chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the shot at 115PM I waited and within a couple of mins I tasted metal on the left side of my tongue. the back of my tongue and my left cheek started to go numb and I was taken to the ER, my vitals were taken and was normal and was monitored for a couple hours, triptase was taken and they did bloodwork, the numbness climbed to the left side of my face from my eye to my jaw,  they gave me antihistemines for the next 48 hours and was sent home. Saturday morning I went to the gym and felt fine and 24 hours later I felt complete fatigue like I had been hit by a bus, Sunday I had congestion and still numbness on my face. On Monday I got a call from an allergist, they couldn't figure out if it was an allergic or adverse reaction. I was put on a high dose of Allegra  to see what it could be. Tuesday the congestion went into my lungs and was out of breath and was having trouble breathing. My PCM called me and asked me to video call and said I looked terrible. my pulse oximeter was 99. Wednesday when I woke up my difficulty breathing was starting to get better. I was tested for covid twice on Wednesday and both were negative. Wednesday to 12/28 I continued to have serious fatigue and I'm  very active I feel much better 12/28  and 12/29 I feel better but I've had the numbness on my left side of my face this whole time and it feels like I've had Novocain I can't get rid of it.
He almost passed out a couple times; Fever; weak; Awful shakes; Sweating; Chills; Stomach like on fire; Diarrhea; He lost about 4 pounds; has autoimmune disease, lupus; has autoimmune disease, lupus; he thinks he was almost dehydrated; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, on 22Jan2021 14:30, at SINGLE DOSE for COVID-19 immunization.  Medical history included autoimmune disease, systemic lupus erythematosus diagnosed in 2018 (over 3 years ago). Concomitant medication included baricitinib taken in a clinical trial, a study, unknown if 2 or 4mg plus placebo for lupus. On 25Jan2021, at 14:30 in the afternoon, the patient was sweating and it was awful shakes and chills, and it lasted over three hours, and on 26Jan2021 he was weak. The patient lost about 4 pounds on 25Jan2021, with all the water running out of of him. The sweating and shakes happened so suddenly and stomach felt like it was on fire on 25Jan2021. The stomach feeling like it is on fire has gone away, he almost passed out a couple times on an unspecified date, he had diarrhea on 25Jan2021, it was unbelievable. The sweats with awful shakes has gone away on 25Jan2021, but it was horrible, he has recovered with a lasting effect, he is a little weak, but he can move he had to take his dog to the beautician. Diarrhea: the is not eating (had no breakfast this morning) however it was also reported that the patient had a little slice of roast beef and blackberries not many, and he has been drinking, he thinks he was almost dehydrated in Jan2021, he drank about a quart of water so far today. On an unspecified date, the patient had fever. His doctor called the day before and said it was alright; his rheumatologist said it was ok. Outcome of the events he almost passed out a couple times, fever, chills, weak, Diarrhea, He lost about 4 pounds, he thinks he was almost dehydrated was unknown; the events sweating, awful shakes recovered on 25Jan2021 with sequalae, while Stomach like on fire recovered in 2021.  Information on the lot/batch number has been requested.
I woke up with hives over my arms and chest. My left eye was nearly swollen shut and my hands were swollen and in a lot of pain. Whole body is very itchy and sensitive to touch. I took sudafed because it is all I had available at the time.
No additional AE reported; pharmacist diluted the VARIVAX with 0.9% sodium chloride multidose vial rather than the diluent provided; This spontaneous report was received from a pharmacist and refers to a 25-year-old male patient.  The patient's pertinent medical history, current conditions, drug reactions or allergies were not reported. Concomitant medications included sodium chloride.   On 20-APR-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 05-MAY-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX). Before the administration, the pharmacist diluted the varicella virus vaccine live (oka/merck) (VARIVAX) with 0.9% sodium chloride multidose vial rather than the diluent provided (Product preparation issue). The patient was not having any problems at the time of the report. No additional adverse events details or product quality complaints were reported (no adverse event).
Fever Tmax 102.7 started approx 12 hrs after vaccines given, lasted over 48 hrs.
Pt received the 1st dose of Prevnar on 12/18/00. Called back on 12/19/00 at 16:00. Pt has complaint of hives from head to toe. Entire body.
Patient was seen byMD on 06/21/2006 with a diagnosis of Chicken Pox.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21
I contracted COVID-19 on 07/14/2022 with symptoms of cough, runny nose, sore throat, congestion, headache, fatigue, and watery eyes. I was prescribed PAXLOVID on 07/15/2022. My sore throat, watery eyes, and congestion began to improve after taking PAXLOVID. I am not fully recovered yet, but my symptoms are improving.
pt recv vax 13DEC95; following vax lab eval revealed that pt was not immune;pt was then given a booster & no antibodies were detected 4wk post vax;
Every year received flu shot and was so soo sick; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case is linked to case 2020SA302659.  This case involves a patient with unknown demography who was soo sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient who was soo sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patients received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Fever 102, uncontrollable chills for 5 hours, incredibly severe headache, pain at injection site, nausea, sore throat, mild congestion, lethargy
Red, swollen, tender to touch area around injection site left deltoid. Benadryl OTC x 3 days ordered and Betamethasone Depropionate ointment 0.05% to area twice/day.
Narrative: Patient received Moderna COVID vaccine series on 1/4/21 and 2/1/21. During "welcome" visit with clinical pharmacist, patient reported adverse reaction of rash and pruritus to vaccine.
minor headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (minor headache) and PAIN IN EXTREMITY (sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN), MULTIVITAMIN & MINERAL, CARBINOXAMINE MALEATE (OMEGA 100) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (minor headache) and PAIN IN EXTREMITY (sore arm). On 19-Mar-2021, HEADACHE (minor headache) and PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PT STARTED TO FEEL NERVOUS. PT SAID HE FELT HE NEEDED SOME AIR SO HE WALKED OUTSIDE. MOTHER WITNESSED HIS FALL. PT FELL ON HIS ELBOWS, HANDS SHOOK FOR 2 TO 3 SECONDS.  PT DID NOT RECALL FAINTING. REPORTED HAVING A HEADACHE IMMEDIATELY AFTER.
Itchy Arm (Injection Site); Redness from Injection Site Spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Redness from Injection Site Spreading) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Redness from Injection Site Spreading). At the time of the report, VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Redness from Injection Site Spreading) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient was a former 23 wk 6 day gestation premature infant who was discharged home from NICU on 2/27/14 into child protective services. She had her 2 mo immunizations in hospital and followed up with us on 3/3/14. She was given her 4 mo vaccines - which were the same as 2 mo shots. Became more lethargic on 3/3/14 and decreased PO intake. Died the following day.
Treatment includes: Supplemental O2, Decadron, Remdesivir, IV Fluids
Patient received 0.4 ml of J+J vaccine instead of normal dose of 0.5 ml
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Tiredness, body aches within first 12 hours. By almost 48 hours, I had numbness down the whole left side of the body. This was in the evening, I was not laying on that side of the body in bed but I could barely move that side. Afterwards, I had a slot of pain at the injection site and needed to use a cold compress to settle the swelling and pain.
052506 1350 PM Telephone call to client, as RN had a report that this client had numbness and tingling in her arm following an MMR.  Client reports she had tingling and swelling in her left arm just above her elbow and she noticed this almost right after the MMR.  Indicates that the tingling and swelling are better and now her arm feels a little prickly.  Client denied any numbness.  This client didn't report this while at the MMR Clinic.
Narrative:  Patient died after COVID vaccine dose #1 01/20 pt presents to ED with left neck swelling x 1 month, weight loss, coughing, left AMA before being seen by provider 02/10 seen by PCP for initial visit and sent to ED to evaluate neck mass, dizziness and neck pain upon standing, depressed and forgetful, hypophonia; CT HEAD/NECK showed neck mass, likely malignant, admitted 02/12 COVID vaccine dose #1 02/13 discharged from hospital, FNA showed advanced squamous cell carcinoma in neck 03/07 admitted to hospital due to malnourishment 03/10 pt enrolled in hospice care 03/28 pt passed away Death likely due to aggressive malignant carcinoma and not related to COVID vaccine. Patient was hospitalized before and after vaccination for comorbidities. Did not experience ADR at time of vaccination. Was never diagnosed with COVID infection.
Chronic hives that moves around whole body, neck, shoulders, arms, legs, stomach, back, hands, and feet. Itches, red swelling and little raised bumps. Comes and goes. Been a month and hasn't gone away yet.
Had a small rash near injection site along with pain. Went away after day 8, but night 9 developed hives and still persisting on day 15. Hives appear all over body. Itchy and burning.
Pharmacist states that they were having an event and two patients ages 11,16 were inadvertently given the Flublok immunization; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was issued in publication with one other linked case 2020SA273639 (cluster)  This case involves a 11 years old patient for whom pharmacist states that they were having an event and two patients ages 11,16 were inadvertently given the flublok immunization (Product administered to patient of inappropriate age) was reported while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ463AA, Expiry date:19-MAR-2021) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date (of unknown latency), the patient developed a non-serious pharmacist states that they were having an event and two patients ages 11,16 were inadvertently given the flublok immunization (reported to be wrong product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No lab details were reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome was reported to be not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Physician reports: "crying/fussy and not consolable for 48 hours, following vaccine."
Post vax, Hep-B #1, that evening, had fever to 102F, queasy and pale X 2 days. Also, upper arm had a painful knot. Not red or warm.
tingling, left side  (still exists two days post shot) Chills (severe night of shot, ended early next morning) Body aches (severe night of shot, ended early next morning) Mild body sore Headache (still exists two days post shot)
legs became painful; right wrist hurt; swollen lymph node right side of my Armpit; could not lift my right arm above my head; Fever; Chills; Achy; headache; injection site right arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (could not lift my right arm above my head), PAIN IN EXTREMITY (legs became painful), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Achy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (could not lift my right arm above my head), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Achy), HEADACHE (headache) and INJECTION SITE PAIN (injection site right arm hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (legs became painful), ARTHRALGIA (right wrist hurt) and LYMPHADENOPATHY (swollen lymph node right side of my Armpit). At the time of the report, PAIN (could not lift my right arm above my head), PAIN IN EXTREMITY (legs became painful), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Achy), HEADACHE (headache), INJECTION SITE PAIN (injection site right arm hurt), ARTHRALGIA (right wrist hurt) and LYMPHADENOPATHY (swollen lymph node right side of my Armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 99.3 (abnormal) 99.3.         Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Within two days of receiving PREVNAR 13, left side of my face and eye became intensely painful. Saw eye doc and he prescribed ZPAK. He said my eye was fine but I had a major sinus infection. During this time a rash appeared on my upper torso from neck to hips. Itching ensued and continued through Sept, Oct. and November to present. Doctor who administered PREVNAR 13 recommended ZYRTEC to help with itching. Hopefully I'll be better soon.
"A final dose Hep B vaccine was ordered and upon retrieving from the vaccine fridge i had another staff verify the correct vaccine and expiration date prior to giving the vaccine. The vaccine that was pulled was not automatically coming up in the system so i manually typed all the information in and then I documented the patients, information as well as vaccine information at the end of the day in the binder. Myself and my site supervisor received an email today 11/28/2022 stating the error of giving a pediatric vaccine to an adult patient was made."
had a lot of blood in her stool; busted hemorrhoid; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team and via Pfizer-sponsored program  support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included stroke in 2015, transient ischaemic attacks (TIAs) in 2015, and breast cancer. She reported she had breast cancer in her right breast and they still gave the shot on her right side, after she told them not to. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient reported she had a lot of blood in her stool on an unspecified date and had a colonoscopy a few days before reporting (Oct2021), it was a busted hemorrhoid, she knew it wasn't the vaccine. The patient reported she recently had an antibody test to measure the antibodies that are created against COVID-19 and no antibodies were present. She asked what should she do about booster shot if the first 2 did not give her antibodies. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
930 given vax, later given APAP by mom; 3PM just laid there-didn't move, but jerked frequently by not constantly; t100a; screamed when touched; 330 taken to ER t103.8; leg painful & screamed if touched; diarrhea;
High fever and took about 2weeks to recover.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (High fever and took about 2weeks to recover.) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever and took about 2weeks to recover.). At the time of the report, PYREXIA (High fever and took about 2weeks to recover.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient was immunocompromised and  received the Moderna COVID-19 vaccine developed high fever and took about 2weeks to recover. No concomitant medications and treatment medications was provided.
"flu symptoms" headache, aching in face and body, vomiting, runny nose, "lungs hurt"
Pt came into pharmacy on 2-10-12 with complaints of pain and bruise at injection site from INFLUENZA vaccine. Pt stated has been to orthopedist and urgent care, both stating not from flu shot.
Pain at injection site - 48 hours. Mild fever, fatigue, headache, chills, muscle pain - 72 hours. Rest and ibuprofen for severe headache.
3x4" reddened area at site. IBUPROFEN PRN. Triamcinolone cream BID.
This spontaneous report was received from a healthcare worker via a company representative refers to a female patient of unknown age. Approximately on an unknown date in March 2013 (reported as within the last month) the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in March 2013 (reported as within the last month and came in the next day) the patient experienced rash on the arm by the injection site. The nurse stated that they put her on CLARITIN and she was fine at the time of this report. The outcome of the event was reported as recovering/resolving. Causality was not reported. The patient sought medical attention by returning to the physician's office. Additional information is not expected.
Swelling and erythema at vaccination site within 24 hours, hot, tender, and itchy. Treatment with Benadryl and resolved within 72 hours.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients' were vaccinated with improperly stored VARIVAX (lot # M009764 23-FEB-2018, L040422 15-OCT-2017, L019124 27-MAY-2017) for prophylaxis. The vaccine were exposed to a temperature of 21F at a time frame of 8 hours. No adverse effects reported. Additional information has been requested. This is one of the two cases received form the same reporter.; Sender's Comments: US-009507513-1612USA010514: