chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was vaccinated, I am being treated for shingles/ Suspect vaccination Failure; I am being treated for shingles/in my eye; I am being treated for shingles/right side of my head.; So painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated that even though he/she was vaccinated, the patient was being treated for shingles without a rash. The patient had it in the eye and right side of my head at the time of reporting, and it was painful. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed  nurse reported that since 17-JUL-2014, improperly stored (Oka/Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Additional information has been requested.
Red rash initially in inguinal creases, later spread all over body some urticaria and many target lesions, treated with Benadryl; was out of town and seen by another MD prior to returning to our office 05/02/2013 with clear reaction of erythema multiforme.
Paxlovid indication:Treatment of COVID-19; Paxlovid indication:Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Aug2016, stop date: 02May2022. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2021, outcome "unknown" and all described as "Paxlovid indication:Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2021) Positive, notes: Began Paxlovid 1 day after positive test. Therapeutic measures were taken as a result of covid-19. Clinical course: Began Paxlovid 1 day after positive test. Finished course in 5 days as recommended. Complete reversal of symptoms. Felt fine for 8 days. Day 9 symptoms reoccurred, exactly as they had previously. Currently on day 2 of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She reported pain the date she received the vaccination in her left arm. She reports pain progressively became worse, reporting limited range of motion. She pointed to the acromion area as the site of injection. Diagnosed with left deltoid bursitis. Symptoms improved with Physical Therapy (PT). Once physical therapy was completed, her symptoms gradually returned. She was referred to clinic and received a steroid injection on  6-29-17 and was diagnosed with left shoulder impingement and adhesive capsulitis, and to restart PT.
Started having constant chest pain on left side from middle of chest into armpit. Pains then started shooting down left arm. Elevated heart rate and elevated blood pressure and headache Went to ER, and EKG was performed and found it wasn't a heart attack and was told to follow up with my Primary Care Physician Still have elevated blood pressure (higher than normal), still have chest pains occasionally (about 10-12 times a day but don't last longer than 10 minutes
The vaccine was administered to a 6 month old; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comment: The physician's assistant stated that the Havrix vaccine was administered to a 6 months old patient, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
MIGRAINE; STOMACH PAIN; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced migraine. On APR-2021, the subject experienced stomach pain. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, headache, stomach pain and nausea was not reported. This report was non-serious.
On Friday, 7/30, the vaccination site was itchy and there was a large red swollen area which was warm to the touch. By Monday 8/2, the red swollen area had decreased but was still slightly warm to the touch a little bit itchy.
Covid-19- September 1, 2022 I experienced a low grade fever of 100.00, sore throat, fatigue; I was taking TYLENOL PM to help with the symptoms.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 2 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
got second dose more than 35 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first dose) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20 and 030L20A) for COVID-19 vaccination.     No medical history were reported by reporter.  Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA AND LEVODOPA) and PROBENECID for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first dose). On 02-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first dose) had resolved.            No treatment information were reported  by the reporter.   This case was linked to MOD-2021-327740 (Patient Link).
Onset of severe flu symptoms within 12 hours after vaccine. Headache, chills, severe sweating. Also vomiting. Pt. saw MD because symptoms so bad and he had just had heart surgery.
First vaccine shot - No adverse events.  Second vaccine shot - on the next evening (02/18/21), I had a very slight fever lasting just a couple of hours.  Later in the evening, I had  swelling and pain under my left arm pit lymph node.  The pain continues as of this writing.  The pain is dull in nature and more sensitive to the touch.
I got a rash at the injection site about 4in high/3in wide. It was warm to the touch and firm. I also got a rash that started in the center of my upper chest to spread to my right side and come up to the bottom of my cheek. The rash was mildly itchy and felt kind of irritated. My heart rate had risen for about 6 weeks by about 6 points.
Large and agitated skin rash on right side of my belly down to my waist. There was a rash on my left shoulder, neck, shins, right leg and arms. I also had what looked like blisters on my left ring finger and left middle finger. Treatment was one week of 40mg Predinsone, followed by 1 week of 20mg Prednisone, followed by one week of 10mg Prednisone. The Prednisone started to work in about a day, and after two weeks it was feeling better and was no longer itchy.  The rash is completely gone now. However, I am currently suffering from muscle cramps in my neck and was just treated for it with cyclobenzaprine and methylPrednisonlone.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows. The only event she experienced with that SHINGRIX was a sore arm which resolved. This case has been linked with case US2018GSK151145 reported by the same reporter for the same patient.
erythema, swelling & tenderness @ inject site lt thigh; irritable; t99; treated w/Motrin; pt recovered;
14JAN94 5Pm small sz, t102 15JAN93 1230AM breathing shallow, purple, taken in ambulance to to hosp dx w/viral bilateral pneumonia; released 17NOV94 EEG pending; has rash now said to be caused by virus;
Patient felt dizzy and sick after the vaccine. Patient also reported feeling like his blood pressure dropped after the vaccine. Otherwise the patient felt restored after a few minutes of laying down and was able to mobilize himself. There were no changes in skin color or difficulty breathing. The patient was about to return back to his home safely.
Nose Bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleed) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced EPISTAXIS (Nose Bleed). At the time of the report, EPISTAXIS (Nose Bleed) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
new onset seizure 11/14/21 of unknown etiology (DDx include: febrile sz d/t parainfluenza, post vaccine fever/seizure/encephalitis, IPH vs cavernoma) 2 seizures (first in home ~1230, second in ED ~1450)
Urticaria rash involving mainly the axilla and groin area appearing 48 hrs after vaccine. No associated fevers. BENADRYL 3/4 Tsp every 4-6 hours.
after first shot itchy rash on top half of torso, after second shot in left arm lower body rash. Red raised skin and very itchy.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with incorrectly stored doses of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type unknown). No concomitant therapies reported. No adverse effects reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 35-year-old male patient who received FLUARIX QUADRIVALENT (batch number 3CG9P, expiry date 22nd June 2017). Previously administered products included FLUARIX QUADRIVALENT with an associated reaction of dizziness (dose received on 5th December 2015, refer case US2016GSK160877). On 15th October 2016, the patient received FLUARIX QUADRIVALENT. On 15th October 2016, 10 min after receiving FLUARIX QUADRIVALENT, the patient experienced dizziness and blood pressure decreased. In October 2016, the outcome of the dizziness and blood pressure decreased were recovered/resolved. The reporter considered the dizziness and blood pressure decreased to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported to the pharmacy that he was experiencing severe dizziness shortly after receiving the vaccination. They took his blood pressure and the systolic number was around 90 rather than his normal 120. After about 30 minutes, the patient felt better and left the pharmacy.
This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Tingling in her hands, little prickling), PAIN (Little stings), HYPOAESTHESIA (Numbness in both her hands but more so in her right hand), PAIN OF SKIN (Feels this in other parts of her body especially her legs, across her shoulders, and up into her scalp) and PAIN (After getting the vaccine it's as if those sensations have been exacerbated and gotten worse by the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling in her hands, little prickling), PAIN (Little stings), HYPOAESTHESIA (Numbness in both her hands but more so in her right hand), PAIN OF SKIN (Feels this in other parts of her body especially her legs, across her shoulders, and up into her scalp) and PAIN (After getting the vaccine it's as if those sensations have been exacerbated and gotten worse by the vaccine). At the time of the report, PARAESTHESIA (Tingling in her hands, little prickling), PAIN (Little stings), HYPOAESTHESIA (Numbness in both her hands but more so in her right hand), PAIN OF SKIN (Feels this in other parts of her body especially her legs, across her shoulders, and up into her scalp) and PAIN (After getting the vaccine it's as if those sensations have been exacerbated and gotten worse by the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment details were not provided
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: she developed rash on the left side of her body about 2 weeks after the vaccine. mmr vaccine was given sc in left arm. started with small rash and got larger. got rx from dr today 4/25/22 for triamcinolone crm and an antifungal crm. is going on beach vacation soon and wants rash resolved.
Soreness and redness at injection site; Redness at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) 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 VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
soreness and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness and pain) in a 77-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 recorded medical history). Concomitant products included LEVOCETIRIZINE for Allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (soreness and pain). At the time of the report, PAIN (soreness and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included timoprazole 40 mg for her stomach.  =Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-004666 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
ANXIOUS, LIGHTHEADED, DIAPHORETIC  WITH SYNCOPE  S/P VACCINATION. PARAMEDICS CAME, VSS, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.
female child received 0.4% Sodium Chloride instead of the reconstituting it with the ActHIB, no AE; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 months old female patient who received a dose of 0.4% sodium chloride instead of reconstituting the vaccine HIB (PRP/T) VACCINE [ACT-HIB] (solution for injection, lot: UJ161AA, expiry date: 02-May-2021) via intramuscular route in the right thigh on 08-Jan-2020.  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation on 08-Jan-2020.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient had no adverse 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 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.
Two hours after vax, pt was unresponsive and mildly cyanotic. Eventually he was able to be aroused but was irritable when he awoke. Normal the next day.
Began as a small red circle about the size of a golf ball the day after the injection, by the evening of the 28th it was itchy and hot to the touch.  The weekend of the 30th and 31st the swelling and redness began to get larger, I just assumed it was a general reaction to the vaccine.  By Wednesday morning it was about the size of a softball.  First thing Thursday morning I messaged my physicial because it took up 75% of my uper arm...  I was seen at 10am at Dr. office.  I was prescribed Cephalexin 500 mg (1 capsule by mouth twice a day morning/evening for 10 days)  I was home from work Thursday and Friday the 4th and 5th of February due to discomfort and being very tired from the
Rec'd H1N1 on 11/18/09. Reports near syncope on 11/19/09 - AM. Event lasted about 30seconds.  12/02/09 OB visit notes for DOS 11/18/09  12/01/09: Near syncope  Pt c/o near syncope episode that lasted 30 sec.  The event resolved.