chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Adacel given, no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years old male patient  who was administered an expired 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5726AA (Expiry date 11-Jul-2019) via intramuscular route in the right deltoid on 09-Sep-2019.  The patient's past medical history, vaccination(s) and family history were not provided.  Concomitant vaccination included Flu vaccine.    It was a case of actual medication error due to expired vaccine used.  At a time of reporting No adverse reactions reported.  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.
2 episodes of numbness in his legs from the thigh down; This case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2022, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In March 2022, less than 2 months after receiving Shingrix, the patient experienced numbness in leg. On an unknown date, the outcome of the numbness in leg was unknown.   It was unknown if the reporter considered the numbness in leg to be related to Shingrix.   Additional Information: GSK receipt date: 24-MAR-2022 Reporter's comment: The case was reported by the patient. The patient had received Shingrix vaccine in his left arm at his pharmacy.  Two weeks ago, he had 2 separate episodes of numbness in his legs from the thigh down while he was standing.  In order for the numbness to resolve, he had to lay down and move around his legs.  The reporter could not provide the lot or expiration date. The reporter did not consent to follow-up.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 07-AUG-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness continuing in right arm muscle and in underarm and all the way down arm into hand at times after 2 weeks. Motion and use not limited except being careful because of aggravating soreness.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA002453: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Narrative: Patient contacted call center with chief complaint of fatigue/increased joint pain starting on 10/15 in evening into 10/16 (after his 2nd COVID-19 Vaccination on 10/15). Stated on night of 10/17 he developed a fever (100 F) along with a lump in his left axilla (same side as his injection).On 10/19 patient reports he is improved. Lump in axilla is "much better, I can barely feel it now". Denies any further fever, chills. Endorses some remaining fatigue and joint pain. Nurse recommended continued warm compresses, apap or NSAIDS, rest and plenty of water, and call back with any additional concerns or changes in status.
Nurse gave the patient the Rotavirus vaccine orally and a bright red rash on face and neck with tiny little bumps appeared within 2 minutes. The nurse and NP assessed the child and there was no respiratory distress and patient was breathing normal. Patient was sent to the Emergency Room for observation, rash was already starting to fade at this time.
Euphoria; Some soreness at injection site; Excess amount of energy; Excessive energy has slowly decreased.; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Excess amount of energy), ASTHENIA (Excessive energy has slowly decreased.), EUPHORIC MOOD (Euphoria) and VACCINATION SITE PAIN (Some soreness at injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008AMA) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome (No recent changes occurred in the status of chronic condition) since 06-Jan-2003. Concomitant products included TRAZODONE, METFORMIN HYDROCHLORIDE (METFORMIN ER) and ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ENERGY INCREASED (Excess amount of energy), ASTHENIA (Excessive energy has slowly decreased.) and VACCINATION SITE PAIN (Some soreness at injection site). On an unknown date, the patient experienced EUPHORIC MOOD (Euphoria). On 23-Mar-2021, ENERGY INCREASED (Excess amount of energy) had resolved. At the time of the report, ASTHENIA (Excessive energy has slowly decreased.), EUPHORIC MOOD (Euphoria) and VACCINATION SITE PAIN (Some soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.Patient's heart rate stayed normal as did blood pressure and no insomnia experienced.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10 May 2021.Added patient demographics, medical history,concomitant medication's dosage details and new event. Updated outcome of event, excess energy from unknown to resolved,updated re-challenge and de-challenge.
18 yo recruit on day 24 of his training was brought in for syncope. Was told he passed. States he has been having F/C, night sweats, coughing up blood-quarter size amount of blood at night, and loose bowel movements for past 3 weeks. He has been having decrease in appetite and a 26lb weight loss since starting training. Denies of any CP or SOB. However, has been having N/V and dysuria with increase in frequency. Patient had clinical picture consistent with menigoencephalitis. LP performed showed elevated protein and lymphocytes. CSF culture and gram stain were negative. Patient started on and completed full courses of vancomycin, ceftriaxone, doxycycline, fluconazole, acyclovir, tamiflu, steroids and IVIG. All of patients CSF lab tests for possible causes of menigoencephalitis (sent to state encephalitis project) have returned negative; tests include HSV 1 and 2, VZV, enterovirus, adenovirus, influenza, parainfluenza, WNV, EBV, CMV, and coccidiomycosis Ag. CSF pathology negative for malignancy and parasites.  - Patient developed evidence of opacity of left lower lobe on 23July 2009. Felt to be a result of aspiration pneumonia. Patient treated with vancomycin, ceftriaxone, and doxycycline. Most recent CXR shows resolution of opacity.
Information was received from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX on 22-AUG-2011 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster. On or about 09-JUL-2017 the patient was treated at an urgent care for a blistering vesicular outbreak which was then diagnosed as herpes zoster, shingles. The patient was prescribed valacyclovoir and prednisone to manage his painful symptoms. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
2.75cm x 3.25cm warm, erythematous macule (R) upper arm.
24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-incontinent urine, confused, pain in extremities with movement, sent out to hospital. returned same evening. 01/12/2021- difficulty communicating, confused- sent out to hospital, returned same day. 01/15/2021- symptoms improved
Entire arm that shot was given was sore with 12 hours. Within 24 hrs entire left extremities were sore including arm, and leg. Within 48 hours right leg was hurting also.
tested positive; tested positive; she did not feel well the next day; she got so sick but it only lasted 1 day; she had pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunization; Bnt162b2 (dose 2, single), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), single), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (dose 4 (booster), single), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 12Oct2023, outcome "unknown", described as "she did not feel well the next day"; ILLNESS (non-serious) with onset Oct2023, outcome "recovered" (Oct2023), described as "she got so sick but it only lasted 1 day"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "she had pain in the arm"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Positive, notes: she felt horrible and she tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: On 11Oct2023, patient got her 5th COVID vaccine called Comirnaty. She stated she only got Pfizer vaccines. Patient did not feel well the next day, reporter stated she got so sick but it only lasted 1 day. Aside from that she had pain in the arm. Reported stated on that Monday morning, she felt horrible and she tested positive. Her doctor ordered Paxlovid and her symptoms irradiated. Reporter stated this was her first time getting COVID. Reporter wanted to know if the vaccine caused her to test positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Went into arrhythmias and blood pressure was elevated for 3 hours.  took extra dose of metoprolol and both arrhythmia and blood pressue came down slowly during the subsequent 3 hours
Client was undergoing routine lab monitoring with his oncologist - Dr.  and was noted to have developed hypothyroid in August 2021 (first lab testing after his April booster shot). Although according to Dr. - the therapy he had received nivolumab is associated with hypothyroidism - Client was already off that therapy (stopped March 26, 2021) and his prior thyroid testing had been in normal range. After discussing with other friends it became apparent to him that others had also been diagnosed with hypothyroidism after the vaccine series so as an abundance of precaution in case there is an association he requested reporting.
During sleep on Friday (3/28/08) night, child woke up screaming for one hour and fever of 103.  Child continued with fever 102-103 and "fits of fussiness and screaming" through 3/29/08-3/31/08.
Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work about an hour early that day due to rising nausea, migraine and fatigue. By the time I got to my car in the parking garage I had thrown up and was so dizzy that I called my boyfriend to come pick me up. When I got home I immediately laid down to take a nap. 3 hours later I woke up very sore and achy and still had a migraine. I remained in bed and later that night I spiked a fever as high as 101.8 fahrenheit. I had severe chills and the aches were so bad that my bones hurt all over and it felt like someone was stabbing me with a metal broom handle. Pain spiked to 8 on the pain scale and with the length of time I had this pain, it was one of the worst experiences of my life. The dizziness and fatigue caused me to need help to get out of bed to use the restroom. I took ibuprofen frequently and Nyquil at night to help relieve the effects without it doing little more than taking the edge off. Saturday night was the same as Friday night with no relief of symptoms. Fever remained around 100.9. Sunday night it dropped to 99.8 with chills, dizziness and fatigue still remaining but aches slightly lessening. Monday night I was still dizzy and weak but not nearly as in much pain and fever had subsided. Tuesday I started to feel more normal by the end of the night, just easily out of breath and off and on again headache.
Pt complained of shortness of breath, dizziness, and near syncope.  This started approximately 2 weeks ago.  Patient was admitted for NSTEMI, she was indecently found to be COVID 19 positive.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 11:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23, lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reporter cases. Additional information has been requested.
Pt given 1st dose of vax & devel rxn @ site of inject; 3 to 4 days following vax exp shoulder tendinitis & was treated w/Ibuprofen & ultrasound; 2wks later sx subsided; 19NOV90 exp pain in lt posterior buttock & lateral thigh, dx sciatic;
Extreme swelling of the arm. Patient came in on 10/12 and showed me his arm, he stated it was very painful and I could see it was very red and swollen. He came in again on 10/13 and showed me that it had swollen up 3 more inches and had moved to the middle of his forearm.
Patient presented to the pharmacy with complaints of stiffness and pain in the left arm. Patient spoke with assistance of interpretor. Patient stated she could not raise her arm due to pain. She was asked about fever, dizziness, rash, or change in color at injection site. Patient stated she did not have any of these other ADRs. Reporting pharmacist assured patient that pharmacy department would follow up with her on her progress. Pharmacist gave details to patient on ways to reduce effects of any pain she may be having which included applying a cold compress every 15 minutes and taking an Advil or Motrin to reduce pain and swelling. Pharmacist expressed concern for patient and well being for a quick recovery. Pharmacist inquired on patient's primary care physician and patient wrote down a name. Patient was given a complimentary bottled water and was reassured that symptoms would eventually subside. Patient was encouraged to contact pharmacy and physician's office if effects do not subside. Patient and daughter expressed gratitude for pharmacy's concern and was told pharmacy will contact her soon to see how well she is progressing. Patient and daughter thanked pharmacy and walked away.
Patient experienced lightheadedness and faint feeling while driving  4 days post vaccination. She immediately went to ER and was diagnosed with vertigo upon discharge. Her vision was still blurry and she followed up with a neurologist and ultimately diagnosed with vestibular neuritis. Possible cause from an inflammatory response due to receipt of the yellow fever vaccine. Symptoms lasted 10 days before visual improvement.
Pt has no temp, area not reddened, not irritated, not warm to touch. There is a small area where the needle was inserted, that has a grey to silver particle that is just under the skin. Area is not raised mom noticed this the next night when she was giving daughter a bath - Inj site at lower lateral thigh.
The next day after receiving the vaccine I had lower back pain that came out of the blue and was quite severe. It lasted for three or four days to lessen but did take a week to ten days subside all together. When the pain first came on, I waited three days to see if it would go away before I called my doctor. I spoke with my doctor, she ordered and MRI for Friday 10/07/22 to rule out what was causing the pain. The pain has improved significantly, my doctor and I have agreed to not pursue this further at this time.
The child broke out in hives all over her body about an hour later. Mom was instructed to give BENADRYL and cleared up within 30 to 45 minutes.
Shingles vaccine site swelled and turned red, and was hot to touch. Swelling and redness lasted 8 days; heat lasted 3 days.
pt recvd vax & exp local edema & mild pain w/gross erythmia to lt medial forearm;
Shortness of breath 2 days later, folliculitis one week later, burning skin and extreme vertigo 8 weeks later.  I also had extreme differences with my period where they lasted longer, were coming sooner, were heavier, and accompanied by cramping (which I never had a problem with before).  Burning skin is becoming intermittent and each time not as bad as the last.  Shortness of breath is starting to happen intermittingly, but still happening all the time with activity.  Vertigo is still going on and lasting just as long each time.  Folliculitis is going away with long term steroid cream use, but is coming back once a month.  All of these seem to get at their worst during specific times in my cycle.  Testing is still going on to find cause for all of these, because we haven't found answers yet.
No adverse event occurred. Med error happened when 23 year old patient was given flu shot indicated for ages 65 and older. She reported to reaction.
Case  number PHEH2014US020050 is an initial spontaneous report received from a pharmacist on 03 OCT 2014. This report refers to a 45 year old male patient. His past medical history and concomitant medications were not reported. On 03 OCT 2014, he was vaccinated with FLUVRIN 2014/2015 (batch number: 1411301) intramuscularly. On the same day after 15 minutes of vaccination, the patient noticed a funny taste in his mouth and had pain at the injection site. The reporter also stated that the patient felt a little disconnected. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
after 5 days went urgert had serious pain in shoulder.  Then patient came today at 10/29/19 and indicated had terrible arthritic  pain from possible shot
gray spots on tongue day 3. Bilateral calf pain, alternating sides, starting day 6.
Several mins after vaccine, patient began to feel weak. felt like she was going to pass out. has hx of tinnitus, ringing in left ear intensified after injection. was diaphoretic and clammy. sat in med obs, drank some water, and felt better. 1630 bp 120/80 hr 82 rr 18 sats 95% on ra.  1647 bp 117/78 hr 82 rr 18 sats 96%. s/s resolving. 1700 escorted to vehicle with no issues.
Patient developed urticarial rash and some facial swelling. She took oral antihistamines with relief.  She was given cetirizine to take after she was examined the day following her vaccine.
throwing up; Nauseated; Chills; This is a spontaneous report from a contactable other hcp/nurse (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 10:00 as DOSE 2 (age at vaccination: 66-years-old), SINGLE for covid-19 immunisation. The patient received dose 1 of BNT162B2 on 11JAN2021 for COVID-19 immunisation (Lot Number: EL1283, Expiry Date: unknown, Anatomical Location: Right Arm). The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced nauseated and chills on 08Feb2021 (In the middle of the night on 08Feb2021 is when she got nausea and chills), throwing up on an unknown date. The patient underwent lab tests and procedures which included blood test: everything was within normal range on an unknown date. Outcome of the event (nauseated) was Not recovered, chills and throwing up was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
I had numbness in my left and right foot after receiving my J&J vaccine. After the Moderna, I had a sore arm that lasted for about a week. Three days after receiving the Moderna booster (half dose). I started to have numbness in my hands, but it's usually in my feet and legs. It gradually worsened over the following week and has remained the same since it first started.
9 days after vaccination I felt as if I had the flu. Cold chills, loss of appetite, fever of 100.5, fatigue, body aches, out of breath when up, and stomach cramps. The adverse effects lasted an entire day. I went to doctor thinking it was something. Finally broke the fever that evening sweating and really hot.
I have EoE.  My last EGD dated 12/18/2020 showed my eoe of was well managed and until the vaccine I had had no issues.  This was clearly the cause.  I called off work on Monday the 18th  and have been on a liquid diet until last night.  doing better.  Grateful for the vaccine.
Patient admitted on 11-24-21 - COVID test positive 12-2-21 - Patient negative for COVID symptoms - discharged 12-9-21.
Per phone contact w/pt, nausea, cramps, upper respiratory congestion, fever & "flu-like" sx were reported as persisting for a 2 wk period;