chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom reported began vomiting at 3AM on 12/30/06. Temp 101 (orally) saw MD two days later and was admitted to the hospital with "flu and bronchitis". See attached.  4/24/07 Received D/C summary w/VAERS report which reveals patient experienced severe diffuse cough, earache, flu-like symptoms, nausea & vomiting for 3 days prior to admit on 1/8/07-1/11/07.  Had been treated as outpatient for several days w/antibiotics & neb tx w/o improvement.  Temp on admit was 100.8, resp 32.  Exam revealed wheezing & rhonchi.  Treated w/IV antibiotics & nebs.  Continued to have significant bronchospasms until Atrovent added to nebs & fevers of 102-103 until placed in mist tent.  Treated for bacterial appearing conjunctivitis.   Wheezing resolved by d/c but had continued cough.  Continued on nebs, cough meds & antibiotics upon d/c. FINAL DX: influenza Type B, community-acquired pneumonia associated w/influenza, allergic bronchial asthma and respiratory distress.
After administration of HPV9 (1st dose) and FLUMIST (2nd dose) patient woke up for 2 nights complaining of severe headaches.
difficulty breathing; vision issues; cloudy and fogginess; vomiting; While in the hospital she was stated to have been on 100% oxygen, couldn't breathe at all; A spontaneous report was received from a 50-year-old female patient.  The patient's medical history included Lupus, and COPD. Products known to have been used by the patient, within two weeks prior to the event, included Salbutamol Sulfate, Alprazolam, Lisinopril, Ezetimibe, and Pantoprazole Sodium Sesquihydrate.  On 31 Dec-2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot unknown) by injection (site not provided) for prophylaxis of COVID-19 infection.   On 31-Dec-2020,  the patient developed difficulty breathing, vision became cloudy/foggy and vomiting. The patient spent New Year's day in the hospital (admission and discharge date and times were not provided), she was treated with 100% Oxygen, Zofran and Morphine. The patient also had nine symptoms while she was in the hospital however details were not reported.   Action taken with mRNA-1273 in response to the events was unknown  The outcome of the events were unknown.; Reporter'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.
A non-serious spontaneous report of administration to a 69-year-old and fatigue has been received from an other health professional concerning a 69-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 23-Sep-2010 for an unknown indication. On 23-Sep-2010, the patient experienced fatigue. Treatment information was not provided. The event of vaccination error resolved. The outcome for the event of fatigue was not reported.
I started feeling achy around 9:00 pm and felt like I was going to get more ill. I took some Tylenol in hopes it would help but it got worse throughout the night. During the night, I couldn?t hardly sleep due to feeling really hot and achy. I felt like I had a fever but did not have a thermometer to check it. When I woke up this morning, I noticed I had a knot on my clavicle which I believe it to be a swollen supraclavicular lymph node. I was unable to go to my internship today due to feeling ill but I am feeling better now after sleep and medication.
Flu-like symptoms; This is a spontaneous report based on the information received by Pfizer. A non-contactable nurse reported similar events for two patients (herself and her husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Reporter states she was speaking to a friend of hers last night, who is nurse who told her that both she and her husband, who is a Physician's assistant, experienced flu-like symptoms after receiving their second dose of Pfizer COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021222420 same reporter/drug/event & different patient
PEDIATRIC PATIENT WAS GIVEN PEDICATRIC PFIZER COVID 19 VACCINE  0.2ML WITH OUT DILUENT.  PT AND MOTHER STAYED FOR 15 MINUTE OBSERVATION TIME NO ADVERSE REACTION REPORTED DURNING 15 MINUTE WAIT TIME.
intense arm pain radiates up into shoulders and down other arm.  Very painful.  Lasted 2 weeks
I have been taking Benlysta infusions for 5.5 years and I have never had an allergic reaction until 5/25/21. The only thing different in my body was the Janssen Vaccine. Midway through my IV I started itching, numbness in my fingers, lips, and feet. My face was on fire and my tongue was swelling and I could feel my throat closing. My arms turned red and blotchy and swelled. My nurse stopped the Benlysta and started Benadryl and a saline flush. The symptoms then went away.
Right arm vaccinated. Within 36 hours, large knot around site, swelling, hurt. Within 3 days, lymph nodes swollen. I had fever, site hurt. I had a hard time moving my arm without pain. Then I got severe ear infection.
No additional AE; Inadvertent exposure to vaccine; Accidental needle stick; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 28-FEB-2023, the patient's daughter was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 ml, lot #W027250, expiration date: 09-JUL-2024, administered for prophylaxis (strength and route of administration were not provided), after administration the nurse attempted to put the safety on the needle and the entire luer lock snapped off. The needle that was still attached to the luer lock punctured the patient, who was holding her child who had just received the vaccine, in the leg (accidental exposure to product) (injury associated with device). No additional adverse event reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA000493:
pt recv vax 9APR97 & 24APR97 pt devel chickenpox w/15 lesions;
Tested positive for COVID-19, resulted in hospital admission. Symptoms include fever, subjective fever, chills, cough, and shortness of breath. The patient developed pneumonia, acute respiratory syndrome, and admission into ICU.
I have had full body hives over all of my skin that have been present from 12/19/22 through to today (2/13/22). The hives are incredibly itchy. For the first month I have also had diarrhea. When the hives are flaring up I also have nausea. I had nausea with vomiting on 1/16/22. The hives negatively impact my ability to sleep, creating severe fatigue. I was initially prescribed a 6-day course of prednisone (40mg, 40mg, 20mg, 20mg, 10mg, 10mg), which I started on 12/23/21 and had no effect on the hives. The hives are responsive to Benadryl, and I took two 25 mg Benadryl tablets (for a total of 50mg) every four hours in the first 7-10 days of the reaction. After that point I would take 1-4 25mg Benadryl tablets a day as needed. During only the second week of the reaction I also had intense vertigo. After about six weeks I saw a decline in the number, frequency, and intensity of hives, although they are still present. I have been able to treat the hives with Claritin or Zyrtec after the 6-week point instead of Benadryl. Previous to the 6-week time point, Claritin would not reduce the hives enough to where I would not also need to take Benadryl. I have only tried taking Zyrtec starting 2/12/22 and have found it to have a similar effect as Claritin. I continue to have nausea whenever the hives flare up. Throughout the entire reaction, hives have come and gone quickly, usually staying in one place for about 20-30 minutes at a time. They move around rapidly on my skin. I saw a primary care physician and an allergist for this complaint. I was not able to see an allergist until 2/10/22, and she indicated that she believes this reaction is from my Moderna Covid-19 booster shot on 12/9/21. She stated that the hives may disappear on their own or may develop into a chronic condition that waxes and wanes and may have future flare ups. She had no recommendations for treating the cause of this problem. She recommended Zyrtec for symptomatic relief.
since 12/31/2020 experiencing Dizzy, Lightheaded, Chest tightness, nausea, Diarrhea , dry mouth, dry throat, chills, swollen lymph nodes, symptoms progressing
Adverse Reaction: Eight hours after receiving the injection I felt a burning sensation in the groin and scrotum.  The scrotum turned bright red in color and the testicles swelled.  The inflammation and swelling continued overnight until 07/10/21 when it later subsided.  The scrotum and testicles remained sensitive but without inflammation until 07/11/21.   Additional symptoms: In addition to the adverse reaction I experienced a fever of 101 degrees from 07/09/21 through 07/11/21.  I experienced an extreme headache, nausea, dizziness, fatigue, muscle pain, and swelling of the injected arm which started 3 hours after the injection until the end of the day on 07/11/21.
Myalgia, Fever, chills Narrative:  Per nursing report: "had 2nd dose of Moderna yesterday [3/15]. C/o flu-like symptoms with fever, chills and body aching. States will not be at work today due to not feeling well."  Other Relevant History:
Patient died at home on 8/12/2006. Patient was cosleeping with parents. Breastfed at 3am and found dead next to mother at 6am, according to her mother. Autopsy ruled cause of death as undetermined.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 12:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 12:11 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.35. Concomitant products were not provided. On 27-Feb-2021, Excursion time was 09 AM, 11 AM, 12 PM,1 PM, 2 PM, 3 PM, 4 PM, 5 PM, temperature was 33, 35, 35, 35, 35, 34, 34, 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 27-Feb-2021, 28-Feb-2021, 02-Mar-2021 and 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 27, 27, 51, 10 AM: 36, 40, 29, 34, 11 AM: 35, 44, 32, 44, 12 AM: 35, 46, 33, 46, 1PM: 35, 26, 36, 35, 2 PM: 35, 37, 35, 36, 3 PM: 34, 43, 36, 36, 4 PM: 34, 45, 37, 36 and 5 PM: 35, NA, 37, NA. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
No AE; mishandling of the product; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  In April 2021, there was a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. On 28-MAY-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026168, expiration date was reported as 04-DEC-2022; site and route of administration were not reported) for prophylaxis. There was no previous temperature excursion/ No digital data logger was involved. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005005: US-009507513-2106USA005001:
Fever between 100-101, nausea, abdominal Pain, injection site pain and redness
Patient returned to the pharmacy shortly after receiving the vaccine around 12:55 pm. She complained of generalized itching and she was rubbing her throat and mildly coughing. 911 was contacted and a single dose 25 mg Benadryl solution was administered at 1:00 pm. The patients itching increased and she couldn't tell if her throat was swelling. By 1:06 pm, the patient started to calm down and the itching decreased. EMTs arrived by 1:10pm and continued to monitor the patient. No additional medication was given. EMTs left around 1:30 pm and patient left with her husband.
Pt received vaccine (1st dose, Pfizer lot #EW0185) at 9:42 am and was seated in observation area. Patient raised hand and told observation/charge nurse her stomach hurt and she wanted to use the restroom. When asked to describe pain, pt stated she felt a little nauseous. The pt also stated she felt sick before getting the vaccine. The nurse accompanied to the patient to the restroom, and pt used the toilet. When pt came out of the stall, the nurse asked if she was feeling better. Pt stated her stomach still hurt, and she wanted to go to the school nurse's office. Charge nurse escorted pt to school nurse's office. The nurse stated "oh, we know her," and told charge nurse pt had frequent abd pain. Charge nurse left pt in care of school nurse and returned to vaxxing area. Nurse who administered vax to pt stated to charge nurse that the pt told her her stomach was hurting when she asked if she was well, and that it was an "ongoing thing," and she was getting an ultrasound for it Friday. Pt had no fever and no other complaints, but stated she was "only getting the vaccine because my grandmother wants me to." One-half hour later, school nurse came to auditorium asking if charge nurse could speak to pt's GM. Per school nurse, pt's GM had picked pt up from school d/t stomach complaint and now was on the phone with a question about vax SEs. Charge nurse spoke with GM on the phone. Per GM, pt had vomited x 1 and her ears were "very red." GM stated pt had recent issues w/ vomiting, but was concerned that pt's ears were red. GM denied any itching, rash, SOB, voice changes, dizziness, redness or weals anywhere else, or other symptoms of concern. Advised GM to give pt benadryl following dosing instructions on bottle, give her small sips of water and bland food as tolerated, and monitor pt at home. If pt's condition worsened, GM should take pt to UC/ED immediately for assessment. GM agreed w/ plan of care.  At 2:30 pm, the school health director emailed the school site coordinator and told her the "student had an adverse reaction after today?s vaccination. She is currently in the emergency room and the docs believe it is definitely an allergic reaction to the vaccine. ....She did speak with your NP who was on-site this morning after she was dismissed to home, and advised to take Benadryl. Symptoms worsened and she went to ER where she received 2 doses of epi." Charge nurse reached out to school health director for information on where pt was treated to call for a report of symptoms prompting the epi intervention, but had not received a reply at the time of this report.
Patient experience NO adverse events after receiving the 1st dose of Pfizer Covid19 vaccine per his mom.  However, he was under the approved age to receive this vaccine (he is 11 years old).  When his father filled out the Vaccine Consent Form online, he put the year he was born as 2008 vs. his actual birth year of 2009.  When I called to confirm his birthday on 8/4/21 after I was notified of an age discrepancy, he told me the same as on the consent form.  However his mother called the pharmacy a short time later and told me that his actual date of birth.
PATIENT PRESENTED WITH WHAT APPEARED TO BE CELLULITIS OR SHINGLES ON HER FACE ON 3/6/2019.
Extreme nausea and moderate stomach pain that is still ongoing 6 days after first injection. The nausea is keeping me awake at night and I have strong food aversion. I?ve forced myself to eat toast or ramen a few times to take medication, but otherwise I don?t want to eat. I had chills and an achy body in addition to these other symptoms but those went away after 48 hours but the nausea and stomach pain continue.
On 2/22/03, pt c/o syncope,dizziness,lightheadedness,headache,neck pain,fever,generalized weakness, and urinary retention.  Now with weaknes and numbness in legs. Diagnosed: acute disseminated encephalomyelitis likely secondary to anthrax vaccine.  Treated with steroids and physical therapy. Awaiting transfer to Hospital . The 60 day follow up states pt was transferred to hospital.  Annual follow up on 03/24/04: "It is unknown if the pt recovered from adverse events.  Please contact the US Army."
pt recv vax 13FEB97 & pregnancy test indicated pt pregnant (LMP approx 10APR97);@ approx 10 3/7wk of pregnant pt underwent an IVP;pt exp unexplained, intermittent abd pain approx 33wk into pregnancy & tx w/med;2JAN97 @ 38wk gestation pt del
I have COVID-19; I have COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Interchange of vaccine" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
full blown seizure and had several since then; little mini twitches on her face; This is a spontaneous report received from a contactable consumer reporting for his mother in law. An 89 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Feb2021, for COVID-19 immunisation. Medical history included pacemaker ongoing from 2015 and open heart surgery several years ago. The patient was very strong and lucid and could remember everything from the past. This lady was small. Until recently, she never took meds. Concomitant medications included alprazolam (XANAX) taken occasionally at 0.25 mg and maybe omeprazole (PROTONIX) for cholesterol. 2 to 3 days after the first vaccination, on an unspecified date in Feb2021, the patient started having little mini twitches on her face. They thought nothing of it. On the fifth day (in late Feb2021 or early Mar2021) she had a full blown seizure and had several since then and was hospitalized for like 20 days the first time. The reporter thought the patient had a total of about 4 or 5 seizures. When she experienced another seizure, they took her back and she was in the hospital for about 5 or 6 days, then released her. She had been back twice since then. The last time, they took her late at night and was out in the morning. That last time, she was not admitted. She was hospitalized at least 4 times, maybe a week or two apart, each time, all at the same hospital. They could not find out what was wrong with her. They put her on anti-seizure medication. They had tried several (the reporter thought more than 2). It was really a lot worse. It was really bad on her. The medications they had been giving her had really thrown her for a loop. They now believe she was way over medicated and sitting at home. They suggested for her to see a neurosurgeon who won't see her until the end of May. She had been having seizures and never had before. Seizures required ER visit. Events outcome was unknown. The hospital said they would give the second dose but they never did. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501795 same drug/patient, different vaccine dose/AE
dizziness noted when pt presented for annual physical exam also reported dyspnea. EKG done in office-revealed-pericarditis