chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756515A, A0756517A - A7056562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient is a surgeon, developed pain and swelling right palm and 5th finger with swelling, gradual development of pain and decreased ROM right shoulder and neck. He believes this is a manifestation of post vaccination arthropathy with tenosynovitis as reported.
p/vax pt exp mild flu sx initially;also w/pain in lt thigh after shots;no injury known;also w/induration @ site of anthrax;
Syncope at home-transported to ER via ambulance-Temperature 95 degrees, pulse 50
on his back / active case of shingles; history of a rash / on his lower back / after / first / dose / rash on his back; left arm soreness and tenderness at the injection site; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bacterial infection, itchy rash, red rash, skin irritation and shingles (outbreaks since age nineteen).   On 16th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th June 2021, 4 hrs after receiving Shingrix, the patient experienced shingles, rash, injection site pain and pain in arm. On an unknown date, the outcome of the shingles, rash, injection site pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The reporter reported that a long history of intermittent shingles outbreaks since age nineteen. He states that they have became less frequent and less intense as the years have gone by. He also reported a history of a rash, diagnosed as a bacterial infection on his lower back. It was itching, sore, red and irritated.  The patient was treated by a dermatologist. The patient experienced left arm soreness and tenderness at the injection site and shingles.   About four hours after receiving the Shingrix dose, his wife noticed the rash on his back was an active case of shingles. The reporter consented to follow up.
Pt reported R sided chest pain that started around 5 PM after receiving the vaccine the same day. She did not seek medical advice. She went to bed and when she woke up the pain was gone. She came into the health center to report it the next day.
Day 11 - Red, pin point rash on arms, legs, and stomach - itchy.
She also received a PPD at this time. The patient stated that about one hour after receiving the injections, she started to feel itchy on the outer aspect of both elbows. When she rolled up her sleeve, she noticed a rash. She returned to the clinic. A purpuric rash, red in color, non-raised, was noted on the outer aspect of both arms just below the elbows. She stated it did itch, but no swelling was noted. There was no spreading to other parts of the body. She denied nausea or dizziness. She denied any involvement of her face, throat or tongue.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Left arm was Red) and VACCINATION SITE PRURITUS (Itching) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm was Red) and VACCINATION SITE PRURITUS (Itching). On 19-Mar-2021, VACCINATION SITE ERYTHEMA (Left arm was Red) and VACCINATION SITE PRURITUS (Itching) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-061461 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: No new information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061461:wife dose 1 case
AFib / rapid heartbeat an hour after receiving first dose. AFib again two days later around 11a on 1/30. Lasts for about 45 minutes
This spontaneous case, initially received on 05-Oct-2018 reported by pharmacist and concerns a 70-year-old, elderly male patient. The patient did not have any medical history and did not take any medications at the time of vaccination. On 05-Oct-2018, the patient was administered expired FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 179303 and expiry date: 30-Jun-2018). At the time of this report, the patient did not experience any adverse events. The reporter assessed this case as non-serious. Follow-up received from the pharmacist on 30-Oct-2018: The route of administration was confirmed to be intramuscular. Narrative was amended accordingly.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/05/2021, 01/26/2021, and 10/06/2021. The individual tested positive for COVID-19 on 02/05/2022 but COVID-19 symptoms were not the primary complaint on admission to hospital. The individual was in overall declining health at this time. It is not known if the individual had a specific symptom onset date as they had been non-verbal for a number of weeks, having suffered a CVA some time previous. The individual had been receiving end-of-life comfort cares at home but was brought to hospital on 02/05/2022 because the family no longer thought they were able to manage their condition and keep the individual comfortable at home. The individuals' end-of-life, comfort cares were continued in the hospital until their death on 02/06/2022.
Flu Mist was given and patient is currently 14 weeks 4 days pregnant  EDD 04/11/2022
States no symptoms for 5 days then she began running a temp of 104-105 F.  States she "lost her mind and an ambulance was called.  She stated that her WBC's doubled after the shot and she began having seizures.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5/1- weakness, woozy, queazy 5/2-continued same 5/3-better but still no energy 5/5- mid day sudden violent vomitting and full body muscle spasm 5/6-nausea gone but finger tips numb, scalp tingly, cold inside, itchy all over 5/7-seriously sharp chest/back pain. Worse when lying down.  Had to pace until it eased about 2 hours. 5/8-felt better most of day but chest pain woke me up again that night 5/10 all over thoracic pain, and stomach cramps  5/11 better, symptoms gone
Migraine for over a week (still going)  Chills Sweats Sore muscles Swollen eyes  Swollen lymph nodes Extreme tiredness
vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (vaccination site rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (vaccination site rash). At the time of the report, VACCINATION SITE RASH (vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 14-AUG-2018, the patient was vaccinated with a properly stored but expired M-M-R II lot # M034387, expiration date 19-JUL-2018, for prophylaxis. No adverse effects were reported.
Pain in both of her arms / legs hurt / arms hurt; body aches / total body aches all over; feels terrible; feels like she has a cold; she feels like she / is running a fever, but she was not running a fever; back hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 14:00 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EN6199. Expiry date: 30Jun2021; at 14:00 in left arm), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation, reaction(s): "arm sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "Pain in both of her arms / legs hurt / arms hurt"; PAIN (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "body aches / total body aches all over"; MALAISE (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "feels terrible"; NASOPHARYNGITIS (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "feels like she has a cold"; PYREXIA (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "she feels like she / is running a fever, but she was not running a fever"; BACK PAIN (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "back hurts".  Additional information: She felt like she really needed to go to bed in order to feel better. She does not think it has gotten worse, but she was not okay.  No follow-up attempts are possible. No further information is expected.
brief generalized tonic/clonic sz w/fever 101 approx 24 hrs p/vax; nl exam in ER, nl labs;
The very next morning had a severe stabbing headache, the headache subsided some the following  day but was still bothersome. A couple days later developed a pain behind my right eye and the headache moved to the top middle of my head and was sore to touch. A few days later I woke up with severe double vision. I had pain in the right side of my neck and in my right temple area. My right eye also developed a redness on the lower right side. This all lasted for about 4 weeks. Everything seemed to go away at the same time.
Sever cold chills with high? fever for over 7 days. extreme headache for 5 days  Urge to cough when taking deep breath. Your office has more info from the Physician that called
Heart does not feel right, Heart feels 'strained'; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA7485), via an unspecified route of administration in left arm on 12Aug2021 13:15 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8729), via an unspecified route of administration in left arm on 09Apr2021 16:00 (at the age of 51-years-old) as dose 1, single for COVID-19 immunization. The patient was not having any known allergies. Prior to vaccination, the patient did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced heart does not feel right, heart feels 'strained' on 13Aug2021 01:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Initial information received on 14-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient of an unknown age who received a dose of IMOVAX RABIES lot number not reported via unknown route in gluteal area on an unknown date. The patient's past medical history included bat attack on face. The patient's medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine administered at inappropriate site as the vaccine was administered into the gluteal area which was not supposed to be administered into the gluteal area. It was unknown whether the patient experienced any adverse reaction after vaccination. 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.
Shortly after vaccination, pt was having syncope-like reactions. he nearly lost consciousness and regained consciousness after a few moments. I asked him how he was and he stated that he felt dizzy and he was pale and sweating. The technician called 911 while I was attending to the pt.
I was diagnosed with hyperthyroidism. I was sent to an Endocrinologist who did a thyroid ultrasound and echocardiogram and I was diagnosed with graves disease. I were placed on medication for this condition. My hair has become thinner and my concentration is not good. I have symptoms with dry irritated eyes. A swollen eyelid where an MRI was done of my head core. I have a growth in my gland which is causing my eyelid swelling and the doctors believe its related.
Awakened in the middle of the night with fever and  chills.  Fever subsided  by 9am but extreme fatigue persisted another 12 hours accompanied by nausea.  No vomiting; however I experienced two very loose stools during the aforementioned 12 hours period.  I  had L. arm pain and redness at the injection site for 3 days following  the vaccine.
I received a seasonal flu vaccine at the same time (drugstore), but do not have the information as to what type.
diarrhea; experienced eight menstrual cycles after getting vaccination; throwing up with menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jul2021 (Lot number: FW0198) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (ongoing), notes: Patient history: ADHD (From: Unspecified To: Ongoing), Additional Information for Other Conditions: diagnosed since she was 4 years old; "to help sleep" (unspecified if ongoing), notes: Why was the patient taking Concomitant Products Melatonin (Verbatim): to help sleep. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder (ongoing); MELATONIN taken for sleep disorder (ongoing). The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "experienced eight menstrual cycles after getting vaccination"; VOMITING (non-serious), outcome "unknown", described as "throwing up with menstrual cycle". Therapeutic measures were not taken as a result of diarrhoea, menstrual disorder, vomiting.  Additional information included: No investigation assessment was done. Reporter was calling about the Pfizer covid vaccine. Her daughter took the first dose on 22Jul2021 and after she took it, her first menstrual cycle after the vaccine, she started having diarrhea and throwing up. For her last three menstrual cycles since the first dose of the vaccine she get diarrhea and is throwing up. Prior to getting the vaccine reporter's daughter never had any problems with her menstrual cycle, she was always light one day, then a little heavier then a little heavier then its over. Reporter was asking if anyone has reported anything like that before, if it had been reported as a side effect of the vaccine. She had 8 periods prior to the vaccine and did not have this issue.  No follow-up attempts are possible. No further information is expected.
had it after my shot around my side/suspected vaccination failure; had it after my shot around my side; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice, first was on right eyelid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got the Shingles shot and had shingles after his/her shot around his/her side. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
My 14 year old felt flush, dizzy, disoriented and light headed the day after his HPV vaccine, which was unusual especially b/c his younger brother who also had the vaccine and had similar symptoms. They have both received all their childhood vaccinations and never had any adverse reactions until now.
A pharmacist reported that a female may have inadvertently received 1 ml of Tetanus Toxoid Adsorbed, Ultrafined. She developed a "little" pain at the injection site. No further information was available at the date of this report.
Swelling in arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 09:00, the patient experienced swelling in her arm. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were taken as a result of swelling in arm and included treatment with unspecified allergic medication. The clinical outcome of the event swelling in arm was unknown at the time of this report.   No follow-up attempts are required; information about lot number cannot be obtained; No further information is expected.
12 hours after receivng vaccines patient had temp (102F), n/v, chills and malaise.  Mom treating with tylenol and fluids.
pt recvd vax & 10 days later exp blisters, rashy hands, arms, legs, feet; also exp itching; tx Cortisone cream;