chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced raised rash/hives extending over entire neck and chest with itchiness running down arms.  Unknown how long after administration that it started.  Patient stated lasted for at least 2 weeks.  When patient presented to pharmacy 4 weeks later for the second dose, there were still some welts visible on patients neck/chest area.
Headache, Sedation, Myalgia, Arthralgia, Phlebitis, Fever, NauseaVomiting, SORE THROAT, RUNNY NOSE, CHILLS, SEVERE STOMACH ACHES Narrative:  Other Relevant History:
Patient was given a Kinrix at 4 month well child exam, this vaccine is not recommend for this age. No adverse event noted, parent reports patient is doing fine.
red thumb-print sized bump on his left arm; This spontaneous case was reported by a physician and describes the occurrence of SKIN MASS (red thumb-print sized bump on his left arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Influenza and DTAP. Past adverse reactions to the above products included No adverse event with DTAP and Influenza. Concurrent medical conditions included Type 2 diabetes mellitus and Pneumonia.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN MASS (red thumb-print sized bump on his left arm). At the time of the report, SKIN MASS (red thumb-print sized bump on his left arm) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had a red thumb-print sized bump on his left arm that started after receiving his first booster dose. This became more indurated, inflamed, and painful after an additional 2 booster doses of the vaccine.  Patient had tried anti-inflammatories, topical steroids, oral steroids, and anti-fungal with minimal improvement. patient requested a biopsy, and this lump was diagnosed as a patch stage T-Cell Lymphoma. patient had received 5 doses of the Moderna COVID-19 vaccines in total all to the left arm.   This case was linked.
1436 - PATIENT RECEIVED 2ND VACCINE TO RIGHT DELTOID.  1438-PT REPORTS NAUSEA AND FEELING "HOT". DIAPHORESIS NOTED. O2 SAT AT 86% INITALLY BUT INCREASED TO 94% OR ABOVE WITHIN MIN. (SENSOR UNABLE TO GIVE CONTINUED NUMBER RELATED TO FREQUENT MOVEMENT OF PATIENT.) BP 132/82 PULSE 70s.  PATIENT ALERT AND ORIENTATED . COOL RAG APPLIED TO NECK AND PATIENTS BLE RAISED IN CAHIR. 1438 - 911 CALLED. PATIENT VERBALIZES SHE IS "FEELING MUCH BETTER" REMAINS ALERT AND ORIENTATED. PULSE REMAINS 70s. 1446- FIRST RESPONDERS ARRIVE. NO CHANGE IN PATIENT STATUS. 1450- PATIENT WALKED TO STRECHER AND DISCHARGED FROM FACILITY PER AMBULANCE TO ED.
redness on her arm/arm still red; Arm was still red and warm; itchiness on her arm; severe headaches to this day; severe joint pain/ joint pain was horrible; fever; chills; sore arm; sick for 3 days, in bed sick; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness on her arm/arm still red), FEELING HOT (Arm was still red and warm), PRURITUS (itchiness on her arm), ILLNESS (sick for 3 days, in bed sick) and HEADACHE (severe headaches to this day) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A5716313) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal fracture and Colitis (for many years.). Previously administered products included for Product used for unknown indication: Pfizer (1st dose.) on 27-Mar-2021, Pfizer (2nd dose.) on 18-Apr-2021, Pfizer (1st booster, Dose 3.) on 19-Oct-2021, Pfizer (2nd booster, Dose 4.) on 07-May-2022 and flu vaccine (3 weeks before Moderna booster dose.) in September 2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer and flu vaccine. Concurrent medical conditions included Drug allergy (gabapentin), Food allergy (gluten free), Osteoporosis and Osteoarthritis. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], CALCIUM, VIT D [VITAMIN D NOS], ATORVASTATIN and TRAZODONE for an unknown indication.  On 02-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Oct-2022, the patient experienced ILLNESS (sick for 3 days, in bed sick). On an unknown date, the patient experienced ERYTHEMA (redness on her arm/arm still red), FEELING HOT (Arm was still red and warm), PRURITUS (itchiness on her arm), HEADACHE (severe headaches to this day), ARTHRALGIA (severe joint pain/ joint pain was horrible), PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 04-Oct-2022, ILLNESS (sick for 3 days, in bed sick) had resolved. At the time of the report, ERYTHEMA (redness on her arm/arm still red), FEELING HOT (Arm was still red and warm) and HEADACHE (severe headaches to this day) had not resolved and PRURITUS (itchiness on her arm), ARTHRALGIA (severe joint pain/ joint pain was horrible), PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm) was resolving.            It was reported that patient had experienced not like this nothing like sore arm in the past. It was reported that patient had never tested COVID positive test nor diagnosis. It was reported that adverse events does not cause patient to seek medical care.
This spontaneous report as received from a pharmacist refers to a 60 year old patient with drug reactions/allergies to: penicillin, cephalosporin, macrolides, ketolides, carbapenem, aztreonam, tacrolimus, sirolimus, pimecrolimus. Patient's medical history included ZOSTAVAX on 19-JUL-2014. The reporting pharmacist stated that 2 patients reported injection site reaction to PNEUMOVAX 23. On 27-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K005957, expiration date: 08-MAR-2015; 0.5 ml, intramuscular, anatomical location not reported). On 27-OCT-2014, the patient experienced injection site reactions, swollen arm, hard to touch, aches, pains, fever 101 Fahrenheit (F) and "knot in arm". There was no treatment given for the reported events thus far and the pharmacist suggested ice to the patient which "did nothing". The outcome of hard to touch, aches, pains and injection site reactions was reported as not recovered/not resolved. The outcome of "knot in arm" ("is now gone") and fever 101F ("is now gone") was reported as recovered/resolved (in approximately October 2014, exact dates not reported). The patient sought medical attention by contacting the pharmacy. The relatedness between the therapy with PNEUMOVAX 23 and the reported events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
NO difficulties for 15 minutes after injections. In car she experienced what appears to be a short vasovagal episode in which she was unresponsive for less than 1-2 minutes per mother. No memory of event by patient. Not postictal and BP and exam WNL when returned to clinic immediately after.
Patient reports feeling "dizzy", "achy", "clammy", and having a "fever", which can all be typical side effects. However, she also reports having ears that are "stuffed up" and pain in both ears that continues through today after vaccination yesterday.
I had vaccination on 09/20/2022. I started to experience headache and feeling unwell on 02/27/2023. I tested COVID-19 positive on 02/28/2023. I was prescribed PAXLOVID. The symptoms went away really quickly.
chronic headaches since the second dose; Primary provider advised to take ibuprofen and/or Tylenol;  I rarely get headaches, so to have them all day and everyday, was very unusual.  I've had one for the last three hours and it's not going away.  I've missed a lot of work from these headaches and other activities when not at work
1 hour post vaccine menstruation immediately stopped 4 days early; This is a spontaneous report from a contactable consumer. This 26-Years-Old female consumer (patient) reported that:   A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP8735), via intramuscular route of administration administered in Arm Left on 07Apr2021 (at the age of 26-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Apr2021, the patient experienced 1 hour post vaccine menstruation immediately stopped 4 days early. The clinical outcome of event was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient didn't experience any adverse event.   We administered the Bivalent Booster by accident instead of the first dose that patient was supposed to received.
COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Moderna / dose #4 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative proctitis" (unspecified if ongoing); "Celiac's" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Gluten, reaction(s): "known allergies: Gluten". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Nov2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Moderna / dose #4 Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The Anti-viral drug Paxlovid from 03Jan2023 to 08Jan2023 for the COVID-19 treatment. The other medication in 2 weeks product was Prenatal vitamin started on 01Nov2022 and stopped on 12Jan2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Woke up yesterday morning (1/20/21)  flu like symptoms. Body ache, headache, stiff joints. Today woke with mass in armpit, injection side, left arm.  About golf ball size, soft and squishy to touch.  Flu like symptoms are gone.  Has followed up with Dr. Currently treating with warm compress and seems to be helping pain
Left anterior/medial thigh with large area of erythema and warmth it measures 11.5 cm in diameter by 14 cm in length at greatest dimensions. Non tender, but itching.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted and unresponsive for about 3 minutes. Upon awakening patient felt dizzy and nauseous. EMS called and patient taken to ER.
Patient fainted after vaccine, had patient lay down, called 911, Fire and Rescue responded, patient left with father.
Patient received Rotarix mixed with Merck Diluent (for live vaccines) IM, instead of PO.  Currently no adverse reactions.
Event occurred after 2nd vaccine. First vaccine was on 3/10/21 and the second one on 3/31/21. Pt tested positive for COVID-19 on  1/9/22.
Janssen COVID-19 Vaccine EUA Fever of 102 degrees F - began about 5 hours after shot and lasted for >24 hours.  Dropped down to 99 withing 48 hours. Chills, dizziness, and nausea accompanying fever.  Persisting after fever decreased. Weakness and fatigue still persisting. Bad headache persisting since the shot (currently 48 hours in)
heart rate and sugar go up after their shots; heart rate and sugar go up after their shots; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that, "I have a nurse friend that is by far the smartest nurse that I've ever met. She and her husband both have had their heart rate and sugar go up after their shots, too." The outcome of the events was unknown.    Information on the lot/batch number has been requested.
dose administered past the 30-day use be date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use be date) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use be date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use be date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Mom states 2 days after vaccines patient's eyes rolled back in her head, she stiffened out and was "slobbering". Denies increased temperature. Called ambulance but they did not tale her to hospital.
Fever, Chills, body pains 11:30 PM 4/2/2021 Only body pains remaining at 12:00PM 4/3/2021 Symptoms resolved night of 4/3/2021
PT C/O OF SWEATING, BLURRED VISION, LIGHT HEADEDNESS, AND GRADUAL MIDSTERNAL CHEST TIGHTENING POST VACCINATION.  VS @ 1:35 BP 120/68 HR 60 SpO2 97%  VS @  1:54 PM BP 111/67 HR 54 SpO2 98%  PT APPEARS TO BE IN MILD DISTRESS. BREATHING IS NORMAL WITHOUT USE OF ACCESSORY MUSCLES.  NO SKIN RASHES PRESENT. PT STATES HIS VISION, LIGHT HEADEDNESS, AND CHEST TIGHTENING DID IMPROVE 100% AFTER 15-20 MIN OF CLOSE OBSERVATION. PT BECAME STABLE ENOUGH TO DRIVE. HE WAS EDUCATED ON HIS LOW BP AND TO F/U WITH HIS PCP.
Significant local reaction of approximately 3 inches diameter of redness and induration at injection site.
FATIGUE, DIFFUSE JOINT PAIN, FOLLOWED BY SWELLING, INDURATION AND ERYTHEMA AT INJECTION SITE, APPROX 4-INCHES IN DIAMETER.  NO TREATMENT.
I developed vertigo at the end of December. In January and February I started developing weakness and a lot of muscle pain. March 1st it was diagnosed as polymyalgia rheumatica. I am still having these issues. I am on a slowly declining amount of prednisone.
12/20/04 left eye red, itching, headache; 12/26/04 eye sensitive light; 12/30/04 diagnosed iritis vision reduced to shadows; 1/13/05 eye improving not resolved.
Heart racing the next day after vaccination. I went for a walk in the park and i noticed my hear rate jumped up to 165bpm on my fitbit for a period of time even though i just began walking. I wasnt running or anything. I was foggy and very jittery. I also experienced the same symptoms today, 4.12.21 while also heading for a short walk. Im an athlete and in great shape and ive never had my heart jump to 165bpm just walking. That would happen normally after a sprint or long run, but not just walking.
Patient developed confusion four days after receipt of vaccine.  At presentation to the hospital was confused, dehydrated.  Neuroimaging negative, LP showed aseptic meningitis with 30 neutrophils, normal protein and glucose.  Numerous tests for bacterial and viral pathogens were negative.  Patient improved, and was discharged after a three day stay.
5/4/16 came to Dr - itching, swelling, red at site of vaccination.
Pt recv vax on 3/11/98 (vax expired 1/98); on 3/12/98 pt exp tiredness, malaise, non-productive cough, chills, fever (99-100F), diarrhea, vomiting; dx=pneumonia
to develop a rash yesterday. It started off as large red spots last night, and this morning they are smaller red spots. She said the rash started in her feet and is moving upwards. This morning it is now on her arms. She also said she was having numbness and tingling from the waist down as well. Last night she did take Benadryl. She is not experiencing any other side effects. She did not have this reaction after the first dose.   prednisone, benadryl given at urgent care, prescription for prednisone given at Urgent Care
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. Hepatitis B vaccine COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored dose of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
around 8 pm on the same day of my vaccine I began to feel chills. around 10pm then the body aches started. this continued for about 3 days until I started feeling my usual self again. at midnight my husband took my temperature and told me it was 100.2. the following day I noticed a lump in my armpit. it continued to get bigger so i decided to go to Dr. she advised me to give it a week to see if it will go back down. It did.
ADMINISTRATION ERROR RECEIVED PFIZER DOSE #1 ON 3/11/2021 (LOT# EN6202) RECEIVED J&J DOSE ON 05/06/2021 (LOT#201A21A)
Blood pressure (high), loss of concentration, cramp legs, memory loss, memory: trouble remembering recent information. Sleep problems. Numbness and tingling: fingers. Infection fungus in toes.
Redness at injection site exceeding 2 inches in diameter, fever 100.4 degrees F, pain at injection site, inflammation at injection site not relieved by otc anti-inflammatory's, injection site hard and hot to the touch. Received PCV-13, Influenza Inactivated, HIB.
RIGHT AFTER THE VACCINE, PATINET HAD VERY HIGH FEVER 102.6 F FOR 3 DAYS, THEN SHE GOT BETTER . BUT A WEEK LATER , SHE HAD A STROKE. IT HAPPENED IN THE MORNING, PATIENT SUDDENLY HAD NUMBNESS OF HER RIGH ARM. HUSBAND TOOK HER TO HOSPITAL AND SHE WAS DIAGNOSED WITH A STROKE. PHYSICIAN SAID IT WAS THE SECOND STROKE THAT SHE HAD A MINI STROKE BEFORE BUT SHE PROBABLY DIDN'T NOTICE IT. THEY COULD NOT IDENTITY CAUSE OF THE STROKE BUT RECOMENDED TO REPORT.
Soreness; Electrical shocks throughout her body; Pain in both hands with tingling and burning; Pain in both hands with tingling and burning; Pain in both hands with tingling and burning; This spontaneous case was received on 05-Oct-2021 from other non-health professional (consumer)(reference number: SEQW21-03331) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 23-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279785 and expiry date was 18-May-2021. The patient did not have an immediate reaction, as reported.  On an unspecified date in 2020, reported as after a week or two after receiving Fluad Quadrivalent, the patient experienced soreness and electrical shocks throughout her body. Within a month she had pain in both hands with tingling and burning. She thought this could be arthritis and now this has spread through her whole body. The patient will be seeing a neurologist tomorrow.   At the time of initial reporting on 05-Oct-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  Company comment: A patient of an unreported age experienced pain and electric shock sensation throughout body, burning sensation, pain, and paraesthesia in both hands after vaccination with the suspect product Fluad Quadrivalent. Due to lack of information regarding patient's medical history, diagnostic findings and alternative aetiology, causal role of the suspect vaccine is unassessable.; Sender's Comments: A patient of an unreported age experienced pain and electric shock sensation throughout body, burning sensation, pain, and paraesthesia in both hands after vaccination with the suspect product Fluad Quadrivalent. Due to lack of information regarding patient's medical history, diagnostic findings and alternative aetiology, causal role of the suspect vaccine is unassessable.
Patient c\o dizziness and nausea s\p vaccination and had emesis on site. Spoke with patient mother today. Patient's mother states she has been worked up and nervous with prior vaccination but never had a vomiting episode like she did after the Pfizer vaccine. Notified mom that per CDC/Affiliated Physicians guidelines patient should not receive dose #2 and should follow up with PCP. Patient's mother is in agreement that she will follow up with patient's PCP tomorrow.
Arm soreness  Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue  Took advil (400 mg) 1/9/21 @ 2 am and another 400 mg on 1/9/21 at 5:30 pm.  Sxs did not recur since 1/10/21
"Covid Arm" Redness and swelling starting on day 14, patient reported on day 17 stating less swelling but still some swelling and rednesss
Patient was seen at 0710 he was sleeping but at normal cognitive behavior Patient was again assessed at 0720 where he was noted to be unresponsive, BP 180/100s, HR 230s, he was a DNR therefore not CPR was administered. EMS arrived at facility patient was noted to be in full cardiac and respiratory arrest. Time of death 0735
Starting 04/08/2022, I had a scratchy throat and achy/sore arms. I took an at home COVID-19 test which was negative. However, my husband took one and his was positive. We knew we were exposed to COVID-19. On Monday 4/11/2022, we went into the clinic and I got a COVID-19 test and it was positive. I was given Paxlovid for treatment by the clinic. Within 48 hours of taking the medicine, I was feeling better. After that, I had no symptoms except runny nose and occasional phlegmy cough. These symptoms lasted for about 3 more days then stopped.