chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; a 36 year old patient received ZOSTAVAX; This initial spontaneous report was received from a lawyer on 24-MAR-2020, regarding a case in litigation and refers to a 36-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (the dosage regimen information was not reported). As a result of vaccination, on 09-SEP-2017, the patient was caused to suffer serious and dangerous side effects including shingles and any and all of its sequel. She has been caused to suffer severe personal injuries which are permanent and lasting in nature, physical pain, suffering, emotional distress, and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, as well as to incur substantial economic damages.  The reporter considered that shingles was serious (medically significant).
ONE MONTH AFTER VACCINATION, PT COMPLAINS THAT SORENESS WENT AWAY IN ONE DAY, BUT 2 DAYS LATER A MUSCLE/NERVE PAIN FURTHER AWAY FROM THE SITE DEVELOPED.  SHE IS CONCERNED THE ADMINISTRATION HAS CAUSED NERVE DAMAGE.
Diagnosed with Bell?s palsy 7 days after vaccination. In 3rd trimester of pregnancy, baby was born at 39 weeks, 0 days gestation weighing 7lbs, 0 oz. Symptoms began 1 day post vaccination. Symptoms included numbness in tongue, face, & eye, immobility in left side of face.
inj given 06/24/08- reaction/illness eval'd at Dr 07/03/08-dermatitis and pneumonia
We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of. Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vial was initially stored in the refrigerator on 31 Mar 2022. The vial did not undergo temperature excursion.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document included no new information.
Violent shaking; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shaking) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no historical condition was reported).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced TREMOR (Violent shaking) and CHILLS (Chills). At the time of the report, TREMOR (Violent shaking) and CHILLS (Chills) 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.
This spontaneous report was received from a physician via company representative refers to a 16 year old female patient. The patient had no pertinent medical history. On an unknown date in JUL-2013 (reported as 2 months ago) the patient was vaccinated with a first dose of 0.5ml GARDASIL (lot number, expiry date was not reported and route was intramuscular). On an unknown date in 2013 (reported as 2 weeks after first dose), the patient experienced hair loss which was progressively getting worse. There was no treatment rendered for the event. There was no lab diagnostics performed. The outcome of hair loss progressively getting worse was reported as not recovered. The patient sought medical attention. Additional information has been requested.
headache from hell; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache from hell) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Antidepressant drug clearance NOS, BUTALBITAL for Headache.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache from hell). At the time of the report, HEADACHE (headache from hell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: follow up added
Pt recv vax on 2/23/99; 3 min post vax pt fainted, eyes rolled then closed, tense then limp body, pale face; tx=ammonia inhalant
Feeling discomfort in left ribs. Felt like a strained muscle. Hurt a little more the next  day. By the third day, pain was so bad, couldn't eat. By fourth day, pain was so bad went to the emergency room. Hurt to breathe. Felt like "being stabbed with steak knife."  Given antibiotic shot, saline drip. Diagnosed with Pulmonary Embolism. Also diagnosed with Lupus Anticoagulants Currently on Eliquist 5ml 2x day. Need clinic.
Patient noticed some redness and swelling around the injection site 3-16-16 per ER notes. BP 131/103, other vitals "within normal limits". Normal range of motion. Lungs clear, no wheezes, rhonchi or rales. No rashes - area of redness approx size of baseball. Warm to touch, slightly painful to palpation - patient states painful to move arm - ER gave clindamycin for cellulitis 3-16-16. Cold compresses ibuprofen for pain/swelling suggested by office 3-17-16.
Pain/soreness at injection site (upper left arm); muscle aches; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration in left arm on 24May2021 at 18:15 PM as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ibuprofen, famotidine, cetirizine hydrochloride (ZYRTEC), melatonin, paracetamol (TYLENOL): all for an unspecified indication and start and stop dates were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration in left arm on 03May2021 18:15pm as single dose for COVID-19 immunization. Patient previously took diphenhydramine hydrochloride (BENADRYL) and bupropion hydrochloride (WELLBUTRIN); had allergy with both drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Pain/soreness at injection site (upper left arm), muscle aches, tiredness and feeling unwell on 24May2021 at 20:00 PM. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as recovering.  Information on Lot/Batch number was available. Additional information has been requested.
I gave immunization and patient began to lean forward and passed out. He was passes out for about 20 seconds or less. He asked for some water and I got him a cool cloth for his neck, because he was sweating. After sitting for some time he felt better.
Cramping on left side of chest, irregular, rapid heart beat. Muscle soreness, fever, shortness of breath. No treatment
Adverse event: Within 30- 45 minutes of injection the following symptoms occurred : hives on leg , neck/face, back , abdominal pain, nausea and headache.Treatment: The following meds were taken Benadryl, Zantac and prednisone.Outcome : Symptoms are no longer present.
Chronic cough; Tiny asthma attacks; Shallower breath; When I lay down, there's some wheezing; Couldn't sleep through the night/the coughing kept me up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Chronic cough), ASTHMA (Tiny asthma attacks), HYPOPNOEA (Shallower breath), WHEEZING (When I lay down, there's some wheezing) and SLEEP DISORDER (Couldn't sleep through the night/the coughing kept me up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced COUGH (Chronic cough), ASTHMA (Tiny asthma attacks), HYPOPNOEA (Shallower breath), WHEEZING (When I lay down, there's some wheezing) and SLEEP DISORDER (Couldn't sleep through the night/the coughing kept me up). At the time of the report, COUGH (Chronic cough), ASTHMA (Tiny asthma attacks), HYPOPNOEA (Shallower breath), WHEEZING (When I lay down, there's some wheezing) and SLEEP DISORDER (Couldn't sleep through the night/the coughing kept me up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Inhaler and cough drops and drinking water were reported as treatment.  Concomitant medications were included Inhaler.  Patient were received the Johnson & Johnson COVID-19 Vaccine on 31-Mar-2021.
This spontaneous case, initially received from other health professional on 13-Sep-2018, concerns a 40-year-old, adult patient of an unspecified gender. On 13-Sep-2018, the patient under age of 65 years was administered FLUAD (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration). No adverse reactions had occurred since administration. The reporter assessed the case as non-serious. This case was considered as lost to follow-up since the reported had not given consent to provide further information.
This patient received a vaccine on 04/13/01, he developed a large bruise to the site of injection. Cellulitis extends from the site of the injection to below the elbow. The patient was treated with Augmentin for 10 days, Motrin as needed for the pain, and warm compress to the site.
ON 10/28/2023 PT CAME IN FOR PHYSICAL AND  PROVIDER HAD ORDERED A FLU SHOT. PT HAD NO SYSTEM VITAL WERE GOOD, NO ALLERGIES TO MEDICATIO, NOT TAKEN MEDICATION. WRONG VACCINE WAS GIVEN INSTEAD OF FLU VACCINE I GAVE PNEUMOCCAL CONJUGATE 13, AFETER ADMINISTRATION NO REACTION. THE REASON WRONG VACCINE WAS GAVEN THE PCV 13 WAS BEACAUSE VACCINE WAS PUT INSIDE THE FLU VACCINE BOX.
5 year old female, presented with chicken pox lesions. Less the 50 total lesions today.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (have rash on their bodyave rash on their arm, from shoulder to elbow.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (have rash on their bodyave rash on their arm, from shoulder to elbow.). At the time of the report, RASH (have rash on their bodyave rash on their arm, from shoulder to elbow.) had not resolved. Reported data: Rash on their arm since the night of 20Jan2021, from their shoulder to their elbow. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medications were not provided by reporter. Reporter did not allow further contact.
hot arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot arm) and VACCINATION SITE ERYTHEMA (red arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot arm) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION SITE WARMTH (hot arm) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On day 2 I work up with redness and warmth from approximately an inch above the injection site to the elbow on the lateral side of my left arm.  I also had a temp of 101.5 with moderate flu type symptoms which lasted for 2 days.  The following two days I had GI type issues with nausea and diarrhea which also lasted for 2 days.  On the fourth day the redness and warmth on the arm had moved more toward the inside of the arm and is still continuing , now on day 10.  However, the warmth is almost gone and the redness is lighter. Still am very tired and just don't feel quite back to normal.
Firmness and itching at injection sight. Itching strong enough to distract from everyday activities. Injection site is still sore to the touch 7 days after the shot.
Extreme redness of right eye and beginning of pox blistering surrounding; went to doctor & diagnosed as shingles.
redness/swelling/circular lump at the injection site for 36 hours after injection. Resolved. one week after injection, redness/swelling/circular lump at injection site returned along with itching,  still occurring
axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness left underarm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 TENDERNESS (Tenderness left underarm). At the time of the report, TENDERNESS (Tenderness left underarm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-FEB-2016, the patient was administered with STELARA and approximately on 15-FEB-2016 (reported as "approximately 2 weeks after having STELARA), the patient developed shingles. Then on 25-MAY-2016, the patient was vaccinated with ZOSTAVAX (dosing details not provided) after having shingles (inappropriate schedule of drug administration). No further information provided. Additional information has been requested.
Felt very cold on first day of vaccination. Insomnia. Soreness. Fever of 101 24hr after injection. Slight headache. Fatigue.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 12-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Injection site began to hurt about 9 hours after my second shot and  was very tender. It was slightly swollen.  I have treated it with ibuprofen but today (1/24/21) my upper arm , shoulder and left scapula are aching and have not responded to analgesics.
Rash on traunk and face for approximately 2 days.  Associated with itching but no other consitutional symptoms; i.s. no fever, chills, n/v/d.  No fever
12/30/2021 I discovered that I had COVID after visiting with family, took a quick test and it was positive. Quarantined myself and did so after notifying others that I had COVID short of my plane ride back home, but I was asymptomatic at that time. Later around 1/15 I had a gastrointestinal issue that I called my GP and asked for a referral. He referred me to a gastrointestinal doctor, and I met him on the first few days of March. After a physical exam and interview, we did an 4/2022 endoscopy (normal) but found inflammation of the duodenum. They took a biopsy of one of the polyps in my intestine and found no abnormality. Currently using Pepcid per MD advice and have yet to recover. Will be going back at a later time for a consultation.
following vax pt devel GBS; sx included weakness & tingling in the legs; Hospitalization was required due to progressive weakness; pt improved p/an initial course of 5-6 plasmapheresis tx; 1 wk later, pt was retreated w/5-6 plasmapheresis;
Swelling and pain left shoulder across the chest and down arm. Induration, some adenopathy. Decreased movement.
Received call from healthcare provider with Clinic on 10/9/19.  Client presented with parent with redness, swelling, and pain in right arm at site of injections.  Discussed with her, client received TDaP and Menactra in right arm.  Health care provider reported that she felt would resolve on it's own. Reports she was going to give client hydrocortisone and encourage client to use ice.  Spoke with client's father today, 10/10/2019, reports client missed school yesterday, but arm is doing better today, though not resolved, and went back to school today.
Approximately 2 hours after being injected with the Zoster (SHINGRIX) vaccine I began to experience extreme fatigue, muscle aches, chills, a mild headache and irritability, in addition to having a sore upper arm with a red, blotchy appearance. This lasted about 36 hours. This was the same reaction I had to the first dose of SHINGRIX which I received in mid June, but did not report. I was hoping that my body would react less the second time it encountered the SHINGRIX vaccine, but that was not the case. I am happy to be protected from shingles, since I had chickenpox as a kid, but I am not happy about the severity of this reaction. I have never had a vaccine reaction like it.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of Hepatitis B vaccine (manufacturer unknown) (dose, dose number, lot/batch# and expiration dates were not reported). On an unknown date(s)(reported as years later), when the titers were drawn for Hepatitis B on these patients, the titers were low. The outcome of the event was unknown. The relatedness between the event and Hepatitis B vaccine (recombinant) (manufacturer unknown) was not reported. This is one of the several reports from the same reporter. Additional information is not expected as the physician did not wish to be contacted.
inadvertent administration of an expired product to a patient with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-months-old female patient who had inadvertent administration of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar); rotavirus vaccine live reassort oral 5V (Rotateq); and hepatitis B vaccine for Prophylactic vaccination (immunization).  On 19-Sep-2023, the patient inadvertently received 0.5 mL (Dose 1) of expired suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Frequency: once; Strength: standard) (batch number: U7331AA; expiry date: 16-SEP-2023) via intramuscular route in the right thigh for Immunization with no adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of RECOMBIVAX HB (dose, lot#, expiration date, route of administration were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.