chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited case received from a consumer on 24-Mar-2016. Manufacturer report number-2015_014613. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus Vaccine) and a dose of INFLUENZA VACCINE (Influenza Vaccine) (batch number, expiration date, dose, route and site of administration were not reported) both on an unspecified date in 2015. Patient also received 400 mg dose of Abilify Maintena (Aripiprazole) (manufacturer:Otsuka, as a suspension for injection via intramuscular route) for schizophrenia on unspecified date in 2014 and on an unknown date in 2015, patient started to take 30 mg daily dose of oral Abilify for unknown indication. The patient's relevant medical history was unknown. The patient's past drug history includes Haldol and Prolixin which lead to alopecia, hair growing slowly and thinning hair both for unknown indications. Patient's ongoing current conditions involved schizophrenia. The patient's concomitant medications were unknown. On an unknown date in 2015, the patient received influenza shot and a tetanus shot which diluted the Abilify Maintena out of her system which was also described as the shots lessened the Abilify Maintena in her blood. When Abilify Maintena was diluted her hair had gotten healthier. On an unknown date in late Oct-2015 or early Nov-2015, the patient had psychotic episode because Abilify Maintena was diluted out of her system and she was subsequently admitted to hospital on unspecified date in 2015, where she was started on Abilify 30 mg daily and Abilify Maintena was not given in the hospital. On an unknown date the patient reported that Abilify made her extremely hungry and made her feel depressed. At the time of this report, the patient continued to take Abilify and is not taking Abilify Maintena, Influenza shot, or the Tetanus shot. It was unknown if there was relevant lab data. Corrective treatments were not reported. It was reported that outcome of the event psychotic episode was resolved and the outcome of the event: influenza shot and tetanus shot diluting Abilify Maintena out her system were unknown. This case was considered as serious due to hospitalization and the reporter did not provide causality between the events and suspect drugs. List of document held by sender: none. Sender's Comments: This is a non-medically confirmed case. Time to onset is unknown. The patient had a significant medical history of Schizophrenia and was on Abilify Maintena for treating the same. The patient's past drug history also included Haldol and Prolixin for unspecified indication. Further information on medical confirmation of the case, time to onset, data confirming the decrease of the antipsychotic drug level in the body, etc. will be needed for further assessment. Based on the information available, role of the vaccines cannot be assessed.
3 days p/recvd immun devel hives, x 3 days; 4 days p/vax devel rash x 1 day;
3SEP98 routine 2mo immun given 9AM-reported child home 930AM parents found pt limp & blue @ 12:00;taken to ER;
I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104625:Same reporter US-GSK-US2023AMR104620:Same reporter US-GSK-US2023AMR104628:Same reporter US-GSK-US2023AMR104622:Same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104620:same reporter
Narrative:  The patient received two doses Pfizer COVID 19 Vaccine. The patient tested positive for COVID 19 on 3 Jan 2022. The patient presented to the ED with dizziness after falling, and fever. The patient was admitted with acute kidney failure. The patient was admitted and during hospital stay experienced sepsis due to COVID 19. The patient was discharged on 9 Jan 2022 in stable condition.
I gave patient a DTAP instead of a TDAP.  In immunization register stated patient had 2 DTAP one in 8/6/2019 and 3/12/2021.  I conferenced with the Primary Doctor and my Supervisor regarding any concerns over adverse affects to relay to parent regarding error in vaccine.  The Dr. advised that there is no adverse reaction expected and patient will need to get the TDAP at age 10 -11.  Called patient at 5 pm on 3/15/2022 Parent stated that there is no reaction, site is not read and child is not running a fever.
This spontaneous reprot as received from a certified medical assistant refers to unspecified patients. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (doses and lot numbers were not reported), oral. Additional information has been requested.
I had extreme weakness and a temperature of 103 that spiked in the night so likely higher than that. I could not eat even a bite of food. In the night I woke up dripping in sweat. I was fine the next morning just very tired.
Patient had throat swelling, anxiety, & chest pain. Patient was given 25mg Benadryl. Patient declined transport.
The patient was given the Pneumococcal vaccine on 10/31/07 at Pharmacy. On 11/6/07 she called the pharmacy and reported her arm was swollen to the "size of an orange." The swelling was in the area on the right deltoid that the Pneumovax vaccine was given in. The patient is unable to take any OTC antiinflammatory medications due to a severe salicylate allergy, so has been using ice to treat the swelling. In speaking with the patient today, she is feeling much better, the swelling has decreased, and her only complaint is that she can't sleep on her side.
I got shingles for the first time less than a month after receiving my second shot.  I then got shingles again 4 months later on 9/10/2021.
Within couple hours of vaccination felt weak. Was seen at clinic 05/09/02. She had light colored loose stools which were negative for pathogens. Liver enzymes were transiently elevated to peak of ALT 115 and AST 60. Liver enzymes returned to normal 05/24/02.
After the first dose I had chest pain, shortness of breath and dizziness which seemed to last for a week. It felt like there was a weight on my chest. The feeling came and went and I still went to work. I went to the ER. I got the second dose of the vaccine. Within ten minutes of the second dose I had chest pain and I felt dizzy. and strange. I felt like I was having an out of body experience. I need help to stand. I was taken to the Urgent care. All of the tests were negative. The next day I was very tired and I had chills so bad I couldn't stop shivering. I felt like that for three days and was unable to  Work.
vertigo; Extreme dizziness/ vertigo. To the point of falling.; feel lightheaded; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, lot # Ek9231) at single dose at right arm on 07Jan2021 12:00 AM for Covid-19 immunisation, administered at hospital.  Medical history included non-Hodgkin's lymphoma, allergy to penicillin. Concomitant medication included amlodipine (AMLODIPINE), lisinopril (LISINOPRIL), escitalopram (ESCITALOPRAM). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced feel lightheaded on 08Jan2021 around 4 pm, extreme exhaustion on 08Jan2021 around 4 pm, vertigo to the point of falling on 08Jan2021 around 8 pm and feel lightheaded, and he was still feel lightheaded, not badly. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae (recovered with lasting effects).
intended to administer the full Pentacel dose to the patient, but instead only the liquid DTaP-IPV portion was administered to the patient, and the lyophilized Hib component was not administered with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (MI) (Reference number- 00665578) and transmitted to Sanofi on 01-Jul-2021.  This case involves a four month old male patient who only received the liquid DTaP-IPV portion (liquid-DTaP-IPV) and not the lyophilized Hib portion (powder-Hib) (product preparation issue), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) (PCV) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 28-Jun-2021, the patient received a second dose of series of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [only received the liquid DTaP-IPV portion (liquid-DTaP-IPV) Lot Number:U6940BA, Expiration Date :21-May-2022 and not the lyophilized Hib portion (powder-Hib) UJ464AB (powder-Hib),Expiration Date : 21-May-2022] via an intramuscular route at the left thigh for prophylactic vaccination.   It was a case of actual medication error due to inappropriate reconstitution technique. (latency: on the same day)  It was reported that, the practice intended to administer the full Pentacel dose to the patient, but instead only the liquid DTaP-IPV portion was administered to the patient, and the lyophilized Hib component was not administered.   Event outcome was unknown for product preparation issue.  At the time of report, 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.
Pt presented with redness and pain x 10 days and streaking, moving medially into the Axilla and lymphadenopathy in the cervical region.
Marked erythema surrounding injection site. Fever, chills, nausea and vomiting on day 7-8, after vaccine. Also areas of possibly dissemination on upper and lower extremities. Levaquin 750mg daily X 5 days empirically.
Arm hurting me; Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised; Itchy; Whole arm turned red from where he gave me the shot all the way down to the elbow.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Whole arm turned red from where he gave me the shot all the way down to the elbow.), PAIN IN EXTREMITY (Arm hurting me) and EXTRA DOSE ADMINISTERED (Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029K20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Whole arm turned red from where he gave me the shot all the way down to the elbow.). 30-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurting me). The patient was treated with Physical therapy for Pain in extremity. On 30-Aug-2021, EXTRA DOSE ADMINISTERED (Caller states she received a third dose of the Moderna vaccine but is not immuno-compromised) had resolved. At the time of the report, PRURITUS (Itchy), ERYTHEMA (Whole arm turned red from where he gave me the shot all the way down to the elbow.) and PAIN IN EXTREMITY (Arm hurting me) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Patient was not immunocompromised. Patient's physician was sending her for physical therapy.
Came down with covid.; Came down with covid.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had received 1st dose of covid vaccine. Came down with covid. 2nd dose of vaccine due next week. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
a quarter-sized reddened area at the injection site; patient received Menactra subcutaneously rather than intramuscular route; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case from an other health professional  This case involves a 19 year old female patient who had a quarter-sized reddened area at the injection site (vaccination site erythema), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] subcutaneously rather than intramuscularly (Incorrect route of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. No other vaccines were given.   On 09-Jul-2020, the patient received a 0.5 ml once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6522AA, Expiry date 29-Jan-2021) once via subcutaneous route in the left upper arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious quarter-sized reddened area at the injection site (vaccination site erythema) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was a case of an actual medication error due to Inappropriate route of vaccination as the vaccine was administered into the subcutaneous tissue of the left upper arm rather than deltoid muscle (intramuscularly).  No laboratory data was provided  Final diagnosis was vaccination site erythema.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome of clinical event was unknown.  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
A female patient was given a tetanus vaccine either Dip/Tet or just tetanus on 09/21/2002 for a dog bite. The following day her arm swelled from her shoulder to her elbow. She also had a large lump form at at the site of injection. She experienced general pain and chills/flu-like symptoms. She was not given any treatments and the symptoms gradually disappeared over the following week.
Allergic reaction at the site of injection, redness on left arm and stinging, rash on left arm.
Had signs on the 7th day of adm, for HIB vaccine swelling, redness and abcess type of symptoms. I informed mother to place warm comp to pt. Pt complains of no pain.
developed large superficial thrombosis in left leg; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The first dose was received on 30Dec2020 13:00 (lot number: ELO140) on the left arm. Medical history included hypertension, coronary artery disease, status post intracoronary stent, hyperlipidemia, history of prostate cancer from 2004, history of throat cancer from 2007, factor 5 deficiency and no history of prior clotting problems. Concomitant medication included acetylsalicylic acid (ASPIRIN), carvedilol and valsartan; both taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient developed large superficial thrombosis in left leg on 15Feb2021 which resulted in a physician's visit. Treatment for the events include Eliquis 5 mg twice a day. Outcome of the event was not recovered. Patient was not diagnosed with covid prior to vaccination and has not been tested post vaccination.
I took an at-home pregnancy test on 1/26/21 and 1/27/21 after a missed period of which both were positive.  On Saturday 1/30/21, I began to have heavy bleeding of which lasted through the weekend.  I also experienced cramping and low back pain.  On 2/1/21 I had an Hcg lab value of 3.5 confirming I had miscarried.  This has lasted through 2/2/21.
patient received shot in the morning and in the evening began experiencing muscle pain all over her body.  She rested and took tylenol. Pain continued until the next evening and then she had the chills but muscle pain was less.  Muscle pain was gone about 48 hr after shot
Right thigh, at site of vax administration, 80mm X 60mm erythema area, raised 10mm above skin line at DTaP site per father. Looks totally normal 03/21/2000.
I had a little bit of a scratchy throat and a slight sniffle. Then, my temperature was 100.4 and 100.3 then would go down to normal. I was tired also but wasn't sure if it was related to travel or not. Symptoms continued for about 4-5 days and I  ended up testing positive (at home) and then went to the HCF and got a PCR test which was positive. I called my doc the next day to see if I was a candidate for Paxlovid. He called it in the next day and I ended up taking the 5 day course of Paxlovid. I felt okay and stayed home. Today was the first real day I have been out.
twitching on my left eyebrow and lid; Facial twitching increased and spread to right eye lid, brow and musclesaround both eyes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 29Jan2021 (Lot number: EL3249) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hay fever" (unspecified if ongoing); "known allergies: molds" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE.  The following information was reported: BLEPHAROSPASM (non-serious) with onset 01Feb2021, outcome "not recovered", described as "twitching on my left eyebrow and lid"; MUSCLE TWITCHING (non-serious) with onset 01Feb2021, outcome "not recovered", described as "Facial twitching increased and spread to right eye lid, brow and musclesaround both eyes". Therapeutic measures were not taken as a result of blepharospasm, muscle twitching.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not tested for COVID-19. The twitching occurred all day and while the patient was trying to go to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
This is a prospective pregnancy case. This 30-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV (unknown) .5 ml on 25th August 2014. The subject's past medical history included no adverse event (The patient was not allergic to eggs). Previously administered products included flu vaccine with an associated reaction of no adverse event (It was unknown if the patient already received FLUARIX/FLULAVAL shots but she had no reactions following previous flu shots vaccinations). The subject's last menstrual period was on 7th February 2014 and estimated date of delivery was 14th November 2014. The subject received Flu Seasonal QIV at week 28 of the pregnancy and during the second trimester of pregnancy. On an unknown date, several days after receiving Flu Seasonal QIV the subject developed generalized rash (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of generalized rash was recovered/resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the generalized rash to be related to Flu Seasonal QIV. Additional information received on 26 September 2014: The patient was not sick the day of vaccination. The patient reported that after the vaccination, she got a fine rash down both of her arms and her chest for a few days after injection was given. The rash ended up spreading to her left leg at some point. The rash was resolved without symptoms. The last menstrual period was not reported but was calculated with the due date.