chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was swollen; Runny nose; Sneezing; Hot; Arm was red; Rash; Patient with allergy to hydrocortisone was administered Fluad Quadrivalent; This spontaneous case was received on 08-Sep-2023 from other non health professional (consumer) via Communications (reference number SEQW23-02109), and concerned an 83-year-old, female patient.  The patient's concurrent conditions included unspecified thyroid disorder and allergy to hydrocortisone. The patient's concomitant medications included unspecified medication for thyroid and cholesterol for unreported indication.  On Wednesday, 06-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) (explicitly coded as 'Contraindicated product administered') for influenza immunization. The batch number was not reported.  On 07-Sep-2023, when the patient got up at 7 am, after vaccination with Fluad Quadrivalent, the patient had runny nose, was sneezing, arm was red and swollen, was hot, and experienced rash. Treatment measures associated with adverse event was reported as Benadryl (diphenhydramine hydrochloride) and allergy pill from Consumer Value Store Pharmacy. The patient stated that she never had an issue with the flu vaccines before.  The reporter assessed the events as related to Fluad Quadrivalent, as reported that the patient took Fluad vaccine and had some reactions to it.  At the time of initial reporting, the patient had not recovered from the events, as reported it was still going.  This case was assessed as non-serious.  Company comment: An 83-year-old patient with allergy to hydrocortisone was vaccinated with the suspect product Fluad Quadrivalent (explicitly coded as 'Contraindicated product administered'). The patient developed swelling, erythema, and hot feeling on arm, as well as rhinorrhoea, sneezing, and rash one day after vaccination. Based on available information causality between the suspect vaccine and all events is assessed as probably related. Contraindicated product administered is assessed as unrelated per company's conventions.; Reporter's Comments: The reporter assessed the events as related to Fluad Quadrivalent, as reported that the patient took Fluad vaccine and had some reactions to it.; Sender's Comments: An 83-year-old patient with allergy to hydrocortisone was vaccinated with the suspect product Fluad Quadrivalent (explicitly coded as 'Contraindicated product administered'). The patient developed swelling, erythema, and hot feeling on arm, as well as rhinorrhoea, sneezing, and rash one day after vaccination. Based on available information causality between the suspect vaccine and all events is assessed as probably related. Contraindicated product administered is assessed as unrelated per company's conventions.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to 14  patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14  patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14  patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14  patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 14-Mar-2022 The vial did not undergo any temperature excursions. No concomitant medication reported. No treatment medication details reported.
SARS-CoV-2 Antigen detected 11/11/2021 Hospitalized 11/12/2021 ARDS
Vertigo on each of the two nights after the vaccine, lasting into the morning and disappearing by about 9 am.  Medical treatment was not sought.
Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 5/11/21. Presented to ED 1/31 with SOB, sxs began 1/23. Covid+, stable in ED on 4L NC. Workup revealed CO2 22, AST 64, Lactic 2.2, Procal 0.29, WBC 18.2. Also positive for adenovirus. Admitted for acute hypoxic resp failure 2/2 Covid PNA c/b severe sepsis. BC x2 sent + for Salmonella GNR Bacteremia on 1/31. Intubated on 2/3/22. Continued to decline. Tx'd with tylenol, decadron, Rocephin, Azithromycin. Transitioned to comfort care/DNAR and expired 2/17/2022.
This spontaneous report as received from a patient's mother refers to a patient of unknown age and gender. No medical history, concomitant medications, concurrent conditions or drug reactions and allergies were reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ orally, (lot #, expiry date, and dose were not reported). On an unknown date, the patient experienced unspecified reaction to ROTATEQ. The outcome of the event was unknown at the time of the report. The reporter considered vaccination adverse reaction to be related to ROTATEQ. Additional information has been requested.
This spontaneous report was received from a nurse via a company representative refers to a male patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 0.5 ml, intramuscular. On an unknown date, the patient experienced swelling in his face after receiving the initial dose of GARDASIL 9. The patient was given MEDROL and CLARITIN for treatment and has recovered on an unspecified date. The patient planned not to receive the second and third dose of GARDASIL 9. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information has been requested.
Headache that didn?t go away with Tylenol and severe chills  both that lasted about 8 hours
HEAVINESS IN THE CHEST; SINUS ISSUES; LOST SENSE OF SMELL; DIZZINESS; NAUSEA; MUSCLE PAIN MOSTLY IN THE BACK; FEELING VERY TIRED; HEADACHE; FACE WAS PUFFY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced muscle pain mostly in the back. On 26-MAR-2021, the subject experienced feeling very tired. On 26-MAR-2021, the subject experienced face was puffy. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced sinus issues. On 29-MAR-2021, the subject experienced lost sense of smell. On 30-MAR-2021, the subject experienced heaviness in the chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heaviness in the chest, and the outcome of headache, nausea, dizziness, muscle pain mostly in the back, sinus issues, lost sense of smell, feeling very tired and face was puffy was not reported. This report was non-serious.
Pain and swelling in all joints - hips, knees, back, arms, legs, feet - more pronounced pain and swelling in both hands. States fingers are swollen on both hands preventing her from removing her rings.
Pain in upper right thigh on day after vaccine and next day. Badly swollen calf on third day after vaccine. Hospitalized with "Right femoral acute thrombosis; no compression; no flow detected."
Left shoulder swollen, red, very tender 3in x 2in. Started last night after DTAP.
given by injection instead of orally; This case was reported by a physician via other manufacturer and described the occurrence of inappropriate route of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (injection) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20th July 2022 Reporter's Comments:  Reporter stated patient was given Rotarix by injection instead of orally. Additional supportive information: As patient was administered Rotarix by injection instead of oral route, which led to inappropriate route of vaccination. Reporter consented to follow up. This case has been linked with US2015103988 reported by same reporter.; Sender's Comments:  US-GSK-US2015103988:Same reporter
PATIENT FELL TO THE FLOOR AND HAD A SEIZURE WHICH LASTED ABOUT 45 SECONDS.  THIS WAS FOLLOWED BY VOMITING.
pt c/o rt arm numbness fr inj site distally to fingertips; sensation returned w/in 3 hrs;
17NOV92 6PM sudden elevated temp & chills; no fever 18NOV92; so went to work 18NOV92 6PM elevated temp, chills & sl sore throat; had fever, chills, body aches, sore throat & cough;
She was unable to go down; Rashes on her chest and arm; She had allergic reactions; This spontaneous case was reported by a non-health professional and describes the occurrence of MOBILITY DECREASED (She was unable to go down), RASH (Rashes on her chest and arm) and HYPERSENSITIVITY (She had allergic reactions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (She was unable to go down), RASH (Rashes on her chest and arm) and HYPERSENSITIVITY (She had allergic reactions). At the time of the report, MOBILITY DECREASED (She was unable to go down), RASH (Rashes on her chest and arm) and HYPERSENSITIVITY (She had allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were provided.  The patient received first Moderna Vaccine and had allergic reactions and rashes on chest and arm. The patient was unable to go down.   The patient was afraid to receive second shot. The patient was not a trial participant.  Was reported as 2694.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 3 (booster), single (Lot number: EW0161) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Virus return on day 13 tested negative on day 10 then symptoms returned on day 13 and tested positive; Positive, notes: Virus return on day 13 tested negative on day 10 then symptoms returned on day 13 and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : Paxlovid is given to the patient for COVID 19. Treatment start date: 04May2022, Treatment stop date: 08May2022, Lot number: 0069108530, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Overall, wellbeing "off" and crying for no reason. brain fog and confusion. general weakness, easily winded walking upstairs, fatigue, severe muscle pain/soreness. originated underarms and back on 24th & 25th. ended in the left calf and occasionally entire left leg and sometimes right.
Received IM Hep B left u arm, within 60 secs became nauseated, dizzy, chest tightness, flushing and swelling on left side of face.
-Intense muscle aches, onset: 01/30/2021 duration: 40 hours -Fever, onset: 01/31/2021 duration: ~12 hours although treated with Tylenol  -Headaches, onset: 01/30/2021 duration: steady for 30 hours (treated with Tylenol), intermittent until 02/05/2021
Information has been received from a physician's assistant concerning a 2 month old female who on 08-JAN-2007 was vaccinated with a first 2 ml oral dose of Rotateq (human-bovine). On 11-JAN-2007 the patient's mother called the office and reported that the patient had a bloody stool. It was reported that the physician would monitor the patient for the next 48 hours to see if there were any changes. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, bloody stool was considered to be an other important medical event. Additional information has been requested.
First dose the needle broke.... seemed like none went in. Second try successful administration. Headache, minor, immediate. Three days later a rash began on upper body and progressed to entire body. Thick, very itchy. No respiratory response. Treated with Claritin, Benadryl, hydrocortisone and oat baths. Lasted 9 days.
Patient called pharmacy on 10/17/13 stating that she couldn't move her arm at night after administration stated difficulty turning on bed. In the morning had severe pain shoulder to elbow. On 10/18/13 spoke w/t patient -> now a little better, but unable to move with ease. Also pain in injection site, no swelling.
Breakthrough case admission after three vaccines Pfizer 2/24/21 Lot# En6202;  Pfizer 3/17/21 Lot# ER2613;  Pfizer 10/16/21 Lot# FF2590
Since the vaccine, I have had very painful and irregular menses; Since the vaccine, I have had very painful and irregular menses; Cramps and break through bleeding have been on and off since the second vaccine.; Cramps and break through bleeding have been on and off since the second vaccine.; This is a spontaneous report from a contactable consumer. This 29-year-old female consumer (Patient) reported that:  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration, administered in arm left on 23May2021 (at the age of 29 years old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in arm left on 29Mar2021, as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021, the patient experienced since the vaccine, i have had very painful and irregular menses and cramps and break through bleeding have been on and off since the second vaccine. The adverse event resulted in Physician Office Visit. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035508, expiration date 12-MAY-2017; lot # M004508, expiration date 29-JUN-2017; lot # M014318, expiration date 30-SEP-2017, lot # reported as M019706, expiration date 24-OCT-2017 (dose was not reported, orally). None of the patients reported adverse effects. Administered doses of the vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients with unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA 25/0.5 (unit not provided) (lot # K018181, expiration date 04-JUN-2017; dose and route were not reported). The vaccine was improperly stored at 1 Celsius (C) for 7 hours and 9 C for 5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe sore throat.  Unable to swallow food or liquids including water.   By the next day I couldn't even swallow tylenol pills.   Constant cough throughout the night approximately 3 times a minute.  Unable to sleep due to this.  Spread to ears approx 14 hours later.  Very painful.
Onset of Headache 4 days after injection.  Headache continuous for 48 hours, then subsided for about 8 hours, reoccurred overnight and is continuing.  Attempted treatment of acetaminophen every 6 hours but nothing is working to stop it.  Headache is contained to to left side and behind left eye, some tension in neck and shoulder on that side. Currently day 6 post injection with no relief.
She had a delayed reaction; she has swelling; itching; She also had a burning sensation; Soreness from the where the shot was down to the beginning and closing of her elbow; She felt under her left breast, about an inch underneath the nipple that it was slightly soreness; This spontaneous case was reported by a consumer and describes the occurrence of NONSPECIFIC REACTION (She had a delayed reaction), SWELLING (she has swelling), PRURITUS (itching), BURNING SENSATION (She also had a burning sensation) and BREAST PAIN (She felt under her left breast, about an inch underneath the nipple that it was slightly soreness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052521A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced BREAST PAIN (She felt under her left breast, about an inch underneath the nipple that it was slightly soreness). On 08-Aug-2021, the patient experienced NONSPECIFIC REACTION (She had a delayed reaction), SWELLING (she has swelling), PRURITUS (itching), BURNING SENSATION (She also had a burning sensation) and VACCINATION SITE PAIN (Soreness from the where the shot was down to the beginning and closing of her elbow). At the time of the report, NONSPECIFIC REACTION (She had a delayed reaction), SWELLING (she has swelling), PRURITUS (itching), BURNING SENSATION (She also had a burning sensation), BREAST PAIN (She felt under her left breast, about an inch underneath the nipple that it was slightly soreness) and VACCINATION SITE PAIN (Soreness from the where the shot was down to the beginning and closing of her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains no new information.
febrile, body aches beginning at 15 hours post injection, red rash below injection site that began 24+ hours and is increasing in size and itching severely 72hrs post injection
BAD REACTION; DIFFICULTY BREATHING; HIVES; This spontaneous report received from a parent 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad reaction, difficulty breathing, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad reaction, difficulty breathing and hives was not reported. This report was non-serious.
Patient called clinic 10/25/02. Had flu shot on 10/23/02. Had reaction at site; red, swollen, itching around site. 5-6" diameter. Applied ice 10/24/02 and heat 10/25/02. Told her to take Tylenol for fever and Benadryl for itching and to call 10/28/02 and let us know how she's doing.
Anaphylaxis after H1N1 vaccine:got it at different facility and not hospitalized at our facility. Difficult to report w/o details. Symptoms: Symptoms: 1. Anaphylaxis. Treatment Drugs Used: Mercury, Ammoniated.
rash on right breast; swollen and painful axillary lymph node; swollen and painful axillary lymph node; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730; expiration date: unknown) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient medical history was not reported. The patient diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen (ADVIL) and birth control medication. The patient first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. On 15Jan2021, the patient had rash on right breast, and swollen and painful axillary lymph node. The patient did not receive treatment for the adverse events. The events were non-serious, and the events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.