chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient inadvertently received second dose of Adacel and Menactra on 18-Jul-2019, patient had previously received both vaccines on 24-Apr-2019/ no symptoms; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 11 years old male patient who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) on 24-Apr-2019.  On 18-Jul-2019, the patient received a second dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6202BA via intramuscular route in the right arm. On 24-Apr-2019 he also received a first dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 18-Jul-2019, the patient received a second dose 0.5ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6219AA via intramuscular route in the left arm. On 24-Apr-2019 he also received a first of the same vaccine with an unknown batch number via unknown route in unknown administration site.  It was an actual medication error due to extra dose administered.  It was reported that patient inadvertently received second dose of Adacel and Menactra on 18-Jul-2019, patient had previously received both vaccines on 24-Apr-2019.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Headache, nausea, extensive right leg charley horse and pain/tenderness  just below hips  with bruising
This spontaneous report as received from a nurse refers to a 66 year old male patient who is her husband. The patient's concurrent condition included hypertension, allergy to latex and allergy to aspirin. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX, (lot # J006831, expired date: 14-SEP-2014), intramuscularly, (dose and frequency were not reported) instead of PNEUMOVAX23. Concomitant therapy included blood pressure medication. Patient experienced pain around the injection site on the following day. The patient was not received treatment for adverse event. The patient did not seek medical attention. No lab diagnostics were performed. Action taken of therapy with ZOSTAVAX and outcome of adverse events was not reported. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; This solicited report received from a physician via JS2020-26741: a regulatory authority concerned a female of unspecified age and Unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccination failure was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and suspected clinical vaccination failure as possible.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666881-COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever for 2 days starting 5 days after receipt of vaccine and rash started 10 days after receipt of vaccine.
Narrative: Pt is a 68y.o. male who died on 05/06/2021 w/ h/o COPD, CAD, T2DM, HLD, asthma, sleep apnea, depression, lung nodules, AFib, and obesity. Pt received Moderna Covid-19 Vaccination 2/2 on 4/28/2021. Pt died enroute (ambulance) to hospital on 05/06/2021. Unlikely Moderna Covid-19 vaccine caused/contributed to pt death.
Low grade fever (99.5-100.5), headache, nausea, fatigue, sore and swollen arm.
15 minutes following vaccine I began having tingling in my outer three fingers on left hand followed by numbness in hand, wrist and forearm.  That evening I also had tingling in mouth, lips, tongue and teeth numbness.  I also had lightheadedness (last about 5 days), head flushing (5 days), diarrhea (1 day), and elevated blood pressure.  It has been almost two weeks, and I still have numbness and tingling on and off in both hands, fingers, wrists, forearms, numbness in teeth, and a burning sensation in both calves and ankles.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
She began to have symptoms the end of October. She had "pins and needles" sensation both feet which progressed up to her knees. She also developed this sensation in her hands which progressed up to her forearms. She experienced weakness in her legs and arms. She stated there were days she had extreme fatigue. She had twitching of her left eye constantly for 4 weeks. She continues to have "random muscle twitches" which is the only remaining symptom.
severe bruising within 30 minutes of vaccination appx 2" above insertion site - bruise 3-4" in diameter
Patient with history of 3 COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "71 year old male with past medical history AS s/p TAVR, Afib s/p PVI and ablation, CHF s/p PPM, DM2, hx DVT, ESRD on HD MWF, FSGS, hypothyroidism, OSA, hx R BKA who presented to the ED on 12/15 with worsening wound on the L 5th digit for 2-3 months. Patient follows with o/p wound care who had attempted multiple courses of antibiotics. Had o/p XR of digit prior to ED visit which demonstrated swelling and ulcer of distal finger, suspicious for osteomyelitis. Labs significant for Hgb 12.8 (at baseline), ESR 73, CRP 4.4, LA 2.6, INR 4.5. Last took coumadin on 12/13, INR was 8.0, holding. In the ED, patient started on vancomycin and cefepime. Receiving HD on 12/16. Hand surgeon consulted, reviewed XR and does not believe patient has osteomyelitis. Plan to continue managing patient non-operatively at this time with follow-up appointment on 12/19. Nephrology consulted for ESRD on HD. Wound care consulted for R BKA draining and chronic LLE wounds.  Medical team consulted for wound cultures growing Proteus Vulgaris, E. Faecalis, Corynebacterium Striatum. Upon review of the case and imaging, medical team recommends 6 weeks of oral antibiotics with ciprofloxacin 500 mg daily and amoxicillin 500 mg q12h with medical team follow up in 4 weeks. He was otherwise medically optimized and discharged in stable condition.   Necrotic wound of L 5th digit - Follow-up appointment with hand surgeon on 12/19 - Start taking ciprofloxacin 500 mg daily and amoxicillin 500 mg twice daily for 6 weeks - follow up in clinic in 4 weeks   Afib Elevated INR - Last dose warfarin 12/13 d/t elevated INR 8.0 - Currently INR 3.4, planning to give 3mg tablet - Continue home warfarin at discharge   Issues Requiring Follow Up:  Medical team for antibiotics, treatment of necrotic wound Hand Surgery for further evaluation of necrotic L 5th digit wound"
1/5/20 :  7 AM - and noticed swollen, red, and firm raised  area just under injection site. Warm to the touch and slightly itchy like sunburn.  6 PM - Area  is doubled in size (about the size /shape of a thumb), much redder, and in a well-defined elongated oval shape.  Hot to the touch, firm and painful swelling that made sleeping difficult. Took Aleve and iced it. 1/6/20 7 AM -  Red area has spread out into a less defined circle about 2in in diameter.  Less swollen and painful but still hot to the touch. 6 PM - Area has spread into tear-drop shape about the size of my palm. Drew a line around the area. Still causes some difficulty sleeping. 1/7/20 - Area is less red and not as painful but I can still feel the original area swollen under the skin and hot to the touch. Spread slowed significantly and mostly stayed in the lines.
PT became very fussy for over 3 hrs. Went to ER. Will no longer get DTaP - only DT.
Patient called Wed (11/10/10) said Monday night she ran a low fever, felt weak and had a sore arm.  As of the next day (Tues) she was already feeling better.  Fever and weakness is gone, just has a sore arm.
At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck (no discomfort or itching).  At the 12-hour mark I developed severe chills and body aches and exhaustion which came on very quickly.  At (approx.) the 13-hour mark my temperature was 103.3 but it never got any higher than that.  For the next 24 hours my temperature hovered around 101-102.
Client reports he rec'd pneumococcal vaccine here and then and had flu shot the next day at another location. A few days later he began having joint pain in his knees, shoulders and hops which required follow up with his PMD. At this time client reports sx's 75% resolved.
right lower chest pain progressive over 2-3 days - clinical suspicion for pericarditis - started on ibuprofen therapy which has helped greatly
partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors.  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.
Pericarditis, causing chest pain.  Pt seen and treated in ED.  Pt discharged home.   Flu/SARS tests were NEGATIVE on date of diagnosis of his pericarditis.  Pt discharged on anti-inflammatories.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L008660, expiration date 10-NOV-2016) and of an improperly stored dose of ROTATEQ (lot # and expiration date not reported). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA00142, 1509USA001921 and 1509USA001922). Additional information is not expected.
Second lifetime tonic-clonic seizure occurred around 2300 June 24,2021 while sleeping. Fell out of bed with approximately five minutes of tonic clonic activity that were observed by patient's mother (in the same bed as patient).  Blood sugar was in the 90s-100s at time of event (no hypoglycemia-induced seizure). EMS called, patient transferred to Hospital emergency room. Patient's neurologist notified of second seizure, EEG completed. Patient started on 500mg Keppra 2x a day with a follow up with neurology on August 23, 2021.
pt. c/o of upper abdominal pain and back pain.  symptoms was resolved and patient went home.
This patient has generalized hives, onset 1 hour after her immunizations; along with fever and vomiting. She was evaluated in the ER approximately 5-6 PM same day. Prescribed Benadryl. The hives subsided after 24 hours.
32MAY rash devel on chest, neck, shoulder & arms; 25MAY sz occurred @ approx 455PM @ day care; 911 called; sz lasted approx 4 mins; t100.2; pt had rash on chest, neck shoulders & arms as a result of vax; poss bacterial infect
Severe headache, fever 102.? per mom, nausea and diarrhea beginning "about 23 hours" after vaccine-began suddenly. Began vomiting Sunday evening. Low grade fever Tuesday-no fever Wednesday. "Better" per mom Wednesday following vaccine.
Pt developed fever p/shot & had brief generalized sz approx 8 hrs p/immun;
Some chest pains after first dose but went away prior to second dose appointment. Unaware it was related. Significant chest pain and rapid heart beat after second dose. Ongoing chest pain. Rapid heart beat and loss of breath when sleeping. Feels like running when seated.
Started with a headache and elevated temp the next  day with temp peaking at 102 degree. Progressed to brain feeling swollen and to large for head with ringing in head with every step or movement - Squeaking in ears when swallowing - Eyes hot and burning - Extremely dizzy and off balance - Chills- Body aches - Tired - Shortness of breath like with the  Covid - Injection site swollen, hot, red and itchy still at 6 days out.
Patient admitted as inpatient on 08/18/2022 due to Acute respiratory failure with hypoxia (*) 2/2 covid. Patient was tested for COVID-19 and was positive on 08/18/2022.
Patient's right arm had a hive that was swollen, red, warm to the touch that covered about 3/4 of the arm from the shoulder to wrist. Dr. called. 50mg Diphenhydramine capsule with H2O given sent to Dr.
11 year old female received 2nd dose of Pfizer vaccine and inadvertently was administered adult dose of Pfizer instead of 5-11 year old dose.
Shingles vaccine given at 1:35PM. At 1:45PM itching, facial swelling, difficult breathing, signs of shock began. Taken to emergency room at 1:50PM. After being given I.V. antidotes to relieve the swelling and symptoms, she recovered and was released at 4:00PM.
Patient describes a severe headache and severe dizziness/vertigo. She fell twice on 11/3/2019 and hit her head and back on the first fall and fell forward landing on her hands and knees down 3 stairs the second time.
reporter states an inc # of inj site rxn following vax;6 out of 10 children vaxed devel erythema & tenderness;rxn 2-3" in size;rx included motrin, APAP & warm compresses;all 6 children have h/o chronic sinusitis and/or pneumonia
Thrombocytopenia (plt=6k).  Epistaxis, petechial rash, bruising, mouth sores on tongue 10/19/09 Medical records received from hospital date 10/1/09 and Labs from 10/01/09 to 10/9/09. DX: Thrombocytopenia. Presenting SX: pt states received flu vaccine 9/24 c/o arm soreness same day. 9/25 c/o left side neck pain. On 9/26 c/o right side neck pain. 9/30 pt developed epistaxis. 10/1 presented with epistaxis, sores on tongue, buccal mucosa, petechial rash, increase bruising on legs. Assessment: increase BP, buccal and tongue bleeds, petechial rash over body greater on legs with ecchymosis. Pt admitted to hospital.
Itching and rash on arm above injection site.  Continued to be itchy for a week.  One week from time of injection, skin flaked off.
Subsequent to receiving third dose of Engerix B the pt experienced injection site soreness, left chest soreness, left head soreness and achiness. The pt was treated with one dose of Advil 200mg. The pt started feeling better by noon and progressed to fine by the next day. The most recent information received, reports the condition of the pt is resolved.
Local adverse reaction to injection site. Injection site redness, purple colored bruise with small fluid filled blister. Pt reported pain and burning to Lt upper arm (deltoid area).
2 days after vaccine had slight rash at vaccine site (RA-VARIVAX) with itching.  Following day had rash on face - more pronounced with itching.  No blisters either site.  Resolved on own.
Our son had sever joint pain and swelling several days after the vaccination when his heart rate elevated after playing tennis. His response - everything hurt.  This past weekend had a 102 fever. Was tested for covid and strep - negative. Has mono symptoms with sever ulcers in his throat and mouth. Continued fatigue and loss of appetite.
BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patients weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
typical first two days: fever chills nausea fatigue aches 3rd day: severe abdominal pain was diagnosed with diverticulitis father & paternal gmother had diverticulitis patient was diagnosed with diverticulosis in 2011
VACCINE GIVEN 4 HOURS AFTER FIRST VIAL PUNCTURE AT ROOM TEMPERATURE FOR THE 4 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-OCT-2021, the patient experienced vaccine given 4 hours after first vial puncture at room temperature for the 4 hours. On 30-OCT-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given 4 hours after first vial puncture at room temperature for the 4 hours and incorrect product storage was not reported. This report was non-serious.
Nausea comes and go, fever for a couple of days, tired, sweating, and a headache.
Bruising at site of injection, with sub-cutaneous nodule.  Bruising resolved quickly in a day or two but nodule has persisted for a month, and is still present.
This spontaneous report as received from a pharmacist via the agency (LRN MK4439) refers to a 19 years old female patient with latex allergy. The patient was vaccinated with dose 1 of VARIVAX (Merck) (reported lot # H011553; expiry date 11-JUN-2014) on 17-SEP-2012. Route was unknown. She also got a flu shot (not further specified) within 4 weeks prior to receiving VARIVAX (Merck). Exact vaccination date, route and lot number of the flu shot were not reported. Concomitant medications included: ENGERIX-B (first dose 23-AUG-2012, second dose 24-SEP-2012). On an unknown date the patient experienced itching. In September 2012, right after receiving the VARIVAX (Merck) injection, the patient experienced full body hives. However, it was unknown if the full body hives started on 17-SEP-2012. The patient said BENADRYL was just helping with itch and was not relieving the hives; they have not changed in size or "anything like that". It was unknown if there were any relevant laboratory tests. She was due to receive the second VARIVAX (Merck) injection on 17-OCT-2012. As of 13-OCT-2012, she still had full body hives and it was unknown if she was still experiencing itching. The relatedness for full body hives and itching was not reported for VARIVAX (Merck). Additional information has been requested.