chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was sitting in chair after getting his vaccine. The patient then passed onto the floor. He was placed on a cot, pillow under his head, both legs elevated on a chair. He was given water and crackers. A red mark noted on the left side of forehead.   09/6/22 @ 1122 - Client found lying in prone position, unconscious after hearing client falling from chair. RN and LPN assisted client back to chair and client quickly regained consciousness, A&O, speech coherent, able to answer questions that was ask. Skin pallor and red bruising noted on the left forehead, skin intact. Client denied any discomfort. BP @ 1043 sitting position 100/49 pulse 53. Client drinked 1/2 water bottle during observation. Client noted to become weak not as alert. Client c/o of feeling lightheaded. RN and LPN assisted client to lie down, skin noted to become pallor BP 109/75 P 63 RR 20 in lying position @ 1050. MD called regarding situation and she responded that she will send NP to clinic. NP arrived, assessed client. Client was then able to answer all questions. Client sat up on the floor for several minutes before sitting back in chair. Client stated that he felt "fine" and denied any discomfort. A snack was given to client to eat. BP 118/82 pulse 62. Writer witnessed NP encourage client to call someone to have them be aware that client is driving along and that person need f/u. After monitoring client for 30mins, client remain A&OX3, denied any discomfort or needs. Writer escorted client to vehicle and watched him drive out of parking lot.
Cold sore outbreak and sores inside the mouth as well. Pain (including tooth pain) for a few days. Took acyclovir for cold sores, just barely going away now.
Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.; no adverse event; Expired vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.) and NO ADVERSE EVENT (no adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.).    Concomitant medication not reported.   Treatment medication not reported.
The day after the shots I had a bad headache. The next day I was extremely sick with vomiting and diarrhea. I went to the emergency room 3 times and to several doctors. They can't seem to figure out what's wrong other than the shots. It's the only thing that was different.
Patient was given full dose (0.5ml) Moderna for a 3rd booster dose instead of 0.25ml - patient states they did not have any negative outcomes from the vaccine
Arm rash and Itch. Swollen appeared within a couple of days then was getting better. Reappeared on day 9, now have huge red area size of palm. Itching again and more swollen than first time.
She got the second shot and the noise disappeared for one month and then came back again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "After the first shot the next day she got a strong noise". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "She got the second shot and the noise disappeared for one month and then came back again". The patient underwent the following laboratory tests and procedures: blood test: result unknown.  Additional Context: The patient got a shot in Jul and from then till now she has a noise. After the first shot the next day, she got a strong noise. She got the second shot and the noise disappeared for one month and then came back again. She went from doctor to doctor and saw a neurologist. Before she went to the neurologist she went to therapist and did 4 pages of blood tests and there was nothing else. She was looking on the internet and found out the a lot of people get ear noise, called tinnitus. She went to the neurologist two weeks ago and he checked her hearing and found nothing wrong. Sent her to get an MRI and she would go to get the MRI today. The neurologist was sure it was nothing and nothing to do with her brain. Stated this happened after the first shot and it was really bothering her like when she sleeps. She did not want to take medication. Advised to consult with hcp for treatment recommendations. Stated she saw three doctors. Clarifies it was for the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Mar2023 at 14:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jul2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Aug2021 at 15:15 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Apr2022 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: yes. Concomitant medication(s) included: WARFARIN, start date: 15Mar2023; TRAMADOL, start date: 21Mar2023; LEVOTHYROXINE, start date: 14Mar2023; METHOTREXATE, start date: 05Jan2023; ALLERTEC [CETIRIZINE], start date: 01Jan2023; VITAMIN C [ASCORBIC ACID], start date: 15Mar2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course- Treatment included Paxlovid from May2023 to Jun2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218279 same patient, different drug, different events;
Shaking and numbness in my legs for more than six days; Shaking and numbness in my legs for more than six days; A paralytic feel; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on 15Apr2021 15:00 (Batch/Lot number, Expiry date was not reported and Age at the vaccination: 40-years-old) as single for covid-19 immunization. The patient's medical history and past drugs reported as no. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19 was mentioned as no whereas since the vaccination, the patient had been tested for COVID-19 was mentioned as yes. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination was reported as No. On 16Apr2021 12:00 AM, the patient experienced major shakes throughout the body within 24 hours of the first dose. The shakes went away but had persistent numbness and shaking in the lower extremity of both her legs. A paralytic feel. After taking antihistamines, the side effects got better but still to this day had not gone away when going down a flight of stairs. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test (Nasal Swab) was negative on 26Jun2021. The outcome of events was not recovered.   Information about lot/batch number was requested.
pt began crying unconsolably from 630Pm on;mom called voice mail w/baby crying & MD was unable to get phone number;mom never called back & never followed instructions on voice mail to call MD @ home;mom called ER nurse & gave motrin;
Exactly 7 days after my first dose my left arm began to itch, has hives, very red, has fever in it. Also felt like my skin was crawling all night long. I tried benadryl cream with no luck. Im trying liquid benadryl orally today to see if that helps.
PAIN RELIEF AFTER VACCINATION IN HANDS AND SHOULDER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced pain relief after vaccination in hands and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain relief after vaccination in hands and shoulder was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of alkaline phosphatase increased in a 70-year-old male patient who received SHINGRIX. The patient's past medical history included multiple myeloma. Concurrent medical conditions included neoplasm and blood pressure. Concomitant products included Aspirin, ELIQUIS, POMALYST and ZOMETA. On 6th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th April 2018, 29 days after receiving SHINGRIX, the patient experienced alkaline phosphatase increased. On an unknown date, the outcome of the alkaline phosphatase increased was unknown. It was unknown if the reporter considered the alkaline phosphatase increased to be related to SHINGRIX. Additional details were provided as follows: On 6th March 2018 10:00, the patient received SHINGRIX. The patient stated that he had a blood test done on 7th March 2018, which showed normal alkaline phosphatase levels of 47 micro per liter. The next report was performed on 4th April 2018 and the blood test results showed elevated alkaline phosphate levels of 493 micro per liter. The patient stated that he was feeling okay at the time of reporting. The patient gave permission to contact his health care provider.
Normal for the 2nd - fever, chills, headache.  The reason I'm writing is because I've had a huge increase in Tinnitus.  Saw ENT today (5/6/21) who said it was most likely due to the vaccine. They are seeing many patients with this issue.
Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms; Skin is inflamed; Ankles are black and blue; Ankles are super swollen; Rashes all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms), DERMATITIS (Skin is inflamed), SKIN DISCOLORATION (Ankles are black and blue), JOINT SWELLING (Ankles are super swollen) and RASH (Rashes all over his body) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 037A21B and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Infection in March 2020.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced URTICARIA (Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms), DERMATITIS (Skin is inflamed), SKIN DISCOLORATION (Ankles are black and blue), JOINT SWELLING (Ankles are super swollen) and RASH (Rashes all over his body). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms), DERMATITIS (Skin is inflamed), SKIN DISCOLORATION (Ankles are black and blue), JOINT SWELLING (Ankles are super swollen) and RASH (Rashes all over his body) outcome was unknown.      The patient experienced "a hives reaction of some sort".  He stated his skin is inflamed and if he scratches the rash it causes "flares".  It was reported that he has huge hives and welts on his hands and palms, and it hurts to walk on feet due to the bad rash.   He stated his ankles are black and blue and "super swollen". He also reported taking Benadryl. He reported the doctor did not think the rash was diet related. Went to doctor (02Dec2021) as was prescribed Steroids   No known food or drug allergies reported.  not had hives in the past.  No concomitant medication details was provided.
This is an instance of COVID-19 breakthrough disease after which death occurred.   The individual was vaccinated with the Pfizer product on 02/01/2021 and 02/02/2021. They became symptomatic for COVID-19 disease on 08/13/2021 and tested positive for COVID-19 on 08/15/2021. They presented to emergency dept on 08/19/2021 and were admitted to hospital on 08/19/2021. They were transitioned to comfort care only and died on 09/01/2021.
Awoke Wheezing with no previous hx.  Given Albuterol Nebulizer treatment and sent home with a machine.  Went to ER later that day with increased symptoms
Four days after the first does patient was admitted to the local ER for stroke like symptoms. She was diagnosed with a TIA at the time. Since then she has been diagnosed with Hemiplegic Migraines. Her symptoms involve light sensitivity, sound sensitivity, nausea, dizziness, prolonged and intense headaches, and weakness of the left side. She's unable to walk unassisted a majority of the time and struggles to control left appendages. She complains of feeling "foggy" and having severe cognitive issues. Her ability to speak and comprehend are severely impacted.
BROKEN ANKLE; TWO DEEP VEIN THROMBOSIS IN LEFT LEG; PULMONARY EMBOLISM IN BOTH LUNGS; This spontaneous report received from a patient concerned a 44-year-old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included Skyrizi (risankizumab) [form of administration unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date (reported as several months earlier), the patient broke her ankle. On unspecified date, in JUN-2021, the patient had pain and swelling in her left leg. The patient went to an urgent care to check it and discovered that she had two deep vein thrombosis in her left leg and pulmonary embolism in both lungs. She received treatment (unspecified) for it and was recovering. The patient's physician felt that the events was not due to Skyrizi but possibly due to Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two deep vein thrombosis in left leg, and pulmonary embolism in both lungs, and the outcome of broken ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210729466-covid-19 vaccine ad26.cov2.s  two deep vein thrombosis in left leg, and pulmonary embolism in both lungs. This event(s) is considered unassessable. The event(s) has a unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt with erythematous injection site with 2 lines of tracking redness down upper arm. (L) neck -> clavicular area with slight edema. BENADRYL taken without relief. Tx'd with IV ceftriaxone, SOLU-MEDROL and course of oral BACTRIM.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of PNEUMOVAX23 that were exposed to temperatures out of range on 02-JUN-2014 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effect has been observed or reported. The outcome of the event was unknown. No PQC reported. The case has been linked with the cases (same reporter link) #1406USA012405, 1406USA012409 and 1406USA012415. Additional information has been requested.
patient is tearful, and reports she is is feeling anxious and like she does when she is having a panic attack. After spending a little time talking through some of her concerns, she began to feel better and symptoms resolved.
pt states she developed a severe headache.  Her heart start burning and could feel this down her left arm. She felt so hot she felt like she was burning.  She developed chills which continued during the night.  The next morning she felt better but it took at least 2 days before feeling good again.  She contacted her PCP to let them know her symptoms. She was told she had a reaction to the vaccine.
Developed sores in mouth; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (formulation, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient developed sores in mouth. At the time of reporting, the outcome of the event was not known.  The causal relationship between sores in mouth and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001254: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513:
I had an occasional dry cough for a couple days with no other symptoms. I took a COVID-19 test on 12/30/2022 and it came back positive. I spoke to an on-call doctor who prescribed me PAXLOVID. The PAXLOVID did leave a metallic taste in my mouth but it did help.
antibody test came back negative; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration first dose on 17Dec2020 and second dose on 07Jan2021, both at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that the patient received both doses of Pfizer COVID vaccine, antibody test came back negative. 1st dose 17Dec 2nd dose 07Jan, antibody test 12Jan2021. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Patient presented to emergency department on 8/28/2021 for fever. He was found to have acute metabolic encephalopathy and UTI. He was admitted for further management. He was found to be COVID-19 positive on 9/30/2021 when screening was performed for post acute placement.  Patient was asymptomatic for COVID-19 during admission. He was discharged to inpatient rehab on 10/6/2021.
This is a spontaneous report from a contactable consumer reported for her granddaughter. A 18-year-old female patient received TRUMENBA for immunization on 14Jun2017 13:00 at 0.5ml single dose. On 09Jun2017 the patient had received MARIJUANA for migraine. On unknown date the patient also received a hepatitis B vaccine. Relevant medical history included Post concussion migraine, Ehler-Danlos genetic disorder and Wiedemann-Steiner syndrome. The patient was a premature baby. On unknown date the patient experienced extremely tired, groggy, really sleepy and slept for 3 hours, little bit loopy, little tiny bit disoriented and the patient had pain in her head which has not been higher than 2 out of 10/ 5 out of 10 when she woke up then 6 and now 7 out of 10. The outcome of all events was reported as not recovered.
Allergic reaction, shortness of breath, dizziness, itchiness  Iv steroids and Benadryl and follow up with pcp
Sleepy, muscle soreness, upset stomach, sore arm, headache.   IBD flare up.  I have not contacted anyone.  Trying to let time heal.
Irritation, swelling, pain to injection site left deltoid area duration 2 days today slight erythema