chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for each time were 40, 34 and R; 136, 33 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
One week after covid vaccine  a swollen  red hot spot where shot was injected. Slowly went away days later
Extreme pain in knee opposite injection site. Had hip pain first day. Knee second day. Now it is the fifth day after vaccination and she has trouble standing. Slid off be trying to stand up and required EMS assistance to get her to stand.
Initial unsolicited report received from a consumer on 14 October 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed myelitis. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: myelitis. List of documents held by sender: none.; Sender's Comments: Listed event Myelitis following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administration. Time to event onset, patient demographics, medical and family history, concurrent medication, investigative details etc. would help assess the case better. Based on the information provided, the case cannot be completely assessed.
Day after shot - extreme weakness, dizziness, nausea.  Following months increasing fatigue.  Sleeping over 12 hours a day and still fatigued.  Finally contacted PCP and given blood test which showed hypokalemia and anemia.  (An earlier blood test showed potassium levels were normal 4 days before first covid shot on 3/5/21)  Currently taking potassium pills prescribed by doctor.
Patient hospitalized.   On 10/27, patient was diagnosed with COVID-19 at his nursing home where he has been residing since discharge from the hospital in September after being treated for pneumonia with sepsis.  Patient was vaccinated with Moderna on 2/9/2021, 3/16/2021.  He was being followed by APNP for his COVID-19.  The nursing home reported abnormal lung sounds and some coughing which prompted a chest x-ray on 10/28 showing bilateral pleural effusions with a completely opacified right lung.  Patient presented to the emergency department   At the time of evaluation, patient was not reporting significant cough or shortness of breath.  He was down to 1 L nasal cannula.  Due to his history of cognitive impairment/dementia, he was unable to give details as to the history of his current condition.  He claims that he has been short of breath for many years, ever since being diagnosed with OSA.  Not feeling particularly more short of breath at this time.  Per chart review, patient had cough productive of phlegm. His primary concern was his back pain for which an L2 compression fracture was treated with kyphoplasty.
I experienced frequent bowel movements on October 14, 2013 and had gotten worse throughout the years.  As for treatment, I started with Prednisone, Lialda, Imuran, and Humira.  I had experience negative side effects with Imuran such as fatigue, muscle aches and chest pain to name a few.  And with Humira I had also experienced negative side effects such as skin rashes all over the body, itchy skin, red, swollen, and painful skin at times mostly during the night, and did not sleep well.
Patient received Pfizer-BioNTech COVID-19 vaccine dose 1 on 9/20/2021 and dose 2 on 10/11/2021. Received Moderna COVID-19 vaccine booster dose (0.25ml) on 8/12/2022.
tender, swollen & erythematous inj site about 3x4 inches in diameter
Upper arm probably sore from previous shot; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter would like to know if hip can be used instead of upper arm. Further prompted reporter why alternative site, reporter mentioned patient that probably sore from previous shot.  This was 2nd shot of Shingrix. No other information was available.  The reporter did not consent to follow-up.
Information has been received from a registered nurse (RN) concerning a 42-month-old male who on 18-MAR-2003 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). The RN reported that on 02-SEP-2005, the patient developed 10 lesions after he was exposed to his mother who had wild-type chickenpox. Unspecified medical attention was sought and the patient was noted to be afebrile. At the time of this report, the patient was recovering and he was noted to be doing well. Additional information has been requested.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. Follow up information has been received from the C.M.A. via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 31-JUL-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated. Additional information has been requested.
Pt came to scheduled appointment for 1st Pfizer vaccine.  Vaccine software alerted nurse that pt received another vaccine.  Pt denied twice of receiving any Covid vaccinations.  Vaccine was given.  Later received state record, which showed he had received a J & J vaccination on 4/8/21.
Donor had completed donation successfully. Then donor received tetanus vacc. Left building sat self down outside.  A passerby came in and reported her to staff. Was brought in and placed on exam table, given soda 355ml caffeine free.
Case number PHEH2012US022478 is an initial spontaneous report received from a nurse on 12 Nov 2012 and a follow up received from a physician on 10 Dec 2012: This case refers to a 17-year-old female patient. Her concurrent condition included of chronic stomachache. She received only Men A component of MENVEO vaccine (batch number: A12013) intramuscularly into left deltoid, reconstituted with sterile water on 31 Oct2012. She did not receive Men C, Y W-135 liquid conjugate component of MENVEO. No adverse reaction was occurred following this administration error. She was revaccinated with MENVEO on 16 Nov 2012. No other information was available. Follow up information received from the physician on 10 Dec 2012: Updated concurrent condition, batch number, site of vaccination, revaccination date.
Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "41 YO male with h/o cerebral palsy, severe developmental delay, paraplegia, nonverbal, alpha-1 antitrypsin deficiency, emphysema, seizure disorder, chronic constipation admitted on 10/30 for fever and weakness.  Found to have COVID on admission as well as CT of head on admission showing increasing hydrocephalus.  Regarding COVID patient had fevers for a couple days but did not have any respiratory symptoms and did not require any treatments other than symptomatic care.  CT of the head demonstrating increasing hydrocephalus for which Neurosurgery was consulted and after patient is cleared for procedure from Infectious Disease perspective performed VP shunt revision on 11/03.  Also during hospitalization ID was consulted for patient's fevers and concern for possible infected VP shunt.  Lumbar puncture from 10/31 and 11/3 no growth by time of discharge and in PACS antibiotics provided during admission were changed over to patient's home life time doxycycline for suppression of previous CNS MSSA as well as patient to continue voriconazole through December 12 for previous history CSF growing mold on 08/05.  During hospitalization SLP evaluated patient and recommend that patient have a level for, nectar thick diet.  On day of discharge patient was alert but seem to be as baseline status of being nonverbal and had been afebrile for 3 days prior to discharge.  Neurosurgery and ID cleared patient for discharge and patient will follow-up with Dr. on 11/29 and has follow-up with Dr. on 11/17 for removal of staples.  I did update patient's guardian on day of discharge."
chills, diaphoresis Narrative: Received 1st vaccine dose 1/5/21. On 1/6/21 reported feeling hot then cold at time, with mild sweating. Missed work x 1 day.
Pt received menactra meningococcal vaccination and approx 4-5 min later became diaphoretic,pale weak,nauseated while shopping @ the facility.  BP 82/54 P44 Denied SOB or chest constriction. 911 responded. VS stabilized without any treatment. Pt released to mom per paramedics.
unable to swallow  face, lips, tongue, and neck tingling and itching top lip swelling headache paleness
She completed the series of Pfizer vaccines on 2/23/21. She was the local skilled nurse facility, and tested positive covid. Per the report from the facility, she was transfered to ER due to dry cough, hypoxemia and tachypnea on 9/17/21. She was admitted on 9/17/21 for further evaluation. She is discharged on 9/21/21
I had a lipo cancerous tumor that seemed to develop out of nowhere. Cancer does not run in my family. It was in the colon area and became large enough that I could feel it. I had it removed I am completely cancer free. It did take two surgeries to remove it.
Lower left side of my jaw dislocated for a day.  It was followed the next day with extreme mucus and chills.
This is first flu shot pt received in her life. Pt had fasted because had blood work appointment before flu shot. Pt has no egg allergies. Started with cough which then subsided. Then layed down and noticed heart was racing (83 beats/minute). White of eyes turned red like if had pink eye. There was sticky residue. Felt bloatness in stomach. Then chills started. Called doctor who directed her to ER. By then every single joint in body hurting/aching. Felt weak, light headed. Was given oxygen. They swabbed nose to test for influenza and was negative. Was given MOTRIN (6) and doctor ordered TAMIFLU and amoxicillin. Had 102 fever but resolved with TYLENOL. Continue taking TAMIFLU and amoxicillin. By Thursday eyes itched a bit but were better.
Fever 101F fever, feeling unwell, swollen submandibular nodes Narrative:  took day off from work 1/27/2021  Other Relevant History:
Pt experienced numbness/tingling down (L) arm following injection - referred to ER.
This spontaneous report was received from health care worker refers to a patient of unknown age. On 06-APR-2013, the patient was vaccinated with a dose of VAQTA, (lot number, expiry date was not reported and route was intramuscular) and could not support the temperatures they went down to. Concomitant medications were not reported. No adverse reactions were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported a similar event for two patients. This is the second of two reports. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient complained that she had swelling at the injection site on an unspecified date. The patient was recovering. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016573776 Same reporter/ product/ event, different patient.
This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), FEELING HOT (warm to the touch), DIARRHOEA (diarrhea), NAUSEA (nausea) and TINNITUS (ringing in ear) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), FEELING HOT (warm to the touch), DIARRHOEA (diarrhea), NAUSEA (nausea), TINNITUS (ringing in ear), VERTIGO (vertigo) and ILLNESS (cant get out of bed). At the time of the report, PAIN IN EXTREMITY (Pain in arm), FEELING HOT (warm to the touch), DIARRHOEA (diarrhea), NAUSEA (nausea), TINNITUS (ringing in ear), VERTIGO (vertigo) and ILLNESS (cant get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not  provided.  Concomitant product use was not provided by the reporter.
Varicella #2 given to right upper arm, SQ on 1/16/08. Patient came in on 1/18/08 with redness, swelling, and pain to the site measuring 7.5cm. There was also heat to the site.
one hour after shot, patient developed rash on right arm. Injection site was left arm. At 8 p.m. the patient developed a fever on 103F and severe body aches.
pt recvd 2 doses of Engerix-B vax JUL91 & AUG91 & p/2nd dose AUG91, about 6 hrs later pt exp t101, mild swelling, redness & soreness @ inject site; pt exp no rxn p/1st dose of JUL; 3rd dose has not been given yet;
Nausea, acute blindness. Evaluated by EMS-Refusal to transport.
Headaches, muscle aches, fatigue, swollen lymph nodes under arm, nausea, abdominal cramping. Started with severe headaches and fatigue. Additional symptoms came within a few days. All symptoms still present 8 days after the first vaccination. Abdominal cramping continues. Can only eat bland diet.
Vaccine administered 6/7/22 Patient experience arm pain same day and next day Experienced L sided facial paralysis, numbness and pain with hearing changes L sided, Dry L eye with tearing presented 6/22/22 with L clavicular node enlargement
Information has been received from a pharmacist concerning a 16 month old infant who on 14-Nov-2006 was accidently vaccinated with a dose of varicella-zoster virus vaccine live. The pharmacist reported that the patient received half of a dose and the other half spilled out onto the nurse's hand and sheet. She explained that the pharmacy had stored both varicella-zoster virus vaccine live and varicella virus vaccine live next to each other and inadvertently picked up the wrong box of vaccine when dispensing it. She reported that this was not confusion. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information from the pharmacist explained that the problem was that ZOSTAVAX (Merck) is a frozen vaccine and was stored next to VARIVAX (Merck) in the freezer. The technician inadvertely grabbed the wrong vaccine and handed it to a nurse, who handed it to another nurse and who in turn, handed it to a third nurse. Nof of them double checked the vaccine. The reporter inteded on more clearly lableling the vaccines in the freezer. No further information is expected.
PATIENT WAS ADMINSTERED 0.2ML INSTEAD OF 0.3ML ON 12-29-2021
Eight to nine days after the shot the arm got sore and it is sore still; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Eight to nine days after the shot the arm got sore and it is sore still) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Eight to nine days after the shot the arm got sore and it is sore still). At the time of the report, VACCINATION SITE PAIN (Eight to nine days after the shot the arm got sore and it is sore still) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.
Patient hospitalized due to breakthrough covid infection from 7/19/21 to 7/28/21. Patient completed Pfizer vaccine series in January .  Information below is copied from discharge summary:  Principal Problem:   COVID-19 Active Problems:   Acute respiratory failure with hypoxemia   Dementia   SSS (sick sinus syndrome)   HTN (hypertension)   A-fib   Pneumonia due to infectious organism Patient is a 90 y.o. Female, COVID-Vaccinated with PMH of HTN, dementia, reported A-fib, sick sinus syndrome with pacemaker who was admitted to the ICU for acute hypoxic respiratory failure in the setting of COVID after being found hypoxic by staff with O2 saturations 70 and experiencing SOB for 5 days. Patient required HFNC 60L/80% in the ED to maintain saturations above 90%, EKG showed atrial fibrilation rate controlled, CXR showed increased density in both lung fields consistent with interstitial and pulmonary vascular congestion. In the ICU, the patient was treated with Solumedrol, Lipitor, Tocilizumab x1 and covered for CAP with Rocephin and Azithromycin. Her O2 requirements were weaned to HFNC FiO2 60 at 55L/min. She is transferred to IM for continued management. Patient was continued on Solumedrol 20mg q12 hours x 10 days, s/p Azithromycin/Rocephin x 5 days, s/p daily IV Lasix 20mg. TTE showed LVEF>70% with severe concentric LVH, elevated LA pressure, severely dilated LA by volume, RA severely enlarged. Resumed home lopressor 12.5mg BID along with 200mg Amiodarone. Patient weaned to NC 2L and stable. Patient accepted to return back to COVID unit on 7/28.
A fever of 100.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (A fever of 100.7) 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 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (A fever of 100.7). At the time of the report, PYREXIA (A fever of 100.7) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) fever of 100.7.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.  The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (a fever of 100.7). At the time of the report, PYREXIA (a fever of 100.7) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter did not allow further contact
pediarix expired and was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The health care professional reported that expired dose of Pediarix was administered to a patient on 13th September 2022. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Pediarix, which led to expired vaccine used.
Patient became pale and had near syncope 1 minute after vaccines were given. Cool wet paper towels were applied to her forehead, and she was fanned. She was given a cup of water and when she was feeling better, she was moved to the table to lay down, BP 78/40 -> 90/62 -> 100/70. She was monitored for 45 minutes and was asymptomatic prior to leaving office.