chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (1st dose received on 05th July 2022, from batch number X9HS4 and refer case US2022AMR171088) and Hiberix with an associated reaction of skin discolouration (1st dose received on 05th July 2022, from batch number FY4E9 and refer case US2022AMR171088).   On 29th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171088   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The reporter reported that the patient after received Hiberix and pediarix experienced gray dot on the right thigh of the leg The reporter was consented to follow up. Additional supportive information: This case had been linked with US2022AMR171088 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: US-GSK-US2022AMR149560:
flu like symptoms: pain, chills, pyrexia, headache; shaking; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms: pain, chills, pyrexia, headache) and TREMOR (shaking) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Moderna 011) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included IBUPROFEN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms: pain, chills, pyrexia, headache) and TREMOR (shaking). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms: pain, chills, pyrexia, headache) and TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes:blood pressure medication and cholesterol medication. She has been taking ibuprofen since yesterday and has been doing the same today.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
PARALYZED; ON THE BRINK OF DEATH (CLOSE TO DEATH); This spontaneous report received from a parent's via a company representative concerned an 18 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had never took birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter stated that, on an unspecified date, the patient was on the the brink of death (close to death). She was paralyzed and was in the hospital (date unspecified) for 3 months. She was still confined to a wheelchair, and could not do anything on her own. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed (confined to a wheelchair, and could not do anything on her own), and the outcome of on the brink of death (close to death) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210941226-Covid-19 vaccine ad26.cov2.s- Paralyzed, On the brink of death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
PT left the pharmacy ok 15 minutes after receiving the shot. She called 5 days later reporting redness on left arm, pain, and fever for 3 days.
Pt received the vaccine, was fine and went to check out with her mom and passed out at the check out desk. Pt was pale and hot. We took off her sweatshirt and put a cold compression her neck. Then we gave her a juice box to sip on, and she refused crackers. She felt sick to her stomach, no emesis, we took her B/P-normal. She laid down in a room for awhile, then felt better to leave. 11:10am to about 12:00pm.
HE IS UNDER THE AGE OF 18. AT THIS TIME HE IS EXPERIENCING NORMAL SIDE EFFECTS. WE ARE MONITORING HIS SYMPTOMS THROUGH HIS PARENTS.
Unsure of actual time of onset. Patient's wife reported that redness at injection site has moved down past his elbow. (Pt got SubQ Pneumovax 23).  Red area is sore and hot. Patient is contacting physician. At this time has not seen doctor, but we recommended he call/see physician.
Erythema neg 4-5cm around right deltoid area, developed after 4/19/2000, pt was seen on 04/25/2000.
arm pain w/in 6hr p/vax;chills & fever w/in 12hr of inj;moderate swelling & erythema extending from triceps to midforearm;no adenopathy;lung sounds clear saw MD 31OCT96;
40 minutes after vaccine,complained of throat swelling,palpitations. Diagnosed in ER as anaphylactic reaction. Treated with epinephrine,Benadryl and solumedrol.
Information was received from an office manager concerning a 22 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 31-OCT-2016, the patient was vaccinated with his first dose of GARDASIL 9. On 23-FEB-2017, the patient was vaccinated with his second dose of GARDASIL 9. The third dose of the GARDASIL 9 was given on 24-APR-2017 (lot numbers, dosages, and routes of administration not provided). It was realized after the patient was vaccinated that he was not on schedule and there were not enough months between the 2nd and 3rd dose. Additional information has been requested.
Multiple bruises with different sizes on back of thighs on both legs, bruises on knees, shins, and feet.
This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 16-Aug-2022, the patient experienced UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose). No concomitant information were reported by the reporter. The patient was an adult patient of 18 plus age received first dose of Moderna COVID-19 vaccine. Patient received 0.25 ml instead of 0.5 ml. The reporter was not sure which vial was used, but guessed it was red cap vial. No treatment information were reported by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 80-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included Losartan, metoprolol and ZYRTEC. On 30th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, 7 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving Tartrate. The reporter reported that the patient followed up with his physician on 31st May 2018.
After vaccine I was fine went home and took a nap, when I woke up at 2pm I was a little dizzy. By 7pm I was dizzy and nauseated, and it got worse, I got chills and shook and shook and shook, I had a fever and the next day I tried to get out of bed, and I fell to the floor and couldn?t stand up, I had no energy or appetite. I had covid in August 2020 and the wasn?t made aware of the possible side effects if you had covid. They didn?t ask if I had covid in the past and the pharmacist told me later that people who has had covid has reported having bad side effects. I had gone a couple weeks ago to see if I had the covid antibodies and I was positive for antibodies and the injection works against the antibiotics. This part of the procedure was overlooked. I have no one else to help me and going through this alone, it would have been better to have been made aware of this ahead of time.
Previously healthy male presented with severe chest pain 2 days after 2nd dose to Emergency Dept (no records obtained), transferred to another Hospital and admitted for < 48 hours.
I had a COVID booster and I had a mild fever about 12 hours later.  and a slight headache the next day. I was, and am, fine. Beginning about an hour after injection, my arm ached around the injection site. That increased over time and my arm felt stiff around the injection sight and I was still able to move it. Finally, I had a Flu shot in my left arm about twenty minutes after I had my COVID Booster shot.
This spontaneous report was received from a healthcare worker and refers to a currently 16 year old male patient. The patient had no pertinent medical history and had an unspecified reaction to BACTRIM. On an unknown date, reported as "as a child", the patient was vaccinated with M-M-R II (dose, frequency, route of administration, lot# and expiration date not reported) and VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date not reported). No information about concomitant medication was provided. The patient developed leukemia (date not specified). As a treatment, patient received chemotherapy. On an unknown date in 2015, also reported as "now when the patient was 16 year old", titers showed no immunity for varicella, measles, mumps and rubella due to the chemotherapy. As a result, the patient was administered PROQUAD (Merck) (reported in MARRS# 1506USA005942). The outcome of events was reported as not recovered/not resolved. The patient sought medical attention, he saw physician. No relatedness between M-M-R II and VARIVAX (Merck) and adverse events was reported. Leukemia was considered by reporter to be serious due to cancer. Additional information has been requested.
Normal symptoms and reactions all besides very strange/geometric/spotted looking rash on arms two days after vaccine.
Pneumonia and Flu vaccines given in same arm 1 inch apart. Pt experiencing severe pain at site. Low grade fever, headache, generalized artnralgia and hylgias.
BLINDNESS; RETINAL ARTERY OCCLUSION; VISUAL ACUITY REDUCED; This spontaneous report received from a healthcare professional via VAERS (Vaccine Adverse Event Reporting System, VAERS ID 1201402-1) concerned an 82 year old female. Initial information was processed with additional information received from VAERS on 23-APR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and anatomical vaccination site was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced blindness in both eyes, retinal artery occlusion and visual acuity reduced (no light perception in the right and counting fingers in the left). She went to the emergency room and was hospitalized.  Work up for other causes (not further specified) was reported as negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness in both eyes, retinal artery occlusion and visual acuity reduced. This report was serious (Hospitalization Caused / Prolonged, Disability Or Permanent Damage).; Sender's Comments: V0:  This 82-year-old female patient of unspecified ethnicity was hospitalized for blindness in both eyes, retinal artery occlusion and visual acuity reduced (no light perception in the right and counting fingers in the left) 14 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Patient's left arm became red, warm and swollen beginning the day of injection in the afternoon. One the second day  she felt like the flu.  Today she still has an area of erythema and tenderness of about 4cm by 5 cm distal the injection site without swelling, erythema or warmth.
Patient presents the ED after an episode of unresponsiveness at home on sitting in her chair.  Family reportedly did CPR for several minutes EMS arrived on the scene to find the patient with irregular respirations but a strong pulse.  The airway was supported and she was transported to the ED.  Patient noted to be diaphoretic, very hot with rectal temperature of 102.   Airway protected and patient intubated. Possible seizure activity. Patient transported to Tertiary Care Facility
After about 10 minutes after the vaccine, patient started to feel faint. She got very tired and flushed. She acted like she was going to pass out but did not. I got her a drink. It lasted about 10 minutes.
03/18/2019: INITIAL OFFICE VISIT: Chief Complaint(s): Sore throat  All over body rash Hoarseness, lost voice HPI: Notes Pt presents today for an acute visit. Dermatology c/o rash  generalized, upper extremities, lower extremities, trunk, groin , itchy, spreading, raised lesions, hives since yesterday morning, was spreading, has been taking benadryl with some relief, woke up this morning with hoarseness, and sore throat, voice is improving now. Itching is much better, voice is raspy, denies feeling ill or achy or fever, chills, abdominal pain, nausea, vomiting, diarrhea. ENT Denies : COUGH. Denies : EAR PAIN. Denies : EYE SYMPTOMS. Denies : HEADACHE. HOARSENESS  laryngitis, improving since this morning, denies difficulty swallowing. Treatment: Rash and other nonspecific skin eruption  Notes: Discussed various etiologies, most likely allergic reaction. Will start prednisone taper and Benadryl x 5 days. To go to ED with any worsening of symptoms. Advised patient to stay away from hot showers as much as possible, Keep well moisturized, may need to follow up with dermatologist if persistent. Acute laryngitis Notes: Most likely viral vs due to postnasal drip, symptomatic treatment advised. Symptoms are improving. Rapid strep negative. PATIENT RE-EVALUATED ON 03/21/2019: Symptoms mostly resolved PATIENT RE-EVALUATED ON 3/26/2019 TO ENSURE RESOLVEMENT OF ABOVE SYMPTOMS All symptoms resolved.
Heart Failure, Breathing Stopped. Spent 14 days in Intensive care to recover.
36 hours following injection of my second Pfizer COVID vaccine on 3/21/21, I suffered an afib episode lasting 15 hours starting in the early morning hours of 3/23/21.  I then experienced another episode of afib lasting 19.5 hours on 4/10/21.  On 4/16/21, I suffered my third afib episode following my second injection, which lasted three hours.  As I was converting to a normal sinus rhythm on that day, I went into sudden cardiac arrest for 10-20 minutes and was transported to the local hospital emergency room via ambulance where I was held for approximately 24 hours for observation and testing.  Since that sudden cardiac arrest event, I have experienced two more afib episodes to date, one on 4/26/21 lasting 8 hours and one on May 5, 2021 lasting 6.5 hours.  While I have experienced afib in the past due to a virus attacking my heart in 2018, I had not had any afib episodes for 14 months and had built my ejection fraction back up to 60-65% over a three-year period.  I have never experienced afib episodes with such frequency since my initial conversion to sinus rhythm three years ago following the virus attacking my heart until I received the second dose of the Pfizer COVID vaccine along with never, ever experiencing sudden cardiac arrest following the second dose of the Pfizer COVID vaccine.
muscle pain; fatigue; headache; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
1st day after vaccine:  Fever of 99.9°F, Felt achy, Arm sore, Slight cough when exhaling -- Took extra strength acetaminophen and ibuprofen 800mg 2 days after vaccine:  slight fever of 98.8°F, Didn't feel 100% better -- No meds
Reccived at vaccination clinic without a problem.  One week later, I developed a circular rash on my Left ( about 2 - 3 inches in diameter) at at and below the infection site.  The site itches and feels war,m and slightly swollen.  I am using antihistimines and a cortisone cream to treat the problem.
we had very mild (drowsy/arm pain) symptoms; we had very mild (drowsy/arm pain) symptoms; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiration date was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced very mild (drowsy/arm pain) symptoms. The outcome of the events was unknown.  Information about batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595764 Same reporter/drug/AE and different patients.
brain bleeds that happened 45 or 60 days after the vaccine.; This is a spontaneous report from a Pfizer sponsored program . A contactable Consumer (patient s wife) reported for a patient (reporter s husband). A male patient of 90-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9629, and Expiration date: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 89-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), on 14Jan2021 (at the age of 89-year-old) for COVID-19 immunization. The caller (reporter) mentioned that her husband had "brain bleeds that happened 45 or 60 days after the vaccine" on an unspecified date in 2021. The caller had not been vaccinated she recently discovered she had an Iron overload in her blood. Asked if the Pfizer COVID-19 vaccine (COMIRNATY) was going to be toxic. No Information found regarding product medical question. Spoke from attached CONS document, referred to HCP, offered to email for review. The caller asked how she can get ingredient list and she was offered to email ingredient list. The outcome of the event was unknown.