chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One large blister that is not with injection site. Just on same deltoid that injection was given, rash and swelling. Treatment with BACTRIM DS and steroid shot.
VARIVAX that underwent a temperature excursion was administered; No additional adverse effect reported; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T012551 with an expiration date on 10-APR-2022) for prophylaxis, which experienced a temperature excursión of -10°C Celsius degrees to 8°C for an unknown amount of time (product storage error).   It was unknown if previous temperature excursions were experienced. The data logger was not involved. No additional adverse effects were reported.
I had a mild rash on my lower abdomen. Did not have any with Moderno one or two. I went to the allergist because I had a rash that was much more widespread from the shingles Second vaccine which I reported to you in May. Doctor tested me for allergy to PEG and other components of the vaccine but so far inconclusive. Slight red dot where the PEG was on the arm test. I did patches on my back for four days and no allergic reaction. Not sure why I got a rash
Within 10 minutes of administration pt. developed "bad taste" in mouth and moderate swelling of tongue.  Treated w/epi, Benadryl, steroids and swelling resolved over about an hour.  No airway compromise but certainly potential. Dx of anaphylaxis.
NAD with c/o tongue lips and rt side of face tingling ca 8 min after receiving COVID vaccination. Reaction most noticed in right cheek.
Diarrhea & stomach cramps occured 5-9 hrs p/shot; not notified of rxn till next day;
vaccine was administered on 28Oct2019 and had expired on 23Oct2019, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5307AA via intramuscular route in the left thigh on 28-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used. It was reported that the vaccine was administered on 28-Oct-2019 and had expired on 23-Oct-2019.  At the time of reporting, no adverse event was reported.  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.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 35-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 16Oct2021 as dose 3 (booster), single (Lot number: 30135ba) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation (corrected)" (unspecified if ongoing), notes: Other medical history: Atrial fibrillation (corrected), Asthma (childhood); "Asthma (childhood)" (unspecified if ongoing), notes: Other medical history: Atrial fibrillation (corrected), Asthma (childhood). Concomitant medication(s) included: ASPIRIN (E.C.); LISINOPRIL; XYZAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergies. The patient had taken Paxlovid from 27July2022 to 31July2022 for the treatment of covid-19. No follow-up attempts are required. No further information is expected.
lightheadedness; Diarrhea; Dizziness; Nauseous; Chills; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nauseous, chills, diarrhea, dizziness, lightheadedness.  The patient's medical history was not provided. Concomitant medications reported were acetaminophen, levothyroxine, fluticasone proprionate, fluticasone proprionate and salmeterol xinafoate, multivitamin for drug use for unknown indication.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events nauseous, Chills, diarrhea, dizziness, lightheadedness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, nauseous, chills, diarrhea, dizziness, lightheadedness were  unknown.
On May 15th around 11:00pm I started having chills really bad.  Went to bed and started having a horrible headache with body aches .  May 16th couldn't get out of bed all day due to the horrible body aches and headache with a fever of 101.00.  Today May 17th feeling better but really tired .
bronchitis 5NOV65; Furuncle (boil) 2AUG66;Bronchitis 29JUL69;
This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-AUG-2013, the patient was vaccinated with the third dose of HPV vaccine (dosing details were not provided). The patient received first and second dose on 21-JAN-2013 and 12-APR-2013, respectively. Medical assistant reported that she was unable to specify if these doses were GARDASIL or GARDASIL 9 (lot/ expiry dates were unknown for first 3 doses administered). She also mentioned that on 09-NOV-2016, the patient inadvertently received a fourth dose with GARDASIL 9 (lot # M026306, expiry date: 30-APR-2018). No adverse effects were reported. Additional information has been requested.
Left axillary lymphadenopathy, Left supraclavicular lymphadenopathy, pain left arm6/10-8/10
pt devel temp102-103F;generalized tonic/clonic seizure lasting 15 min;pt difficult to arouse; focal lt sided sz w/fever;  Todd's paralysis on lt resolved p/fever x24 hr; pt had multiple flea bites/vesicular lesions; tx w/ATB & dilantin
Within hours of my vaccination I got a headache, fatigue and within five days after my vaccination I got a severe migraine which lasted a total of eight days. I went to the hospital to get an MRI which was clear of a blood clot. All side effects have passed now.
Hives post MMR, VZV, Comvax, no fever no respiratory distress, activity of appetite OK.
really sick; nausea; diarrhea; chills; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, nausea, diarrhea and chills. On an unknown date, the outcome of the sickness, nausea, diarrhea and chills were unknown.   It was unknown if the reporter considered the sickness, nausea, diarrhea and chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 80 or 81 years old. The patient was really sick with nausea and diarrhea and chills. The patient asked what would happen if do not  take the 2nd shot of vaccine.
Pericarditis or myopericarditis on post-vaccine day 3. Had myalgias and subjective fever on post-vaccine day 0 and 1, blurry vision post-vaccine day 1, episode of emesis on post-vaccine day 2,  then developed acute onset pressure-like chest pain on post-vaccine day 3.
A nurse reported that a 42 year old male received an injection of Flu Shield '00-'01 on 11/18/00 and subsequently, developed a fever, hoarseness and a sore throat. On 11/22/00, she was seen by the physician. Follow up information received from the physician on 01/05/2001 indicated the patient recovered.
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. On or about 09-MAY-2013, 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. On or about 13-MAR-2016, the patient was treated at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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.
Moderna COVID-19 Vaccine EUA Started a fever around 10:30 p.m., chills, headache and nausea. Fever broke around 3:30 a.m. on 1/3/2021. Sweated out of clothes Took Acetaminophen
29MAR96 1PM throbbing pain @ inj site, neck hurting, severe h/a;30MAR96 in bed all day, felt weak & tired, t101, inj site swollen to size of tennis ball;31MAR96 arm still swollen, called ER, compresses used
Pt given Flu vaccine (R) thigh on 2/13/07. Mother reports that rash began (R) thigh about 1 hr later, spread to other leg, trunk, arms. No itchy, no trouble breathing. Pt has been on Amoxicillin since 12/6/07 for (R) otitis media. No h/o egg allergy.
Fatigue (began noticing 8 hours after injection, slept a lot), body aches (20 hours after), chills (20-24 hours after), fever (24-28 hours after). Symptoms continued until I took Tylenol following night (33 hours after injection). Pain/soreness at injection site almost immediately + swollen left underarm lymph nodes noticeable 40+ hours after. Tenderness and bruise-like pain there.
No adverse event; second dose was bivalent booster instead of monovalent; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 30-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent) 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 INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent).    No concomitant medication was provided by reporter.  The nurse states that there is a nursing student who received her first dose of the Moderna on 02Sep2022. On 30-Sep-2022, instead of receiving the second dose, the patient got 0.5ml of the bivalent booster because the patient was in nursing school, the nursing director had said that need to be fixed by 31-Dec-2022 otherwise she would be kicked out of the program. The HCP would like information in writing what to do for this patient.  No treatment medication was provided by reporter.
Shingrix reconstituted with sterile water instead of with adjuvant; Shingrix reconstituted with sterile water instead of with adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-OCT-2023, the patient received Shingrix. On 02-OCT-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with sterile water instead of with adjuvant) and inappropriate dose of vaccine administered (Verbatim: Shingrix reconstituted with sterile water instead of with adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that a patient was accidently given a dose of Shingrix which was not properly reconstituted. The dose was reconstituted with sterile water instead of with the Shingrix adjuvant which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
I had a fever temperature 101, muscle ache, fatigue and headache medium the effects lasted abut a day and a half. I took Tylenol and was fine after that. I also was dizzy that lasted for about 4 month that started about 3 days after the vaccination.
Patient seen in office on 9/29/15 for physical. Provider did not see the prior date of 1/28/15 which showed that patient had already received this vaccine. Patient informed.
Approximately 10 minutes after covid vaccine, the pt. approached a vaccine site volunteer and advised him that he received the different manufacturer vaccine for the first dose on March 09th, 2021.  Dr. consulted with the pt.
Missed the second dose; Spontaneous report received on 06MAR2020.   A pharmacist reported that a consumer "missed the second dose" (PT: Product dose omission) while being on Vivotif for immunisation. It was reported that the consumer missed the second dose of Vivotif on 05MAR2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif (missed dose). Vivotif should be taken every other day, and the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif (missed dose). Vivotif should be taken every other day, and the causality of missed dose is assessed as not applicable to Vivotif.
Chills, Fever 102+, severe headache, vomiting,  dizzy, body aches. All symptoms lasted for 1.5 days. Headache, dizzy, body aches lasted for 3 days.
tingling and numbness in right foot developed in evening following vaccination; this has happened previously 4 years ago after an international flight; tingling and numbness in right foot developed in evening following vaccination; this has happened previously 4 years ago after an international flight; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient (family member) a 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER2613; Expiration date: unknown) via intramuscularly, administered in Arm Left on 30Mar2021 17:15 (at the age of 30-years-old) as first dose, single for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. Patient had not any allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 30Mar2021, patient had tingling and numbness in right foot developed in evening following vaccination and this has happened previously 4 years ago after an international flight. Patient had not received any treatment for the adverse events. Patient was not diagnosed with COVID-19 prior and since the vaccination. Seriousness was reported as No. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: (To update the patient information.)
Suspected Vaccination Failure/Had 2 doses last year, had shingles in June; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received on an unknown date several years ago from reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In June 2022, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received the new Shingles vaccine (2 doses) last year (in 2021) and he/she still had shingles back this June. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt had a previous hospitalization at Medical Center with a positive COVID test on 12/31/21; was treated and sent to a nursing home; 1/28/22 pt presents to ED (at the Medical Center) with c/o abdominal pain and SOB with exertion; desaturating on room air (mid 80s); admitted for evaluation; evaluated for gallbladder and HIDA scan came back negative; pt was a high risk candidate for any type of surgery; AHRF; fibrosis on CT perhaps sequela of COVID infection vs COPD/Emphysema; discussed condition with family;  2/1/22 pt dc'd to home with Home Health; pt dc'd to home where he passed away
diagnosed with SARS COV-2; he started feeling really ill; his fever at its highest was 101.6 degrees Fahrenheit; lingering cough; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Aug2021(at the age of 54-year) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history, and no concomitant medications were reported. Reporter states, the patient was diagnosed with COVID on 04Sep2021 after he had symptoms the day before, where he started feeling really ill on 03Sep2021. He says his wife's diagnosis was when she had surgery, within two days she had COVID and he has been taking care of her at home. He says two days after he was taking care of her he started feeling ill so he went Saturday and it was positive when they did the COVID nose swab test. Caller said that they gave him monoclonal antibodies last Monday. He said he has also treated the COVID, they gave him a nose spray but he was not sure what that is called, and he was taking a zinc supplement, and he takes Quercetin 800mg capsules three times a day, and a vitamin pack, and Tylenol to help keep fever down. The patient said his fever at its highest was 101.6 degrees Fahrenheit. He said his Tylenol dosage was the Quick Gels, he takes 400mg at a whack, he does not have the bottle with him but he thinks it is 200mg a piece, and he takes two each time, usually one in the morning and one at night before bed. The patient said he takes Zinc one a time day, Zinc dose unknown. The patient said he feels better now, there were 2-3 days he was getting worried, it seems like a roller coaster ride, but he was much better the last two days, and today is his best day yet. He said his negative test was on 16Sep2021, and the only real symptom he still has was the lingering cough that he has ever so often, and that has eased up a lot on an unknown date in 2021. The patient lab included body temperature: result was 101.6 degrees Fahrenheit on an unspecified date in 2021, COVID nose swab test/COVID test: positive on 04Sep2021 and negative on 16Sep2021. Patient received treatment for all events. On 16Sep2021, the patient recovered from COVID-19 and feeling ill. The event outcome for fever and cough was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Shivering; Soreness at the injection site/ arm is very sore; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2020, 13 hrs after receiving Shingrix, the patient experienced shivering and pain in arm. On 23rd October 2020, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received his first Shingrix shot was administered at his MD office by the nurse who injected into the left shoulder (deltoid). The reporter said that he had since gotten over it and was fine at the time of reporting and did not had a fever. The reporter stated that the nurse warned him that his arm was going to be sore and he said that it was very sore. The soreness at the injection site had not resolved. The reporter did not see the lot or expiry date of the Shingrix but gave permission to contact his MD office. The reporter consented to follow up.
Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9F - 101F
Client experienced post immunization syncope approximately 3 minutes after vaccines were given. States her throat felt tight and she was dizzy". This appeared to last approximately a few minutes and client returned to pre-vaccine state within 10 - 15 minutes total. VSS B/P 100/60, Pulse ox 99%. No intercostal retractions. EMT called at request of mother. Mother declined taking child to hospital.