired.  It was drawn up 10/21/21 at 10:15am and administered 10/25/21 at 11:25am.
Injection site pain, tiredness, headache, muscle pain, chills, injection site swelling, injection site redness and feeling unwell.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a 0.5 ml dose PNEUMOVAX 23 (Lot No. 665707/1407Y) IM. the patient experienced redness and swelling at the injection site after receiving the dose of PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of the report the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccune EUA  Headache, alternating chills/sweating throughout the day, Lower intestinal distress including cramps and minor diarrhea, general muscle aches between shoulders.  Occurring on Day after injection (3/12/21), 3 days after injection (3/14/21), 5 days after injection (3/16/21), 7 days after injection (3/18/21), and continuing every other day to every 3rd day through today (3/28/21).
This spontaneous non-valid report as received via social media (Twitter) concerning "at least 9 girls per year". It was reported that "at least 9 girls per year are killed by the GARDASIL vaccine" (strength, dose, route of administration, lot# and expiry date unspecified) (dates of injections or adverse event not specified). Additional information is not expected as all available information has been provided and there is no patients and physician's contact information and we could not do follow up with them.
Heart palpitations; shortness of breath; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), DYSPNOEA (shortness of breath) and FATIGUE (extreme fatigue) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 02-Nov-2022, the patient experienced PALPITATIONS (Heart palpitations), DYSPNOEA (shortness of breath) and FATIGUE (extreme fatigue). At the time of the report, PALPITATIONS (Heart palpitations), DYSPNOEA (shortness of breath) and FATIGUE (extreme fatigue) had resolved with sequelae.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
So, it was sinus problems, stuffiness and discomfort. It was very mild symptoms and to be honest with you, I would not have even gotten tested except the contact tracing person told me to do so since my parents got COVID. My symptoms were not very bad, also had swollen glands. I was also dealing with my parents dying so I had a lot of symptoms from crying. The effects of crying were combined with the symptoms of COVID, and they were very similar. I only got the COVID test after the contact tracing person told me to go, she told me it was very important that I went. I got the test on May 27th, 2021 and it was positive so I did get COVID after my vaccine.