chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened) 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 EXPIRED PRODUCT ADMINISTERED (A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
i received my booster shot on the 21st and within 6 days i was hospitalized and diagnosed with myasthenia gravis. i was in the hospital for three days and placed on pyridostigmine which helped but had severe side effects that interfere with my abdominal seizures. however my bloodwork and tests results didn't confirm the diagnosis i had every symptom. i have seen three neurologist that cannot explain what happened to me. two of them said they believe it was booster related, although none of them reported the adverse effects. i suspect that's happening to patient's everywhere. i couldn't speak, my right eye was drooping, i had right side weakness, extreme fatique, choking and swallowing difficulty, shortness of breath, and so much more. my nocturnal Oximetry test showed my oxygen dropping to 70 while i slept sitting up. i had to close my private counseling practice of 40 years and apply for disability. i got rid of many belongings and prepared for my death. .prior to the booster i ran my thriving private practice, a non profit organization and managed 13 rental units. i cleaned my own large home, worked out, and led a healthy active lifestyle regardless of my complicated medical history. i just purchased an 86 pound pit bull in may to work out with and now i cannot walk him. i still have many difficulties but show some improvement, with bedrest. i would like to speak to someone about this as i am seeing more reports similar to mine in news journals including one from specialty clinic that sounded very similar to my situation. i have been a social worker since i graduated high school. my undergraduate history was in community activism. i will not accept this being pushed under the rug. i will go public quickly if i do not feel these concerns are taken seriously. i am not a trump supported, i am obviously not an antivaxer, but the public needs to know the risks are greater than we have been told!
On 7/23/01, telephone call from client, reported a rash and was instructed to take Benadryl. On 7/24/01, telephone call to client, reports noticed scratching on Friday and "pins and needles on hand" denies fever. Rosy patches reported on torso and legs. Took Benadryl/Ultra Allergy and reports it made him very tired. Took Ultra Tab on 7/23/01. Today, reports that the rash has improved and he was encouraged to drink fluids and to avoid scratching. Suggested Benadryl ointment to apply for itching.
COVID 19 (Drug ineffective); COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 as dose 5 (booster), single (Lot number: GJ3268) at the age of 67 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Drug allergy"; Septra, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "unknown", described as "COVID 19 (Drug ineffective)"; COVID-19 (medically significant) with onset Sep2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 17Sep2023 (Lot number: 0069-0345-30) to 22Sep2023.   No follow-up attempts are possible. No further information is expected.
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine (2nd dose in series) on 02/10/21. Hospitalized from  08/02/21 -08/06/21. Below is copied from discharge summary:   Case of 67 yo male w progressive SOB and cough, admitted due to hypoxemic resp failure secondary to COVID 19 PNA.
Shingles; sore arm/arm still hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-AUG-2023, the patient received the 1st dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and pain in arm (Verbatim: sore arm/arm still hurt). The outcome of the shingles was not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the shingles and pain in arm to be related to Shingrix.     It was unknown if the company considered the shingles and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-AUG-2023 The case was received from the patient via interactive digital media. The patient yesterday (06August2023) just received one of two shots. The reporter stated that after receiving the one shot of Shingrix vaccine, he had sore arm and his arm still hurts. He also had shingles. The insurance company was paying for it. The follow-up would not required per process
Vaccination time : 10:10 am  At 10:25 patient c/o headache and blurred vision , Vital signs at that moment : BP 75/43 P44, BS 87, Sat 98%. Patient was placed in observation room where EKG was performed and water and snacks were offered . At 10:31 am the vital signs were rechecked: BP 102/70 , P49 , Patient was encouraged to notify his primary physician  about the event ,. At 10:40 am patient was discharge home with no medical complaint VS :127/80 P48
Initial report received from a consumer (who was a physician) on 27 Sep 2010: This patient with an unknown medical history was vaccinated first time with MENVEO (batch number A10044) on 16 Sep 2010. After vaccination, the patient developed facial paresis (no side reported), ptosis, dizziness (recurrent), headache, and otalgia on 23 Sep 2010. No hospitalization took place. Outcome of the events was reported as condition unchanged.
A report has been received from a health professional concerning a 7 year old , male subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced patient tested positive for influenza which started on 27-OCT-2014. The outcome of the event of patient tested positive for influenza is unknown. The report was considered to be non-serious.
the patient was administered ActHIB with sterile water instead of ActHIB diluent with no adverse event; Initial information regarding this unsolicited valid non-serious case received from the other health professional (medical assistant) via Global Medical Information (GMI) (Reference number- 00369951) and transmitted to Sanofi on 24-Nov-2020.  This case involves a patient with unknown demographics who received a dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (batch number: UJ351AA, expiry date: 09-Aug-2021) with sterile water instead of ACT-HIB diluent (product preparation issue), via an unknown route in unknown administration site for prophylactic vaccination on an unknown date.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   It was a case of an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Patient was sore in body and had a headache that night and started coughing the next day.  Coughed so hard at times, could not catch breath.
became sick with the flu after getting a flu shot; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional.  This case involves patient (age and gender unspecified) who became sick with the flu (influenza), after patient received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient became sick with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.   At the time of reporting it was reported that, reporter's step father also became sick with the flu after getting a flu shot hence reporter had not from decades gotten nor will ever wanted to receive flu shot again as well as never wanted to get a corona virus disease (COVID) shot too.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was reported as unknown for influenza.   There will be no information available on the batch number for this case.
8 days post initial injection site became mildly swollen, hot to touch and intensely itchy. lasted for2.5 days then resolved.
Swelling of hands, arthritis-like symptoms in hands and wrists. Have been to clinic and to a arthritis specialist.
Low-grade fever, body ache, chills, headache, fatigue, pain at shot site. Took one Tylenol PM. Resolved about 36 hours after onset of symptoms.
No fever. On Saturday evening 01-26 after shot my left arm was slightly red and swollen. Still uncomfortable 01-27. Then at 3:30 AM Monday (01-28) I woke with really awful diarrhea and throwing up. Episodes would last 15-20 minutes or so, then repeat in about 1 1/2 to 2 hours. Could not take even water called Dr. about 3:30 pm 01-29 and he sent me to emergency room for fluids and nausea shot. Last in 2 days. Better 02-01.
Inject site rxn of redness, swelling and pain. Unable to lift arm. This is 1 of 2 patients from this facility to develop an inject site rxn
After 5 minutes the patient became weak, white, and sweaty with trouble walking.  He did not pass out. He agreed for us to call 911. He did drink some water and felt better. He thought he may have been dehydrated , anxious about the shot, and concerned when reading the shot info.  He has had flu shots in the past but  has not been  to a doctor in recent memory. The paramedics checked him and offered him a ride to the hospital . His vitals were fine so they released him to his girlfriend who was able to drive.
Diverticulitis; Sore arm; Fatigued/ very tired; sluggish; pain with getting up and walking; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8731), via an unspecified route of administration on 24Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727) on 01Apr2021 (at the age of 55-years-old) for COVID-19 immunisation. On 24Apr2021, the patient experienced sore arm that lasted for about 3 days; felt fatigued and sluggish for the first couple of days post vaccination which started to taper off by 27Apr2021. It was in and out now. On an unspecified date in 2021, after the second vaccination, the patient was fatigued and very tired, had pain with getting up and walking. On 08May2021, the patient ended up in the hospital and was diagnosed with diverticulitis from eating a lot of nuts (as of an unspecified date in 2021). She was hospitalized from 08May2021 to 10May2021. The clinical outcome of sore arm was resolved on Apr2021 (reported as 27Apr2021 or 28Apr2021), of diverticulitis and pain with getting up and walking was unknown, of "Fatigued/ very tired" and sluggish was not resolved.
I'm still in chronic muscle spasms as of 11Apr2021; severe neck pain; severe shoulder pain; severe pain in my trap muscles; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).   A 68-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration, administered in Right arm on an unknown date in Mar2021 (age at the vaccination 68-years-old) as dose 2, single for covid-19 immunization. Medical history was Arthritis from an unknown start and stop date. Concomitant medication included other medications the patient received within 2 weeks of vaccination was alprazolam taken for an unspecified indication, start and stop date were not reported. No Allergies to medications, food, or other products. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration, administered in Right arm on an unknown date in Mar2021 08:45 AM (age at the vaccination 68-years-old) as dose 1, single for covid-19 immunization and experienced with sever muscle inflammation under left breast, she thought she broke a rib and intense pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was reported that Two weeks after her second shot, on an unknown date in Mar2021 patient experienced severe neck, shoulder and sever pain in her trap muscles. She went to withheld on 24Mar2021 after her second Pfizer shot and explained all of this to her doctor. Adverse event result in doctor or other healthcare professional office/clinic visit. Seriousness was reported as No. Therapeutic measures taken as results of events caused which she was prescribed with Baclofen and that has not helped her, also received Tramol. She was still in chronic muscle spasms as of 11Apr2021. Outcome of the all the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected
pt slept for 4 hrs p/office visit, woke & cried approx 1 1/2 hrs, cried so hard appeared SOB; taken to ER: no resp distress, only irritable;
Information has been received from a nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies reported who on  22-MAY-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 657736/0389U) 0.5 mL IM. The patient, on 02-OCT-2007 was vaccinated with a second dose of GARDASIL vaccine (lot# 658558/1061U) 0.5 mL IM. On 25-JUN-2008, the patient became dizzy, pale and diaphoretic after a third dose of GARDASIL vaccine (lot# 660555/0279X) 0.5 mL IM. Subsequently, the patient recovered from dizzy, pale and diaphoretic. The patient sought medical attention in the office, the events occurred in the physician's office. Additional information has been requested. This is one of several reports from the same source.
(L) medial upper arm with 3.5 X 1.5" area of warmth, tenderness, redness, edema; no induration; able to move extrem. with difficulty; tx for cellulitis and started on BACTRIM.
Error: unauthorized age group (16-year-old, Moderna EUA approved only for persons 18 years and older at time of administration. Parent signed consent form with incorrect DOB indicating age greater than 16 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
1hr p/immun given c/o ha/, cold feeling, fever 101; vomited 2 cups emesis 2 hrs p/immun; mom gave non-ASA product x 1 dose also given DPH tsp q4hrs & children's nyquil x 2 doses @ night; Improved next day;
Initial information received on 20-Mar-2019 and additional information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a six years old patient (gender unknown) who received a 0.25ml dose of FLUZONE QUADRIVALENT lot number and expiration date not reported via unknown route in unknown administration site on 04-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. A 6 year old patient received a 0.25 mL dose of FLUZONE QUADRIVALENT instead of 0.50ml. It was unknown whether patient experienced any adverse event following vaccination. 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.
Pain at injection site. Chills, general achiness and continued muscular pain in left are around injection site occurred approximately 14 hours after vaccination. Followed by general tiredness for 24 hours.
having period pain and bleeding discharge; having period pain and bleeding discharge today; have a low fever (less than 100.3); This is a spontaneous report from a contactable consumer (the patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included: COVID-19 and known allergies: penicillin, sulfa drugs, and shellfish. The patient was not pregnant at the time of vaccination. Concomitant medications included: creatine, glutamine, and beta-alanine, all taken for an unspecified indication, start and stop date were not reported; and levonorgestrel (KYLEENA) for an unspecified indication from an unspecified date and ongoing. The patient previously took and had allergies to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated she had a KYLEENA IUD (intrauterine device) and had not had a menstrual cycle in 3 years. On 20Apr2021 08:00, the patient started having period pain and bleeding discharge, 4 days after the first dose. She continued to have a low fever (less than 100.3) for the fourth day. No treatment was received. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot number has been requested.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of pericarditis in a 59-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 27 October 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown deltoid). On 30 October 2011, 3 days after vaccination with FLULAVAL, the subject experienced symptoms ("became symptomatic") and on an unknown date in 2011, less than a year after vaccination with FLULAVAL, the subject was diagnosed with pericarditis. The subject was hospitalised for 4 days and the healthcare professional considered the events were clinically significant (or requiring intervention). The healthcare professional reported that the subject was told by the hospital physicians that these events were related to his receiving the flu vaccine. At the time of reporting the events were resolved.
Redness noted same night vaccines given. Seen in office 3 days later with 3 1/2" x 3" large raised circular reddened area over half of (R) deltoid; area sl. warm, non-tender. (L) arm with red papular round rash (also on abx for BADM). Tx: BENADRYL, 2.5% hydrocortisone cream BID x 7.
The day after getting my first dose of the vaccine my ears started to get really itchy. A week later I went to get my ears checked and I have a rash inside both ears.
Deep vein thrombosis in left gastrocnemius vein; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Apr2021 at 11:00 (at the age of 46 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included drug hypersensitivity (known allergies: Penicillin) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021 at 03:00, the patient experienced deep vein thrombosis in left gastrocnemius vein. Therapeutic measures taken as a result of the event deep vein thrombosis in left gastrocnemius vein included apixaban (ELIQUIS). The outcome of the event deep vein thrombosis in left gastrocnemius vein was recovering. Since the vaccination, the patient had not been tested for COVID-19.