chrisvoncsefalvay/vaers-outcomes huggingface dataset:
event of a surgery; Missed dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SURGERY (event of a surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (event of a surgery) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, SURGERY (event of a surgery) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient intended to receive her second dose on 14-Apr-2021 from pharmacy. The pharmacist recommended her to confirm with Moderna whether she can get her second dose after missing her scheduled dose. Concomitant medications were not reported.  This report refers to a case of missed dose for mRNA-1273.  Very limited information regarding the event of surgery has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: This report refers to a case of missed dose for mRNA-1273.  Very limited information regarding the event of surgery has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Pt woke up with her left deltoid red and painful. It was also warm to the touch.  As the day went on, the redness became bigger and swollen.  It continued to be red, warm to the touch, painful, and itchy.  Mom brought pt in to be seen and she was dx w/ cellulitis and started on Augmentin.  Sxs started within 24hs of injection.
Pt recvd MMR vax as child & pt currently exhibited a lack of response to mumps; no further details were provided;
Developed multiple-approx 50-papule rash scattered over legs, arms, bottom itchy
hard to move arm; redness of left arm; Swellingof left arm; slight fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 27-OCT-2023, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swellingof left arm) and fever (Verbatim: slight fever). On 28-OCT-2023, the patient experienced movement disorder (Verbatim: hard to move arm) and erythema of extremities (Verbatim: redness of left arm). On 28-OCT-2023, the outcome of the fever was resolved. The outcome of the movement disorder, erythema of extremities and swelling arm were not resolved.   It was unknown if the reporter considered the movement disorder, erythema of extremities, swelling arm and fever to be related to Shingrix.     It was unknown if the company considered the movement disorder, erythema of extremities, swelling arm and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter was the patient who received her second Shingrix Vaccine and stated that she did not had this reaction after the first vaccine, however it was not at the same pharmacy. The reporter stated that she had hardness to move arm, redness, swelling and a slight fever since receiving this second vaccine. The reporter asked questions about what to do for these issues and was advised to speak to her pharmacist of for medical advice.  The reporter consented to follow up.
Initial misuse report received from a healthcare professional on 6 February 2014. A 23-months-old patient had received second dose of FLUZONE on an unspecified date when second dose was not indicated. No adverse event was reported. List of documents held by sender: none.
During the 2nd or 3rd week of 01/2022, I started experiencing Lt posterior headaches. Also, experienced small (4 to 6 mm) bloody, firm pieces of mucosal tissue with very thick mucous drainage, post nasally. This occurred 1 to 2 times per week thru mid 2/2022. Continues now about once a week, without the tissue; small blood tinged clot with thick mucous. Almost resolved.
Patient presents to clinic for right arm redness/swelling. . She had high dose Quadrivalent flu vaccine for the first time on Wednesday at around 11am. She noted moderate right arm swelling at 5pm. Patient reported swelling resolved by 9pm same day with ace wrap. On thursday, pt noted redness to the right arm below the injection site. She marked the swelling area along with erythema. Increasing erythema outside the marked area.  discussed with patient Monitor for increasing erythema, swelling, pain, fever or chills F/U with PCP if symptoms doesn't resolve or condition worsens Urgent care precautions reviewed.
On the evening of the 9th, patient reports feeling numbness in her left leg. Since then, the numbness and tingling had spread up her leg and has since moved to her right leg as well. The feeling has not abated. Patient has gone to the ER, her primary care physician and an endocrinologist. No testing was ordered, and told the patient to return if there is a loss of sensation or an impact on mobility.
Rash head to toe; Lymph node swelling; On and off arm spiking pain near shot area; Have had a tingly, prickly feeling in left arm; Hand and thumb numb; Hand and thumb numb and stinging hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 15:00 as dose 2, single (Lot number: EW0161) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Anatomical location: Arm Left; Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 53-year-old, for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Hand and thumb numb"; PAIN IN EXTREMITY (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Hand and thumb numb and stinging hurt"; PARAESTHESIA (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Have had a tingly, prickly feeling in left arm"; LYMPHADENOPATHY (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Lymph node swelling"; VACCINATION SITE PAIN (non-serious) with onset 15Sep2022, outcome "not recovered", described as "On and off arm spiking pain near shot area"; RASH (non-serious) with onset 15Sep2022, outcome "not recovered", described as "Rash head to toe". The events "rash head to toe", "lymph node swelling", "on and off arm spiking pain near shot area", "have had a tingly, prickly feeling in left arm", "hand and thumb numb" and "hand and thumb numb and stinging hurt" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, lymphadenopathy, vaccination site pain, paraesthesia, hypoaesthesia, pain in extremity.  Additional information: The patient did not receive other vaccines within four weeks and other medications in two weeks prior to COVID vaccine. The patients had early symptoms-rash head to toe, lymph node swelling, and on and off arm spiking pain near shot area, last 2 month, have had a tingly, prickly feeling in left arm throughout every day, sometimes sitting, sometime laying, sometimes standing, makes hand and thumb numb and stinging hurt. Treatment included Chiropractic making sure not pinched nerve in neck. The patient had no known allergies and other medical history. The patient had no COVID prior vaccination. Since the vaccination, the patient had been tested negative for COVID-19.
stroke; cognitive difficulties; Information has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age at the time of the events and unknown gender. The patient's past medical history, concurrent conditions and concomitant therapies were not reported. On or about 21-OCT-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, route of administration, and anatomical location were not reported), at a pharmacy, for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a stroke (cerebrovascular accident) and had continued to suffer from cognitive difficulties (cognitive disorder) as a result. As a result of those symptoms, the patient was seen and treated by medical providers in and at the time of the report was still under their care. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The lawyer reported the cerebrovascular accident and cognitive disorder as disabling events.  Upon internal review, the event cerebrovascular accident was considered to be medically significant.
At the end of March 2021, I was having some effects. I know you get effects with vaccines. Come the 2nd vaccine, the effects never went away. I started getting dizziness, I fell a couple times. I've had an ambulance here at my home and take me to the hospital. I found out I was anemic, and my legs and ankles were all swollen. I was getting headaches. I had COVID tests done, and they all came back negative. I haven't been the same since. The booster shot really put me up and over the edge (Pfizer). I don't know if mixing Pfizer with Moderna made a difference, but I haven't been able to find a job. Haven't been able to go to work. I can hardly walk, and ever since getting these vaccines, I've had the sniffles, stuffy nose, congestion. My blood count is so low RBC. They wanted to give me blood, but there was a shortage. They told me to go ahead and take iron supplements. I've pretty much been put on the back burner. Joint pain and everything hurts. I've never had any issues before and I was healthy prior to the vaccines.
slight bruise at the injection site; slightly swollen; red; warm to touch; Low grade fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE ERYTHEMA (red) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (Low grade fever), FATIGUE (fatigue) and MYALGIA (body aches). On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (warm to touch). On 16-Mar-2021, the patient experienced VACCINATION SITE BRUISING (slight bruise at the injection site). At the time of the report, PYREXIA (Low grade fever), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE SWELLING (slightly swollen), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE BRUISING (slight bruise at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment medications were not provided by reporter.
Runny nose, congested, fever, cried for at least 2 hours straight.
No additional adverse event.; patient was inadvertently administered a dose of PNEUMOV AX 23 that was expired.; This spontaneous report has been received from a pharmacist concerning a 71 year old male patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 07-OCT-2019, the patient was inadvertently administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # N019838, expiration date 16-FEB-2019) that was expired. The vaccine was administered for prophylaxis (dose, dose number, anatomical location and route of administration were not provided). No adverse event was reported.
Fainted; high heart rate; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0196), via an unspecified route of administration, in right arm on 06Aug2021 12:45 (at the age of 14-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 and allergy to amoxicillin. Concomitant medication included fish oil (OMEGA 3) and multivitamins. The patient experienced high heart rate, fainted and had low blood pressure on 07Aug2021 11:45. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures taken as a result of fainted, high heart rate and low blood pressure included fluids. The patient underwent lab tests and procedures which included x rays, blood work, EKG and CT scan in Aug2021. The outcome of the events was recovered in Aug2021.
Facial lymph nodes swollen ~2 hours after injection, body aches  ~5 hours after injection, skin sensitivity to touch (felt like overactive nerves), fever ~1 day after injection. Symptoms completely cleared after 3 days.
Sore injection site evening of injection Sore muscles & joints over entire body during night 101 Fever & chills, fatigue  Continued next day 1/27/2021 No fever 1/28/2021 but continued joint & muscle pain Bad headache  all day 1/29/2021 and joint pain Back flank pain both sides, some joint pain, sweating but no fever 1/30/2021
Site: Bruising at Injection Site-Mild, Systemic: Patient developed Left side mastitis after recieving vaccine-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: Pt developed left side mastitis according to her doctor and pt had gotten the COVID vaccine in the left arm just 2 days prior. Pt is only 15 and there is no other origin possible according to her dr.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No medical history provided. On 26-SEP-2012 the patient was vaccinated (first dose) with GARDASIL (route unknown, lot# unknown). On-20-DEC-2012 the patient received a second dose of GARDASIL. No adverse symptoms were reported. No further information was provided. Additional information has been requested.
Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, everything went black and felt like I was going to pass out.  Husband got to me and laid on the floor.  Never passed out completely, but it was a very weird and odd feeling.  Felt better  after about 20 mins.  Have felt great since.  So did not go to primary care physician but felt the need to report.
Caller states 1 dose of ROTATEQ was administered to unknown patients. No additional AE reported. No PQC reproted.   Names of vaccines involved  ROTATEQ (unspecified lot/exp)  Temperature/Time frame 0.8C for  8 Hours 2 Minutes 1.5C for 4 Hours 56 Minu; No additional AE reported; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral (dose, lot number and expiration date not reported) for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccine was of 0.8 degrees Celsius (°C) for 8 hours and 2 minutes; 1.5°C for 4 hours and 56 minutes; 1°C for 7 hours and 14 minutes and 10.1°C for 34 minutes. No other excursions were detected.
Treatment of COVID-19; Treatment of COVID-19; Dose 1=PModerna, Dose 2=Modernah, Dose 3= Moderna and dose 4= Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 11:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 at 14:30 as dose 1, single (Lot number: 013A21A), in right arm, on 01Apr2021 at 14:00 as dose 2, single (Lot number: 002821A), in left arm and on 27Aug2021 at 11:00 as dose 3 (booster), single (Lot number: 009D21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer survivor" (unspecified if ongoing); "Thyroid Cancer survivor" (unspecified if ongoing); "Chronic Sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Oct2022, outcome "unknown", described as "Dose 1=PModerna, Dose 2=Modernah, Dose 3= Moderna and dose 4= Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2022) tested positive; (13Nov2022) tested positive, notes: tested Positive with a dark line similar to 1st day I tested positive; (Nov2022) barely detectable line. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient's symptoms started getting better on 11Nov2022 and Covid test showed a barely detectable line. On 13Nov2022, symptoms returned (chest tightness & congestion, runny nose, slight fever) and tested Positive with a dark line similar to 1st day I tested positive (01Nov2022). The patient doesn't know if this was "Paxlovid rebound" but wanted to share info with Pfizer.
Patient husband called concerning his wife and her symptoms post immunization.  Last night she developed fever, chills, diarrhea, upset stomach, etc.  All side effects mentioned by husband are listed as potential side effects of shingrix.  Patient received shingrix and flu shot at visit.  Advised OTC pain reliever for fever and to follow up with physician if symptoms do not diminish.
Foggy mind; wobbly gait; Slept a lot; This case was reported by a nurse via sales rep and described the occurrence of foggy feeling in head in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than an hour after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced foggy feeling in head, abnormal gait and sleep excessive. On an unknown date, the outcome of the foggy feeling in head, abnormal gait and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the foggy feeling in head, abnormal gait and sleep excessive to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in summer of 2017. Within 30 to 40 minutes after receiving Bexsero, the patient started having wobbly gait and foggy mind. The reporter believed that the patient slept a lot. The patient did not went to the emergency room but did recover. The reporter did not consent to follow up. This case has been linked with the case US2021155645, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021155645:Same reporter
Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions; Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day; Sore arm; Felt slightly tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions), INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported by reporter.  It was reported after taking Ibuprofen or Tylenol (pain reducer) patient slept through night and felt fine after waking up next morning.   This case was linked to MOD-2022-607286, MOD-2022-607284 (Patient Link).
Patient reports a pain in the area under her right rib starting 9-7 and continuing till 9.10. She denies any N/V/fever or changes in bowel or urine.