chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 21 August 2009 from a health care professional. A 13-year-old female patient, with unknown medical history, had received a dose of MENOMUNE (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. On day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provider for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009; however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Documents held by sender: None.  10/2/09 Hospital records received DOS 8/15/09 to 8/18/09. Assessment: Viral syndrome, gastroenteritis. Patient presents with a history of myalgias and fever. Back pain, headache. muscle aches involving back, legs, knees, ankles, feet and neck. Nothing po for 2 days. Nauseated. Cough, chills, eyes hurt and swollen. Erythema cheeks and shins. Abdominal pain.  10/2/09 Hospital records received DOS 8/21/98 to 8/25/09. Assessment: Viral meningitis. Prior admission for presumed viral illness. Patient c/o worsening headache and back pain. Vomited, fever, loose stools. Bothered by sounds, light and smell. Cough. Macular rash on chest, arms, and cheeks. 1/13/09 Medical records received. PMD notes for DOS 6/9-8/21. . Sports physical. Vaccines given. H/O sinusitis.  Approx 2 months later emesis, worst HA of life. Possible prolonged viral illness.ED visit.  CT head neg. To be admitted. LP planned.  Follow up information received on 18 September 2009 from a health care professional who reported that the patient was diagnosed with viral meningitis. Lot number was provided for MENOMUNE, UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
For the entire night after getting the vaccine I was the most sick I have EVER been. Fever of 103, vomiting profusely, diarrhea, chills. It was terrible. Then for the next week I had a headache that felt like someone hit me with a hammer between my eyes. I get tested weekly for corona and have always tested negative... I had a negative result the same day I got the second dose of the vaccine as well. All I know is that I NEVER want to feel like that again ?? my lungs still bother me and it?s a month later
Patient got 1st Moderna vaccine 4 days before 18th birthday. He did not sustain any adverse reaction. The patient was not available to be informed, but his guardian (aunt) has been informed of the error. An investigation took place and interventions are in place to prevent a recurrence.
After a few hours I started to feel ?off? and then after about 8 hours my headache started, my arm hurt so bad I couldn?t move it, and I started to have to spins. The spins gradually got worse and so bad to the point where walking became difficult. Even after a good nights sleep I continues to have terrible spins abs body aches. It took over 24 hours for them to get better but over 72 hours to go away
Within 8 hrs aches, fever, and lethargy, over 2 days. By end of second day temperature returned to normal.
she's been very ill since then; It started as normal aches, but then it evolved into pain and vomiting; It started as normal aches, but then it evolved into pain and vomiting; She now has rash, itch, and her skin is ripped open; She now has rash, itch, and her skin is ripped open; She now has rash, itch, and her skin is ripped open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she's been very ill since then"; PAIN (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "It started as normal aches, but then it evolved into pain and vomiting"; RASH (non-serious), PRURITUS (non-serious), SKIN LACERATION (non-serious), outcome "unknown" and all described as "She now has rash, itch, and her skin is ripped open". The events "she's been very ill since then", "it started as normal aches, but then it evolved into pain and vomiting", "it started as normal aches, but then it evolved into pain and vomiting", "she now has rash, itch, and her skin is ripped open", "she now has rash, itch, and her skin is ripped open" and "she now has rash, itch, and her skin is ripped open" were evaluated at the emergency room visit. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt filled dizzy, light headed and became pale.  Provided immediate treatment. Pt got better before 911 arrived.
her adverse event as having absolutely no saliva at all about 2-3 minutes later after getting the COVID-19 vaccine; did not have a good night's sleep; anxious; This is a spontaneous report from a contactable consumer reporting for herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown reported as "EL9281 or EL9261" as the reporter cannot tell, pending clarification, expiry date: 31May2021), via an unspecified route of administration on 28Jan2021 12:00 at SINGLE DOSE (first dose) for covid-19 immunisation.  Medical history included COPD from an unspecified date (not taking any medication for COPD) and she was 5'5 and has gotten a little bit tinier on an unspecified date. The patient's concomitant medications were not reported. On 28Jan2021, the patient stated everything was perfect and she was made to sit there for 15 minutes. The patient reported her adverse event as having absolutely no saliva at all about 2-3 minutes later after getting the COVID-19 vaccine. Her mouth stopped producing the saliva almost immediately and it was total. She stated she never had anything like that before. She stated it did not make her feel ill. She was still breathing alright, so she did not tell anybody.  She did not have a good night's sleep and anxious about whether she won't be able to breathe with this experience. At 07:00 the next day, everything went back to normal and it was very noticeable for her. She was concerned about taking the second shot in 3 weeks considering her experience with the first shot. The patient stated afterwards that the information provided to her helped her to be relived and be confident about taking the second shot. Outcome of the event was recovered on 29Jan2021 07:00.   Information on the lot/batch number has been requested.
This was her second/last vaccine given after 6 months from the first vaccine. She had blood drawn prior to the vaccine while fasting, but was fine after the blood was drawn. Then they gave her the vaccine and she fainted within approximately 15 seconds after injection. She began to breathe heavily and shake, and then came back into consciousness and was pale in the face, and slightly warm. She was weak for a couple of hours after that, and then back to her normal self. She also developed a blister at the injection site.
Prior to my vaccines February 2021 I began to have heart palpitations I had issues with getting into a doctors office. I had to wait to see my cardiologist in March 2021, They did blood tests and Holter monitors showing everything was fine except my thyroid levels. I then met with cardiologists in May 2021 and I was originally taking the generic brand of Synthroid  and I was then after meeting my cardiologist, given name brand Synthroid and my thyroid level stabilized however the heart palpitations continued. The palpitations continued and are still continuing today. Metoprolol was given and it seems to help a lot with my palpitations. I had another Holter monitor test in April 2022. I have had two major life events. My husband had a stroke June 4th 2021, we had caregivers,  on April 13th, 2022 he had a heart attack and passed away. During this time however my Holter monitor never showed any issues. I am still experiencing higher heart rates still to this day.
Pediatric Pfizer dose: Product was not diluted before administration. No symptoms reported as of the time of this report.
This spontaneous report as received from a medical assistant refers to a 8 week old female patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was invloved. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA010964: US-009507513-1807USA006807: US-009507513-1807USA006809: US-009507513-1807USA006810:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. Concomitant medication(s) included: OTEZLA, start date: 06Sep2017, stop date: 24Jul2022.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: 3 days after finishing paxlovid; (unspecified date) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received treatment of COVID-19 with Paxlovid from 08Jul2022 to 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Starting 2 days after my second Pfizer vaccine and continuing to present (one month later) I'm  experiencing an unpleasant smell that I an best describe as 'metallic sweet burnt corn' when I smell raw onions, basil, or organic matter like feces (I have a baby so I smell this when I change her diaper, or when I go to the bathroom), compost, or my own arm pits when sweaty. I believe this to be "parosmia" as no one else can smell it and it just started after my second vaccine.
On 8/29/09- morning Pt noticed a swollen area on her left deltoid measuring 2 1/2 diameter.
Body aches; Nauseous; fever 100.9; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), NAUSEA (Nauseous), PYREXIA (fever 100.9) and FATIGUE (fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B214) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body aches), NAUSEA (Nauseous), PYREXIA (fever 100.9) and FATIGUE (fatigue). At the time of the report, PAIN (Body aches), NAUSEA (Nauseous), PYREXIA (fever 100.9) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 100.9 (High) fever of 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
patient got vaccine on saturday, on wednesday she woke up with an aura and was unable to see in one eye, after 6 hours she could see shadows out of the eye and the problems resolved overnight and she was fine on thursday
Swollen lymph node on my left collar/ Others on left side around armpit and neck swollen.; Swollen lymph node on my left collar bone that was painful; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9263) via an unspecified route of administration in the left arm on 22Mar2021 at 09:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol high and seasonal allergy (going through allergy shots for seasonal allergies). Concomitant medications included allergy shots from unknown date. The patient previously took morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced swollen lymph node on the left collar bone that was painful. Others on left side around armpit and neck swollen which was still swollen but no longer painful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful lymph nodes was resolved on an unknown date in Apr2021; while that of swollen lymph node on my left collar bone and others on left side around armpit was and neck swollen were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, reporter reiterates that because the facility was unable to download the digital data and reporter also stated that they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State. Reporter did not stated that no adverse reactions were reported by any Patient.   No treatment medication was provided.
Woke up in middle of night 8/26 with stomach pain and nausea.  Headache later in the day. 8/28 and 8/29 Moderate Diarrhea.
she was getting soreness in her muscles that continued throughout the night; neck was becoming sore with some pain in her collarbone area; her warm was "very, very" sore and could not even lift it; feeling like "swollen jelly gland" and "pea size."; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported, expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included endometrial cancer, COVID-19 twice - once in May where she was asymptomatic and the second time in July, respiratory disorder where she had "every symptoms but respiratory problems" and was subsequently hospitalized and given steroids. The patient's concomitant medications were not reported.  The patient experienced little sore, getting soreness in her muscles (myalgia) on the day of vaccination, neck was becoming sore with some pain in her collarbone area, her arm was very, very sore and could not even lift it (pain in extremity), feeling like swollen jelly gland and pea size. (lymphadenopathy) on the next day of vaccination with the outcome of unknown.  Information on the lot/batch number has been requested.
Initial unsolicited report received from a physician on 14 April 2016. This case involves a 74-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HD batch number UI434AA, expiry date 04 April 2016, intramuscularly in the left deltoid on 30 March 2016 at 8:30 am. The patient also received a 0.5 ml dose of PREVENAR 13 batch number M56417, expiry date 01 June 2017, intramuscularly in the left deltoid on 30 March 2016 at 8:30 am. It was reported that no other vaccines were given within four weeks prior to the vaccination date. The patient had a medical history of arthritis (localized in left knee, Osteoarthritis of left and right knee, from 30 Mar 2016 which was ongoing), type 2 diabetes mellitus (from 30 Mar 2016 which was ongoing), hypertension (from 30 Mar 2016 to ongoing), immunization reaction (from 08 April 2016 to ongoing), obesity (unknown date, unknown outcome), endometrial cancer (unknown date, unknown outcome), lipoma (unknown date, unknown outcome), foot pain, vitamin D deficiency. The patient had no known allergies. Concomitant medications included Benazepril for hypertension (10 mg, one tablet daily by mouth, from 06 August 2013 to ongoing), Glipizide for Type 2 diabetes mellitus (5 mg, one tablet twice a day by mouth, from 05 April 2016 to ongoing), hydrochlorothiazide for Hypertension (25 mg, one tablet every day by mouth, from 13 January 2014 to ongoing), fish oil for health maintenance (1000 mg, one capsule daily by mouth, from 28 April 2011 to ongoing) and calcium for health maintenance (500 mg, one tablet per day by mouth, from 11 October 2012 to ongoing). On an unspecified date, following the vaccination, the patient experienced left arm was hurting and could barely lift it at times (she had severe pain to left upper arm), pain into her neck (arm pain was moving into her neck), swelling and possible nerve irritation due to the injection. Patient had no lab data (relevant tests). The patient received corrective treatment with over the counter pain medicines, tramadol and physical therapy. The patient required doctor visit. The outcome for the events was reported as recovering (swelling had improved, there was some improvement in the original symptoms but she still had left upper arm pain). The reporter assessed the causal relationship with suspect vaccines as related. List of documents held by sender: none.
Patient received HIB vaccine in office that had a good expiration date on the actual vaccine and an expired date on the diluent.  Manufacturer contacted and HIB vaccine is invalid due to diluent beyond use date.  Patients mother contacted and is aware of the expired vaccine that was given and that the dose given is therefore invalid.
Urination bleeding; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Solution for injection, lot number and expiration date not provided), via an unspecified route of administration at single dose on 22Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced urination bleeding in Dec2020 and wanted to know if it was going to be a side effect. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Information has been received from a health professional concerning a 12 month old female with no past medical history who on 01/11/2002 was vaccinated with the first dose of varicella virus vaccine live SC in the left thigh. Concomitant therapy that same day included the third dose of Prevanr IM in the right thigh. There was no illness at the time of vaccination. On 01/24/2002 (previously reported as ten days post-vaccination), the pt developed a rash on right thigh  at site of injection which was noted to be 3 small vesicles filled with fluid. It was noted that the pt's mother called the physician's office on 01/25/2002 and reported that the pt had 2 fluid filled "pimple" on the left thigh at insertion site of vaircella. It was noted that they crusted over. The pt was afebrile and did not have any signs or symptoms of illness. The pt recovered 01/28/2002 or 01/29/2002. The pt sought unspecified medical attention. Additional info has been requested.
Booster; Off label use; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 130130814) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14May2022 at 12:00 as dose 4 (booster), single (Lot number: 056m2/h), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Controlled high HBO" (unspecified if ongoing), notes: Other medical history: Controlled high HBO; "Cholesterol" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Moderna: vaccine dose number: 4/Pfizer / BioNTech: vaccine dose number:3. The patient took concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 14May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 14May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.