chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. Physician reproted the patient was administered a dose of VAQTA strength: 25/0.5 (units not provided) injection (dose, route of administration, indication, lot# and expiry date unspecified) outside of the prescribing information schedule: patient received the first dose of vaccine on an unspecified date in 1997 and a booster, second dose of VAQTA on an unspecified date in 2007. No concomitant medications were reported. Additional information is not expected as the reporting physician did not grant permission to contact him.
Vasovagal response. pt lowered to the ground initial BP 82/41 diaphoretic was with her mom and sister.  BP taken at lying, sitting and standing, BP at D/C 83/56.  Pt looked better and not dizzy.  Pt able to walk with a steady gait.
Info has been received from a CMA concerning a 16 month old white female with no medical history who on 10/7/05 was vaccinated, SC in right arm, with a 0.5ml dose of varicella virus vaccine live (lot 647952/0985P). Concomitant vaccinations on that same day included a 3rd dose, in the right thigh of Hib conj vaccine (OMPC), (lot 651475/0205R). There was no illness at the time of vaccination. The CMA reported that on 10/19/05, the pt developed 10 scattered papules on her thigh, chest and arms. On 10/20/05, the pt presented to the physician's office with a fever and 7 vesicular lesions. No other symptoms were noted. The pt was treated with Benadryl prn. The pt's scattered papules subsequently resolved. At the time of this report, the pt was recovering from the fever and vesicular lesions. Additional info is not expected.
Continuous dry cough approximately one to two hours after injection.fatigue.next morning congested sounding cough headache fever. Next day or two productive cough no smell or taste.
Patient is a 95 y.o. female with history of COVID-19 pneumonia, hyperlipidemia, and hypertension who presented to the emergency room with complaints of fever, increasing shortness of breath and hypoxia. Acute hypoxic respiratory failure due to COVID-19 pneumonia, Full barrier precautions, Procalcitonin negative. Patient tested positive on approximately 1/25/2022 and was admitted to local Hospital from 1/26/2022 to 1/28/2022. Probably continued symptoms of her initial Covid infection. Monitor inflammatory markers: CRP is improving, continue IV Solu-Medrol 40 mg every 8 hours, Encourage proning and I-S use, Wean oxygen as tolerated, currently needing 3 L via nasal cannula, As needed antitussives. Bronchial asthma: Continue PTA Arnuity Ellipta, No wheezing noted on exam. Hypertension: Blood pressures are fairly well controlled, Continue PTA Lopressor. Patient is bradycardic but not symptomatic. Hyperlipidemia: Stable, Continue PTA Lipitor. Hyponatremia: Likely due to dehydration, Slight improvement. Constipation: Scheduled MiraLAX and as needed Senna ordered. Generalized weakness: PT OT to evaluate. Approved to return to her ALF with support. DVT Prophylaxis: On Lovenox subcutaneous route. Was on heparin but patient refused heparin. Universal COVID-19 Screening: Per daughter, patient tested positive on 1/25/2022. Disposition: If patient remains stable, could consider discharging back to her senior living facility on home oxygen. She had been prescribed a tapering dose of Decadron after she was discharged from local Hospital. D/C 02/08/2022 PER RN NOTE.
Patient had new onset diabetes type 1, 5 days after he received his second shot. He went into DKA and presented to the hospital 5 days after that and had to be lifeflighted to Hospital
lupus after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Caller read that COVID vaccines (no particular manufacturer) can give symptomatic lupus. Patient is not identificable.   This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of Systemic lupus erythematous after mRNA- vaccine. Identifiable patient and brand of vaccine needs to be confirmed. Very limited information is available at this moment. Systemic lupus erythematosus was automatically upgraded as serious as per list. However, due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. However, there is insufficient evidence to exclude it as serious. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-429358 (Patient Link).
VACCINE WAS DILUTED WITH INCORRECT VOLUME OF SALINE, QTY OF 0.8ML INSTEAD OF 1.8ML WHICH LED TO PT RECEIVING CONCENTRATED DOSE OF VACCINE. PT WAS OBSERVED FOR AT LEAST 30 MINUTES AND WAS OBSERVED BY A MEDICAL DOCTOR ON SITE WHO ADVISED PATIENT OF WHAT HAD HAPPENED. AFTER OBSERVATION PATIENT LEFT THE CLINIC WITHOUT ANY NOTED ADVERSE EVENT OR EFFECTS AT THE TIME.
pt recv vax 21JUN96 & 1JUL96 pt exp lower back pain in the lumbar region;back pain persisted for 24hr & spontaneously resolved;MD felt pt back pain was not r/t vax;
No ADR, timing ERROR, 2nd dose given 45 days after 1st Narrative: No ADR, timing ERROR, 2nd dose given 45 days after 1st
Red, warm, raised area at site of injection. Denies pain. Complained of mild nausea. No fever or other symptoms. Started 2 days after injection per patient.
I was disoriented & confused the day after I got my last vaccine shot.  I didn?t know how to even send a text message.  I?ve had a headache since I got the last vaccine, dizzy, blurred or abstracted vision.
No adverse event. Extra Dose DTAP given. DTAP given when not indicated. Client had received DTAP #5 on 5/25/17.
PT CALLED 9/17 TO REPORT RED CIRCLE AROUND INJECTION SITE AND MUSCLE TENDERNESS.  PT PRESENTED 9/18 WITH REDNESS EXTENDING TO ELBOW AND SLIGHT SWELLING BUT STATED TENDERNESS WAS BETTER. PT ALSO RECEIVED FLUVIRIN IM THE SAME DAY AS PNEUMOVAX SQ
Information has been received from an approximately 14 year old female who on approximately 07-SEP-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included Vaqta (inactive) (manufacturer unknown).  On approximately 07-SEP-200 right after vaccination the patient experienced dizziness when she attempted to stand up.  Unspecified medical attention was sought.  On approximately 07-SEP-2007, the patient recovered.  Additional information has been requested.
tingling in my fingers, hands and wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling in my fingers, hands and wrist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (tingling in my fingers, hands and wrist). At the time of the report, PARAESTHESIA (tingling in my fingers, hands and wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
p/vax pt became SOB; pale, vomited & was shaking; no temp;
onset 12SEP92 chills, fever, aching, night sweats lasting until about 8OCT92;
He received his first COVID19 shot (Pfizer) reportedly on 3/2/21, then began a new chemotherapy regimen on 3/10/21. On 3/18, he fell to the floor and could not get up. He was admitted to the hospital for sepsis, pneumonia, and chemotherapy-induced neutropenia, treated on IV antibiotics and discharged on PO antibiotics. His home insulin was also decreased but continued to have hypoglycemic to hyperglycemic events. Insulin was decreased in clinic afterward and was compliant on antibiotics. Returned to hospital again a few days later for sepsis and pneumonia/effusion. He later went to a nursing facility / on hospice. He ultimately required supplemental oxygen and breathing increasingly became labored. Patient ultimately died on 4/9/21.
shivering, chills; felt like crap; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   On 1st September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced chills and feeling bad. On an unknown date, the outcome of the chills and feeling bad were unknown.   It was unknown if the reporter considered the chills and feeling bad to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and flu vaccine on that same day also in his left arm and experienced shivering, chills and felt like crap.  The reporter did not consent to follow up. Both caller and husband both have the same initials ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197211:Same Reporter
A (Name)-Anti_SARS-CoV-2 S semi quantative immunoassay was done 20 days after the second injection revealing extremely low titers; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received BNT162B2 second dose on unspecified date at single dose for COVID-19 immunization, first dose on unspecified date at single dose for COVID-19 immunization. Medical history included type 2 Diabetes. Concomitant medications were not reported. Patient received both doses of Pfizer COVID-19 Vaccine with no side effects. A semi quantative immunoassay was done 20 days after the second injection revealing extremely low titers. Result was 1.75 (positive range is 0.8 to 250). This result is much lower than expected. The concern is that one of the doses he received was ineffective due to unknown improper handling of the vaccine. Has Pfizer done any studies using this assay after vaccination? The only studies patient found for this assay was after infection. The outcome of the event was unknown. The seriousness was reported as no.
Patient became faint, paleness to face, cold sweat, convulsing. Nausea after gaining consciousness.
No additional AE reported; Proquad got administered to a patient via intramuscular route instead of subcutaneous route; This spontaneous report was received from an office manager on behalf of a healthcare professional, concerning a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot number U026795 with expiration date reported as 24-FEB-2023 but internally validated as 26-FEB-2023, administered intramuscularly instead of subcutaneously (incorrect route of product administration) for prophylaxis (dose and anatomical location were not reported).  No adverse events or product quality complaints (PQC) were reported.
PATIENT WAS GIVEN VACCINE 10 DAYS PAST EXPIRED DATE,  WAS KEPT IN REFRIGERATION 10 DAYS LONGER THAN RECOMMENDED.    NO REPORTED ADVERSE EFFECTS.  MOTHER HAS NOT RETURN CALL TO CLINIC.
Fever of 103-104 degrees for 4 days. Rash all over body 2 days after fever began lasting 4 days. Eye irritation at onset of fever lasting 7 days.
Extreme fatigue, shivering they would not stop until taking a hot bath. Uncontrollable shivering, fever and headache. Shivering like if I was having a seizure. This is my booster shot and it?s approximately 10 hours after injection
Received 1st MMR on 4/28/14. Mom report broke out with rash from face to groin area on 5/6/14 1 week after receiving vaccine. Fever ranged from 100-101 F. Child felt aching and tired. Mom gave MOTRIN and BENADRYL.
Pt recvd vax 23OCT92 & exp warmth @ soreness @ the inject site but no pain in back until later that day; also exp body aches, sore throat & mouth felt like ulcers were forming; also felt like was getting the flu;
Knee pain, stiffness and swelling developed post vax. Dx'd with osteoarthritis due to booster. Medicines and treatment with Vioxx, Voltaren, Celebrex, steroid injection, arthroscopy, non-steroid medication and knee braces. Per 1 year follow up: Pt has not recovered. NOTE ATTACHED. 12/16/2002 As of today, I am still wearing braces on both knees when I walk. The pain never goes away. I take from 6 to 8 Extra Strength Tylenol every day. It helps some but not completely. As I have stated before I have never had any problems of any kind with my knees until I took the booster shot in April of 2000. About a month later I could hardly walk, and as they say the rest is history. i thank you for your interest. Signed, Pt
Sleepy; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, the patient experienced sleepy a few hours after the vaccine was administered. No therapeutic measures were taken for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sleepy was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received flu shot at pharmacy on 9/9/17, arm was sore the day after but woke up on 9/11 with red spot on the arm at the injection site. She said it was not itchy or warm, just red. She went to doctor office, diagnosed with cellulitis, was given antibiotic to treat infection.
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient who experienced fever and chills while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route. On an unknown date, the patient developed a non-serious fever and chills after receiving FLUBLOK vaccine following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data.) Final diagnosis was patient had fever and chills after receiving FLUBLOK vaccine and patient had fever and chills after receiving FLUBLOK vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for patient had fever and chills after receiving FLUBLOK vaccine. List of documents held by sender: none.
A medical assistant reported that a 5 month old male who was being treated for a bronchial infection with an unspecified medication via nebulizer since 1/7/01, received his 3rd dose of Prevnar on 1/18/01. On 1/23/01, he was admitted to the hospital with a dx of bronchiolitis. On 1/27/01, he was discharged.
15 min. post receiving the vaccine, patient with c/o dizziness. BP noted at 109/75, PR81, Pulse Ox noted at 99%.  No s/s of respiratory distress, noted, patient relates "I am feeling dizzy". and denied any other symptoms at this time. He was encourage to remain in the vaccine area for further observation and he was given a bottle of water to hydrate.  15 minutes later, patient reported feeling cold, BP noted at 137/89, PR76. patient request to  go outside because he to warm up. This nurse offered to contact EMS  for further assessment, however patient said "I believe I will be fine, there is no need to do that".  This nurse walked with patient to his car.  He reported warming up once outside and reported feeling better.  Patient advised of adverse effects associated with vaccine and informed to contact EMS should symptoms worsen.  Patient left AAOx3, ambulatory (gait steady), with no s/s of respiratory distress noted.
daughter age 17 received vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter age 17 received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter age 17 received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter age 17 received vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2.  The mother was 11 weeks pregnant at the onset of the event.  The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC).  Information of lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarriage' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information.  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 found by ems crew incomapny of mother in vaccine booth after having recieved vaccine. pt appeared to have suffered a syncapo episode due to a vaso vagal response. pt mother had consented to all ems evaluation and treatment. pt was assessed on scene and pt wa then transfered to hall way for further evaluation. original vitals at vaccine booth was bp63/42 hr 46 rr 18 spo2 99 ra. pt had perspiration on forehead and pale skin and mild visual disturbances. pt improved once in hallw ay. vitals bp 87/59 hr 52 rr 18 spo2 99 RA. pt began to "feel better" PTs mother denied any allergies or pmhx. pt care was released and pt was escorted out of center by staff with mother
On 10/2/12 received pneumococcal vaccine had swelling and pain afterwards for 6-8 hours then swelling spread, pain increased, had limited range of motion and temp 100.7 for 12 hours.
I got home from my 2nd dose and about 2 hours later, I just started with a terrible nose bleed and the thing about it is that I'd never had a nose bleed in my entire life. I felt it was strange so I called my PCP who said to keep an eye. It stopped for a day and a half. Then it started couple days later while I was driving so I put a towel on it. It was fine for 2 days. Then 2 days later while out and it started pouring out again. I went to the ER who said that I had a ruptured blood vessel in my left nostril and they cartelized the vessel in my nose. My point is that it makes no sense that I had this nose bleed and happened on the same day of my vaccine. Since I went to the ER I've not had another nose bleed and have had 2 more vaccines after that.
Swelling at injection site. Injection site and surrounding area raised, red and swollen. Swollen area is larger than 5 inches in diameter. Swelling and redness has persisted for 5 days. Patient has still not recovered.
Case number PHEH2014US024299 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 49 year old female patient. Past medical history was not reported. Concomitant medications were none.  The patient had tolerated vaccines well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes.  The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21JAN2015: updated site of vaccination and reporter comment.
First / vaccine in 2019 / wondering if it is okay to get the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.