chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired vaccine as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication was provided.
Intradermal flu vax administered at 0900 10/11/13. Rxn 1100-1200, pt began having itching, felt "hot", rash "red" noted on chest/upper chest neck.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 15:00 as dose 1, single (Lot number: EN 6203), in left arm, on 18Mar2021 at 15:00 as dose 2, single (Lot number: ER 8727), in left arm, on 28Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FE 2592), in left arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FJ 4991) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergy: Sulfa drugs" (unspecified if ongoing), notes: known allergy: Sulfa drugs; "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) positive, notes: tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as anti-viral drug Paxlovid.
Nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unspecified route of administration in the left arm on 06Feb2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. The patient had no medical history, had not been diagnosed with COVID prior to vaccination, and had no known allergies. Concomitant medications included cetirizine hydrochloride (ALLERTEC) from an unknown date for an unknown indication; ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) from an unknown date for an unknown indication; and ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iron, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenite, thiamine mononitrate, zinc oxide (ONE A DAY MEN'S 50+ HEALTHY ADVANTAGE) from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to administration. On 07Feb2021 at 10:00 the patient experienced nausea and vomiting. No treatment was provided for the events. The clinical outcomes of nausea and vomiting were recovering. It was also reported that the patient had not been tested for COVID since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
SEVERE REACTION; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reaction, headache and chills was not reported. This report was non-serious.
About 10 days after the second Covid vaccination on 29 March (first shot was on 8 March) a single skin blister appeared on my left forearm.  I though is might have be poison ivy, though I had no reason to believe I had contacted poison ivy.  Over the next month, additional blisters and skin eruptions appeared, notably around right ear lobe and surrounding  tissue, along underside of jaw line to similar area of the left ear lobe.  On 14 April my primary doctor suggested topical Hydrocortisone or similar cream as treatment giving at best very short relief from the itching.  On 1 July I was seen by Dr's PA who took 2 skin biopsies and prescribed Clobetasol cream.  Still only very short symptomatic relief.  Spraying alcohol mixed with witch hazel works as well. Blisters start small (pin head to eraser size) may or may not grow to as large as a dime.  May be singular or in clusters.
Patient started experiencing dizziness and light headedness approx 10 minutes after administration of vaccine. Pt stated that he felt like the room was shaking, and also felt his body shaking. Vital signs were taken an were as follows: 180/80 on right arm HR 73 o2 99, temp 97.6, respirations 19.  Vitals retaken throughout the course. bp at 1002 decreased to 180/100 on right arm. Pt stated that he still felt same symptoms with no improvement. Pt was given epinepherine auto-injector for adults. BP taken at 1014 bp 175/82. stated that he was feeling a little better but still felt jittery, light headed and dizzy still. ems arrived at the scene at 1031 and took over. pt BP on right arm was 138/100. left arm was 135/83. ems asked pt if he wanted to go to hospital. pt stated no. pt  determined that pt was stable and did not needed to go to hospital.
sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 019B21A, 032F21A and 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.            No concomitant medication were reported.  Patient experienced  of sore left arm on 6-APR-2021 and on 12-APR-2022. Patient had no adverse reactions reported with third dose.                No treatment information was provided by the reporter.
Student stated, "I went to the cafeteria to eat with my friends after taking the shot.  Then I realized that I couldn't see any of my friends.  I could only hear their voices."
I did not have a reaction to the vaccine. I have had heart palpitations for 30 years. I noticed that after the vaccine, they progressed in intensity and frequency. I went to my primary care doctor and was referred to a cardiologist. I had several tests all of which resulted in within normal range. I was given a prescription for metoprolol to relieve my symptoms.
Headache, Myalgia, NauseaVomiting, fatigue, site pain, redness swelling Narrative:
local reaction rt deltoid pain, swelling, inc warmth w/o abscess; seen by MD 1NOV93 dx of localized react w/early infect;
pt had sl cold @ time of inj;pt became fussy a/returning home;started crying which lasted for 2hr;called PMD & recommended warm bath & DPH q 4hr;pt wouldn't eat;
04/01/05 PC from mother with report of macule and papular type rash on trunk, face, red. No open or draining lesions. No fever. Eating, playing, sleeping all ok. No itching started 3/31/05. Spread today 04/01/05.
C/O dizziness/vertigo and diaphoresis at 3:00 AM 10/23/09. Seen in ED-> Caller states she received H1N1 vaccine at health dept at noon on 10/22. She just woke up this AM w/feelings of increased heart rate, sweating on hands and feet, no fever, feeling pulse in her throat. Walked through taking pt's pulse w/her and pulse is 64. States no allergy to eggs, latex, chicken protein, neomycin, polymixin. Pt then complains of feeling faint, feels like she may pass out. Advised ED for eval, 911 prn, husband is w/pt. Called ED, spoke w/RN who states pt was fine, dx anxiety, not an adverse reaction to vaccine. Pt has been seen in ED for similar anxiety related complaints. She had EKG done which was wnl, was monitored for a little while and discharged home. VSS-numbers not available.
Severe Irritability, Ear piercing crying, fever of 103 and higher, huge hard ball at site of injection, hurt to walk for a few days, sleeplessness, lack of appetite.
Ct. had mild headache prior to vaccine. Migraine developed Friday, 11/6/09 PM. 11/7/09-Ct's arm began to swell (right arm). Arm swollen from deltoid muscle to elbow. Arm is sore and is very bruised all over swollen area. Ct. has been taking OTC pain reliever. As of this time, Ct's arm is still swollen.
Approximately 2 weeks after my vaccination I started developing rash that started on my foot and spread all over my body and I decided to put cortisone cream for treatment to stop the itching then after a few months I had COVID and it has gotten so much worse and when I went to the Doctor she said it was a COVID rash and it could last for a couple of months and she prescribed me with Betamethasone Cream, Hydroxyzine tablet and gave me a steroid shot and referred to see a dermatologist and so I did and they did a Shave and Punch Biopsy and was prescribed with  Bactrim and will get the result of the Biopsy sometime on February 23. None of the treatments are currently as of February 14, 2022 and no improvement with the symptoms.
This case was reported by a physician via call center representative and described the occurrence of malaise in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved. It was unknown if the reporter considered the malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The vaccine had been administered at several local pharmacies. The physician reported that approximately 3 patients reported that after receiving 1st dose of SHINGRIX they experienced malaise which lasted 2 to 3 days. The patients reported symptoms to the doctor over the last few months from the date of reporting. The physician did not keep a log of patient information and had no access to product details. It was possible (but not verifiable) that these patients had previously been reported.
Tested positive for COVID; Tested positive for COVID; very mild symptoms of slight sore throat; tired; dose 3 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Nov2021 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 14Oct2021; FASENRA; MONTELUKAST; OMEPRAZOLE; DULERA. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "dose 3 (booster)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "recovered" and all described as "Tested positive for COVID"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021, outcome "recovered", described as "very mild symptoms of slight sore throat"; FATIGUE (non-serious) with onset 14Dec2021, outcome "recovered", described as "tired". The patient underwent the following laboratory tests and procedures: Covid-19: (20Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, oropharyngeal pain, fatigue. AE resulted in: None of the above.
he noted a lump at the injection site; arm swollen; arm warm; elevated pulse 15 beats per minute over normal; feeling very tired; sleeping most of the time; arm pain at the injection site; redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac operation (Previous cardiac surgery).   On 17-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 17-OCT-2023, 5 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm pain at the injection site), injection site erythema (Verbatim: redness at the injection site), swelling arm (Verbatim: arm swollen), skin warm (Verbatim: arm warm), pulse increased (Verbatim: elevated pulse 15 beats per minute over normal), tiredness (Verbatim: feeling very tired) and sleepiness (Verbatim: sleeping most of the time). On 18-OCT-2023, the patient experienced injection site lump (Verbatim: he noted a lump at the injection site). The outcome of the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site lump, swelling arm, skin warm, pulse increased, tiredness and sleepiness to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-OCT-2023 The patient reported that he received his first Shingrix shot on Tuesday (from the reporting day) and within 5 minutes of the vaccination he started experiencing arm pain and redness at the injection site. About 12 hours later (after vaccination) patient began feeling very tired, sleeping most of the time. His pulse has been elevated about 15 beats per minute above what was normal for him. The next day after vaccination, he noted a lump at the injection site. All symptoms were ongoing till the time of reporting. No consent, as patient had not yet consulted with his doctor. The reporter did not consent to follow-up. Note: Events from entire source document had been captured, even if it was not reported into the narrative description and clarification raised for its confirmation.
I experienced bronchitis, sore throat, coughing, runny nose, also tested positive for COVID-19.
Patient was admitted to hospital with acute respiratory failure with hypoxia and sepsis due to COVID-19 associated pneumonia.  He was started on IV antibiotics as well as IV steroids.  He was not a candidate for remdesivir secondary to acute renal failure. Discharged to rehab.
couldn't move left leg or foot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move left leg or foot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A211A) for COVID-19 vaccination.     The patient's past medical history included Stroke (patient had stroke in 2017). Concomitant products included SIMVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't move left leg or foot). At the time of the report, LIMB DISCOMFORT (couldn't move left leg or foot) outcome was unknown.            Treatment drugs were not provided, Action taken with mRNA-1273 in response to the event was not applicable.
Pt is a previously healthy 12 Y 4 M  male who received his second COVID Pfizer vaccine on 8/19/21 presenting with acute onset chest pain on the morning of 8/21. He describes it as sharp, worse with inspiration, and on the left side of chest, 10/10 at worse and now at 0/10. Initial troponin was 1.99 with a normal EKG/Echo. He was admitted to local HCF and was treated with acetaminophen, ibuprofen, and toradol; but around 1700-1800, his chest pain got worse. Repeat troponin was significantly increased to 19.5. Regional cardiology recommended he be transferred to a facility with specialty.  Pt was transferred to another HCF on 8/22 Suspect myopericarditis 2/2 covid vaccine, less likely myocarditis 2/2 viral illness as no sign/sx of infection. Also endorsed passive SI to multiple team members, to be assessed by psychology.   Neuro: - pain: ibuprofen 600mg TID with meals, pepcid 20mg PO qHS while on ibuprofen. - discharge with total 2 week course ibuprofen and pepcid   CV: - Chest pain resolves with doses of ibuprofen. - Echo and EKG normal on 8/21/21. - Troponin peaked at 23.67, downtrended and was 0.91 at discharge.
PAIN IN THE LEGS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced pain in the legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the legs. This report was non-serious.
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs.  01/25 Called dr and had a Telemed call with NP on Tues. 01/26.  Predisone and Benadryl was prescribed.  Thurs. 01/28 Call to let them know that it wasn?t working.  I went into the office for one shot of Solumedrol.  This help and they were gone.  They gave me second dose of Predisone to take in case it came back and to continue the Benadryl.  02/8 Second vaccine.  Hives began that night: arms, torso, thighs, hair.  Call the Dr. on 02/10 and suggested I go to an allergist.  Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime.  The Predisone created a major brain fog, I had to stop.  Saw the allergist on 2/18, she agreed to get off the Predisone.  02/11 I passed out in the am and when I woke up with vomit running down my face.  Still suffering with hives this entire time.  02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes.  My feel swelled and I have hives so bad on my feet I could not walk or put on shoes.  02/20 Woke up with sweat on my chest.  My hands were so swollen I had to have my wedding ring was cut off .  02/21 I went to the Urgent Care and received a shot of Solumedrol.  They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
Back in May one evening my ankles started hurting and swollen. Within the next week swollen knees and ankles. On  6/5/21 went to the emergency for extreme swelling. Diagnosed me with Dependent Edema and Enlarged Lymph Nodes
Stiffness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (soreness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
7 days after vaccine, I developed a fever of 100.7, sore throat, muscle aches, pain at injection site, redness at injection site
Friday noon 3/30/12 complain sore throat, generalized rashes from neck down to legs front and back, tired and body aches. Low grade temperature.
Severe Vertigo, profusely sweating, vomiting, severe dizziness, hearing loss (left), tinnitus.
Red ring around injection site 9 days after shot.  Not itchy, painful or swollen.