chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/4/09 Volunteer with EMS was in the after injection waiting area with the children and called for a nurse to come. I found patient curled up in a ball. I removed the child's shirt and monitored his blood pressure and pulse. The child appeared pale in color. His blood pressure at 9:20 am was 102/80, pulse was 96. At approximately 9:27am the child was placed on a stretcher and his color returned to pink. Patient's grandmother is one our team nurses and she called his mother to come and pick the child up and, waited with the child until the mother came. About a half hour later, patient's mother came to pick him up. The child voiced no complaints. He was talking laughing and playing when he left school with his mother. 12-5-09 Called patient. Mother patient is doing ok. No problems. After patient took the shot he was talk to me, said he couldn't hear & felt weak. I had him sit down & took jacket off to cool down. Grandmother was here with Health Dept. Called mother & went home. Said he was feeling better when he went home.
Booster; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; I got this block but I did touch it but now I have seen it but it hurts me; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FH8028) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization; Bnt162b2 (2nd Dose), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I am having allergic reactions; I am itchy like allergic reaction in different parts of my body"; MASS (non-serious), AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I have a lump under my left armpit. I have a lump and it hurts, it is swelled up"; BREAST PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I got this block but I did touch it but now I have seen it but it hurts me".  No follow-up attempts are possible. No further information is expected.
reconstituted Menveo with Sterile water; reconstituted Menveo with Sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA689A, expiry date 31st October 2022) for prophylaxis.   On 9th March 2022, the patient received Menveo. On 9th March 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The medical assistant reconstituted Menveo with sterile water and administered to a patient on 9th March 2022, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was all the information that was provided by healthcare professional. The reporter consented to follow up.
Felt weak specifically in her legs; Felt lethargic; Nauseous; Had episodes of diarrhea; Sweating in the day; Hot at night; Loss of appetite; Silly cough as she described it; Swelling at injection; Arm soreness; Severe whole body achiness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on 30th October 2020,for further tolerance of 1st dose refer case US2021AMR002816).   On 30th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, pain in arm and general body pain. On 3rd January 2021, the patient experienced lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and pain in arm were recovered/resolved and the outcome of the general body pain, lower extremities weakness of, lethargy, nausea, sweating, feeling hot, appetite lost and cough were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, pain in arm, general body pain, lower extremities weakness of, lethargy, nausea, diarrhea, sweating, feeling hot, appetite lost and cough to be related to Shingrix.  Additional details were provided as follows: The patient received  2nd dose and experienced early in the morning the following day, she felt severe whole body achiness. By the 4th day other symptoms presented,felt weak specifically in her legs,lethargic, nauseous, had episodes of diarrhea, sweating in the day and hot at night, loss of appetite and a silly cough, arm soreness and swelling at the injection which resolves by day 4.  The reporter stated that the symptoms listed in this report following the second dose have not resolved with the exception of the injection site reactions. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002816:Same reporter
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored RECOMBIVAX HB (dose, route of administration and lot # were not reported). It was reported that the vaccine was exposed to 1 degree C for 48 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
TEMP. 0VER FOUR DAYS AS HIGH AS 103 TREATED WITH TYLENOL AND MOTRIN.HAD CRYING FOR EIGHT TO TEN HOURS UNABLE TO SATISFY. WOULD NOT TAKE LIQUIDS NOR EAT.DEVELOPED RASH PRIOR TO TEMP.RASH REMAINED AFTER TEMP WAS NORMAL.
Information has been received from a 64 year old female consumer with no known medical history or allergies who on 03-FEB-2007 was vaccinated with a dose of varicella-zoster. Concomitant therapy included levothyroxine Na (SYNTHROID) and duloxetine hydrochloride (CYMBALTA). Subsequently since vaccination, the patient has had mild constant headaches, a low grade fever and feels lethargic. She reported that she was vaccinated in a pharmacy. The patient did not seek medical attention. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Freezing; Arm felt hot; Vomiting; Severe Headache; slight temperature; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Freezing), FEELING HOT (Arm felt hot), VOMITING (Vomiting) and HEADACHE (Severe Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (Freezing), FEELING HOT (Arm felt hot), VOMITING (Vomiting), HEADACHE (Severe Headache), PYREXIA (slight temperature) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Freezing), FEELING HOT (Arm felt hot), VOMITING (Vomiting), HEADACHE (Severe Headache), PYREXIA (slight temperature) and CHILLS (Chills) outcome was unknown. Not Provided          No concomitant medications reported.  Treatment medications was not provided by the reporter  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-051543 (Patient Link).
Pt got very hot & flushed then had a sudden urge to urinate. Heart then started racing. Feeling passed quickly and she relaxed and started feeling better.  Stayed for about 20 minutes in pharmacy area and was feeling well when she left.  I called her later that evening and she was fine
Ever since the second week of May 2021 one month after my Covid-19 vaccine my menstrual has been continuous. Im bleeding every single day. Some days are heavier than others. Ive been to the doctors for it and they cant find anything wrong. Nothing abnormal with uterus. They thought i might have cyst in my uterine lining causing the bleeding but i don?t. Because of the bleeding I've been dizzy, extremely tired, foggy headed  and just don't feel myself.  I contacted my doctor to have my birth control switch so i switched it and it didn't help. I also started taking it every day instead of skipping a week. I have an identical twin sister and shes experiencing the same exact thing. She was on the same birth control as me, took it the same time, she got the same covid vaccine as me, at the same time, at the same place. We went together to get the vaccine. Our bleeding started at the same time too. She hasn't seen a doctor yet for it because everywhere is book out until at least December. Ive seen my doctor since August of 2017.
I got Covid after my 2nd booster in the last week in August 2022.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got Covid after my 2nd booster in the last week in August 2022.) in a 94-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced COVID-19 (I got Covid after my 2nd booster in the last week in August 2022.). At the time of the report, COVID-19 (I got Covid after my 2nd booster in the last week in August 2022.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.18 years.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Rash starting on neck and face continuing to torso. Arms and legs unaffected. No fever.
after recv vax pt exp stomach pains, nausea & diarrhea sx increased, saw m.d., had endoscopy, showed green bile in stomach, emptying problems & esophagitis. pt still being treated.
Patient presented 9/11/07 with a local reaction at vaccination site, on left thigh. She had a 3cm x 5cm red, slightly raised area, + blanching, slightly warm to touch, non-tender. Patient was well, in no pain and active. She had no fever.  9/28/07 Reviewed hospital medical records which reveal patient experienced fever with progressively increasing injection site redness, warmth, rash & itching on left leg DTaP site. Failed outpatient treatment w/oral antibiotics.  Admitted 9/14-9/16/2007.  Tx w/IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics FINAL DX: left leg cellulitis s/p immunizations.
experienced a wave that started at her head and moved downward; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (experienced a wave that started at her head and moved downward) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0401321A) for COVID-19 vaccination.     The patient's past medical history included Panic attack.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VERTIGO (experienced a wave that started at her head and moved downward). At the time of the report, VERTIGO (experienced a wave that started at her head and moved downward) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Patient received first dose of Pfizer COVID-19 vaccine on 8/18 in his right shoulder and felt sore afterwards.  The following day he began to feel weak in his right shoulder and by the end of the day felt weak in his right leg as well.  The weakness has progressed and he has also felt chronically fatigued since then.  Patient seen at outside hospital ED for the same, had negative CT head without contrast, normal serum chemistries and blood count, normal EKG, and was discharged for low concern for stroke.  He denies numbness, tingling, shooting pains, trauma, history of autoimmune disease.  He also denies recent illnesses, fever, chills, nausea, vomiting. Patient does have family history of early strokes in his father and uncles. He reported to another ED for progression of weakness. On my exam, patient had weakness of his right upper extremity and right lower extremity, pronator drift on his right arm, but normal sensation throughout.
Employee rec'd COVID vaccine. Monitor for adverse reaction. Employee c/o tingling in lips/no swelling noted upon assessment. No other complaints offered, VS taken at 1757 BP 128/74 HR POX 98 Rapid response/ER offered-refused, Continue to monitor Last VS taken 1828 BP 133.77 HR 82 POX 100 Employee reports tingling in lips to be minimal/no swelling no other complaints offered Refusing rapid response/ER eval DC'd from monitor area
Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do anything due to lack of energy. The week of the vaccine I had to go 3 days early due to the exhaustion. I also had stomach pain and bowel issues. I went to the clinic and the first time they thought it was diverticulitis and the second time they ordered a CT scan of the abdomen and some labs and they all came normal.
Woke up this morning with severe shoulder and rib pain. Very limited movement. Did ice injection site yesterday and took ibuprofen but pain got so bad am. Putting heat taking ibuprofen not working decided to take Lortabs 375/5 very little relief.
Headache Low grade fever 99.7 Back ache Body ache Chills Cold hands Nausea  These started Dec 20, the night of my vaccination.  My symptoms continued on Monday the 21.  On Tuesday Dec 22  I still have a slight headache  and body aches. I just feel run down.  I took regular strength Tylenol I-II PRN
Because I had reported some changes in my body previously, I received a phone call from someone in late 2021  that I should file my concerns. 1.  After both injections I suffered fever, chills and headaches for about 1/5 - 2 days. 2.  I've noticed since I've had the injections, I have developed a tremor when I hold things in my left arm. NO, I do not know if this is related to the vaccine, but so little is known regarding the vaccine, I decided to go ahead and document in case others have complained about the same thing.
Pt recvd 3 doses of Engerix-B 5NOV90, 2DEC90 & 29APR91 & 4SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
This spontaneous report was received from a certified medical assistant regarding a 42 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 11-JUL-2017, the patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route and site of administration were not provided) lot # N003997, and expiration date of 20-OCT-2018 pertain to both doses of PNEUMOVAX 23 for prophylaxis. No adverse effects were reported. No further information was provided. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-AUG-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Some of the symptoms that were felt after 3 minutes of getting the Moderna vaccine, I felt dizziness. I couldn't see anything and I felt a little nauseous in the stomach. I was able to lay down for a couple of minutes and felt fine afterwards. Some of the symptoms going home are a sore arm, can't seem to lift it up, tired, the vaccine site seems to sting, and some chills.
This spontaneous report was received from the registered nurse regarding a 15 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 18-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
ANAPHYLAXIS/SHORTNESS OF BREATH/TIGHTNESS OF CHEST; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma since 11 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total administered on 01-FEB-2022 23:30 for prophylactic vaccination. Non-company suspect drugs included: prednisone ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported received on  01-FEB-2022 18:35, 20 mg and 03-FEB-2022 2.5mg for asthma. And patient reported she did not take Prednisone on 02-FEB-2022 really need to take every day for asthma, at least 5-10mg per day No concomitant medications were reported.  On 01-FEB-2022, after receiving vaccine at 23:30 and prednisone at 18:35, the patient experienced anaphylaxis after 30 minutes and patient visited emergency care unit. On 03-FEB-2022, the patient experienced (Felt tightening in chest and shortness of breath) anaphylaxis, but not enough to use Epi-pen or go to urgent care. Treatment medications (dates unspecified) included: epinephrine for anaphylaxis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis/shortness of breath/tightness of chest was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220213102-Covid-19 vaccine ad26.CoV-2.s- Anaphylaxis/Shortness of breadth/tightness of chest. This event(s) is labeled per RSI and is therefore considered potentially related.
Sore arm, sore throat, fatigue, body aches, swollen glands, headache  Took Tylenol  Made symptoms less severe for a little