chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got Yes and still got the worst flu in years; Initial information received on 17-Dec-2022 regarding an unsolicited valid social media non-serious case received from a Patient   This case involves an unknown age and unknown gender patient who experienced patient got yes and still got the worst flu in years after receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic Vaccination   On an unknown date the patient developed a non-serious event patient got yes and still got the worst flu in years (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action Taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient got Yes and still got the worst flu in years).  At time of reporting, the outcome was Unknown for the event patient got yes and still got the worst flu in years.
Pt seen in clinic 15APR92 @ approx 1030AM, vax recvd approx 1045AM; grandma reported pt's leg swelling @ suppertime approx 530PM; stated pt felt hot; t102; during noc T went up; pt taken to MD 16APR t102; MD gave meds;
Hives, Rash, Welts - lasted for 7 days. More severe on the first 3 days
really really sick; more than 36 passed since the first dose and she did not get the second; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (really really sick) and PRODUCT DOSE OMISSION ISSUE (more than 36 passed since the first dose and she did not get the second) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really really sick) and PRODUCT DOSE OMISSION ISSUE (more than 36 passed since the first dose and she did not get the second). At the time of the report, ILLNESS (really really sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 36 passed since the first dose and she did not get the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-291699 (Patient Link).
Joint pain, muscle pain, chills, low grade fever, shooting pains in head behind right ear, extreme fatigue, injection site pain and swelling
Exactly a week after I got the Gardasil shot I started noticing small bumps appearing on my skin, we didn't know what they were at first but eventually it got worse to the point where there were dozens on my arms, legs, chest everywhere! After a few hours they eventually went away but left small pink marks which gradually faded. The same thing happened the next day, but not as bad. Off and on through the weeks they came and went, some worse than others. One day when we went to the mall, I suddenly broke out to the point where I was covered in them from the neck down. Some were even as big as quarters if not larger. That by far was the worst outbreak to this very day. I have had blood tests done and an allergy test, changed detergent, shampoo, soap, everything my allergy doctor and home doctor have told me and they still come back. Before I got the shot I NEVER had them in my life. I am scared that this will affect me for the rest of my life seeing as how it's lasted over five months off and on every day.
Eight days after the vaccine, my arm began itching (like a mosquito bite) at the injection site.  This has proceeded to a slow constant itchy burn and the spot is warm and slightly hardened.  It is aggravating and consistent.
I have had 4 episodes of dizziness. I do not ever experience dizziness in my daily routine, typically. The first 3 were minor and brief - they occurred while I was standing or walking - I was aware of it and paused, but recovered before having to sit down or stop moving. These occurred between 18 and 42 hours after receiving dose 2 and seemed to be triggered by bending over, getting up and down. The 4th episode happened almost exactly 48 hours after dose 2, occurred 35 minutes into my daily 3 mile walk, and was more significant. I had to sit down by the side of the road and call for my husband to come get me. It has been nearly 48 hours since that episode and I have not experienced any more dizziness since that time.
Case number PHEH2013US015050 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an 11 year old patient (gender not reported). Medical history and concomitant medications were not reporter. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 25 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-FEB-2015 the patient was vaccinated with PROQUAD (Merck) (dose 1; dosage, route and lot number unknown). The nurse reported that on 12-MAR-2015 the patient received a 2nd dose of PROQUAD (Merck) (dose 2; dosage, route and lot number unknown). No adverse effects reported. Additional information has been requested.
exposed to 82.62 F for 15 minutes/medication error due to temperature excursion exceeded the stability data (with no reported adverse event); IPOL was administered to 4 patients after excursion with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 6 years old female patient who experienced exposed to 82.62 f for 15 minutes/medication error due to temperature excursion exceeded the stability data (with no reported adverse event) and ipol was administered to 4 patients after 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 an unknown date, the patient received a 0.5 ml dose of suspect ipv (vero) lot T1871M, expiry date: 10-Oct-2022 (route, strength, formulation, frequency: unknown) in unknown administration site for Immunization.  On 03-SEP-2021 the patient developed non-serious events exposed to 82.62 f for 15 minutes/medication error due to temperature excursion exceeded the stability data (with no reported adverse event) (product storage error) and ipol was administered to 4 patients after excursion with no reported adverse event (poor quality product administered) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events (product storage error and poor-quality product administered).  At time of reporting, the outcome was Unknown for both the events product storage error and poor-quality product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional adverse effects reported.; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 02-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S022755 was verified to be a valid lot number, expiration date reported and established as 02-JUL-2021), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion -13.4 degrees Celsius for 1 hour 30 minutes (product storage error), as recorded by a data logger. There was no adverse effect reported.
COVID-19 infection symptoms started on 02/27/2023 in the afternoon. I had chills and sore throat. The next day I felt better because the symptoms were mild but at night I felt bad again with chills and a sore throat. I did 2 COVID-19 tests which were negative on 02/28/2023 and 03/01/2023. On 03/01/2023 I developed cough, fatigue, sinus drainage, and congestion. On 03/02/2023 I used a home COVID-19 test and the result was positive. I contacted the pharmacy and did a telehealth with a doctor. She prescribed me molnupiravir for 5 days. All the symptoms I had were mild. The cough lasted for 2 weeks.
Bigger and itchier rash come back again; Unexplained episode of diarrhea after the 1st dose; Black and blue marks under the skin in the injection site left arm after the 1st dose; Itchy left arm after 1st dose; Red left arm after 1st dose; Swollen left arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose). On 11-May-2021, the patient experienced VACCINATION SITE RASH (Bigger and itchier rash come back again). On 09-May-2021, DIARRHOEA (Unexplained episode of diarrhea after the 1st dose), VACCINATION SITE PRURITUS (Itchy left arm after 1st dose), VACCINATION SITE ERYTHEMA (Red left arm after 1st dose) and VACCINATION SITE SWELLING (Swollen left arm after 1st dose) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Black and blue marks under the skin in the injection site left arm after the 1st dose) had not resolved and VACCINATION SITE RASH (Bigger and itchier rash come back again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 39-year-old female patient who received FLUARIX Quadrivalent. Concurrent medical conditions included food allergy (Allergic to mammal products, including pork, beef, gelatin, and dairy). On 10th November 2017, the patient received FLUARIX Quadrivalent (intramuscular). On an unknown date, less than a year after receiving FLUARIX Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. The reporter considered the allergic reaction to be possibly related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received FLUARIX Quadrivalent in right deltoid. The patient had seen an increase in the number of reactions to these products since received the vaccine. The reporter gave permission for the patient's physician to be contacted but did not have their name or telephone number at the time of the call and the reporter was not able to provide the lot number or expiration date for the vaccination.
started to bleed the day after the 1st Moderna shot; Doctor prescribed some antibiotics but still does not know what is happening to me/my whole body is messed up, i have to go for some tests first because they don´t know what is; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (started to bleed the day after the 1st Moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (started to bleed the day after the 1st Moderna shot) (seriousness criterion medically significant) and FEELING ABNORMAL (Doctor prescribed some antibiotics but still does not know what is happening to me/my whole body is messed up, i have to go for some tests first because they don´t know what is). At the time of the report, HAEMORRHAGE (started to bleed the day after the 1st Moderna shot) and FEELING ABNORMAL (Doctor prescribed some antibiotics but still does not know what is happening to me/my whole body is messed up, i have to go for some tests first because they don´t know what is) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment for the event include some antibiotics but didn't specify one in particular.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
This case was reported by a healthcare professional (nurse) and described the occurrence of headache in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of ENGERIX B (unknown details). Immediately after vaccination with ENGERIX B, the subject experienced headache. At the time of reporting the event was resolved. Per the nurse, the event "lasted 4 days."
Narrative:  COVID infection following COVID vaccine series 01/15, Pfizer,  dose #1 02/05, Pfizer, dose #2 06/18 DDIMER result: 0.77 06/18 CXR impression: Pronounced peribronchial vessels centrally, RIGHT more than LEFT, could reflect true interstitial pulmonary edema or ongoing bronchitis. Alternatively consider artifact due to portable technique. Needs correlation for signs and  symptoms of systemic volume overload versus lower respiratory tract infection. No focal pneumonia or pleural effusion. 08/17 pt cc: cough, rhinorrhea, fatigue exposure: unknown 08/26 COVID swab, result: detected 08/26 SARS-COV-2 Variant Sequencing RESULT: pending 08/30 clinically resolved
pt recv vax 16SEP97 &  pt devel a rash on elbow described as flesh colored lumps;MD noted that this was a questionable rxn;
Information has been received from a nurse practitioner via a company representative referring to a 17 year old non-pregnant female patient. The patient's pertinent medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with the first and second doses of GARDASIL (dose and strength unknown) intramuscularly in the arm. In 2010 the patient completed all the 3 doses of the vaccine. Concomitant medication was not reported. In 2012, the patient was diagnosed with type 1 diabetes mellitus. The patient sought medical attention. At the time of reporting, the outcome of the event was unknown. The patient's mother thought it was the GARDASIL that caused her daughter's adverse event. The causality from the reporter was not reported. Additional information has been requested.
lost complete hearing in her left ear/hearing was almost completely gone based on the audiology test; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EN5318 and expiry date unknown, via unspecified route of administration at the left arm on 02Feb2021 15:30 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no covid prior vaccination. On 02Feb2021 16:00 (30 minutes after receiving the vaccination), The patient lost complete hearing in her left ear. The patient informed that it came on very suddenly and did not improve by the next morning. The patient contacted her doctor at the clinic and was scheduled for a hearing test on Thursday at 9:30 and an appointment with an ENT afterwards. The hearing was almost completely gone based on the audiology test (Feb2021). The patient began very high levels of steroids for a 14-day program and her hearing has started to return. The patient also had an MRI done on Monday (Feb2021) showing no abnormalities. The patient was not covid tested post vaccination. The patient informed that this seemed to be a very real coincidence that the vaccine triggered this response to her hearing. The outcome of the event was recovering. The event was considered serious (disability).
10 ITCHY RED DOT/MODERATE ITCHY FEELING; FEVER AT 37.9C; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced 10 itchy red dot/moderate itchy feeling. On 01-MAY-2021, the subject experienced fever at 37.9c.  Laboratory data included: Body temperature (NR: not provided) 37.9 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever at 37.9c and 10 itchy red dot/moderate itchy feeling was not reported. This report was non-serious.
persistent temp above 102 despite APAP q 4 hrs; temp 24 hrs p/receiving immun 104.2, vomiting x 2 p/24 hrs;
No issues at time of injection or that night.  Woke up and had rash on the back of thigh and calf only on leg received injection in.  Rash has worsened over the past week but stayed in the same area.  Not itchy or painful to toddler.  No change in ability to run and climb.  Rash is raised, small papules/pustules on erythematous background that gets darker with heat.  Toddler was more tired than usual for a few days and took naps alone when she usually only contact naps.
Sat night approx 12 MN developed rash-small red dots on face& T of 104-105. 4Feb saw MD & DX /w otitis & is currently being TX /w Pediazole. Pt had some vomiting & extreme muscle aches. 6Feb continues to have increase T & muscle aches
Within 20 minutes of receiving vaccine, patient complained of passing out, headache and dizziness. Her pupils were slightly dilated and her color was pale. She had occasional tremors to the right hand.
24 hours after injection, site swelled to size of an egg. Flu-like body aches developed, lasting 48+ hours.
Patient received 0.5ml of Moderna monovalent for ages 6 months-5 years, but should have received 0.5ml of Moderna bivalent for 6+ years old
Narrative: Patient tested positive for Covid-19 and was hospitalized despite full vaccination of Pfizer 1st and 2nd dose, 2nd dose given 04/08/2021. Booster was not received. Admitted 11/12/21 hx DM2, bipolar, HTN, OSA, multiple DVTs on warfarin, presenting w/ 3 day history of malaise, cough, diarrhea, myalgias, starting 11/9. COVID+. Vaccinated x2 and on room air at current time. Patient was in his usual state of health until about 3 days ago (11/9) when he felt significant diffuse weakness and malaise. He also noted significant nausea, diarrhea (3-4x/day, non-bloody, no melena), and vomiting ( like water no blood or coffee grounds). He reports cough of yellow sputum, fevers up to 101F, and some dyspnea. Denies chest pain. Denies loss of taste or smell. Notably, he stopped taking all of his pills over the last few days, including his insulin and his warfarin. He lives with his wife who is also vaccinated and symptomatic, she is getting tested for COVID. He presented to ED for mAB infusion, which he received. However due to significant weakness and dehydration, hyperglycemia, decision made to admit to medicine for further monitoring and supportive care.
10/18/06 had ProQuad thigh, 10/20/06 saw MD red, warm, non itching rash site of 50 cent piece at injection site.
Patient complaining of swollen and painful left arm after COVID vaccine administered on 3/16. Had pain initially, which subsided then returned 3 days ago. Has a swollen area on her arm that is warm and tender Taking Tylenol which isn't really helping.  46yo woman with vaccine site reaction after first COVID vaccine. Exam is reassuring that she likely doesn't have a DVT or cellulitis. (No significant erythema, no fevers or chills, no arm .). Arm is tender and warm. Recommend watchful waiting, may apply ice, take ibuprofen, use a menthol cream. RTC with any worsening of symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX. On 1st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating. On an unknown date, the outcome of the fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating were unknown. It was unknown if the reporter considered the fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The registered pharmacist reported this case. The patient received SHINGRIX on the left arm. About 6 hours after receiving SHINGRIX, the patient experienced non-descriptive flu like symptoms, fatigue, loss of appetite, left arm soreness, chills, and sweating.