chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MENQUADFI that were administered in August were administered in error again yesterday with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 13 years old male patient to whom menquadfi that were administered in august were administered in error again yesterday with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; and varicella zoster vaccine (varicella zoster vaccine) for Prophylactic vaccination.  On 16-Aug-2022, the patient received suspect meningococcal a-c-y-w135 (t conj) vaccine at a dose of 0.5 ml (batch number: U7450AB) via intramuscular route in unknown administration site for Immunization 1 other doses were administered on unknown dates for suspect.  On 12-Dec-2022 the patient diagnosed with a non-serious event of menquadfi that were administered in august were administered in error again yesterday with no reported adverse event (inappropriate schedule of product administration) 3 months 27 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
Patient had itchiness, rash and redness in the arm in 3 places in the arm that she received the vaccine.  Shot was given 11:55am, itchiness started at 12:10pm, admininstered #2 25mg capsules at 12:15pm, checked on pt at 12:23pm symptoms not worsening, 12:30pm still itchy, but getting better, 12:45pm no itchiness, redness was gone,  no breathing issues through out whole time
Circular patch that was red and itchy.   Somewhat swollen and tender with a slight rash.    2 days later the swelling and tenderness had gone away but the rash remained and the redness spread as if disipating.
This is a spontaneous report from non-contactable physician via Pfizer Sales Representative. A patient of unspecified age and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's concomitant medications were not reported. The patient was post partum and supposedly received the vaccine at another office. The patient developed cellulitis on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, vaccination details and event term descriptions including onset date and location of cellulitis. 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.
pt recvd 2nd dose of vax 24JUN92 & on 26JUN92 heavy vaginal bleeding;
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX. On 12th March 2019, 3 hrs after receiving SHINGRIX, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: On 12th March 2019, about 3 hours after receiving the SHINGRIX, the patient begun to experience muscle aches and fatigue. The reporter did not consent to follow-up.
On the 26th I was having a cough, which turned into a hoarse voice and then I started having a sore throat and it moved down to my chest. By Saturday it was very bad and Sunday was worse. I was coughing up brown liquids and I was congested with a green drainage and I was constantly coughing and congested. It was so bad that and it moved into my nose. I was bed ridden from May 31st until the 6th.
Administered expired havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number 94j24, expiry date 26th September 2021) for prophylaxis.   On 30th September 2021, the patient received Havrix. On 30th September 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient was administered havrix that was expired on 26th September 2021.  The patient was administered on the 30th September 2021. The reporter was consented to follow up. This case has been linked with the case US2021221679 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221679:Same reporter. Patient 1 of 2.
Improperly adm. seasonal influenza vaccine (too high). Resulted in chemically induced bursitis + physical therapy is in progress.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine expiry date was on 15-Oct-2021. No adverse effects was experienced by the patient. The Moderna vial was removed from the freezer to the refrigerator on 11-Oct-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials.   This case was linked to MOD-2021-355973 (Patient Link).
-Diaphoretic, dizzy. -Brought to medical screening by wheelchair for evaluation. -BP: slightly elevated. -No interventions -Left in stable condition at 10:45 -Recorded by RN Medic:
Reason for Hospital Admission (Admitting Diagnosis):  SOB/Hypoxia/COVID 29 y.o male with no PMHx here with COVID.  See admission H&P for details of his presentation.  History: 29 y.o male with no PMHx who presented to ER with worsening cough, decreasing O2 saturation at home, fevers.  Patient reports that he developed dry cough in the evening of 8/31/2021.  He got tested for COVID at work on 9/1/2021 and the test came back positive.  He has been isolating himself since then at home.  He reports that his cough got worse during the last week and Mucinex, Tessalon Perles and Robitussin have not been helping much.  He reports SOB only when he is having a coughing fit.  Otherwise, denies SOB with ambulation.  No CP.  He was measuring his O2 saturation at home which was around 95% for most of the days but today came back 90-93% on one time check (unclear if patient was coughing at the time).  He also reports fevers up to 101 that started about couple of days ago.  Last time took Tylenol 500 mg at about 2 PM today.  Patient denies any N/V.  He did loose the sense of smell and taste but his appetite has been relatively OK.  He reports some loose stools but no actual diarrhea.  No abdominal pain.   He was asked to do 10 squats in the ER room after which he felt very SOB.  Per patient, has done squats in the past and never felt that SOB when doing them prior to COVID diagnosis.  Per RN documentation, "pt not able to tolerate doing 10 squats in room. Pt desated to 86%RA, RR 42 and HR 137".   Patient lives with his parents and sister who all have been OK and all tested negative for COVID recently.  They have all been vaccinated.  Patient works in School - possibly got sick from one of the kids.   COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 8/31/21. COVID positive on 9/1/21. Last fever on 9/7. - Was on nasal Cannula at 2 Lpm. Still borderline hypoxic with activity but sats fine (>93%) on room air at rest.  Feels ok to go home today.   - Got Decadron and Remdesivir on 9/8 and 9/9.   - Supportive cough medication as needed. - Close outpatient follow up.
About a week or 2 after the second shot I started having shortness of breath every day and tightness in my chest. It feels like a big person has been sitting on my chest. I'm exhausted any time it has been like this. Some days my back has hurt from trying so hard to breathe. I don't have asthma or underlying health problems that I'm aware of. This has been going on consistently since the second shot back in March.
Very bad pain in neck and brest area; Very bad pain in neck and brest area; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 months prior to the reporting date).   On 16th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced neck pain and pain. On an unknown date, the outcome of the neck pain and pain were unknown.   It was unknown if the reporter considered the neck pain and pain to be related to Shingrix.     Additional Information: GSK receipt date: 16-Aug-2022 Reporter's comments: The patient had very painful shingles. The patient received the shot and will receive another one in September. The patient had the shingles 2 months prior to the reporting. The reporter tried to clarify if the patient experienced shingles after 1st dose and he/she stated after but then stated yes, had shingles first.  When reporter again asked if he or she had an episode of shingles after receiving the first dose of Shingrix, he or she stated, no but had Very bad pain in neck and over breast area. The reporter asked for the patient's information, but they did not provide it.  No additional information was provided. The reporter did not consent to follow up. Additional supportive information: Note: No clear information was given regarding event shingle as well at last stated that patient did not had shingle so not code as event.
Vaccine given on 8-25-2010. Mother called 9-7-10 and said her child had broke out in a rash on the following Sunday and running a low grade temp. She the mother said child fussy and sleeping a lot. Appetite still good "patient just not himself".
Patient received her 2nd dose of the Moderna primary series on March 25, 2022 at approximately 1:30pm. On March 26, the patient noted feeling "ill" and with a severe constant headache with fevers. She then noted a raised, red area surrounding the injection site.  She reports the redness and swelling as progressively gotten worse in terms of area increasing as well as firmness of the area and in swelling and redness. Itching and "the sensation of blisters after a burn" were also described by the patient referring to the injection site location. The patient reports taking mild analgesics and Benadryl with no relief. The patient reported her reaction to local health department staff at approximately 10:30 on March 28, after 48 hours of no relief or improvements.
About 1-2 hours after the vaccine, my arm (at site of shot) and shoulder began to hurt - extreme soreness.  After 4 or 5 days the pain at the site went away but the pain in my shoulder/joint of arm has never gone away.  Pain when moving the arm in certain positions.  On a scale of 1-10, 10 being the worst pain, it's a 3 or 4, depending on how the arm is used.  I have not been to my doctor, as I kept thinking it would go away with time.
This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. Age group was captured as adult as per SHINGRIX vaccine indication. The patient received SHINGRIX during the normal course of business. No additional information was provided.
Headache, chills, fever, severe muscle and joint pain in arms, back and legs.
This is a 47y.o. male with pmh of  Hypertension  hyperlipedemia  S/p cholecystectomy 6/21 Present to ed with cc of right sided abdominal pain not associated with nausea or vomiting. When seen in ed patient c/o bout of nausea earlier but no vomiting,point towards epigastric region where the pain starts and goes towards the rt subcostal region,lipase was found to be elevated at 549 and abdominal ct was negative for any acute process. Patient also c/o being hungry and want to know if he can eat  Admits to drinking 2 to 3 times a week and takings ibuprofen on and off for pain. Patient also tested positive for covid and had vaccination and is not time for him to take the booster,no symptoms of cough,sorethroat , fever or chills. No headache or diarrhea.
Pneumonia; Loss of taste; Loss of smell; stared into space for hours; Covid Positive Test; Felt Spacy; Cough; A spontaneous report was received from a consumer concerning a 46 year-old female patient who experienced Covid-19 positive test [COVID-19], felt spacy [dizziness], stared into space for hours [staring], and pneumonia.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 13 Jan 2021, approximately five days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient started experiencing symptoms of coughing.  On 17 Jan 2021, the patient tested positive for Covid-19.  The patient reported she felt spacy and stared into space for hours.  On 19 Jan 2021, the patient experienced symptoms of loss of taste and smell.  On 24 Jan 2021, the patient's oxygen levels were going down.  Treatment for the event of Covid-19 included azithromycin, prednisone, albuterol, and cough medicine.  On 28 Jan 2021, the patient tested positive for pneumonia.  Treatment for the event of pneumonia included levofloxacin.  Action taken with mRNA-1273 in response to the events was unknown.  The event of pneumonia was considered resolved on an unknown date.  The outcome of the event of Covid-19 was unknown.  The events, felt spacy and stared into space for hours, were considered resolved on an unknown date.; Reporter's Comments: Based on the concurrent Covid-19 infection, the events are assessed as unlikely related to mRNA-1273.
This spontaneous report was received from a Certified Medical Assistant referring to an unknown number of patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with incorrectly stored doses of GARDASIL lot # K007828 and expiration date 02-MAR-2017. Dose, route and anatomical location were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Fever of 101.8, joint pain, chills, nausea beginning at 0300 on 01/12/2021 and continuing currently (1/12/2021 1030). Poorly controlled with Motrin and Tylenol every six hours. Symptoms return 3-4 hours after taking medication.
Significant swelling, itching and redness in area of injection site. Progressively got worse over the next week. Itching has remained x10 days.
Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Patient developed an instant whelp and redness appeared at injection site, tingling in her left hand, and her left hand was noticeably colder to the touch than her right hand. Injection site bled significantly.  When administering the vaccine, it appeared like a vein came to the surface when retracting the needle. Patient was held for observation for 15 minutes and no other symptoms appeared.
Rash under her bosom; Tender injection site, Sore injection site; Rash in injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under her bosom), VACCINATION SITE PAIN (Tender injection site, Sore injection site) and VACCINATION SITE RASH (Rash in injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (Rash under her bosom), VACCINATION SITE PAIN (Tender injection site, Sore injection site) and VACCINATION SITE RASH (Rash in injection site). At the time of the report, RASH (Rash under her bosom), VACCINATION SITE PAIN (Tender injection site, Sore injection site) and VACCINATION SITE RASH (Rash in injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Feb2023 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (09Jun2023) positive, notes: testing positive again. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 19May2023 to 24May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Conjunctival edema, upper and lower eyelid edema, erythematous and painful eyes; diffuse muscle, joint and bone pain; bad sciatic nerve distribution pain. Nausea, dizziness, photosensitivity
No symptoms reported. No fuerther AE details; Expired dose administered; Temperature 70F / Time frame 0 Hours 9 minutes 0 Seconds; This spontaneous report was received from pharmacist and refers to a 7-year-old. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 14-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered for prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; therapy type rHa, valid lot number W024548 with an expiration date: 31-JAN-2024 (conflicting information, also reported as it was mentioned that an expired vaccine was administered with an expiry date of 06-JUN-2023)). The administered dose of the vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported.