chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Both lips started swelling on Saturday March the 27th and worsening on Sunday the 28th, lips tingled, very chapped above and below lip line and burning when touched by acidic foods,  mint toothpaste or soft drinks. Messaged doctor's office on Tuesday March 30th  which included a picture of my lips and oncall doctor in Dr  office prescribed 4 oral Prednisone 20 mg tablets which  I finished on April 3. My lips have gone down but are still swollen, still chapped and I have dry mouth symptons which I did not have prior to the Covid injections, so this reaction is ongoing.
This case is linked to case number 2013-08217 (same reproter and same product for different patient). Initial report received from a healthcare professional on 30 July 2013. A female patient, whose medical history and concomitant medications were not reported, had received pre-exposure rabies vaccine series with IMOVAX rabies vaccine (lot number: D0869 for 2 doses and lot number D1101 for 1 dose, (dose number, route and anatomical site of administration not reported), June 2010 date not specified. On an unspecified date of July 2013, the patient had undergone titer level test and was found titers less than 0.1. Other laboratory details and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
developed itchy skin rash on upper left chest (near injection site).; developed itchy skin rash on upper left chest (near injection site).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ep7533) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 62 years old, for COVID-19 Immunization, reaction(s): "itchy skin rash". The following information was reported: PRURITUS (non-serious), RASH (non-serious) all with onset 2021, outcome "not recovered" and all described as "developed itchy skin rash on upper left chest (near injection site).". The event "developed itchy skin rash on upper left chest (near injection site)." and "developed itchy skin rash on upper left chest (near injection site)." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: The patient had no known allergies, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had been tested for COVID-19, he did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not take other medications within 2 weeks of vaccination. It was reported that About 3 weeks after the second injection, the patient developed itchy skin rash on upper left chest (near injection site). The doctor thought it might be a contact allergy and administered steroid injection (treatment). Rash cleared up for 2 weeks but then returned and has continued for 10 months now. The fact that it remained in just one spot on his body was proof that this is not a contact allergy. No follow-up attempts are possible. No further information is expected.
Shortness of breath, shallow breathing Fatigue Headache some body ache at first I went to the clinic, nothing prescribed but did take a Covid test which came out negative
Body aches; Feels like she had COVID-19 again; Feeling of sickness; Hurting head; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), SYMPTOM RECURRENCE (Feels like she had COVID-19 again), MALAISE (Feeling of sickness), HEADACHE (Hurting head) and CHILLS (Cold chills) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), SYMPTOM RECURRENCE (Feels like she had COVID-19 again), MALAISE (Feeling of sickness), HEADACHE (Hurting head) and CHILLS (Cold chills). At the time of the report, PAIN (Body aches), SYMPTOM RECURRENCE (Feels like she had COVID-19 again), MALAISE (Feeling of sickness), HEADACHE (Hurting head) and CHILLS (Cold chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: TCR received on 6-Aug-2021 contains updated outcome of events and patient details (gender and initials).
Irritated; Swolen; Hot; Little rash; Itchy; Red; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy), RASH ERYTHEMATOUS (Red) and RASH (Irritated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pain in arm from 14-Jan-2021 to 15-Jan-2021, Rash on 17-Jan-2021, Vaccination site pruritus on 17-Jan-2021, Red rash (Not able to code "sort of largen than the injection site") on 17-Jan-2021, Rash aggravated, Vaccination site swelling, Vaccination site joint warmth and Facial swelling (Facial swelling in the past (before the vaccine).). Concurrent medical conditions included Vaccination site rash (the shape and size of rash have moved) since 26-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Jan-2021, the patient experienced VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy) and RASH ERYTHEMATOUS (Red). On an unknown date, the patient experienced RASH (Irritated), VACCINATION SITE SWELLING (Swolen) and VACCINATION SITE WARMTH (Hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy) and RASH ERYTHEMATOUS (Red) had not resolved, RASH (Irritated) and VACCINATION SITE WARMTH (Hot) outcome was unknown and VACCINATION SITE SWELLING (Swolen) had resolved. Not Provided
patient was given vaccines onthe date of 7/6/2006 and on the morning of 7/7/2006 was found in the bed (with parents) not breathing, was bought to ER via ambulance and pronounced dead. The autopsy was inconclusive.    8/8/08 Autopsy report states COD as undetermined & manner of death as undetermined.  Report also states that patient was co-sleeping w/parents in adult bed. PMH: patent foramen ovale; reducible umbilical hernia  7/11/08 Reviewed PCP clinic records, vax records & hospital medical records.  Clinic records reveal patient had congestion & cough, poor weight gain, thrush, umbilical hernia & 2/6 systolic heart murmur.  Cardiac consult done for ASD which was felt to be unlikely to cause s/s.  Was in usual state of health on day of vaccination.  7/11/08 Hospital medical records of 7/7/2006 reviewed.  Patient had been fed approx 4 hours prior to being found unresponsive, cyanotic, asystole, w/jaw clenched.  Unable to determine from records if patient was in crib or in bed with parents, reported in varying ways in records.  EMS unable to obtain IV access or intubate.  ER unable to resuscitate.
Swelling of thigh - injection site - with redness - tenderness started a few hours after injection. Given prednisone & BENADRYL.
HYPOXIA 11/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Within 1.5 hours, I started getting a bad headache.  She was not hungry, was nauseated and was becoming clammy.  She tried to eat but it did not make it better.  When she got home, she continued to feel "really bad like she was getting over the flu."  She slept for over 10 hours.  When she got up, she could not move her arm and her arm was sore at the injection (it was hard, a little swelling but was not red).  Then she started feeling worse with bad pain (like she had a stroke).  This was around 12 noon to 1 PM on 1/21/21.  Around 7 PM that night, she presented to the ER.  The ER doctor said he thought she was having a migraine but she has never had one before.  Her blood pressure was high at 127/110.  Her supervisor walked into the room and said her face was pulling and it looked like a stroke to her.  She reported severe pain from her ear to her neck on the right side of her head.  She left due to having to provide care to her newborn.  She went to hospital on 1/21/21 about 2100.   Her blood pressure was still high and she had a heart rate of 120 bpm.  She did lab work and CT scan.   ER doctor believed she was experience Bell's Palsy and that she had had a mini-seizure.  She provided prednisone 60 mg X 1 dose, Valtrex tid and shot of Toradol.  She prescribed Toradol for outpatient pain relief.
A subnormal temperature as low as 96.2 but around 97.4 for the past 10 days, with an occassional temp above 98. I am normally 98.6. A  sensation of  very sharp prickles ( very fine like stinging nettles) followed by itching.  The sensation would last for approximately 15 minutes and then stop.  This happened all over my body, not just in the same place all the time.  Occasionally there were tiny raised bumps, but they disappeared after a short while. Little tiny bumps in my mouth on the inside of my lips, that look like blisters or tiny pinpricks.  I also have had some on my gums. They have  remained in some areas but gone away in others.  I gone to urgent care to be examined and they cannot tell me what they are.
hurt a little bit; big red slash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (big red slash) and PAIN (hurt a little bit) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE STREAKING (big red slash). On an unknown date, the patient experienced PAIN (hurt a little bit). The patient was treated with CLINDAMYCIN at a dose of 150 milligram. At the time of the report, VACCINATION SITE STREAKING (big red slash) and PAIN (hurt a little bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included regular medications.
This is a 23 year old who presents to the Vaccine Healthcare Center for clearance prior to deployment. He received his first three anthrax vaccinations within a 12 day period. He denies any symptoms, such as fever, chills, nausea, vomiting or diarrhea. He has not experienced any dermatological reactions as a result of his scheduled being compressed. The product line leader for immunizations has requested that he be evaluated and cleared prior to receiving any addition vaccinations or deploying. Additional guidance has been requested in regards to future vaccinations.
PCR result: Positive; PCR result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2021 as dose 1, single (Lot number: FA7485), in left arm and on 26Aug2021 as dose 2, single (Lot number: FA7485) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN; FARXIGA nasal. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2022, outcome "unknown" and all described as "PCR result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199410 Same Patient/drug, different dose/AE;
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date since 06-OCT-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot# K002527 exp. 18-FEB-2016 and lot# K14833 exp. 14-SEP-2016). There was no concomitant medication described. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
This case is linked to case number 2012-06128 and 2012-06129. A 10-year-old male patient, who has medical history of seasonal allergies, whose and concomitant medications were not reported, received first dose of IMOGAN (batch number, route and site of administration not reported) and IMOVAX (batch number, route of administration not reported) in the buttock on 10 August 2011. The patient received subsequent dose of IMOVAX on 13 August 2012, 17 August 2012, 24 August 2012 and 7 September 2012 in the alternate arms. The mother of the patient informed that after each dose of IMOVAX, the patient complained of flu like symptoms with nausea, fever, headache, fatigue and malaise starting after few hours of vaccination and lasting approximately for 2 day. Corrective medications were not reported. The patient had recovered on an unspecified date. List of documents held by sender: none
Immun administered on 2MAR92 redness & hardness @ inject site started on 4MAR92 on 5MAR92, deltoid area became red, hard, & hot, approx 18in in size; po t100;
Prolonged crying irritability diarrhea watery 5 per day. Lasted thru Sunday night 4/20/2017. Guardian reported extreme irritable crying abdomen pain distention no fever. Returned to normal Monday.
administered in 17May2022, expiration date 08May2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th May 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 17th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 17-MAY-2022 Reporter's Comments: Office Manager reported, that a 10 month old male patient was administered second dose in Pediarix series. It was then discovered the dose had an expiration date of 8th May 2022.   At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility is the same as Primary Reporter Reporter gave permission to contact for follow-up. The reporter consented to follow up. Additional Supportive Information: On 17th May 2022, the 10th month old patient received a dose of Peadiarix, which got expired on 8th May 2022, which led to expired vaccine used.
COVID-19; This spontaneous report received from a pharmacist via company representative concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 28-JUL-2021. 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,1 total administered 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 patient acquired COVID and was hospitalized in the past weekend (JUL-2021) of the day of reporting. Number of days of hospitalization was not reported and it was unsure that the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint number 90000187388.; Sender's Comments: V0. 20210758452-covid-19 vaccine ad26.cov2.s- Covid-19. These events are considered unassessable. The events has an unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
fatigued; dizzy; slight shortness of breath; face cheeks and tongue felt numb; face cheeks and tongue felt numb; tingling sensation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included positive Purified Protein Derivative (PPD) test and migraine with aura. The patient was allergic to bee stings. Concomitant medications included fluoxetine hydrochloride (PROZAC), taken for an unspecified indication from an unknown date. The patient previously took vicodin and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 at 18:00, 6 hours after the first dose, the patient felt fatigued, dizzy, slight shortness of breath and face, cheeks and tongue felt numb. The event resulted in emergency room/department or urgent care. At the emergency room, the patient was told that it was tingling sensation and not numbness since he was able to move the tongue. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. On 13Apr2021, the patient underwent COVID-19 test (nasal swab) in the emergency room and the result was negative. The clinical outcome of the events fatigued, dizzy, slight shortness of breath and numb/tingling at face, cheeks and tongue were resolved on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Paralyzed vocal cord. F/u with EENT -> confirmed vocal cord paralyzed. X-Rays done -> unknown. Now speaks only in whispers. f/u with Cancer Center re: possibility that vocal cord issue secondary to radiation -> indicated too long after end of radiation to have cause paralyzation of vocal cord.
Sore arm; Arm burn; Arm itchy; Like skin infection from the upper arm to the elbow; weakness for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Arm burn), PRURITUS (Arm itchy), SKIN INFECTION (Like skin infection from the upper arm to the elbow) and ASTHENIA (weakness for about 4 days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced ASTHENIA (weakness for about 4 days). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Arm burn), PRURITUS (Arm itchy) and SKIN INFECTION (Like skin infection from the upper arm to the elbow). On 02-Mar-2021, ASTHENIA (weakness for about 4 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Arm burn), PRURITUS (Arm itchy) and SKIN INFECTION (Like skin infection from the upper arm to the elbow) outcome was unknown.            Treatment Cream with antibiotics. Action taken was not applicable .
About a week and a half after getting the 1st Moderna  COVID vaccine I develop a rash on my L arm where I got the vaccine. It was about the size of a grapefruit for about 4 days. Itchy slightly raised rash. It went away. Starting about 3 weeks after the injection, my L shoulder and upper arm started to hurt. It has been going on now for about 5 or 6 days. Symptoms have gotten a little worse. Painful to lift my arm to reach for things, difficulty holding anything with any weight. The pain goes from my shoulder down to my bicep. I felt that the pharmacist did the injection to high on my arm. I don't know if that is why I am having this pain.
Patient called 6/30/11 to report a reaction that looked like hives or shingles. Patient saw MD and was told to keep an eye on it. Update on 7/1/11 says still looks like elongated hive & itches.
Developed petechaie and evidence of low platelets on blood testing. Diagnosed with idiopathic thrombocytopenic purpura suspected to be secondary to vaccination.
He has already crossed the window period.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He has already crossed the window period.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He has already crossed the window period.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He has already crossed the window period.) outcome was unknown. Not Provided      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 medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up was done,  no new information received.