chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt parents messaged PA saying that they think she is having an allergic reaction. They said that she was breaking out in a rash and starting to swell up. PA suggested that they go to the ER. At the ER they confirmed that it was an allergic reaction and gvae her steroids.
Color of skin was changing possibly from varicose veins; Color of skin was changing possibly from varicose veins; Loses sleep; Stiff; Aching down legs/ thigh/ behind the knee hurts bad and in front; Aching down legs/ thigh/ behind the knee hurts bad and in front; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front), SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep) and MUSCULOSKELETAL STIFFNESS (Stiff) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 07-Dec-2021, the patient experienced PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front) and ARTHRALGIA (Aching down legs/ thigh/ behind the knee hurts bad and in front). On an unknown date, the patient experienced SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep) and MUSCULOSKELETAL STIFFNESS (Stiff). At the time of the report, PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front), SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep), MUSCULOSKELETAL STIFFNESS (Stiff) and ARTHRALGIA (Aching down legs/ thigh/ behind the knee hurts bad and in front) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of aching down legs/ thigh/ behind the knee hurts bad and in front with Humira was no reasonable possibility, for the events of color of skin was changing possibly from varicose vein, loses sleep and stiff was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
The patient reports pain immediately after injection and it felt like a "bullet." The next day, she had chills. The day after (today 3/26/22), she reports nausea, chills, and noticed tenderness and erythema at injection site. She has pictures on her phone of the injection and rash corresponded with where the injection was. She reports having active breast cancer and she responded similarly when she had the COVID vaccine but without the rash. She reports feeling unwell after COVID vaccine as well.  The macular rash was tender on palpation and measures at 5 in x 3.5 in. No drainage noted.  She had a 101 degree farenheit fever (tympanic).  I prescribed Keflex 500 mg QID for cellulitis 10 days but asked that she check in with PCP/oncologist prior to starting because of previous reaction to COVID-19 vaccination (? if she has heightened response due to immunosupression vs infection). I markeed rash and asked her to go to ED if symptoms persist or worsen. I asked her to take acetaminophen for the fever. She will call her oncologist who she thinks has an on-call line.
Large, red, swollen area on arm at the injection site (several inches wide). Very sore when moving arm and to the touch. Started itching a day later.  Headache & tiredness.
No additional adverse events; The HCP reports that a patient was administered a dose of PROQUAD that was involved in a temperature excursion. The HCP also reported that VARIVAX had been administered (see AE case 02335887). No addi; This spontaneous report was received from a registered nurse and refers to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 13-FEB-2023, the patient was vaccinated with an improper storage dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5ml, lot #W023869, expiration date: 24-JAN-2024 who had been verified to be a valid number administered for prophylaxis (strength and route of administration were not provided). The vaccine was storage at temperature of 14.1 degrees centigrade (C) with a time frame of 125 Hours and 59 Minutes, there was no information about previous temperature excursion.
Information has been received from a physician concerning a white female patient who on an unspecified date was vaccinated with a dose of Varicella-Zoster virus vaccine live.  Subsequently the patient developed swelling, pain, and inflammation all over the arm down to the elbow.  The patient came to the physician's office three times because of the reaction.  The physician was able to treat the symptoms with antibiotics (not further specified).  A product quality complaint was not involved.  Additional information has been received from the physician who reported that the patient experienced swelling, pain, and redness and was treated with antibiotics.  The patient subsequently recovered.  The patient's experience were considered to be other important medical events by the physician.  Additional information has been requested. (OMIC)
1st vaccine given on 2/20/21 @3:30 pm. On 2/21/21 around 12:30 pm I started feeling weak all over, didn't feel I could move, both arms hurt in the bicep area to the shoulder.  Was cold, tired and ran slight fever, not being able to function to do anything but lay around covered up ,sleeping.  On Monday 2/22/21 I felt some better in am other than having an ear ache and sore throat, by evening my ear was hurting and I was again aching in both arms and weak.  As the week went on I felt a little better each day. I continue even today to get tired easy. Hope not vaccine is not this bad.
Pleurisy; coughing as if throat needed to be cleared; dripping sweat; Chills; unable to get muscles to relax and unclench; fever; patient woke up at 2 AM; This case was reported by a consumer via call center representative and described the occurrence of pleurisy in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date unknown) for prophylaxis.   Co-suspect products included QUADRIVALENT INFLUENZA VACCINES (FLUAD QUADRIVALENT) for prophylaxis.   The patient's past medical history included lung operation (at an unspecified date) and pleurisy. Previously administered products included Shingles with an associated reaction of ill-defined disorder (received on unknown date).   On 27th August 2020, the patient received the 1st dose of Shingrix and FLUAD QUADRIVALENT. On 27th August 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 28th August 2020, the patient experienced sweating, chills, muscle stiffness and fever. On 30th August 2020, the patient experienced pleurisy and cough. On an unknown date, the outcome of the pleurisy was not recovered/not resolved and the outcome of the cough, sweating, chills, muscle stiffness, insomnia and fever were unknown.   It was unknown if the reporter considered the pleurisy, cough, sweating, chills, muscle stiffness, insomnia and fever to be related to Shingrix.  Additional details were provided as follows: The reporter husband is the patient. The patient received 1st dose Shingrix in left arm and Fluad Quadravalent  flu vaccine in right  arm.  During bedtime that night, caller reports patient woke up at 2 AM putting on quilts and unable to get muscles to relax and unclench. Patient was dripping sweat yet still had chills and a fever.  The patient reported her husband did not have a headache. On Saturday, patient reportedly up and moving doing some activities. On Sunday, patient started coughing as if throat needed to be cleared. Coughing became worse and patient noticed cough inability to rid cough.  The patient reported patient developed pleurisy after having a lung surgery at an unspecified date and assumes he has pleurisy again. The patient reported this has not been confirmed by a  physician. Caller reports her husband went up for a 3 to 4 mile hike and noticed pleurisy became worse. Caller reports her husband had the previous shingles vaccine, and that after lung surgery he had shingles in March or April 2020.  The reporter consent to follow up. This case has been linked with case US2020176972 and US2020AMR177786 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176972:same reporter US-GLAXOSMITHKLINE-US2020AMR177786:same reporter
Emphysema flair-up; I was short of breath/was short of breath , I just couldn't catch my breath; heart isn't functioning right; my lips were purple; I pushed the 2nd dose out a little, because I was still recovering from bronchitis.; This spontaneous case was reported by a consumer and describes the occurrence of EMPHYSEMA and EMPHYSEMA in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral regurgitation. Concurrent medical conditions included Mitral valve prolapse and Ex-tobacco user (quit in May 2021).   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 25-Jul-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization). On 12-Aug-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization) and LIP DISCOLOURATION. On an unknown date, the patient experienced CARDIAC DISORDER. The patient was hospitalized from 25-Jul-2021 to 27-Jul-2021 due to EMPHYSEMA. The patient was treated with PREDNISONE at an unspecified dose and frequency and ALBUTEROL at an unspecified dose and frequency. At the time of the report, EMPHYSEMA, EMPHYSEMA, LIP DISCOLOURATION, CARDIAC DISORDER, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 25-Jul-2021, Computerised tomogram (abnormal) Emphysema flair-up. On 25-Jul-2021, Oxygen saturation 84% Low. On 12-Aug-2021, Heart rate 155 beats/min (High). On 12-Aug-2021, Oxygen saturation (Low) 84%.         On 12-AUG-2021 patient went to Emergency room due to Emphysema flair-up.  No relevant concomitant medications were reported  This case concerns inappropriate schedule of vaccine administration in a 56 year-old female patient with no relevant medical history reported, who experienced the unexpected serious event s of Emphysema flair-up x2. The events occurred approximately 3 weeks and 5 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Although history of emphysema not reported, the source document indicates hospitalization for 2 events of emphysema flair-up.
Patient reports she feels like she can't get out of bed.  The lethargy started the evening of the vaccine and has continued through the day of report (4/17/2021)
Miscarried at 7.5 weeks between vaccination #1 and #2. I do not believe the vaccine was a cause, however, it was recommended to report just in case.  This was a second pregnancy, first miscarriage.  EDD was 9-1-2021.  First pregnancy was uncomplicated. Pregnancy tests were negative prior to receiving the first vaccine and then turned positive on 12-29-2020 (5 days after getting first vaccine.)
This is a well-appearing 67-year-old male who presents to the emergency department for evaluation of abdominal pain and black tar stools.  Patient with no history of GI bleed, denies anticoagulation.  He is hemodynamically stable.  He is non peritoneal examination does exhibit some tenderness to palpation in the right upper quadrant and epigastrium.   Patient will be provided intravenous fluids.  Abdominal lab series has been ordered and will be followed up by the oncoming provider.
Pt developed firm,  tender, indurated area at injection site 2cm after initial soreness wore off about 2-3 days ago.  Also having some night sweats and mild sweating during the day.  Temp of 99.3.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a seven-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 27-NOV-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # R007991, expiration date on 18-OCT-2019, orally, for prophylaxis (strength, dose and anatomical location were not reported). The vaccine was improperly stored at a temperature between 32°F to 35°F during a time frame of 30 minutes and between 47°F to 77°F for 30 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012116: US-009507513-1811USA012115.
tired; sleepy; pulse has been up and down from 103-104 back to the 70's; Pain in the armpit area and it is sore to the touch; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported 66, units not specified) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 09Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient reported being tired and sleepy and her pulse has been up and down from 103-104 back to the 70's in Feb2021. The patient also had pain in the armpit area, and it is sore to the touch in Feb2021. The patient wanted to know if the shot does something to the lymph nodes, and if it is a side effect of the vaccine. The outcome of the events was unknown.   Information on Lot /Batch Number has been requested.
missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Medications were not provided by the reporter.
Pt had 3 imms at WCE on 2/29/13. Today at 11:00 am mom called because of rash on (L) thigh, arm & back. "Hive like". Denies RD, V & D, fever. Resolved by 3/10. Per patient's mom - 3/18/13.
Moderate soreness to injection site, mild fever, chills, body ache and head ache all started the day after the vaccine, and lasted for 2 days.
Pt received an pneumonia inj on 8/5/09, and came into the non-urgent care clinic on 8/7/09 claiming that and as soon as he received it he stated it hurt and then progressed to swell up by the evening. He did take an ALEVE x 1- did not use any ice or any antihistamines. Patient was discharged from non-urgent care clinic with BENADRYL 50mg q8pm the next 2-3, day and a prednisone taper.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 29 year old female. 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, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958423, 20210958321, 20210958993, 20210958502, 20210958716, 20210958892 and 20210958366.
Shingles on stomach, groin, leg and arm. All on the right side. Verified as shingles by my doctor. No pain. No itching. Just large areas of redness & spots.
pt recvd vax & began screaming & refused to eat; & continued to cry; pt taken to ER & given benadryl elixir & motrin;
Patient started to feel anxious and dizzy during observation period.  Stated that the bubble on his arm "freaked him out".  Assisted to seated position on floor with back against wall.  1140: BP 130/80; HR 82; pulse strong; sweaty; hot; started yawning a lot; pale; blurry vision 1145 - BP 120/80; HR 82; difficulty speaking 1150 - BP 120/80;  HR 68; patient stated he?s starting to feel better; stopped sweating; color is coming back to skin.  Held in observation for another 30 minutes then released from field clinic.
expiration was 10/31/2022 for the 10 week expiration but  stated 9/30/2022 for this lot
At 4:03 pm on 1/29/2020 Pt. called RN at Clinic. Pt. reported to RN that at about 3:30 pm she had started to experience what she referred to as hives on her chest and like her skin felt "chilled like it was touched with an ice pack", that the back of her head was "itchy", and that her throat felt a little "full". Pt. reported that her s/s had not gotten any worse in the past 30ish minutes she had been experiencing them. RN reinforced education on s/s of progressing allergic reaction, that there is a spectrum of mild to severe allergic reactions however there is no definitive answer on how fast anaphylaxis can set in, and encouraged pt to report to ER or Outpatient at Hospital for assessment. Noted that today was the first time pt had received an influenza vaccine in 10 years (according to statewide vaccine tracking system, pt received an influenza vaccine on 10/29/2009. Pt. was confident in assessing her own status to monitor if s/s progressed to anaphylaxis reporting she believed she was having a "mild reaction" and would "go to the ER after work if it got worse". RN will continue to monitor by F/U via phone with pt.  Pt. reported to Health Center Outpatient Department for assessment on 1/29/2020. At about 6:30 pm Dr. assessed pt and reported the following: "Patient, a 55 yo female with PMHx including GERD, HLD, and anxiety, presents to clinic today after having a reaction to her flu shot.  Was sick last year for about 3 months and states her illnesses began with influenza.  Wanted to get an influenza vaccination.  Has never had a flu shot in the past.  As her mother has come to stay with her, she decided she needed to get one now.  Went to Health Center today shortly before noon and received a flu shot.  About 1530 she developed a headache with nausea.  Felt that her chest was cool to the touch so went to the restroom and noted that she had hives all over her chest.  States her throat felt scratchy "like it is after vomiting."  Felt she had "extra saliva and had to swallow hard."  Around 1600 she tasted a medicine taste.  Her scalp also began to itch.  Called nurse and was told to present to clinic to be checked out.  States her symptoms all stopped around 1700 and she has no new symptoms at this time.  Denies any shortness of breath or difficulty breathing.  Denies any food allergies.  Endorses having hives after taking Augmentin but denies any other reactions. Currently still endorses headache, nausea, hives, itching, and scratchy throat.  Denies any fatigue, chest pain, shortness of breath, abdominal pain, or joint pain." Dr. administered Benadryl 50 mg IM in clinic and encouraged pt to take Benadryl as needed for hives/itching.
Initial and follow up information has been received from a nurse concerning a 61 year old female who on 06-OCT-2006 was vaccinated in the left deltoid with Pneumovax 23 (Lot# 655588/0883F). On 06-OCT-2006, the patient developed a rash and swelling to the left upper arm (previously reported to have a developed redness, swelling and warmth. The patient sought unspecified medical attention. The patient was treated with DECADRON 8 mg and an ice pack. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Fever 100.9. Redness, swelling and warmth in an approximately 6 mm circle at injection site.
It began with severe diarrhea and arm soreness, then came the extreme chills & fever (101F) and the worst body ache of my life. Then my arm and armpit and back and breast on the left side began to swell and swell and swell until I couldn't keep my my arm down because it hurts my armpit but I also could not lift is because of the pain my shoulder and armpit and breast are all very swollen and red and hot. The fever and swelling are now working it's way down my torso and hip and leg and foot all on the left side. On Wed 4/21 I went to  Urgent Care and was tested for uti or kidney infection the result had blood in urine but as I am menstruating it was inconclusive. I had been give Ciprofloxacin to take Monday evening by a tele doc. Urgent Care ordered Prednisone 20mg 2 pills daily but the swelling keeps spreading. I have also been breaking out in sweats even just walking to the bathroom and am experiencing tiredness and severe loss of appetite and have lost 4 pound since 4/20 despite the swelling.