chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local reaction of: itching, erythema 3"x5", edema of 1 3/4" > than opposite arm, warm to the touch - onset = 24 hours after immunization given, low-grade fever x 24 hours after vaccine; no limited range of motion, no decreased activity level
administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021; 1st dose 21Apr2021; 2nd dose 23Jul2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)/ Moderna Covid-19 vaccine on 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 at 10:00am) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21Apr2021; 2nd dose 23Jul2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 047B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 4:11 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21Apr2021; 2nd dose 23Jul2021). On 16-Dec-2021 at 4:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)/ Moderna Covid-19 vaccine on 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 at 10:00am). On 23-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21Apr2021; 2nd dose 23Jul2021) had resolved. On 16-Dec-2021 at 4:11 PM, EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)/ Moderna Covid-19 vaccine on 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 at 10:00am) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported. How was the vial stored post puncture (ambient room temperature or refrigerator)? - refrigerator Total amount of time the vial was exposed to room temperature range (8° to 25°C/46° to 77°F) - 35-45 minutes
Hives; Itching; Rash; Soreness in arm after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm after first dose), URTICARIA (Hives), PRURITUS (Itching) and RASH (Rash) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Leg pain and Blood pressure high. Concomitant products included BENAZEPRIL for Blood pressure high, GLICLAZIDE and INSULIN for Diabetes, GABAPENTIN for Leg pain, ALLOPURINOL for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm after first dose). On 15-Apr-2021, the patient experienced URTICARIA (Hives), PRURITUS (Itching) and RASH (Rash). The patient was treated with HYDROXYZINE ongoing since an unknown date for Rash and Itching, at an unspecified dose and frequency. On 17-Apr-2021, PAIN IN EXTREMITY (Soreness in arm after first dose) had resolved. At the time of the report, URTICARIA (Hives), PRURITUS (Itching) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included taking steroid tablets for the rash and itching.   This case was linked to MOD-2021-226049 (Patient Link).
Mild fever; Arm was sore; Dull ache; Hurts at the injection site; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer(patient) reported. A 51-year-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: EN6201) via unknown route of administration in right arm on 12Feb2021 at 10:30AM (at the age of 51 years old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included she had been taking Tamoxifen but have stopped it and it had had no impact on the pain. Patient did not have the allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications the patient received within 2 weeks of vaccination. On 26Feb2021, the patient had mild fever after a day but when she resumed going to the gym realized the arm was sore and the arm was sore to this day. It was very unusual because she had major surgeries in the past and there was never this kind of soreness. When she sleep on the side there was a dull ache and when she change clothes, stretch to pull a t-shirt over her head, it was hurts at the injection site. The patient did not diagnose with COVID-19, Prior to vaccination and not tested for COVID-19, Since the vaccination. Patient did not receive treatment for events. At the time of this report the outcome of the events were not recovered.  Follow-Up (30Jun2021): Follow-up attempts were completed. No further information was expected.
injection site swelling; This a spontaneous report a Pfizer Sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2, dose 1, via an unspecified route of administration on 13Apr2021 (Lot Number: EW0153) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced injection site swelling on 13Apr2021. The patient just received first dose of Pfizer COVID vaccine and noticed injection site immediately swelled. The patient was wondering if this is ok or does it mean that the medication was inserted at the wrong location, underneath muscle or subcutaneously? The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Rheumatoid arthritis flare up; Swollen, itchy and sore at injection site; Swollen, itchy and sore at injection site; Swollen, itchy and sore at injection site; This is a Solicited report based on the information received by Pfizer from a company manufacture number (21K-163-4148934-00).   A contactable consumer (patient) reported that an 83-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) intramuscular in 2021 (at the age of 83 years old, Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported at unspecified dose for Moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On 01Oct2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer and experienced pain in arm and potassium levels were low. On 25Oct2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. In 2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer. Reported events of non-serious Rheumatoid arthritis flare up and got booster covid vaccine and arm get swollen, itchy and sore at injection site with HUMIRA (ADALIMUMAB). In 2021, the patient experienced Rheumatoid arthritis flare up and got booster covid vaccine and arm get swollen, itchy and sore at injection site. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the events for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was recovering. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of Rheumatoid arthritis flare up and got booster covid vaccine and arm get swollen, itchy and sore at injection site onset in 2021, got booster covid vaccine and arm get swollen, itchy and sore at injection site onset in 2021 and got booster covid vaccine and arm get swollen, itchy and sore at injection site onset in 2021 was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE as per reporter was possible for all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Six days post vax, this pt experienced low-grade fever and one lesion on the neck that was "mosquito-bite like." There were erythematous papules on right anterior neck, chest, groin, and stomach.  Also occurring was redness at the injection site. He recovered.
I had a cough, sore throat, and congestive.  These lasted for about 10 days. I tested positive for Covid-19 on Jan 25th.
convulsions; colic; unbearable crying that would not stop; sz; delayed speech; rx: phenobarb; feverish; dyspnea; heart muscle problems; all kinds of problems; major illness
tested positive for COVID earlier in the week; was seen in ED and transported to Hospital due to lack of beds; brought to hospital by EMS due to increasing SOB and cough; O2 sats in mid 40s on RA; has had monoclonal antibody infusion; on NRB mask; pt kept pulling mask off and O2 sats going down into 40s; pt required intubation with mechanical ventilation; DNR; condition deteriorated and pt was made comfort care; pt died in the hospital
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route were unknown, lot # L027733 with expiration date 13-SEP-2017, lot # M006708 with expiration date 02-JUN-2018, and lot # L033343 with expiration date 13-SEP-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Edema. Swelling began in right arm where shot was administered , predominantly in middle and ring finger. After a few days, it spread to the left arm, same fingers. Swelling  was worst at about 2.5 weeks after the vaccine. Edema progressed to noticeable swelling in ankles too. It took two months to reduce the swelling in the fingers. There is still some slight swelling not present prior to the vaccine, but it is vastly improved, improving and no longer painful. No prior history of edema.
Sensory loss on right hand; fine motor skills (unable to hold a pen to write - sleepy hand); chills; slight body aches; This is a spontaneous report from a contactable nurse.  A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK9231), intramuscular at right arm on 15Jan2021 17:00  at single dose for COVID-19 immunization. There was no known allergies, no other medical history. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK9231), intramuscular at right arm on 28Dec2020 12:30 for COVID-19 immunization. The patient had no COVID prior to vaccination, and had not been tested for COVID since the vaccination. It was reported that, on 16Jan2021 10:00, the patient experienced "sensory loss on right hand-fine motor skills (unable to hold a pen to write - sleepy hand)" that started the next day after receiving vaccine. By the time of reporting, which is the second day post vaccination this symptom still persist. The patient also experienced some chills and slight body aches, the patient took some paracetamol (TYLENOL) which helped. No treatment was received for the event "sensory loss on right hand-fine motor skills (unable to hold a pen to write - sleepy hand)". The outcome of the event "sensory loss on right hand-fine motor skills (unable to hold a pen to write - sleepy hand)" was not recovered, while for the rest of events was unknown.
It was reported that a pt experienced a local reaction sometime after receiving combination vaccine of Tripedia and ActHIB given as TriHIBit.
Fever, chills, muscle aches, headache, sore injection site, neck pain, arm pain, swelling and redness at the injection site. Treatment was Tylenol every four hours for a day and a half. Fever broke after 14 hrs, muscle aches lasted for two days, headache lasted for three. Arm soreness lasted four days.
Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies, who on 26-DEC-2006 was vaccinated with a 0.5 mL dose of Gardasil (Lot not reported). There was no concomitant medication. On 23-Jan-2007 the patient developed numbness of her face which eventually spread to her hands and legs. The patient was treated with prednisone and acyclovir. The numbness partially cleared but she then developed double vision, weakness of her right side, unbalance, decreased coordination and clumsiness of her hands. The patient sought unspecified medical attention. On 23-FEB-2007 the patient had a magnetic resonance imaging (MRI), which revealed demyelination and a spinal tap (results not available yet). The physician stated that the patient was starting to get better but was told the patient's parents stopped the Gardasil vaccine series. The dose of Gardasil vaccine was administered by the patient's primary care physician (PCP). The reporter considered the patient's numbness of her face, hands and legs, double vision, weakness of her right side, imbalance, decreased coordination, clumsiness of her hands and demyelination to be other important medical events. Additional information has been requested.
Problem in walking; Numbness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Problem in walking) and HYPOAESTHESIA (Numbness in the legs) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Problem in walking) and HYPOAESTHESIA (Numbness in the legs). At the time of the report, GAIT DISTURBANCE (Problem in walking) and HYPOAESTHESIA (Numbness in the legs) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Mom reports that approximately 7 hours after vaccine was administered, infant became very irritable and cried inconsolably. Infant only slept 1 1/2 hours during the night. Continued to cry next day (6/23/09) until 700pm. Then infant slept through the night. Awakened in am 6/24/9-acting completely normal. No fever noticed.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 18-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
2weeks after getting 2nd shot I woke up with swollen lymph nodes under right arm and feeling warm and sweating  Moderna COVID?19 Vaccine EUA
Itching, warmth and redness in the area of the vaccine with a certain rash I have been like this for two days
Patients parent claimed patient  to be twelve, we failed to double check patients age. as a result patient received an adult dose.
Patient developed hives from the middle of her neck down to the middle portion of her thighs. She also had some present to her entire back. The rash felt like "sunburn" and was not itchy per her report.
(L) sided facial nerve palsy. Treated with 5 days prednisolone.
Approximately 2 weeks after my 2nd dose - I felt my heart was really aching and I called my heart doctor for assessment. They did a CT scan, blood test and the results were normal. There was no prescriptions given or any treatment. The pain has increasingly improved as of today but I did not fully recover from.
Received expired booster more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster more than 12 hours post puncture) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster more than 12 hours post puncture). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired booster more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Right shoulder with 9 cm x 5 cm blotchy red somewhat warm and slight firm swelling in area surrounding shot.
Patient was given high then recommended dose.  The vaccine was not diluted.  There was no adverse event that happened to the patient.
Caller stated that he "felt the dose"/when he got the first shot he felt pain; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A non-contactable consumer(patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, on his left shoulder. Caller stated that he felt the dose, and the Caller said the people in the vaccination centre were very nice. Caller got his second dose today (13JUL2021) on his right shoulder, 21 days after the first dose. Caller mentioned he did not have any response. He also expressed concern if the dose was properly administered. Caller said that the people where disinterested and only saw the syringe being thrown. Caller stated that, years ago, his right shoulder was injured and fell. It did not do any serious harm, but possibly the nerves may have been damaged. Caller mentioned he would check after 2 weeks if he did develop antibodies to see if the vaccine worked. patient was worried after he got the second shot of the Pfizer COVID-19 vaccine since he is not sure the vaccine was given. caller says he did not feel it when it was given, so he was worried nothing was injected when he got the second shot. Agent reports that the caller told him when he got the first shot, he felt pain, but for the second one he did not feel anything. caller was also wanting to get an antibody test to make sure he was already fully immune and has antibodies to COVID-19, which he will get it in the next two weeks to make sure. Caller says that for his first shot he felt the puncture, his second shot was not painful. He says when he looks online, he sees the big needle there, a big gauge online, a big needle, an inch and a half long. caller says maybe they did give the dose, and maybe it wasn't a coronavirus injection, or maybe they didn't give the dose at all, he didn't feel it, maybe wrong. He says he took a TB test a year ago and it was just like a scratch, he felt a little scratch, this shot he didn't feel. The outcome of the event caller stated that he felt the dose/when he got the first shot, he felt pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (PRD13Jul2021): This is a spontaneous report from a Pfizer sponsored program COVAX support. A non-contactable 72-year-old male patient reported that:  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediately after receiving vaccine, right arm became very sore.  Redness developed at 11:00 PM.  Warm to touch.  Area is very swollen.
Several papules, some are mild vesicles and others are crusted lesions over her chest, pelvic area, upper legs and arms.
at time of vaccination, client's mom reported patient's date of birth making him 5 years old
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura  with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
Mother states "Left leg from diaper edge to one inch below knee was swollen double the size.  Warm to touch but not red.  Walked with weight on tip of toes.  Lasted 5 days." Contacted Dr., was not seen, instructed to bring in if progressed.  Child was never examined by MD.
Since the first vaccine i've been losing a TON of blood each month, and passing massively large blood clots.  my period went from max 5 days to minimum 7.  i have to use S+ tampons in conjunction with multiple pads to keep from soaking my clothes in blood.  the first few days i change the tampon 1-2 times an HOUR.  it is UNREAL.  i told my OBGYN last year but she was not concerned.  my recent booster vaccine was in November and i am STILL going through HORRIFYING periods each month.  this months' started 2 days ago.  i have to set alarms throughout the night so i can get up and change the tampon or i will wake up in a bed soaked in blood.  this is scary and unreal.