chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient's parent has been contacted and informed of the vaccine administration error.  Mom reports patient had a sore arm for 1 day after receiving the vaccine. Mom reports no adverse reactions to the vaccine.
Pt had sensation of nausea/no emesis 20-30 mins post vaccine.  Felt lightheaded, felt SOB. Sent to ED-complained of tongue "thickness" no angioedema nor acute respiratory sx noted.  Advised possible vasovagal but to report to CDC.
Redness, swelling at site on left thigh, sore to touch. No fever.
8/2/21 @ 5:30/6am- I had my first drug trip.  I saw freaky things as I was waking up and couldn?t make it stop.  They were frightening images. 1:30pm- I had a very intense hot flash that rose into my body, an anxiety attack came on and confusion took over.  I couldn?t change a doctor appt in my calendar, I had a hard time making a pot of coffee.  It was like there was some disconnect in my brain.  I contacted my doctor because it was so frightening.  7pm- I had a very difficult time reading a bedtime story to my little guy.  Again, a disconnect.    8/3/21- From this point on for the next three weeks I experienced severe anxiety attacks (not normal for me at all) and brain confusion but it was more like a disconnect.  I had trouble reading and putting what I was reading into action.  I have somewhat of a photographic memory and while I could pull up a picture I was unable to zero in on anything in the picture, especially if it was a word.   I was unable to make an appointment at my doctor?s office for these issues.   The anxiety attacks have calmed but I still have trouble reading, though not as bad as the last month.
had the shot / have outbreaks/ suspected vaccination failure; outbreaks; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and still had shingles outbreak. The patient stated he/she that 3 percent that Shingles shot did not work on. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
pt reports about 1hr p/vax lt arm, had swelling of rt ear lobe & then lt lobe;they both became itchy, then lymph nodes below ears became swollen & devel a blister in mouth;DPH was started by MD;devel body aches, chills & sweats, t99.6;
Received DTaP, IPV, hep B on 07/01/02. Noted bumps on 07/05/02 on entire body that started to spread and get larger. No fever reported. No other symptoms. Went to ER on 07/07/02 was given Benadryl.
Patient stated he got the Moderna vaccine on 4-9-21 and next day had the chills, fever, dizzy. He stated his wife and child then tested positive for COVID. He has not tested, Side effects could be COVID or vaccine related.
patient was inadvertently administered a dose of PNEUMOV AX 23 which expired; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 18-MAR-2020, the patient was inadvertently vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot# R007721 which expired on 01-MAR-2020 (dose and route were not provided) for prophylaxis.
pt states that she got the vax that she is in constant pain from her waist down and cannot walk with out a walker.  She has knots in the muscles in her hips and legs.  She has been taking pain relievers for her symptoms and has had diarrhea since she got this vax so is not sure if it is from the vaccine or the medicine.  She went to Hospital ER.  Pt was referred to see her orthopedic surgeon.  Her Orthopedic surgeon took x-rays(negative results) and scheduled her for physical therapy.  She went back to the Hospital ER.  They did a sonogram to rule out blood clots in her legs.  She starts her physical therapy today 4/5/2021.
This spontaneous report as received from a physician via a company representative refers to a 67 year old male patient with anemia, diabetes mellitus and hypertension. No information regarding the patient's medical history or drug reactions and allergies was provided. On 12-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously, lot number reported as K010968, expiration date: 07-NOV-2015, (injection site was not reported). The patient's concomitant medications included unspecified medications for the treatment of diabetes, anemia and hypertension. On 22-OCT-2015, the patient was diagnosed with shingles. The patient sought medical attention via contacting his physician and was given VALTREX and NORCO for the treatment of the event. The outcome of shingles was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
I did get an allergy started from underneath from where tears comes up bottom of eye, eye lid was uncomfortable; I did get an allergy started from underneath from where tears comes up bottom of eye, eye lid was uncomfortable; felt cheek little hard and bone little tougher; An allergy reaction on corner right side of lip that side I received vaccine, not thicker but different; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, in right side, on 18Mar2021, as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, after receiving the COVID vaccine, the patient experienced an allergy it was not severe, was like a mild allergy, started from underneath eye lid, from where the tears come up bottom of eye, and was little like uncomfortable. After 40 minutes taking the vaccine, the corner of right side of lip was like the little, not thicker but, different and then felt cheek a little hard and on cheek bone just like a little tougher. It was reported that, the patient does not know how to explain it. The patient called doctor and she recommended to take Benadryl and she said that was a reaction, because that was not really swollen it was tiny. The patient didn't take anything. The patient woke up on 19Mar2021 (reported as today) in the morning and it was little bit swollen. So, the patient took Benadryl. The patient asked how long this would stay, for how long to be taken the Benadryl. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administered 4 doses of the bivalent booster which were beyond the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     It was unknown if patient ever diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was unknown if patient had any chronic or long standing health conditions.  Concurrent medical conditions included Penicillin allergy (penicillin allergy) and Drug allergy (compazine allergy).    On 06-Feb-2023 at 4:20 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 4 doses of the bivalent booster which were beyond the 30 day BUD).    Concomitant medications details were not reported by the reporter. It was reported that 2 doses were administered on 06-Feb-2023 and 2 doses on 07-Feb-2023. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710235, US-MODERNATX, INC.-MOD-2023-710238, US-MODERNATX, INC.-MOD-2023-710239 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2023: Follow up contains significant information: Patient details added. Medical history added. Suspect product details updated. narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710235:Patient  US-MODERNATX, INC.-MOD-2023-710238:Patient Male US-MODERNATX, INC.-MOD-2023-710239:Patient
Patient was given varicella injection on 03/05/2005 as well as Prevnar, hib, and MMR.  03/14/2005 Patient was seen for temp. 101 and rash on body.  Diagnosed as chicken pox per Physician.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/9/2022 Discharge Date: Oct 20, 2022  PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1] Acute on chronic encephalopathy likely toxic/metabolic in setting of COVID-19 infection exacerbated by underlying dementia HOSPITAL COURSE: Patient is 87-year-old male with the a PMH significant for BPH, hypothyroidism, insomnia and recent declining mentation over the last year is transferred to Hospital on 10/09 due to generalized weakness.  Normally patient is able to ambulate using a walker in his assisted living facility but suddenly was not able to stand up or bear weight and was noted to be more confused and perseverating on certain things.  He was noted to be febrile, tachypneic in ER by chest x-ray was negative.  He tested positive for COVID-19 and was admitted. From a COVID-19 standpoint, patient was neither hypoxic nor had any infiltrates on chest x-ray.  His symptoms of cough and runny nose, unclear date of onset.  After discussion with family, patient will receive 3 day course of remdesivir with close monitoring of  liver function tests. PT/OT evaluated patient and recommended subacute rehab.  He was out of COVID isolation 10/19/22. Patient was discharged in stable condition to SAR.
Admitted on 12/20/13 with markedly weakened feet/ankles and tingling dysesthesia in same. The patient underwent laparoscopic cholecystectomy on 12/12/13 and received influenza vaccination on the same date prior to DC. The patient developed a cough productive of greenish purulent sputum on 12/20. He reports one other member of his family with an acute URI in the home enviornment. Symptoms: and numbness and tingling in feet, inability to stand. Treatment: Globulin, Immune 72 GM every day.
The night she had the injection she developed a rash at the injection site and swelling on the opposite side of her face.  She took Benadryl for about 1 week and symptoms improved but she still had migrating urticaria. Then she was given a prednisone taper and this helped for about a week but then she woke up with hives and rash on multiple areas of her body. She also had swelling that was affecting her face so she went to the ER. She was admitted to the hospital and spent 3 days there.  She was treated with steroids, epinephrine and other allergy medications. She was discharged on a prednisone taper and cetirizine. Her discharge diagnoses were urticarial reaction and erythema multiforme with allergic reaction to immunization.
Fever getting higher for the last two days; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via unspecified route of administration on 16Apr2021, as a single dose for COVID-19 immunisation. Medical history and Concomitant medication were not reported. Patient has had a fever for 6 days in 2021 with it getting higher for the last two days. She has been alternating Tylenol and Ibuprofen. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 17JUN97 & fever present noc a/-temp taken-no fever detected the day of shot 99-100;Motrin given;while sleeping sz  to hosp;dx acute febrile illness/upper resp tract infect, ROM, febrile sz;
injected with Shingrix adjuvant, not the reconstituted product; injected with Shingrix adjuvant, not the reconstituted product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7ta92, expiry date 29-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: injected with SHINGRIX ADJUVANT, not the reconstituted product) and inappropriate dose of vaccine administered (Verbatim: injected with SHINGRIX ADJUVANT, not the reconstituted product). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-NOV-2023 The reporter was health care professional (HCP).   The patient was injected with Shingrix adjuvant, not the reconstituted product (Inappropriate Reconstitution Technique), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
13 days after injection, woke in middle of the night with excruciating pain in left arm, between shoulder and elbow. Pain was a  bit  relieved by sitting up. Not so bad during the day. Pain level at night was a ?8?.  Nighttime pain lasted 5 or 6 nights. A large, hard lump  had developed, about 3? x 1? and was numb. Numbness  a 9 on a scale of 1 to 10, mostly at center of ?lump? or knot. Almost one month later, lump is almost gone, but still numb in that area. I?d say 7 on a scale of 1-10.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported.  No treatment drug was reported.
Local redness, swelling, tenderness. Refuses to bear weight on leg. Fussy. Fever to 102 deg F. Treated for local skin infection with cephalexin starting 6/8/17.
Information has been received from a pharmacy technician concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored unspecified doses of ZOSTAVAX (lot number L040443 with an expiration date of 15-JAN-2017) (strength, dosage schedule, route and anatomical location were not reported). It was also reported that other multiple unspecified patients were vaccinated with VARIVAX (Captured in MARRS# 1610USA004193). No other suspect and concomitant medications were provided. There was no adverse effect reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
headache; Fatigue; Chills; This is a spontaneous report from contactable pharmacist (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 25Feb2021 at 13:45 as single dose for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 on 06Feb2021 at 11:45 AM for covid-19 immunisation. Medical history included Rheumatoid arthritis, HTN, hypothyroidism and Shellfish allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Amlodipine/Valsartan 10/160, Synthroid 150mcg. On 25Feb2021 at 04:45 PM, about 3 hours post second dose developed a headache and fatigue. The following day fatigue persisted and was accompanied by chills that lasted for two days. On the third day post dose, symptoms resolved and felt normal. The patient did not received treatment due to the events. The outcome of all the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Narrative:  82yo male discharged to outpt hospice with discharge diagnosis of Acute on chronic systolic HF exacerbation. on 9/9/2021. Pt died at home in home hospice on 9/12/2021. Pt had one covid vaccine on 3/19/2021. This death is likely not related to the vaccination due to comorbidities, age, and length of time from vaccine administration.
Fever; chills; pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number and Expiry date: unknown) (age at the time of vaccination was 47 years and non-pregnant at the time of vaccination) via an unspecified route of administration, administered in arm right on 29Mar2021 05:00 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included known allergies to codeine from childhood. Concomitant medications included Adderall, Lisinopril, baby aspirin and multivitamin. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in arm right on 08Mar2021 15:00 as DOSE 1, SINGLE for COVID-19 immunisation. On 30Mar2021 10:00 AM, the patient experienced fever, chills and pain for 4 days so far. The patient underwent lab tests and procedures, which included SARS-Cov-2 test showed result negative. The patient received treatment pain shot of Toradol. The patient visited emergency room for the events. The outcome of the events was not resolved.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where shot was given; rapid heartbeat; Lethargic; This is a spontaneous report received from a contactable consumer (reporting himself). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via intramuscular in left arm (left upper arm) on 22Apr2021 at 23:30 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medication included diltiazem hydrochloride tablet; once a day by mouth for High Blood Pressure, Irbesartan/ Hydrochlorot tablet; 300-12.5 mg; frequency as once in a day and route of administration as orally, daily for High Blood Pressure. Patient stated, I trying to report, I have severe reaction to the Pfizer 2nd Covid shot. On 22Apr2021, the patient experienced fever, running around 102 it spikes to 104.5, nausea, bodyache, vomiting, soreness in my arm where shot was given, rapid heartbeat and lethargic. The patient received Advil 200 mg, took two pills for total 400mg as treatment medication for events. Patient confirmed about taking the shot from the nurse. The outcome was not recovered.   No follow-up attempts are needed. No further information was expected.
Developed hives and severe itching about 12 hours after receiving the vaccine.  Went to ER and received steroids.  Was discharged after about an hour and half.  Symptoms returned the next evening and she returned to the ER.  Received steroid and was discharged with oral steroids for home.
I started having a cough and then I had worse headache that I've ever had. I had a little fever. I had body aches all over. I went to ER - They gave me an IV with steroids in it. They gave me a CAT scan and chest x-ray and they sent me home with cough medicine. I took little Perl cough drops, too. They gave me a breathing treatment at hospital and an inhaler. Reglan (METOCLOPRAMIDE) and tylenol and they gave me Decoron Phosphate and Iopamidol for cough  at the hospital. I have been very tired and I'm still hurting. I have used the Albuterol inhaler a few times but not today. My chest is hurting and I still get headaches. COVID positive test at ER. I have noticed that I do feel like I am improving some - I'm not coughing as much - don't have to take the cough drops as much - just in morning and at night.
Numbness spread from injection site to rest of arm down to fingers.  Then about 50 minutes after injection, numbness spread to right side of face and neck, throat started closing. Took Benadryl as soon as the numbness and swelling started on face neck.  I went to her and could not be seen within 20min waiting, left to ER.  They took me right in and started steroid and antihistamine IV , I was discharged with rx for prednisone once the swelling went down and throat opened up.  I had to take Benadryl every 4 hours after being discharged, some my throat would start swelling again.  Prednisone prescription was picked up following morning.