chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 15 year old male patient. On 24-AUG-2012 the patient was vaccinated with a fourth dose of GARDASIL (0.5 ml, intramuscular, in the left arm, lot number was not reported). The reporter stated that this error occurred when they were converting paper charts to electronic records. Vaccinations dates of the previous vaccinations with GARDASIL were not reported. The reporter stated that the patient did not experienced any adverse effect due to the extra dose of GARDASIL. This is one of several reports from the same reporter. Additional information is not expected because the reporter doesn't want to be contacted.
Pt recvd MMR vax on 6MAY91 & on 20MAY91 pt devel a generalized rash & t102; no further details were provided;
Severe chills, mild headache, extreme lethargy, body ache.  Lasted 24 hours.
Severe skin inflammation- burning,  itching on entire body began 3-5 days after vaccine given
Weakness in legs and arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs and arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULAR WEAKNESS (Weakness in legs and arm). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided    This case was linked to MOD-2021-044585 (Patient Link).
RED RESILD MIST RASH THAT STARTED ON FOREHEAD & EARS ON 3/18/08. AS OF 3/19/08 RASH NOW IS ON HEAD, NECK, FACE, TORSO, BACK GROIN, ARMS & LEGS.
No adverse event; Temperature excursion occurred on 29Nov2022; Temperature excursion occurred on 29Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022).    Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:original case US-MODERNATX, INC.-MOD-2022-687786:
Within seconds of receiving the vaccine I began to feel slightly dizzy. By the time I walked across the room to the observation table I was feeling lightheaded. They sat me down, gave me water and a cookie, but about 2min after the injection the dizziness was so intense that I began to black out. I was unconscious for about 1-2min, then came to but my vision was still unclear. I was taken via wheelchair to the paramedics on the opposite end of the gymnasium, and at this point I was heavily perspiring and very pale but still coherent. I felt my vision and dizziness significantly improve after being able to lay down. I was transported to the hospital for observation but had much improved by the time I arrived. An EKG, bloodwork, and cardiac tests were recommended to discern possible underlying heart related conditions, but I declined because I already had a PAT for thyroid surgery scheduled the next day that would be running those same tests. This reaction was likely due to not having eaten  for several hours prior to the vaccine. After about an hour I felt well enough to drive myself back home and dealt with mild aches and pains that evening, chills, and a low grade fever all of which resolved themselves by the next morning.
sepsis regarding to a cancer; A spontaneous report was received from a consumer concerning an unknown aged female patient.  Medical history included unspecified cancer  No relevant concomitant medication was reported.  On 11Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On 10 Feb2021, the patient was hospitalized due to sepsis regarding a cancer.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, sepsis, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. However, patient's medical history of unspecified cancer is a confounding factor that may play a possible contributory role.  Further information has been requested.
Achy; headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 11:30 hours as dose 2, single (at the age of 62-years-old) for COVID-19 immunisation. Patient had no relevant medical history and had no known allergies. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Concomitant medication(s) included levothyroxine sodium (Synthroid) taken for an unspecified indication, start and stop date were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID -19 prior to vaccination and had not been tested for COVID-19, post vaccination. On 16Feb2021 at 20:00 hours, patient experienced achy, headache and sore arm. Patient received no treatment for the events. The outcome of all the events was recovering.   Follow-up attempts completed. No further information expected.
Symptoms began about 45 mins after. Lower part of jawline was swollen. Not sure if it was the n95 mask. Throat got scratchy, sounding hoarse. Took Benadryl, extremely fast heart rate when moving around.  SOB walking to and from the bathroom. Extreme pain in back. Took Tylenol.  6am, Sat, woke up with headache and back was a tremendous pain. Took Tylenol every 6-8 hours. Today muscles in back are sore. No fever. Very fatigue today.
pt states on day of imz her arm was very sore and felt like she had been punched in the arm then the next day or tow the pain moved down to her elbow causing a burning on fire pain that changes places and moves around her elbow in addition her had on the right arm seems colder than her left hand and sometimes has a numbing feeling
metallic taste that lasted for 3 days and subsided. Calf pain that woke me up at night and lasted for 5 days
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed. No treatment medication details was provided.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored Liquid PEDVAXHIB (lot# L002867, expiry date 11-NOV-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
received vaccine at 1500 on 12/22.  woke up at 0200 with mild headache and moderate vertigo.  went back to sleep.  woke up at 0730 with ongoing vertigo.  vertigo resolved after 2 hours without any intervention
got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Lot number: FK5618) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no prior vaccination (4 weeks prior). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient got the Covid shot on 02Dec2021 and then was due for his second dose but then got Covid, tested positive for Covid on 03Jan2022. The parent stated that, "When they got Covid they did had headache and coughing" (for clarification). Product investigation received from product quality group on 20Jan2022 for COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 PEDIATRIC with lot number: FK5618. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111074 same product and event, different patients
Immediate ringing and loss of hearing in ears, blurred/starry vision, excessive sweating, nausea, and faintness.
Shaking chills, fever, headache, extreme tiredness, stomach ache/nausea, pain and redness at injection site.
This spontaneous report was received from a registered nurse referring to a patient of currently 58 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
12:15 pm pt. was vaccinated 3-4 min. before w HPV, Tdap, MCV, Flu - pt has a loss of consciousness for seconds and drop off w hard sound in floor - pt. had apparently seizure movements 2-3 seconds and apparently disoriented, excessive sweat and pale recovery partial feeling was weakness. Was referred to ER for observation.
32 year old female with mild reaction following vaccination of COV-19 Pfizer vaccination.  Reports swelling of her top lip about 20 minuets following her vaccination. Patient walked back into the Vaccination site and discussed with Provider her symptoms.  Vitals on patient were taken. Normal RR, SPO2,  HR.  BP elevated 144/100. PT was given 50 Mg of Benadryl. Monitored for 30mins, symptoms improved and she was released.  Gave pt instructions to seek medical attention if her symptoms worsen or go to the ED if she has wheezing, SOB, difficulty breathing.
Patient experienced an asthma exacerbation after her 1st Pfizer COVID-19 vaccine.
No adverse effects reported.; a 18 year old patient received an adult dose of VAQTA; This spontaneous report was received from a Nurse Practitioner concerning to an 18 years old patient of unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 27-JUN-2019, the patient was vaccinated with an adult dose (product administered to patient of inappropriate age) of Hepatitis A Vaccine, Inactivated (VAQTA) 50/1.0 U/mL, lot number S001485 with expiration date on 12-MAY-2020 (dose number, frequency, and route of administration were not reported) for prophylaxis. No adverse effects reported.
Pneumovax23 given at 12mo well child appt; mom today reported fever but unsure if due to this vaccine, other vaccines given or if child is sick (attend daycare).
Initial report received from healthcare professional on 15 OCTOBER 2014. A 25-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number U5018BA, expiry date 30 JUN 2015 and dose number was not reported) on 15 OCTOBER 2014. The patient index finger was bleeding and when she put the syringe down she had glass in her index finger. Index finger was bleeding on 15 OCTOBER 2014. The patient had no lab investigations were reported and corrective treatment included antibiotic and band aids. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies and birth defects included Seasonal Pen. At the time of this report the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 02 JANUARY 2015. Patient details are updated. No adverse event reported after vaccination. No vaccination was done with 4 weeks prior. Other medications, illness at the time of vaccination and pre-existing physician-diagnosed allergies were reported as none. At the time of this report, the outcome of the patient was reported as recovered on an unspecified date. Documents held by sender: none.
Immediately following vaccination extreme injection site pain and soreness. Five hours after vaccine was received a minor headache and chills started, some nausea/loss of appetite was present. Six hours after vaccine was administered headache and chills had progressed to being extreme, extreme muscle and joint aches were felt throughout entire body, nausea was extreme and worse when in upright position, low grade fever was noted, some weakness was present, polyuria, thirst, and minor photosensitivity were all present within seven hours of vaccine being administered. All symptoms were persistent throughout night until 20 hours after vaccine was administered. Muscle aches, chills, thirst, and nausea/loss of appetite persisted for first 48 hours after vaccine was administered. Pain at administration site persisted for 2 weeks after vaccine was administered with limitation to use of left arm. Muscle soreness returns with increased use over extended period of time of left arm still at a month after vaccine was administered.
Patient began getting cold, unable to hold his body temp, shaking and shivering, no longer able to breathe on his own. Was transferred to nicu at another hospital
No additional AEs or PQC reported; PROQUAD was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to a 17 month old male patient with no illness at time of vaccination or pertinent medical history. The patient had one brother. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # W029552 exp date 14-MAR-2024) (dose not reported) subcutaneously in the right leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2301USA001095:
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-SEP-2018, the patient was vaccinated with 4th dose of GARDASIL 9 (lot # N023828) (expiry date: 25-JUN-2020) for prophylaxis (extra dose administered). No adverse event was reported.
6 hours following vaccine administration pt developed fever, myalgias, anorexia for approximately 36 hours. Temp to 104.4.  Also developed localized erythema, induration, warmth at injection site, area 10cm x 6cm in area.
Acute on chronic hypoxemic/hypercapnic respiratory failure COPD exacerbation COVID pneumonia, possible CAP OSA and Obesity hypoventilation syndrome, suspected Recent admission at Hosptial for similar presentation, was discharged with home CPAP and oxygen but has not been able to make home equipment working CXR with cephalization , interstitial infiltrate versus edema .  Patient initially intubated for severe hypercapnia and unresponsiveness Change to dexamethasone 9/30, started remdesevir (9/29), COVID positive 9/29 (prior infection in 2/2023) Extubated 9/29, stable on home oxygen requirement He has functioning home cpap and oxygen concentrator and he was given equipment and education to add continuous oxygen Plan of care at discharge: dexamethasone to complete 6 day course, oral cefdinir, Breztri (has been on advair previously, eos count at 300), resume home cpap with added oxygen, close follow up at Facility   Update 10/4, received formulary options through Facility for home bronchodilators, changed to Wixela BID and Spiriva, I called Pt to discuss and he is agreeable. Also will order home oxygen concentrator.
Patient returned to clinic about 1/2 hour post administration c/o sore, pink, itchy area where flu shot was given.  Slightly warm to touch.  BP 110/80 P 84 and SPO2 98% room air.  No signs of distress.  Ice pack applied x 10 minutes.  Patient left stated feeling better.  Patient advised to come back to clinic with any further c/o or address here at the hospital, if needed.
A few minutes after receiving the immunization, she felt hot, sat down, then passed out for a couple minutes before waking up.  She said she hadn't eaten yet, and we gave her water and juice.  She said she was feeling a lot better and just needed to rest for a minute before getting up.
0.25 ml (booster) was given to pt. after vaccination it was discovered that pt was immunocompromised.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous)  On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Vaccines administered. Seen 2 days later with pain, swelling, erythema to right arm from shoulder to elbow.Vitals BP118/50,P85,R16,T98. RX- Zyrtex, Naproxan, Benadryl.Patient monitored-then dc'd. Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.
I started feeling like i had a bad cold a little bit like the flu. It felt like i had a fever but i didn't. I took a COVID-19 test and was positive. I felt the same way for 48 hours. I now feel better but i still have a cough and sore throat but i have more  energy to be up and moving around.
This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 4 patients. This is the fourth of 4 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced acute hepatic process within a few days of a PREVNAR 13 vaccine on an unspecified date with outcome of unknown.