chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cancer; COVID-19; COVID-19; Sore arm after Covid 19 vaccine; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on the information received by Pfizer from Regulatory Authority. The Manufacturer Control Number is 21K-163-4060366-00. A contactable consumer (patient himself) reported that a 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 14Apr2021 (Batch/Lot number was not reported) as dose 2, single; and via intramuscular route on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; adalimumab (HUMIRA) citrate free via subcutaneous route from an unspecified date (Batch/Lot number was not reported) to an unspecified date at an unspecified dose for moderate to severe Crohn's disease. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced possible cancer and abnormal test result. The patient reported that his physician found some abnormal test results and ordered a colonoscopy with contrast to get a better picture and rule out any possible cancer. In 2021, the patient experienced sore arm after Covid-19 vaccine. On 13Jul2021, the patient experienced COVID-19. The action taken in response to the events for adalimumab was unknown. In 2021, the sore arm after COVID 19 vaccine and COVID-19 resolved. On an unknown date, abnormal test result resolved. Outcome of possible cancer was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for adalimumab (HUMIRA): The reporter's causality for the events of possible cancer and sore arm after COVID 19 vaccine was not provided. The reporter's causality for the events of abnormal test result and COVID-19 with Humira(adalimumab) was a reasonable possibility. Manufacturer opinion is that the events of possible cancer and abnormal test result are not assessable. While there is no reasonable possibility that the events of sore arm after COVID 19 vaccine and COVID-19 are related to adalimumab (Humira).  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): reporter's causality for the events possible cancer, abnormal test result and COVID-19 was not reported; for sore arm after COVID 19 vaccine was possible.  The reporter's assessment of the causal relationship between the events possible cancer, abnormal test result and COVID-19 and the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "COVID-19" and "Sore arm after Covid 19 vaccine" cannot be completely excluded based on temporal association. There was not a reasonable possibility that the event "Cancer" was related to the suspect drug, but most likely represents patient intercurrent medical condition.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (COMIRNATY), on 26Jan2021 at 12:00 as dose 1, single (Lot number: EN5318), on 16Feb2021 at 12:00 as dose 2, single (Lot number: EN5318), on 01Oct2021 at 09:30 as dose 3 (booster), single (Lot number: EW0217) and on 08Apr2022 at 15:15 as dose 4 (booster), single (Lot number: FH2048) at the age of 55 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05May2022 at 23:00, outcome "unknown", COVID-19 (medically significant) with onset 05May2022 at 23:00, outcome "recovering" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: Covid test type post vaccination: Nasal Swab; (05May2022) Positive, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course includes the patient did not receive vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies.
Not getting full dose; A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and vaccine spilled on her and the dentist's pants and not getting full dose.   The patient's medical history and relevant concomitant medications were not reported.   On 11-Jan-2021, at the same time as the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   When the nurse went to administer the vaccine dose, the needle fell off of the syringe and some vaccine spilled on the patient's pants. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event the needle fell off of the vaccine syringe was resolved.  Reporter causality for the events was not provided.; Reporter's Comments: This report refers to a case of male patient who experienced non-serious unexpected event of the needle fell off of the syringe and some vaccine spilled on the patient's pants. (Incomplete dose administered) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with this case of Incomplete dose administered.
Patient stated that within 3-4 hours of receiving the covid-19 vaccine he began to lose his sense of taste and smell.  Patient presented to ER (12-17) with  his arm was hurting, headache, weakness, back hurting, and blood pressure was up.  B/P was 204/112; pulse 84;resp 19; temp 102.4; Covid-19 test- negative. He had no sob or cough. Meds given:Tylenol tabs 650mg x1, Toradol 30mg iv x 1; NS 0.9% 1000ml iv, Tusssionex 5ml x1; Lopressor 50mg po x1,  Patient released at 10:23am
Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 18-OCT-2021 and not undergone any temperature excursion.  No adverse events were reported.
I have not seen, but the patient's husband described as a rash from the injection site down to the elbow.
Initial case was retrieved from the scientific literature on 03 February 2012. Verbatim from abstract: "BACKGROUND: The risk of immune thrombocytopenic purpura (ITP) after childhood vaccines other than MMR is unknown. METHODS: Using data from 5 managed care organizations from 2000 to 2009, we identified a cohort of 1.8 million children ages 6 weeks to 17 years. Potential ITP cases were identified by using diagnostic codes and platelet counts. All cases were verified by chart review. Incidence rate ratios were calculated comparing the risk of ITP in risk (1 to 42 days after vaccination) and control periods. RESULTS: There were 197 chart-confirmed ITP cases out of 1.8 million children in the cohort. There was no elevated risk of ITP after any vaccine in early childhood other than MMR in the 12- to 19-month age group. There was a significantly elevated risk of ITP after hepatitis A vaccine at 7 to 17 years of age, and for varicella vaccine and Tdap vaccine at 11 to 17 years of age. For hepatitis A, varicella, and Tdap vaccines, elevated risks were based on one to two vaccine-exposed cases. Most cases were acute and mild with no long-term sequelae. CONCLUSIONS: ITP is unlikely after early childhood vaccines other than MMR. Because of the small number of exposed cases and potential confounding, the possible association or ITP with hepatitis A, varicella, and Tdap vaccines in older children requires further investigation." Verbatim from the article: "Of the 6 cases of serious adverse events, only one was a vaccine-exposed case, a 4-year-old girl who developed Immune Thrombocytopenic Purpura (ITP), complicated by hematochezia and hematuria requiring a packed red blood cell transfusion 4 weeks after receiving DTaP, MMR, and IPV". Documents held by sender: None.
body achiness; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 49 year old male patient who had body achiness (pain), while he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 23-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the upper left arm for prophylactic vaccinations.  On 26-Oct-2020, the patient developed a non-serious body achiness (pain) 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided   No corrective treatment was received.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Red, hot, painful oval (6 cm x 4 cm) approxmately 10 cm below injection site on Right deltoid.
No additional AE reported; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature; This spontaneous report has been received from an office manager and refers to a patient of an unknown age and gender.  The patient's medical history, current conditions, concomitant therapies, allergies and drugs reactions were not provided.  On an unknown date in 2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, dose reported as 1 (units not reported), lot number U017138, expiration date: 28-NOV-2022, administered for prophylaxis (strength, route of administration and anatomical location were not provided). On 20-JAN-2022 a temperature excursion occurred at a temperature of -14 degrees Celsius for 7 hours (product storage error). No previous temperature excursion was reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004990:Case number: 02167746 US-009507513-2205USA005067:Case number: 02167784 US-009507513-2205USA005084:Case number: 02167789 US-009507513-2205USA005023:Case number: 02167763 US-009507513-2205USA005071:Case number: 02167774 US-009507513-2205USA005002:Case number: 02167802 US-009507513-2205USA005130:Case number: 02167643 US-009507513-2205USA005126:Case number: 02167756 US-009507513-2205USA005229:Case number: 02167797
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies. Add" (unspecified if ongoing), notes: Allergies. Add. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti viral medication Paxlovid, orally starting on 29Jun2022 and stopped on 03Jul2022. There were no other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported events COVID-19, drug ineffective cannot be completely excluded based on temporal association and known drug safety profile
Client reported warm feeling to face and neck, lightheadedness 3 minutes after receiving the vaccine Care initiated by facility.  Vital signs within normal range.  Client declined further treatment.
About a week and a half after receiving the first and only dose of the Johnson and Johnson Covid-19 vaccine, I developed small bruises (Petechiae) on my chest and arm. I decided to consult my doctor just in case. My doctor did a blood draw and ran a CBC panel. The next day I was rushed to the ER as my platelet count was reported at 7. By the time I got to the ER my platelets had dropped even further to a count of 2. I was treated inpatient for 3 days 2 nights. At this time I was diagnosed with IPT (Immune Thrombocytopenia Purpura). It was treated with two rounds of IVIG (Intravenous immunoglobulin) and 75 mg of Prednisone daily (which I have been slowly tapering off of since). My platelets restored to a non-critical level and have continued to hold steady ever since.
Information has been received on 29-JUN-2017 from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, an unknown number of unspecified patients were administered doses of VARIVAX lot # L045956, expiration 17-NOV-2017, subcutaneous for prophylaxis that were improperly stored. Concomitant medications included sterile diluent (lot number and expiration are unknown) which was properly stored. No adverse effects were reported. The vaccine doses were stored at 30 degrees Fahrenheit for 5 hours. There was no previous temperature excursion reported. The call was made because of a data logger. No additional information is available. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm and influenza-like symptoms to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the shingles vaccine would bring a week of pain to the arm and a week of severe flu symptoms, and need two, months apart. The follow-up would not be possible as no contact details were available.
Left hip pain that radiated down the left leg to left foot. Developed about 12hrs after vaccination and started to relieve about 36hrs after vaccination. No treatments.
end up in the hospital everytime with the flu; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved unknown age patient for whom end up in the hospital everytime with the flu (Flu) was reported, while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, for the patient end up in the hospital everytime with the flu (Flu) was reported, unknown latency following the administration of INFLUENZA VACCINE.   Final diagnosis was end up in the hospital everytime with the flu.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for end up in the hospital everytime with the flu.  There would be no information available on batch number for this case.
she had a runny nose; she had chills all day; This is a spontaneous report from a contactable consumer(husband) or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that in Feb2021 his wife got shot at the same time as reporter did but she hardly had any reaction. He clarified his wife said she had a runny nose and she had chills all day when she got the vaccine. The events outcome was unknown.   Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Wed-Swelling and inflammation at injection site; Thurs-Sat nausea, fever; Sunday passed out; symptoms progressed until Friday. Went to ER and was admitted to hospital for 3 days with extremely low blood pressure and pain both of unknown origin. Continues to experience symptoms.
Facial redness, flushing - severe myopathy - uncontrollable sleepiness/drowsiness.
Aprox. 24 hours after vaccinations started experience lower back pain.  No other symptoms.
Rash & urticaria pruritus. Diphenhydramine 25-50 mg other.
Approximately 5 minutes after injection pnt complained throat feeling funny - difficulty swallowing - thirsty. Called 911 - emergency personnel on site in about 3 minutes. Just given BENADRYL pnt refused EPIPEN.
Noticed a bump above L clavicle that was tender; when checking injection site on L deltoid, noticed it was red and slightly tender.
This is a spontaneous report from a contactable consumer, reported similar events for herself and her husband. This is the second of two reports. A male patient of unspecified age received PREVNAR 13 via an unspecified route of administration at single dose on an unknown date for pneumonia immunization. On an unknown date the area that patient got shot in started to bruise about two inches around and then further out, it became blazing hot and it was at least 6 inches around that came to be really hot and swollen. It lasted a week and finally went to the doctor. On an unknown date the patient also experienced little patch, where it has swollen and turned red, the colour was not returned to normal. When was in so much pain, could not sleep and  took couple of TYLENOL. The doctor prescribed a cream, Triamcinolone for the itching when the swelling had come down and the pain had started to go away. The patient recovered completely. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017016070 same drug/event, different patient.
From initial information received on 5/16/03 from the patient's relative, regarding an adverse event, it was reported that a 74 year old female patient received FLUZONE SV 2002-2003, lot number U0930FA, given on 10/23/02. About one week later, the patient developed a sore throat and weakness in her legs, was seen by a health care professional. On 11/27/02, the patient was admitted to the hospital for three months and was diagnosed with GBS. Reportedly, it is unknown if the patient recovered. The patient had triple bypass surgery in 200 and has allergies to Penicillin and Protamine. The reporter will send additional information.  Follow up on 07/08/2003:.  Follow up on 01/21/04: "No additional information is anticipated. Case is closed."
Couldn't sleep, shoulder muscle sore to touch and movement, red splotches were hot somewhat swollen.  Sunday broke out (large hive type areas - real itchy and red) on right hand between thumb and index finger, between mouth and right ear and between eyebrow and hair line.  Took naproxen sodium and Benadryl.
Information has been received from a physician referring to a 50 year old male patient with diabetes mellitus. On 12-SEP-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expiration date, strength and dose were unknown) intramuscularly. The patient's concomitant medication was not reported. On 13-SEP-2015, the patient developed pain and redness at injection site. The patient also experienced a fever of 103F. On 18-SEP-2015, the patient visited the physician complaining that the pain and redness was getting worse. The patient was prescribed KEFLEX (500mgs), as well as ADVIL for pain. No lab diagnostics studies were performed. The outcome of the events were reported as not resolved. Additional information has been requested.
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm at the injection site). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Arm is extremely sore in the muscle. Not tender to touch, but painful to strain the muscle. Any type of force the arm does is painful. It is currently about two and a half weeks ago I had the shot and I am just now feeling relief.
Suden rash with Redness and swelling and itching at injection 8 days after vaccine administration. New Pain in arm pit    At same time as rash symptoms from above.
Pt had vaccine on Friday 9/21/12/. On Sat 9/22 at same she noticed redness swelling & discomfort at side of injection on Sun 9/23 she started with headache at 6 am.