chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fall; fracture; A spontaneous report  was received from a pharmacist concerning a 93-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fall and a fracture.    The patient's medical history was not provided. Concomitant product use was not provided.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (batch no. 012M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.    On an unknown date after the first vaccination, the patient experienced a fall and sustained a fracture and was hospitalized.  The pharmacist stated that the patient has crossed 42 days to received the second injection due to hospitalization (the day of this report was day 42).  The patient was in a nursing home at the time of this report.    The action taken with mRNA-1273 COVID-19 Vaccine) was unknown.  The outcomes of the events of fall and fracture were unknown.   The reporter did not provide causality assessment.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-056578:Cross linked case for patient 2
I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, waited a bit hoping it would go away and when it didn?t we alerted the EMT on site. My lungs sounded ok so I was instructed to go home and take Benadryl.  On the way home my tongue began to swell and get a tingling sensation. My cheeks became extremely hot and had a red rash. I ended up having to take two Benadryl to get the symptoms to go away.
This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender's Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.
Spaced out Fever Runny nose A non-serious spontaneous report of spacey, feverish and runny nose has been received from a consumer (patient's mother) concerning a 30-month-old male patient, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history includes seasonal allergies since April 2008. No concomitant medications were reported for this patient. The patient received his first dose of FLUMIST intranasally on 08-Aug-2008. The patient was described as "feverish, spacey and had a runny nose" for the next three days after receiving FLUMIST. The patient was not evaluated by a physician for his symptoms. The patient experienced the events from 08-Aug through 11-Aug-2008. The patient did not receive another dose of FLUMIST.
Breakthrough case admission after 4 vaccines Moderna 2/25/2 Lot# 002A21A;  Moderna 3/25/21 Lot# 017B21A;  Moderna 11/30/2 Lot# 057M21A;  Moderna 6/24/22 Lot# 057M21A
excessive amount of hair coming off of my head every time I washed my hair. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "excessive amount of hair coming off of my head every time I washed my hair.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned, never had any issues before the vaccine and now left with less than half of used to have. (abusive language).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reported pain at first then swelling later in the evening of her arm where the vaccine was given.
Joint pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN1318) via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The concomitant medication includes patient was taking other medication (unspecified).On an unspecified date, patient experienced joint pain and tiredness. Consumer stated, "All I want to know is, I want some information okay. Is the tiredness and joint pain been reported before or just I provided. I want to know if it's possible. They said that the COVID Vaccine cause the irritation and symptoms that I am going through right now, is that (incomplete sentence)" No treatment received for adverse event. Patient was taking other medication. consumer stated, "I have had my second dose on 04Mar2021 at arm Left." Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Body aches, chills, fever of 102, nausea, stomachache, pain at injection site
RASH: RED, PRURITIC, WIDESPREAD & DIFFUSE IN ITS LOCATION   TREATMENT: BENEADRYL, PREDISOLONE, & ZANTAC
This spontaneous report as received from a consumer via Henry Schein (HSI control# 52255), refers to a female patient around 72-85 age range. On 18-OCT-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J006242, expiration date 03-AUG-2014, dose not reported). Per the reporter, the patient was affected. On 19-OCT-2013, the patient complained the area being red/hot and swollen the next day after the vaccination. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Possible re-activation of latent HPV.  Clinical manifestation of genital warts two days after Jynneos administration
painful blisters on hand; itchy hand; painful hands; This case was reported by a other health professional via call center representative and described the occurrence of blister in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2019, the patient received the 1st dose of Shingrix. On 11th May 2019, less than a day after receiving Shingrix, the patient experienced blister, itching both hands and pain in hand. On an unknown date, the outcome of the blister, itching both hands and pain in hand were not recovered/not resolved.   It was unknown if the reporter considered the blister, itching both hands and pain in hand to be related to Shingrix.  Additional details were reported as follows: The healthcare professional reported that the patient received Shingrix at their pharmacy in the right arm.  On 12th May 2019, the patient woke up to painful, itchy blisters on their right hand.  On 13th May 2019, in the morning patient woke up to painful, itchy blisters on both hands.  The healthcare professional would like to know if MI had treatment options and recommendation on receiving the 2nd dose in 6 months.  The healthcare professional was unaware of the healthcare professional that administered the vaccine. The healthcare professional did not have lot number or expiry date. The outcome reported for all AES in the structured field of database is recovering instead of Not Recovered/Not Resolved (outcome uploaded in database)
at 1:30 am I started with the chills and feeling that i was going to vomit when i got up to go to the bathroom i because very dizzy and laid down and passed out this time i am not sure how long i was out for at approimently 430 am I had the same feeling went to the bathroom and yelled for my husband as i was very dizzy again when he got into the bathroom he said i was passed out and was doing some convulsing I was out for over a minute and he was trying to get me to wake up.  Prior to waking i could feel him touching me and i could hear noise but i could not make out the noise or open my eyes and was unware at that momment what was going on after I woke i threw up and then went back and laid down. then again about 7:30 am I had to use the restroom so walked into the bathroom I went to the bathroom after I felt very dizzy again and laid down on the floor at this point i passed out again and this time i could feel myself shaking see bright light but couldnt stop the shaking or see anything else.  I am unsure how long this lasted.   After that I went and laid down again and felt better I then was only tired.  After resting I felt good and didnt feel i should go in since i was feeling better I did call my dr a few days after and inform her on what happend.    ** I had also started my period during this morning.
Fever, runny nose and cough.  Fever for 3 days of 101-102.  Mom reports croupy cough
Severe rashes/inflamed  all over stomach, chest, back and face . Itchy and burning sensation  this lasted for 72hrs needed to take aveeno bath to sooth itching.  Spoke w with pediatrician started on Benadryl, then Allegra and then Zyrtec helped the most with a chewable tablet of Pepcid
Information has been received from a consumer via a company representative referring to the consumer's daughter, a 2 year old female patient. In 2004 the patient was vaccinated with a first dose of MMR (manufacturer unknown) and in approximately 2006 was vaccinated with the second dose (dose, route and lot# were not reported for both doses). The consumer reported that the patient experienced extreme swelling at the injection site of her left leg after administration of her first dose of MMR (manufacturer unknown), when she was aged 2 years. The patient also lost some speech ability as well as her memory of the alphabet and numbers on unknown dates. The swelling at the injection site resolved after several months and the speech and memory difficulties resolved after 2 years. In approximately 2006, when the patient was aged 4 years, she also experienced swelling at the injection site after administration of her second dose. In 2006, an magnetic resonance imaging (MRI) revealed a growth on the left femur near the same location as the site of the MMR (manufacturer unknown) injection. The outcome of the second injection site swelling and "a growth on the left femur" was unknown. The relationship between these events and MMR (manufacturer unknown) was not reported. Upon internal review, the event "lost some speech ability" was considered to be medically significant. Additional information has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-DEC-2017, the patient was vaccinated with ZOSTAVAX lot number M042850 and expiration date of 18-JAN-2018, via intramuscularly route instead of the subcutaneous route for prophylaxis. No apparent adverse effects were reported in the patient.
Pt. fully immunized with Pfizer vaccine above but tested positive for COVID on 08/09/21.
pt devel periorbital edema, hand edema, arthralgias, h/a, weakness & mild hypotension, as well as erythema, redness & swelling @ inj site;
got the shingles last fall and I had gotten the two part vaccination/suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the two part Shingles vaccination a couple years ago and got the shingles last fall. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting
Information has been received from an 84 year old female patient referring to herself. The patient was allergic to penicillin. No pertinent or historical conditions were reported. On an unknown date (reporter as a few years ago), the patient was vaccinated with ZOSTAVAX, one shot, (lot#, strength and route unknown). Unspecified concomitant medication was reported. On an unknown date in about "a year and a half" later, the patient got a small case of the shingles on her head, lasting a few weeks (2-3 weeks). The patient sought medical attention and was given unspecified treatment. Additional information is not expected since no reporter contact information available.
headache; not feeling well; arm started to swell; itch; warm; adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction), VACCINATION SITE SWELLING (arm started to swell), INJECTION SITE PRURITUS (itch), VACCINATION SITE WARMTH (warm) and MALAISE (not feeling well) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION COMPLICATION (adverse reaction), INJECTION SITE PRURITUS (itch) and VACCINATION SITE WARMTH (warm). On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm started to swell). On 23-Jan-2021, the patient experienced MALAISE (not feeling well). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with ANTIBIOTICS ongoing from 22-Jan-2021 at an unspecified dose and frequency; STEROIDS ongoing from 23-Jan-2021 at an unspecified dose and frequency and ANTIHISTAMINES ongoing from 23-Jan-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (adverse reaction), VACCINATION SITE SWELLING (arm started to swell), INJECTION SITE PRURITUS (itch), VACCINATION SITE WARMTH (warm), MALAISE (not feeling well) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and alot of chest pain has decreased.
I noticed the same issue with shingles because I had it before. Still, I was unsure until I saw the start of a rash. Sought care from a local clinic I trust. There I was examined and was given a prescription for the antiviral. It was a 7 day course and at the end of the course was clear and no other issues came about as of 12/28/2021. Got a new PCP in August, and advised of the event.
Myositis; cellulitis; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOSITIS (medically significant), outcome "unknown"; CELLULITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown results; Antinuclear antibody: Unknown results; Autoantibody test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162b2 cannot be excluded. This case will be re-evaluated upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300128901 Same article/patient/drug and same event;
Client notifed paramedics she didn't feel well.  LOC-alert Lung sounds- clear Skin-pale Pain-no oxygen- non rebreather at 10 L   11:36AM- BP was 110/80;Pulse 60; O2 sat 99 11:39AM- pulse was 107 Benadryl 50mg was given at 11:36AM 11:42AM- O2 sat 95 Slow capillary refill numbness and tingling in extremities cold/shivering/goosebumps shaking rapid/thready pulse  Did not eat prior to coming to appointment Blood sugar 91 Gave the client water during all of this, she stated she felt heavy. We laid her on the floor and elevated her feet. The ambulance came and took her to the local hospital.
Woke up at 3am with the worst nausea and stomachache of my life. tried to get to the bathroom. all of a sudden had massive ear ringing in my left ear and then everything just went out. my hearing. my vision started to blur, saw black spots. Couldn't speak. felt cold all over and then started pouring sweat from my forehead. Ripped off my sweatshirt and laid in bed until it passed about 20 minutes later.
Pain at injection site. Pain/discomfort in shoulder. Range of motion loss. All symptoms persist.
flushing of cheek and face and ear-- very hot and red, within 24 hours vaccine administration, on the side of the injection
ACHES; SHAKES; NEVER FELT SO BAD EVER; UNCONTROLLABLE CHILLS; VOMITING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, shakes, never felt so bad ever, uncontrollable chills, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, uncontrollable chills, shakes, vomiting and never felt so bad ever was not reported. This report was non-serious.
Headache, Myalgia, NauseaVomiting, lightheaded, left thigh at injection site swollen, red, & painful Narrative:  Other Relevant History:
73 y.o. male former smoker with PMH significant for coronary artery disease with history of CABG in 12/22/2020, hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypertension, non proliferative diabetic retinopathy, sleep apnea presents to emergency room complaining of generalized fatigue and body aches ongoing for 2 weeks.  Patient received Johnson and Johnson COVID-19 vaccine 2 weeks ago.  Patient denies any fever or chills.  Denies any chest pain or shortness of breath.  No nausea or vomiting.  Poor appetite.  Patient had is the cardiac catheterization rehab post CABG, last session was 1 week ago.  Denies any sick contacts. ED vitals stable, afebrile.  Patient on room air.  Labs remarkable for lymphocytes 15.3, monocytes 10.9, glucose 190, BUN 21, creatinine 1.3, sodium 133, potassium 5.3, chloride 97. Lactate normal at 1.6, troponin 14, Last A1c 6.7 from 12/19/2020. EKG no acute ST wave changes EKG changes. CTA chest no pulmonary embolism seen.  Patchy airspace disease of the lungs suspicious for mild to moderate bronchopneumonia. Ultrasound Dopplers of the lower extremity right negative for DVT. COVID-19 positive. Patient received Rocephin, Zithromax in ED, ER asked to admit patient the hospital for observation due to ongoing fatigue and body aches from COVID-19 pneumonia.