chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kidneys and liver shutting down; Kidneys and liver shutting down; Heart started racing 3 days later; Vomiting; A spontaneous report was received from  a consumer concerning a 39-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing, kidney failure, liver failure,vomiting and death.   The patient's medical history included Sjogren's syndrome, Hashimoto's, inflammatory joint disease, osteoporosis, osteoarthritis. She has history of fractured tail bone and leg in three places. Concomitant medications included D3 2 pills a day, folic acid, B12, and calcium citrate. She was allergic to 15 different antibiotics two of which she had anaphylaxis; had huge autoimmune issues; had had reaction to Pneumovax vaccine.   On an unown date ,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Approximately after three days of receiving  second dose vaccine patient experienced heart racing and went to the emergency room .The patient started vomiting and developed a kidney and liver failure. And on the next day she died.Autopsy is doing and the results are not available at the time of report.  Action taken with mRNA-1273 in response to the events was reported as not applicable.   The events heart racing, kidney failure, liver failure and death were considered serious and medically significant.  The outcome of the events renal failure,hepatic failure,palpitations and vomiting was considered as Fatal.; Reporter's Comments: This is a case of death in a 39year-old female subject with unknown medical history of anaphylactic reactions, allergic reactions to pneumovax vaccine, Sjogren's syndrome, Hashimoto's, inflammatory joint disease, osteoporosis, osteoarthritis, who died 4 days after receiving second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Renal failure; Hepatic failure
HARD KNOT AT INJECTION SITE; SWELLING IN ARM; SWELLING INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1801018, and batch number: 1801018 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced swelling in arm. On 06-MAR-2021, the subject experienced swelling injection site. On 07-MAR-2021, the subject experienced hard knot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling in arm, had not recovered from hard knot at injection site, and the outcome of swelling injection site was not reported. This report was non-serious.
On 2/1/2021 he vomited and his pulse began to drop. A doctor from the hospice visited him days before and found him in good health and pressure.  Patient was in the Home Care hospice.
Pain, swelling, headache, stomach ache, nausea, chills, redness whole arm, sweating, can't move arm as normal, skin very hot.
The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.; Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) In a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not have COVID-19 preceding the month of vaccination.  No allergies were reported.  Concurrent medical conditions included Hypertension, Diabetes mellitus, Hyperlipidemia and Chronic kidney disease.    On 01-Apr-2022 at 10:18 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 10:18 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022.Vial didn't undergo any temperature excursions.  Patient did not experience any side effects yet.  Concomitant drugs were not reported.  Treatment details were not given.
Rash (bump 4 days) 3 los(?) bumps arm & face. 3/8 day 7 - 18 local and neck and arm (left)
Patient inadvertently given 3rd dose; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 2 doses of Shingrix on an unknown date).   In June 2022, the patient received the 3rd dose of Shingrix. In June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: The nurse manager reported that the patient received 3 doses of Shingrix. The patient got the 3rd dose about a month ago. There were no side effects but should not have received a third dose. No further details provided on voicemail.  The reporter consented to follow up.  Additional supportive information: The patient received the 3rd dose of Shingrix, which led to extra dose administered. The case US2022106699 was identified as duplicate of case US2022AMR106530. All future correspondence would be added in case US2022AMR106530, which stands as case of record for this patient and the case US2022106699 would be deleted. As per the intake response, considering this case as valid with extra dose administered.
White, raised bumps on hands and arms.  Bumps are worse on the right hard and arm, which is the arm short was administered.
This is a spontaneous report from a contactable pharmacist. A 68-year-old male patient received PREVNAR 13, via an unspecified route of administration in Aug2017 at 0.5ml single dose for immunisation. The patient also started apixaban (Eliquis) at the same time at unknown dose for an unspecified indication. Medical history included atrial fibrillation and hypertension from an unknown date and unknown if ongoing. The patient broke out in hives or a rash all over his body in Aug2017. The doctors thought it was the apixaban causing the rash, so they discontinued the apixaban and started him on warfarin. He was also treated with steroids and the rash slowly went away. Seven or eight days before reporting, the patient broke out in severe hives and rash all over the body again. He was treated with steroids again. The hives and rash are a little better now, but they are not gone. The pharmacist considered the events Medically significant and unrelated to apixaban but related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "hives/rash all over his body " cannot be fully excluded considering the known adverse event profile of PREVNAR 13. Co-administration with apixaban may also provide an explanation for the event.
extremely tired; super lathargic,; sore throat started; Fever was ranging between 101-102 degrees; chills; headache; nausea; glands in neck on left side swollen; Day 1 (day after getting vaccine) woke up with severe pain next to the left ear Day 2: same pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) in the left arm 21Mar2021 at 13:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Patient medical history included high cholesterol and eczema. Concomitant medications included norethindrone (NORTREL) and sertraline (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had undergone a COVID-19 nasal swab test and the result is pending. The patient reported no known allergies to medications, food, or other products. On 22Mar2021 at 06:00 am, the patient had severe ear pain next to the left ear, on 24Mar2021, the patient had glands in neck on left side swollen and hurt to touch, sore throat, fever at 101-102 degrees, chills, headache and nausea, on 25Mar2021, the patient was not able to get out of bed, the patient also had fever at 102 degrees, sore throat and was super lethargic and on 26Mar201, the patient woke up with throat on fire and extremely tired. The events resulted in emergency room visit/ doctor or other healthcare professional office visit. Therapeutic measures taken as a result of the events ear pain, painful lymphadenopathy, sore throat, fever, chills, headache, nausea, lethargy and tiredness included treatment with TYLENOL extra strength. The patient underwent lab tests and procedures, which included COVID nasal swab test on 26Mar2021 and the report was pending, on 26Mar2021, the patient had strep test and the result was negative. The clinical outcome of the event severe ear pain was resolved on 24Mar2021, the clinical outcome of events headache and nausea was resolved on 25Mar2021. The clinical outcome of the events painful lymphadenopathy, sore throat, chills, lethargic, tiredness and fever was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
I had my first shot of Pfizer vaccine on 1/27/2021 and my second shot on 2/17/2021. About a few days after my second shot, I began to have some blisters on my lips, but I did not take Valtrex for fear that it might compromise the vaccine's effectiveness.  On 2/28/2021, I had a sudden bilateral hearing loss, along with dizziness and vomiting. I was rushed to the emergency room, where it was diagnosed as vestibular neuronitis, and might be due to the vaccine stirring up some immune system.  I was given a 12-day prednisone regimen. The dizziness and vomiting were gone the day I started the prednisone, but the bilateral hearing loss did not recover. On 3/24 a head MRI was performed and it demonstrated subdural hematoma.  The question I have is that might the 2/28 events be triggered by the Covid vaccine I received, directly or indirectly. If there was such a possibility, what measures should be taken to prevent or to minimize the possibility for it to happen again with future booster shots?
Approx 6 hours after administration, developed visual problems (blurred) x 10 mins-followed by onset of headache.
I tested positive for covid-19 7 days ago on September 27th.; I tested positive for covid-19 7 days ago on 27Sep2021; This is a spontaneous report from a Pfizer-sponsored program Pfizer, by a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that: I want to report that I have been fully vaccinated with Pfizer against COVID-19 since 13Apr2021 and I tested positive for COVID-19 7 days ago on 27Sep2021. I have been bed bound and incapable of taste, smell and a heavily congested nose and chest. No fever to report. The outcome of the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Right upper arm is warm and painful to touch. Has erythema. Was put on Augmentin ES for cellulitis.
Burned really bad going into my arm. About 8 hours later I developed a rapid heart rate from 70BPM to 130BPM. It lasted all night and into the next day. A total of 12 hours. Then slowly it decreased.
A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a five-year-old male. The patient's concomitant medication history included receiving a dose of FLUMIST four weeks ago. On 02-Feb-2009, the patient received a booster dose of FLUMIST, which expired on 01-Feb-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors ere caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of an investigation regarding a medication error. Additional information was received on 09-Apr-2009 that included the results of an investigation regarding a medication error.
Received vaccine approximately 3 PM 4/6/04. Child did not feel well after vaccine. Fatgue and fever approximately 1-1.5 weeks. On 4/24/04, had temp of 104; went to doctor. Had red ear, dried blood in ear. Was given Zithromax for 5 days. Approximately 1-1.5 weeks after vaccine had purple mottling of skin that came and went (looked like he was cold). Fatigue continued this month. On 5/6/04 at 5:40 PM, had grand mal seizure that lasted 2 hours. Had respiratory arrest; was placed on ventilator and transported to hospital and admitted 5/6/04 through 5/12/04. No fever. Was diagnosed with viral encephalitis, but spinal tap negative. Then 5/13 and 5/14 was in hospital with petit mal seizure. 5/15/04 had grand mal seizure that lasted 30-45 minutes and was transported to hospital until 5/21/04. Then had ear infection treated with antibiotics by doctor. Saw doctor, ENT; she said that ear drum had been ruptured. Is currently on Topomax. Is having behavioral problem; aggression. Currently seizure free; staring.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2023 at 13:15 as dose 6 (booster), single (Lot number: GJ6743) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 21Aug2023 to 25Aug2023  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Patient received the vaccine on 11/6/14 at 2:45 pm. That night his lips started to swell, and around bedtime area under his tongue started to swell. He had difficult time sleeping and in the morning his eyes were also swollen. This doctor called in prescriptions for ALLEGRA, SINGULAIR and prednisone.
Noticed a bump below my collarbone 12 hours after injection. Now believe that it is a swollen lymph node based on what other people have reported and pictures of lymph nodes online.
Within 20 min of vaccines, onset of anaphylactic reaction: swelling of eyes, reddening of face, itching eyes; profuse nose and mouth secretion; agitation. Treated wtih epinephrine, prednisolone, Benadryl. 1/12/06 Review of d/c summary confirms anaphylaxis.
Patient received the dose and sat down for 15 minutes. After 15 minutes he got up and looked to buy something on one of the aisle when he fell down, he was on his knees. The pharmacist got out there set him on a chair, looked for any injuries and asked him if his breathing was ok. He said everything was fine, and that he just tripped over his flip-flops. The other pharmacist called 911 while I stayed with the patient. He was fully aware of what was happening and he didn't present any signs of an allergic reaction. EMT showed up after 5 minutes and talked to him for 2 minutes, and told him he was ok to leave.
This spontaneous report was received from a other health professional referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On 15-OCT-2018 the patient was vaccinated with ROTATEQ orally for prophylaxis (lot # N005617, expired date 03-OCT-2018, dose and frequency were not reported) No adverse effect was reported. No lab diagnostics and medical attention was performed.
mom states that on 14NOV95 930AM pt had episode when eyes rolled back & had twitching of whole body;taken to hosp;afebrile;mild ear infect;on ATB;21nov95 had similar occurance;returned to hosp;kept 1 noc for observation;placed on phenobarb;
day after vaccine, pt woke w/ a swollen upper lip that lasted a couple of days after that had swelling and redness at the injection site.
Information has been received from a registered pharmacist concerning a 54 year old female patient with hypothyroidism and no drug reactions or allergies, who on 26-OCT-2009 was vaccinated IM in the left arm with a 0.5 ml first dose of PNEUMOVAX 23 (Lot number 662842/1296X). Concomitant therapy included unspecified thyroid medication. The registered pharmacist reported that the patient developed pain at the injection site of the left upper arm several hours after receiving her first dose of PNEUMOVAX 23. On 27-OCT-2009 the patient developed a 4 inch by 4 inch area of redness and swelling extending from the injection site of the left upper arm down to just above the left elbow. At the time of the report the patient had not recovered. No laboratory tests were performed. The patient sought medical attention at the pharmacy. Additional information has been requested.
Aches; weakness; loose stool; flu like symptoms; Not eating well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well). At the time of the report, PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a consumer and described the occurrence of unsteady gait in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject reported that in the early 1990's, she developed a wheal after one flu shot. Ever since then, she stopped taking the flu shot until this year (2010). On an unspecified date in 2010, the subject received unspecified dose of FLULAVAL (unknown, unknown arm). On an unspecified date in 2010, less than one day after vaccination with FLULAVAL, the subject experienced unsteady gait. At an unspecified time after the vaccination, she experienced erythema of arm at injection site and arm swelling (injection site). The subject was treated with BENADRYL. At the time of reporting, the unsteady gait was resolved and the outcome of the erythema of arm at injection site and arm swelling (injection site) was unspecified. The reporter indicated after the vaccination with FLULAVAL, she developed a localized reaction of redness and swelling on her arm. The night of the vaccine administration, she got up in the middle of the night and her gait was off to the left. This gait problem resolved by the next morning after taking BENADRYL. There was no further information provided due to the reporter's time constraints.
Went to school to complete the Covid-19 series with patient in relation to completing clinicals for a CNA course. Before leaving office, I removed vial out of fridge from the only Box of Pfizer vaccine we had stocked. Due to the frequency of giving the bivalent  covid shot, I had in my thought process this was the correct vaccine to complete vaccination series. Verified with co-worker, the other office vaccine coordinator of the Lot #. I withdrew the needed number of doses and placed in secure container to transport along with other necessary supplies. Upon arrival, I reviewed the questionnaire form and found no contraindication in the questions. I proceeded to administer dose in requested arm and monitored for 15 minutes as recommended. Upon returning to the office, was entering it into the system, she realized we had administered the incorrect vaccine. I immediately called nurse manager, and reported the incident in which she said she would contact the state to see what the recommendation would be. Later that day, I was able to contact the patient's mother and inform her of what the daughter received.