chrisvoncsefalvay/vaers-outcomes huggingface dataset:
evening p/vax t103 & very lethargic-was on APAP q 4 hrs; following morning t105 taken to MD; showed inc WBC; started on Motrin & APAP for elevated temp; dx w/ear infect;
No adverse effects have currently been reported. This is being completed due to patient receiving vaccination with a vial that was left out greater than 12 hours (23 hours) at room temperature after first puncture.
had COVID; had COVID; collapsed on 14Jan2022; vomited; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 89 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hard of hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Dose: 02), administration date: Apr2021, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "recovering" and all described as "had COVID"; CIRCULATORY COLLAPSE (medically significant) with onset 14Jan2022, outcome "recovering", described as "collapsed on 14Jan2022"; VOMITING (non-serious) with onset 14Jan2022, outcome "recovering", described as "vomited". Therapeutic measures were taken as a result of drug ineffective, covid-19, circulatory collapse, vomiting.The caller's dad got COVID first, he goes out of the house more than her mother dose. He didn't wear his N95, only a cloth mask. He had a sore throat that started on 13Jan2022 and collapsed on 14Jan2022 and couldn't get up, he also vomited, and then 15Jan2022 he was was diagnosed with COVID. The doctor also ordered Paxlovid for him which he started on 17Jan2022 and has been stellar on it, his symptoms have revolved pretty quick and he is much better. He did great on it. Her dad had the COVID vaccines at the same time as her mother, they went as soon as they were able to for their age group. She thinks maybe around Mar2021. Caller knows that his Paxlovid was also 4 mg PO BID and it was issued on 15Jan2022 but he didn't start it then because it took 2 days to get it. He had no side effects to that, it was going good and she has no concern with that. He started on 17Jan2022 and did the whole course and he says that he feels 90 percent better than when he was really bad, which was a week prior. He seems to be fine so she doesn't want to do a report for him.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between reported events Drug ineffective, Covid-19, circulatory collapse, vomitting and the suspect BNT162B2 cannot be excluded/assessed.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
01/27/22 Covid symptoms started with sore throat, stopped up nose but also a runny nose, cough, and pains in my chest. Symptoms lasted for at least 5 days but maybe a little longer than that. A week into it I started having stomach problems and I was nauseated, I couldn't eat, and had mild diarrhea. My stomach stayed queasy and upset until about 2 days ago. 02/16/22 I felt like I was getting a sore throat again but it went away so it might be unrelated. 01/28/22 I went to the local emergency care and they did the Covid test which was positive and I seen a Doctor and he said I had the symptoms and so he gave me antibiotics, prednisone, and liquid cough syrup. I didn't need the cough syrup because the cough wasn't bad enough to take it. I did have a cough but it wasn't very bad. I took all the medication and quarantined for 10 days. The whole illness was not bad and I wasn't sick enough to be afraid and didn't have to call paramedics with any breathing issues because I do have a history of bronchitis and this didn't effect or bring on any of that. The pains I had in my chest did frighten me more than anything else but they weren't severe enough to go back to the Doctor or call 911. Hardest thing to get over is getting my strength back.
Fever, leukocytes, headache 1 day after the vaccinations. Local swelling at the arm.
Pulmonary embolism; died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) and PULMONARY EMBOLISM (Pulmonary embolism) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Prostate cancer and Memory loss. Concomitant products included METFORMIN for Diabetes.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) (seriousness criterion death). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion death). The patient died on 04-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was multiple blood clots.            Action taken with mRNA-1273 in response to the event was not applicable  Other concomitant medications were reported included unspecified medications for memory loss and diabetes.  No treatment information was provided.; Sender's Comments: This is an 83-year-old, male patient who received mRNA-1273 Vaccine who experienced multiple thrombosis and died, 2 days after receiving second dose of vaccine.  Medical history includes Diabetes, and Prostate cancer.  Conmeds including some unspecified medications for memory loss and diabetes. The autopsy-determined cause of death was multiple blood clots.  Very limited information has been reported at this time. Further information is expected,; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: multiple blood clots
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route were unknown, lot # M009766 with expiration date 23-FEB-2018). The vaccines were exposed to temperature excursion of -10.4 degree centigrade for 50 minutes on one occasion and -10.4 degree centigrade for 19 minutes on another occasion. No previous temperature excursion was reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
within fraction of seconds I fell down (lost conscious); After sometime i woke up I barely could see; On the same night, my left arm (where shot is injected) started paining; This is a spontaneous report from a contactable consumer (patient).    A 26-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 17:45, at the age of 26 years old, (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. The patient previously took Tetanus shot and after 5-10 mins of it he lost conscious for a while. The patient experienced lost conscious on 22Apr2021 07:45 with outcome of recovered, vaccination site pain on 20Apr2021 with outcome of recovered, vision blurred on 22Apr2021 with outcome of recovered.   The clinical course was as follows on the same night of vaccination the left arm (where shot is injected) started pain and became pain relief after a day i.e., 21Apr2021. The next day on 22Apr2021 he woke up and went to bathroom for his daily routines. He stepped in shower and stood under water for sometime then he removed the band-aid from the left arm (where the shot is given) within fraction of seconds he fell down (lost conscious) on the left hand side from the bath tub (him legs still in the bath tub) after sometime he woke up and now fell in the bath tub. After sometime he woke up, and he barely could see, tied him towel and came out to him room and laid down for a while. Then everything went back to normal. The patient didn't receive treatment for the events.
On 9/4/09@ 1400 client called me and notified me of the following information...9/3/09 @0630 client states woke up with tingling pain in bilateral lower extremities. States was able to attend school but also had tummy ache, head ache but no temp.  Denies having taken any other meds to help aleve some of the discomfort.  On 9/4/09@0630 client stated when getting out of bed that morning she was unable to walk due to pain in both legs.  Client describes pain as feeling like your legs are asleep but they're tingling so bad it hurts to move them.  States pain is bilateral lower extremities and nowhere else.  Client denies having taken anything for the pain.  I was taking the report on 9/4/09 at approx. 2pm and asked if she had taken any meds to help alleviate pain and client denies at this time, but does state that symptoms have subsided.  I instructed her to see a pcp at the local walk in clinic immediately to evaluate symptoms.  Client voices that she will do so as soon as we hang up. 9/7/09@0815 Phone call made to client to check on progress.  Aunt state's she is better and is at school @ this time but will have patient call when she's back from school today.  9/8/09@1600  patient returns call and states that all the s/sx have disappeared.  She worked an 8 hour shift on that Saturday 9/5/09 following onset of her s/sx and did fine.  Denies having seen a doctor for any follow up care states that she feels fine and didn't feel like she needed further care.
This case was reported by a consumer and described the occurrence of arm soreness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 16 October 2009 and on an unspecified date the subject received unspecified dose of FLULAVAL (unknown). On an unspecified date, at an unspecified time after the previous vaccination with FLULAVAL, the subject experienced arm soreness and tiredness. On 16 October 2009, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness and expired vaccine used. On an unspecified date in October 2009, a few days after vaccination with FLULAVAL, the subject experienced tiredness. At the time of reporting the outcome of the arm soreness and tiredness (after the previous dose of FLULAVAL) was unspecified. The outcome of the arm soreness and tiredness (after the 16 October 2009 dose of FLULAVAL) was unresolved. The subject consulted a health care professional regarding the event (s). On 21 October 2009, the subject reported that she received FLULAVAL last year and experienced side effects similar to what she had experienced with the FLULAVAL dose given on 16 October 2009 (arm soreness and tiredness). She received last year's FLULAVAL again this year and the product expired (July 2009). No other information can be obtained, the subject preferred to remain anonymous.
positive for Covid; positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient in his 20's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The event "positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Ultrasound scan: 3 blocked veins, notes: one going from liver to heart, another from intestines to liver, and one other one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Patient had received the second booster dose. No treatment information provided.
BLOOD CLOT IN BRAIN; ANEURYSM; This spontaneous report received from a consumer (patient's husband) via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had issues with blood clots. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 09-APR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 08-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in brain and had an aneurysm. On 14-MAY-2022, the patient died from blood clot in brain and aneurysm. It was unknown whether autopsy was performed (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20221227620.; Sender's Comments: V0: 20221227681- blood clot in brain. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.  20221227681- aneurysm. The event 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. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN; ANEURYSM
No adverse event; HCP called to report that a patient was administered an expired dose of RECOMBIVAX ( expiration date 04/28/2023).  The list states the administration period is supported. No additional AE/PQC; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 05-MAY-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #T035865, expiration date: 28-APR-2023, administered for prophylaxis (expired product administered) (dose, route of administration, and anatomical location were not provided).  The list stated that the administration period was supported. No additional adverse event was reported.
Tonic clonic seizure on day 11 after the vaccine.  Of note (see other VAERS report of the same kid) he also had a seizure on day 9 after the first vaccine)
Started on 2/27/21:  Swollen lymph nodes under left arm, in left neck, stiffness in left neck, swollen arm, blisters or raised areas forming at sight of injection.  As of 3/1/2021 the redness has spread some.
R Thigh, indurated, erythematous, swollen, hot and painful. Child more fussy than visual! exacerbation of asthma x1 day. Treated with Ibuprofen. Now resolving. No fever.
patient had Moderna the M.A said there was an issue because the patient got moderna; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (patient had Moderna the M.A said there was an issue because the patient got moderna) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (patient had Moderna the M.A said there was an issue because the patient got moderna). At the time of the report, VACCINATION COMPLICATION (patient had Moderna the M.A said there was an issue because the patient got moderna) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.
Swollen left arm with redness, began Pepcid 20 mg, Benadryl 50 mg, and cool compresses to arm 10/29/21
Near immediate shortness of breath that progressively worsened over the following 3 days with unrelenting chest tightness leading to presentation to ED with subsequent hospital admission and ICU transfer immediately after admit.  Diaphoretic with elevated troponin, BNP and requiring non-invasive vent support.
Pt c/o being lightheaded and stated this happens to him when he gets shots or his blood drawn. Car put into park, and seat laid back. pt ate and drank and was observed for additional time. Pt's mother was with him. Pt d/c'd home feeling better.
She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     The patient's past medical history included Hot flashes.   On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced HOT FLUSH (She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine). At the time of the report, HOT FLUSH (She started having hot flashes after not having them for two or three years/She's been having hot flashes more frequently than before the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
no period since receiving first vaccination; no period since receiving first vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18May2021 18:30 (Lot number: EW0162) at the age of 15 years as dose 1, single and administration date 08Jun2021 16:00 (Lot number: EW0180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID19 positive in Feb2019- asymptomatic", start date: Feb2019 (unspecified if ongoing), notes: COVID19 positive in Feb2019- asymptomatic. Date of last menstrual period: 18May2021. There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset Jun2021, outcome "not recovered" and all described as "no period since receiving first vaccination". The event "no period since receiving first vaccination" and "no period since receiving first vaccination" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of amenorrhoea, menstrual disorder. First day of last menstrual cycle was on 18May2021. No period since receiving first vaccination. Periods prior had been fairly regular. First menses at age 12. It had now been 5 months with no period. Full blood work completed on 08Oct. No abnormalities or pregnancy in lab results.   No follow-up attempts are possible. No further information is expected.
pt recv vax 18JUN97 pt devel erythema multiforme on 22JUN97;
6-7 hours after the vaccine she developed arm pain, fever and chills.  About an hour later she started to have abdominal pain which worsened over the course of the day to excruciating.  She went to the Emergency Room where a CT scan revealed a perforation of her sigmoid colon and had a resection of the area of the colon and a diverting colostomy surgery done the evening of 1/3/2021.
I started to feel tired once I got the shot, I got the shot at around 1:15 pm. About 5 pm, I started to feel really cold and my whole body was shivering and vibrating. My whole body also started to ache and my bones felt heavy. At about 10 pm I started to get really high fever and felt so cold. I could not sleep even with a winter jacket on, I had a really bad headache in the center of my forehead, lower back pain and felt extremely sore and weak. I found it difficult to stand or walk. I woke up at 2:30 am from bed, to get a snack and took 2 ibuprofen to ease the symptoms. Woke up at about 10 am next day, felt slightly better. Fever has gone down slightly but not completely. Still feeling really cold and shivering.
Severe pain and limited movement in both arms and shoulders.  So severe cannot sleep.  Taking Tylenol and Advils.  Pain and symptoms continued thru October and still persists.  Since it persisted, patient thought it could be arthritis and went to family doctor on 10/21 and he prescribed an anti-inflammatory but it has not helped! Going back to Dr on 11/10 to request blood test and xray/MRI.