chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started feeling dizzy after the administration of 4 out of 5 vaccines scheduled. After a couple of seconds he fainted for a couple of seconds. She was still very dizzy and nauseous and her blood pressure was very low. Since patient was not recovering the paramedics were called. They performed further test and when stable she agreed to go to the hospital for further testing with them and her husband.
This initial spontaneous report was received from a female patient of unknown age referring to herself. The patient reported that she had no pertinent medical history or drug reactions/allergies and that she was taking no concomitant medications. In approximately March 2013, the patient received her first dose of GARDASIL for prevention of human papilloma virus (HPV). In an unknown month in 2013, she received her second dose. In approximately June 2013, the patient received her third dose of GARDASIL (patient reported she received three doses in "Spring and Summer 2013"). Route, dose, and lot # were not provided for any of the doses. The patient stated that the third dose she received was recalled. She began to experience depression one month after receiving the third dose of GARDASIL and was started on ZOLOFT but it did not help. Four months after receiving the third dose, she started to experience dysthymia and was hospitalized on unspecified dates due to the dysthymia. On an unspecified date, she began to experience chronic fatigue syndrome "which lasted one year". The outcome of the events was not recovered/not resolved. Causality assessment was not provided. The patient was asking for compensation (not further specified). Follow-up could not be performed because the patient did not provide her contact information.
Inadvertently administered the vaccine to a 16 year old individual; A report was received from a pharmacist concerning a 16-year old male patient who was participating in the mRNA-1273 Emergency Use Program and inadvertently administered the vaccine to a 16 year old individual.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient, who was 16 at the time, received the first dose of vaccine. The vaccinating pharmacist did not realize until after the fact. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event inadvertently administered the vaccine to a 16 year old individual was considered resolved on 09 Jan 2021.  The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
This spontaneous report was received from a health professional refers to a patient of unknown demographics. On an unspecified date, patient was inadvertently administered with RECOMBIVAX HB, GARDASIL, VAQTA, ROTATEQ and PNEUMOVAX 23 which were improperly stored at 47 degree Fahrenheit (F). No adverse effects were reported. Outcome of the event was unknown. No product quality complaint (PQC) was reported. The reporter considered event to be not related to RECOMBIVAX HB, GARDASIL, VAQTA, ROTATEQ and PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
Both legs became "paralyzed" starting with the toes, moving to the ankles, then to the calves, knees, thighs & bottom. This occurred simultaneously in both legs. It felt like I did not have strength or feeling other than numbness - pins & needles. I couldn't stand & sat immediately. After maybe 3 or 4 minutes, the feeling started returning but both legs still felt extremely weak with a moderate amount of numbness, pins & needles. My entire body felt extremely weak & fatigued. I haven't felt right since - extremely fatigued. ER doctor initially thought it was Guillain-Berre Syndrome but I didn't have diarrhea before the event so he ruled this out. I am still seeking an answer as to why this happened but with the timing of the event, the vaccination is suspected.
On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This progressed the following days, became itchy and painful. The pain was shooting. I saw my PCP office on 1/6 and was diagnosed with Shingles.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that on unspecified dates ranging form 15-JUN-2015 through 18-JUN-2015, the patients received doses that were improperly stored of PNEUMOVAX 23 (strength, lot number, expiration date, dose # and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Small area of swelling and induration apprx 2.5-3 inches below vaccination site on L upper arm. Denies itching, pain. No discoloration or tenderness to palpation. Area is irregularly shaped d/t gravitational pull of fluid towards her elbow.
This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult (between 18 and 50 years old) female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).   On 3 March 2009, between 08:30 and 11:30, the subject received 2nd dose of ENGERIX B and upon returning to her seat, the subject started to rub her arm where she was injected complaining of injection site pain and injection site burning.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were probably related to vaccination with ENERGIX B.  It was reported that ENGERIX B vials were used with Integra syringes and needles that were 25 gauge, 1 inch.  The reporter stated that these events occurred in 22 to 25 out of 30 students receiving their 2nd dose of ENGERIX B on 03 March 2009.  Both male and female.
G.I. side effects using the bathroom up to seven times a day constantly bloated aches and pain in lower back felt as if I was 20 years older. A sense of mental confusion felt as if I could not breathe very well symptoms lasted a day and a half
12x6cm area redness and swelling with 3x3cm central area erythema.
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 10-AUG-2016, the patient received M-M-R II, (rHA) (dose unknown), lot number L032182, expiration date 25-AUG-2017, intramuscularly (drug use via unapproved administration route). No adverse effect was reported. Additional information has been requested.
My platelets are elevated but not my red or white cells. I have annual blood work done and this is new. There is not a history of elevated platelets in my family. I believe the vaccine triggered my marrow to produce more platelets.
This spontaneous report was received from a pharmacist concerning a 60 year old female patient. Medical history and concurrent conditions were not provided. On 18-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M032141, the expiration date: 02-OCT-2017 (dose and route were not reported) for vaccination. There was no concomitant medication provided. The consumer came to the pharmacy on 20-MAR-2017 due to swelling at the injection site. Pharmacist confirmed "2.5 inch with and 3 inch length" swelling and redness at injection site, back of arm, (specific arm unspecified) on 19-MAR-2017. The patient did not receive any treatment for the events and there was no laboratory diagnostics performed. At the time of reporting, the outcome of injection site swelling and injection site erythema was reported as not recovered. The relatedness between the therapy with ZOSTAVAX and the events injection site swelling and injection site erythema was not reported. Additional information has been requested.
Initial misuse report received from a healthcare professional on 28 January 2014. The cases were received on 21 March 2014 at agency. This case is link to case no: 2014SA046378 with same reporter. A 4-year-old patient had received 0.25 ml of FLUZONE as the second dose in the priming series. It was a vaccine underdose. No adverse event was reported. List of documents held by sender: none.
9/9/02 mother calls to report, pt's LA is swollen as large "as a lemon," warm to touch, tenderness. Denies other s/s. Started swelling evening 9/8. Refer to PMD if increase s/s infection, worsening. Encourage cont. assessing, cold compresses. Ibuprofen accord. to MD recommendations.
Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.  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.; 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.
INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 1-AUG-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of incorrect product storage was not reported. This report was non-serious.
Patient is fully vaccinated. COVID + on 11/24/2021 .  ED visit 11/25/2021. Patient with body aches, cough, subjective fevers. Also decreased appetite.  Normal oxygen saturation on room air, normal respiratory effort. Stable for discharge home. She was given a referral for monoclonal antibody therapy. Strict return precautions for any new or worsening symptoms.She states her husband and son were also recently diagnosed with COVID. She reports using her prescribed albuterol and Tylenol at home with temporary improvement of her symptoms. Patient does state she has a history of asthma and CHF. CXR: no acute process. Medications given: decaron and tylenol. Instructed to return to ED with any new or worsening symptoms. Patient will follow up with PCP. Patient in stable condition with stable vitals for discharge and outpatient follow up.
Redness, warmth, swelling was noticed on 9-2-16. Came into office at 11-10 on 9-3-16. Diagnosed with cellulitis. AUGMENTIN started.
Patient was given booster on 8/4/2022 with vaccine that had been in the fridge for 10 weeks on 7/30/2022. CDC was contacted and recommended revaccination. Patient was notified.
Diarrhea starting 14 hours after shot. Started early this morning, so not sure how long it will last.
I had heart palpitations in the middle of the night. The next morning, I took my blood pressure, it was high, so I went to the emergency room. When I went to the emergency room they did an EKG, that showed a small depression they advised me to see my primary care physician, my bloodwork came back normal. My doctor ordered a CT scan of my heart, it did not show any calcium build up, I was put on beta blocker that has helped mu blood pressure stay regulated.
Well I get sick but the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Well I get sick but the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION COMPLICATION (Well I get sick but the second shot). At the time of the report, VACCINATION COMPLICATION (Well I get sick but the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
pt recv vax & devel skin rash & fever;pt was felt to have a hypersensitivity rxn to MMR vax;
The Dr seated at station 2B administered the shot.  Some of the medicine went into my arm, and the syringe broke apart.  The rest of the medicine went down my arm.  It is unknown how much was injected.  I was then given a 2nd shot. Then entire shot.  The Dr claimed the syringe was not put together correctly, and he did not know how much vaccine I actually received from the first shot.  I felt some enter my arm, but, also felt some drip down my arm. So, I do not know how much of the vaccine I actually received since I received a partial amount from the first injection and then, a full injection from the second attempt.
The night I received my Moderna booster I started having back pain. The back pain has gradually gotten worse and now the pain is excruciating. It hurts to sit, walk, bend, twist, lift my legs, or tilt my head. This week my right side is numb and weak from my hip down to my feet. There is also a pain radiating down my right side.
I received my first dose on February 28th at 5:00pm. My right arm was incredibly sore the next day and I was fatigued. Symptoms lasted about 24 hours. I received my second dose on March 28th at 11:00am. My arm was less sore than the first time. Around 9pm I developed a fever, chills and body aches. I slept most of the next day and felt much better by the following evening. By Tuesday, March 30th I was fatigued/brain fogged but otherwise felt much better. On Saturday, April 17th I noticed three small itchy blisters on my left ribcage below my breast along with tingling on my left side. On Sunday, April 18th I did a telehealth appointment and was diagnosed with shingles. I took Valtrex for 7 days and after about 2 weeks the blisters began to heal.  My period was supposed to start on Wednesday, May 12th and usually lasts 5 days (end Sunday, May 16th).  This cycle I began spotting on April 30th and bled straight through to May 13th (approx 2 weeks).  I just completed my next cycle which came as expected on June 9th and ended 5 days later on June 13th.
her arm is sore at the injection site; This is a spontaneous report from a non contactable consumer (Patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 72 years). Medical history and patient's concomitant medications were not reported. On 05Aug2021 the patient had experienced her arm is sore at the injection site. It was reported that when she did the shot, it was wonderful and she could barely feel anything. After a while, it was sore and also reported that they scheduled her for another shot in two weeks for 25Aug2021. She would like to know when is the latest she can get the second dose. She will be out of town and wants to know if it needs to be done in 2 months, 3 months, 5 months, or whenever is the time frame she would need to have it done in or does she have to schedule another one. She did not wish to provide a mailing address or email and did not wish to complete report. She requested to be transferred to have her question answered. The clinical outcome was unknown.   Information on the lot/batch number has been requested
A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 07-Oct-2013. The patient experienced administration of expired dose which started on 07-Oct-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Numbness of legs, arm and face. Started as mild and each day progressively got worse. Went to hospital on 5/31/16. Also started to have fatigue, nausea, dizziness, and mouth drooping. No recent acute illness, surgery, or dental work. Required intubation on 6/4/16 due to worsening paresthesias. Dx with AIDP, Acute inflammatory demyelinating polyneuropathy (level of Guillain-Barre Syndrome.
asymptomatic until early Sunday morning Woke up coughing with nasal congestion. Did a COVID at home test  later that morning twice which came back positive. I?ve been out of work since then
FEVER; WEAKNESS; MUSCLE ACHES; FATIGUE; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th September 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 3rd July 2019, 5 hrs after receiving Shingrix, the patient experienced fever, weakness, muscle pain and fatigue. On an unknown date, the outcome of the fever, weakness, muscle pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, weakness, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced a fever between 104 to 106.5 degree F.  Less than a day after vaccination, the patient experienced weakness, muscle aches, and fatigue. These symptoms lasted 5 days.  The health care professional would like to know if the patient should receive the 2nd dose based off these reactions.  The reporter consented to follow up.
Patient previously received 2 doses of Moderna (02/27/21 and 03/27/21). Was given Pfizer as a 3rd dose booster
PATIENT PREVIOUSLY RECIEVED 1 DOSES OF PFIZER VACCINE AND THEN RECEIVED TWO DOSES OF MODERNA VACCINE.
Rash on thighs, itching all over and in eyes, nasal congestion, sore throat, body aches, chills, fatigue, groggy continuing through today 10/31/2014 and maybe longer.
Pt was clammy with dizziness, shortness of breath, weakness, nausea and dyspnea. Pt ended up in the ER. The flu shot was given at another facility (not through our office).
A non-serious report of expired dose of FluMist administered was received from a physician concerning a 31-year-old female.  No medical history or concomitant medications were reported.  The patient received FluMist vaccine on 05-Feb-2008.  The FluMist vaccine administered had an expiration date of 31-Dec-2007.  Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FluMist vaccine.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional information received on 04-Mar-2008: reporter confirmed patient did not experience any adverse events.
Tested positive for covid; Tested positive for covid; her first 2 doses were from Pfizer, her 3rd dose was Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (COMIRNATY), on 05Jan2021 as dose 1, single (Lot number: EK9231) and on 26Jan2021 as dose 2, single (Lot number: EL9261) at the age of 42 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2021, outcome "unknown", described as "her first 2 doses were from Pfizer, her 3rd dose was Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Oct2022, outcome "recovered" (14Oct2022) and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2022) positive, notes: She had tested positive for covid with an at home test; (14Oct2022) negative, notes: she tested negative for covid on 14Oct2022 with an at home test.  Clinical course: No other conditions and allergies to patient. The patient tested positive for covid after the covid vaccine. She had tested positive for covid with an at home test, it was taken on the 05Oct2022, she tested negative for covid on 14Oct2022 with an at home test.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events "COVID-19', 'vaccination failure', 'Interchange of vaccine products' and the suspect drug BNT162B2 cannot be excluded.
Sore Throat; Itchy Sensation; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) and PRURITUS (Itchy Sensation) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and PRURITUS (Itchy Sensation). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and PRURITUS (Itchy Sensation) outcome was unknown. Not Provided      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.   Concomitant medication were not reported by the reporter. Treatment medication was not reported by the reporter.