chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received Jynneos intradermally (ID), instead of subcutaneously (SQ); The patient was 17 years old when received Jynneos; Case reference number US-BN-2022-004821 is a spontaneous case report initially received on 02-Dec-2022 from a nurse via Communications (reference number: USBAV22-2050) and concerns a 17-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On *04-Nov-2022*, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, *batch number: FDP00016, expiration date: 19-Dec-2022), at a dose of 0.1 ml*, administered intradermally, *in the left arm*, for prophylaxis (explicitly coded as 'intradermal injection' and 'inappropriate age at vaccine administration').  At the time of this report, *the patient did not experience any adverse event due to Jynneos vaccination.*  Additional information received from Bavarian Nordic on 02-Dec-2022 included the local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a nurse on 06-Dec-2022: New information included vaccine details: batch number, expiration date, anatomical site location, dose for the first Jynneos vaccine and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos vaccine at a dose of 0.1 ml, administered intradermally in the left arm, for prophylaxis (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos vaccine at a dose of 0.1 ml, administered intradermally in the left arm, for prophylaxis (considered as intradermal injection and inappropriate age at vaccine administration). Injection and product administered to patient of inappropriate age are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Injection and product administered to patient of inappropriate age are both assessed as not related to suspect product but to human factor. The case is non-serious.
diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. In the morning of 26Jan2021, four and a half hour ago (unspecified time), the patient experienced diarrhea, she used the bathroom twice thus far. The reporting consumer asked if diarrhea was also reported as a side effect of the vaccine, if they recommend for her to consult a healthcare professional (HCP) at this stage. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Case number PHEH2015US000683, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 27 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 12 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error (incorrect storage of drug).
Patient went home after work and took a nap; awoke around 8PM with the following symptoms: Headache (24 hrs); Diarrhea (18 hrs); Vomiting (18 hrs); Nausea (6 hrs).  Reported to Medical at 11AM following day. Afebrile (98.3) with symptoms subsiding a little.
My first COVID Shot on 030221 I was fine, 2d shot on 03/31/21, I was fine however the next day 040121 I felt like someone was pulling me back when I tried to get up or move forward, my legs felt like they were going to give out I needed to hold on to something or someone. I was afraid I would fall.  I had no appetite, went to sleep and the next day 040221 I was fine. First Booster 102921 I was fine the next day 103021 the same thing happened to me it was like gravity took over just like what I described above.  2d Booster 060622,  on 060722, I could not get out the bed something was pulling me back the force was so strong I wet myself trying to get to the bathroom, I tried to get up off the toilet and fell, I had to drag my body from the bathroom to my bed to try and pull myself up.  Each time with the exception of the very first shot, I have had the same reaction the day after the shot, it last that day and when I go to sleep and wake up the next day I am fine.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) 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: HEADACHE (non-serious), outcome "unknown", described as "Headache". Additional information: The patient reported that the only symptom she had after her first dose was a headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information had been received on 28-APR-2017 from a registered nurse who reported that improperly stored doses of VARIVAX (lot# M025865, expiration 24-MAY-2018) (lot# M039316, expiration 20-SEP-2018) and PROQUAD (lot# M034692, expiration 24-JAN-2018) (lot# M038861, expiration 13-MAR-2018) were administered to unspecified patients from "06-MAR-2017 - 27-APR-2017". Temperature was 6 degrees F to 14 degrees F for a time frame of 32 minutes. There was no previous temperature excursion. Call was because of a "data logger". Nurse confirmed that the sterile diluent used to reconstitute the VARIVAX and PROQUAD was not improperly stored. No adverse effects. No further information to report. Additional information has been requested.
Patient reported to RPh on 12/11/19 that 2nd dose of Shingrix given on 12/06/19 gave patient severe shivering and shaking, sore throat, and headache. RPh counseled patient that these are listed as possible side effects.  However patient felt they were adverse effects because it lasted 4 days (12/6-12/10) and was severe. Patient had to rest at home. Patient almost went to the ER but did not. Patient resolved with home OTC medication. Patient did not reach out to MD to consult. Patient requested this to be reported as an adverse event  Patient only had soreness at injection site after the 1st dose in 8/8/2019
Acute cerebellar ataxia, abrupt onset, resulting in head titubation, truncal and axial ataxia.  Currently being monitored
I started  getting hives couple of days after the vaccine. I?ve never experienced hives before in my life. I?ve never had allergic reaction to anything. The hives are coming back almost every week. I had to leave work a couple of days ago because of them. I?m worried that this has become a chronic condition and vaccine might have triggered something
A patient received Daptacel and Pentacel on same day, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598259) and transmitted to Sanofi on 12-May-2021.  This case involves a 15-month-old female patient who received 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ389ABA and expiry date not reported) via an unknown route in the right thigh, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via an unknown route in the left thigh for prophylactic vaccination on 12-May-2021 (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect PREVNAR [PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)] (not produced by Sanofi Pasteur) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  This was a case of actual medication error case due to extra dose administered (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.
Rash visible at site of vaccine injection over triceps muscle. Pt given course of antibiotic treatment (cephalexin) and prednisone by primary care provider.
pt reports today that she has had ear issues and vertigo since the injection was given, she continues and believes this all began after receiving the inj. She has been seen a couple times and also seen chiropractor for the vertigo. She request this be reported today
PATIENT WAS GIVEN PEDIATRIC 5-11 DOSE OF COVID BOOSTER INSTEAD OF THE ADULT PFIZER DOSE.
Received PCV vaccines left thigh 2 days ago, at night mild redness local, since yesterday increasing in size, no fever. Pt is on AUGMENTIN for ear infection.
Patient received the vaccinations at the age of 11, because the mother misinformed the clinic and stated the birth date was date, so they would appear to be 12 and eligible for the COVID vaccine.  A school nurse brought this up to our attention. The mother admitted to the school she intentionally misrepresented her daughter's age.
Pfizer bivalent 12 and up was administered to 9 year old in error. Dose administered was 0.2ml.  Parent notified, child had normal expected reaction following vaccine. 01/04/2023 child had mild headache. Also received influenza vaccine same day.
Redness, tenderness to palpation, itching and increased temperature locally. Nasal congestion , chills, clear rhinorrhea (systemic)
Child reported numbness in both feet that over time went up his legs.  After Dr apt in am he went back to school. He called from school reporting difficulty with coordination and walking. Took child to ER.
COVID-19; COVID-19; Moderna: dose number 5/dose number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B-12, start date: 01May2023; CETRIZINE, start date: 01May2023, Vitamins and eye vitamins taken on 01May2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2022, outcome "unknown", described as "Moderna: dose number 5/dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 17May2023 to 22May2023 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300206999 same patient, different drug/AE.;
Breakthrough Case of COVID-19: I was expose to COVID-19 from my spouse, he tested positive on the 17th. I started to feel symptoms of fatigue and chills on the 18th. I started to have tightness in my chest, my symptoms were mild. I tested positive for COVID-19 on the 20th, I contacted my doctor and was prescribed Paxlovid.
Shingles; Painful blisters on the forehead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) and BLISTER (Painful blisters on the forehead) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles) and BLISTER (Painful blisters on the forehead). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) and BLISTER (Painful blisters on the forehead) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient's physician diagnosed shingles.
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received TWINRIX (batch number unknown, expiry date 13th September 2014). On an unknown date, the patient received TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to TWINRIX. Additional information received: A patient was administered an expired vaccine. No more details available due to vaccine given at another facility.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/31/2021. PATIENT FULLY VACCINATED ON 03/11/2021.
The patient had a brief loss of consciousness approximately 2 minutes after second dose of his covid vaccine. The patient's father caught him so he didn't sustain any injuries. The patient and parent refused EMS twice. The patient's initial heart rate was 54. After sitting in a chair and drinking gatorade the patient stated that he felt better. His heart rate was 66 about 15 minutes following the episode. and left the store at 11:43 am "feeling a lot better."
Fainted. Denies SOB, chest pain. refused to ER. states he feels much better after 5min. History of same symptom in the past with needle stick. Seen and cleared by EMS
11-6-09 Rash, amoxicillin 125 mg TID x 10 day. 11-11-09 Rash, erythema multiforme, BENADRYL, ORAPRED.
Arrived home at 09:30, post vax, at 10:00, noted red blotches on face and within 8-10 minutes, noted spreading to arms and legs. Went to ER and was seen around 10:30. Treated with Benadryl and prescribed Tylenol. Flu appointment scheduled for 2 weeks. Mother called, concerned about welts returning along with fever of 100.6 through the night with fussiness and irritability. Mother concerned, had no insurance. Senn in urgent care and he called with report that he had seen child. Unsure if vaccine related or coincidental virus. Child also had ulcer-like sores in throat. Recommended continued treatment with Benadryl and Tylenol PRN. 10/17/99, mother reports pt is better, less welts and throat is better. On 01/18/2000, mother reports no further problems. Dr requested no more pertussis vaccine. Mother will bring child in form MMR/HIB, then return for DT.
vaccine was administered outside of the two hour time limit for the vaccine to sit out at room temperature after first puncture.  vaccine had sat out at room temperature for about 4 hours after first puncture. no adverse events reported.
Patient developed shortness of breath  and weakness the morning after he received the COVID vaccine.  He also reported diarrhea and fatigue. Per the patient he went to 2 urgent cares before being referred a day or 2 later to the emergency department.  The patient was diagnosed with NSTEMI and later transferred hospital.
COVID-19 test positive; COVID-19 test positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 21Aug2022, outcome "recovered" and all described as "COVID-19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive, notes: he counts the first day as 21Aug2022; (22Aug2022) Positive, notes: COVID back on probably the 1st day was 22Aug2022 and took Paxlovid immediately that day. Therapeutic measures were taken as a result of COVID-19.  Clinical course details: The patient was fully vaccinated and boosted and came down with COVID back on probably the 1st day was 22Aug2022 and took Paxlovid immediately that day and took a five day full course and finished on 26Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Information has been received from a registered nurse concerning one "geriatric female" with "cardiac condition" who on 10-OCT-2006 (also reported as 11-OCT-2006) was vaccinated with Pneumovax 23 (lot number 650541/1004F). On 11-OCT-2006 the patient experienced local adverse reactions, including pain, redness, "fever" in the arm, tenderness and swelling near the injection site. The patient sought unspecified medical attention. The patient's local adverse reaction, pain, redness, "fever" in the arm, tenderness and swelling near the injection site persisted. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Pt states her arm is painful especially when reaching across chest or lifting arm above shoulder height. Shoulder area is sore but she has no other symptoms.
Case number PHEH2013US016149 is an initial spontaneous report received from a nurse on 26 Jul 2013. This report refers to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12118, expiry date: Aug 2014) intramuscularly on an unspecified date. On an unknown date, after vaccination, the patient experienced cellulitis and was treated with antibiotics (unspecified). The seriousness, outcome and causality of the event were not reported.
Had 3 shingles vaccine and had shingles/ suspected vaccination failure; Had Shingles 4 times; Had 3 Shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 3 shingles vaccine and had shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had Shingles 4 times) and extra dose administered (Verbatim: Had 3 Shingles vaccine). The outcome of the vaccination failure and extra dose administered were 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, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a son or daughter of patient via interactive digital media. The reporter reported that the Shingles vaccine does not work. The reporter stated that his or her mother received three doses of Shingles vaccine and experienced Shingles for four times. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingles vaccine in error, which led to extra dose administered. Follow-up would not possible as no contact details were available.
I had swelling under my arm for about 7 days. There was no pain and the swelling is gone.
Hive on each thigh distal to immunization site. Size equal or smaller by 40 minutes after admin. No respiratory distress, cough, wheeze, site edema, emesis.
Pt states when vaccine was injected she experienced dizziness "metallic taste in mouth" H.A. mid on forehead - States was also seen black spots in eyes. Lt eye "blood shot" which wasn't present prior to injection. Pt observed for 30 minutes. Symp. decreased except metallic taste. Pt will notify PCP and F/u as needed. Also will have someone taken her home.