chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has had several cases of pneumonia; she has had several cases of pneumonia, at least two occurrences in recent years as well; shrunk a few inches for her height; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 11Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "pneumonia shot") via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunization. The patient's medical history included pneumonia when she was a child about 5 years old, ongoing obstruction COPD (patient stated this is a mild case), chronic pancreatitis (not active now), ongoing blood pressure high, different heartbeat (patient initially referred to condition as an irregular heartbeat. She later clarified and stated it is not irregular, but just different. She stated she took medication to stabilize her heartbeat). The patient's concomitant medications were not reported. The patient previously received flu vaccine (unspecified product name but stated first flu vaccine in 1956 or 1957) and experienced terrible reaction where she was unconscious for days when she was 18 years old. The patient then received smaller components; she would have to get 2 or 3 shots when newer model flu shot was introduced. Since getting the newer model flu shot vaccine the only problem she would have was an occasionally issue with redness around the site of injection and maybe a little ache. She did not even have a fever. She would just get the routine flu shot that was being given. Patient reported that she had no reactions to the pneumonia shot. However, she had several cases of pneumonia. She had one occurrence when she was a child, about 5 years old. She had at least two occurrences in recent years as well. She confirmed she did not know the name of the pneumonia shot received. She just received it as directed. She did not have exact dates of when she received the pneumonia shot. She then sated she had had one was within the last 3-5 years. The last case of pneumonia she had was in Sep2019. Patient also mentioned she had shrunk a few inches for her height. The outcome of events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.
Injection site pain; Injection site swelling; Tiredness; This is a spontaneous report from a contactable consumer (Patient herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EL3302) via an unspecified route of administration in Arm Left on 11Feb2021 at 14:30 as single dose for COVID-19 immunization. Medical history included Obese and arthritis. Concomitant medications included ergocalciferol (VITAMIN D). On 11Feb2021 at 15:30 the patient experienced injection site pain, injection site swelling and tiredness. The seriousness of the events was reported as non-serious. The outcome of the event was recovered on an unspecified date in 2021.
Patient was requesting a flu shot, and onsite nurse provided incorrect vaccine (Pfizer COVID vaccine)
Following shot 2 beginning at 1am hands and ankles became very painful; Following shot 2 beginning at 1am hands and ankles became very painful; could not lift left arm had to move it with support from right arm; Severe headache; lower back pain; extreme neck pain; tremendous stomach distress; diarrhea; severe cramps; gas; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0153, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:15 at the age of 65 years old as single dose for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6204, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 11:00 as single dose for COVID-19 immunisation which leads to cause chills for 5 hours after 4hours of vaccination. Medical history included, extremely high cholesterol, maintains around 310. Known allergies included Many food items, penicillin, and many statin drugs from an unknown date and unknown if ongoing. Concomitant medication(s) included FLAGYL taken for an unspecified indication, start and stop date were not reported; CRANBERRY taken for an unspecified indication, start and stop date were not reported; VITAMIN B2 taken for an unspecified indication, start and stop date were not reported; MULTIVITAMIN taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. The patient received other medications in two weeks which includes, FLAGYL, VITAMIN B2, MULTIVITAMIN, and CRANBERRY supplement. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter states that, Following shot 2 beginning at 1am (on unspecified date) hands and ankles became very painful, could not lift left arm had to move it with support from right arm. These reactions were gone by midnight of the following day. Also had Severe headache, lower back pain, and extreme neck pain. These reactions were gone by 1 am 2 days later. Beginning at 2 am on day 2 had tremendous stomach distress, with diarrhea every half an hour which began to calm down around 11am. Had severe cramps and gas, associated with diarrhea. The patient did not receive treatment for events. The patient underwent lab tests and procedures which included pain assessment 10 plus on pain scale, on unspecified date, terrible pain. The outcome for the event was unknown.  No follow-up attempts are possible. No further information is expected.
Extreme reddish discoloration in my right arm from the injection point halfway down my forearm, worst on the underside of my arm. The color is like a moderate sunburn. Also the area is extremely sensitive. The discoloration and sensitivity on a scale of 1-5 with 5 being the worst, it is a 4.5.
Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious) with onset Mar2021, outcome "unknown", described as "Sinus infection".  Additional information: The reporter wanted to know if an antibiotic would interfere with the patient on getting the vaccine on Friday (second dose).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child died 1/2/03. Enclosed is copy of obituary. No cause of death given. Discharge summary received on 4/30/2003 indicates Acute Cardiac Arrest.
lymph's node - the area around my collar bone and my neck I just was not feeling well.
Fatique, Burning rash on my left arm from the top of my shoulder down to the elbow, Saturday the 19th a full rash from my right arm all the way down to my fingers. Burning and extreme itching, symptoms have continued through yet another day, today is Wednesday the 24th of June 2020.  Some of the rash has turned to small blisters, the rash today looks like hives.  It is much more aggressive at night making it difficult to sleep. The itch is something i have never experienced.
Diffuse myositis - Unclear if first presentation of autoimmune polymyositis due to positive ANA, SS-A and anti-smooth muscle antibody and strong FMH of autoimmune disease versus reaction to vaccine.
experienced a neurological deficit in my right hand; right hand is 50% useful; sickest I've ever been; left hand is numb and lost 10-20% function; neurosurgeon said it has to be some immunological response to something; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2022SA411736(CLUSTER).  This case involves a 58 years old male patient who experienced a neurological deficit in my right hand, right hand is 50% useful, sickest i've ever been, left hand is numb and lost 10-20% function and neurosurgeon said it has to be some immunological response to something after receiving yellow fever vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Blood pressure abnormal and Blood cholesterol abnormal.  Concomitant medications included losartan; hydrochlorothiazide; finasteride; fenofibrate; and amlodipine.   On an unknown date, the patient had received an unknown dose of suspect yellow fever vaccine (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date,  the patient experienced a neurological deficit in my right hand (nervous system disorder), right hand is 50% useful (mobility decreased), sickest i've ever been (illness), left hand is numb and lost 10-20% function (hypoaesthesia) and the neurosurgeon said it has to be some immunological response to something (immunisation reaction) (latency: unknown) following the administration of yellow fever vaccine.  The patient reported experiencing the following: "I got the live yellow fever vaccine and I'm suffering a neurological deficit. It wrecked me. I was out for 8 hours, I couldn't move, the sickest I've ever been. Everything broke after 8 hours, then a couple of days later I experienced a neurological deficit in my right hand. My right hand is 50% useful. My left hand is numb and lost 10-20% function. I had an MRI with the neurosurgeon, and he said there's no mechanical issues. The MRI is clear. He said it has to be some immunological response to something. They told me not to take my next dose." Currently these adverse events remain unchanged.  Relevant laboratory test results included: Magnetic resonance imaging - On an unknown date: no mechanical issues, clear  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the Neurological disorder NOS, Numbness in hand and Immunization reaction; was Recovered / Resolved on an unknown date for the event Mobility decreased and Illness.
I received the first vaccine and donated blood 17 days later but I showed no antibodies.; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine and donated blood 17 days later but showed no antibodies. The patient was interested in knowing if blood should show antibodies 17 days after 1st vaccine. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
R hip and knee effusion; seen by orthopedics at ER of Hospital, ESR 23 CRP 4.5 felt to be c/w inflammatory, post-infectious type arthritis
the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 18-AUG-2020, the patient was vaccinated subcutaneously with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: rHA, lot # T005406, expiration date: 12-AUG-2021(dose was not reported) for prophylaxis (reported as "well check"). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 116 hours in the temperature between -14 degrees Celsius (C) and -10 degrees Celsius and for 13 hours in the temperature between -9 degrees Celsius and 8 degrees Celsius (-6.1C) (multiple excursions). There was no previous temperature excursion. Digital Data Logger was involved.  The outcome of product storage error was unknown.
I developed itching, throat itching, cough with wheezing and hives on my left arm.  Elevated BP 197/94 Pulse ox was good.
About 45 seconds after injection. A warm cloudy feeling spread over my body from the injection site. Became dizzy, when I sat down I passed out. They estimated about 15-20 minutes. When I came to my body was limp, sweaty, shivering, I had motor functions but could not feel my body. Fingers and toes had a painful pulsating feeling. EMS was called I was placed on oxygen why they took my vitals
I started with a terrible headache about 2-1/2 hrs after receiving the 2nd shot. Later that day, the arm where I received the shot was very sore. After supper, I got chills so bad my teeth were chattering and my hands were shaking. I also had bad body aches. At 9 pm, my temperature was 99.9; at 10:30 pm, it was 100.6; at 11 pm, it was 101.9. The next day, I was fatigued and still had headache, body aches, sore arm and temperature came down to 99.2 by 8 pm. At 10 pm on the 2nd day, temp was 99.5. By Sunday, temperature was normal.
Metallic taste/still experiencing intermittent of metallic taste; Brain fog; confusion; right arm went numb/still experiencing numbness in hand/right leg with numbness; right leg also went cold; right leg with tingling; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness) and PERIPHERAL COLDNESS (right leg also went cold) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and INFLUENZA VACCINE (FLU) from 19-Nov-2021 to an unknown date for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness), PERIPHERAL COLDNESS (right leg also went cold), PARAESTHESIA (right leg with tingling) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at a dose of 1 dosage form and ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]) for Headache, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness), PERIPHERAL COLDNESS (right leg also went cold), PARAESTHESIA (right leg with tingling) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392012 (Patient Link).
Arm is still swollen; Still not feeling that great; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is still swollen) and MALAISE (Still not feeling that great) 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 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PERIPHERAL SWELLING (Arm is still swollen) and MALAISE (Still not feeling that great). At the time of the report, PERIPHERAL SWELLING (Arm is still swollen) and MALAISE (Still not feeling that great) had not resolved.            Concomitant information was not provided.   It was reported that the patient took her booster dose on Saturday around noon.  Treatment information was not provided.   This case was linked to MOD-2021-411501 (Patient Link).
administered only the ASO1B adjuvant component of the vaccine; administered only the ASO1B adjuvant component of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 1st April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments:  The reporter administered only the ASO1B adjuvant component of the Shingrix vaccine to a husband and wife. The reporter was not sure which of them received only the diluent or the full vaccination. The reporter consented to follow up. Additional Supportive Information: The reporter administered only the ASO1B adjuvant component of the Shingrix vaccine to a patient in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case is linked with case US2022058811 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058811:same reporter
Vaccines were kept frozen after expiry and then administered; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported as vial would be in freezer about 1-3 days  It was reported that 1 to 3 bottles of the vaccines were stored within the fridge to thawout and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No concomitant and treatment medications were reported by the reporter..
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included blood pressure and thyroid medications. No treatment information was provided.
More frequent bowel movements; Feeling off; Joint pain; Body aches; The injection site the area was raised; Area was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site the area was raised), VACCINATION SITE WARMTH (Area was hot), FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off) and ARTHRALGIA (Joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE REACTION (The injection site the area was raised) and VACCINATION SITE WARMTH (Area was hot). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off), ARTHRALGIA (Joint pain) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE REACTION (The injection site the area was raised), VACCINATION SITE WARMTH (Area was hot), FREQUENT BOWEL MOVEMENTS (More frequent bowel movements), FEELING ABNORMAL (Feeling off), ARTHRALGIA (Joint pain) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter Email address and report media was updated.
pt recv vax & devel high fever,vomiting & diarrhea which lasted for 5 days;pt was hosp for 2 days;pt recovered;