chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Children in clinic with mother who's language is limited. The 17 year old child said they needed covid vaccine. Their records were pulled and no Covid vaccine had been given. After the nurse gave the vaccine and presented the CDC vaccine card to the mom. She reached into her purse and pulled out a CDC vaccine card for both kids. Both of the children had been fully vaccinated.
Information has been received from a case in litigation via a case report concerning a baby who on an unspecified date was vaccinated with a dose of HEPTAVAX (manufacturer unknown). The patient had an upper respiratory infection at the time of vaccination. Subsequently, the patient experienced a very high fever and death. A special Master cited that "each of the two factors (the vaccine and the infection) were a substantial factor in causing the patient's very high fever and death and, but for the presence of each of these two factors, the baby would not have had the high fever and would not have died." No further information is available.
Patient was administered an expired tenivac, no AE; Initial information received on 28-Apr-2021 regarding an unsolicited valid  non-serious case from nurse manager (inquiry number :00580496).  This case involves a patient (student of unknown age and gender) who was given an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number not reported and expiration date:19-Apr-2021) via unknown route in an unknown administration site for prophylactic vaccination by one of the nurses on 27-Apr-2021 (expired product administered).  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used (same day latency).  It was reported that they asked about what to do, and if they should revaccinate. Nurse manager was not able to provide the patient's information due to HIPAA (Health Insurance Portability and Accountability Act). She will inform the patient first, and the patient may call Medical Information back for the information needed.  It was unknown if the patient experienced any adverse event or not.    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.  There will be no information on the batch number for this case.
Immediately after show injection site pain redness swelling. 6-7 hours after shot fever, chills, shortness of breath, and fatigue began. Day after the shot injection site swelling and redness were worse, it was hot to touch, and constantly burning with pain on a scale of 7/10, and fevers continued. One week after shot arm pain has not had an relief there is hard painful knot at the injection site. I am experiencing ulnar never pain with tingling and loss of feeling in pink and ring finger on left had that comes and goes. Sciatic never pain that radiates down my left leg numbness and tingling in pinky and fourth toes on my left foot. Fevers continue on and off,  averaging 101.5, improve with Tylenol.
no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant products reported.  Nurse supervisor reported that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. The beyond use date was 08-Jan-2023. The patient was 12 years and above but HCP did not have the information if some of them were below 17 years old.   No treatment products reported.  This case contains information for the 7th of 15 adult patients described by the reporter, 3 of 4 patient who was administered  bivalent dose on 11-Jan-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
County Health Department Imm clinic about 11 am, I reviewed child's imm needs on schedule in records noted that he needed hep B as well as DTP HIB polio flu and roto. I substituted pediatric hep A, HAVRIX .5 ml GSK by mistake for the hep B. Child was 6 mo 11 days, given in right thigh. Contacted CDC next day as soon as I was made aware of wrong imm given, found on vacc error report (call/31-129830289) spoke with, advised min age for pediatric hep A 12 mo. Early dose off label therefore no info on adverse events because hasn't tested on this age group. Child does need to be revaccinated for hep A at appropriate age and still needs hep B. Contacted parent by phone 1:45 pm advised pt of above, she expressed understanding that hep A was given too early and the it would need to be repeated at appropriate age, and that child needs hep B. She will bring the child in the next few wks for hep B and pneumo. Patent states child is well and will observe for any adverse reaction to hep A and other vac given. Parent states child is well and will observe for any adverse reaction to hep A and other vacc given.
On 4/18/21, it was reported that the patient had a seizure following the 2nd dose of Pfizer vaccine.  This is a 19 year old female patient with a known history of a seizure disorder.  She has been under the care of a neurologist x 6 years, is not on any seizure medications, and no diagnosis made.  She reports she has a seizure every two weeks, which are triggered by anxiety/stressful events.  On this day, 3 minutes after received the 2nd dose in the supine position, she fell unconscious and developed eyelid and arm twitching.  Vitals signs remained stable.  MD described seizure as 'starting as a sleep state, moving to slight twitching, then tonic clonic.  Duration of seizure symptoms was 12 minutes. '  The patient regained consciousness, symptoms resolved, and patient was discharged home with family following increased observation.  No medication treatment needed.  Upon chart review, it was identified that she has a similar reaction following her 1st Pfizer dose.  On 3/28/21, the patient received Pfizer (Lot ER8730 in the left deltoid).  Following her 15 minute observation period, she rose from her chair and fell to the ground unconscious.  She was taken to the treatment tent and observed to have 'seizure like jerking of upper and lower extremities, fluttering eyelids, unarousable.'  Vitals stable (BP=103/68, HR =111, SpO2=98%).  Patient and family described this seizure as similar to the ones she experiences due to stress/anxiety.  Symptoms resolved, no medication treatment needed.  She was advised to follow-up with PCP regarding 2nd dose, and if proceeds, recommended to lie down in treatment tent for 2nd dose (which was then done on 2nd dose).  Patient reported that she has not had seizures with other vaccine administrations.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HAV (Havrix 1440 adult) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received the 1st dose of Havrix 1440 adult (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The caller consented to follow-up from GlaxoSmithKline, was transferred to medical information for next steps. Additional supportive information: The patient received an expired dose of Havrix vaccine in left deltoid, which led to expired vaccine used.
Had Tdap booster 6/9/11 at office visit with URI.  Then local reaction & fever -> Pneumonia. Hospitalized for PNA - Recovered.
Initial report was received on 12 September 2011 from a health care professional. A male adolescent patient (age and date of birth not reported) had received an injection of MENACTRA and FLUZONE (unspecified); lot numbers, routes, sites and dates of administration were not reported, and "shortly after" the patient fainted. Afterwards, the patient reported numbness to their arm. No additional information was provided at the time of the report. Outcome was not reported. Documents held by sender: None.
Pt. and sibling both given immunizations, tray with immunizations labeled, but given to wrong patient.
LOSS OF HEARING IN BOTH EARS STARTING DAY AFTER VACCINE AND HAS CONTINUED TO DECLINE TO THIS DAY
Very dizzy all the time, even when laying down and not moving. Rapid Heartbeat. Anxiety. Headache.
First Day-fever, chills, nausea, severe headache, fast heartbeat, severe muscle & joint pain, extreme fatigue Second Day-fever, chills, nausea, severe headache, fast heartbeat, severe muscle & joint pain, extreme fatigue Third Day-severe headache, hives on torso, nausea Fourth Day-hives on torso (day I'm reporting)
severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 05Jan2021 03:30 as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. Concomitant medications included sotalol (SOTALOL), Olmesartan (OLMESARTAN), Amlodipine (AMLODIPINE), tamsulosin (TAMSULOSIN). On 06Jan2021 at 09:00 the patient experienced severe pain in back and right-side thigh, knee and leg, rheumatism, sciatica. Pain started within one day of shot and has not stopped. I have never experienced this before now. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107296 same reporter/ drug/ AE, different patient
Severe muscle aches and pains, chills, nausea, fatigue, leg and arm pain, weight loss (10 lbs so far), loss of appetite, numbness and tingling in feet and legs, skin hypersensitivity. Am treating with a neurologist now. 12/1/2009 , 12/10/2009 PCP and Consult  records for visit dates 11/14,11/21,11/25,11/30 and 12/1/2009 patient with c/o's myalgias, fatigue, weakness, tingling in feet, nausea, dysphagia and wt loss.
arm was very sore; arm was swollen; itchy; red around it; can´t scratch since it hurts; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it) and VACCINATION SITE PAIN (can´t scratch since it hurts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it), VACCINATION SITE PAIN (can´t scratch since it hurts) and HEADACHE (Terrible headache). On 01-Feb-2021, HEADACHE (Terrible headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was very sore), PERIPHERAL SWELLING (arm was swollen), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red around it) and VACCINATION SITE PAIN (can´t scratch since it hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Generalized macropapular to vesicular rash >50 lesions to face,  chest, bilateral legs, arms, torso, and buttocks. Identified as possibly chicken pox 4/28/2022 and continued spread for the next 2 days before crusting and healing over the next week.  No fever, respiratory symptoms, vomiting, or diarrhea. Benadryl taken for itching.
Covid-19; Covid-19; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: 4680) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccine and medication in 2 weeks. Paxlovid was taken as treatment for COVID -19 from 10Oct2023 to 14Oct2023
Sometime post vax, pt developed a red area measuring 2 in x 1 in at site. From additional correspondence received on 07/06/2000, it was reported that the pt recovered from this experience. Additional pt, vaccine and responsible physician info was also provided.
I have a redness on my arm at the injection site on my right arm and there is a knot under the skin.
Patient reported tingling in gums, feeling faint, shortness of breath, is 22 weeks pregnant.  Checked out by Emergency Medical Services.
Within a few hours, upper arm where injected became stiff and very painful, resulting in limited mobility of the arm. Later  that evening, my whole body became tired, achy and it lasted all night and into the next day.
Headache, fatigue, lightheaded, pain at injection site.  All resolved in 36 hours
late for 2nd dose. 1st dose on 8/16/2021; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th August 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The nurse reported patient was late for 2nd dose.  The reporter consented to follow up via email. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Site: Pain at Injection Site-Medium, Additional Details: patient called pharmacy and stated that he had limited mobility in his arm that he received flu shot in. said hes gone to ER and will follow up with us if any further issues or improvement
Patient states that she has been getting these itchy lumpy lesions on her arms, chest, abdomen, and legs that started approximately 2 weeks after receiving the smallpox vaccination on 6/23/04.  Has not noted any lesions on her face, hands, and feet.  States that rash gets better than reoccurs in approximately 2-3 weeks.  States that she has about 2 episodes a month.  Has taken the following medication in the past for the reoccurring rash: Allegra, Benadryl, hydrocortisone cream and steroids.
3"x4" area of redness, warm to touch left upper arm! Some tingling of fingers 10/11/2013. None now. Took ibuprofen with relief on 10/11/13.
STREAKS OF BLOOD COMING OUT OF IT UNDER THE SKIN; EXCRUCIATING PAIN/SORENESS IN NECK MUSCLE UPTO EAR; BRUISED AT LEFT ARM; WARM TO TOUCH; LEFT ARM SORE; REDNESS AT THE INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included psoriasis, non alcohol user, non smoker, morphine allergy, penicillin allergy, and sulpha allergy. The patient experienced drug allergy when treated with rabeprazole sodium, cefaclor, ciprofloxacin, erythromycin, meloxicam, nabumetone, and administration reaction to vaccine when treated with tetanus vaccine.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced streaks of blood coming out of it under the skin. On 07-MAY-2021, the subject experienced excruciating pain/soreness in neck muscle upto ear. On 07-MAY-2021, the subject experienced bruised at left arm. On 07-MAY-2021, the subject experienced warm to touch. On 07-MAY-2021, the subject experienced left arm sore. On 07-MAY-2021, the subject experienced redness at the injection site. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from redness at the injection site, headache, bruised at left arm, excruciating pain/soreness in neck muscle upto ear, left arm sore, streaks of blood coming out of it under the skin, and warm to touch. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Died 5 days p/1st DTP vax; Noticed spitting-up increased p/vax.
Shot received 1/30/07. 1/31/07 developed redness around in.
RN was informed by his primary care doctor that he needed to have his COVID bivalent booster. It was charted that he previously received 4 COVID vaccine doses (with the most recent one charted in 5/27/22). RN confirmed with patient that this was correct. RN gave COVID vaccine and charted this. When RN asked for COVID vaccine card, it was noted that he previously did receive a COVID bivalent vaccine at another pharmacy on 9/22/22. Since this was at another location, it was not in patient's chart yet and patient wasn't sure of what vaccines he previously received. I reached out to patient on 1/18/23 to discuss if he was feeling any side effects of vaccine administration the day after and he denies.
This spontaneous report as received from a clinical coordinator via a field employee refers to a 14 year old female patient. The patient's historical drugs included immunisation with 2 doses of GARDASIL on unspecified dates. She did not have any drug allergies. On an unknown date the patient was vaccinated with GARDASIL lot # K011562, dose 3. The patient was not on any concomitant medications. On an unknown date, 1 day following the immunisation, the patient experienced headache lasting until today (16-FEB-2016). It was reported that if the headache persists an Magnetic resonance imaging (MRI) will be done. Laboratory tests included CDC (results unspecified) on an unknown date. No product quality complaint (PQC) and insertion and removal related events (IRRE) was involved. The outcome of the event was reported as recovered/resolved on 16-Feb-2016. The causality assessment was not provided. Additional information has been requested.
Patient developed urticarial rash both around injection site (in approximately 8 cm diameter circumscribed area) and on torso.
administered only liquid component of Menveo; administered only liquid component of Menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 8-Aug-2022 Reporter's comment: The physician called back to report that a medical assistant inadvertently administered only the liquid component of Menveo to two unknown patients out of a group of a possible six patients. It was unknown which two of the group of six patients received only the liquid component.  Confirmed with the caller that no patients only had the powder component. The reporter declined follow-up.  Did not consent to follow-up. The case is for 1 of 6 linked patients reported by same reporter. Additional supportive information: The patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022116445:Same reporter US-GSK-US2022AMR116728:Same reporter US-GSK-US2022AMR116731:Same reporter US-GSK-US2022AMR116736:Same reporter US-GSK-US2022AMR116737:Same reporter
Day after shot, redness, swelling, hot touch, pain in joints through (R) arm and where shot was given. Took ALEVE to help w/pain - which subsided, redness, swelling did not.
Chills, low grade fever, body aches, headache, fatigue, diarrhea, nausea