chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse and referred to 22 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose, and frequency were not reported; lot number M042822 with an expiration date 19-JUN-2018) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015158: US-009507513-1705USA011313: US-009507513-1705USA015157:
Swelling of face nose and throat; Swelling of face nose and throat; Severe panic bc of lack of air; Severe panic bc of lack of air; swelled lips mouth and nose; swelled lips mouth and nose; swelled lips mouth and nose; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Oct2021 at 09:00 (at the age of 39-years-old) as dose 2, single for covid-19 immunisation. The medical history was not reported. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), fluoxetine hydrochloride (PROZAC) buspirone hydrochloride (BUSPAR). The patient did not have covid prior to the vaccination. The patient was not tested for COVID post vaccination. The patient had no Known allergies and no other medical history. The patient did not receive any other vaccine in four weeks. The patient received first dose of BNT162B2 on 04Oct2021 (Location: Arm Right) at 09:15 AM for covid-19 immunisation. On 29Oct2021 at 22:00 the patient experienced swelling of face nose and throat, severe panic bc of lack of air and swelled lips mouth and nose. Therapeutic measures were taken as a result of swelled lips mouth and nose. No treatment received for swelling of face nose and throat and severe panic bc of lack of air. The patient reported swelling of face nose and throat Severe panic bc of lack of air Mainly, swelled lips mouth and nose Took Benadryl and seemed to help some No new foods ingested. The outcome of all the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started having chest pains, shortness of breath, and cold sweats.  Told my wife to take me to the hospital.  We went & they diagnosed me with a mild heart attack and advised me to seek a cardiologist.  I have met with the doctor, he had me do a stress test, which came back normal, he then scheduled for an echocardiogram, which also came back normal.  In fact the technician administering the echo was wondering why I was even there since she couldnt find any damage to my heart or any blockage.  I have a follow up appointment with the doctor tomorrow, 8/18/2021, to go over all my results.
Patient feel dizziness, nausea, arm pain 45 minutes after vaccine. Mom took her to ER. next day for a finger cut because of the dizziness.
No adverse event; Expired vaccine used; This spontaneous report was received from a consumer of unknown age and gender referring her/himself. Information about patient's pertinent concurrent conditions, medical history and concomitant medications was not provided.  On 19-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) as prophylaxis (concentration, vaccination scheme frequency, dosage, route of administration and anatomical location, lot number and expiration date were not reported) (experienced expired product administered). No additional adverse event was involved.
Slight muscle soreness; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to cases 2020SA293225 and 2020SA292917(same reporter).  This case involves a patient with unknown demographics who experienced slight muscle soreness (myalgia), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious slight muscle soreness afterward (myalgia), unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
10/22/02 10pm-tep 99.2 degrees. 10:30 99.4. 11:00-100.2. 11:30-100.1. Chills accompanied temperature elevation beginning at 10pm. Temp spiked again on 10/23 at 6pm-99.2.
I applied PPD test to left forearm and then gave Varivax, Menactra, and Gardasil, Patient wanted band-aid on PPD site because she didn't want to look at it. She became very pale and fainted onto exam table. She got up after a few second and took BP 130/30. Waited in office 30 min, BP 100/64. Stated she felt fine and went home.
This serious initial spontaneous case, was received from other non-health professional (consumer) on 27-NOV-2017, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered with INN (dose, batch number, expiry date, manufacturer, trade name, route of administration, anatomical location; not reported) for an unknown indication. On an unspecified date, after the vaccination, the patient woke up in middle of the night with sharp pain in right shoulder into chest and was diagnosed with pleurisy. The patient also had watery and itchy eyes. The outcome of the events was not reported. Case comment: Considering the limited information regarding the vaccination date, onset date of the event, the temporal latency, treatment received and any other contributory factors, the company assessed causal role of the vaccine as unassessable. The assessed the event pleurisy as serious (medically significant).
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 23-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009788, expiry date: 17-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012657, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
States noted right jaw pain at the joint area (tempors1-mandibular area) after administration. Aggravated with opening mouth wide with chewing. Also noted with pressure toward right ear when lies down. States still has discomfort today, though lessened in nature (approximately 3 weeks duration). States taken Advil for relief. Lessening/ improving symptoms.
Inappropriate age for Vaccine Administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for Vaccine Administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for Vaccine Administration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for Vaccine Administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include high blood pressure medications. Treatment details included Tylenol.   This case was linked to MOD-2021-052934 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up email added, Patient age updated, Inappropriate age for Vaccine Administration
Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache, chills Day 3: fatigue, raised area, itching in the arm, pain in arm Day 4: nausea, diarrhea, itching in arm, raised bump at injection site, itchy throat, cough, runny nose
On 3/23/02, office call, AOM/Bronchiolitis, apnea, hand nebulizer. Admitted to hospital on 3/31/02 with epilepticus, aspiration pneumonia and respiratory failure. Pt also had a fever. Pt has had long hospitalization, over 5 weeks, was discharged from ICU on 4/24/02. Pt was on aspirator and ventilator over 4 weeks. Pt with decreased movement of extremities but improving. Will need outpatient treatment.
Within 15-minutes of vaccination, the patient reported shortness of breath and difficulty breathing. EMS managed the patient's care on-site. No further documentation has been provided on the patient's treatment or outcome.
I developed chest pain within a week of vacation.  I thought it was acid reflux. Pain worsened. Went to er multiple times. Had elevated heart enzymes, abnormal ekg . Started having severe cardiac Vaso spasms admitted to hospital. Many test and many medications later we are sure my myocarditis was caused by vaccine booster
first dose 15Jul2020, has not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: The patient had not yet received the second dose of Shingrix.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not received the second dose which led to incomplete course of vaccination.
Moderna COVID 19 Vaccination administered IM L deltoid. Client stayed 30 minutes for observation. Left and approximately 15 minutes later experienced numbness in tongue and neck area-felt like throat was constricting. Drove self back to clinic with epi and benadryl  administered IM and oxygen placed at 8l. Blood pressure 170/98, HR 108. States felt better but after approximately 15 minutes became flushed and felt like it was returning. Left with practicing MD & NP to go to ER.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-SEP-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # reported as M022947, expiration date 12-NOV-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 68 degrees Fahrenheit for 50 hours. Data logger was involved. Additional information has been requested.
Had shot 11/12/2020.  Woke up at 4:00 am  11/13/2020.  I tried to get up and fell back into the bed.  My head was spinning, I couldn?t see and I couldn?t move??.  I tried reaching my phone but I couldn?t because it felt like I was going to throw up!  It felt like someone was pushing me holding me down and my limbs felt like jelly and I was very dizzy and couldn?t see.  I laid there terrified but couldn?t even call 911.  I panicked and after a period of time fell back  to sleep,  I then woke up at 7:00 am still unable to walk.  I had to use the bathroom so I forced myself up and held on to the bed, doors and walks finding my way to the bathroom.  I was terribly nauseated too.  That day I couldn?t even watch tv because I felt so nauseous and dizzy.  The following day 11/14/2020 and 11/15/2020 I was still nauseous.  Today 11/16/2020 I felt a little better but not perfect yet.
pt recvd vax 10JUN93 & 11JUN93 pt exp numbness, tingling, swollen lymph nodes, lightheadedness w/dizziness, nausea & some rather weird & vague reaction; MD felt these reactions could have been due to anxiety react; pt ingested 100 pills;
2 hours after vaccination, pt is feeling disoriented & lightheaded during lunch.  BP 170/110.  After 10 minutes lying down BP 200/130.  Said he is on BP meds & was anxious getting shot.  Pt refused to have EMS called.  He was advised to f/u with primary Dr. today.  His wife agreed & pt left w/o assistance.
1. Low grade fever more than 99.2 after 5hours 2. Both  Knee pain and burning whole night  3. Lower back pain right hip and right thigh
This is a spontaneous case, initially received from other health professional on 24-Jan-2019, concerning a male neonate patient. The patient's mother was a 30-year-old female with height 160 cm and weight 65.77 kgs. The patient's mother had no previous pregnancy. The patient's mother had no history of offspring with major congenital malformation. Also, the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The last menstrual period (LMP) date of the patient's mother was 12-May-2018. The type of pregnancy was singleton. The pregnancy status of the patient was collected, and no pregnancy complications were noted. On 10-Aug-2018, the patient's mother underwent prenatal tests for cystic fibrosis which revealed no major congenital malformation. On the same day, 1st trimester screening was also performed and was noted that the patient was positive for the risk of Down's syndrome. On 18-Aug-2018, non-invasive prenatal testing (NIPT) was performed, and no major congenital malformations were noted. On 08-Sep-2018, 2nd trimester screening was performed, and no major congenital malformations were noted. Concomitant medication included Vitafol one for healthy pregnancy. On 06-Oct-2018, at approximately 21 weeks of gestation, the patient's mother received FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, batch number: 252232, dose, route of administration, anatomical location, expiry date: not reported) for an unknown indication. The patient was exposed to the vaccine via transplacental route (explicitly coded as foetal exposure during pregnancy). On an unspecified date, after administration of vaccine, the patient's mother developed constipation and haemorrhoids. 3 months and 10 days after vaccination, a male infant was born via vaginal type of delivery with weight 2.34 kg (reported as low birth weight) at 35.7 weeks gestational week (reported as pre-term birth), length 44.5 cm and head circumference 30.5 cm. The APGAR (appearance, pulse, grimace, activity, and respiration) scores were 9 (one minute) and 9 (five minutes). At the time of this report, the outcome of the events was unknown. This case is linked to (201805958), the corresponding maternal pregnancy report.; Reporter's Comments: A neonate had preterm birth with low birth weight, more than 3 months after fetal exposure during pregnancy to FLUCELVAX QIVc. The event preterm birth have multifactorial aetiology. Considering the implausible temporal relationship between vaccination to events onset and no known biological mechanism post-vaccination, the event preterm birth with low birth weight were assessed as not related to suspect vaccine. The high risk of down syndrome during pregnancy screening can be other possible risk factor. The event foetal exposure during pregnancy was considered as not related to suspect vaccine considering the intended use of the vaccine. Company assessed the case as serious (medically significant).
On 5/19/2022, I began to have a scratchy throat and a little nose congestion. A couple of days later, my stools became pasty, but I don't know if this was the result of the DayQuil I had taken or COVID-19. I went to the doctor on 5/24/2022 to get tested for COVID, and the result was positive. At the time of this writing, I have just a tinge of a sore throat. I also still a little bit of congestion, though not as much as yesterday. I haven't had a fever or muscle aches at any time during my bout with COVID. I also haven't had a loss of taste or smell. My symptoms are so mild that I haven't felt the need to use an antiviral.
This spontaneous report was received from a nurse refers to a patient of unknown age. Information regarding patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021719, expiry date: 10-AUG-2019 for prophylaxis (dose and route was not reported). It was reported that VARIVAX was exposed to a temperature of 6 degree F to 14 degree F for one hour and 15 degree F to 46 degree F for 7 hours. It was reported that there  was no previous temperature excursion. The sterile diluent used for reconstitution of VARIVAX was properly stored. No adverse effects were reported. There was no product quality complaint (PQC) involved. It was reported that  call was because of a data logger.
This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with an improperly store dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA002653: US-009507513-1710USA011218: US-009507513-1710USA011215.
Report a side effect; 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 (Report a side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Extreme Fatigue; Pain moved from one shoulder to the other, down her spine and tail bone; Red Flushing of the Face; Red Flushing of the Face; Severe Headache; Severe body ache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Red Flushing of the Face), ERYTHEMA (Red Flushing of the Face), HEADACHE (Severe Headache), MYALGIA (Severe body ache) and ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (never did a PCR test to confirm that in fact she had COVID-19 in 2020.) in 2020.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced FLUSHING (Red Flushing of the Face), ERYTHEMA (Red Flushing of the Face), HEADACHE (Severe Headache) and MYALGIA (Severe body ache). On 22-Jul-2021, the patient experienced ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone). On 24-Jul-2021, the patient experienced FATIGUE (Extreme Fatigue). The patient was treated with TYLENOL for Pain, at an unspecified dose and frequency. On 21-Jul-2021, FLUSHING (Red Flushing of the Face) and ERYTHEMA (Red Flushing of the Face) had resolved. At the time of the report, HEADACHE (Severe Headache), MYALGIA (Severe body ache), ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone) and FATIGUE (Extreme Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Two weeks after vaccination, the patient visited her doctor's office. The ARNP told her that some spike protein may have deposited into her joints, that is why she is having so much pain. Also the ARNP told her that because she had COVID-19 Disease early on, she had this reaction to the vaccine and experienced severe side effects. ARNP prescribed Anti-Inflammatory medication which helped with the pain. But the patient states that she is still aware the problem is there, even after taking the anti-inflammatory medication. Patient stated that she was very unhappy.
Patient developed redness, inflammation from shoulder down to elbow.  Also complained of fever, chills and headache.  I believe it to be cellulitis.   Making appt with MD