chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narcosis tissue injection site; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 3 (booster), single (Lot number: 9895) at the age of 48 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Facility type vaccine was reported as Pharmacy or Drug Store. There were no concomitant medications, reported as no other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination and reported as patient tested for covid post vaccination. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0177, Location of injection: Arm Left), administration date: 06Jun2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0196, Location of injection: Arm Right), administration date: 27Jun2021, when the patient was 47-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE NECROSIS (medically significant), outcome "not recovered", described as "Narcosis tissue injection site". The event "narcosis tissue injection site" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Negative. Therapeutic measures were taken as a result of vaccination site necrosis included Surgery.; Sender's Comments: Based on information provided in narrative , there is reasonable possibility of causal association between the event Vaccination site necrosis and the suspect vaccine bnt162b2. 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.
Maybe a wet cough; This is a spontaneous report from a contactable consumer. A 88-year-old male patient (consumer's father) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter's father was 88 years old and he had the first dose of the Pfizer vaccine "yesterday", so he had a cough already and (distorted voice) it appear that the cough now was kind of more of a 'loop' cough maybe a wet cough it was not a constant cough and regular but it was about 30 minutes in between maybe longer but reporter was wondering was that something you should to be concerned with and should we have him with that. Reporter stated, Okay reporter have provided that twice already. So, the number that you just gave me these are the people that probably can answer reporter's question that if we should be concerned about his cough. They are answering reporter's question about the COVID vaccine or they are answering reporter's question that should we be concerned, was this a possible side effect or something. Reporter stated, "the number of the vaccine?" Okay so reporter's sister took him, she has that, and reporter do not have that. The reporter stayed with him last night just to make sure you know that he did not have any side effect. The reporter's other sister took him, and she has that card. The outcome of the event was unknown.  Information for Batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 24-OCT-2015, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
PRESSUERE  RT SIDE HEAD AND DIZZINESS . ON METFORMIN 1000MG BID FOR DM, PER PT BS=250MG, BP118/80 HR85 SPO2 97,NO SOB. PT VOICED RELIEF OF DIZZINESS AT 18;35. SEEN BY MD , RECOMEND TO SEE PCP IF WORSEN
Pt. received FLUMIST 10/19/13. Developed itchy rash on 10/20/13. Parent giving BENADRYL at home. On 10/21/13 -> brought to ER where diagnosed with urticaria, discharged to home on ORAPRED.
Patient given Zoster vaccine 11/23/15. Patient received an extra dose of Zoster vaccine 8/2/16.
febrile sz, OM admitted for evaluation-discharged;  EEG scheduled; had CT scan, LP;
Very sore arm, sore throat, headache since afternoon of 4/19, fever, nausea, some dizziness.
10 hours after shot: arm soreness, body weakness, fatigue, 12 hours after shot: continued weakness,  continued fatigue, continued arm soreness, mild fever 99 degree fahrenheit, 24 hours after shot: gone fever, no weakness, arm soreness
administered Flublok to a 23 month old patient, No AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 23 months old patient who was vaccinated with vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on an unspecified date. The lot number and expiry date not reported.  It was actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
this is 1 of 6 pt from this site to have an unspecified adverse exp p/Td vax;
Pain after receipt; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, every patient he gave Shingrix vaccine to, complained about pain after receipt. There were no details about patients or vaccines collected. The reporter called to show how much he disliked Shingrix and made the above blanket statement.
Patient was given 0.25mcg of Moderna Bivalent Booster, Patient was to receive 0.5mcg . Wrong dosage given.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-513803 (Patient Link).
Itchy palms and mouth started 1 hour post injection. Stomach pain/nausea/burning started 3 hours post injection. Still the same the day after.
Patient  received a 2nd dose of janssen on 10/17/2021 , the immunization information system has it in the system that he received a dose on 9/22/2021 , patient denied getting this dose.
Extreme left arm pain;  arm and shoulder incapacity,  constant  throbbing in outer arm, top of shoulder, front of shoulder, inability to lift arm, severe range of motion difficulty. Symptoms started with hours of vaccine and have remained acute after 10 days of vaccine delivery.  Interruption of sleep;  Inabilty to use arm ; severe pain.    Doctor  prescribed 800 mg of Ibuprofen. 3x/day for 10 days beginning 6/17/21.
Chills,  bad aches, headache from temple  to temple, possible fever, chest heaviness. Left arm  1st injection site  3 in frm 2nd injection site  swollen and hard as knot after second injection.  Still feel light headed and  clammy.
Heart palpitations and fluttering with no prior history. Started in September and lasts for 8+ hours.  Then stops and doesn't happen again until several weeks later.  Ultimately on January 1, 2022, I went to ER because the palpitations were non-stop for 2 days straight.
Right arm red, raised, and heat to injection site approx. 12cm X 7cm. Mother brought son to health dept on 06/26/14 to have nurse look at arm. Discussed local reaction. Told if arm was worse tomorrow to take him to doctor to have evaluated. Keep cool compress and use motrin to help with swelling. C/o nausea day of injection per mother.
Lethargic; Not feeling well; symptoms are worse; tired; itching; swelling at injection site; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), MALAISE (Not feeling well), CONDITION AGGRAVATED (symptoms are worse), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE ERYTHEMA (injection site redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (itching). On 01-Feb-2021, the patient experienced LETHARGY (Lethargic), MALAISE (Not feeling well), CONDITION AGGRAVATED (symptoms are worse) and FATIGUE (tired). At the time of the report, LETHARGY (Lethargic), MALAISE (Not feeling well), CONDITION AGGRAVATED (symptoms are worse), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (injection site redness), FATIGUE (tired) and VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included blood pressure medication, antioxidants and losartan.
Redness and soreness to biceps muscle of right arm below the injection site. Pain began almost immediately after injection. Redness appeared 24 hours after injection.
12 y/o received KINRIX vaccine. KINRIX is approved for ages 4-6 years.
Weak; Dizzy; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. He had a side effect of dizziness and he was weak yesterday. The weakness had improved and he got his strength back. He still has dizzy spells. He is wondering since his strength came back today if he should wait to see how he feels tomorrow before he goes to the ER. He also began to feel tired and weak that day, yesterday he felt dizzy, light headed and weak. Today he is still weak. He has heard of other people feeling tired for a few days but were fine after that. The outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
i havent started a period and all pregnancy tests have read negative; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (i havent started a period and all pregnancy tests have read negative) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-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 MENSTRUATION IRREGULAR (i havent started a period and all pregnancy tests have read negative). At the time of the report, MENSTRUATION IRREGULAR (i havent started a period and all pregnancy tests have read negative) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
02/08/2022 I had sudden pain in my right lower back closing a window. I had been carrying my 18-month-old son on my hip and he would lean back. I did PT for a while and was still having significant pain. In the summer I saw my PCP. I thought I had injured my SI joint.  We did imaging, a  CT in June of 2021. There was severe bilateral SI and possibly minor erosion on the left side. After that, I saw an Orthopedist and he could not tell if it was degenerative or the Silicic joint. He ordered an MRI in January, 2022. It showed inflammation on both sides and some disc disease at L5, S1. I had several injections in July of 2021 and another injection with Pain Anesthesia in early October. I had acute pain after that. I went to emergent care and had Toradol injection. My pain doctor prescribed Tylenol 3 and Tizanidine for pain. Since then I had more pain in the left side and had sciatica going down the back of my left leg. I tried an epidural injection to see if it was the back causing pain in December of 2021. I had a spinal fluid leak after that and missed a week of work. A week ago today, I had a steroid injection. My PCP ordered labs for the sacroiliitis to see if it was rheumatoid vs a skeletal issue in March 2022.  The doctor said the results showed it could be Rheumatoid arthritis. I see a Rheumatoid Arthritis specialist next week.
Patient is a 71-year-old male who tested positive for Covid 7 days ago. Began having cough and shortness of breath 2 weeks ago. He was seen in the emergency room 7 days ago and treated for COPD but he ultimately tested positive for Covid. Patient did go through a course of Levaquin and steroid.  He presents back to the emergency room tonight concerned about decreasing oxygen levels despite being on home O2 at 4 L. Patient states his oxygen saturations were in the low 70s at home on oxygen.  He increased his oxygen to 4 L/min however his oxygen saturations only went up to 84%.  Patient presented to the emergency room by private auto and his oxygen level on presentation was 60%. He denies fever or chills. He does admit to some generalized aches and pains and generalized weakness. Denies chest pain. Patient also has a history of COPD, congestive heart failure and hypertension.
pt recvd vax & devel sl low grade fever; later seemed fussier but not other sx; next day t101 given Motrin; 9PM onset of sz activity; pt taken to ER dx febrile seizure; pt exp limpness & staring; poss viral illness;
Pt recv vax & devel rash on face,arms, legs, trunk & a fever w/chills. No further details
Started to stare & chew on cap of bottle w/bottom teeth; began to shake like w/chills was staring straight up w/o tilting head, tried to reach & grab for something that wasn't there; started jerking & foaming @ mouth; t102 @ home 104.8 hosp
Patient presented to ED on 02/07/2022 with increased SOB.  Patient had chronic hypoxic respiratory failure on 3 L O2 at home.  Patient experienced several syncope episodes.  Recently had a carotid surgery back in December 2021.  Patient stated he developed increase cough over past several days and coughed to point of passing out.  Patient tested Covid-19 positive on 02/07/2022.  Patient presented to ED in hypoxic respiratory failure.  Chest Xray shows edema and infiltrates.  Patient admitted to hospital.  Patient was started on Remdesivir, dexamethasone, and baricitinib due to bilateral covid-19 PNA.  Patient was started on Vapotherm.  Patient was discharged home with home health and oxygen on 02/20/2022.  Patient expired on 04/06/2022.
I got one shot I didn't know it was supposed to be two shots; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not applicable for this report. The patient never had shingles, but patient got one shot patient did not know it was supposed to be two shots. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
PATIENT REPORTED SHE HAD A 100.6 TEMP 4 HOURS AFTER VACCINATION, SHE ALSO STATED SHE THREW UP AND WAS CONGESTED. NO TREATMENT WAS SOUGHT BUT ALL SYMPTOMS WERE RESOLVED WITHIN 24 HOURS.