chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient felt very sick on Apr2021 with outcome of unknown. Patient stated that she took the vaccine and she felt very sick and could not move out of bed and asked whether this normal 4 days after receiving the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness below the deltoid muscle; Swelling below the deltoid muscle; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown.   It was unknown if the reporter considered the localized erythema and local swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 63 or 64 years. The reporter stated that the patient after vaccination developed redness and 2.5 cm swelling below the deltoid muscle. The reporter consented to follow up.
After receiving the vaccine the pt's arm became sore, it then developed a small amount of induration and was tender to the touch.
03/04/2003 knot appeared with redness, warmth, and tenderness on left thigh. 03/06/2003 redness decreased, warmth decreased, knot still there.
non tender swelling 3.5 x 2.5inches w/minimal erythema lt thigh;oral APAP/warm compress;
Difficult breathing. Chest pains. Aches in whole body. Difficult sleeping had to use oxygen continuously for 2 weeks.
collapses on the field with cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 13 years old and unknown gender patient who was collapsed on the field with cardiac arrest while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose, (lot number, expiry date, strength, form, frequency not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event of collapses on the field with cardiac arrest (cardiac arrest) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses on the field with cardiac arrest).  At time of reporting, the outcome was Unknown for the event collapses on the field with cardiac arrest.; Sender's Comments: Sanofi comment dated 07-Feb-2022: This case involves a 13 years old and unknown gender patient who collapses on the field with cardiac arrest while receiving vaccine influenza vaccine. The time to onset was unknown for cardiac arrest. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Mom called today, stated pt's arm is very reddened and has a lump where inj was given. Arm is stiff and very sore and swollen. Bruised at inj site.
Patient was vaccinated with Pfizer Bivalent. Already had previous dose 2/12/2023.
Anthrax 3rd shot + 2 days- blisters all over body- Anthrax & smallpox shots given- meds for itching given. Jan- no shots- blisters all over again- doctor took cultures with a neg. result to small pox. Feb 4th Anthrax- 2-3 days post blisters all over body Atarax given- reffered to Immunology Dermatology.
Muscle cramps, lower back, one thigh, one arm, one thumb, one toe,  pins and needles in limbs.  Course of prednisone. Also had reaction in 2005 and 2001 but did not connect them with flu shots at that time but timing was suspicious according to Dr records.
Site: Pain at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: pt called and reported she started to have diarrheas since this morning for 3 times already. Besides, she had headache and nausea. She did not have this problem with 1st and 2nd shot; however, she stated she had this time with her booster shot. She stated she also felt tired for the 1st two days after the booster shot.
This spontaneous report as received from a medical assistant refers to a 10 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 18-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3/ Vaccine brand other=Moderna, Vaccine dose number=4, Vaccine dose number=2, Vaccine dose number=1; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asplenic" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3/ Vaccine brand other=Moderna, Vaccine dose number=4, Vaccine dose number=2, Vaccine dose number=1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Report about covid treatment: Yes. If vaccine received: Yes. Other medication in 2weeks: No. Product=COVID 19 Treatment, Brand=Paxloxid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was ordered a booster dose for the Pfizer covid vaccine - dose was mixed by pharmacist in the office - after administration it was noted that the dose was mixed from a vial that expired on 01/15/2022 - dose was given on 01/18/2022 (three days after the listed expiration date).  Patient was monitored post vaccine administration - patient denies any reactions or symptoms - patient was made aware that the dose was 3 days expired - patient stated he was not concerned. Attending Physician and precepting physician were also made aware before the patient left - no further orders given. Manager of the office spoke with Pfizer who sent over paperwork to be completed as well.
severe shivering for an hour as I mounted a fever of 103.3 I ameliorated it by taking Tylenol and Ibuprohen every alternate 2 hours.
covid vaccine 1/21, 24hrs latere developed tach, dysphagia , difficulty swallowing, difficulty speaking, weakness left side of face and progressive weakness LUE. and SOB
Pt presented because of vomiting & diarrhea, afebrile, no rash, not dehydrated by exam or labs; had generalized sz x 2 adm to peds ICU complete work up neg including LP;
mild headache and malaise started about a day after injection and lasted for about six days.  Swelling of left armpit lymph node (same side as injection site) started about 5 days after injection
Muscle cramps, fever, dizziness, nausea experienced over the course of 3 days (from 09/15/2017 to 09/17/2017).
On January the 15th I attended a mega vaccine hub to get injection. Later on that night around 4:00 in the morning I woke up to a numb, pain full, swelling, hardness of the arm. I was like that through out the day along with tiredness and chills all day long. I could barely pick up my arm. The next day was a bit better but during the week my arm still felt soreness, harness in the area of injection. on Saturday the 22nd, eight days later I woke up to a arm that was more severely swollen with redness in a circle where the injection shot was administered. It felt worse than the day i received the shot. I decided to document this and take pictures of my arm and to let you all know about this. I plan to go to the emergency room if i wake up worse tomorrow. I seemed to have an allergic reaction to the shot. I'm very worried and do not feel right. Been taking benadryl.
This child had a mild rash on the front and back of his trunk, and mild rhinorrhea.
Needle administering the vaccine detached from the syringe and patient did not receive the dose. New dose given, patient does not report any symptoms during or after administration.
Noticed infection on my hip, had red bumps and swollen lasted from 10/10/21 to 10/20/21.
Patient fully vaccinated and hospitalized due to Covid related symptoms.  She developed symptoms on 09/04/2021 and is still symptomatic. major symptom was shortness of breath. She was admitted to the hospital on 09/04/2021 and released on 09/05/2021 when her oxygen levels improved.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unspecified date in 2013 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, route not reported). There was no concomitant medication. The patient fainted multiple times within minutes after receiving the first dose of GARDASIL. She hit her head as a result of the fainting and was given ice for her head. The patient did the blood work test and the results unspecified. The patient was instructed to rest for a few moments and then was allowed to go home. The patient did not seek medical attention. The patient planned to continue with the series. The outcome of the events was unknown. Additional information is not expected.
Hives and wheezing, mother gave her BENADRYL yesterday evening. Better this morning 11/7/14.
seizure; death; autoimmune disorder; lupus/autoimmune disorder; POTS; dizziness; headaches; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), seizures, lupus, autoimmune disorder, headache and dizziness. On an unknown date, the patient died. Cause of death was not reported. It was unknown if an autopsy was performed. Reported date of injury was unspecified date in 2007. The outcome of the events was not reported. The causality assessment was considered as related by the lawyer.  Upon internal review, seizures, autoimmune disorder and lupus was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
When I received the injection, it burned quite a bit and then briefly went away. Then about 10 minutes after I received the injection, the burning returned and lasted for over an hour. I also developed a sharp needle stabbing pain in the left foot as I was driving home about 40 minutes after that and it lasted about 30-40 minutes as well. I have never felt that foot pin stabbing pain before in my life nor did that happen after the first 2 injections in the initial series. After it went away, it did not return (either the arm burning or sharp foot pain).
He was too young; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided. The pharmacist recommended getting the Pfizer vaccine as the second dose.
Initial information received on 19-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse (mother of the patient). This case involves female patient of an unknown age who experienced local injection site reaction at each injection site, while she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jan-2019, the patient received two doses of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via intramuscular route in unknown administration site and same vaccine with an unknown batch number via subcutaneous route in the left arm. On an unknown date, the patient developed a non-serious local injection site reaction at each injection site following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was also the case of actual medication error due to extra dose administered and incorrect route of product administration. Inadvertently administered two doses of QUADRACEL yesterday (18 Jan 2019) by a nurse in the practice. Reporter stated that one of the QUADRACEL doses was given Intramuscular, but the other one may have been given Subcutaneous. (Other relevant tests included no lab data). Final diagnosis was QUADRACEL doses was given intramuscular, but the other one may have been given subcutaneous, inadvertently administered two doses of QUADRACEL and local injection site reaction at each injection site. It was not reported if the patient received a corrective treatment. The patient got recovered from local injection site reaction at each injection site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
A menstrual period that is severely heavy, painful, and full of large clots. This has occurred every month since the first administration. It is accompanied by debilitating fatigue.
15 min after injection-flushing, heart rate increase. 30  min some lip itching that went away within 30 min. Took Tylenol in morning (12-17)because started having a few muscle aches. Around 10 am- muscles tightening and needed to stretch them most of day. Fatigue but mild. Mild nausea about 11 am . 5 pm chills started. Ibuprofen taken. Muscles aches continued overnight Dec 17 until 10 am 12-18/ Ibuprofen in morning. Mild fever Friday 12-18--99.1-normal temp 97. Next 2 days mild fever continued and normal Monday 12-22. Muscle aches declined and gone 12-21. Heart rate has remained higher than normal since 12-16--normal is low 70's and has been high 80's and low 90's.
Experienced syncope at 8am on 5/20/21 after feeling chills and fever. Experienced 3 back-to-back episodes of syncope.
Information has been received from a doctor of pharmacy concerning a 3 day old male patient who on 09/08/00  was vaccinated with a 1st dose of Hepatitis B vaccine. Subsequently, the patient developed a temperature of 101.8 F. Unspecified medical attention was sought. Additional information has been requested.
pt recvd vax in JAN93 & approx 3 wks later devel nausea & visual disturbances which lasted for several months; also devel fatigue & bruising;
very stabbing pains in to her ears; very stabbing pains down in to like her little finger and next to little finger on both the hands and the same on her feet and heels; started feels like stuff has been flushed off through her body and it feels very weird; Ache/ Pain; This is a spontaneous report from contactable consumer (Patient's friend) reported for female patient. A female patient of unspecified age received second dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Lot number: EWO168, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose of covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection) on an unknown date as a single dose for covid-19 immunization. On an unknown date in the morning 05:00 or 07:00, patient experienced typical aches and pains that you read about, but she is also very stabbing pains in to her ears and very stabbing pains down in to like her little finger and next to little finger on both the hands and the same on her feet and heels and she started feels like stuff has been flushed off through her body and it feels very weird. Is this something which is normal. or is this something she should be concerned about. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
23 year old male came to the COVID vaccination clinic for a Pfizer vaccination.  Shortly after the vaccination was administered he became lightheaded, nauseated and vomited.  He was given an emesis basis and the emergency room was notified and patient was care for further in the emergency room.  Patient left our area stable and was further evaluated by the emergency room.
pt recvd vax & 5 days later exp angioedema wrists/palms & generalized urticaria; these sx were treated w/Tagamet & Hydroxyzine & resolved in 48 hrs;
Information has been received from a registered nurse concerning an 8 year old male student with no medical history who on 10/21/1996 was vaccinated subcutaneously with the first dose of varicella virus vaccine live.  Concomitant vaccinations on that same day included the first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  The RN reported that in 2004, the patient developed breakthrough chickenpox.  In July 2004, the patient recovered from the breakthrough chickenpox.  Additional information has been requested.
Initial medication error report received on 03 December 2013 from nurse. An 18 year patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on 03 December 2013. Reporter stated that consumer received one extra dose of FLUZONE. Patient already vaccinated in November and again in 03 December 2013. Patient did not have any adverse events. List of documents held by sender: none.
13JUL94 pt devel hives all over body sometime during noc; mom said had fever but did not take temp referred to pvt MD & told to use DPH;
Sore, painful, raised red bump (2 inches in diameter) starting 24 hours after, lasting until day 3.  And starting today, at day 8, itchy, splotchy red rash, and feels flat and hard (3 inches in diameter).
Non itchy rash; Weird rubber smell; Chills; Verysore arm; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness), RASH (Non itchy rash) and PAROSMIA (Weird rubber smell) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 03L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness) and PAROSMIA (Weird rubber smell). On 05-Mar-2021, the patient experienced RASH (Non itchy rash). On 03-Mar-2021, PAROSMIA (Weird rubber smell) had resolved. At the time of the report, PAIN IN EXTREMITY (Verysore arm), CHILLS (Chills), ASTHENIA (Weakness) and RASH (Non itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported
p/vax pt leg tripled in size, & exp a bump where the inj was given;
Numbness in hand/fingers. Tingling felt like finger "went to sleep".  Persist persisted for 3 weeks or so then resolved. Hand now feel sore (arthritic)
A physician reported that a 12 month old female received a 1st dose of Prevnar on 8/3/01. The physician "is not sure when the 2nd dose was given, but the series was halted". On 11/24/01, the child developed erythema nodosum. The child has been admitted to the hospital numerous times. As of the date of this report, the symptoms still persist. No additional information was available as of the date of this report.
Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with two improperly stored doses of M-M-R II (dose, unit, route unknown, lot # L023386, expiration date 25-JUN-2017, another lot # K014832, expiration date 14-SEP-2016) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Firm, warm red area 2 1/2" x 3" on (L) deltoid x 2 days.