chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with GARDASIL (dose, lot#, route of administration and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Abdominal cramping; frequent bathroom trips, loose stool (bristol 6); chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) on 26Apr2021 10:00 at dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613) on 05Apr2021 10:00 at dose 1, single, both the doses via an unspecified route of administration, administered in arm right (at the age of 25-year-old) for covid-19 immunisation. Medical history included generalized anxiety disorder, depression, adhd, trichotillomania. Patient had no Known allergies. Concomitant medications included escitalopram (ESCITALOPRAM); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); cetirizine hydrochloride (ZYRTEC ALLERGY) all taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient did not have covid prior vaccination. Patient has not tested for covid post vaccination. Patient did not have other vaccine in four weeks. On 26Apr2021 10:15 the patient experienced Abdominal cramping, frequent bathroom trips, loose stool (bristol 6), chills. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional (a nurse who also knew the subject) and described the occurrence of Guillain-Barre syndrome in a 47-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). In 1997 the subject received a dose of Influenza vaccine (details unknown). In 1997, less than one year after vaccination with Influenza vaccine, the subject experienced Guillain-Barre syndrome. According to the nurse, another person at a facility she knows received influenza vaccine (unknown manufacturer) and developed "GB syndrome" [Guillain-Barre syndrome] in 1997. She explained that she is now retired. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The vaccination course with Influenza vaccine was discontinued. The healthcare professional considered the event was possibly related to vaccination with Influenza vaccine.
When I got the vaccine, within a few hours my arm was red at the injection site and sore. I woke up in the middle of the night with severe stomach pains and cramping a few days after the vaccination.  In the next few days I had a bad headache, nausea, and diarrhea.  Something felt different and wrong in my abdominal cavity.  I had shooting pains and my whole abdomen hurt and was sensitive and sore when I pressed it.  My husband put me on the phone on Friday night April 9 with    They took all of my information (name, phone #, address, email, vaccination information and location, symptoms).  They said they searched the database and could not find my matching reaction symptoms. They offered no guidance.  The next day I passed blood through my anus without stools.  I was still in pain and soreness for a few more days.  I called the  again on Tuesday to report the blood.  They claimed to not be able to find my original report in the system.  They seemed not to care which really upset me. I did not fill out a new report with them as I felt I would just be wasting my time.
Patient had syncopal episode 2 days after flu vaccine (also treated for URI symptom). Pt had residual UE & LE pain & weakness.
Not sure if this is relevant since I am including it, I had the J&J vaccine on 4/7/2021 so I got the Pfizer as a booster shot since I am eligible. I got my period the next day 10/24/2021, which is abnormal since I am on double the normal dose of Norethindrone (.70mg daily) to treat endometriosis - I do not get my period at all because of this medication. I am on day 3 of having my period and my flow has not gotten lighter - granted the flow is lighter than a normal period for me when I am not on medication but it is heavier then when I have had break through bleeding on the normal dose of norethindrone (.35mg daily)
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 3/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9699) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6207), in left arm and on 07May2021 as dose 2, single (Lot number: EW0162), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Former smoker" (unspecified if ongoing); "known allergies: Allergic to lithium" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Nov2021, outcome "unknown", described as "Moderna Dose Number: 3/vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative, notes: symptom-free and tested negative for 3 days after finishing paxlovid,; (Feb2023) positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid treatment.
// fatigue; // headache; mareos // dizziness;  // nausea; // vomiting;  // all day in bed; // pain in both arms and hands; // chills; A spontaneous report  was received on 15 Mar 2021, from a consumer concerning a 61-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, fatigue, headache, dizziness, nausea, vomiting, all day in bed, pain in both arms and hands, chills.  The patient's medical history was not provided. Concomitant medications reported were High blood pressure pills for drug use for unknown indication.  On 13 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002821A) Intramuscularly for prophylaxis of COVID-19 infection.  On 13 Mar 2021, the patient experienced the event(s) fatigue, headache, dizziness, nausea, vomiting, all day in bed, pain in both arms and hands, chills.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue, headache, dizziness, nausea, vomiting, all day in bed, pain in both arms and hands, chills was unknown.
March 20, 2021 - Sore arm, legs weak like "Jello", fatigue. Resolved March 21, 2021  March 28, 2021 - ringing in right ear begins and has not resolved March 31, 2021 - dizziness, pain in right ear, ringing continues April 1, 2021 - nauseous, resolved same day April 9, 2021 - 2nd COVID dose received April 12, 2021 - severe right ear pain, right ear stuffy, right ear very loud ringing, left ear seems to be ringing as well, but lighter than right April 14, 2021 - severe ear pain continues, tried ear wax removal drops and no wax came out. April 16,  2021 - saw ENT. Hearing exam and ear exam revealed no issues with hearing and no ear wax, no problems with ear drum. Suggested taking ibuprofen and may need steroid. Suggested it could be jaw related. Kept taking ibuprofen until ear pain resolved, approximately 5 days. As of August 30, 2021 - ear ringing in both ears continue to this day. The right ear is worse than the left.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 19-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
pt recvd vax & pt devel a hematoma, rash which spread down arm, & pruritus; pt was treated w/IM or oral steroids;
L deltoid pain immediately after vaccine & persisting for >2wk.  Required (per pt) urgent care visit.
Complex febrile seizure last about 40 minutes requiring midazolam and lorazepam for lysis. No seizures since. No signs of infectious vector.
FELT SICK; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FELT SICK) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ankylosing spondylitis.    Concurrent medical conditions included Psoriatic arthritis and Ankylosing spondylitis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (FELT SICK). At the time of the report, MALAISE (FELT SICK) had not resolved.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of FELT SICK was not provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Patient had complaints of headache, dizziness, slight itching and feeling warm. Pt was taken to ED for further assessment. Reaction occurred <15min after COVID vaccine administration
Nausea, muscle aches, headache, chills w/ uncontrollable shaking, rapid pounding heartbeat for 12 hours, then headache and muscle ache for another 24 hours. Have not had any symptoms in previous 20 years of flu shots.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heptatis B carrier" (unspecified if ongoing), notes: other medical history: heptatis B carrier. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 12Aug2023 to 16Aug2023 were taken as a result of drug ineffective, covid-19.
At home tests(Nasal Swab): Positive; At home tests(Nasal Swab): Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2021 at 10:30 as dose 1, single (Lot number: Er8733), in left arm and on 11Jun2021 at 10:30 as dose 2, single (Lot number: Ew0167) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "At home tests(Nasal Swab): Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: COVID-test type post vaccination: Nasal Swab.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine: List of other medications the patient received within 2 weeks of vaccination:Multi vitamin, birth control and Zrytec D. Patient had permanent hearing loss in my left ear, along with Titinus and vertigo and balance issues. 1 hour after receiving the booster this all started along with muscle weakness, numbness in face, hands received treatment with antibiotics, prednisone and meclizine ae resulted in: [Disability or permanent damage]. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient been was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Unusual dreams/nightmares ? at least 2 nights Swollen armpit lymph node ? 2 days Fatigue ? 2 days ?Brain fog? ? 2 days
After vaccination upon documenting, it was realized that vaccine was given 14 days from 1st dose, rather than 221 days.
Rash on the arm of injection; become noticeable nine days after the injection; slightly itchy; no treatment (keeping an eye on it)
really sick; temperature; Redness; nauseated; bad headache; 2nd dose administered on 1 March; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature), NAUSEA (nauseated) and HEADACHE (bad headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Tachycardia (with heart rate of 202 BPM that lasted roughly for 5-10 minutes (occurred after the administration f first dose).).Concomitant products included DEXLANSOPRAZOLE (DEXILANT), VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 1 March). On 02-Mar-2021, the patient experienced ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature), NAUSEA (nauseated) and HEADACHE (bad headache). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 1 March) had resolved. On 02-Mar-2021, ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature) and NAUSEA (nauseated) had resolved. At the time of the report, HEADACHE (bad headache) outcome was unknown. Treatment medications were not provided. Patient was scheduled to receive the booster vaccine on Sunday. This case was linked to MOD-2021-029272 (Patient Link).
15 minutes post vaccination patient demonstrated with hives on both arms bilaterally and some light hives on chest. Patient described the hives as "very itchy". Patient did not report any SOB, anxiety, or airway obstruction.  Patients vitals were: HR 84, RR 16, SP02 99, BS clear bilaterally, and BP 122/24. Diphenhydramine was administered 50mg IM . Hives decreased substantially and itching subsided, according to the patient.  Patient was monitored for 2 hours. Final vitals were: HR 76 , RR16, SP02 99, BS clear bilaterally, and BP 115/76. Patients hives were still visible on arms bilaterally, but were markedly improved, with decreased redness and decreased quantity. Hives on chest had subsided. Legs, torso, and back were assessed and no hives were noted. Patient was sent home with family friend for transport and overnight observation at the home. Instructed to call 911 ASAP for worsening S/S.
The weekend after receiving vaccinations, patient felt a stiffness in her neck that traveled down her spine to her lower back. Today October 22, 2020, the patient still experiencing the stiffness in her lower back along with a cluster of blisters.
Patient stated that vaccine was given too high and she experienced shoulder pain from the injection. She saw a physician 9/20/2021 for the pain and physician diagnosed her with bursitis.
Raised, red, blotchy rash around injection site from shoulder to elbow. Mild to moderate pain that resolves temporarily with ice. Has worsened since onset (currently 48h post-Injection).
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. presents to the ED complaining of shortness of breath and cough.  Patient started with URI symptoms, associated with cough dry, sore throat for last 3 weeks.  Patient states despite taking multiple medications has not got any better.  Per the patient just finished a course of antibiotics/Z pack. Apparently patient has lost 13 lb since this started. TREATMENT MEDICATIONS ARE Cefepime, Solu-Medrol, AND Protonix.
Initial pregnancy report received from a healthcare professional on 07 June 2013. A 35-year-old female patient had received intramuscular dose 1 of ADACEL (Lot number U4612AA) in left deltoid on 07 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 11 October 2012 and the expected date of delivery is 18 July 2013. At the time of the report, the patient had not experienced any adverse event. The patient's health during pregnancy, risk factors were not reported. Concomitant medications and past medical history was not reported. Treatment for infertility was not reported. List of documents held by the sender: None.
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone.   2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
No adverse event; expired Moderna Covid-19 vaccine (monovalent) was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered) and NO ADVERSE EVENT (No adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered).    No concomitant medication was reported.    No treatment information was reported.
The reason I scheduled the virtual appt was because I had a Dead Arm (numb arm) - Nickle size red rash at injection site.  I had symptoms like mild flu. I didn't lose my sense of smell but I was really stopped up. It lasted about 3 days. There was an element of fatigue for several days.