chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US015874 is an initial spontaneous report from a nurse received on 06 Aug 2014 with a follow up report received from another nurse on 16 Sep 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. On 06 Aug 2014, she was vaccinated with an initial application of MENVEO (batch number: M14022/A14022) at a dose of 0.5 ml intramuscularly where MenA lyophilized conjugate component was not mixed with proper diluent (MenCWY). Rather it was reconstituted with sterile water. No adverse event was reported following this medication error (wrong solution used in drug reconstitution). It was reported that patient would return for revaccination. Follow up report received from the nurse on 16 Sep 2014: Updated patient demographics (height and weight), updated alternative batch number (A14022) and added reporter's statement regarding revaccination.
Within a few house of receiving vaccine, patient states that arm became fiery red and feverish so bad that she iced her arm. It also was swollen and extremely sensitive to touch (didn't even want her sleeve to touch it) which lasted for 3 weeks. Eventually her arm began to itch and lasted for about a week. There is still a noticeable knot in her arm by sight and touch.
on 2/27 patient's wife called and stated that he had fatigue, body aches, low grade fever, and poor appetite.  on 3/4, patient's wife called and stated he had some shortness of breath and extreme fatigue.  on the evening of 3/4,  he experienced sharp back pain and shortness of breath and was taken by ambulance to the hospital, where he was diagnosed with CHF exacerbation and NSTEMI and worsening CKD.   he developed cardiogenic shock and renal failure.  on 3/10 he was started on milrinone, then on 3/11 he went into pulseless VT and expired.
DONOR WAS WAITING REQUIRED 15 MIN POST IMMUNIZATION PERIOD WHEN APPEARED PALE AND DIAPHORETIC, SKIN WAS COOL TO TOUCH. DONOR HAD LOC OF APPROX 10 SECS. DONOR ASSISTED INTO RECLINING POSITION ICE PACKS APPLIED TO CHEST AND NECK, AND FEET ELEVATED. VS TAKEN PRIOR TO IMMUNIZATION, DURING REACTION AND PRIOR TO RELEASE ALL WNL. DONOR RECOVERED QUICKLY. GIVEN CRACKERS AND H2O AFTER A&O x3. TOTAL APPROX TIME OF REACTION EVENT 20 MIN FROM ONSET TO RECOVERY/RELEASE.
received J and J vaccine on 03/27/2021 Flight on 04/07/2021 Flight home on 04/11/2021 Calf Pain started on 04/12/2021 + DVT on US 04/16/2021
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/24/2023 Discharge Date: Mar 30, 2023 PRESENTING PROBLEM: Dehydration [E86.0] Hypernatremia [E87.0] Acute cystitis without hematuria [N30.00] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: 54-year-old female past medical history of cerebral palsy, spastic quadriplegia, bipolar disorder, chronic constipation who lives in nursing facility and presented from nursing facility for weakness, fatigue, abnormal labs.  At baseline patient is nonverbal although reported that she can communicate with few words intermittently.  Mother is her guardian.  Patient and mother diagnosed 5 days prior to admission with COVID-19 after developing fevers, fatigue.  In the ER, pt noted to be tachycardic.  Lab significant for sodium 151. COVID-19 +.  KUB showing gas pattern but no obstruction.  UA suggestive of urinary tract infection.  Patient was started IV fluids and IV antibiotic for suspected urinary tract infection and admitted to Medicine.  She was felt to be more confused than baseline feeding diagnosis metabolic encephalopathy.   After admission, sodium did improve IV hydration.  She was on IV Cipro for antibiotic treatment for urinary tract infection.  Urine culture came back showing E coli pan susceptible.  Mental status did improve as well.  She was cleared to have diet by SLP on 03/26.  Pt was continued on bowel regimen as pt has history of constipation and pt with recurrent issues with fecal impaction.  Patient did have bowel distension despite bowel regimen and repeat CT/abdomen performed consistent with proctitis with rectum distended with stool.  GI consulted and recommended Gastrografin enema.  Post Gastrografin enema patient was having good bowel movements with improvement and abdominal distension.  Day discharge patient appeared comfortable.  GI recommends that patient continue with tap water enema scheduled 2 times a day in place of MiraLax.  It is likely that patient is having constipation from her rectum muscles not working well GI recommends that enemas scheduled her best treatment to prevent recurrent impaction.  If patient continues to come back to the hospital for repeat admissions for impaction may need to consider colostomy in the future with Colorectal consult and this was explained to mom.  She was also started on new medication of Linzess and given that this new medication was started does not need to continue with senna.  Sodium normalized by discharge.  To continue with 2 more doses of Cipro to complete 7 days total of urinary tract infection treatment.
I received the shingles vaccine 7-07 and developed shingles exactly at the injection site and then spread down my arm numerous lesions and tremendous pain associated.
Presented to ED on 5/13/21 with trouble breathing, chest pain, back pain and numbness.  Had been exposed to boyfriend with flu like symptoms 3 weeks prior and had had some symptoms around that time but had been improved. SARS-CoV-2 PCR negative in ED. patient afebrile but workup in ED revealed troponin of 0.71, no EKG changes. Symptoms resolved in ED but given troponin was admitted to the hospital for further evaluation. Echo performed and normal. Troponin trended in hospital and patient discharged without events.
12:16 shot.          12:30.    15 minutes after shot Heart racing, body tingling, light headed, dizzy.       2:30 same symptoms plus face tight, lips and tongue tingling , tongue swollen, body numb 3:30 same symptoms plus head is hot 4:30 same symptoms plus chest pains 24 hours after shot - most other symptoms  are gone. Now fever 100 degrees and body aches, headache
stiff neck; 2-3 days after second dose, aching; pain at the base of my skull; radiated out to my shoulders; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (2-3 days after second dose, aching), HEADACHE (pain at the base of my skull) and ARTHRALGIA (radiated out to my shoulders) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (2-3 days after second dose, aching), HEADACHE (pain at the base of my skull) and ARTHRALGIA (radiated out to my shoulders). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (2-3 days after second dose, aching), HEADACHE (pain at the base of my skull) and ARTHRALGIA (radiated out to my shoulders) had resolved.            No treatment medication was reported. No Concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-377139 (E2B Linked Report). This case was linked to MOD-2021-377123 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-377139:Dose 3 case
pt recv vax 23JUN by 24-36hr had neck pain, severe h/a not relieved by advil or APAP;48hr fever 102.6 & severe chills & mild dizziness starting improving;mild encephalitis or meningitis;sx consistent w/rare occurrence described on package
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Amoxicillin), fish allergy, shell fish allergy, and asthma. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 for prophylactic vaccination. Age at time of vaccination 26 years old. Concomitant medications included beclometasone dipropionate, and venlafaxine. The patient additionally received booster dose with non-company suspect vaccine Spikevax (elasomeran) (Dose number in series 2) (form of admin and route of admin not reported, batch number: 023C21A expiry: Unknown) dose was not reported, administered in left arm on 14-DEC-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. On 30-MAY-2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 1) and confirmed covid-19 infection (Dose number in series 2). The patient reported that, she tested negative on 27-MAY-2022 and was feeling better. On the same day at night, the patient started having runny nose and on 31-MAY-2022, she tested positive again. On 27-MAY-2022, Laboratory data included: COVID-19 virus test Negative. On 31-MAY-2022, Laboratory data included: COVID-19 virus test Positive. The patient took Paxlovid from 21-MAY-2022 to 26-MAY-2022 for Covid-19 treatment. The patient thought it was the Paxlovid rebound. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and confirmed clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000235165.; Sender's Comments: V0. 20220617357-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
pt called on 10/23/20 to report that she has been diagnosed with a hematoma at the injection site and stated that the pain and difficulty in using the arm started approx. 1 week after injection (received vaccine on 10/1/2020)
a dose of Fluzone Quadrivalent given to a patient from a shipment that arrived late, No AE; a dose of Fluzone Quadrivalent given to a patient from a shipment that arrived late, No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via phone.  This case involves an INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] which had temperature excursion as its shipment arrived late hence not viable to use and a six months old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of this vaccine (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was an actual medication error case due to incorrect product storage.  It was a case of Product shipment delay.  No adverse event reported at the time of reporting.  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.  There will be no information available on the batch number for this case.
Vomiting, with no associated fever, headache, nausea or chills.  Also decreased appetite.
There was no adverse event involved. only a series of moderate side effects that went on for about 8 days. My father received his first dose on 1/21 after 3 days on Sunday evening of 1/24 he started chills and fever till 1/31. He experienced persistent fever as high as 104.7 even 105 at one point followed by fatigue and body-ache. He no longer had any fever on 2/1, just mostly fatigue and not having much energy and also couple episodes of coughs. As of 2/2 he is doing much better looks to be fully recovering. I wanted to know if you would advise if he should get his second shot as well.
Papular pruritic rash on torso and extremities that started ~1week after the injection
Maculopapular pink rash on ant & post trunk; both arms & a few areas in scalp. Started 10/16 - took BENADRYL 25 & hydrocort. cream. Recur 10/18 given BENADRYL & PEPCID & hydrocort. cream - sent to PCP.
The pt experienced redness and swelling at the site of injection. The reaction started within 1-2 minutes of receiving vax. Treated with cold packs to the site. The pt was monitored for 15 minutes. and the pt's condition had resolved at 75% when they left the clinic.
SORE ARM; NAUSEA; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, mental health, penicillin allergy, and sulfa allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, chills, and fatigue on 06-MAR-2021, was recovering from fever, and had not recovered from sore arm, and headache. This report was non-serious.
On day 9 post injection I developed itching at the injection site. On day 10 I developed a red bump that is the size of a nickel and painful to touch and still itchy.
very amped up and could not lie down or sit down; feels like his blood pressure was raised like racing inside; very amped up and could not lie down or sit down; massive migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jul2021 10:00 (Lot number: EW0217) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 16Jul2021, outcome "recovered" (17Jul2021), described as "massive migraine"; AGITATION (non-serious) with onset 16Jul2021 10:30, outcome "recovered" (16Jul2021), BLOOD PRESSURE INCREASED (non-serious) with onset 16Jul2021, outcome "recovered" (17Jul2021) and all described as "feels like his blood pressure was raised like racing inside"; MOVEMENT DISORDER (non-serious) with onset 16Jul2021, outcome "recovered" (16Jul2021), described as "very amped up and could not lie down or sit down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine. No follow-up attempts are possible. No further information is expected.
Patient received a dose from a vial that had been used on a previous day. The vial used was actually pulled from the fridge and doses were withdrawn on 9/24/22. The vial was not appropriately  disposed of at that time. The technician then thought the vial was pulled for doses to be given on 9/26/22, but it was the vial from 9/24/22. Once this was discovered the patient received a dose from a new vial in  her opposite arm's deltoid.
8-31-18 9:00 p.m. headache, shivers, chills, slight nausea. 9-1-18 1:30 a.m. headache, shivers, chills, slight nausea. 9-1-18  7:00 a.m. dizzy, headache, weakness, slight nausea; fainted. 10-3-18 weakness continues.
Patient got Moderna COVID-19 vaccine dose #1. Few minutes later, she was not feeling well. She indicated she was feeling uneasy and hot. I advised her to lay down on the bench and put her feet up. At that point, we checked her BP. It was 77/47. Then we gave her ice packs to put on her cheek and feet. She said that ice packs are helping her. We took second BP reading and it was 99/60. We also took a 3rd BP reading 5 minutes later and it was 108/79. At this point, she was feeling lot better. We asked her to stay under our observation for additional 30 minutes, which she did. She indicated she does not have PCP.
Dizziness, Headache, Myalgia, Arthralgia & Fever Narrative: Ill and unable to work 03/02/21 3/1-chills, a headache and body ache took naproxen. 3/2-dizzy; chills; bodyache; ha; fatigue 3/3-ha ; fatigue  Other Relevant History:
8-24-12 Child received DTaP, IPV, MMR et Varicella required for school attendance. 9-9 or 9-10 Presented to ER with fever. Eval. 9-10 Returned to ER. Fever cont. to spike to 104 degrees. Admit. Elevated WBC et fever spikes thru 9-13-12. 10-1-12 Pt remained in hosp 1 week. Dx Pneumonia et ear infection. Resolved et child is back to school.
Shingle Shot hurts like hell; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported. The age at vaccination was unknown. The patient reported that the shingles shot hurt like hell. The follow-up would not possible as no contact details were available.
Patient was given pentacel, hep B, rota and prevnar--3 days later had bruising and petechiae with plts of 4 consistent with ITP.
HYPOXIA 11/17/2022 ADULT OBSTRUCTIVE SLEEP APNEA  HYPOXIA 11/17/2022 EMPHYSEMA  HYPOXIA 11/17/2022 ADULT OBSTRUCTIVE SLEEP APNEA
This case was reported by a pharmacist via other manufacturer and described the occurrence of fatigue in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue and pain in arm. On an unknown date, the outcome of the fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The patients were of age 65 or older than that. The pharmacist reported that, many patients had adverse reactions after receiving SHINGRIX, that was fatigue and soreness in entire arm for several days. These side effects were often prevent patients from wanting to get more than one vaccine on same day, even when eligible for both.
Initial unsolicited report received from a nurse on 15 October 2015. This case was linked with 2015SA164323 and 2015SA165706. This case involves a patient (age, gender not reported), who was vaccinated with first dose of FLUZONE QIV (batch number: UI444AB expiry date: 30 June 2016) (dose and site of administration was not reported) via intramuscular route on 14 October 2015. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medication was not reported. On 14 October 2015, few hours after vaccination, patient experienced larger local reaction which was greater than 5 inches. It was reported that patient required ER/doctor visit. No laboratory investigations were performed and patient was requested to be reviewed by the primary care doctor and considered antibiotics as corrective treatment. At the time of this report, patient had not recovered from the events. Documents held by sender: none.
We are not sure whether this is related to vaccine or not. After 6 days of taking the vaccine, he started having a tummy ache every time after he eats. The stomach ache lasts for 2-3 hours after eating and then it subsides down until next meal. During this 2-3 hours of pain, initially he was feeling nausea, but never vomited. We have taken him to ER and PCP regarding this pain as the pain was severe and they could not conclude anything. They did do sonogram but could not find anything. Doctors suggested him to take Nexium and he is on it right now. Pain is subsiding a little but it is still there.
Initial report was received on 02 October 2012 from a consumer who is also the patient. A female patient had received an INFLUENZA vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, became "very ill". The patient reported she had nausea, vomiting, loss of weight and was unable to get out of bed for days. She reported she started to feel better in April of 2011 but was only able to be out of bed for short periods of time. According to the reporter, the patient continued to have asthma type symptoms which included wheezing and chest congestion. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
dizzy; feeling weak; fell down on her bed after getting up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (feeling weak) and FALL (fell down on her bed after getting up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and ATORVASTATIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (feeling weak) and FALL (fell down on her bed after getting up). At the time of the report, DIZZINESS (dizzy), ASTHENIA (feeling weak) and FALL (fell down on her bed after getting up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
There was not an adverse event reported yet, but I administered 0.6 mls instead of 0.3 mls which is the correct dose. I have called and advised the patient of the potential for increased risk of side effects.
covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid".  Clinical course: Patient reported that her first covid vaccines were Pfizer. She got covid but she did not end up in the hospital. She was attribute that to her vaccine. The reporter consider event as caused by suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.