chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB  with no ae; Initial information received on 30-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional. This case involves a 34 days old male patient who was administered POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (product administered to patient of inappropriate age). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL),  HIB VACCINE CONJ (TET TOX) (ACTHIB),  DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL),  ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR). On 08-Nov-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) lot number: U1A451M and expiry date not reported via intramuscular route in the left thigh for prophylactic vaccination. It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day). At the time of reporting, no adverse event was reported. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Numbness of upper lip and lower part of nose.  The upper lip was swollen.  The numbness lasted for approximately 12 hours.  The lip was swollen for 3 days.
This spontaneous report as received from a licensed practical nurse referred to a unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigerator malfunction, VAQTA was exposed to -2 F for one month; this includes more than two cycles into and back out of the temperature range of below 0 F. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccines (Lot #, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of the several reports received from the same source. Additional information has been requested.
arm soreness; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date Jan2021, patient experienced arm being sore (pain in extremity). The patient reported that, in the back of card issued to her, was given time to return for second dose on 23Feb2021. The patient enquired about getting second dose, if she has to go early like she did the first time and get in line. The outcome for the event was unknown.  Information on the lot/batch number has been requested.
Nurse assigned to give second dose Moderna vaccine identified that the first dose was inadvertently given and age requirement was not met. No  adverse reactions or events noted. Parents with child, notified of age discrepancy. Parents informed to refer to pediatrician and return for second dose in one month when child turns 18.
Information has been received from a nurse concerning a 60 year old female with no known allergies or pertinent medical history who on 12-JUL-2007 was vaccinated subcutaneously in the arm with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 12-JUL-2007 the patient developed an injection site rash.  At the time of this report the patient was recovering.  No lab studies were performed.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
patient was given 2 doses of Fluzone High-Dose / no AE; the patient was supposed to receive the Prevnar 13 but received Fluzone High-Dose second time/ no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 91 years old male patient who received 0.5 ml two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AB (Expiry date 10-Apr-2020) via intramuscular route in the left deltoid on 01-Nov-2019 instead of PREVNAR 13.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient has not been allergic to Flu vaccines.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.  It was reported that the patient was supposed to receive the Prevnar 13 during the visit but after the double dose the pharmacist contacted the doctor who instructed to not provide the patient the Prevnar 13 today. Caller did not have the doctor's name or information. Reporter mentioned that he got distracted during the administration and picked up the Fluzone High-Dose instead of the Prevnar 13. No other vaccines were given during this clinic to this patient.  At a time of reporting no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Left deltoid area - Reddened, hot edematous extending to most of all dorsal upper forearm. Treated with antibiotics, eval. everyday till resolution (cephalexin 500 QID 10 days).
Pt reports skin rash under left arm. Rash is round, light pink in appearance and non-pruritic.  Pt states noticing rash about 2weeks after first dose of Pfizer Covid19 vaccination
There were no adverse events.  There were no vaccines given within 1 month prior to 5/17/23.  This vaccine was the only vaccine given on 5/17/23.
tested positive on 09Jan2022; tested positive on 09Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) at the age of 31 years as dose 2, single and administered in arm left, administration date 11Feb2021 (Lot number: EL9265, Expiration Date: May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "tested positive on 09Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive; (09Jan2022) positive.  Clinical course: She has natural immunity. She had COVID mid Jan and her work is mandating the booster vaccine in March, either the 29th or 30th. She is wanting to know if you should wait a certain amount of time between having natural immunity and getting the booster, and is it still indicated. She got the COVID vaccine last year. States the first 2 shots are approved, she is asking if the booster is being studied, is it approved for pregnant women.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200276294 mother/baby case
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 26Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 041L20A), in left arm and on 08Feb2021 as dose 2, single (Lot number: 0271n20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing); "Von Willowbrande type 2A bleeding disorder" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "feral cat bite" (unspecified if ongoing), notes: just took 5 rabies vaccines and immuglobin for a sick, feral cat bite. Concomitant medication(s) included: ESCITALOPRAM, start date: 01Feb2022; PROGESTERONE, start date: 01Feb2022; ESTRADIOL, start date: 01Oct2021. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: cipro"; Known allergies: keflex, reaction(s): "Known allergies: keflex"; Known allergies: amoxicillin, reaction(s): "Known allergies: amoxicillin". Vaccination history included: Rabies vaccines (just took 5 rabies vaccines and immuglobin for a sick, feral cat bite.), for IMMUNIZATION; Immuglobin (just took 5 rabies vaccines and immuglobin for a sick, feral cat bite.), for IMMUNIZATION; Just took 5 rabies vaccines (just took 5 rabies vaccines and immuglobin for a sick, feral cat bite.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took other medication in two weeks.
Weakness for 2 weeks. Presented to ER on 4/5/23, with continued weakness, dizziness, and fever.
Rec'd phone call 803A 3.10.11 mother of above infant. Immunization rec'd 3.9.11 at 1pm at 5pm noted baby warm temp 98.9, Rec'd - 4 mL inf TYLENOL and tepid bath. 8pm temp 102. Increased use cool towel on head. Mom and inf slept from 8pm - 5A at 5AM temp 102.9 cool towels 8AM - temp 100.3. No doctor 3.10.11 ref to clinic. No medical insurance.
left arm hurt with blood on second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (left arm hurt with blood on second shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Panuveitis.    No medical history reported by reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (left arm hurt with blood on second shot). At the time of the report, VACCINATION SITE HAEMORRHAGE (left arm hurt with blood on second shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.   This case was linked to MOD-2021-165707 (Patient Link).
After 15 mins of observation, student reported redness and itching to right arm where injection was given. Mild rash also noted. Scratching discouraged, no S/S DOB, Benadryl 125mg with ice pack to site. Parent notified at 1515.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-OCT-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
experiencing soreness from the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose 1 ,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "experiencing soreness from the first shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her 4 year old daughter with no medical history and drug allergies who on 19-JAN-2009 was vaccinated with 0.5 ml dose of MMR II (lot #660581/1209X). There was no concomitant medication. About a week after being vaccinated the patient experienced a swollen lymph node in her groin area and a rash at the injection site. She also experienced a fever. The patient recovered about a few days ago. No further information was provided. The patient sought unspecified medical attention. Additional information has been requested.
pt recv vax 13NOV97 & 13NOV97 pt devel a local rxn on lt forearm which was described as a 5 inch red wheal that was warm to the touch;
Patient describes feeling "tingling sensation all over her body" and "itching all over their body".
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was just found dead on 4/14/21 at age 41. He was reported to be having some diarrhea, but no other suspected cause of death is evident. Patient comorbidities including chronic pain, homelessness, depression, HLD, tobacco use.
As soon as I received the shot I begin to start shaking, I have been diagnosed with internal tremors. Also I developed shingles, had a rash on my face, and high blood pressure. Numbness in my hand and feet. I was diagnose with muscle deterioration. I have extreme headaches.
Swollen glands, both ear drums are hurting, break out in hot sweats but cool down 20 mins later, have headaches and a slight fever
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided). In August 2007, the patient developed a mild localized reaction that was about 1 cm nodule below surface. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Flu-like symptoms Sept 29-30-31.  Approximately 1 week later, fine red rash on left arm, torso & neck & ear lobes, bilateral & nostril area (both sides) red & swollen.  Swelling & redness on ear lobes & nostrils lasted 7 days with skin sloughing.
Pt recv vax on 11/8/98; immediately post vax pt exp swollen LA; tx=Benadryl
Pt was seen in the emergency department for substernal chest pain four days after his vaccination. He was found to have an elevated troponin.  Echocardiogram in the ED was unremarkable. The patient was diagnosed with myocarditis and admitted for observation.  Patient is currently stable and admitted.
Had all vaccines and still break out/ suspected vaccination failure; Break out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had all vaccines and still break out/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Break out). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by patient via interactive digital media. The patient had all vaccines and still break out. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
slight swelling along the upper lip line and below the philtrum; numbness; tingling; itching; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself. A 59-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL8982, Expiration date: 31May2021) via an unspecified route of administration, administered in left arm on 15Jan2021 at 11:00 am (age at vaccination was 59 years) as dose 1, single for COVID-19 immunization. The patient's medical history included diabetic, obesity, blood pressure high and sleep apnea (uses CPAP (Continuous positive airway pressure) machine for sleep). The patient did not have any family medical history relevant to adverse events. The patient did not receive any concomitant medications. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was drive through clinic. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of the Pfizer COVID-19 vaccine on 15Jan2021 and she experienced mild symptoms. On 15Jan2021, 30 mins after getting the shot, the patient experienced numbness, tingling, itching and slight swelling along the upper lip line and below the philtrum. It lasted for 30 mins and resolved on its own the same day with no treatment. The patient wanted to know what would be considered a severe adverse effect. The patient wanted to know if she could get the second dose of the vaccine. The patient wanted to know if she was still eligible to get the 2nd dose. The adverse events did not require a visit to Emergency Room or Physician Office. No treatment was received for the events. No relevant tests were done. The outcome of the events was resolved on 15Jan2021.  No follow-up attempts are needed. No further information is expected.
Korsakoff dementia -  retrograde and anterograde short term memory loss, worsened aphasia, confusion, apathy, cognitive decline  improves with b1 supplementation but cognition and memory may be permanently affected
I woke up in the middle of the night after the vaccine with hot flashes. I was really sweaty and warm. My whole body was sweaty. It was just that one night, and it did not occur again.
This spontaneous report was received from a medical assistant refers to a unspecified number of patients of unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL Lot # K006960 (expiry date: 19-FEB-2017) at an unknown dosage. The temperature of the vaccine was 33.8 F and time frame was 96 hours. There was no data logger. No adverse reactions were reported. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Chief Complaint Patient presents with Hypotension Fever (75 Years or >)Respiratory Problem Hypoxia with O2 sat 70 on 5 L/ NC at NH.  diagnosed in sept with COVID.  Worsening hypoxia secondary to COVID-19.  Steroids, antibiotics.  Septic shock (HCC).
I haven't had a normal period since receiving the vaccine. I actually noticed it sometime during Dose 1 that my menstrual period has changed. It has been either been very light, no present or skips. I am currently under care with my OB/GYN.
Patient received vaccine at 10:16a.m., patient indicated they were feeling dizzy, while seated. He was immediately attended to prevent possible fall. Given orange juice. Patients head slumped back and had labored and guppy breathing, then went unconscious for a few seconds. His pulse was monitored, breathing monitored. He became alert and was talking. He was laid on the ground in supine position. Vitals were monitored continuously throughout the rest of the patient?s extended observation period.  Vitals are as follows:  Time: 10:20    Pulse: 69  RR: 24 O2 Stat: 97    Time:  10:27   Pulse: 78  RR:  22  (laying) Time:   10:31   Pulse 82  O2 stat: 98(sitting up) Time:   10:35   Pulse: 83  RR:   22  O2 Stat: 99 (laying) Time: 10:37     Pulse 66    RR: 26   O2 Stat: 98 (laying ) Sitting up from here forward Time: 10:48    Pulse 86. O2: 98 Time: 10:55.   Pulse 81.  O2: 98 Time: 11:01.   Pulse 77.   O2: 98 Time: 11:20.   Pulse 75.    O2: 97 BP: 132/78 Patient was instructed to have someone drive him, he was instructed not to drive   OF NOTE: Patient stated he did not have breakfast.
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A + GTiH 0038777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna = no need to repeat the dose.
12 hours after - chills, sweating, fainted/seizure, fatigue, headache, body aches, rash at chest and arms. Lasted 24 hours. Rash is still visible after 24 hours