chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On an unknown date the patient was vaccinated with (Oka/Merck) PROQUAD (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported that vaccines were reconstituted with less than the recommended amount of diluent. No adverse effect was reported. No product quality complaint was reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA007501, 1407USA008558 and 1407USA008557 via same reporter link. Additional information has been requested.
Received call from ER physician that infant had died. Mom reported child was a little fussy yesterday due to teething. She swaddled him and put him to bed. When she went in to check on him in the middle of the night he had expired.
Patient he had a sharp pain in stomach during the night of 4/18/23. His roommate then told him that he passed out for 10-15 seconds. When he awoke, he felt fine and the stomach pain was gone. He said that he did go to the emergency department. They did testing and said that there were no findings of merit. He was told to follow up with primary care physician.
Platelet count fell critically low,  <5. I'm now taking prednisone to try to bring count back up.
Patient claimed she had delayed allergic reaction at site of injection. Claims it was swollen, hot and red about 24 hours after vaccination. Doctor on cruise ship gave Benadryl and swelling went down.
Oral lichen planus; Gums were inflamed; This case was reported by a nurse via sales rep and described the occurrence of oral lichen planus in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced oral lichen planus and gingival inflammation. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the oral lichen planus and gingival inflammation were not recovered/not resolved.   The reporter considered the oral lichen planus and gingival inflammation to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The reporter stated that the patient told her that she was diagnosed with oral lichen, planus by her periodontist following her first shot of Shingrix.  The patient said that her gums were inflamed and that having the Shingrix shot was the only thing that she thought of that she had done differently that had caused this inflammation. The patient was currently being treated with steroids and appropriate care by her periodontist. The reporter did not consent to follow up.
itchy left arm; swollen left arm; lump on her left arm; left arm a little sore, sore left arm; red left arm; headache; achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache), PAIN (achiness) and VACCINATION SITE PRURITUS (itchy left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache) and PAIN (achiness). On 28-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE SWELLING (swollen left arm) and VACCINATION SITE MASS (lump on her left arm). At the time of the report, VACCINATION SITE PAIN (left arm a little sore, sore left arm), VACCINATION SITE ERYTHEMA (red left arm), HEADACHE (headache), PAIN (achiness), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE SWELLING (swollen left arm) and VACCINATION SITE MASS (lump on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Multiple red macules and papules L. arm from wrist to vaccination site. Patient stated that he noticed them in the AM of 2-19-03. At 1:30pm when examined by RN, the rash was starting to go away. On further inspection, the same rash was noted on the R. forearm. No rash noted on the chest or stomach. Patient denies any other problems. He was instructed by RN to see his primary care MD if condition worsens. Patient was seen on 2-19-2003 @ 1:30PM. The follow up states "follow up with pt on 4/17/03 #9 'yes'."
Infant given #1 series-Rotateq not given due to mom reports watery diarrhea stools x several days-saw Dr was told put cereal in bottle to help with diarrhea had 2 res EP SAT doctor. Injection given within 2 min developed hive like rash entire head no where else Resp-80 with wheezes Ephephrine 0.05 in right thigh, 10:32 am 911 called
This dose was given in error as the patient had already received a bilvalent covid vaccine in September 2022.   As of 24 hours after the vaccine was given the patient was reporting only mild pain at the injection site and no other adverse reactions.
My son died the morning of 5/25/21. He was 22 year old. Autopsy cites cause of death to by unknown.
developed fever  103  2 days after   vaccination  . resolved without  any  sequelae
Came down sick with occlusion; Stenosis; Vertigo of central origin; Dizziness; Came down sick; This spontaneous case was reported by a consumer and describes the occurrence of OBSTRUCTION (Came down sick with occlusion), STENOSIS (Stenosis), VERTIGO CNS ORIGIN (Vertigo of central origin), DIZZINESS (Dizziness) and ILLNESS (Came down sick) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 031m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBSTRUCTION (Came down sick with occlusion) (seriousness criterion hospitalization), STENOSIS (Stenosis) (seriousness criterion hospitalization), VERTIGO CNS ORIGIN (Vertigo of central origin) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and ILLNESS (Came down sick) (seriousness criterion hospitalization). At the time of the report, OBSTRUCTION (Came down sick with occlusion), STENOSIS (Stenosis), VERTIGO CNS ORIGIN (Vertigo of central origin), DIZZINESS (Dizziness) and ILLNESS (Came down sick) had not resolved.            No Concomitant medications were reported.  Patient was in the hospital for his symptoms and he was treated. Patient started to experience events on late November-early December.  No Treatment information was reported.  Company Comment: This case concerns a 93-year-old-male subject, with no relevant medical history reported in this case, who experienced serious unexpected adverse events of Obstruction, Stenosis, Vertigo CNS origin, Dizziness and Illness. The events occurred in an unknown date after the administration of the second dose of a proper schedule of product administration of mRNA-1273 vaccine. The rechallenge is not applicable since the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Follow Up received include no new information.; Sender's Comments: This case concerns a 93-year-old-male subject, with no relevant medical history reported in this case, who experienced serious unexpected adverse events of Obstruction, Stenosis, Vertigo CNS origin, Dizziness and Illness. The events occurred in an unknown date after the administration of the second dose of a proper schedule of product administration of mRNA-1273 vaccine. The rechallenge is not applicable since the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever/chills, left arm rash, itchy legs, myalgias.   Tylenol/benadryl with good effect. No symptoms today.
Approximately 20 minutes after receiving  2nd  pfizer dose, I started feeling lightheaded/dizziness without vertigo.  Feeling of head tightness.  Still have the feeling while reporting this event.
OXYGEN WAS AT 92%; BLOOD PRESSURE 62/80; EDEMA OF FACE; EDEMA OF THROAT; EDEMA OF TONGUE; EMESIS; WHEEZING; ALLERGIC REACTION; NAUSEA; This spontaneous report received from a patient concerned a 23-year-old white, Not-Hispanic/ Latino female. The patient's weight was 230 pounds, and height was 64 inches. The patient's concurrent conditions included non-smoker, alcoholic, penicillin allergy, anti-biotic allergy, food allergy, factor VIII (a), endometriosis, bilateral urinary reflex, arthritis, slipping rib syndrome, asthma, and PTSD (Post-traumatic Stress Disorder), and other pre-existing medical conditions included no illicit drug use or drug abuse. The patient was previously treated with Leuprorelin acetate for 10 years which was ended on FEB-2020 and 2 rounds of Intravenous chemotherapy for 6 months apart ending 22-NOV-2019, for drug used for unknown indication; and experienced drug allergy when treated with acetylsalicylic acid, gabapentin, ethinylestradiol/ferrous fumarate/norethisterone acetate, meloxicam, ibuprofen, paroxetine hydrochloride, topiramate, ketorolac tromethamine, venlafaxine, and sertraline hydrochloride for drug used for unknown indication. The patient mentioned that she had also taken 2 oral chemotherapy drugs of which names she did not remembered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A 21A and expiry: 23-JUN-2021) dose was not reported, frequency of 1 total, administered on 04-JUN-2021 18:10 for prophylactic vaccination on right deltoid. Concomitant medications included cannabis sativa flower for arthritis. The patient reported that after vaccination on 04-JUN-2021 at 18:15 she began experiencing allergic reactions with symptoms of nausea, vomiting, wheezing, and swelling of face, throat and tongue. She also mentioned that her oxygen was at 92% and blood pressure was 62/80.  Laboratory data included: Blood pressure (NR: not provided) 62/80 62/80, and Oxygen saturation low (NR: not provided) 92% 92%. On 04-JUN-2021 18:20, treatment medications included: epinephrine. On 04-JUN-2021 18:20, treatment medications included: Epinephrine, 2 doses had been administered. The patient had visited the emergency department for monitoring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen was at 92%, blood pressure 62/80, emesis, and nausea on 04-JUN-2021, was recovering from wheezing, edema of face, edema of throat, and edema of tongue, and the outcome of allergic reaction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210611762-COVID-19 VACCINE AD26.COV2.S-OXYGEN WAS 92%,BLOOD PRESSURE 62/80,EDEMA OF FACE,EDEMA OF THROAT,EDEMA OF TONGUE,EMESIS,WHEEZING. 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).20210611762-COVID-19 VACCINE AD26.COV2.S-ALLERGIC REACTION,NAUSEA. This event(s) is labeled per RSI and is therefore considered potentially related.
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of VARIVAX. No adverse effect reported. The temperature excursion details included exposure to temperature of 6 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
8.5 cm x 5.5 cm indurated, reddened, swollen area noted on left deltoid. Began noticing reaction right away. Prescribed Keflex 500 mg PO QID x 7 days, tylenol, ice packs
This is an instance of breakthrough  COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/30/2021 and 02/20/2021. They tested positive for COVID-19 on 09/29/2021 and again on 10/02/2021. They  presented to emergency department via EMS on 10/06/2021 with a primary concern of shortness of breath. They were admitted to hospital same day. The individual was found to be having complications and co-occurring conditions including coagulopathy, encephalopathy, COVID-19 pneumonia, hypoxic respiratory failure, shock, and a Gastrointestinal Bleed. They remained hospitalized until their death on 10/12/2021.
Patients husband called and said her arm started hurting the next day after the shot (11/14/21). Said it was round and red around shot area (about size of half dollar he said, and painful with a small knot. Today (11/15/21) he said it was not any worse but still sore. I told them to take both Ibuprofen and tylenol, rotating them, and to do that for the next 2 days and to call back tomorrow to see if getting better. He said she had no other symptoms.
Felt like she was gong to to pass out; Dizziness; Felt somewhat confused; Felt hot; Felt it was hard to breathe; Heart was racing; Fatigue; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D22B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out) (seriousness criterion medically significant), DIZZINESS (Dizziness), CONFUSIONAL STATE (Felt somewhat confused), FEELING HOT (Felt hot), DYSPNOEA (Felt it was hard to breathe), PALPITATIONS (Heart was racing), FATIGUE (Fatigue) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out), DIZZINESS (Dizziness), CONFUSIONAL STATE (Felt somewhat confused), DYSPNOEA (Felt it was hard to breathe) and PALPITATIONS (Heart was racing) outcome was unknown and FEELING HOT (Felt hot), FATIGUE (Fatigue) and NAUSEA (Nauseous) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient experienced dizziness and felt somewhat confused. She also felt like it was hard to breathe, and she was going to pass out. Her heart was also racing. At the time of reporting patient further stated that she experienced fatigue, and she felt nauseous and hot but she was feeling better now.  Company comment: This case concerns a 29-year-old female with a serious unexpected event of loss of consciousness, and nonserious dizziness, confusional state, dyspnea, palpitations, feeling hot, fatigue, and nausea. Event onset 3 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 29-year-old female with a serious unexpected event of loss of consciousness, and nonserious dizziness, confusional state, dyspnea, palpitations, feeling hot, fatigue, and nausea. Event onset 3 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient started having trouble breathing about 2 minutes after his vaccination. Began to develop trouble hearing and having yellow vision. Within 5-8 minutes patient began sweating on his forehead and was feeling very tired. Patient was given water and 911 was called for more advanced observation. At the point fire fighters came to the seen, patient was feeling better and symptoms were almost completely gone.
A report has been received from a Health Professional concerning a 3 year old, Female patient. The patient had been receiving Nasal FLUMIST. FLUMIST started on 15-Jan-2012. The patient was administered expired FLUMIST which started on 15-Jan-2013. FLUMIST was discontinued on 15-Jan-2012. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by reporter.
left arm has bump on Injection site it?s also very warm and tender to the touch  headaches left side very tired fevers nausea lost of appetite
Breakthrough case after 4 vaccines Pfizer 4/30/21 Lot# Er8733;  Pfizer 5/21/21 Lot# EW0158;  Moderna 12/3/21 Lot# 034F21a;  Moderna 4/28/22 Lot# 002M21A
Fever Chills Sweat Jaw stiffness Headache Muscle soreness in injection site
Dizzy w/ HA, Nausea-passed out in chair. Aprox 2 mins immediately came too when moved to wheelchair. Previous Hx of passing out with IV's. IUD removed today at 11:00am. No recall of event prior to passing out. Urinary incontinence. Vitals 107/71; 71; 99%SaO2.
No adverse event; 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) in a kids patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:unknown.     On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date).    No Concomitant medication was reported.  It was reported that 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date. Vials expired on 11Feb2023. No AEs were reported. Caller did not have any patient demographics but stated patients were kids.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710351:Patient 2 case
16mos p/vax pt broke out w/full blown varicella lasting 2wks
Potential vaccine-associated AE noted onset 4 days after Moderna dose 1: "Covid arm", but also had chills, headache, nausea, feverishness.  Headache lasted about 10 days.  Patient did not seek medical evaluation.
weightloss; Dyspnoea exertional; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of WEIGHT DECREASED (weightloss), DYSPNOEA EXERTIONAL (Dyspnoea exertional) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2101886) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included PIRFENIDONE (ESBRIET) and WARFARIN.    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 WEIGHT DECREASED (weightloss), DYSPNOEA EXERTIONAL (Dyspnoea exertional) and HEADACHE (Headache). At the time of the report, WEIGHT DECREASED (weightloss), DYSPNOEA EXERTIONAL (Dyspnoea exertional) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Itchy rash x 5 days. Several days prior to onset, had some discomfort. Treat with NSAID and gave patient education handout.
Lump on left collarbone about size of a cashew. feels like a bruise. I can move it around my collarbone with my hand. Suspect it's the side effect of the swollen lymph nodes.
I was sick 03-04-2021 through 03-06-2021, was on a bed pain, extreme vertigo but on 03-09-2021 lightheaded after waking up, not completely well. I also vomited and had diarrhea. It took me several weeks where I could not move my head. I was on fluids and could not eat, complete liquid diet. Very sick. I could not get out of bed at all. It was several weeks where I could not my head side to side, was acutely ill for about two days and third day. On the 9th day of March I was lightheaded and I was not completely stable on my feet for several weeks. On 03-11-2021, I also had a gynecologist appointment, which I had already scheduled and she told me to use a hormone cream because I was having a post menopausal problem. My symptoms lasted about three days then by the end of March 2021. I am sure I recovered completely.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020353 and expiration date 28-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
Hives covering arms and legs, some on torso. Extremely itchy.  Still present one week later. No change in severity for the first five days with daily use of antihistamine.