chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Triggered the contact dermatitis on the right elbow /  in the forearm area of his right arm; This case was reported by a consumer via call center representative and described the occurrence of contact dermatitis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of folliculitis (1st dose received on 11th September 2020 intramuscularly in right arm and the patient experienced contact dermatitis, skin discoloration, milia, scratch, erythema, blister and injection site pain, refer link case US2020254962.). Concurrent medical conditions included diabetes.   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced contact dermatitis. The patient was treated with ammonium lactate (Ammonium Lactate 12%). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the contact dermatitis was recovering/resolving.   It was unknown if the reporter considered the contact dermatitis to be related to Shingrix.  Additional details were provided as follows:  four to five days following the shot, while resting his right elbow on a bar the patient experienced contact dermatitis on the right elbow and later that day he rested his forearms on the table and contact dermatitis presented in the forearm area of his right arm where it has rested against the table. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254962:Same reporter
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (felt fatigued) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (felt fatigued). At the time of the report, HEADACHE (headache) and FATIGUE (felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-403107, MOD-2021-403181 (Patient Link).
Is diarrhea a side effect?; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Is diarrhea a side effect?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Is diarrhea a side effect?). At the time of the report, DIARRHOEA (Is diarrhea a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
shingles; rash on shoulder/neck; This case was reported by a physician via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the right deltoid. The physician reported that the patient developed a rash possibly shingles one week after receiving Shingrix. The rash was on the patient's neck and upper left shoulder. The rash has faded significantly ever since. The reporter consented to follow up.
asthma flare up after second shot; headache second shot; back ache; Hip ache; This spontaneous case was reported by a nurse and describes the occurrence of ASTHMA (asthma flare up after second shot), BACK PAIN (back ache), ARTHRALGIA (Hip ache) and HEADACHE (headache second shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BACK PAIN (back ache) and ARTHRALGIA (Hip ache). On 25-Feb-2021, the patient experienced ASTHMA (asthma flare up after second shot) and HEADACHE (headache second shot). On 25-Feb-2021, BACK PAIN (back ache) and ARTHRALGIA (Hip ache) had resolved. At the time of the report, ASTHMA (asthma flare up after second shot) and HEADACHE (headache second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included nebulizer treatment, rescue inhaler, 2 steroid inhaler.
Took vaccine 6:30am; around 11:00 am: Flu-like/fever symptoms, abdominal pain that came and went in waves, nausea. Over the counter medications (tums and pepto bismol) did nothing for the side effects. Received ondansetron from doctors office after same symptoms occurred on dose #2 and premedicated with that and ibuprofen for dose #3 which lessened all side effects to be manageable with mild stomach ache and gassiness. The 4th capsule/dose had a broken capsule that was leaking powder out of the capsule in the packaging.
Seen for follow up of 4+ edema and weight gain, with mild SOB.   Given 40mg Lasix IM, She had some congestion and was started on Rocephine and Azithromycin.  Chest Xray revealed moderate congestive heart failure.
Patient calls reporting having rash and a fever of 100 along with aching. She was told to take Benadryl for the itching, and Ibuprofen for the aches. Patient was given a phone call on 10/6/2016 where she reported she was feeling better. A follow up call was made on 10/7/2016 where she reported no symptoms and feeling healthy.
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever and fatigue the evening of the vaccine. The next morning seemed fine. By 2pm the next day began to feel tired. By 2:30pm fever and fatigue returned.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has already received the first dose, she was diagnosed with COVID-19 8 days ago (15Mar2021). The second dose was originally scheduled (today) on 23Mar2021, but the doctor recommended waiting 30 days after the COVID-19 diagnosis before considering receiving the next dose. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
R thigh has redness, swelling and slight bruise, non tender, moves well. Slightly warm, about 2 inches.
Pt recvd vax & 1 day p/2nd dose devel flu-like sx; seen by MD on 4DEC92; enlarged liver dx; reporting RN indicates that pt is now doing very well w/complete resolution of all sx & that per the pt sx were found not to be related to vax;
Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss lasting 6 weeks
12/24 - Nausea/general discomfort. 12/28 - Skin pain (sharp pricking and general skin ache) on left torso from belly button around to back. 12/31 - eruption of painful welts in the same area. 1/8/2013 - pain is abating and welts are shrinking.
01/03/2023 I had laryngitis, congestion and coughing, low grade fever symptoms lasted for 2 weeks. Contacted my Physicians' tele-med service and diagnosed with a Respiratory tract infection. I was prescribed a 10-day dose of Z-pac and Antibiotics.
Severe sepsis without septic shock - He improved over hospital course with antibiotics.  ID was consulted and added on tick studies. ID recommended finishing 7 day course of doxycycline outpatient.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient complaining of pain in upper arm, weakness raising arm both upwards and sideways and difficulty sleeping - patient states may be due to incorrect administration.
From phone contact received at a manufacturer on 4/22/02, it was reported that a 3 y.o. male began post exposure treatment on 4/12/02. PT's mother reported that PT received RIG and Imovax given in gluteal region. Approximately 3 hrs after doses received, PT was nauseated, began vomiting which persisted for 2 hrs. Inject site was very swollen and sore (not sure if RIG or vaccine). PT was cold and sweaty. PT received 2nd dose treatment on 4/18/02. Inject site (gluteal) was sore. He also experienced cold sweats and pale for approximately 2 hrs later, and continues throughout the day. Another report needed for PT's sister who also has had local irritation, redness, warmth, and swelling at inject site (gluteal). PT's mother called in report. This case is linked w/U2002-00336.
unusual and extreme tiredness; rash on the face; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number was not reported), via an unspecified route of administration on 28Jan2021 (dose number=2) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. On 28Jan2021, the patient experienced unusual and extreme tiredness and rash on the face. The seriousness considered as non-serious. It was unknown if patient received any treatment for the adverse events. Since the vaccination, it has been unknown if the patient been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 16Jul2021 16:00 (Lot number: EW0217) at the age of 19 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Adhesive allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. There were no concomitant medications. Past drug history included: Ubrelvy, reaction: "drug allergy". Vaccination history included: BNT162B2 (dose 1, single, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 25Jun2021, when the patient was 19 years old, for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 28Oct2021, outcome "not recovered", described as "neuropathy"; HYPOTENSION (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Low blood pressure"; TACHYCARDIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "tachycardia"; HEADACHE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "headaches"; FATIGUE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "fatigue"; TEMPERATURE INTOLERANCE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "temperature intolerance"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "dysautonomia". The events "neuropathy", "low blood pressure", "tachycardia", "headaches", "fatigue", "temperature intolerance" and "dysautonomia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 PCR test: (08Feb2022) negative, notes: Nasal Swab; blood pressure: (28Oct2021) low. It was unknown if therapeutic measures were taken as a result of neuropathy peripheral, hypotension, tachycardia, headache, fatigue, temperature intolerance, autonomic nervous system imbalance. Follow-up attempts are completed. No further information is expected.
Breakthrough case admission after 3 vaccines  Pfizer 5/11/21 lot# EW0177;  Pfizer 6/1/21 lot# Ew0180;  Pfizer 12/20/21 lot# 3313308A
Minor client was immunized with Moderna booster following Pfizer vaccine series on 6/25/21 and 7/10/21. No adverse reaction noted. Vitals stable.
Red somewhat sensitive and itchy palm-sized patch of irritated skin on left bicep about 2-3 inches below shingles vax injection site. Appeared 1-2 days after vax. Symptoms decreasing with time but still somewhat noticeable 11 days after vax. Not a bad reaction but just surprising that symptoms persisted this long. Seems a little unusual compared to typical post shot  symptoms for shingles vax described on CDC website.
Severe headache, nausea and vomiting, confusion, fever (102), muscle and joint aching lasting 72 hours with severe symptoms.  Still having to take Zofran for nausea and having moderate to severe joint pain as of today (11/21/21)  Was treated with IV fluid bolus, Zofran IV,  Reglan IV, Toradol IV, Benadryl.  Given Zofran for home use
Chief Complaint: Difficulty breathing Additional Medical History:  70-year-old female with a history of COPD presents to the emergency department in no acute distress by EMS from home.  Vital signs were stable on 15 L.  She is complaining of difficulty breathing.  She was diagnosed with Covid on 10/17 and has been having increased difficulty breathing since then.  She still smokes.  She wears oxygen at home at 3 L but has been putting at at 4 L.  According to paramedics she was 82% on room air when they arrived.  She did receive Solu-Medrol in route but no DuoNeb treatment secondary to her Covid status.  No chest pain.
Swelling large oversized, itchy, red, hard n sore. Friday 11/14/14 ended up in emergency room throat swelling shut.
at a childhood immunization clinic, the nurse gave eleven vaccines to the child.   the child experienced a sore arm with inflammation and an elevated temperature the evening of the vaccinations, but was reported fine the next day.
Immediately after vaccination the patient dropped to the floor and jerked a few times. He said his head hurt,thumb hurt and had nausea. We gave him water and saltine crackers and gave him ice to put on his thumb. He felt better and left after 40 minutes with his mother.
pt's child was vaccinated and pt devel herpes zoster;f/u indicated that it was the child's father who actually devel herpes zoster not mother;
Information has been received from a physician concerning a 65 year old male who on 18-JUL-2007 was vaccinated with ZOSTAVAX. There was no concomitant medication. On approximately 25-JUL-2007 the patient developed shingles. The patient's shingles persisted. Additional information has been requested.
Narrative:  7/26- first noted sx was loss of taste/smell, congestion seemed like seemed like allergies 7/29- COVID positive, also report stuffy nose 7/30- also reports cough and fatigue 8/3- fatigue improving 8/5- reports headache and muscle pain
DPT/OPV given 1Feb91, 3 days later pt developed swelling in both feet, blotchy rash over body. F/U 22Jan91 symptoms lasted over night.
The Menactra vaccine expired on 25may2020, was given to a patient of 15 years old on 08Jun2020, no AE; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 15 years old male patient who was vaccinated with an expired 0.5ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6207AA, expiry date: 25-May-2020) via intramuscular route in the right deltoid on 08-Jun-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for prophylactic vaccination and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination 08-Jun-2020.  It was an actual medication error case due to expired vaccine used.  Nurse reported that the child came in for a sports physical and received expired Menactra as well as Adacel and Hepatitis A on the same day. States the Hepatitis A was also expired and she was calling Merck.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
L deltoid with 8cm x 10cm warm red area-tender on 5/23/02 at 10am.
He got his vaccine, the day after the vaccine he was very fatigued, slept all day.  His right arm hurt to the touch, but as it did before.   Last night he had night sweats, woke up drenched in sweat, and today has had clammy skin, hot.  He called his PCP and was told to take Motrin and to drink a lot of fluids, and to call pharmacy to let them  know he had an AE to the shot and they told him to report to us.
12 patients received the vaccine that underwent a temperature excursion; 12 patient doses administered from one vial (instead of the standard 10 doses); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (12 patients received the vaccine that underwent a temperature excursion) and INCORRECT DOSE ADMINISTERED (12 patient doses administered from one vial (instead of the standard 10 doses)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Dec-2020, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (12 patients received the vaccine that underwent a temperature excursion) and INCORRECT DOSE ADMINISTERED (12 patient doses administered from one vial (instead of the standard 10 doses)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (12 patients received the vaccine that underwent a temperature excursion) outcome was unknown and INCORRECT DOSE ADMINISTERED (12 patient doses administered from one vial (instead of the standard 10 doses)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Reporter did not allow further contact
12 hr p/ vax pt devel high fever;chills; listlessness; 36hr p/ vax adm to hosp w/persistent fever; lt leg pain; refusal to walk; WBC=21K; CRP=34.5; remained febrile for 6 days;
pt recv vax 12MAR96 & devel a dry tongue, sl fever & became very pale;pt was seen @ hosp;mom states MD told her that pt had a rxn to the vax;parents & pt do not want to recv a 3rd vax dose
t103.5 x 2 days, episode of staring x 24 hrs; unresponsive, periods of apnea, vomited 2-3 days under care of MD during this time; order to receive DT 3rd immun;
This spontaneous report as received from a pharmacist via a company representative refers to a 78 year old male patient. The patient's medical history and drug allergies were not reported. On 26-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expired date were not reported). Concomitant therapy was not reported. On an unknown date the patient developed shingles after receiving ZOSTAVAX. She reported that the shingles appeared as a "disseminated rash" on the patient's back "resembling chickenpox". She stated that the patient was hospitalized on an unspecified date due to the shingles at an unspecified hospital. She also stated that the patient had unspecified labs drawn while in the hospital and that the patient was diagnosed with lung cancer on an unspecified date and given an unspecified treatment. The outcome of the adverse event was not reported. Upon internal review, lung cancer was considered to be medically significant. This is one of several reports from the same source. Additional information has been requested.
Information has been received from the mother of a 7 year old female who in March 1997 was vaccinated with a dose of varicella virus vaccine live. On the morning of 2/6/04, the patient developed a stomach ache, and she complained of being tired. There was no fever. The stomach ache later resolved. Upon waking up the next morning on 2/7/04, the patient's skin was clammy and she developed a mild case of chicken pox. It consisted of 4-5 pox across her forehead, 1 on each cheek, 1 on her chin, 6-8 on each arm and 3-4 on each leg with the majority of the breakout occurring on her chest, stomach, and back .The blisters were different sizes. Although she did not complain if itchiness, she did experience a stinging sensation when a few of the blisters popped. On 2/7/04 at 11:30, the patient was seen by her family doctor. At that time, her temperature was normal and a diagnosis of chicken pox was confirmed. Acyclovir 200mg/5ml, 2 teaspoon 4 times a day for 5 days was prescribed. At the time of report the patient had not yet recovered. Additional information has been requested.
Tdap vaccine given 3/21/13. Bells palsy dx 3/23/13.
Left upper arm erythema over triceps no signs of infection or cellulitis, swelling and 3 cm hard nodule is TTP and easily moveable at injection site, under skin. Tender to touch pain scale 8/10. No lymphadenopathy of submandibular, axillary or trochlear areas.