chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it is bright pink; Two and a half inches in diameter (it is a circle); the area is pink; tiny itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (tiny itch), ERYTHEMA (the area is pink), ERYTHEMA (it is bright pink) and VACCINATION SITE INFLAMMATION (Two and a half inches in diameter (it is a circle)) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRURITUS (tiny itch). On 13-Jan-2021, the patient experienced ERYTHEMA (the area is pink). On 19-Jan-2021, the patient experienced ERYTHEMA (it is bright pink) and VACCINATION SITE INFLAMMATION (Two and a half inches in diameter (it is a circle)). At the time of the report, PRURITUS (tiny itch), ERYTHEMA (the area is pink), ERYTHEMA (it is bright pink) and VACCINATION SITE INFLAMMATION (Two and a half inches in diameter (it is a circle)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.     Treatment details provided include Antihistamine for several days
14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple tests, including CT scans, Lumbar puncture, abnormal lab work with no known cause.  High lymphocytes count (abnormal lymphocytes), abnormal red blood cells, high D Dimer, etc.. Most recent labs show Monoclonal paraproteinemia, Im currently waiting to see a hematologist.  Have seen internal medicine, infectious disease, rheumatology, . No one can determine the cause of the ongoing symptoms.
dizziness; weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 06-Feb-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness) and FATIGUE (Fatigue).   At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GJ6759) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Oct2022 as dose 3 (booster), single (Lot number: FE3592) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iv contrast, reaction(s): "Allergy", notes: IV contrast.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, latency 1 year 7 months 5 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, the event drug ineffective is considered related to BNT162b2 and BNT162b2 omi ba.4-5.
This case was reported by unknown type of reporter and described the occurrence of fever in a 18-month-old male patient who received INFANRIX (batch number N5339, expiry date 25th March 2016). Concomitant products included Hepatitis A vaccine. On 20th September 2014, the patient received the 4th dose of INFANRIX. On 21st September 2014, 1 days after receiving INFANRIX, the patient experienced fever. On an unknown date, the patient experienced injection site mass, bullous eruption at injection site, injection site discoloration and vaccination site scar. The patient was treated with BENADRYL, KEFLEX and MOTRIN. On an unknown date, the outcome of the fever and bullous eruption at injection site were recovered/resolved and the outcome of the injection site mass was unknown and the outcome of the injection site discoloration and vaccination site scar were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site mass, bullous eruption at injection site, injection site discoloration and vaccination site scar to be related to INFANRIX. Additional information received: Parent reports son received 4th KINRIX vaccination in left thigh. Within 24 hours post vaccination, he developed a fever, which lasted 24 hours. She noticed after vaccination that, at the injection site, there was a white spot with a dot in the middle. The white spot continued to spread out and within 48 hours it became approximately the size of a softball. The softball sized area is still there at time of report. The week following the injection, the skin bubbled up around the injection site, taking about 2 weeks to resolve. At the time of the report, there is a permanent scar and skin discoloration in the area around the injection site. Son received a Hepatitis vaccination in right thigh same day, and experienced no reaction. The parent sought medical treatment at a walk in clinic approximately 18 hours after vaccination. Son was given BENADRYL, KEFLEX AND MOTRIN. The bloodwork done at time of clinic visit indicated no infection.
Information has been received from a 62 year old female patient referring to herself. The patient had upper respiratory infections. Concomitant therapies included gabapentin, lisinopril (manufacturer unknown), VALIUM and ibuprofen. The patient was allergy to penicillin and DURICEF. On 27-NOV-2016, the patient was vaccinated with ZOSTAVAX, (dose and route unknwon) subcutaneously for preventing shingles. On 29-NOV-2016, two days after vaccine was administered, the patient reported her arm was painful and was as red as the inside of a plum around the injection site. The patient also reported she was feeling nauseous on the same date. The patient called her physician's office and was told to come in as soon as possible. The patient did ultrasound on left arm and diagnosed the patient with cellulitis and started her on anitbiotics as treatment. The patient had not recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from a sales representative. This case involves approximately 160 patients under 65 years of age who received FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate age at vaccine administration and overdose. It was unknown whether patients experienced any adverse reaction. 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. List of documents held by sender: none.
Carpal Tunnel Syndrome in both hands; lot of pain in both hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. In MAY-2023, 6 weeks after receiving Shingrix, the patient experienced carpal tunnel syndrome (Verbatim: Carpal Tunnel Syndrome in both hands) and pain in hand (Verbatim: lot of pain in both hands). The outcome of the carpal tunnel syndrome and pain in hand were not resolved.   It was unknown if the reporter considered the carpal tunnel syndrome and pain in hand to be related to Shingrix.     It was unknown if the company considered the carpal tunnel syndrome and pain in hand to be related to Shingrix.   Additional Information: GSK Receipt date: 19-JUL-2023 The reporter reported that patient received her first Shingrix vaccine later patient developed Carpal Tunnel Syndrome in both hands and also reported patient was on a lot of pain in both hands.  The reporter reported that the patient left hand was going to be operated on 17th August 2023, the other hand would be operated on later.  The reporter did not consent to follow-up.
EXPECTED SIDE EFFECTS; This spontaneous report received from a consumer concerned a 34 year old female. 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the subject experienced expected side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expected side effects was not reported. This report was non-serious.
Swelling on her arm the size of her palm, chills. Fever. Ibuprofen, bag.
raised rash; very itchy.; welt; Rash started out on both legs and now her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised rash), RASH PRURITIC (very itchy.), URTICARIA (welt) and RASH (Rash started out on both legs and now her arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Disability. Concomitant products included ATENOLOL, VENLAFAXINE, DILTIAZEM, MONTELUKAST, FENOFIBRATE and DROSPIRENONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH PAPULAR (raised rash), RASH PRURITIC (very itchy.), URTICARIA (welt) and RASH (Rash started out on both legs and now her arm). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (raised rash), RASH PRURITIC (very itchy.), URTICARIA (welt) and RASH (Rash started out on both legs and now her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of exposure during pregnancy (pregnant) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On an unknown date, patient experienced exposure during pregnancy (pregnant). At the time of the report, exposure during pregnancy (pregnant) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. The patient wanted to know whether pregnant women get the shot.
She has had 4 Pfizer shots and boosters./ she finished her doses last night; She has had 4 Pfizer shots and boosters./ she finished her doses last night; This is a spontaneous report received from contactable consumer (patient). A 67-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: ELU142), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL3247), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: EW0198), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "She has an autoimmune disease and was high risk" (unspecified if ongoing). Concomitant medication included: HYDROXYCHLOROQUINE oral taken for rheumatoid arthritis, she initially was taking 2 tablets and she felt funny and switched it to 1 tablet, the product is in a pharmacy vial, she did not take it within 4 hours of taking the Paxlovid though. She has been on the medication for about a year. Patient has had 4 Pfizer shots and boosters. She had COVID after receiving 4 doses of the Pfizer COVID-19 vaccine. She had their grandchildren and they all had COVID and between last Saturday night to Sunday morning (25Jun2022-26Jun2022) she tested positive with symptoms. She was dispensed Paxlovid 5-day treatment regimen and finished her doses of Paxlovid last night (30Jun2022) and today (01Jul2022) she woke up and was very dizzy and nauseated today (AER# 202200920594). Outcome of the events was unknown.
vertigo; 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 VERTIGO (vertigo) 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 VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
As per the time line described above, I developed waxing and waning numbness that  runs along the bottom of my jaw, from bilateral mastoid process to roughly 3/4 the way to  the clavicle.  It persists from 30 min up to 150 minutes.  Almost 1 year after my second injection the adverse event occurs.  Out of 7 days I would estimate it averages about 4 days.  I have no trouble swallowing, maintaining my airway or handling secretions.  For some of the most intense events I do feel a fullness in my neck.
Hypotonic/hyporesponsive episode. Neck full extended, eyes rolled back and fixed and lasted 10 minutes, then moaning. Recurred 4 times; each episode slightly shorter between 5 PM and 8 PM. Had runny nose but no fever. Fever to 101 in hospital, but not associated to event. Discharge Summary received on 1/06/2005 states URI.
Headache/Sweating/Insomnia- 2:30AM  4/25/21 Body Aches/Fatigue- 10AM 4/25/21 All Symptoms Self-Resolved- 4PM 4/26/21
an unspecified number of doses of improperly stored PEDVAX HIB, ROTATEQ, and GARDASIL 9  was possibly administered to an unspecified number of patients on unspecified dates; no adverse effects; This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported.      On unknown date, the patients were vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent(ROTATEQ), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of 34.7 degrees Fahrenheit for 19 hours as recorded by a data logger. There was no adverse effect reported.
The pharmacist that gave the shot I questioned her if she was giving the correct dose for my 7 year old and she said yeah, but the needle used before was a total of about 5 inches this one was about a 4 inch needle & 4 inch vial it was huge with quite a bit of med in val. So she gives my daughter the shot and when she pulled the needle out it made a loud popping noise and a good amount of blood which has never happened before.
PAIN IN ARM, SWEATING, FEELING LIGHT HEADED WITHIN SECONDS OF RECIEVING ANTHRAX VACCINE.  PATIENT PASSED OUT, EYES ROLLED INTO BACK OF HEAD AND STARTED DROOLING WITHIN 3 MINS OF VACCINES.  PATIENT CAME TOO ABOUT 1 MINUTE LATER. PATIENT THEN BEGAN GETTING SICK. 911 WAS CALLED WHEN PATIENT COLLASPED AND AN AMBULANCE TRANSPORTED HER TO HOSPITAL FOR EVALUATION.  AMBULANCE ARRIVED 5 MINS AFTER CALL WAS PLACED.
Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400.  I was taking additional insulin to try and bring it down and I wasn?t eating.
Chronic fatigue everyday since the day after the 2nd dose of the Modern COVID-19 vaccine.
Patient developed severe allergies(scar tissue in throat); Difficulty swallowing; Allergy to wheat, soy, gluten, tree nuts; scar tissue in throat; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 20-year-old male patient who received Men B NVS (Bexsero) (batch number ABX794AB, expiry date 30th August 2020) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Bexsero. On an unknown date, 2 months after receiving Bexsero, the patient experienced allergic reaction, swallowing difficult, food allergy and oropharyngeal scar. On an unknown date, the outcome of the allergic reaction, swallowing difficult, food allergy and oropharyngeal scar were unknown.   It was unknown if the reporter considered the allergic reaction, swallowing difficult, food allergy and oropharyngeal scar to be related to Bexsero.  Additional information was provided as follows: The patient developed severe allergies (scar tissue in throat, difficulty swallowing, wheat, soy, gluten, tree nuts). The batch number was updated as per sales data sheet. The reporter consented to follow up. The reported batch number ABX794SB for Bexsero did not exist and was updated to ABX794AB as per the sales database.
Two days after injection, child went to the ER with a chief complaint of left arm red and swollen. Rx'd with Augmentin. On 1/10/03, the redness and swelling were 5" X 5". On 1/14/03, seen by PCP and redness and swelling had decreased to 2" X 2". Rx'd was Augmentin 6cc po bid and continue plan of care.
Initial unsolicited report received from nurse on 20-Oct-2017. This case is linked with 2017SA207217 and 2017SA207221 (Same reporter). This case involves female patient (Age not reported) who was vaccinated with 0.5 ml dose of FLUZONE QIV (Frequency: once, batch number, expiry date and site of administration were not reported) intramuscularly on 04 Oct 2017 at Flu clinic. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination, patient had developed hives and shortness of breath. Laboratory investigation was not reported. Patient required BENADRYL in the ER. On an unspecified date, patient was recovered from events. Follow-up report received from nurse on 05-Dec-2017. It was reported that 52-year-old patient was vaccinated with FLUZONE QIV (Batch number: UI839AA) at left deltoid. Patient had a medical history of penicillin allergy. Patient was previously vaccinated flu vaccines without any adverse events. It was also reported that no other vaccine was administered within 4 weeks prior to vaccination date. On 04-Oct-2017, same day following vaccination, the patient had experienced generalized rash and throat closure. It was reported that patient felt as though throat closing. As corrective treatment, patient received Dexamethasone injection at a dose of 10mg, BENADRYL at a dose of 25 mg and PEPCID tablet at a dose of 20 mg. Lab test were none. Event outcome were resolved on 04-Oct-2017. List of documents held by sender: none.
Lightheaded, nauseous - observed for 10 min., no resolution, given ondansetron by EMS, transported to ER -
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed.  No treatment medications were reported
Redness, itching, warmth on face, palms of hands, chest & legs started 4-13-2012 (3 days post immunization) itchy eyes - swelling rim of eyelids. No difficulty breathing or swelling of tongue. 4/15 Face is peeling eyes still itching. 4/16 - Redness gone still face peeling no eyes itching.