chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 67 years old female patient who was vaccinated with 0.5 ml once dose of FLUZONE QUADRIVALENT (Batch number: UT6310KA and expiry date: 30-Jun-2019) in the right deltoid on 27-Sep-2018 instead of FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. It was a case of actual medication error due to wrong vaccine administered because patient was vaccinated with FLUZONE QUADRIVALENT and inappropriate age at vaccine administration because a 67 years old patient mistakenly received the following vaccine. No known reported symptoms. 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. Documents held by sender: none.
The stick was put in my upper muscle in my left arm.  The next day, the same arm, but lower muscle, there was a whole section of my muscle that was red, hot and swollen. That went on for several days, almost the entire week. The redness has gone away but my arm is still week. I am still feeling the effects after a week.
(1) Flu shot given 9/20/16.  (2) 9/21/16 9:06AM Patient called pharmacy complaining about swollen, burning, arm hurt, hard to move.
I have Hx of Lyme disease in 2006 when I noticed a bullseye rash. It wasn't until 18 months later that I found out that I had Lyme disease. Towards the end of February I started to notice pain in the right side of my neck. And this was constant until October 2021 I began to feel pain creeping up to the base of my skull until it enveloped the entire right side of my head. This equated to severe headaches and I met with a neurologist. I was then given a Igenex Test for tick born illnesses by my PCP and then I was diagnosed with Lyme disease and bartonella in April of 2022. I then needed to find a doctor that was an expert in Lyme disease and I was also then given antibiotics to treat my symptoms as well last Wednesday 4th of May 2022. Since taking the antibiotics I have been starting to feel better.  I do not believe that this was directly caused by the vaccine however I still had long term Lyme disease and believed that it may have triggered a response.
Initial report received on 23 January 2009 through literature that in 2008, one child aged 5 months had received two doses of ACTHIB (date of vaccination, lot number, route and site of administration not provided) in accordance with the primary series schedule at age two and four months. The patient was too young to have finished its first series of Hib shots. At an unspecified amount of time later, in November 2008, the patient was found to have Haemophilus influenzae Type B Meningitis. Diagnostic tests and laboratory data performed were not provided. The patient's outcome was reported as "survived." Documents held by sender: None.
Extreme foot pain in left foot; big toe area. Suspected gout, however, not responding to medication. Pain exists 4 weeks after symptoms began.
tested positive for COVID 9/5/21, was admitted to the hospital 9/20/21
This spontaneous report as received from a nurse refers to multiple unspecified patients. On unspecified dates multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018; lot # M010212, expiration date 21-JAN-2019). RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018) was stored in temperature: 31°F or colder (30 F) for 46 hours 30 minutes and 47°F to 77°F (75 F) for 15 hours 30 minutes. No temperature timeframe was reported for RECOMBIVAX HB (lot # M010212, expiration date 21-JAN-2019). Digital Data Logger was involved. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA011056.
Sore arm; Felt "like I´m sick again with COVID...real tired!"; Felt "like I´m sick again with COVID...real tired!"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Felt "like I´m sick again with COVID...real tired!") and FATIGUE (Felt "like I´m sick again with COVID...real tired!") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 14-Nov-2020.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MALAISE (Felt "like I´m sick again with COVID...real tired!") and FATIGUE (Felt "like I´m sick again with COVID...real tired!"). At the time of the report, PAIN IN EXTREMITY (Sore arm), MALAISE (Felt "like I´m sick again with COVID..real tired!") and FATIGUE (Felt "like I´m sick again with COVID..real tired!") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
osteoarthritis is going crazy; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis is going crazy) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.   In May 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis is going crazy). At the time of the report, OSTEOARTHRITIS (osteoarthritis is going crazy) outcome was unknown.            No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD21-126466, MOD21-126467, MOD21-126468 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-126466: MOD21-126467: MOD21-126468:
3 vials that were punctured and stayed at room temperature for longer than 12 hours; There were 3 doses given to patients out of expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There were 3 doses given to patients out of expired vial) and PRODUCT STORAGE ERROR (3 vials that were punctured and stayed at room temperature for longer than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There were 3 doses given to patients out of expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (3 vials that were punctured and stayed at room temperature for longer than 12 hours). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (There were 3 doses given to patients out of expired vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (3 vials that were punctured and stayed at room temperature for longer than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient had not experienced any adverse event and No Temp excursion was happened to the suspect vaccine. . It was reported that vaccine was placed in refrigerator on 4-Nov-2021
The patient called the pharmacy and told the pharmacist that he had red rash on his arm. Patient stated he didnt have a fever or anything just mild rash. Patient came up to pharmacy and showed pharmacist patient was instructed to take benadryl and if rash got any bigger to go to ER or MD.
Patient received a flu vaccine on 10/14/22. The morning of 10/15/22 patient reports a 3 inch wide, swollen, hot, red spot 2 inches below vaccine administration site. The night of 10/15/22 patient reports feeling flu-like effects. The morning of 10/16/22 patient reports that the swelling went down but the site is still hot and red.
The day after my vaccines I started experiencing a fluttering feeling in my chest and, when checking my pulse manually, could feel my heart skipping beats. Several blood pressure checks showed elevated pulse and pressure throughout the following weekend. My right arm (Moderna) swelled significantly and developed a large, hot, itchy red patch that lasted about 5 days.
Patient reported a red circle about 1-2 inches in circumference as well as a little bit of warmth to the touch.  Other than that she is not bothered by it.  We discussed using a cold compress and will be calling her daily to check on her until it resolves.
On 7/21/00, the counselor saw him shake in bed, they weren't sure if he had a seizure or not. He was hard to arouse but when he woke up he was alert. He was treated with Depakote.
Pt administered full dose of booster shot (0.5 ml) in left deltoid. No adverse event occurred during observation, pt exited clinic without reaction
Pt recvd 3 doses of Engerix-B on 4NOV90, 6DEC90, & 29APR91 & 13SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
pt recv vax 10MAR97 & that evening pt exp fatigue w/general body aches & h/a;11MAR97 pt devel a swollen upper lip & an erythema-type rash on forehead form brow extending down the side of face along hairline;
After 3-4 days after first vaccine, I began to develop pain in my left shoulder and arm. Which has still been occurring since then. Symptoms are there all the time and if I try to raise my arm up over my head I can feel the pain immediately.
Following his first anthrax vaccine, which was given subcutaneously in the left triceps area, he describes a reaction consistent with a large local. He received two other vaccines that day in right arm and denies any significant problems at their vaccination sites. Per patient history, he had swelling, pain erythema, increased warmth, pruritus and a marble-sized subcutaneous nodule on left upper arm which was first noted about 6 hours after vaccine receipt. Symptoms increased to the point where swelling, redness, warmth and tenderness (rated as 4-5/10 on pain scale) extended from posterior left shoulder area to just blow his left elbow. He sought evaluation on post vaccine day 4, but was told that it was a normal reaction and was given Tylenol or Ibuprofen, he does not recall which. He self limited his activities due to pain and swelling, but was not placed on quarters. Range of motion of his left upper arm was limited. No VAERS was filed. All the symptoms except the subcutaneous nodule resolved by the time of his second anthrax vaccine on 1/21/03. He denies paresthesias, fever, chills, joint or muscle pains, fatigue or headaches. He denies left axillary lymphadenopathy. Service member reports small local reactions (minimal redness, swelling, tenderness and nodule lasting a couple days) following anthrax vaccines 2-4. He believes at least one of these vaccines was given over the triceps area.
Administered vaccines on Tuesday, 4/17/18. On Monday, 4/23/18, patient notified us that she has not been feeling well since "Friday 4/20/18." She reported to be experiencing fatigue, joint pain, and swelling to her upper and lower extremities. States that she is unable to put on her watch due to the excessive swelling. Sent patient to Occupational medicine on 4/23/18.
Cellulitis of right arm shoulder to elbow, redness; swelling; warm to touch, arm discomfort .  Treated with antihistamine; prednisone 20 mg  and Sulfamethoxazole-Trimethoprim 800-160mg
grumpy; fidgety; jittery; nervous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: ZTL5384026) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: She can only have left because of her breast cancer.; "Blood pressure high" (unspecified if ongoing); "Restless" (unspecified if ongoing); "lymphedema" (unspecified if ongoing), notes: The therapy is since she got the vaccine.; "blood clots", start date: 2009 (unspecified if ongoing), notes: She has been taking it for 9 years, She had blood clots in 2009. Concomitant medication(s) included: ELIQUIS taken for thrombosis; LOSARTAN taken for hypertension; CARVEDILOL taken for hypertension; SERTRALINE taken for restlessness. Vaccination history included: Bnt162b2 (dose 1, single, Lot ZTC2948, Expiration is unknown., Injected in left arm., Batch/lot number: FD0809), administration date: 16Mar2021, when the patient was 77 years old, for COVID-19 Immunization.  The following information was reported: IRRITABILITY (non-serious) with onset Apr2021, outcome "unknown", described as "grumpy"; PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset Apr2021, outcome "unknown", described as "fidgety"; FEELING JITTERY (non-serious) with onset Apr2021, outcome "unknown", described as "jittery"; NERVOUSNESS (non-serious) with onset Apr2021, outcome "unknown", described as "nervous".  Additional information: Dates for Concomitant Products Losartan: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Losartan: Started it about 5 years ago. Dates for Concomitant Products Carvedilol: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Carvedilol: Started it about 5 years ago. Dates for Concomitant Products Sertraline: (Start: Unspecified Stop: Unspecified) Additional Information for Concomitant Products Sertraline: Started back again about 1 month ago. Previously 5 years ago. She is grumpy and short. She is fidgety, nervous, and jittery. It looks like everything started around the same time right after, or 2-3 days after she got second dose. She noticed the changes in her body.     No follow-up attempts are possible. No further information is expected.
Temp 100, 11x12 cm area upper LT red & tender at site of injection. Advised to observe.
Pt was inoculated with smallpox on 06NOV2019.  On 10NOV2019 at 1200 pt got a tattoo directly below the inoculation sight.  Tattoo shows no signs of possible infection due to the inoculation.
Vaccine administered to immunocompromised patient; This spontaneous report has been received from a pharmacist via Agency referring to a 40-year-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 07-DEC-2020, the immunocompromised patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis (contraindicated product administered). This was all the information that was provided regarding this adverse event.
I was a little tired and cold the first day but the second day i woke up with a swollen lymph node in the arm pit that i received my shot in.
Both the flu and COVID bivalent shots were given at the same time in different locations on Wednesday, September 21, 2022. The patient states, "I am established with psychiatry and a primary care provider and therapist. I see these professionals regularly and am on daily medications for anxiety and depression.  I woke up on Thursday and was not myself. I realized Thursday evening that not only was I achy but I was having extreme anxiety and depression symptoms. Friday afternoon I realized I was feeling suicidal and needed to complete my workday at home and be in the presence of supportive people to keep me safe. These feelings continued into the weekend. I slept for 9 hours Saturday evening and woke up on Sunday morning feeling like a new human, no body aches and no anxiety or depression symptoms."
1st shot 2-2-21 Felt good for 2 days after then crashed all symptoms returned 2nd shot 3-2-21 Had to go to ER for lung infection. Feb 2020 My husband went to hospital By February 14th we were both deathly sick He went Feb 4th, 2020  Hi, My twin sis sent me these paper from beach. My husband went to the Hospital Feb. 4, 202 & by February 14th we were both deathly sick: body ache (like someone had hit us across back with baseball bat), chills then fever, nausea, diarreah, no appetite because could not taste food (all tasted like cardboard), metal taste & I had braces taken out years ago but metal taste lingered - extreme fatigue (worse than CEBV that I have), stomach, kidney, heart pain - throat still feels like its closing up. Both have had 2 Covid 19 shots. Can try to work 1/2 day just cleaning, cooking & exhausted before that. We both yell at each other because of memory things - he can't use new can opener (use on top not side), if I have paid such & such a bill, etc. Me - trying to get all cats, dogs in & fed especially in cold weather.   Thanks.
This case was reported by a healthcare professional and described an 8-year-old male subject who was inadvertently vaccinated with FluLaval and experienced queasiness. On 25 October 2006 the subject received unspecified dose of FluLaval. FluLaval is recommended for immunizing individuals 18 years and older. Follow-up was received on 27 October 2006 from the reporting healthcare professional. The subject had no pre-existing medical conditions. Information regarding previous immunization with influenza virus vaccine was not provided. The subject received FluLaval at 2:00 pm on 25 October 2006. At approximately 5:30 pm on 25 October 2006, three and one-half hours following the administration of FluLaval, the subject experiences queasiness and fatigue. The subject vomited "the evening of" 25 October 2006. The subject was seen at a  physician's office. The events resolved on an unspecified date on or after 25 October 2006 and on or before 27 October 2006. The healthcare professional considered the events unlikely to be related to vaccination with FluLaval.
Information has been received from a consumer concerning an adult female in her late twenties with no medical history in 2002 was vaccinated with a second dose of varicella virus vaccine live. The patient received her first dose of varicella virus vaccine live in 2002. There was no concomitant mediation. The reporter indicated that a titer was drawn in the end of May 2003 and was negative. Unspecified medical attention was sought. No treatment was required for the event. It was also noted that it was unknown if the patient was pregnant. A product quality complaint was not involved. Additional information has been requested.
LOC for 15 seconds post IM. Patient was in chair and didn't fall to ground or have injury related to LOC. Twitching S/S during LOC. Gave juice and observed patient in clinic for 20 minutes. Changed positions slowly. S/S resolved before client left the clinic.
Patient came in for vaccine 03/21/2023, RN received call  03/27/2023 0900 AM with patient reporting adverse event. Patient states that from post vaccination to present, they have felt pain exacerbated with movement of the injected arm. Patient states that it takes approximately one hour to subside and comes back once again with movement. Patient is concerned with problems working due to pain.  Patient has been recommended to visit local urgent/primary provider/emergency room for further evaluations and proper course of treatment. Patient  does not feel any other symptoms per patient report, no swelling, numbness or tingling. There is no rash, only pain of neck, arm and shoulder. Unable to complete patient interview of due to abrupt disconnection of phone call, after RN explanation of adverse reporting process and appropriate medical course of action. Patient was notified of adverse event reporting on VAERs.
Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who in approximately September 2007 ("about a month ago"), was vaccinated at a different facility, with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided).  The patient visited the physician to report that since the vaccination, she had arm pain that had not yet resolved.  Additional information has been requested.
Chills, Fever, myalgia, vertigo, nausea, neck pain.
I had this out of no where, vomiting and diarrhea  on 5/21. i continued to have diarrhea the entire day of 5/22 . in the early am hours of sunday 5/23 my stool turned to all blood.  I was then diagnosised with colitis and told i had a severe Bleed. I believe it was brought on my the vaccine.  i did have undiagnosised colitis. I was at the hospital and did not speak the language. no one asked me if  i had a covid vaccine.
pt recv vax 5APR97 & 14APR97 pt devel a fever of 100.2 & on 15APR97 pt devel a varicella-type rash w/greater than 50 vesicular, maculopapular lesions on the upper trunk & face;rash spread to entire body w/total of 164 lesions;
Severe chills/shakes 3/17/23 11pm throughout night.  High fever 102.5+ 3/17/23 night.  3/18/23 all day fatigue, aches/pains similar to flu.  Chills stopped after 11am 3/18/23/. Low grade fever 99.2 to 99.9 on 3/19/23.  Injection site red and swollen with redness diameter of 3.25" across left deltoid.