chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/15/95, the pt received her 1st dose of Engerix-B. Forty days later, on 1/24/96, the pt was hospitalized and dx'd with an intraventricular stroke. She was on life support for the first 7 to 10 days of the hospitalization, which lasted 85 days. Now, at age 5, the vaccinee did not walk or speak and was visually impaired (NOS). She also had a seizure disorder and "global delays" (NOS). She had a "shunt" placed to control hydrocephalus. As of 3/30/01, the outcome of the events is ongoing. On follow-up on 06/04/2001, the vaccine provider stated that the child's chart had been reviewed. There was no documentation of any reaction to immunization in the chart and there was also no documentation in the chart that the child experienced an intraventricular stroke. As of 06/04/2001, the outcome of the event was unknown.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored LIQUID PEDVAXHIB (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of LIQUID PEDVAXHIB underwent temperature excursions at 47 Fahrenheit degrees, for unknown times frames. Information about the previous temperature excursion was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Reported she felt like something was stuck in her throat after the second vaccine was administered 4/13/21 Narrative: Pt reported she developed hives after receiving the first dose of the Pfizer COVID vaccine. Took OTC BENADRYL; unsure for how long she had to take this medication. Reported she felt her symptoms were moderate in nature.
patients received dose from vials beyond 30-day use by date; patients received dose from vials beyond 30-day use by date; Date of refrigeration - 07-MAY-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (patients received dose from vials beyond 30-day use by date; Date of refrigeration - 07-MAY-2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (patients received dose from vials beyond 30-day use by date; Date of refrigeration - 07-MAY-2021). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (patients received dose from vials beyond 30-day use by date; Date of refrigeration - 07-MAY-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Woke up Friday morning with pain in right arm, red area and warm, high fever 100+ and pain in stomach.
At 7:00pm on 4-2-21 (11 hours after vaccine) I started experiencing hot flashes, goosebumps, and nausea. I then began having severe chills, fever of 101, muscle soreness all over my body, and vomiting. I vomited 7 times between 8:00pm and 6:00am on 4-3-21 and could not keep any food or liquids down.  My fever and chills were gone at 9:00am and I was no longer vomiting but still feeling nauseous.
Cold sores (herpes simplex 1) in nose and rarely on mouth; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) in the left arm on 09Mar2021 at 14:00 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation. Medical history included herpes simplex in nose. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Mar2021, since the patient received covid vaccine, the patient experienced cold sores (herpes simplex 1) non-stop (till the time of reporting). The patient suffered from cold sores (herpes simplex 1) in nose and rarely on mouth. The outbreaks were once or twice a year. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sores (herpes simplex 1) in nose and rarely on mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended product details (BNT162b2 Dose 2 was removed from suspect drug) and Vaccine Facility Information (details were added).
Quadracel was missed when the patient was younger with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00657506) and transmitted to Sanofi on 25-Jun-2021.  This case involves a 7 years old male patient who missed a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and expiry date were not reported) when he was young (product dose omission issue).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was reported that a dose of Quadracel was missed when the patient was younger at a different clinic. Because of this, the patient is now 7 years old and behind on his Adacel dose. The Quadracel dose was never given.  It was an actual medication error case due to missed dose (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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.
Very swollen axilla lymph nodes 2 weeks after receiving first does; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 21Jun2021 at 17:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included being allergic to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jul2021 at 00:00, two weeks after the vaccination, the patient experienced very swollen axilla lymph nodes. Since the vaccination, the patient had been tested for COVID-19. On 08Jul2021, the patient underwent nasal swab Sars Cov-2 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event swollen axilla lymph nodes was not recovered at the time of the report.
Vaccine given R upper arm on 8/8/06. Mom brought her back 8/10/06 with tender warm red area around site. Advised to use OTC Benadryl 1/2 1 tsp every 6 hrs prn local care. Message left on mom's phone 8/11/06, no call back.
Patient lost consciousness immediately after administration of the Anthrax vaccine. The flu vaccine had been administered directly prior to the Anthrax vaccine. Patient was unconscious for 20 seconds.
Patient stated that she the typical achiness and fever,  then her arm started to feel warm, red and swollen. She stated it has been getting worse everyday with the swelling moving down her arm. She showed her arm it was enlarged and red.
Experienced mild local site injection pain; This is a spontaneous report from a contactable physician. This report was received via a sales representative.    A 36 year-old male patient  received  bnt162b2 (BNT162B2) vaccine , 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 experienced mild local site injection pain on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Asymptomatic COVID infection/Nasal swab positive; Asymptomatic COVID infection/Nasal swab positive; This is a spontaneous report received from a contactable reporter (Physician). A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 4 (booster), single (Lot number: GJ3274) at the age of 61 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 12Apr2022 as dose 2, single (Lot number: EP6955) and on 09Jun2022 as dose 3 (booster), single (Lot number: FF2589), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2023, outcome "recovering" and all described as "Asymptomatic COVID infection/Nasal swab positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: the reporter considered the events as non-serious. The patient did not receive other vaccines in the four weeks.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Pt. symptom began on 9/12/10 - pain, swelling, redness, hives pruritus went to the E.R. on 9/12 pm was sent home BENADRYL - Prednisone. Symptoms continued 9/13 went back to ER in pm. Sent home with BENADRYL - ZANTAC came to PMD 9/15 - Tx with ZANTAC PM, BENADRYL/CLARITIN and F/U 9/21.
After receiving PENTACEL, PREVNAR & ROTATEQ, pt was extremely fussy, inconsolable on/off for 3-5 days with intermittent periods of blank stares.  Symptoms not routinely seen in our other patients.
Case number PHEH2014US015872 is an initial spontaneous report received from a nurse on 06 Aug 2014. This report refers to a six month old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: not reported) intramuscularly according to the four dose infant series at six months of age on 18 Dec 2013. No additional doses of MENVEO were administered to the patient since the first dose on 18 Dec 2013. No adverse events were reported following these medication errors (inappropriate age at vaccine administration , incomplete course of vaccination).
Severe itching, varying sized hives starting on trunk and spreading to extremities and face.  Some swelling noted to shoulder blades and left eye with redness to affected sites.  50 mg Benadryl given at onset of symptoms with visit to emergency room.  No anaphylatic episode.  Prescribed benadryl 25-50mg every 6 hours. 11/23/2009 ED records for 11/16/2009, Dx allergic reaction patient with c/o's itchy, burning rash all over his body. Tx: Benadryl
Dizziness, nausea, dry heaves, headache, abdominal pain, loss of appetite. Reports SOB when talking, but not ambulation.
Mother called 10/3/02 to PCHD about left arm swollen and running temperature. Referred pt to put MD on telephone call to grandad 10/10/02 at 8:50 AM to check on child. Doing fine. Stated "Dr said had local reaction to immunization."
headaches continuing into 11 days post vaccine  liver pain flare up began post vaccine fatigue and muscle aches that began post vaccine
Swelling of tongue. Treated in the ER with epinephrine and solumedrol
Information was received from a registered nurse referring to a 26 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-JUN-2016 the 26 years old patient was inadvertently administered a dose of PROQUAD (lot # L006388, expired on 25-AUG-2016, human serum albumin (HSA)) via the intramuscular route instead of the recommended subcutaneous route. No adverse effect was reported. Additional information has been requested.
Information has been received from a consumer concerning her 13 month old child who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 instead of a PCV vaccine by mistake. No AE reported as a result. No further information was available at the time of this report. Follow-up information has been received via a telephone call from a medical assistant who indicated that the 13 month old child who on 23-NOV-2009 was vaccinated with the dose of PNEUMOVAX 23 (route not reported, LOT# 664556/1307Y). Concomitant vaccination included a dose of DAPTACEL (LOT# C3322AA, manufacturer Sanofi) on unspecified date. The medical assistant stated that the patient received PNEUMOVAX 23 instead of PREVNAR due to a medication error. The medical assistant also stated that the physician had written that the patient should receive the "Pneumonia vaccine". Follow-up information has been received from the physician who reported that the patient had no pre-existing allergies, birth defects nor medical conditions and that there was no illness at the time of vaccination. It was indicated that the patient who was on 23-NOV-2009 at 10:30 AM was vaccinated with the dose of PNEUMOVAX 23 (on left thigh, LOT# 664556/1307Y). Physician also noted that they gave PNEUMOVAX 23 instead of PREVNAR upset the mother of patient because they gave a shot that was not required. The patient did not experience any symptom signs and no adverse event. No further information is available.
Headache; Nausea; Muscle aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 10:45 (Lot number: Ew0178) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; SYNTHROID; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=Ew0161, lot_unknown=False,, administration date=01/May/2021,, administration time=09:00 AM,, dose number=1,, vaccine_location=Left arm), administration date: 01May2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 26May2021 16:30, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 26May2021 16:30, outcome "unknown", described as "Nausea"; MYALGIA (non-serious) with onset 26May2021 16:30, outcome "unknown", described as "Muscle aches"; FATIGUE (non-serious) with onset 26May2021 16:30, outcome "unknown", described as "Fatigue". Therapeutic measures were not taken as a result of headache, nausea, myalgia, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date was 27May2021.No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Day 15 after covid vaccine I woke up at 12:30am with extreme vertigo and nausea. It woke me up with violent spinning. I could not focus my eyes at all. I felt very ill. I almost threw up multiple times during the day and could not move my head up or down and to the left without spinning out of control. I saw the ENT later that day and he performed the Epley Maneuver on me. I followed his directions for home care but am currently still experiencing vertigo. The doctor told me it should dissipate within one week. It has not. I have never had vertigo in the past.
expired dose; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional via call center.  This case involves of unknown demographics patient who had expired dose of pentacel (Expired product administered), while he/she received vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) via unknown route (batch number : UJ059AA and expiry date :04-Oct-2020) for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event Expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
pt c/o dizziness @11:24a, vs checked and within normal limits, d/c by physician at 11:54a
This spontaneous report was received from a pharmacist and refers to a 14 year old female patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 28-DEC-2018, the patient was inadvertently vaccinated with an adult dose of VAQTA as her first dose in the series, lot # R022983 with expiration date on 09-AUG-2019 for prophylaxis (route of administration was not reported). However, no adverse effects were reported.
[Directed to enter VAERS report due to close proximity of vaccine administration] Member received first dose of Pfizer COVID-19 vaccine on 23 September 2021.  On 24 September 2021, member complained to co-workers of abdominal pain with nausea/vomiting, treating symptomatically over the weekend.  On 26 September 2021, member's co-worker contacted him and member was coherent and alert,  On 27 September 2021, after member did not respond to co-workers' attempts to contact him, co-workers and first responders went to member's residence, where member was found somewhat disoriented.  Member was subsequently transferred to local Hospital ED (arrived at approximately 09:15), where member was found to have confusion and hyperglycemia (GCS of 14 and blood sugar reading, measuring as 'high".).  During treatment and monitoring process, member was found to have labored breathing (at approximately 11:00) and a CODE was called at 11:05.  Member subsequently expired at 11:30.
Day 4 noticed rash under the skin on both arms and legs. Lacy pattern under the skin. Day 7 seems to be going away. Taking 25 mg of Benadryl at bedtime since I first noticed the rash.
Right upper arm swelling with a 1X1cm pustule with a 4cm induration all around.  10mL of pus drained with local swelling, then she was injected with 1% lidocaine, incision of 3cm vertical X 1cm lateral, inner loculations broken extending 4-5 cm radially, 10-20mL of fluid drained, packed with iodoform gauze.  Instructed pt to return to clinic in 2 days to remove packing and check wound.  Pt started on cephaxelin 500mg PO Q6H X 7 days; Bactrim DS 2 tab PO BID X 10 days
Severe Panic Attacks and Anxiety, high blood pressure, high heart rate, red welts on forearms and chest. Anxiety still persistent after 6 weeks
Pt received VARIVAX 03/27/1996, broke out with chickenpox October, 2001. Sibling was immunized with same vaccine lot and also broke out with chickenpox on 11/09/2001. Moms wants lot investigated.
Little left arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Little left arm pain at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INJECTION SITE PAIN (Little left arm pain at injection site). At the time of the report, INJECTION SITE PAIN (Little left arm pain at injection site) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-037346 (Patient Link).