chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several days after second shot, first site location began to swell. It was a slow but steady progression that didn?t stop until I contacted my doctor to get a steroid shot to help stop the reaction. I took photographs of the growth of the redness and swelling around the site.
Had Moderna COVID vaccine approximately 1pm on 2/17. Developed headache and right visual field loss approximately 8pm on 2/18. Presented to our hospital at 5pm on 2/19 with progression of aforementioned symptoms and found to have left intraparenchymal hemorrhage with midline shift. Her symptoms are currently stable. Our neurosurgical team is not planning any surgical intervention. MRI of her brain demonstrates potential amyloid deposits, which are likely causative.
Dehydration; muscle weakness; This is a spontaneous report from a contactable consumer (family member) via Medical Information Team. An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in arm at a military facility on 20Mar2021 (at the age of 87-year-old) (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient did not receive other vaccines prior to the vaccination within four weeks. The patient had no relevant medical history. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201) administered in unspecified arm on 19Feb2021 (at the age of 87-year-old) for COVID-19 immunisation. The consumer reported that the patient experienced dehydration and muscle weakness on an unspecified date and was hospitalized for both events from 30Apr2021 to 03May2021. The patient had a negative COVID test about a week ago (30Apr2021), he recently entered the hospital for dehydration and had a whole series of tests, all of which were negative. The patient was in this facility now, mainly he was just convalescing because of the dehydration and muscle weakness. The consumer stated that patient was transferred to this other VA facility, the VA nursing home and that's where he received the third dose today. The events required emergency room visit and did not require physician office visit. It was also reported that patient got a vaccine overdose of Pfizer's COVID vaccine and wanted to know what to do. It was reported that first injection was on 19Feb2021, second injection was on 20Mar2021, and third injection was given today (07May2021). The consumer was informed that the administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine was not approved. The consumer then mentioned that he was able to find that the booster study will be starting in May on news. The consumer was told that no specific information was found from approved sources regarding the specific date the study on the booster dose has begun. Clarified that booster dose was in regard to a 3rd dose 6 to 12 months after receiving both doses and does not apply to his family member's case regarding 3 doses within the span of 1-2 months. Additionally, the consumer reported that the patient gets his primary care at a medical center. The consumer stated that it was another healthcare professional who administered it. The consumer stated that it was probably in the morning sometime, before noon. The consumer stated that it was given he would presume in one of his arms but he doesn't know which one. The outcome of the events dehydration and muscle weakness was recovering.  Follow-up attempts are needed. Further information is expected.
swelling of the eyelids; itching of the eyes; body aches; runny nose; generalized fatigue and tiredness; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that:  A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 29Dec2020 for Covid-19 immunisation.  The patient medical history included high rheumatoid factors diagnosed in 2020 taking Plaquenil for over a year with occasional steroid use for bad flare ups. The concomitant medications included Plaquenil for over a year for high rheumatoid factors increased, steroids occasionally for bad flare ups.  On 29Dec2020 the patient experienced swelling of the eyelids, itching of the eyes, body aches, runny nose, generalized fatigue and tiredness that lasted about 2 weeks. She was feeling better, body aches, runny nose, and fatigue were resolved on 09Jan2021, but her eyes are still a little but itchy with her eyelids not as swollen anymore. The outcome of swelling of the eyelids, itching of the eyes was unknown, of body aches, runny nose, generalized fatigue and tiredness was recovered. She was asking if it would still be okay for her to take the 2nd dose after her experienced side effects. She was due for the 2nd dose on 19Jan2021  Information about Batch/Lot number has been requested.
Friend's daughter was feeling fine one day and the next day she was very ill.  They took her to ER and liver and kidneys were failing.; Friend's daughter was feeling fine one day and the next day she was very ill.  They took her to ER and liver and kidneys were failing.; This is a spontaneous report from a contactable consumer. A 16-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in Jun2021 as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that, the patient was not pregnant at time of vaccination. Stated that, on an unspecified date in Jul2021, friend's daughter was feeling fine one day and the next day she was very ill. They took her to the emergency room, her liver and kidneys were failing. Stated that, she was stabilized and was back to normal in a few days. Stated that, friend told the reporter that, she had received her COVID-19 shot a week or so before this incident, so the reporter wanted to report it. The patient was hospitalized for the duration of 5 days. The AEs resulted in emergency room/department or urgent care, hospitalization, Life-threatening illness (immediate risk of death from the event). Treatment medication included unknown steroids. The device timestamp was on 21Jul2021. The outcome of the events was recovered on an unspecified date in 2021.
Red spots on trunk 1 weeks post shots-happened last set of shots as well but had cold at time then cleared up in two days previously.
Several 'pox-like' lesions formed which have not completely healed at this time.
This spontaneous report as received from a registered nurse refers to an approximately 6 week old patient of unknown gender. On 12-MAY-2014 the patient was vaccinated with RECOMBIVAX HB injection, dose 2, dose: 0.5 ml (millitres), once, (Lot #: J009051; expiry: 26-MAR-2016) intramuscular. No concomitant medications were reported. On 12-MAY-2014, the patient had a medication error who received dose that was improperly stored. Nurse states patient receive dose of RECOMBIVAX HB (second dose in series) that was improperly stored at 0 C (celsius) for less than 72 hours. No adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of received dose that was improperly stored was unknown. Additional information has been requested.
"Rash since May - child" mother believes started after second GARDASIL. Hypopigmented circular areas noted to bilateral arms and legs - child saw dr on 10-16-12.
Inflammation where filler was injected; Generalized facial edema; This spontaneous case was reported by a physician and describes the occurrence of INFLAMMATION (Inflammation where filler was injected) and FACE OEDEMA (Generalized facial edema) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation where filler was injected) and FACE OEDEMA (Generalized facial edema). At the time of the report, INFLAMMATION (Inflammation where filler was injected) and FACE OEDEMA (Generalized facial edema) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.  Late September 2021, the patient received Galderma's co-suspect filler through injection (unknown dosage, unknown anatomical location, unknown batch/lot number). Two months after receiving the co-suspect, patient experienced the events.
Received the flu vaccine around 12 p.m., on Friday, Oct. 28, 2005.  Around 7:30 p.m., I started having trouble breathing.  Starting wheezing, felt weak all over, had heart palpitations.  This lasted until 2:15 a.m., Saturday morning, Oct. 26, 2005.  I never had an allergic reaction like this before when I took the flu shot.  I was almost at the point where I wanted to call 911, but when it subsided, I was able to sleep.  Woke up around 12:10 p.m. on Saturday afternoon, and have been feeling all right since the episode. I will call my doctor on Monday to report the incident of the reaction of the flu shot.  One more thing... when I was given the flu shot in my left upper arm, it hurt terribly. My arm was immediately sore. (it still is somewhat sore) This is an experience that never happened before either.  So can you explain why this happened to me with this flu vaccine?  I'm not sure what to enter in #13.  All I can tell you that it was the influenza vaccine shot in the arm.
sore injection spot; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration into the left arm on 17Feb2021 11:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration into the left arm on 27Jan2021 11:00 AM as a single dose for COVID-19 immunisation. The patient experienced sore injection spot on 18Feb2021. The patient did not receive treatment for the event reported. Outcome of event recovered on an unspecified date.  Information on lot/batch number has been requested.
2 small bumps on face Monday night after vaccination; 5 bumps on stomach on 5/25/10. States bumps itch. No other problems.
Joint pain; muscle pain; fatigue; nausea; fever; chills; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 12Feb2021 (Batch/Lot Number: EL 3247) at 33-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included hypothyroidism, and seasonal allergies; both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); buspirone hydrochloride (BUSPAR); fluticasone propionate (FLONASE); cetirizine hydrochloride (ZYRTEC), and an unspecified birth control medication; all taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EL 3247, administration time: 14:00, location: left arm, dose number:1) for COVID-19 immunization on 22Jan2021. On 12Feb2021 at 23:00, the patient experienced joint pain (non-serious), muscle pain (non-serious), fatigue (non-serious), nausea (non-serious), fever (non-serious), chills (non-serious).  The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Left shoulder , soreness/ pain (site of injection), fatigue, nausea, emesis.
Client had some lumps in his throat. They were bothering him on 2/4/21. He did take some Tylenol and gargled with salt water but lumps were still there. He also complained of some chilling but stated that went away. His daughter took him to his primary care doctor on 2/4/21. He stated the doctor told him to continue taking the Tylenol, gargling, and encouraged him to keep walking. He is supposed to contact his PCP if needed.
Very ill flu like symptoms with out the runny nose or cough.  Hematuria 2 days later
Headache, onsite reaction (arm swelling and redness) fever (38.87 C). Chills (continous, lasting 30 minutes). Treatment: 1000 mg acetaminophen bid, Ibuprofen 800 bid.
sore arm after pfizer covid 19 vaccine and woke up twice during the night post vaccine; sore arm after pfizer covid 19 vaccine and woke up twice during the night post vaccine; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A female patient of an unspecified age (63 was reported and unspecified units) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after pfizer covid 19 vaccine and woke up twice during the night post vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
soreness at injection site (3 days), insomnia (1 night), headache (next day), body aches (next day)
Redness, swelling at injection site, pain going up arm into shoulder and neck to behind ear. Some dizziness reported. Suggest to staff member to see her physician as soon as possible.
lt thigh red, hard swollen & tender; rx w/warm soaks & amoxil;
Vomiting during observation, possibly stemming from a pre-existing condition. It started with fever at the time of vaccination and body pain, was given acetaminophen 500mg. Fever and body pain improved within 5 hours, no further medical intervention was required.
Severe joint pain in left hand and wrist - two months later the wrist is better, but the left index finger joint pain has improved but will not subside. I am a professional musician, so this inhibits my ability to work. Mild joint pain in the knees and big toe joints continue as well.  After daily icing and ibprofen, my doctor has prescribed an oral steroid to see if it will help.
A large lump has developed on the side of the neck near the esophogus.  No treatment has been sought yet.  Just waiting to see if it gets worse necessitating a trip to the ER. The lump developed around 6 pm on January 27, 2022.
My daughter received the 3rd covid vaccine about January 10, 2022. She died suddenly on 01/12/2022, The coroner's report said she died of heart disease.  I had my primary care physician go over the  report with me and he told me it was caused by blood clots and that it was hard to tell the exact cause without a toxicology report. I called the coroner and requested the toxicology report and he refused.
Patient tested positive for COVID on 10/26/2021 Hospitalized 10/26/2021 for generalized weakness, fatigue, diarrhea, frequent falls over 2 days.  Denied shortness of breath, cough, sore throat, no abdominal pain
Patient was approaching seating area and fainted before reaching chair. Was unconscious for less than a minute. Suffered a bloody nose and chipped tooth. Was brought to his feet where he regained consciousness and was immediately seated. Checked to see patient's level of consciousness and EMS was notified. After denying EMS, patient sat in waiting area an additional 30 minutes. Total time was 40 minutes.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised which was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via agency via call center (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310762 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route and administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  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 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.
sz w/fever on 1FEB94 @ 1740; fever lasted 48-72 hrs;
diarrhea; abdominal cramping; Very bad sore arm ,bodyache which lasted for 36 hrs; chills which lasted for 36 hrs; Full body rash,rash spots in head / rash on scalp; scalp was itchy; puffy eyes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp was itchy), PERIORBITAL SWELLING (puffy eyes), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping) and RASH (Full body rash,rash spots in head / rash on scalp) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hives and body rash). Concomitant products included BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]).   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (scalp was itchy) and PERIORBITAL SWELLING (puffy eyes). On 26-Apr-2021, the patient experienced RASH (Full body rash,rash spots in head / rash on scalp). On an unknown date, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), MYALGIA (Very bad sore arm ,bodyache which lasted for 36 hrs) and CHILLS (chills which lasted for 36 hrs). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 26-Apr-2021 to 28-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) from 26-Apr-2021 to 28-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form. At the time of the report, PRURITUS (scalp was itchy), PERIORBITAL SWELLING (puffy eyes), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), RASH (Full body rash,rash spots in head / rash on scalp), MYALGIA (Very bad sore arm ,bodyache which lasted for 36 hrs) and CHILLS (chills which lasted for 36 hrs) outcome was unknown.            This case was linked to MOD-2021-103899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up ADR form appended on 3-JUN-2021:Patient race and ethnicity ,Other relevant history, concomitant medications New events were added
Information has been received from a physician concerning a female patient with a urinary tract infection who on 29-MAY-2007 was vaccinated IM with Gardasil. Concomitant therapy included Menactra. That same day, the patient experienced pain and swelling at the injection site. The patient sought unspecified medical attention. Additional information has been requested.
Pt received DTaP, HIB, Hep B and Prevnar. Before mom left room with infant he had a blanching, blotchy macular rash on face. Pt paths well. No other symptoms. Rash resolved within half hour.
Pfizer vaccine for individuals 12+ years old given to child under this age. No side effects noted.
Information has been received from a pediatrician concerning a 9 week old patient who was vaccinated with the first dose of ROTATEQ.  The patient experienced hematochezia seven days post vaccination with the first dose of ROTATEQ.  "As far as the patient recovering, being hospitalized the Doctor also considered that it could be a milk allergy and had the mother switch the formula so no hospitalizations were reported and no repeat visit to the Doctor's office."  Upon internal review, hematochezia was considered to be an other important medical event.  Additional information has been requested.
Aphthous ulcers vaginal and mouth - appeared 2 days after vaccination. All infectious work-up, including HIV, HSV, chlamydia, gonorrhea, syphilis, has been negative during first hospitalization, which was 6 days from 12/7-12/12/21 .  She had an outpatient follow-up on 12/17 with outpatient provider and noted to be only doing ice chips and sips of water. Patient was hospitalized again within 3-week margin (12/19-12/22) due to inability to eat and drink and was dehydrated. Autoimmune work-up progressed during 2nd hospitalization. She responded to prednisone 15 mg PO daily and triamcinolone cream applied to oral and vaginal lesions. She did require IV fluids and electrolyte replacement during hospitalization. She was seen by rheumatology with low suspicion for Bechet disease, pathergy test was negative. Recovery in process at time of this report.
Teaching in kindergarten class, sudden onset weakness "I had to sit down". Fever noted at that time.