chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat, difficulty breathing, flushed, abdominal cramping, mild stridor. Tx Oxygen, Albuterol Tx 05 + 3cc saline, Epinephrine SQ R thigh 0.2cc Solumedrol 40mg IM right thigh 25-30mg by EMS. Admitted ICU on 4/7/06 discharged 4/8/06. 06/08/06-received 6 page medical records to include pediatric intensivist note dates 04/07/06-No respiratory distress or urticarial rash noted. Past medical history significant for surgically corrected congenital heart disease (dextrocardia with multiple holes in the heart) as an infant. Current medications none. No known medication allergy, no history of reactive airway disease. O2 sat on admission 97% on RA. Atrophic dermatitis noted but no other rash noted TMs clear. No facial or lip edema. Pharynx clear. Sinus rhythm with grade 2/6 systolic murmur. Normal neuro exam. Assessment: immunization reaction-doubt anaphylaxis. Admit for observation. RX with oral Benadryl and Decadron.  Impression on CXR: dextrocardia, close clinical and historic correlation is recommended to evaluate for congenital heart disease.
Patient experienced  other reduced mobility . Onsite EMS was called vitals BP 118/80 98% O2 HR 80.  Patient refused evaluation or care, released against medical advise.
Very sore arm and pain developing several days after shot.  Can barely move arm without feeling discomfort or pain
Breakthrough case admission after 4 vaccines 3/13/21 Moderna Lot# 010A21A 4/10/21 Moderna Lot# 025B21A 12/1/21 Moderna Lot#067F21A 4/6/22 Moderna Lot#042J21A
pt c/o sore arm on day of inj;the next morning pt had hives on trunk of body;by the afternoon hives were on entire body;DPH given;hives gone in 2 days;PMD advised member gone in 2 days;
Have been experiencing extreme fatigue and sleepiness since the 2nd dose.; Have been experiencing extreme fatigue and sleepiness since the 2nd dose.; I experienced a much more painful, longer and heavier menstrual cycle lasting about 2 weeks; Uncharacteristic breast tenderness; I experienced a much more painful, longer and heavier menstrual cycle lasting about 2 weeks; I experienced a much more painful, longer and heavier menstrual cycle lasting about 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 12:00 (Lot number: ER2613) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "Dust" (unspecified if ongoing); "menopause" (unspecified if ongoing), notes: I had already begun menopause as I had not had a menstrual cycle for about 5 months. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=Pfizer,, Lot number:EN6198,, Lot unknown: False,, Administration time:12:00 PM,, Dose number: 1,, Vaccine location: Left arm), administration date: 15Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 07Apr2021, outcome "not recovered" and all described as "Have been experiencing extreme fatigue and sleepiness since the 2nd dose."; MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 07Apr2021, outcome "not recovered" and all described as "I experienced a much more painful, longer and heavier menstrual cycle lasting about 2 weeks"; BREAST TENDERNESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Uncharacteristic breast tenderness". Therapeutic measures were not taken as a result of fatigue, somnolence, menstrual disorder, breast tenderness, dysmenorrhoea, heavy menstrual bleeding.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was 51 and thought she had already begun menopause as she had not had a menstrual cycle for about 5 months. The patient was not diagnosed COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Rash on dorsal surface of right hand Tx: lotion, Aleve Rash not yet resolved.
Post vax, the pt felt minor back pain resembling pressure in the small of the back and transient tingling in the leg. One month later, the symptoms have not abated. Information from follow-up report states: Pressure in the small of back: a female patient received 5 doses of RabAvert for post-exposure prophylaxis. Her first dose was on 16 Aug 1999 and her last dose was on 15 Sep 1999. After her last dose, she felt minor back pain resembling "pressure in the small of the back" and transient tingling in the leg. One month later, the symptoms has not abated. Follow-up information is pending. Follow-up report was received on 09 Nov 1999. The patient received RabAvert on 16 Aug 1999, 21 Aug 1999, 25 Aug 1999, 01 Sep 1999, and 15 Sep 1999. The patient complained of a very minor lower back pain after all RabAvert injections except on her last dose of 15 Sep 1999, and she stated that her back problems were dismissed "with a laugh" and caused by "too tight clothes." She was treated with Motrin, which did not help. Approximately 5 weeks after 15 Sep 1999, she experienced some tingling and numbness in her hands, arms, legs, and feet. She consulted a physician about her numbness, and he dismissed it as hysteria. Her back problems eased somewhat and the tingling and numbness seemed to be lessening.
PATIENT VACINATED ON 11MAR2021. PATIENT WENT TO THE ER ON 01APR2021.  PATIENT WENT TO THE ER DUE TO INABILITY TO SPEAK. CONCERNED FOR TIA VS SEIZURE VS MIGRAINE WITH AURA
Pt broke out with raised rash on both thighs, worse on R mostly resolved by 11/21. No fever.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (lot # not reported) subcutaneously instead of ZOSTAVAX on 14-AUG-2012. No adverse effect reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Headache.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient reported experiencing headache before the vaccine was administered, and the headache continued after she received the vaccine.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: The patient denied follow-up, stated she did not experience any AE
I went to work and bout an hour after being there I felt horrible. I felt as if I was gone vomit, I had dizziness, body was achy, and I had chills. In between the 2 shots I received a positive COVID test.
Tiredness; Feeling so weak; Does not have much of an appetite to eat anything; This is a spontaneous report from a contactable consumer (patient). A 87-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176) 0.3ml, via an unspecified route of administration, administered in Arm Right on 20Jan2021 (at the age of 87-year-old) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included apixaban (ELIQUIS) taken for anticoagulant therapy from an unspecified start date and ongoing; metoprolol succinate (TOPROL XL) taken for hypertension from an unspecified start date and ongoing; amlodipine besylate taken for hypertension from an unspecified start date and ongoing; olmesartan medoxomil taken for hypertension from an unspecified start date and ongoing. Patient had no problems before with her medications. On an unknown date in 2021, the patient experienced feeling so weak, does not have much of an appetite to eat anything. She noticed on Monday it was getting worse, then she had another attack of it today. It suddenly comes on and all of a sudden she is so weak. Its like she can not balance herself out. On 01Feb2021, patient experienced tiredness. The patient underwent lab tests and procedures which included magnetic resonance imaging: cyst on her right kidney on Mar2020. MRI was done prior to the vaccine, she had been having issues with pain on her right side so they did an MRI. They told her she has a cyst on her right kidney. She has not taken any kind of medications for that. They want to do another MRI before doing anything. She asks, what should she do about the second dose. Patient was supposed to get the next dose on 09Feb2021. She does not really want to take it if it will do her like this. The outcome of the events so weak, does not have much of an appetite to eat anything were not recovered and the outcome of the event tiredness was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006476: US-009507513-1806USA006477: US-009507513-1806USA006479.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. It was reported that no adverse reactions were reported by any patients.  No treatment medications were reported.
a little more than 24hr after getting the vaccine pt had two areas of skin rash 1. hives on right hip above ASIC area about 6cm2 2. 3 maculopapular lesions left side at left axillary line, each papule <1mm pt describes as intensely pruritic
Right upper arm with 6 x 7.5 cm area of erythematous, firm/indurated tissue, cellulitis, treated with cephalexin x10 days.
Ran 103 fever for nearly seven days along with flu like symptoms. Have had a fever of at least 100 nearly every day since. Have severe fatigue and have not left the house except for about 5 occasions in a month.  I am missing work or having to work remotely. Some sore throats, swollen lymph nodes. Bloodwork showed an uptick in Epstein Barr virus and a high iron saturation level. Haven't been able to eat normally, having lots of acid reflux, abdominal pains, loose stools. Feels similar to when I had a Small Intestine Bacterial Overgrowth. I am immunocompromised anyway - I have Selective Igm Deficiency. I have had increasing number of infections since I began taking Moderna vaccines. With each vaccine/booster, symptoms are worse.  This fourth shot has seemed to markedly diminish my immune system functioning.
Sister-in-law and nephew have all gotten covid 19 after being fully vaccinated.; Her Sister-in-law and nephew have all gotten covid 19 after being fully vaccinated; This is a spontaneous report from a Pfizer sponsored program via Medical Information team. A contactable consumer reported that a female patient (reporter's sister-in law) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Not Reported), Dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter's sister in law gotten covid 19 after being fully vaccinated on an unspecified date. She had problems and just got out of the hospital. The outcome of event was unknown.  No follow-up attempts are completed. No further information is expected.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials. 16 patients received 0.25 ml booster dose. 3 patients received 0.5 ml full dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-355973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-355973:cluster master file MOD-2021-355973
Rash at injection site day after injection Next day rashes and hives  Swollen eyes and lips
Psychological changes uncommon for PT. Bouts of depression and rapid cycle mood changes despite any attempts of conscious rationalization of the odd emotions. Brain fog similar to that reported by covid patients. Emotional disassociation. Job burnout
Fever, body pain, chills, dizziness, diarrhea, nausea.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
She tested positive for COVID-19 7/21/22. She had a fever, body aches, and just wasn't feeling well, she was crying a lot. I gave her TYLENOL for a couple days. I called the doctor and let them know that she tested positive and they recommended giving PEDIALYTE and fish. Just wanted me to make sure she was eating healthy and staying hydrated. On Saturday 7/23/22 She was feeling good again and I didn't have to give anymore TYLENOL.
He under went Derm eval for the extent of involvement of his arms, trunk, legs and  was diagnosed with "hyperkeratosis with parakeratosis", due to a previously  unknown eczema history
raised welt at injection site; injection site tender; red raised welt at injection site; headache; nausea; run down; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache) and NAUSEA (nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics (amoxicillin), Drug allergy (vioxx), Adhesive tape allergy (adhesive) and Drug allergy (celexa).    On 26-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (run down). At the time of the report, INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (run down) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-036553 (Patient Link).
c/o gen aches & pains beginning 15JUL95; c/o flu-like sx; mild sx cont
RECEIVED BOOSTER VACCINE ON 09/30/2021, ON 10/02/2021  DEVELOPED 102 TEMP,CHILLS, GENERALIZED ACHES AND COUGH, 10/03 103 TEMP SAME SYMPTOMS,REPORTED TO DR AND WAS TOLD IT WAS PROBABLY A REACTION TO VACCINE,10 /04 TEMP 103.8, 10/05 TEMP 104 LOSS OF TASTE AND SMELL,SENT BY DOCTOR FOR COVID TEST, 10/06 COVID TEST POSITIVE, 10/07 RECEIVED REGEN-COV2 TYPES MONOCLONAL ANTIBODIES AT ABINGTON HOSPITAL. MOST SYMPTOMS RESOLVED OVER NEXT WEEK EXCEPT FOR LOSS OF SMELL AND
Blood clots a few weeks after 2nd dose. Currently being treated with Xarelto. No other changes in patient medical or prescription history. Covid vaccine was the only thing that was new. Patient had no prior history of blood clots.
Child was squirmy and restless while sleeping. At 2:00AM he woke up saying he was going to throw up. He went back to sleep for 30 minutes then woke up and began vomiting. Child went back to sleep at 3:30AM and slept for the rest of the morning and so far has been fine.
She has been experiencing a sore throat; lost of her voice; a lot of coughing; Throat very irritated; Sometimes feels like she needs a little bit of air; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Apr2021 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced a sore throat, lost of her voice, a lot of coughing, throat very irritated, sometimes felt like she needs a little bit of air. She does not have a fever, no headache, no chills or any other symptoms. She doesn't have flu symptoms, and she doesn't know if it was a coincidence and if it was allergies. She has taken some over the counter medication. She doesn't know what to do. It has been a whole year without anything. She has been in her house. She doesn't know if these were side effects or what happened. She needs to know if this is normal or if this is just a regular cough. She was fine when she went to get the vaccine. She called her doctor and they were on break. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Acute onset of H/A, dizziness and numbness of hands one day after GARDASIL #2 and HEP A#1. Normal neuro exam and treated as migraine with Sumatriptan.
Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-SEP-2013 at a pharmacy 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 24-FEB-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed FAMVIR for management of her painful symptoms. 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, pain and suffering and other damages. Additional information has been requested.