chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red; AE contact information not updated; red; Itchiness; Spreading to other areas; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ERYTHEMA (red), PRURITUS (Itchiness), CONDITION AGGRAVATED (Spreading to other areas), the second episode of ERYTHEMA (red) and ERYTHEMA (better now) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced the first episode of ERYTHEMA (red), PRURITUS (Itchiness) and CONDITION AGGRAVATED (Spreading to other areas). On an unknown date, the patient experienced the second episode of ERYTHEMA (red), ERYTHEMA (better now) and ADVERSE EVENT (AE contact information not updated). At the time of the report, PRURITUS (Itchiness) and CONDITION AGGRAVATED (Spreading to other areas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: NNI On 03-May-2021: contact information updated
Facial, sinus swelling; irritation to throat, larynx, lungs; appearing after one hour and lasting 24 hours. Residual sore throat.
A couple of days - a normal kind of sore and it went away. 1 week later - quarter size lump - itchy, painful, hot - grew in the next four days - grew to the size of a grapefruit - it spread out - it had a bulls eye  - the center was as big as Cutie orange (and it was red and painful) and the redness spread from their extending out from center about 4 inches. It took up my entire upper arm - the redness day. It was painful to sleep on but I could use it. On the third day of it ( a Wednesday, 13th) - to check in with DR - Telehealth appt - employee health - recommended ibuprofen and ice packs for a few days. They advised if I got a fever etc to seek more treatment. It took about two weeks for it to go entirely away.
Information has been received from a male consumer with no known drug allergies and no past medical history who in 3/00, was vaccinated with MMRII. In 4/00, the pt was vaccinated with a 2nd dose of MMRII. There were no concomitant medications or current illnesses. In approx. 4/00, the pt experienced flu symptoms and pain in his jaw. It was noted that the pt recovered from the flu symptoms and pain in his jaw. Subsequently, the pt experienced fatigue, numbness in his limbs and internal bleeding. It was reported that "there is a long list of things" the pt had experience. Unspecified medical attention was sought. Upon internal review, internal bleeding was considered to be an "Other Important Medical Event". Additional information has been requested. Also stated abdominal pain, rectal bleeding, facial numbness and tingling, and muscle pain throughout his body.
pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on Mar2021 at 11:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing venous insufficiency since 2019. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient stated that he received his first dose on 30Mar2021 or 31Mar2021. On an unspecified date, the next day after the first vaccination, the patient experienced pain in his leg that felt like a clot for the first week and a half to two weeks. Then, the patient got a little bit better, even though he had almost gone to the emergency room, but he got better after a couple weeks. The clinical outcome of "pain in his leg that felt like a clot " was resolved on Apr2021.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507016 Same patient/drug, different dose/event
pt recvd vax 24MAY95 & JUL95 pt devel a large red area @ site of inj;No further details were provided;
Severe Headache, Fever, Chills, Insomnia Rapid Covid Test Positive 01/19/2021 5 Day Course Treated with Monoclonal Antibodies
Myalgia, Fever, NauseaVomiting, Chill, sore arm at injection site Narrative:
No ae reported; expired PNEUMOVAX23 given; This spontaneous report has been received from a health care professional referring to a 66 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R022249 with expiration date of 16-APR-2020 (strength, indication, dose, route, frequency, and anatomical location were not provided) for prophylaxis. No adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R022249; expirationdate: 16-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Erythema, itching, dizziness, feeling "wierd". She was given IM Benadryl 25mg 12 minutes after her IM injection of the Moderna vaccine (12:15) and that was repeated 25 minutes later (12:40). The patient was feeling better after each injection but after her 2nd dose of Benadryl she was still feeling dizzy and "wierd". She was transported to the ED by ambulance  further treated there.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 at 14:00 as dose 1, single (Lot number: EJ1685), in left arm, on 10Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm, on 26Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 11May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "Known allergies: Pcn" (unspecified if ongoing), notes: Known allergies: Pcn. Concomitant medication(s) included: SYNTHROID; ATENOLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
punchered and administered 4 times after the excursion with no reported adverse event; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 5 years old female patient who punchered and administered 4 times after the excursion with no reported adverse event while receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient received a dose of 0.5 ml suspect ipv (VERO) (Suspension for injection) (lot V1B901M,expiry date:02-Jun-2024) via intramuscular route in the left deltoid for prophylactic vaccination(immunization).  On 10-Oct-2022 the patient punchered and administered 4 times after the excursion with no reported adverse event (poor quality product administered) (latency: same day)following the administration of ipv (VERO).  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event punchered and administered 4 times after the excursion with no reported 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 the guidelines. 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.
Ramsey Hunt Syndrome including: Extreme pain in left ear, swelling at the back of the throat on the soft pallet as well as a herpes like sore in the same area. Headaches, sleepiness & irritable. Unable to swallow solid foods for up to a week at this time. Facial parallelizations of the left side including the lips, cheek nostril & lower eye lid.  9/28/07 Received vax record from pcp.  VAERS database updated w/same./ss 11/9/07 Received urgent care facility medical records which reveal patient experienced viral illness x 1 week.  Seen by pcp & tx w/antibiotics for sore throat.  Now presented w/obvious left facial droop, weakness, unable to completely close left eye, left eye droop, left facial nerve palsy.  Tx w/antiviral meds. FINAL DX: Bell's palsy, left.
I had 8 hangovers at once; complete loss of appetite; constant body aches and pain; intrusive brain fog; Any time I would sit down it would take at least 10 minutes to have the physical energy to stand up again.; This is a spontaneous report received from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 26Mar2021 at 14:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. The patient had known allergies to artificial sweeteners, fish and tree nuts. The concomitant medication included lamotrigine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 08:00, the patient experienced feeling like she had 8 hangovers at once after waking up and had experienced complete loss of appetite for full day, constant body aches and pain, and intrusive brain fog. It was also reported that at any time the patient would sit down, it would take at least 10 minutes to have the physical energy to stand up again. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events hangover, appetite lost, general body pain, mental confusion and loss of energy was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FLU SYMPTOMS, FEVER OF 102 DEGREES, HEADACHE, BODY ACHES, CHILLS, TINNITUS
Bell's palsy 10 days after getting 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) 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.   Concomitant product used was not provided by the reporter.  This patient returned to take the second dose of vaccination and mentioned that 10 days after 1st dose of vaccination he noticed Bell's Palsy while taking shower. He did not see a HCP (Health Care Professional) nor given any medication. Pharmacist advised patient to see HCP and discuss about getting 2nd dose.  Company comment: Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also knows as shingles and other complications. Later in 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
nausea; vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 79-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.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: attached : Initiative
Information has been received concerning that an 11 year old patient who was on an unspecified date vaccinated with the first dose of VARIVAX (Merck) (Lot # not reported). Subsequently, the patient presented with mild case of the chickenpox. It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. The patient's sibling also presented with a mild case of the chickenpox after received the first dose of VARIVAX (Merck) (WAES#1009USA00399). No further information is available.
Delayed Reaction to the Covid-19 Moderna Booster shot -  12/28/21 - vomiting and diarrhea - resolved within 24 hours; tiredness12/31/21 - developed rash on arm1/1/22 - woke up with rash and welts on hips, arms, neck, stomach; complained of a 'rock' feeling in his upper stomach which resolved in 48 hours; took Maalox tablet for the "rock" feeling in stomach at bedtime; took one dose of Benadryl for the rash - didn't help. 1/2/22 - woke up with joint pain in shoulders, elbows, hips and back really hurt; Rash got worse.  Determined via home test that patient likely has dermatographia - 'skin writing' reactions.  He cannot place any pressure on his skin or scratch in any way or welts develop within minutes - anywhere on his body.  In the evening, developed fever 100.2 by mouth, chills, muscle aches, sore throat that felt like it was 'closing' although he did not have any difficulty breathing; took 1 Allegra dose for dermatographia - didn't help; took two ibuprofen for pain. 1/3/22 - Dermatographia still a big problem.  Sore throat was better. Fever broke in afternoon.  Still had major muscle aches at bedtime, but joint pain had resolved. PA advised to take 2 Claritin daily for 7-10 days; also took two Tylenol for pain at bedtime. 1/4/22 -  Dermatographia still a big problem. So uncomfortable and cannot do daily activities - must wear loose clothing and not touch his skin or welts develop; took 2 Claritin for dermatographia/rash - seems to help a little with the itchiness/
Patient called on 2/5/21 complaining of redness and itching in the arm around site of injection. Patient states it just came up. Patient then went to urgent care on Sunday, 2/7/2021, and was given steroids and antibiotics, but states she did also have complaints of earache.
Tested positive for Covid-19 on 8/5/2021.  Admitted for AMS
Feeling flushed, raised temperature, chills, sore muscles and joints, fatigue, insomnia, lack of focus - lasted 24 hours after shot - took tylenol, checked temperature regularly, rested
Allergic reaction, Hives. Given Benadryl allergy childrens liquid12.5 mg/5mL, 7.5 Ml orraly every 6 hrs. Prednisolone solution 15 MG/5ML, 10 Ml orally daily for 3 days. Triamcinolone Acetonide Cream 0.1% twice a day.
Activated shingles at only 42 years old. Needed two rounds of acyclovir. Damaged ear. Have had ear infection taking antibiotics for nearly 3 month straight.
Case number PHEH2015US17899, is an initial spontaneous report received from a pharmacist on 10 Sep 2015. This report refers to a 55 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501) intramuscularly in upper arm on an unknown day (last week). On 04 Sep 2015, the patient developed pain in upper arm, pain in armpit and pain in both elbows. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Refrigeration excursions identified/undergone several temperature excursions; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 18-Sep-2022 at 4:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Sep-2022 at 4:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions).    No concomitant products reported.  Patient had received dose 4 on deltoid body site.   It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No adverse reactions reported for the patient.  No treatment products reported.