chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when I spit up, there was blood; couldn't breathe; tired; Caller stated he is as sick as a dog; fever; my stomach feels like push ups; first shot in Jan2021/he didn't get his second shot until 01Apr2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Jan2021 and experienced back injury. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose in January, and he was supposed to go back for second dose on 08Feb2021. However he was not able to attend second dose appointment and did receive second dose until 01Apr2021: yesterday morning (26May2021) he couldn't breathe he was tired and was down, he had a fever, he had 5 blankets on him. His stomach felt like push ups and he had a spit, when he spit up, there was blood. He was as sick as a dog. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Information has been received from an RN concerning a 74 year old female dialysis pt who was inadvertently given Hep-B vaccine IV. Follow-up information from an RN reported that the pt developed a rash from the knees down. Unspecified medical attention was sought. It was noted in the chart on 7/21/00, but may have started before that day. The reporter noted that it appeared to be an allergic response, but that she could not attribute this to the vaccine because she is unclear of the sequence of events. Additional information had been requested.
10x8cm wheat around inject site started 12 days p/inject; mild tender, hot itching, slowly resolved over days;
Within Three to Four Hours I Noticed My Eyes were Bothering me at work. I went to A Mirror - Both eyes were Bloodshot & Bright Red. I Then Developed wheezing & problems breathing My Face swelled and Turned Red I felt Tired & sore. I have never Previously had a reaction to the flu shot. I obtain one every year The only difference in my health since my last flu shot is a Low tolerance and allergic reaction to mold.
Around 4 am on the 27th of January I started having a sever headache and liquid stool diahrrea and nausea. That last for about 24 hours, the headache stayed around for several days. I did not see anyone regarding symptoms.
Symptoms:  Patient complaining of rash to face, neck and hand for the last 10-15 minutes.  States that they look like hives and have a burning sensation.  Had 2nd COVID vaccine about 3 hours ago. Denies any breathing difficulty. Is a 32 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine.    Second Dose in Series: Vaccine was obtained from the following clinic/location: Butterworth on the date of: 1/18 and approximate time of 7pm  Vaccine was administered to patient's: Left Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations   Known COVID Exposure since receiving vaccination?: No    Patient notes the following symptoms: Rash: Location other than injection site face neck and hands - burning sesation  Modifying Factors or additional details:Around 3 1/2 hrs post vaccine she started to break out in a rash on hands and face. She denies any other changes to her environment. Took benadryl and this seemed to help.  ROS
PATIENT WAS GIVEN O.3ML BIVALENT PFIZER FOR 5-11YR OLD INSTEAD OF THE ADULT BIVALENT BUT NO ADR REPORTED YET
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-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 medications were provided. No treatment medications were provided.  The reporter stated that their Moderna vaccine was pulled from the freezer on 13-Oct-2021 with a use by date of 12-Nov-2021, 30 days storage viability in the fridge. The Moderna Vial does not have an expiration date on it, however the Moderna Vail Expiration Date Checker stated that this lot number had an expiration date of 24-Oct-2021. The patient was given vaccine from this lot number vial on 26-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up was received contains no new information.
Tiredness; This spontaneous case was reported by a study coodinator and describes the occurrence of FATIGUE (Tiredness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
second dose administered past 36 days; Not feeling well due to blood pressure and heat; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose administered past 36 days), MALAISE (Not feeling well due to blood pressure and heat) and VACCINATION SITE PAIN (Pain in the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose administered past 36 days), MALAISE (Not feeling well due to blood pressure and heat) and VACCINATION SITE PAIN (Pain in the injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose administered past 36 days), MALAISE (Not feeling well due to blood pressure and heat) and VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
heart failure; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced heart failure after received the pfizer covid shot on an unspecified date. Outcome of event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Headache, Myalgia, Arthralgia, Chills, Soreness to left arm Narrative:
PT RECEIVED MONOVALENT PFIZER INJECTION (EVEN THOUGH PT WANTED BIVALENT PFIZER). PT MADE AWARE OF INCIDENT AND TO COME BACK IN 2 MONTHS TO GET THE OMNICRON BIVALENT ONE. TOLD PT TO UPDATE THEIR COVID CARD TO CORRECT LOT NUMBER.
I had excessive tiredness/fatigue beginning of June and that continued and on June 15th I had extreme fatigue and muscle aches and chills and night sweats that got progressively worse. I spiked a fever of 102.3 on Saturday and that's when I went in for a chest X-ray. Before the fever had come, I was concerned about COVID and I called the doctor and she said to come and get looked at and that was before there was a fever. I had the blood test and COVID test. I had a chest x-ray and they found out it was Bacterial Pneumonia. They gave me two different antibiotics. Those resolved the worst of my symptoms. I went back to the doctor last Wednesday, the 30th. There is still some bloodwork they are looking at; nothing is definite to determine if I'm clear. The last chest x-ray I had was enough to say that they are sure that I'm out of the woods. I'm currently finished the meds. Until they can do a repeat chest x-ray, I don't know if I'm recovered.
A non-serious, spontaneous report of administered to 65-year-old was received from a consumer concerning a 65-year-old female. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sore arm; Swelling; Redness; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, swelling, redness, chills and fatigue.  The patient's medical history included chronic back pain. Concomitant medications reported were Synthroid, Vitamin B Complex, Yeast Rice ( for unknown indication).  On 24 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the events- sore arm. swelling, redness, chills and  fatigue. She claimed after receiving the vaccine her back pain has gone away(26 Feb 2021).  No lab data was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events- sore arm, swelling, redness, chills and  fatigue was considered resolved on 25 Feb 2021.
Information has been received from the Merck Pregnancy Registry for GARDASIL via a 25 year old female with depression, on CELEXA 20 mg daily, who on 29-OCT-2007 was vaccinated with the first dose of GARDASIL, 0.5 ml, injection form (lot# not specified). The second dose of GARDASIL, (Lot# not specified) was administered on 04-FEB-2008, and the third dose of GARDASIL, (Lot# not specified) was administered on 05-MAY-2008. On an unspecified date, she sought medical attention and had blood and urine tests performed (dates, test names and results were not noted). The patient reported that she was pregnant and her last menstrual period was 10-APR-2008, her estimated due date was calculated to be 16-JAN-2009. Follow-up information reported on 20-MAY-2008, 4 to 6 weeks from her last menstrual period, the patient had a spontaneous abortion. It was reported that the products of conception were not examined and it was unknown if the fetus was normal. Upon internal it was reported that spontaneous was an other important medical event. Additional information has been requested.
Patient with hx of multiple sclerosis presented to ED on 5/20/21 with bilateral lower extremity weakness. Patient got her 2nd COVID vaccine on 5/19/21 (Pfizer), and since that time she developed bilateral lower extremity weakness. She generally uses a wheelchair and a walker but at baseline can ambulate with a walker and currently she cannot stand at all. She reports her last MS flare was about 6 months ago and when she has MS flares, she always has symptoms with her legs. She gets ocrelizumab injections every 6 months (last dose was 5/18/21). She denies any vision changes or difficulty with speech, no upper extremity weakness, numbness/tingling. Denies any bowel or bladder incontinence. She denies any chest or abdominal pain, nausea, emesis, diarrhea, urinary issues, cough, fevers, chills. SARSCOV2PCR test on 5/20/21 = not detected. She does report some mild stiffness in her right upper arm but states that also happened with the first dose of the vaccine. Case was discussed with neurologist who recommended admission and observation but deferring on steroids at this time. As of 5/21/21, patient is still hospitalized. Her lower extremity weakness is improving, but the medical team anticipates she will need short term inpatient rehab or possibly home PT/OT before being able to safely return home.
Immediate severe pain at injection site that then resulted in severe ongoing myalgias/subacromial bursitis.  Still symptomatic 9 months later.
Per pt she started having swelling over her body including the face about 30 minutes after receiving the vaccine. She took Benadryl and went to the emergency room where they administered more Benadryl and steroids. She was discharged 08/11. Dropped off script for a 4 day course of prednisone at 7:30pm on 08/12.
Pt received first dose of COVID-19 vaccination on 7 Jan 2021.  She reports 8 days after receiving the vaccine she woke up with her left arm (vaccine arm) feeling like "deadweight".   The vaccine sight was warm to the touch, swollen, and an erythematous, raised, pruritic rash was present.  The rash stayed localized, did not spread.  Interventions include ice, Tylenol, and Motrin with no relief. Pt reported resolution of above symptoms 72 hours after they presented.  She reports some lingering fatigue and a swollen lymph node in axillary chain n the arm pit of the arm she recieved the vaccine.  She denies drainage/discharge from site, pain in area, or overlying pore/punctum.  She denies angioedema or anaphylaxis reaction to the vaccine.
Day 2 in morning discovered light red rash around injection site the size of a dime. Day 3 when waking discovered 1 hive on right, front of chin. Day 3 approx 5pm started intestinal cramping, diarrhea w/5 stools, and passing gas. Day 4 rash at injection site gone by 7am. Cramping, diarrhea, passing gas continues.
I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; my neck arm and shoulder  were killing me; my neck arm and shoulder were killing me; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; This is a spontaneous report from a contactable consumer. A 62-years-old non-pregnant  female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: was not reported),  via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 18:45 (at the age of 62 years old) as SINGLE DOSE for covid-19 immunization. The facility in which the vacation was given was a Pharmacy or Drug Store.  Medical history included hypertension, blood cholesterol increased and covid-19 (prior to vaccination). The patient has no known allergies.  Concomitant medications  included lisinopril (LISINOPRIL),  atorvastatin (ATORVASTATIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient 'was' diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 04Mar2021 at 00:00, The patient experienced flu like symptoms for 2-3 days, Pain chest, Neck pain, Arm pain and Pain. No Treatment was given. The clinical course was as follows patient had the normal flu like symptoms for 2-3 days. Then noticed that her neck arm and shoulder were killing me. Now it is the whole upper left quadrant of her body. This includes the chest area around where my heart is. It is very painful and I do cry out with a pain sound if I move a certain way. No treatment was given for the events. The clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Pt report onset of pain in joints on injection side arm immediatly after injection, this progressed to joint pains in wrists bilaterally x 6 weeks since injection.
p/recv vax pt exp screaming uncontrollable for periods of time then periods of rest;happened twice in one day & once on another day & once more on another day;
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Swollen arm at injection site with tenderness, erythema, TAC oint 0.1%.
Patient has reported that she received a sore arm from the vaccination that was typical for a vaccination.  However, the soreness progressed over the last month.  She is currently experiencing discomfort and weakness in her left arm.
Gave pediatric concentration of Pfizer, diluted with 1.8ml normal saline instead of adult concentration
Pt was admitted to labor and delivery for induction and tested positive upon admission.  Pt is asymptomatic.
it's itching; bump in their skin; it's hot; it's red; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it's itching), SKIN INDURATION (bump in their skin), DRY SKIN (it's hot), ERYTHEMA (it's red) and FATIGUE (felt tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M204) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLONAZEPAM (KLONOPIN) for Anxiety, METOPROLOL and CANDESARTAN CILEXETIL (ATACAND) for Blood pressure management, CRESOL for Cholesterol, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression, CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for Sleep problem, METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Multivitamin Centrum Silver and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (felt tired). On 17-Feb-2021, the patient experienced PRURITUS (it's itching), SKIN INDURATION (bump in their skin), DRY SKIN (it's hot) and ERYTHEMA (it's red). At the time of the report, PRURITUS (it's itching), SKIN INDURATION (bump in their skin), DRY SKIN (it's hot), ERYTHEMA (it's red) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication nclude Benadryl cream on it but they have not done it yet. They took 2 acetaminophens that morning before getting the vaccine
Started in my armpit on right side had pain underneath then the pain moved to top of muscle on upper arm,  discoloration and bruising started to appear on my upper arm at that time. The pain moved down to the crook in my arm then went to fore arm finally ending in top of my hand. My arm was swelled and bruised for a week or more. I have pictures of the bruising
Patient received FLUZONE vaccine approximately at 1:30pm. Allergic reaction occurred at 3:30pm - epinephrine 0.3mg injection delivered to patient. Lost pulse and breathing.
My arm had a big round circle and a rash.  It was also itchy.  I ued Benedryl every day for the next three days and then it subsided.
After a few hours of muscle ache which is usual high pain began. By late evening I could no longer lift my arm over my head due to intense pain.  By the morning following the shot I could no longer move my arm at all without searing pain.  I had to immobilize it with my other hand.  Over the course of the next three days I took Ibuprofen and then switched to Tylenol. I called the Nurse hotline on day three of the pain where I still could not raise my arm over my head but was able to move my arm with some pain. I was told if it did not get better to go to urgent care the next day. The next day it seemed pain was still sharp but diminished and the pain continued to diminish until almost 2 weeks beyond the shot.  At that point it was still painful but tolerable so that I could perform most duties. Then around 2 weeks the sharp pains began to come back more and again it was very uncomfortable to raise my arm high. It also is painful when I turn my body during rest and lay on it.  I made an appt with my GP for 10/29/20. In the meantime he told me to take Ibuprofen daily. It still is painful but the pain is bearable. None
3/29: fatigue and strong leg pain; 3/30 - fatigue gone, some leg pain lingered; 3/31 - normal.
TINY RED DOTS ALL OVER FACE MOSTLY ON EYELIDS AND CHEEKS/PETECHIAE; HEADACHES; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiny red dots all over face mostly on eyelids and cheeks/petechiae. On MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches and tiny red dots all over face mostly on eyelids and cheeks/petechiae was not reported. This report was non-serious.