chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases  2023SA057733 and 2023SA057309 (CLUSTER).  This case involves Child patient of unknown gender and reporter reported influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Initial report was received by a consumer, who was also the patient, on 12 October 2012. A 76-year-old female patient had received an intramuscular injection in the left arm of FLUZONE HIGH-DOSE, lot number U4496AA, on 01 October 2012. The next day after vaccination, the patient had arthritic pain in feet, ankles, wrist, top of thumb, shoulder and neck. The third day the patient had sporadic sharp pain in the left knee and couldn't raise her right arm due to tendonitis pain. The patient was seen by a rheumatologist on 06 October 2012 and a right shoulder x-ray was done. The patient was treated with a cortisone injection in the right shoulder. The patient had no illness at the time of vaccination. The patient had a history of degenerative disc disease, needs a right knee replacement, triple bypass in 2002, two stents in 2002, allergies to multiple drugs and over the counter drugs, lactose intolerance, wheat allergy which is a gastrointestinal (GI) disturbance. The patient had previous doses of influenza vaccine. The patient's outcome was unknown. Documents held by sender: None.
Complaining of feeling warm at head/chest, feeling need to take deep breaths about 5-10 minutes post vaccination. Was given an ice pack and allowed to lie down on gurney. Afterwards, individual felt significantly better with the cold therapy and resting, reported symptoms had resolved by 1611 same day.
24 hrs after taking first Oral Typhoid capsule c/o waking up to abd cramping and mild nausea lasting until bedtime then stopped. 24 hours after second capsule woke up in AM with abd cramping lasting until 12:00 noon. 24 hours after third capsule woke up with cramping more severe than before and nausea. Talked with patient that day at 10:00 AM. Called Crucell for information.  Phone call back to patient with directions to treat symptoms and may consult physician if worsens and to ask about recommendations for taking 4th capsule. Unable to reach patient by phone later that afternoon or next day.  Left messages asking her to return my call but has not at this time.  No information about whether she took the 4th capsule or if symptoms worsened or resolved.
Pt with c/o redness, swelling, warmth, pain at site of injections. Treated with Oral Doxycycline 100 mg BID.
Patient went to the ED on 5/22/21. She had been having pain and swelling in her R lower extremity for approximately 1 month prior. She was diagnosed with a deep vein thrombosis. She did not have any other known risk factors for DVT.
C/O reaction after getting flu shot and pneumonia injection x 3 days ago -notes the day after she received the injections, she developed a rash -symptoms have been worsening since that time. On 10/7/2016 patient presented to ER/UC stating she was seen 4 days ago for well check and started on simvastatin and received influenza and pneumococcal vaccines. That evening she noticed itching around the injection site over the next 48 hours she developed a rash of blisters at the injection site and was seen yesterday in the care clinic. She was started on prednisone 40mg/d x 5 days and has used 1 dose. Today she notes a new lesion on her lower lip and spread of the rash on her arms and chest. Patient seen on 10/7/2016 by Dermatologist for urgent evaluation.  Provider notes: Comment: itchy, diffuse, possible bullous pemphigoid. Most confluent on L upper arm where she got flu and pneumonia vaccines recently. No recent drug starts, including OTC/herbals. Plan: - two 4 mm punch biopsies today on R upper thigh, one of small blister for H&E, one of peri-lesional skin for DIF sent in Michel's media - predniSONE 60 mg daily, start tomorrow since got solumedrol today in UC - camphor-menthol (SARNA ANTI-ITCH) 0.5-0.5 % lotion as needed for itching - see patient instructions - Bullous pemphigoid has been reported fairly frequently after vaccinations in infants. It as been reported only rarely in adults after influenza vaccination, with one patient having a second bout of bullous pemphigoid a year later after repeat influenza vaccination. A flawed case-control study in adults did not support this association. There was one case of generalized bullous fixed drug eruption after influenza vaccination, simulating bullous pemphigoid. RTC 1 week.
11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingling on rt side of head over next few hours ( I wouldn't call this a headache) 4pm- roof of mouth burning 10pm - went to sleep but only one side of head felt like fire/ice along with mouth 7am - upper body and head feels like on fire/ice Never had a fever
Narrative:  Patient was not previously COVID-19 positive and did not have any  predisposing factors(PMH, allergies, ect.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for carcinoma of prostate, parkinson's disease, CAD s/p PCI and  Stenting, hyperlipidemia, impaired fasting glycaemia. Pt was on antibiotics starting around 2/16 for a "bump over the right extension" and treated with bactrim ds x 21 days. Pt admitted to outside facility acute inpatient care center for infection of deep brain stimulator on 3/30/21. Scheduled for 3/31 removal of DBS. Deceased on 4/3 with no cause of death listed.
Erythematous area 4x3.5 cm diameter on the left deltoid.
Pt seen in the office for unrelated illness on 02/28/2000 at which time mother indicated left thigh rippling with slight purple discoloration at site of MMR given 02/23/2000 in our office.
This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 17-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent vaccination included Haemophilus influenzae type b vaccine; manufacturer unspecified; unknown; unknown given in October 1995; combined diphtheria, tetanus, pertussis (A or W not known) vaccine; manufacturer unspecified; unknown; unknown given in October 1995; inactivated poliomyelitis virus vaccine; manufacturer unspecified; unknown; unknown given on October 1995, 12 December 1995 and April 1996. On October 1995, 12 December 1995 and April 1996 the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown details) and experienced drug dose administration interval too long between the 1st and 2nd dose of hepatitis B. The 2nd dose is indicated to be given 1 month after the first dose. The nurse documented that she obtained the dosing information from school records which were not very detailed. On 6 march 2013, 18 years after vaccination with dose 1 of Hepatitis B vaccine, 18 years after vaccination with dose 2 of Hepatitis B vaccine, and 17 years after vaccination with dose 3 of Hepatitis B vaccine, the subject experienced not responding to therapy. Relevant test results included a negative hepatitis B titer drawn on 6 March 2013. At the time of reporting the outcome of the events was unspecified. The nurse stated that the subject was considering repeating the hepatitis B series.
EDC 9/8/21 Fetus developed severe hydrops after COVID vaccination Patient had normal anatomy scan on 4/21/21 at 20 weeks Patient had COVID vaccine on 5/21/21 Patient had a repeat US on 6/3 at 26+1 weeks which showed severe hydrops Patient terminated pregnancy - birth weight unavailable
Onset of granuloma annulare. First appeared after first dose. Increases after second dose. Flared again after booster.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed.  No treatment medications were reported.
Fever, chills, headache, and tiredness (2nd day of receiving  the 2nd dose) Feeling good on the 3rd day Headache, stomach burn, throwing up, and heart attack (4th day of receiving the 2nd dose)  Passed away on April 2, 2021
received 1st dose on 2/20/21 at MVP as per clients information, Not accurate historian. possible inablitiy to provide medical information. Family notified and client monitored closely.
Patient presented to follow up appointment with provider 8-4-14. Left arm very swollen. Swelling extends from clavicle to her mid forearm. States has had fever and headaches. States this started 8-2-14. She states that her left arm was so swollen she couldn't get her sleeve on. Patient states has improved. Patient took BENADRYL at home. MEDROL dose pack order, 8/4/14.
leak from the syringe; leak from the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (leak from the syringe) and DEVICE CONNECTION ISSUE (leak from the syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported. ).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced UNDERDOSE (leak from the syringe) and DEVICE CONNECTION ISSUE (leak from the syringe). On 31-Mar-2021, UNDERDOSE (leak from the syringe) and DEVICE CONNECTION ISSUE (leak from the syringe) 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.   Concomitant product use was not provided.   Treatment information was not provided.
tiredness; weakness; lost of appetite; fever; arm was red; arm sore and hot; arm sore and hot; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, less than a day after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: arm was red), skin warm (Verbatim: arm sore and hot) and pain in arm (Verbatim: arm sore and hot). On an unknown date, the patient experienced tiredness (Verbatim: tiredness), weakness (Verbatim: weakness), appetite lost (Verbatim: lost of appetite) and fever (Verbatim: fever). The outcome of the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm were resolved (duration 5 days).   It was unknown if the reporter considered the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023104702   Additional Information: GSK Receipt date: 27-JUL-2023 The patient self-reported this case. The same night of vaccination she noticed her arm was red, sore and hot.  She also had fever, lost of appetite, weakness and tiredness. All lasted about 5 days. For tolerance of 2nd dose, refer case US2023104702, reported by same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023104702:same patient
Patient received a dose of MNRA vaccine (Pfizer) on  05/04/22 and a vector vaccine (Janssen) on 05/05/22.
COVID vaccinated patient admitted for COVID pneumonia who subsequently died.  Provider discharge note:  "84-year-old male with a PMH of COPD (on home O2), CKD stage 4, CAD s/p CABG, Hx of HITT, and DM2 who presented to a local healthcare facility with worsening hypoxia, shortness of breath, and generalized weakness after COVID 19 pneumonia diagnosis on 10/24/2021. He was fully immunized against COVID. On admission he was hemodynamically stable. Images were concerning for a superimposed bacterial pneumonia showing infiltrate in the left lung base and labs were positive for elevated procalcitonin. IV antibiotics were started. He had been on a steroid course from his pervious hospitalization for COVID pneumonia and that course was continued on this admission until 10 day completion. Throughout his hospital course Pt's respiratory status continued to decline despite proper interventions. Repeat imaging showed a right pleural effusion. The patient was diuresed. Pulmonology was consulted and recommended against a thoracentesis as there would be low benefits and high risks involved. His DDimer continued to increase despite receiving apixaban. The patient was transferred to PCU for higher level of care. His blood glucose remained elevated since admissions, despite finishing his course of steroids and he required a insulin drip. On 11/8/21 the insulin drip was discontinued due to low blood sugar levels and which improved with some orange juice. Rapid response was called overnight due to lower O2 levels and patient exhibiting altered mental status. Patient had taken his high flow off and became hypoxic and unresponsive. He was placed on bipap and he improved. Today 11/08/2021 the patient expressed desire to be transitioned to comfort care and his wife was contacted and both agreed to this plan. He remained in his full capacity to make decisions.  The patient was placed on fentaly and orders were adjusted to reflect comfort care measures. His wife was able to make it to the hospital to be by his side, as bipap was removed and he was kept comfortable until he passed. The patient expired on 1047 on 11/08/2021. Cause of death was COVID pneumonia. The family does not wish to pursue an autopsy."
ITP per heme/onc provider.  Received dexamethasone 40 mg po daily x4 doses from 8/26 to 8/29
Acute respiratory failure, pleural effusion (1.5L removed), heart failure, new onset atrial fibrillation, normal WBC (no sepsis), echo 2 weeks prior to event showed normal LV function with EF of 60%
She got her vaccine, within the first 24 hours her feet went completely numb and can't feel them at all, and now the numbness have traveled up her legs and she is unable to balance due to the weakness.  She went to her PCP on 5/6 and then went to an orthopedist twice as they felt it may be a compressed vertebra, chiropractor and is scheduled to a neurologist in July.  She cannot walk a straight line and leads a very active life, has horses and not able to care for them at this time as she is "completely useless", cannot stand on her feet, cook or anything due to this debility.   She was already having problems from the first vaccine, and now has gotten progressively worse every day and since the 2nd vaccine.  Her feet are cold to touch where they weren't before.   Her PCP said that there was nothing else she could do for her and told her to contact us to report her symptoms.
with second dose of COVID19 vaccine he had a little fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 84 year-old male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9266, Expiration Date: May2021) at the age of 83 years as dose 2, single for covid-19 immunisation. Family history included: "Pacemaker" (ongoing), notes: he has had the pacemaker for several years, maybe 2 to 3 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9262. Expiry: May2021.), administration date: 21Jan2021, when the patient was 83 years old, for Covid-19 Immunization, reaction(s): "He didn't have anything with the first dose of COVID19 vaccine". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "with second dose of COVID19 vaccine he had a little fever".  Additional information: The patient's grandmother may have had some problems a long time ago, but caller did not know much about that because his grandmother died before he was involved with the family. Additional vaccines administered on same date of the Pfizer suspect was none.  Follow-up attempts are completed. No further information is expected.
Vaccine triggered what was peripheral neuropathy in both legs, into ANTI MAG NEUROPAHTY indicated by demylination of leg nerves, difficulty walking, balance, strength. Situation still continues. Was coping fine with regular neuropathy until this shift to autoimmune status and more severe symptoms
TC from mom 28AUG96 stating that pt had a temp of 103 2 days p/vax 20AUG6'pt also has been listless, not sleeping much & wakes up screaming for the past week;mom hopes to get in to see pt MD today;
I received the Johnson & Johnson vaccine 03/21 & wanted to get the booster.  I received the Pfizer vaccine on Friday 11/5 around 4:00pm.  Soon after I noticed my neck was itchy.  As the evening went on, I noticed that I had a rash on my neck.  It was very itchy & red.  I was concerned as that was not listed as a common symptom & contacted the on call nurse for my GP's office.  She said  she was not too concerned unless it turned into hives &/or I had trouble breathing.  It had spread a little further up my neck & the tops of my shoulders by the next day.  It is now 4 days later, & it's still there & a bit itchy but not as bad as it was before.  On Saturday I also had some body aches in my upper back & was more tired most of the day.  That was better the next day.
Having fever, muscle aches, weakness (L) arm pain. No redness Tylenol and rest.
After taking with an agent at V-Safe, they advised I report a breakthrough case of COVID.  I was extremely ill with a high fever (102) for 3 days, cough, body aches and lethargy and head congestion which led to an intense sinus infection and extreme headache pain that lasted for two weeks.  I also had loss of taste and smell.  My PCP prescribed an antibiotic to clear up the sinus infection.
C/O- Hot flashes, voice went away for a second, "There's something in my throat," palpitation. No s/s airway obstruction, states feeling went away in a few minutes.  SaO2 RA = 100%  Action- Monitored in OBS area, released after 30 minutes with no complaints
Patient got a red half-dollar sized mark at injection site; she stated it was warm to touch and itchy. She came back the following day and the redness reduced significantly but the red area increased in size w/o itching. Not warm.
Patient had a vasovagal episode post vaccination. Patient appeared with feeling of dizziness, no paleness, alert and oriented. Patient was by himself   Patient was instructed to lie down and elevate his leg. Patient was given  Water, crackers. Outcome: Patient recovered without difficulties Patient educated about ER precaution. Patient acknowledged understanding. Patient has recovered and was observed for additional 15 minuttes.  Patient left observation.  Vital Signs: @ 8:40 Blood Pressure: 100/ Pulse: 54 O2: 98% room air  Vital Signs: @ 8:43 Blood Pressure: 120/78 Pulse: 60 O2: 100% room air   Vital Signs: @ 8:45 Blood Pressure: 121/80 Pulse: 62 O2: 98% room air
Generalized myalgias, worse in legs. Flu symptoms x4 days. Myalgias persisted x 4 weeks.
I  got the common cold,  runny nose, congestion..I NEVER had a cold in over 5 years before I got this stinking booster. I NEVER got sick.. I have had the COLD  5 times since the booster..1/14,1/31,2/30/3/27/and 4/27.. I didnt go to the dr  it is the common cold ..they can't do anything for the common cold.. I had runny nose, congestion in head and chest..They all lasted about 10 days.. I wish now I had NOT got the booster.   I took  like claritinD and cough drops  and it ran its course,..
COVID-19 Breakthrough case. 8/20/21: Patient states he has had COVID like symptoms for almost 2 weeks now and had an outpatient positive COVID test 9 days ago on 8/11/2021.  He states he has had symptoms of a productive cough, worsening shortness of breath, chest congestion, some diarrhea, subjective fevers and chills that have now resolved.  He states at baseline he has some shortness of breath but since testing positive for COVID, SOB has been worse than his baseline. He states he had a Regeneron treatment 2 days ago but does not believe his symptoms are any better.   Admitted 8/20/21. Note: previously received Moderna COVID-19 vaccines on 12/29/21 & 1/26/21. Diagnosed with ARDS, acute hypoxic respiratory failure, Covid-19 viral pneumonia and sepsis. Condition deteriorated and patient died on 8/29/21.
SOB    Source of Information:  Patient   History of Present Illness:  This is a 59y.o. female with a past medical history of hypertension, type 2 diabetes, history of PE, IBS and morbid obesity who presents with shortness of breath and wheezing.  She started to have the symptoms 1/10 and her husband and son tested positive for COVID.  She was diagnosed with COVID /16.  She was hypoxic on arrival at 88% and required 2 L of oxygen.  Patient states that she was also experiencing orthopnea and lower extremity edema.  She does not know any chest pain, nausea, palpitations.