chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/17/2021: Pt tested positive for COVID. Pt requiring supplemental O2 of 2L continue as tolerated. Will begin Decadron. Outside window for remdesivir. Complains of generalized weakness. 12/18/2021: Pt deferred for remdesivir given GFR at 30. will consider once GFR improves 12/19/2021: Pt increased to 3L of supplemental oxygen wean as tolerated. Continue Dexa 12/20-12/21: Continue Dexa. Remdesivir not indicated since pt is off of supplemental oxygen  12/22/2021: Pt discharged with dexamethasone 6mg tab - 1 tab PO daily for 5 days.
Chills, Muscle Aches, Body Aches, Headache - Onset January 19, 2021 @ approx. 7:00 pm until early morning of January 21, 2021.  Rash on right arm  - same location as vaccine - Onset January 28, 2021 @ 5:00 am until early morning of January 30, 2021.
Thoughts suddenly disjointed, similar to disorganized thinking in a period of psychosis. This has lasted for 4+ months, since about two days after my vaccine. I have started a new antipsychotic in hopes that this will clear up this cognitive issue. I have been on the new antipsychotic for 1 week with no changes in thinking. This pattern of disorganized thinking is different than any side effect or symptom of any illness I have ever experienced. My thoughts seem completely unrelated to each other and constantly jumbled, unless I am focusing very hard on thinking straight.
This spontaneous report was received from a healthcare worker. The reporter informed that an unknown number of patients (no details provided) had been vaccinated with improperly stored GARDASIL (lot number, dose, dose number and route not reported). The vaccines were exposed to 30 degrees Fahrenheit for 15 hours. No adverse effect reported. This case is linked to case reports 1210USA010300 and 1210USA010301 (same reporter; same medication error reported for other vaccines). Additional information has been requested.
only the diluent administered not mixed; only the diluent administered not mixed; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that the patient received adjuvant only and not the active component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The mistake was realized, and the correct formulation was re administered on the same day. The reporter did not consent to follow up. This case is linked to case US2021AMR189327 reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR189327:Same reporter
pt recv vax & w/in 12hr exp hives all over;pt seen by MD & was given DPH;hives resolved w/in several days;
Immediately after vaccination, the patient began complaining of pain and soreness at the injection site ("more than any other injections" she'd received).  She was advised to stay in the store for a few minutes.  This was her first flu shot.  About 15 to 20 minutes later, the patient came back to the pharmacy complaining of arm coldness and a feeling of the "circulation being cut off."  She also said her back was itching.  I took her blood pressure (133/81 with pulse 96).  This was most likely due to anxiety over getting the shot.  I told her it was probably okay to just wait and monitor the condition.  However, I also told her to possibly seek medical treatment as this was her first flu shot and she was pregnant.  That would maybe provide peace of mind.  There were no signs of anaphylaxis at any time I saw the patient.  The patient said she'd probably call her OB.
Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-Jun-2023 This case was reported the patient via interactive digital media. The patient got the shot and two years later, got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Generalized aching, congestion, hoarseness, headache developed 3rd day post immun. Did not take temp; Had congestion & Cough 3DEC90. Encouraged inc rest, good diet; vit/min supplement.
Shingles on right hip, rashes on body (hives), welts on body that turned into scabby red sores.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
pt was anxious to get shot. first time getting flu shot without parents present. was very agitated and anxious while i was giving shot. after shot pt got up and collapse and "blacked out". regain consicinous in a less than a minute. was sweaty. most likely a panic attacked related to shot. EMT did come and evaluated him. let him go on his own accord.
Pt. was administered a pediatric dose of Hep. B vaccine (Engerix-B) 10 mcg/0.5ml on 6/18/2007 instead of an adult dose No adverse events noted
Pt was witnessed starting to fall to the right out of her chair in the waiting room immediately after receiving injection. Transferred pt to urgent care for further evaluation. Pt c/o HA, neuro exam WNL. No bruising or edema noted on head. Superficial abraision (R) elbow. Sent for CT scan of head = negative.
Fever and chills, tiredness, headache for first 36 hours.  Rash in arms started on Sunday 10/31/2021 around 09:00 AM.
Pfizer was left out to thaw for more than 2 hours(1pm - 4pm), mixed at 4pm, then administered dose.
after i sneezed friday morning i lost all sight in my right eye.   the emergency room did not know what was wrong and i see a eye specialist on monday.
eye is still burning; pharmacists that squirted some of the Pfizer BioNTech Covid 19 vaccine in his eye; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE IRRITATION (non-serious), outcome "not recovered", described as "eye is still burning"; OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "pharmacists that squirted some of the Pfizer BioNTech Covid 19 vaccine in his eye". Therapeutic measures were taken as a result of eye irritation, occupational exposure to product.  Additional information:Clinical Pharmacy Specialist is calling on behalf of one of her pharmacists that squirted some of the Pfizer BioNTech Covid 19 vaccine in his eye.  The pharmacist reconstituted the vaccine and he used the negative pressure technique but the vial kind of exploded.  He did a water bath and she suggested he do another but the eye is still burning just a little bit.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has had symptoms that come and go beginning the day after the vaccine. Sore arm, shoulder pain, fever, chills, aching, nausea/vomiting. These symptoms have been going on for 2 weeks.
This spontaneous report as received from a healthcare worker refers to a 9 month old patient. On an unknown date in February 2013, when the patient was 9 months old was mistakenly administered a dose of VAQTA (dose, route and frequency were not reported). It was reported that the patient was now 2 years old. No adverse effects reported. No further information was provided. Additional information is not expected.
Case number PHEH2014US022984 is an initial spontaneous report received from a nurse on 13 NOV 2014. This report refers to an 18 year old male patient. His past medical and concomitant medications were not reported. On 12 NOV 2014, he was vaccinated with MENVEO (batch number: A14071) intramuscularly. On the same day after the vaccination, he developed fever, muscle aches and had dizziness. The outcome, seriousness and causality of the events was not reported.
This spontaneous report as received from a nurse refers to an 11 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
On Sunday afternoon 5/2/21 patient had black looking, bruised looking puffiness below eyes.  Hot to touch at cheek bones.  Eye issue mostly gone, but still somewhat there.  Cheek bone issue resolved by Monday morning.
Stomach Ache; feel really sick; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Ache), MALAISE (feel really sick) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache), MALAISE (feel really sick) and HEADACHE (Headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Ache), MALAISE (feel really sick) and HEADACHE (Headache) outcome was unknown.            No concomitant product was reported. No treatment was reported. Patient got second dose and have feel really sick.   Reporter did not allow further contact
considerable pain in the left at muscle; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received on an unknown date , refer linked case US2020AMR015711).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On 27th January 2020, less than a day after receiving Shingrix, the patient experienced muscle pain. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient experienced pain in the left at muscle after receiving 2nd dose of Shingrix, which was not relieved with Tylenol.
1st shot: Chest pain, pain from arm to lower neck, headache.  2nd shot:  Chest Painober heart, coughing from shortness of breath, pain at injection site, couldn?t lay down flat to sleep the first two nights due to shortness of breath
LVL=8.25cm x 8.89 red, warm to touch, & itchy, irritated RVL= 1.9cm x 1.27 red, irritated
Information has been received from a physician concerning a male who on approximately 24-MaR-2007 was vaccinated PO with the first dose of rotavirus vaccine (human-bovine) (Lot # 656193/0023U). In 2007, the patient developed a week of diarrhea mucous in stool. The patient also developed two days of vomiting. Unspecified medical attention was sought and fluids were administered. The patient recovered. Additional information has been requested.
Information has been received from a physician concerning a 10 year old male who was vaccinated SC with a second 0.5 ml dose of varicella virus vaccine live (lot 652725/0249F). Concomitant vaccination included a dose of diphtheria toxoid + pertussis acellular 3 component vaccine + tetanus toxoid (Boostrix). On 8/9/2006 the pt developed redness and localized swelling and a localized feeling of heat. Unspecified medical attention was sought. The office recommended that the pt take Benadryl. At the time of this report, the pt was recovering. No product quality complaint was involved. The reporter considered the pts adverse experienced to be other important medical events (OMIC). Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in right arm 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 "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The Anti-viral with Paxlovid started on 20May2022 till 25May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea; Headache; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4097881-00.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at weekly (unk, weekly) for posterior segment of eye anomaly, uveitis, psoriasis, colitis ulcerative. Relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing); "non-infectious intermediate posterior" (unspecified if ongoing); "panuveitis" (unspecified if ongoing); "moderate to severe chronic plaque psoriasis" (unspecified if ongoing); "moderate to severe ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. On 01Mar2021, she received first dose COVID 19 Vaccine manufactured by Pfizer Biontech), administration date: 01Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "upset stomach"; Bnt162b2 (In Mar2021, the patient experienced first vaccine caused upset stomach, headache and fever), administration date: Mar2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "headache"; Bnt162b2, administration date: Mar2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "fever". The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Diarrhea". The action taken for adalimumab was dosage permanently withdrawn.  Additional information: The causality for BNT162B2 was reported as possible for all the events and the causality for Humira was not reported for any of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticarial rash covering (R) leg and left buttocks. Treated w/BENADRYL.
Pt got MENACTRA and then at around 8pm that night his arm started aching then later started itching. On 6/23/17 he came in and his scan had swelling, itching, redness and it hurt. Localized allergic reaction.
patient complained of headache and chest pain, patient went unconscious for 5 minutes, ambulatory care
A healthcare professional reported that a 4 month old male received a dose of Hib-TITER, Pneumovax 23, DTaP, and IPV vaccines on 10/14/02. That same day, the patient developed a fever and an unspecified injection site reaction. The events were managed with Motrin (ibuprofen), Tylenol (acetaminophen), and cold compresses. It was also noted that the child was inadvertently administered Pneumovax 23 instead of Prevnar.
swollen at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). At the time of the report, VACCINATION SITE SWELLING (swollen at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Had muscle and joint pain and low fever for 2 days after vaccination. Stayed in bed. 4 days after vaccination a bubble the size of 3/4 of a golf ball popped up on the tip of my left elbow, Olecranon Bursitis. The pain was minimal but I could not put the elbow on a table or the arm of a chair without sudden pain. Bubble stayed the same for 4 weeks and then slowly went down over 10 days. Elbow is still sore when hit or put on a table. Got vaccinated 2nd time in the right arm on 02/22/2021. Right knee started hurting after 4 days. Could only walk by keeping the leg straight. Went away as suddenly as it came after 4 days.
6hr p/shot appetite dec, confused, to bed-lethargic;calling milk "orchard";next AM daughter wnt to pt room had snipped a linen into pieces;incontinent, t101;ached all over especially ribs;dec energy;slept a lot;advised to see MD;
On July 1st it started with a sore throat. Then I just remember congestion and cough after that. By the 3rd I had a fever.  On July 3rd I tested positive. For two or three days I had a fever and chills and fatigue and congestion with cough. I was pretty much laying down from the 3rd to the 8th or 9th from fatigue. I tested negative on the 10th. But I continued to have fatigue for two more weeks. And still today, I continue to have chest congestion with cough. My doctor prescribed cough medicine (Vensonatate) and sent me for a chest X-Ray.
Patient received a ZOSTAVAX vaccine 5/31, came to pharmacy 6/2 with a baseball-sized, red, rash-like patch that was warm. No pain or fever reported. MD suggested cold compresses and ibuprofen. Pt told to call office Monday AM.
Discharge Provider: DO Primary Care Provider at Discharge: PA-C Admission Date: 7/9/2023 Discharge Date: 7/11/2023   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Nausea [R11.0] Weakness [R53.1] SIRS (systemic inflammatory response syndrome) [R65.10] Acute cystitis without hematuria [N30.00] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 80 year old female who lives at home with her son presented to emergency room for generalized weakness, fatigue, fever and nausea.  She has a medical history of asthma, hypothyroidism, hyperlipidemia, anemia and congestive heart failure. On 7/4 she took a home COVID testing was positive she was complaining of fatigue and loss of appetite and was seen in the emergency room and discharged home.  She has fell worsening fatigue and weakness since.  Over the past couple days she has developed nausea with dry heaves and a fever.  The day of arrival she felt so weak that she collapsed, denies injury.  On arrival to the emergency department, she was febrile left with her other vital signs stable.  CMP and CBC were unremarkable.  Procalcitonin was negative.  No lactic acidosis.  UA with infection, urine culture was sent.  EKG with right bundle-branch block without ST changes.  CXR negative for acute findings.  Patient started on Rocephin.  She received Protonix, Zofran, and 1 L of IV normal saline.  Patient is under not feel comfortable with her coming home do to her weakness.  Patient was accepted different Hospital service.  Seems improved markedly.  She had no more shortness of breath or cough.  No dysuria or urgency or back pain.  Urine cultures came back negative.  Laboratory studies stabilized.  She was seen the day of discharge doing well and subsequently discharged home.  Since she is 7 days postop diagnosis for COVID and asymptomatic she can go home without need for ongoing strict isolation.  She was counseled on post COVID care as well as good hand washing and hygiene issues.  We will continue her on cefdinir for total of 5 days of therapy.  She will receive 300 mg twice a day for 3 more days.  She could return to the rest her medications as previously ordered.  She could return to diet and activity as tolerated.  She was given a note to return to work on 07/12/2023 per her request.  She understood her instructions and was discharged home in stable condition.   36 minutes was spent in discharging this patient over 50 percent of which entailed direct face-to-face counseling and coordination of care.
sore arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-547542, MOD-2022-547671 (Patient Link).