chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm itching "like crazy"; "Huge red circle" on arm / "Softball size circle" on arm; Hot arm; Red arm; Fever; Chills; Flu-like Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021, the patient experienced PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm). On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 17-Mar-2021, PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm) had resolved.        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.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
No adverse event; the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, lot number - 026A21A) on 24-Mar-2021, Moderna COVID-19 Vaccine (2nd dose, lot number -017B21A) on 23-Apr-2021, Moderna COVID-19 Vaccine (1st booster dose and lot number - 033F21A) on 16-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Diabetes, Hypertension, Hypertension, High cholesterol and Diabetic foot.    On 22-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The patient states that, she did not have any reaction after getting the 2nd booster dose.   No treatment medications were reported.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with Flulaval for prophylaxis. On 2 November 2007 the subject received unspecified dose of Flulaval in an unknown arm. Immediately after vaccination with Flulaval, the subject experienced an injection site reaction. On 4 November 2007, the event was resolved. Follow-up information was received on 11 December 2007 via a healthcare professional, who reported that the subject immediately developed a lump and redness at the injection site following vaccination with Flulaval. The reporter stated that the events were resolved in two days with no further problems.
pt recvd 1st dose of vax on 24MAR92 & on 26MAR92 had 1 episode of vomiting & also devel fatigue, h/a & lightheadedness; no temp elevation; No further details were provided;
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case from a consumer/non-HCP. This case involves a 12 months old female patient who was given an expired dose of ActHib, while she received ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PCV 13) for immunization on 05-Oct-2018. On 05-Oct-2018, the patient received a fourth 0.5 ml once dose of suspect HIB (PRP/T) VACCINE lot UI806AA via intramuscular route in the right thigh. It was also reported lot number Box UI806AAA Expiry date 30-Sep-2018 and Diluent lot number U5871AA, Expiry date-04-Oct-2018. It was a case of actual medication error due to expired vaccine used. The patient outcome was Not Applicable for gave an expired dose of ACTHIB. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Blood in stool; Stomach discomfort; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, Lot# FL9264), via an unspecified route of administration, on 04Feb2021 at 13:00, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Patient did not have vaccinations within 4 weeks prior. The patient experienced blood in stool and stomach discomfort both on 05Feb2021 with outcome of recovering.
Rash (light pink & raised) to Abd, bilateral lower extremities starting morning of 5-6-11 BENADRYL.
(L) deltoid knot & swelling x 8/19/10 offered appt pt refused.
Information has been received from a consumer concerning his 23-months-old daughter with no past medical history or allergies, who on 06/03/01 was vaccinated with one dose of varicella virus vaccine live (site unknown). There was no concomitant medications. On approximately 06/03/01, the pt developed fever for two days and behavioral changes. According to her father, she had been "pouty" and clinging to her mother. No medical attention has been sought. Additional information has been requested.
On October 14, 2020, both Flucelvax and Pneumovax 23 was administered to a Type 2 diabetic patient. On the same day, the patient noticed that the soreness and pain in her arm was getting progressively worse, as well as her fever. It was so bad that it kept her awake at night. Within the next 2 days, her fever went up to 103 degrees F. After taking Tylenol and Motrin, the fever went down, but as the medication wore off, the fever went back up. By October 16, 2020, the symptoms did not get better, so the patient went to the emergency room. After running tests, they concluded that the patient had an infection in the left arm. However, they could not determine what caused the infection. The patient said they were doing better after receiving antibiotics.
Fever of 100.1-101°, malaise, body aches, pain at the injection site
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
High fever for 2 days, then better for 1 day, then high fever for 2 more days. running nose, swollen throat, running eyes for about a week.
I developed a headache about 4 hours after receiving the injection. I have had a headache the following two days after the injection (up to time of this report). On the second morning after the injection, I woke up feeling nauseous, and vomited.
Patient stated he blacked out while in the store aisle/15 min waiting area. Another vaccine pharmacist and store pharmacist on duty attended to the patient. BP was taken at the store's BP machine, patient was observed for 15 more minutes and went home. Patient was accompanied by a family member/caregiver.
Severe vomiting began one week after vaccine administered.  Vomiting lasted approx. 18 hours.  I had the same reaction last year approx. two weeks after receiving vaccine.  I went to the ER for treatment last year and explained that I had had a flu shot recently, but they dismissed that information.
Pt had bruising in arm at injection site. Reported no pain, just a severe bruise.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient. A 64-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), in Mar2021 at 12:00PM (as reported) as dose 1, single (Lot number: EP7534), in left arm, on 09Apr2021 at 13:00 as dose 2, single (Lot number: ER8729), in left arm and on 10Nov2021 at 16:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Patient received Paxlovid to treat "drug ineffective", "Covid-19". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
weird sensation in chest, tightness  *pt had received a flu vaccine 10/14/21 at another facility.  She does not know which manufacturer or lot number
urticarial rash appeared the day p/vax;worsened @ school, pt sent home;appeared @ clinic about 2PM, itching, scratching;DPH given rash sx resolved;
My last period started Tuesday Feb 2nd and did not stop until 14 days later, more than double my usual menstrual cycle. It seemed pretty normal and painless, but then on 8th day I was surprised to find myself still bleeding . It was a darker color around then, but then became brighter and I noticed myself passing clots when I went to the restroom that were loose, but about the size of a quarter or half dollar. I did not bleed through any menstrual pads, but the return of bright red after it being a darker red that im used to at the end of a period had me concerned. I was in slight discomfort around my uterus/bowels and I couldn't tell if it's my body recovering from the vaccine, or something else.  I received my second dose of the COVID-19 vaccine 2/11/21 (Pfizer) and stayed home from work as I had a fever/headache/chills (this was not unexpected to me, my coworkers had the same symptoms).  Family medical history: grandmother (dad's mom) in remission from stage 4 uterine cancer about 5 years ago. Mom had endometriosis at 45 and had a hysterectomy.
In about 11 hours after the vaccine I experienced physical discomfort and woke up from sleep (3 AM). By 9:30 AM I experienced flu like symptoms; body aches and general discomfort. By 2:00 PM my temperature began to rise and by 4:00 PM it reached 104 degrees Fahrenheit. I experienced violent shaking and called my doctor's office. They recommended certain medications: benedril and Ibuprofin. I took a couple of Tylenol and the temp dropped. I experienced continued discomfort; as if all the nerve endings on the surface of my body suddenly became very sensitive. I went to bed and slept fairly well. In the morning I felt quite tired but the shakes were gone and my temp. was down to 101. I missed my second day of work and rested. By evening I felt quite normal except that I was too tired to do any chores around my home. It took two more days for me to recover.
Liver injury following SARS-CoV-2 vaccination; This is a literature report for the following literature source(s): "Liver injury following SARS-CoV-2 vaccination.  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "HCV" (unspecified if ongoing), notes: (treated); "Compensated Cirrhosis" (unspecified if ongoing); "cholestatic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "Liver injury following SARS-CoV-2 vaccination". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 101 IU/l; blood alkaline phosphatase: 367 IU/l; blood bilirubin: 1.7 mg/dl; international normalised ratio: unknown results. Therapeutic measures were not taken as a result of liver injury.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101834329 same article/drug/event, different patient
pt recv vax;exp extreme fatigue, severe body aches. back pain,fever & soreness at inject site;sx lasted for 2 days; f/u info fr Rn,stated sx not rxn to vax but due to flu;recv  subsequent dose w/ no problems;
I'm actually not sure when they first appeared, but it was at dinner that I noticed a large rash had developed on my forearms and inner upper arms (I'd been wearing a long sleeve shirt throughout the day, so it was only when I was wearing a teeshirt that I noticed the bumps). Surprised by these, I checked the rest of my body and noticed similar hives on my chest. I initially just assumed it was something I'd eaten, though I'd never experienced this before with noodles. It was only the next day as I went through everything I'd done leading up to the rash that I remembered the flu shot I'd received from work a couple of days before. While the hives don't itch, they're definitely unattractive and surprisingly still present after all these days. Since my wife just got her flu shot, I saw the Vaccine Information Statement and decided to report it, just in case others have had similar reactions
"I got a flu shot about 8-9 days ago and had bad pain in my arm for several days. I also experienced mild pain/tingling in two fingers on my right hand (shot was in the right shoulder). Today, my shoulder still hurts but the fingers are more numb than in pain. I had a similar reaction, but without the fingers pain, a couple years back".
patient had itching  at injection site, and itching on face starting 10 minutes after injection.  itching lasted for several hours even after a dose of 25mg  of benadryl was given.
given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received HBV (Engerix B pediatric) (batch number 4RB3J, expiry date 3rd April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2021, the patient received Engerix B pediatric (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Nurse reported that the patient was administered with an expired dose of Engerix-B pediatric in left thigh which led to expired vaccine used. The reporter consented to follow-up.
Approximately 2 minutes after receiving vaccine patient complained of itching at the injection site.  There was found to be a small area of redness, which was warm to touch.  Patient was sent to ED and was treated with Motrin.
Rash on face 12/5/09. Fever 100 degrees 12/6/09. Nausea and vomiting x 3 12/6/09. Diarrhea x 4-5 x 12/6/09. Irritated nose 12/7/09. Runny nose 12/6-12/7
I have had fibromyalgia for 20 years, With the first shot I felt good for five days, with the second shot four days, and with the booster it was all gone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Oct2021 10:00 (Lot number: FF2590) at the age of 77 years as dose 3 (booster), single, intramuscular, administration date 08Feb2021 (Lot number: EL9266) as dose 2, single and intramuscular, administered in arm right, administration date 21Jan2021 17:00 (Lot number: EL8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia", start date: 2001, stop date: 17Oct2021, notes: have had fibromyalgia for 20 years; "Polymyalgia", start date: 2017 (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have had fibromyalgia for 20 years, With the first shot I felt good for five days, with the second shot four days, and with the booster it was all gone".  Additional information: The Patient had fibromyalgia for 20 years, Patient is now 77 years old, and with the booster shot the disease totally went away. With the first shot it felt good for five days, with the second shot four days, and with the booster it was all gone. The patient received the 4th booster dose on 23Feb2022, 01PM (Lot number: FK9729 ). No Prior vaccination (within 4 weeks), No Concomitant drug.   No follow-up attempts are possible. No further information is expected.
Joint/Muscle pain, fever (48 hours), chills (started within an hour of receiving the vaccine, ongoing), nausea (comes and goes), swelling at injection site (immediate onset, ongoing), itching at injection site (immediate onset, ongoing), burning sensation at the injection site (immediate onset, stopped within 24 hours of receiving second dose), swollen painful lymph nodes (right armpit and base of neck on the right side, ongoing), palpitations (started at about 9:00PM 11/18/2021 and lasted about 12 hours), sweating (onset and length of duration same as palpitations), severe sudden headaches that come and go in waves (started at about 9-10PM 11/16/2021, ongoing), feeling of pressure on chest (onset and length of duration same as palpitations and sweating)
Hepatitis A dose #2 was given early.  Was not due until 6/18/21.  No adverse effects noted.
Stick to stomach; Diaphoresis; Felt hot; Disoriented; nauseated; Wanted to throw up; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented) and NAUSEA (nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented), NAUSEA (nauseated) and VOMITING (Wanted to throw up). At the time of the report, ABDOMINAL DISCOMFORT (Stick to stomach), HYPERHIDROSIS (Diaphoresis), FEELING HOT (Felt hot), BALANCE DISORDER (Disoriented), NAUSEA (nauseated) and VOMITING (Wanted to throw up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Diabetes mellitus, bsl= 173.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.   Reporter did not allow further contact
Post vax, the pt experienced transient nausea, muscle aches, stiff neck, and joint aches. He also developed a body rash over chest and abdomen that itched. On 3/8/00, he had an elevated temperature and abdominal tenderness.
Local reaction occurred as soon as vaccine given redness, swelling. Pt has a 1cm knotted area on left thigh outer according to mom better was bigger before. Prev vaccines no site charted so can't identify what vaccine given on that thigh. Script of Benadryl given.
I have had a strong headache since receiving the second dose on 3-9-21. Headache started while in the 30 minute wait period. The headache has been all day, every day. Today is 3-20-21. Pain throughout my entire head, down my neck, across my shoulders and top of upper back. No relief from OTC medications or icing neck.
Crying episode, decrease in appetite, unconsolable, decrease in distal pulses in lower extremities, Dx. probable intussuseption at ER.