chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 27 year old female with mild anemia and a medical drug history of iron supplement. The patient was vaccinated intramuscularly with lot # (671006/1391AA: exp date 12-APR-2014), 0.5 ml dose of GARDASIL on 19-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was at 25 week and 4 days of gestation. The LMP was of 02-APR-2012 and an EDD of 07-JAn-2013. The patient had an office visit, no treatment was given an no lab diagnostic tests were performed. The outcome of pregnancy was pending. Follow up information received. All telephone attempts to obtain follow up had been unsuccessful. The case was lost to follow up and pregnancy outcome was lost to follow up. Additional information is not expected.
The nursing staff brought the patient to receive a booster dose of the COVID-19 vaccine on 7/6/2022 at the facility.  When the pharmacist was documenting vaccinations after the clinic it was discovered that the patient had received a booster dose of Moderna (0.25mL) on 5/25/2022 at the facility.  The pharmacist called the facility and informed the lead nurse of the error and recommended observing the patient for additional side effects.
No additional adverse AE information provided; the patient was administered an improperly stored dose ofROTATEQ on 2/21/2020; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were unknown.  On 21-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# R017932, expiration date 01-MAY-2020; dose and frequency were not provided) orally for prophylaxis (product storage error).  Temperature excursion of this vaccine was highest temperature above 47 degrees Fahrenheit (54.5F) for 2 hours 25 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.
Friday September 23 2022 at 9AM I woke up with a headache. light cough, body aches. sore throat and felt feverish.  On Saturday nigh I took a COVID-19 test and the result was positive.  My symptoms were lighter Saturday daytime but became worse at night and continued through Monday. Sunday I also experienced pain in the joints of my toes and in the arch of my foot. In addition to that I had labored breathing and used my C Pap at night.  Monday September 26 2022 I had started to feel better in the early morning but a few hours later I had cough headache and sniffles. I was prescribed Molnutiravir by the urgent care clinic.
This spontaneous report as received from a consumer refers to a female patient of unknown age who reports on herself. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with the dose of PNEUMOVAX 23 (reported as unspecified pneumonia vaccine) injection (dose, lot# and expiration date were not reported). On an unknown date (reported as after receiving an unspecified pneumonia vaccine), the patient developed pain in her bones and around the injection site. The outcome of the adverse events and the causality between the adverse events and PNEUMOVAX 23 were not provided. This is one of several reports from the same source. Additional information has been requested.
Vaccine administered by RN in left deltoid. Pt tolerated immunization well and discharged from facility. Pt presented to facility a second time on 5/16/22 at 1505 reporting pain in left arm with some difficulty moving and neuropathy onset after injection. Pt evaluated by PA-C who is concerned for vaccine related injury. Pt allergic to oral NSAIDs. Provider advised trialing topical voltaren gel and placed a referral to orthopedics fro evaluation. Provider instructed pt to follow up with PCP in 1 week if symptoms aren't improved.
cellulitis Narrative:  left arm cellulitis surrounding injection site approx 5 in in diameter
The day that I had the vaccine in my left arm I developed a small knot and soreness moved it a lot so it would not stiffen up. A couple days later I had a bad headache seem like right in the temple I took some Excedrin headache pills  it eased up but never completely went away. Same thing next day but not as bad but I knew my headache was there. Since I have a headache every day or every other day. I made appointment with my doctor office did not see my primary doctor but seen one, explain my symptoms, doctor order blood work results were good , doctor talked about maybe a CT scan. have seen my primary doctor since than headache are still happening, taking ibuprofen 800, Tylenol and excedrin for some relief
Pt (surgeon) was vacc. /w Heptavax-B & was subsequently hospitalized /w pancreatitis. There was no concomitant medication. Additonal detail are beig requested
tip of nose was numb, top lip, chin, forehead cheeks were also numb, eyes felt different
I had a sore arm for two days after receiving the vaccine. On 12/06/2022 I had a scratchy throat and sneezing. On 12/07/2022 I tested negative for COVID-19. On 12/09/2022 I tested positive for COVID-19. I contacted my doctor and was given the prescription PAXLOVID. The medicine left a terrible metallic taste in my mouth.
Patient reported arm red, warm to touch and arm aches after vaccine administration.  Moderna vaccine given.  No treatment given
05/24/2021 "... PMH significant for DMII on insulin, CAD, COPD, CVA, kidney transplant that presents with generalized weakness. States over the past few days he has been feeling more tired and weak"
Patient called to report an adverse reaction to her flu shot she received over the weekend. Patient stated she got the shot on Saturday and later that day that she began feeling dizzy. She stated the dizziness got worse and she felt like she was going to pass out so she stayed home. Patient stated by Monday she was feeling fine, but read over the paper she received when she got her flu shot and it said to call and report if adverse reaction were experienced.
Pt recv vax on 10/16/98; on 10/17/98 pt exp cellulitis of Rt arm w/ red, itching,swelling & fever; numb hands to neck; tx=Keflex
No additional AE/PQC; a patient received MMRII that is 10 days expired; This spontaneous report was received from an office manager, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 11-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 milliliter, lot # R031636 has been verified to be a valid lot number, expiration date 01-NOV-2020 (route of administration and anatomical location were not provided)  for prophylaxis. No additional adverse events were reported.
Miscarriage confirmed 9/8/21 at routine appointment  Due : 4/2022 Pregnancy history-  3 pregnancies 1 termination 1 full term birth 1 miscarriage
Information has been received from a physician's assistant and a medical assistant concerning an 18 month old male patient whose sister developed wild type chicken pox about two weeks ago (on approximately 22-JUL-2010). Eight days ago, on 29-JUL-2009, the patient was vaccinated with a dose of VARIVAX (Merck). One day post vaccination, on 30-JUL-2010, the patient broke out in a chicken pox rash. On 05-AUG-2010, eight days after received the VARIVAX (Merck), the patient was vaccinated with a dose of MMR II. There was no adverse effect noted from the MMR II. At the time of the report, the patient was recovering from chicken pox, there was no fever and crusting scabs. The physician's assistant did not feel that chicken pox was related to VARIVAX (Merck) but the related to the wild type exposure. Additional information has been requested. The patient's twin brother experience has been captured in WAES 1008USA01276.
10 days p/inject fevers of 103 & over crying for 4 days as if pt were in pain;
Day 1:Swelling on left side of face, swollen lymph nodes, chills, fever, body ache, headache; Day 2:extreme headache, nausea; Day 3:headache; Day 4:headache; Day 5: Doctor diagnosed with acute Bell's Palsy.
It started out with muscle aches, headache, chills, and a little cough. The next day I tested positive for COVID-19. My doctor prescribed me Paxlovid for 5 days. I started feeling better the next day.
vomiting, dizziness, hot flashes, chills for 8-10 hrs, no temp elevation or aches.
Day following immunization, patient's sister reported pain, mass, and erythema at site of injection.  That evening symptoms spreading and pt went to E.R.  Given PREDNISONE and  culture taken.  Confirmed with patient 9-13-09.
Flu-like symptoms; Low Grade Fever; Feeling of not wanting to do anything; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, fever and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. After receiving Shingrix, the patient experienced flu-like symptoms including a low grade fever. These symptoms resolved within 2 to 3 days. However he had the lingering feeling of not wanting to do anything for about one week. The patient also stated that, his physician told him that he had 10 patients with flu-like symptoms.  The patient would not provide any additional details.
No adverse reaction shown during initial injection. My husband awoke this am to hives on his flanks, ankles, belly, and armpits. I immediately administered Benadryl & contacted his primary care physician Dr. We spoke to the on call doctor for Dr. and she said Benadryl should clear up the hives, but if conditions worsen she would prescribe an Rx for steroids. Rx for Steroids were submitted to our local  pharmacy, but we haven?t picked up as of yet. As of this evening, my husband?s hives continue to be inflamed and he?s been taking Benadryl as directed every 4-6 hours.
This spontaneous pregnancy report as received from a consumer refers to herself (patient's age not reported). The patient reported, "on an unspecified date, I received the second dose of GARDASIL and I later found out I was 10-15 days pregnant." No adverse effects were reported. The patient did not wish to provide any further specific information. During the call the patient stated, "I am not sure if I received GARDASIL or CERVARIX". The LMP and EDD is not known. The outcome of "I received the second dose of GARDASIL and later found out I was 10-15 days pregnant is unknown." No further information was provided. Additional information is not expected.
Pt started feeling bad within 2-3 hours of receiving flu vaccine and went downhill and had an atypical stroke. She kept going downhill otherwise a healthy 86 yo female when left doctor.
Nausea next morning, Then developed a headache in back of head that lasted several days, went to urgent care on 1/16/2221 due to headache still there.  Was treated and sent home, headache continued until 01/19/21.  Second shot given on 01/20/21, resulted in fatigue, and headache returning after injection.
4 days after the second dose, headache , nausea, diarrhea and tiredness occurred. It lasted for 3 days.
pt recvd vax & devel  shingles w/in 4 days of receiving vax;
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator 04Nov2021. Some patients were vaccinated on 05-Nov-2021 and some were vaccinated on 12-Nov-2021. No treatment medication was reported.
1/8 vaccination  Within 24 hours, I started having a minor red rash on upper arm. It became progressively over all extremities, minus face. Itchy, red rash.  I went to the doctor on Monday. She wasn't sure if related to vaccine. Symptom mgt. Antihistamines. She prescribed Singular to help with the itchiness and monitoring. It lasted for 7 days after vaccine.
body aches; chills; headaches; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches) and FATIGUE (fatigue). At the time of the report, MYALGIA (body aches), CHILLS (chills), HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
terminal liver cancer; This is a spontaneous report from a contactable nurse (patient's friend). A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported as healthy as a horse. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient experienced terminal liver cancer on an unspecified date. She got the second shot of the vaccine and literally a week or 2 weeks later, was told she literally had 3 days to live with terminal liver cancer and went into hospice and was dead in 3 days. The reporter thought it was the Pfizer vaccine that did it to her. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event hepatic cancer and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.; Reported Cause(s) of Death: terminal liver cancer
On 5/11/2022, I got my second Moderna booster for COVID-19. On about 6/1/2022, I felt a little bit of pressure and pain above my eyes; my eyes were puffy and watery. I thought that I might have a sinus infection, but I took an at-home COVID-19 test, and it quickly yielded a positive result. I called my PCP that day, and he prescribed me Paxlovid, which I took twice a day for 5 days. The abovementioned symptoms lasted only a day. Afterwards, I was mostly symptom-free, except I did have a runny nose and a little congestion. It was basically like a mild cold. Those symptoms lasted for maybe about 3 days.
Received vaccine at 1600, 3 hours later child c/o shivering, HA, body aches, nausea. Was instructed to go to ER-IV started and IV bolus, BENADRYL, ZOFRAN and COMPAZINE given. ER doctor thought it may be more of viral illness vs. vaccine reaction.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer of unspecified age reported that she received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient tested positive after the 1st dose of Covid vaccine and was wondering what to do about the 2nd dose. Event outcome was unknown. Information on the lot/batch number has been requested.
Hallucinations; delusions; This is a spontaneous report from a contactable consumer. An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration on 14Mar2021 as single dose for covid-19 immunisation. Medical history included asthma, afib, seasonal allergies, hbp. The patient's concomitant medications were not reported. The patient experienced hallucination and delusions on 18Mar2021 which resulted in hospitalization. The outcome of the event was not recovered. Patient is not pregnant and was not tested for COVID post vaccination. Patient did not took other vaccine in four weeks. The treatment for adverse event was unknown  Information on the batch/lot number has been requested.
Very painful between elbow and shoulder. Doesn't feel like a mussel more like shooting pains depending on arm movement. Difficult sleeping.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 09:30am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
EXPOSED TO COVID; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (EXPOSED TO COVID) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    NO KNOWN ALLERGIES.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (EXPOSED TO COVID) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPOSURE TO SARS-COV-2 (EXPOSED TO COVID) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported. Treatment detail was not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
After I received the booster shot on L upper arm. I felt sore and felt like something going through my upper body. I felt slight tightness around my chest area, no SOB, but uncomfortably feeling.  Then I felt weird feeling going through my knee and legs. At the staying for 15 min, I left but the store, but the weird feeing continues. Two hours later, I felt the chills and muscle aches especially in the L arm. No temp. Later in the evening,  I felt nauseous, muscle tightness and  the chills. This morning,  after shower, I noticed a huge lump in my L armpit, about half the size of a tennis ball, very uncomfortable.
Subsequent to receiving one dose of varicella virus vaccine live the pt presented with chickenpox including small bumps, fussiness, runny nose, loose bowels, decreased sleep, and a decreased appetite.
Patient presented to physician's office on 11/24/00 with URI and a fever of 103 degrees. She was put on Lorabid. On 11/27/00, she developed a macular papular rash. On 11/28/00, she presented to the physician and was diagnosed with vaccine related rash. The rash was gone by 11/30/00. On 12/5/00, the patient had chickenpox lesions, vesicular and open, about 25 total.
Slight redness and swelling at 1 injection site which has resolved. Not sleeping well since vaccinations (but wasn't before also). Possibly more fussy, jittery.
Fever of 101.5, chills, nausea, muscle/join pain and weakness, headache sore arm
Flu like Symptoms; Fever; Achiness; Red and itchy at injection site; Red and itchy at injection site; Warm at injection site; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu like symptoms, fever/pyrexia, achiness/pain, red at injection site/vaccination site erythema and itchy /vaccination site pruritis , warm at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events Flu like symptoms, fever, achiness, red and itchy at injection site, warm at injection site.  Treatment medications Not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events flu like symptoms, fever, achiness, red and itchy at injection site, warm at injection site was unknown.
Developed fevers, chills, weakness resulting in fall, possible syncope at home.  Myocarditis, now with improvement since starting steroid therapy. His initial presentation was profound WB physiology and intermittent heart block.