chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: autoimmune disease (3 autoimmune diseases). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis.  It was reported that, the patient did not have any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). It was reported that, "3 autoimmune diseases here. I chose J and J for initial Vax without problems, which really surprised me. Then one booster and got so ill...like Covid all over again. I can't go yhrough that again". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case is a duplicate of 20221237180.
I had a band of pain that went from just under my breast to just above my belly button. It felt as if I had food poisoning, I only threw up once, the pain was not excruciating but it was painful enough to go to an urgent care. When I arrived, the pain had started to subside, they did not run any test. I was advised to see my primary care physician, as the symptoms presented to be gall stones. I will be making a follow up appointment with my primary care physician soon.
I21.4 ACUTE NON ST ELEVATION MI 5/9/2023 HEMATURIA I21.4 ACUTE NON ST ELEVATION MI 5/9/2023 SHORTNESS OF BREATH I21.4 ACUTE NON ST ELEVATION MI 5/9/2023 ASTHMA, UNSPECIFIED
Tinnitus, Flu like symptoms, then large local reaction(erythema, warmth, "knot") 3x4 " area seen by MD.
Participant stated she was warm and dizzy. BP 135, P 65. Denied difficulty breathing and vitals monitored.
Redness and induration 70mm X 75mm and 35cm circumference with itching and pain "1-2/10" achy. DX: Moderate Anthrax reaction. Tx: Medrol Dos-Pak, Prednisone 40mg, Atarax 10mg tid
PATIENT RECEIVED MODERNA BOOSTER 0.25ML 11-4-21 AT APPX 6:00PM. APPX 10 MINS LATER PT STATED THAT SHE FELT CONSTRICTION OF AIRWAY. PT SELF ADMINISTERED 1 PUFF OF ALBUTEROL MDI AT APPX 6:15PM  WHICH DIDNT RELIEVE SYMPOTOMS. PT WAS ABLE TO TALK AND SWALLOW. AT6:17PM I CALLED 911. AT 6;22PM PT STATED THAT CONTRICTION OF AIRWAY WAS LESS NOW.. PT STATED THAT SHE HAD SIMILAR REACTION AFTER SHE RECEIVED HER FIRST DOSE OF JOHNSON AND JOHNSON COVID VACCINE WHICH IS UNRELATED TO MODERNA COVID VACCINE. NO TREATMENT WAS ADMINISTERED AND NO HOSPITALIZATION WAS REQUIRED ACCORDING TO PATIENT. AFTER REACTION TO J&J VACCINE.SHE SAID THAT THE REACTION SHE HAD AFTER J&J REACTION CAME AND WENT AND BECAME LESS OVER TIME AND RESOLVED AFTER 2 HOURS APPROXIMATELY. DURING THIS EPISODE,  PT STATED THAT APART FROM BREATHING ISSUES SHE FELT FINE. PARAMEDICS ARRIVED AT 6:27PM. THEY ADMINISTERED DIPHENHYDRAMINE 50MG BY MOUTH. THE PARAMEDICS ASKED PATIENT IF SHE WANTED TO GO TO EMERGENCY ROOM AND PATIENT INITIALLY DECLINED. PARAMEDICS URGED HER O GO TO E.R. AND SHE FINALLY AGREED. PT WAS TAKEN TO EMERGENCY ROOM. AT 8:00PM WE RECEVEIVED A PRESCRIPTION FOR THE PATIENT FOR PREDNISONE 20MG 2QD FOR 3 DAYS AND A PRESCRIPTION FOR AN EPI-PEN. UNKNOWN WHAT TREATMENT WAS PROVIDED AT THE EMERGENCY ROOM
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Intentional drug overdose; suicidal ideation. Behavioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine.
Injection site redness about the size of a quarter. Still red 2 days after immunization.
Patient lost consciousness while in the waiting area about 5-10 minutes after vaccination.  Gave patient water and he laid down for several minutes and then started to feel better
The following morning I received the first dose of the vaccine, I woke up around 6 am to get some water. I then starting feeling severe cramping like menstrual cramps so I used a heating pad and fell back asleep. I woke up later the same day (4/24) and my period had started a few days earlier than expected. My last few cycles have started at the same time. My main concern were the severe cramps I had this morning as I have not had anything that serious before.
THE PATIENT CALLED 5:30PM ON 08/27/2021 TO INFORM PHARMACY THAT HER LEFT LEG WAS SWELLING , FELT TIGHT, TINGLY, AND HER BIG TOE FELT NUMB
Purpura and macules on legs; purpura and macules on legs; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PURPURA (Purpura and macules on legs), MACULE (purpura and macules on legs) and PAIN IN EXTREMITY (Pain in arm) 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 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PURPURA (Purpura and macules on legs) and MACULE (purpura and macules on legs). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PURPURA (Purpura and macules on legs) and MACULE (purpura and macules on legs) had not resolved and PAIN IN EXTREMITY (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided. It is unknown whether the patient received the second planned dose scheduled for 02MAY2021.
sore neck started 4 days later; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female (non-pregnant) patient received second dose of bnt162b2 ((Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 28Jan2021 15:45 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of bnt162b2 ((Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration, administered in Arm Left on 08Jan2021 15:15 as single dose for covid-19 immunization. COVID vaccine details: product-COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. Patient stated that two days after first vaccine she got a sore area right side of her neck probably lymph node area took acetaminophen and used a heating pad for relief-went away 2 days later. Following the 2nd vaccine-sore neck started 4 days later (01Feb2021) and lasted 6 days-this time back of neck-right side. The outcome of the event was recovered on 03Feb2021. No treatment had taken for AE.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 04-APR-2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
10 minutes after vaccines administered, patient developed red flare with wheel around area between where the MMRV and Influenza vaccine were administered on the left arm. The subcutaneous fluid collection seemed to be "outlined" by redness. In addition her right shoulder above the injection site for the Qudracel also became faintly red. There were no other lesions or skin findings, no respiratory symptoms, no facial swelling or vomiting. Patient did get fussy but was consolable to mom and responding appropriately to both mom and medical providers. We had the patient sit quietly for 15 minutes at which point the right shoulder redness resolved and the intensity of the redness on the left arm decreased a bit (total size of that area was approximately 4x4cm area).  We gave her benadryl and the mom also requested tylenol for pain which we gave. After this, she was discharged to home. Per mom, she looked "pale" at home and today was more tired than normal. She continues to have a small mark on her arm today (9/30/21) per mother of the child (not confirmed with photo)
Father reports bilateral extremity swelling from knees to groin as well as itching and rash.
Pt vaccinated with OPV had aseptic meningitis & CSF culture positive for poliovirus type 2 following ORIMUNE Administration.
Approximately 1 hour after receiving vax, I experienced severe vertigo.  My face felt puffy and hot, but did not appear puffy in a mirror.  I had to lay down for about 2 hours.  For the remainder of the day and following day, I had a spacey feeling about my head.  It took about 3 days for the spacey feeling to wear down.  Also, site of injection was rather sore for about 3 days.
Received second dose of Pfizer Covid vaccine on 3-15 and he passed away 3 days later on 3/18/21
WRONG DOSE PULLED FROM REFRIDGERATOR. IT WAS INTENTED AND PROCESSED TO BE THE MODERNA BIVALENT BOOSTER BUT THE ORIGIANL MODERNA DOSE WAS ERRONEOUSLY PREPPED AND ADMINISTERED
Patient had fever, as high as 101.5. Responded to Motrin. Also had fatigue and malaise. Lasted about 18 hours.
At 12pm immediately after giving the TDP he became pale, I had him lie down, he hen c/o nausea, vomited once, BP 94/52, P70, kept him lying down. He felt better after 10 minutes. BP 100/40, P70. Complete resolution. Allowed to leave at 1220 pm.
pt recv vax 30JUN95 & w/in 1min pt exp a sz which included eyes rolling back, arms postured to the bac & loss of consciousness for 10sec;reported noted that there was no family history of sz
Within 24 hours of taking the vaccine my mom was very sick. She could not get out of bed and didn't leave her room for two days. She was shaking hard as if she was cold and could barely talk.
full body chills and sweating (no fever at all); full body chills and sweating (no fever at all); severe joint pain started in legs (ankles/knees) and moved up to hands. elbows, shoulders and back; bruise/rash; bruise/rash; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non-pregnant female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP7533) via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:30 (at the age of 42 years) as dose 2 single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included type 1 diabetes mellitus, osteoarthritis, hereditary spherocytosis, blindness from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (INSULIN LISPRO); metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP7534) via an unspecified route of administration, administered in Arm Right on 16Mar2021 13:30 (at the age of 42 years) dose 1 single for COVID-19 immunisation. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination she was not diagnosed with COVID-19. Since the vaccination, she has not tested for COVID-19. She was not pregnant at the time of vaccination. 3-4 hours after receiving 2nd dose of vaccine the patient experienced full body chills and sweating, severe joint pain started in legs and moved up to hands. elbows, shoulders and back which lasted about 16 hours, bruise/rash, on 06Apr2021 15:30 which appeared about 1 week after 2nd shot and was still there till 26Apr2021. No treatment taken for the adverse events. The outcome of the events was recovered on an unspecified date in Apr2021 and for events Rash and Bruise was not recovered.  No follow-up attempts are needed. No further information is expected.
fever 100.5F; Headache; weakness; muscle aches; chills; A spontaneous report was received from consumer concerning herself of 50 years old age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever /pyrexia 100.5 F, headache, weakness/asthenia, muscle ache/myalgia, chills.  On 05 JAN 2021, patient was diagnosed with COVID-19 as reported. Concomitant medications were not reported.  On 22 JAN 2021, prior to onset of events, the patient received a first dose of two planned doses of mRNA-1273 (Lot number: 012L20A) via intramuscular route in left arm for prophylaxis of COVID-19 infection.  On 23 JAN 2021, the patient experienced very high fever to 100.5 F, headache, weakness, muscle ache, chills. Tylenol and Ibuprofen treatment medication was reported.  Action taken with mRNA-1273 in response to events were not provided.  The outcome of the events very high fever to 100.5 F, headache, weakness, muscle ache, chills were resolving at the time of this report.
On approximately 6am on 11/30/21, my son mentioned to me that he felt a chest pain, and rapid heart beat at around 5:45am that lasted 20 to 30 seconds.  My son also  mentioned that when he drank water, the chest pain, and rapid heart beat went away.
She reported that her left arm was numb, very limp and sore. She said her right arm was weak.  She had a fever of 102 degrees.
The patient fainted; A spontaneous report was received from a consumer concerning her friend, a female patient of unspecified age, who received Moderna (mRNA-1273) vaccine experienced fainting after getting the vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unspecified date, prior to the onset of the symptoms, the patient received her first dose of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient fainted after getting the vaccine.   Treatment information was not provided by the reporter.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event fainting after getting the vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Covid-19 Bivalent booster given instead of second Moderna dose for primary series.
Pt w/significant cardiac hx p/w from LTC facility w/increasing confusion, decreased appetite, weakness over 4-5 days. No reported hx of cough, SOB, N/V, fever, or URI symptoms. CXR findings were clear. Ther was concern for dehydration due to worsening renal function.  Pt tested positive for COVID-19 (4/24) despite Janssen vaccine (4/7) and pt stating they had COVID in December 2020. Pt admitted for additional management of COVID-19 infection w/acute metabolic encephalopathy, acute on chronic CHF, & AKI. Treated w/dexamethasone & remdesivir. Ultimately discharged 5 days later (4/28).
tries my arm hurting but I develop this lump in my wrist after this shot; tries my arm hurting but I develop this lump in my wrist after this shot; Its swollen my wrist is like got a lump in it; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tries my arm hurting but she develop this lump in my wrist after this shot and its swollen my wrist is like got a lump in it. The caller reported that she received her first dose of the vaccine 3 weeks ago. Caller reported that right after she received the vaccine, she developed a lump in her wrist. Caller reported that the lump hasn't gone down. Caller reported that one of the side effects is swelling in the lymph nodes and that she didn't know there were lymph nodes in the wrist. Caller reported that she is scheduled to get her second dose today and inquired if she is safe to get the second dose. Caller reported that her physician was unaware that she received the Covid-19 vaccine, that she obtained the vaccine per CDC recommendations. Caller reported that she is not on any medications and she hasn't been sick. Caller reported that since the pandemic began hasn't been able to reach her physician because he has been so busy. Caller reported that she is scheduled to get her next dose today which she was planned as the same arm as the last time. The outcome of the events were unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
10 days after Covid booster, started having a rash on different parts of the body, very itchy and when scratched the area welted up. Tried loratadine 3/per day and 10mg steroid treatment for 1 week with not much change. After 1 month from booster shot saw allergy doctor and she said the rash was from the covid booster and from having thyroid issues. She gave me a steroid shot in the buttocks and prescribed cetirizine 2 pill twice a day and hydroxyzine as needed.
Information has been received from a physician, through the Pregnancy Registry for GARDASIL, concerning a 15 year old female who on 17-MAR-2008 was inadvertently vaccinated intramuscularly with GARDASIL (Lot # 659437/1266U).  The patient has not experienced a menstrual cycle for 2 months and is experiencing nausea and vomiting.  The physician suspected she was pregnant and performed a pregnancy test.  On 18-MAR-2008, the serum pregnancy test results were positive.  The patient sought unspecified medical attention in the office.  No additional information is available.  Follow up information was received from the physician who reported that the patient had termination of pregnancy (TOP) few days after she was given GARDASIL, approximately 19-Mar-2008.  This was unwanted teenage pregnancy and the TOP was an already planned before she was given GARDASIL.  Upon internal review, elective termination was determined to be an other important medical event.  Additional information is not expected.
Swelling around eyes and bloodshot eyes, ZYRTEC and BENADRYL.
It was reported that a pt (9 of 13) received a Fluzone SV 2000-2001 vaccination on 10/17/2000. Reportedly sometime after the vaccination the pt developed a local reaction. No specifics were provided. Further information is requested.
Woke up 2/13/21 with lypmh node swelling on both sides of body and moved into right peck which was very painful and swollen; got a bump on the right side that was bluish and 3 in by 4 in by 2/14/21; elevated heart rate;felt fatigue and overall not well; 2/15/21 gout attack in right toe and finger along with other symptoms, took medication for gout; swelling decreased some in lymph nodes. 2/16/21 swelling going down more; patient has been taking ibuprofen which has helped with some relief.
This spontaneous report was received from a pharmacist refers to a multiple unspecified female patients of unknown age. There was no information about concurrent condition, medical history or concomitant medication. Since an unknown date, "multiple unspecified patients complained of the GARDASIL injection hurting". The reporter did not know if the patient's received GARDASIL or GARDASIL 9. The outcome of event was unknown. The reporter did not provide the relatedness of the event with the suspect therapies. Additional information has been requested.
patient received a dose of fluzone high dose qiv at their pharmacy and later was informed by patient's daughter that the patient had already received a flu vaccine this season with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves a 76 years old female patient where she received a dose of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose Quadrivalent] at their pharmacy and later was informed by patient's daughter that the patient had already received a flu vaccine this season with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included elasomeran (spikevax) and rsv vaccine (respiratory syncytial virus vaccine) for Prophylactic vaccination.  On 27-Oct-2023, the patient received 0.7 ml dose of suspect influenza quadrival a-b high dose hv vaccine (lot- UT8150AA and expiration date- 30-Jun-2024) via intramuscular route in the right arm (formulation, strength, lot/batch number and expiration date: not provided) for Immunisation (extra dose administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
03/02/11 -> Tdap and ZOSTAVAX administered. 03/07/11 -> Pt. called - reports awakened with redness & swelling left deltoid area where Tdap given. Area about 3 in. round, red, tender. Satellite area of redness also noted about 1" round. Treated by PCP with KEFLEX and Prednisone.