chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a literature source concerning a patient of unknown age and gender, enrolled in an unsponsored/ non-interventional/post-marketing study. The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between 01-Sep-2003 and 31-Mar-2013. Based on prior reports and biologic plausibility, 18 medically attended health outcomes were examined, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Using self-controlled case series analyses, incident rate ratios (IRRs) were calculated for each outcome.   During 2003-2013, 396173 children received 590018 doses of LAIV. For 124529 (21. 1%) of LAIV doses, other vaccines were administered on the same day. Five outcomes (anaphylaxis, non-anaphylactic allergic reactions, Stevens-Johnson syndrome (SJS), syncope, and respiratory failure) met criteria for manual medical record review. For the remaining 13 outcomes, there was no significant increase in risk after LAIV. After manual, medical record review, most cases were excluded because diagnoses were ruled out or clearly attributable to other causes. One case of medical record-confirmed anaphylaxis was observed following LAIV (FluMist): Wheezing, facial swelling, and hives occurred 2 hours after LAIV vaccination, in someone known to be egg-allergic (observed rate 1. 7 cases per million LAIV doses). In individuals who received LAIV only, and no other same-day vaccines, two cases of medical record-confirmed syncope were observed (3.4 cases per million LAIV doses). This case belongs to one of two patients who experienced syncope (preferred term: syncope) after receiving LAIV. The outcome of syncope was unknown. The company physician considered syncope as important medical event. The reporter considered syncope to be related to LAIV. ; Sender's Comments: Syncope is not listed in the company core data sheet of FLUMIST. Due to limited information on details of syncope (type), exact onset date of event, start date of suspect drug along with its indication, underlying comorbidities, past medical history, concomitant medications, age and gender of the patient, lab details (complete blood tests, blood glucose values), detailed clinical and diagnostic workup (imaging studies), it is not possible to make a conclusive assessment of the causal relationship of syncope with FLUMIST.
I had a swollen lymph node over the thyroid gland on the left side of my neck.  I went to the doctor.  They did blood work. They diagnosis is infected lymph node.  They gave my antibiotic and it has gone away now.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 19-OCT-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N029888 with expiration date in 28-AUG-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001814: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
pt recv vax 3JAN97 & mom reports inc irritability approx 1 hr p/vax;poor sleep that noc w/inconsolable crying (high pitched) for 1-2hr @ a time & fever to 103;more irritable & crampy x 2 days;
Patient experienced back and abdominal pain, nausea 6 hours after the vaccination. As of 4-16-21 (8 days after the vaccination), patient still experienced chest / heart / abdominal pain, nausea and shortness of breath. Pain scale from 1-10, patient said she has level 6.  Per patient, she is going to ER.
sick; she feels like she has the flu; weak; tired; headache; shivering; gastrointestinal symptoms; myalgia; nauseated; doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date and had no side effects).   On 11th February 2020, the patient received the 2nd dose of Shingrix. On 12th February 2020, 1 days after receiving Shingrix, the patient experienced sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia, nausea and feeling unwell. On an unknown date, the outcome of the sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia and nausea were not recovered/not resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia, nausea and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she did not feel well at all and she claims that the product made her sick.  She reported that she got up this morning and she feels like she has the flu and she is weak, tired, has a headache, shivering but no fever. She feels bad with gastrointestinal symptoms, nausea and myalgia. No additional details were available. The reporter consented to follow up. This case linked with US2020AMR025607, reported by same reporter.
Information has been received from a healthcare worker referring to a 49 year old male patient. No relevant medical history or concurrent conditions were reported. On 26-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A nurse reported that a 34-year-old female did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/26/2002 (lot ENG5257A4), 05/20/2002 (lot ENG5257A4) and 11/12/2002 (lot ENG5291A4). 90 days after her 3rd injection of Engerix-B, on 02/10/2003, an unspecified titer was "less than 2". Comment: The reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400568A, A0400569A and A0400571A.
C/o 3 inch by 5 inch patch of red raised skin on upper arm below point of injection. Wife had same reaction. Gone in 4 days.
Janssen COVID vaccine was given to the patient without incident. 5-10 minutes post vaccination, the patient felt lightheaded. They were observed having a tonic clonic seizure that lasted less than 30 seconds. The patient regained consciousness and had normal cognitive function. The patient remained lightheaded and nauseous. The patient was able to walk to a vehicle and was driven to the ER by a family member
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: not reported) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the patient had tested for Covid-19 infection (confirmed covid-19 infection and confirmed clinical vaccination failure). The patient reported that, she had the runny nose, coughing and headache. On 22-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided)  was confirmed positive after two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187584. This case, from the same reporter is linked to 20210760417.; Sender's Comments: V0: 20210760895-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
pain in chest/slight pain in chest; light cough; lethargic; fever; headache; As soon as I received my second dose, my period stopped; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient).   A 28-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 28-years) on 20Mar2021 12:09 as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient historical vaccine included first dose of BNT162B2 Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration received on 26Feb2021, for COVID-19 immunization and patient had no issues with first injection with the exception of some pain in the injection area. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 (as soon as I received her second dose), the patient experienced her period stopped. On 21Mar2021, she experienced lethargic, fever, and headache. On 23Mar2021, she experienced pain in chest/slight pain in chest, and light cough. It was stated that she started back up again after over 48 hours, period basically stopped (was bleeding heavily before, but only produced pink dis-charge after the injection). The patient was on Day 3 of period when she received second dose. It was stated that normally she would have 6-day cycles. She wanted to address this, because she could not found any data in terms of women's periods/pregnancy/fertility/etc. The patient just thought it was really strange. The treatment was not received for the event. The event period stopped was reported as resolved on 23Mar2021, while other events resolved on an unspecified date in 2021.  No follow-up attempts were possible; information about batch number could not be obtained. No further information was expected.
I started to get a sore spot on my scalp. It as spread to most of my scalp now and side of face. Sometimes it burns, does not itch very much, but it is swollen. I went to the dermatologist. They asked if I had any stress and when it started. I completely forgot that I had gotten my vaccine right before the symptoms started.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: A month or 2 months after receiving Shingrix, the patient developed shingles. The reporter did not consent to follow up.
high blood pressure; Getting headaches also but not as intense/ mild headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and HEADACHE (Getting headaches also but not as intense/ mild headaches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 029L21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced HYPERTENSION (high blood pressure) and HEADACHE (Getting headaches also but not as intense/ mild headaches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (high blood pressure) outcome was unknown and HEADACHE (Getting headaches also but not as intense/ mild headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: high (High) high blood pressure.         No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Patient demographics, Vaccine dose details and Treatment medication were updated.
sick in bed; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a 76-year old patient who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Past medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was sick in bed (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
still got COVID virus; still got COVID virus; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 71 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Lot number: 039K20A), on 11Feb2021 as dose 2, single (Lot number: 030M20A), on 07Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 24Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "still got COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Mar2023) negative, notes: next day on Friday, which was her day 10, she tested negative; (14Mar2023) Positive, notes: Today, she had things to do and decided to do home test and did 2 and both were positive; (14Mar2023) Positive, notes: Today, she had things to do and decided to do home test and did 2 and both were positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: All were Moderna except last one was Pfizer. She needed to get glasses to see them. 3rd dose Moderna COVID vaccine booster, 07Sep2021, Lot 107E and either 2 or z, then 1A. It looks like a Z but not certain. Expiration is unknown. Product strength and count size dispensed: not provided. Additional lot numbers: none. Patient mentioned on this report that she previously had all of the COVID vaccines listed below and still got COVID virus. She took last dose of Paxlovid last Thursday morning and next day on Friday, which was her day 10, she tested negative.
Light headness with hot feeling, Scratch thoat with feeling of closing; Increase Blood Pressure, Anxiety
TEMPERATURE EXCURSION. vaccine was stored in the freezer longer than the manufactures recommendation. Patient did not have any adverse reaction to the vaccine.
6 in X 3 in redness, which was warm to the touch. Patient reported itching, redness, pain, and swelling.  Told patient to take Tylenol PRN and Benadryl 25mg po QHS PRN. 5 days later patient reported pain and itching were gone but some small redness remained. Patient reported she only took Tylenol when needed and 12.5mg of Benadryl because she is also taking Allegra for her allergies.
Moderna COVID-19 Vaccine EUA  After receiving the vaccine on January 18, my arm hurt for the first couple of days, similar to what I have experienced when receiving a flu shot in the past.  I first noticed a red spot (almost like an 8-shape)  on my arm around the injection site on the morning of Wednesday, January 27. The area felt warm and was about 4 x 2 inches big. I didn't/don't feel any pain, tenderness, or itching, and there was/is no swelling. Since then, the center area has lost some of its red color, but overall the red area is larger now (about  6 1/2 x 3 inches as of January 30). The area does not feel warm anymore and I don't have any other symptoms besides the discoloration. I have not gone to see a medical professional as I feel totally fine.   I would like to note that I had a similar reaction  (skin turning red, raised, and warm) 6 days after having had surgery under my arm to remove a cyst in 2019. Back then, the symptoms disappeared within a day or two.
This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 as dose 2, single (at the age of 34-years-old) for COVID-19 immunisation. Medical history included allergy to adhesive, ankle surgery (in January), post-traumatic stress disorder (PTSD), attention deficit hyperactivity disorder (ADHD) and anxiety (all from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 hours as dose 1, single (at the age of 34-years-old) for COVID-19 immunisation. Patient had no other vaccine in four weeks. The patient's concomitant medications were not reported. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for the COVID-19, post vaccination. On 04Mar2021, patient experienced stabbing sharp lower left back pain, it takes her breath away and gives her chills it hurts so bad. Patient received no treatment for the events. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Patient was given Moderna COVID19 vaccine on 8/31/22 that expired on 8/27/22.
Pain in right arm. Rashes on inner elbows and top of hands. Rash on hands turned into blisters. Can't physically use right arm. Got second injection in left arm and had no problem at all.
Vaccine given11/04/2004. Pt states she felt numbness and tingling in legs later same evening. Went to Dr office 11/05/2004 with weakness. Dr states symptoms started to resolve 11/06/2004.