chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse referring to an unknown number of patients of unknown demographics. Information regarding the patient's pertinent medical history and drug reactions or allergies were not provided. On an unknown date, an unknown number of patients were administered improperly stored doses of M-M-R II, therapy type rHA, lot # M048036, expiry date:08-DEC-2018 (dose, frequency and indication not provided). Concomitant therapies included sterile diluent (MERCK). The reporter could not provide the lot and expiration for the properly stored sterile diluent used to reconstitute the doses of M-M-R II. No adverse effects reported. The doses were stored at temperature of 47 degree F to 77 degree F (51.2 F) for 30 minutes. Data logger was involved. The outcome of incorrect product storage and no adverse event were unknown. No additional information provided. No product quality complaint was involved. Lot number M048036 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. This case is cross-referenced with 1708USA011806 (same reporter). Sender's Comments: US-009507513-1708USA011806.
A Spontaneous report was received from a consumer concerning a male patient of an unknown age, who received Modern's COVID-19 vaccine (mRNA-1273) and experienced suicidal ideation and severe depression (Major Depression). The patient's medical history is unknown. Concomitant medications is unknown. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date the patient experienced suicidal Ideation and depression after taking the vaccine. The treatment details were unknown. Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events suicidal Ideation and depression after taking the vaccine were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Viral cold sore in lip.; patient had a systemic inflammatory arthritis flare; had a diagnosis of arthritis and that a week after the administration the patient had a systemic inflammatory arthritis flare; Rash in arm/ rash that covered the entire arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included arthritis (diagnosis of arthritis form many years ago).   On 08-OCT-2023, the patient received Arexvy. On 08-OCT-2023, immediately after receiving Arexvy, the patient experienced rash (Verbatim: Rash in arm/ rash that covered the entire arm). On 15-OCT-2023, the patient experienced cold sores lip (Verbatim: Viral cold sore in lip.), flare up of arthritis (Verbatim: patient had a systemic inflammatory arthritis flare) and condition aggravated (Verbatim: had a diagnosis of arthritis and that a week after the administration the patient had a systemic inflammatory arthritis flare). The outcome of the rash was not resolved and the outcome of the cold sores lip, flare up of arthritis and condition aggravated were unknown.   It was unknown if the reporter considered the rash, cold sores lip, flare up of arthritis and condition aggravated to be related to Arexvy.     It was unknown if the company considered the rash, cold sores lip, flare up of arthritis and condition aggravated to be related to Arexvy.   Additional Information: GSK receipt date: 17-OCT-2023 The pharmacist called to inform that a patient that received Arexvy and experienced a rash that covered the entire arm immediately after receiving the vaccine.  According to reporter, the patient had not recovered from the rash at the moment on the call.  Also, reporter informed that a week after receiving the vaccine, the patient presented a viral cold sore on the lip.  The reporter shared that the patient had a diagnosis of arthritis form many years ago, and that a week after the administration of the vaccine the patient had a systemic inflammatory arthritis flare. The reporter consented to follow up.
caller reporting opened ipol at a low of 0.5c out of range for 24 hours. with no reported ae; reporting 4 patients received doses of IPOL post excursion with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 4 patients who received an opened poliomyelitis vaccine (inactivated) [IPOL] after temperature excursion at 0.5 c (Celsius) for 24 hours no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect poliomyelitis vaccine (inactivated) (With unknown formulation, strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination (immunization).  On an unknown date, reporter reported an opened ipol at a low of 0.5c out of range for 24 hours with no reported adverse event (product storage error) (unknown latency) and 4 patients received doses of ipol post excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
couple days after started having some burning on her vaginal area, mainly on the outside of her vagina; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 15Jun2021 (age at vaccination: 52 years) (Batch/Lot Number: EW0155) as DOSE 1, SINGLE for covid-19 immunization. The patient past medical history included high cholesterol (patient stated cholesterol medication is 145 mg once in the morning), irregular heartbeat, allergy, migraine (she used to take Topamax for migraines) and sinuses. Stated she took high cholesterol pills, nose spray, and sinus pills. No family medical history relevant to adverse event. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Concomitant medication included Loratadine (Has been taking for years) taken for sinusitis, fluticasone propionate (FLONASE ALLERGY RELIEF) (Has been taking for years, only takes when the fall is starting) taken for allergy and sinus. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Several years ago, may have been in her middle-forties, there was adverse event prior vaccinations due to flu shot of unknown brand and it made her more sick and she felt like dying, her body shut off. On an unspecified date, it was reported a couple days after started having some burning on her vaginal area, mainly on the outside of her vagina. She wanted to know if this is caused by the vaccine or if it had been reported before. The patient received the first dose of the vaccine on 15Jun2021 and a couple days after started having some burning on her vaginal area, mainly on the outside of her vagina. She wanted to know if this is caused by the vaccine or if it had been reported before. Adverse event did not required emergency room and physician office visit. Patient stated the shot was easy, her daughter got the second one, the Pfizer, she was more tired than usual but she okay now, her daughter got the second shot at the same time as the patient got her first one. Patient clarified this was her first dose. Investigations/Treatment: she was going to wait a couple of days, because she read on some of these, that sometimes, by it being so early, and she just got it, and sometimes can take a few days to do what it's got to do. There were no relevant tests. The event outcome was not recovered.  Additional information has been requested.
Was observing patient one on one in the waiting room of the hospital due to her history of adverse reactions. patient stated that her ears started to itch, they did appear red and swollen from first administration. patient denied and difficulty breathing or itching else where. moments later the patient said her face was "very hot" and states that her nose was swelling "as her glasses were moving." At this point she took a drink of water, and although she denied difficulty swallowing she did slightly gag on the water. I took my flash light and looked in her mouth and the back of her throat was very red. At this time I encouraged her to walk into the ER and be seen. The ER was already aware of the vaccine we were giving in the waiting room and patients history.  immediately patient was brought to a room and assessed and treatment started for anaphylaxis.
Did not verify age of patient before giving injections, unable to reach mother, unknown reaction to vaccines.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 18May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2021 at 14:00 as dose 1, single (Lot number: 001B21), in right arm, on 22Apr2021 at 14:00 as dose 2, single (Lot number: 038B21A), in right arm and on 27Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 7167B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. Concomitant medication(s) included: CRESTOR; VALTREX; ESTRING; FLAXSEED OIL; VITAMIN D NOS, Women's Senior Multivitamin.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2021 at 14:00, outcome "unknown", described as "Vaccine brand other=Moderna,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Dec2022 to 21Dec2022.
Pt in today with siblings for flu vaccine, due for HPV as well. She was given her vaccine in the seated position, and within about a minute, became very stiff, with arms shaking and moving, head leaning back and to the right. She then fell forward and hit her chin/face on the floor, chipping both of her front teeth.  Both mom and RN were unable to grab her in time before she fell as it happened quite quickly.  She was not responsive briefly afterwards- the whole episode was about 1 minute in duration. Afterwards she was tired but responsive and appropriate. VSS, BP and O2 sat WNL,  Heart and lung exam also WNL, good pulses. pale in color after the event.  911 called and ambulance came to transfer her to hospital; for further evaluation.  Report also called to receiving MD in the ER. ED REPORT: dx tooth #8, #9 fracture: tooth #8 - diagonal Ellis Class 2 fracture; tooth #9 - Ellis Class 3 fracture at gum line with exposed pulp. Treatment: applied calcium hydroxide cement paste to exposed root/pulp of tooth #9. Recommendation: needs further repair/reconstruction and possibility implants. Needs to see Trauma dentist.
Patient contacted call center on 11/27 and stated, I had a vaccine at the clinic on 11/7/12 and I have broken out in with a rash in the last two days. Not sure if it is chicken pox or hives? The rash is itchy and red with some scabs where I scratched them. The rash is NOT draining, swollen or painful. I have NOT used anything OTC on them. Had f/u appt with PCP, prescribed calamine lotion plus BENADRYL topical and PO PRN. Diphenhydramine 25 mg PRN.
About 5 minutes after the injection, I started to notice slight numbing down my left arm and 2 fingers.  That started to clear up about 10 minutes later, but then the left side of my face from my jaw line up and over my left eye started to feel the slight numbing.  That lasted for about an additional 10 minutes and then cleared up.  I did notice when I took the bandaid off that night that it was pretty bloody so not sure if the numbing was the result of hitting a vein vs muscle?
Nausea; vertigo; This is a spontaneous report from a contactable other hcp (Patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL8982) via an unspecified route of administration (age at vaccination 26-year) in Left Arm on 11Feb2021 at 01:45 PM as dose 2, single for COVID-19 immunization. Medical history included depression, anxiety, exercise induced asthma, all from an unknown date and unknown if ongoing. Concomitant medications included trazodone 100mg; sertraline 150mg; both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL8982) administered in Left arm on 19Jan2021 at 12:15 PM for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies were reported. The patient received no other vaccine was received in fourweeks. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 11Feb2021 at 06:30 PM the patient experienced nausea, vertigo; onset 6 hours after second vaccine was administered. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of nausea and vertigo, treatment received with Mezicycline. The clinical outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
BLOOD BEHIND THE RETINA; FATIGUE/FEELING TIRED; This spontaneous report received from a consumer concerned an 86 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, latex tape allergy, alcohol user (once in a while), and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The consumer reported that after taking the vaccine, for the first week the patient had no side effect and felt fine. In APR-2021 (about 3 weeks after vaccination), the patient experienced  fatigue and feeling tired and both eyes got blurry and cloudy (left eye more severe than the right eye). Further consumer stated that, the patient went to see an eye doctor because the blurry cloudy vision persisted. The eye doctor referred him to a more specialized eye doctor who diagnosed him with blood behind the retina and gave him shots in the eye to help the blood dissipate. The patient's right eye had been cleared but the blurriness in the left eye had not been resolved. The consumer was concerned that it could had been a blood clot that traveled to the eye because the patient never had any issues like that before. And also mentioned that it could had been some age related eye issue but he was not sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue/feeling tired, and blood behind the retina. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626620-covid-19 vaccine ad26.cov2.s-blood behind the retina- 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: MEDICAL HISTORY, UNDERLYING DISEASE
Pt recvd vax 1JUN94 & in middle of day progressed to inc swelling, redness & heat; devel pain in elbows, knees, spine, t99.4, h/a; went to ER 3JUN, swelling & redness had gone down to elbow on dorsal aspect;
Information has been received from a physician concerning a 15 year old female who on 06-AUG-2007 was vaccinated with first dose of Gardasil (lot # 655619/1427F) injection. Concomitant therapy also given on 06-AUG-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 06-AUG-2007, the patient was sitting on the exam table and was administered the 2 vaccines. The patient fell off the exam table and hit the left side of her head and face. Medical attention was sought (doctor's office and emergency room). The physician admitted the patient into the hospital for a 23 hour observation. The patient had neurology and cardiology consultations and they performed some tests which are unspecified. On an unspecified date, the patient recovered. Additional information has been requested.
This spontaneous report as received from a Certified Medical Assistant via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX that had expired (dose, route, lot # not provided). No adverse effects were reported. Additional information has been requested.
pt recv vax 3FEB97 & 12 days later 15FEB98 it was reported that pt exp acute urticaria;pt reportedly was seen @ ER & was treated w/corticosteroids, DPH, valium & pred;pt hosp for 2 to 3 days;
It was painful and swollen; It was painful and swollen; Case reference number US-BN-2022-001906 is a spontaneous case report initially received on 16-Aug-2022 from a consumer (patient's mother) via agency (reference number: USBAV22-1034) and concerns a 19-year old female patient.  The patient's medical history and concomitant medication details were not provided.  On 09-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose and route of administration, in the left arm, for monkeypox prophylaxis.  On an unspecified date, an unknown amount of time after the vaccination, the patient developed pain and swelling at the injection site. No redness detected. It was reported that the patient had vaccine one week back an it is swollen and very painful.  At the time of this report, outcome of the events was unknown.  The reporter assessed the events of 'injection site pain' and 'injection site swelling' as non-serious. Causality assessment was not provided.  Additional information received from Bavarian Nordic on 17-Aug-2022 included the local BN case ID.; Reporter's Comments: A 19-year old female patient developed non-serious events pain and swelling at the injection site an unknown amount of time after the vaccination with Jynneos. It was reported that the patient had vaccine one week back and it is swollen and very painful. Injection site pain and injection site swelling are listed per the agency 1and the agency 2. The patient's concomitant medications and medical history were not reported. Considering suggestive temporal relationship, both events have been considered as related to Jynneos.; Sender's Comments: A 19-year old female patient developed non-serious events pain and swelling at the injection site an unknown amount of time after the vaccination with Jynneos. It was reported that the patient had vaccine one week back and it is swollen and very painful. Injection site pain and injection site swelling are listed per the agency 1 and the agency 2. The patient's concomitant medications and medical history were not reported. Considering suggestive temporal relationship, both events have been considered as related to Jynneos.
Strong Muscle and joint pain throughout body for 24 hours.  Symptoms subsided completely after 24 hours.
Incorrect product Storage (no patient involved); This case is considered invalid as no patient received the incorrectly stored vaccine, no adverse event.  This is a spontaneous report from a contactable nurse via Pfizer sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported new shipping containers do not maintain as cold a temperature as the old packaging. The new shipment was ok. Event did not take place after use of the product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (20Oct2020): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Query: Could you please help to confirm if the there's a patient involved or had been administered with the vaccine in this report? Query: Kindly see below query and reply all with response.  Response: Thank you for your attention, there was not a patient involved with this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse event; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with 1 dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot #X019553, expiration date: 19-JAN-2025 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion of -9.2 degrees Celsius for 7 minutes, and -11.2 degrees Celsius for 31 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  Lot number [X019553] has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), therapy type rHA.
Information has been received from a consumer concerning an approximately 5- 12 year old child who in approximately 1996 - 2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient experienced a mild case of chicken pox. Unspecified medical attention was sought. The patient subsequently recovered. There was no product quality complaint involved. Additional information has been requested.