chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: MALAISE (non-serious), outcome "recovered", described as "I didn't feel good for couple days and something like that but it was not anything you know major". The patient was a nurse many years ago and now she retired. The patient wanted to know why in the local location for the majority of healthcare providers when they give the Pfizer Covid19 vaccination, why do they not say any instructions to aspirate before injecting into the deltoid muscle. It was stated that people have had reactions to the vaccination (further clarifications unknown) and reporter think part of it was, it was pretty rare to hit a vessel in your deltoid muscle but it was possible. That was the gold standard and want to know there was no, don't think there was any negative reason for aspirating, it would not affect the vaccination at all because the person would still get the same amount of medication. The patient just wants to know why Pfizer just to prevent even a rare instance of a person getting that right in to their vein or their artery, that they wouldn't just say aspirate before injection. The patient had both vaccinations and booster all being Pfizer and never even questioned when healthcare provider was giving the vaccination because assumed that they were aspirating. So, that's question cause  think it was very important because even if it's very rare that they would hit a vessel and inject that vaccinations if even part of it, into a vessel which could cause some serious side effects including myocarditis and pericarditis which has happened to people (Further clarifications unknown. Hence, split case not made. The patient asking why they would not just put in the instructions, must aspirate before injection. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Client states that jaw was 'tight' and 'painful' within 24 hours of receiving Twinrix (hepA/hepB), dose 3.  States that symptoms remained x several days but was experiencing only slight soreness at time of her call to RN on 9/19/03.
Body aches; chills; fatigue; loss of taste; metallic taste. Lasted about 48 hours after onset of symptoms. Symptoms began about 14 hours after vaccination. Treated with OTC medication and rest.
Mother of pt. calls reporting Rt arm swollen, red - received 2 vaccines on.
This spontaneous report was received from a physician referring to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with PROQUAD, recombinant Human Albumin (rHA) (lot # M038861) (dose, route of administration, anatomical location and expiration date were not reported), which was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007310: US-009507513-1705USA007309: US-009507513-1705USA007311: US-009507513-1705USA010146: US-009507513-1705USA010144: US-009507513-1705USA010143: US-009507513-1703USA014463: US-009507513-1705USA010145: US-009507513-1705USA010147.
Pain and swelling at injection site that started almost immediately now into 3rd day. About 29 hours after the injection, I developed chills, low-grade fever (99.1) and aches. Chills and fever subsided by morning, but still have general feeling of being unwell, headache and tenderness in arm.
exp sl fever, pain & reddness in inject site w/2" diameter reddness; was given Keflex TID x 10 days on 22AUG94;
Information has been received from a registered nurse concerning a currently 12 year old child with no known allergies with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently, the patient experienced a "severe reaction" as an infant to the vaccine. Unspecified medical attention was sought. It was unknown if treatment was required. Follow up information reported that no further information was available regarding the "severe reaction" and it was noted that the child was presently healthy and had no current medical conditions. Additional information has been requested.
Covid-19; Respiratory tract congestion; Covid-19; Booster dose; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4224252-00.  A 40 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose=1, Route of Admin: Intramuscular), for COVID-19 immunization; Bnt162b2 (Dose=2, Route of Admin: Intramuscular), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Dec2021, outcome "unknown", described as "Booster dose"; DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 01Jan2022, outcome "not recovered" and all described as "Covid-19"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "Respiratory tract congestion". The action taken for risankizumab rzaa was unknown. The patient had booster dose of COVID one and half weeks prior to 01Jan2022 and reports ended up with COVID on 01Jan2022, physician was aware and Skyrizi will be delayed a week due to continued cough, chest congestion. It was reported that it was unknown if the patient was enrolled in a COVID-19 Vaccine Trial, also the reporter's causality for the events of COVID and CHEST CONGESTION with SKYRIZI(RISANKIZUMAB) had no reasonable possibility, and the reporter's causality for the event(s) of COVID and CHEST CONGESTION with Pfizer Biontech Covid-19 Vaccine was reported as probable. It was not available whether the event abated after stopping the drug.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, suspected covid19, respiratory tract congestion cannot be totally excluded.
Treatment of COVID-19; Treatment of COVID-19; Dose 01, 02, 03: Pfizer/ Dose 04: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EX5730) at the age of 45 years, on 15Jan2021 as dose 2, single (Lot number: EL3249) at the age of 45 years, and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 46 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Sep2022 as dose 4 (booster), single (Lot number: AS7148B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "not recovered", described as "Dose 01, 02, 03: Pfizer/ Dose 04: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment was given with Paxlovid from 12Jul2023 till 17/Jul/2023, Acetaminophen on 13/Jul/2023, Ibuprofen from 10Jul2023 till 12/Jul/2023.
Aprox 4-5 hours later had burning painful urination. Next day aches, chills, pain, 101 temp., diarhea. Became very dehydrated. Sore arm at injection sight.  Lasted 3 days or until Saturday evening.
Approximately one hour after shot was given, client noticed large, red, non-tender welts on L arm, around her wrist.  Later she developed bilateral lower extremity, red, itchy rash.  Severe pain and tenderness noted in L arm where shot was given.
First dose was given on 2/26/2021, after an hour of given the injection I felt dizzy and a bit of vertigo (almost felt tipsy after having alcohol), so went to bed and slept it off. The next morning, I felt normal, but my arm was sore and tender to touch. The soreness lasted 3 days. Second dose was given on 3/26/2021, and felt some sensation of vertigo but that last about 15 minutes. The next morning, had a fever and felt fatigue. Took a tylenol and the fever went away. Fatigue lasted all day and felt normal after that. Injection arm was again sore and tender to touch and last abou3 days.
fever 103F; body ache; coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever 103F), MYALGIA (body ache) and COUGH (coughing) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from March 2020 to April 2020. Concomitant products included DIPHENHYDRAMINE for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Antiplatelet therapy, ATORVASTATIN for Cholesterol, NIFEDIPINE and LOSARTAN for Hypertension.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (fever 103F), MYALGIA (body ache) and COUGH (coughing). The patient was treated with PARACETAMOL on 07-Feb-2021 at an unspecified dose and frequency. At the time of the report, PYREXIA (fever 103F), MYALGIA (body ache) and COUGH (coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Client received 2nd dose COVID vaccine and reports numbness and tingling in same arm down to fingertips at 3:30 pm.  Client reports similar reaction with first dose, medical team consulted and approved for second dose today.  Client denies shortness of breath, trouble swallowing, chest tightness.  Client observed, vital signs stable.  Client educated on ER precautions and when to follow up with primary care provider.  Symptoms lessened within 30 minutes of observation, client reports numbness at 2/10 on scale.  Client left observation area with steady gait at 4:00 pm.
headaches; body aches; chills; joint pain; This is a spontaneous report received from a contactable consumer (Patient). This 52-Year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, on 08May2021 as first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 30May2021, the patient experienced headache, body pain, chills and joint pain. The Patient was denied to receive the second dose. It was reported that the patient asked if those symptoms have been reported this late after the first dose. The patient asked if the fact that his symptoms started 22 days after first dose, does this mean his symptoms are not related to his Covid vaccine. The patient also asked if data on side effects was collected from the clinical trial only or it was based on real world data, like people like him calling and self reporting about the events. The outcome of the events was not recovered.  Information about batch/lot number has been requested.
Pins and needles, tingling, muscle pain, muscle weakness, joint pain, headache, rapid heartbeat, fatigue, nausea, loss of appetite. These side effects are EVERYDAY
One hive appeared on the right abdomen and patient started becoming itchy on abdomen bilaterally.  Over the next 10 minutes symptoms progressed to include itchiness of legs.
Only for 1.5 days sore injection sight; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (Solution for injection, Lot number: EN6203) via an unspecified route of administration on the left arm on 25Feb2021 at 15:00 for Covid-19 Immunisation. The patient medical history included asthma and heart murmur. The patients concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 25Feb2021 at 16:00 PM, the patient experienced sore injection site approximately 2 inches for 1.5 days. The patient did not receive any treatment for the event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
received 2nd round of shot in lower back/buttock at 4 PM and around 5 PM started having extreme muscle pain at injection site. Later that night, i felt like i could not move without extreme muscle pain. Today 11/13/09 i feel muscle pain is at it's worst with muscle pain up and down my entire back with bruising at injection site. - same problem during 1st round of shot, but injection was put in right arm. later that day pain spread from injection site in arm to entire arm down to wrist to under arm and side by the 4th day. 5th day finally had relief.
Information has been received from a nurse concerning a 11 year old female who on 15-SEP-2008 at about 1530 was vaccinated with the first dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. About 2 min after vaccination, the patient said she felt dizzy, became pale , and fainted into mother's arms. The patient was placed on exam table with feet elevated and she spontaneously revived. The events lasted only minutes. The patient was given water to drink. No hospitalization required. The reporter spoke with mother at home and patient remained fine at this time. Additional information has been requested.
Pt has redness and swelling in area, using ibuprofen and Benadryl.
Fever 102.2 within 4 hours of medication . Motrin given at time of vaccinations .
Took 1st capsule had dinner & started throwing up @ around 11:30 & threw up every hr until 8AM on 9MAY93; no cramps; had feelings of nausea & felt weak; diarrhea @ same time as throwing up;
Stopped breathing, shock-like state, loss of color pale/blueish in color, went limp, lethargic
Patient is a 47 year-old female with no significant prior medical history. She had a series of multiple vaccinations from 17Mar2017 through 9Apr2017 in preparation for a planned mission trip to Africa.  The vaccinations administered in this 3-week period included Yellow Fever (SQ), Rabies x3 (IM), Polio (SQ), Hepatitis A (IM), Hepatitis B (IM), Typhoid (PO), and Meningitis. The vaccines were administered at the medical office as well as at her PCPs office. Onset of symptoms began 10Apr2017 including severe insomnia, loss of appetite, weight loss, heart palpitations, and general anxiety with isolated panic attacks. On 20Apr2017 patient visited PCP who prescribed Lexapro (10mg qd).    Patient had first of a series of psychotic episodes on 26Apr2017, lasting two days until 28Apr2017.  Episode included panic, paranoia, delusions, and confusion.  Patient was not hospitalized, but on 28Apr2017 visited PCP who prescribed Xanax (0.25mg qd) and Remeron  (7.5mg qd) stopping the Lexapro.    Patient had second psychotic episode on 26May2017 where she was in a catatonic state for 5 days.  Patient was unresponsive to surroundings and self-reports having been in a delusional alternate state during this period.  Full medical work-up was done with no findings.  CT scan was normal and all lab-work within normal limits.  Patient was in the hospital for 8 days and was discharged on Ativan (1mg bid) and amitriptyline (5mg qd).    Patient had third psychotic episode on 24Jun2017 that required 18-day hospitalization.  Again, etiology of psychosis was unknown with normal CT scan and all lab-work within normal limits.  All medications were withdrawn for 7 days with no improvement of symptoms. Patient was discharged on Ativan (1mg bid) and Zyprexa (15mg qd).  To date, patient has ongoing severe insomnia, general anxiety, and sensitivity to external stimuli.  Her medical team has been unable to identify an underlying cause of the psychotic episodes, but cannot rule out that the series of vaccinations were involved due to the relative timing of events.  Patient has had significant impact to quality of life and unfortunately has been on medical leave from her employment since 27May2017 with unknown date of medical clearance for return.
Direct admit from free standing ED for positive COVID test,  fatigue, decreased PO intake.  SpO2 91% on room air
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 069H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
I noticed I started getting frequent bloody noses about the end of March 2021. I had bad bloody noses when I was younger and had both sides cauterized in 2009. I was getting on average 3-4/week for about 6 weeks that would last about 10 minutes. I would consider them moderate as I would have good size clots. I did Kaiser's chat with a doctor option and he suggested taking some ibuprofen and if it continued, to go see a doctor. I started to see an improvement so I didn't go. By July I noticed I had been almost constantly menstrual spotting. I had an IUD put in 01/ 18/2021 and was told cycles would be different for a while so I ignored it for a while longer. I was asked to come get evaluated for it  08/10/2021. I saw an NP who could not find anything wrong and does not have an explanation for it. I was told I could try taking hormones temporarily to see if that helps anything but declined.
Few vesicles on trunk X 3 days  Dx : VARICELLA  Meds: ZOVIRAX
Case complained of pain at injection site the evening of immunization and had what resembled bruising on bilateral upper and lower legs and ankles the next morning. Severe pain reported. Saw MD at local clinic the day after the immunization.
Patient developed an unknown neurologic disease 3 months after vaccination. This includes abnormal movements and weight loss. Some components of a functional neurologic disease but work-up so far has been negative.
Breakthrough case admission after 4 vaccines Moderna 3/4/21 Lot# 030A21A; Moderna 4/1/21 Lot# 025B21A;  Moderna 12/1/21 Lot# 013F21A;  Moderna 10/27/22 Lot# 14H22A
Patient received a Moderna vaccination that was two days past its BUD in the fridge. Moderna was contacted and stated there was no need for revaccination. No reported adverse events from patient.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received INFANRIX. Concurrent medical conditions included egg allergy, food allergy and peanut allergy. Concomitant products included PCV11 and polio vaccine. On 9th February 2015, the patient received INFANRIX (intramuscular). On 10th February 2015, 1 day after receiving INFANRIX and an unknown time after starting BENADRYL ALLERGY, the patient experienced extensive swelling of vaccinated limb, pain, walking difficulty and pruritus. The patient was treated with steroid (unspecified) and BENADRYL ALLERGY. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain and pruritus were recovering/resolving and the outcome of the walking difficulty was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain, walking difficulty and pruritus to be related to INFANRIX. Additional information was provided: The injection site swelled to about 5 to 6 inches in diameter.