chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse via Pfizer sales representative, who reported similar events for two patients. This is the 1st of 2 reports. A female patient in her late 50's received a single dose of PREVNAR 13 at single dose and the flu vaccine, both in opposite arms on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient's arm became red, hot, and hard the arm where the patient received the Prevnar 13. The adverse events took 2 to 3 weeks for the patient to completely recover. Sender's Comments: Linked Report(s): US-PFIZER INC-2016547364 Same reporter/drug/event, different patient.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced injection site erythema, fatigue, muscle weakness and activities of daily living impaired. On an unknown date, the outcome of the injection site erythema, fatigue and muscle weakness were recovering/resolving and the outcome of the activities of daily living impaired was recovered/resolved. The reporter considered the injection site erythema, fatigue and muscle weakness to be probably related to SHINGRIX. It was unknown if the reporter considered the activities daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The HCP did not have vaccine lot number or expiration date. The healthcare professional (HCP) reported that the patient developed fatigue, muscle weakness, and redness around the injection site several hours after receiving a of SHINGRIX. The vaccine was given at a different facility. The patient was unable to do normal daily activities for 2 days due to the muscle weakness and fatigue. The patients symptoms were improving but have not yet resolved at the time of reporting. The pharmacist recommended the patient use ice for the injection site redness.
Verbal history - states night of receiving vaccine had migraine headache, hot flashes, violent vomiting, fatigue and achiness. Next day GI upset (abd pain) but no vomiting.
Narrative: Patient had RIGHT occipital subacute stroke with symptoms started within a day of receiving COVID 19 moderna 9/21/2021. Patient attempted to wait at home for symptoms to resolve but subsequently presented 9/2/2021 to urgent care for visual field loss and found to have subacute occipital stroke. He was transferred to hospital and seen by neurology. Attempted w/u to determine etiology. ECHO was WNL. cardiac monitoring unclear. MRI confirmed prior infarcts and occipital CVA. MRA neck showed 60-70% atherosclerotic disease. Appears patient had 2 doses of plavix and then left AMA. No rx were written and no clear recommendations. During interim cardiology and neurology consultations were placed pending scheduling. Patient reports continued visual loss but not unchanged, thinks it is staying the same and potentially getter better. Discussed this case with pharmacy. Will continue max dose rosuvastatin 40mg as appropriate therapy. Patient has been compliant with daily baby aspirin. Will increase to 325mg daily aspiring (instructed to take 4 of the 81 mg aspirin daily until received requesting overnight delivery). Decision making with patient on adding pavix to regiment and risks and benefits discussed. Will add plavix 75mg daily x 21 days and then to be determined by neurology followup continued antiplatelet therapy. Addition of LDCT scan and PFT testing as DX of COPD not on problem list but noted emphysema and smokes pipe- recommended cessation patient seems reluctant understands this is a risk factor for recurrent CVA. Pipe tobacco smoker 4-5 bowls/day > 30 years. Added COPD to problem list. Patient has risk factors and prior old infarcts as determined by brain imagine.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted a few minutes after receiving the injection, he regained consiousness immediately. He was coherent, drinking water and eating candy. His mother was with him and they left after fifteen minutes.
urinary incontinence; coughing; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative.  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 25Jan2021, single dose for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Thursday 28Jan2021 late evening patient began new onset constant coughing-"profusely" which led to urinary incontinence. Cough got improved and patient does not have a prior history of persistent cough. The outcome the event cough was recovering on unspecified date of 2021. The outcome the event urinary incontinence was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
6/14/2019 - Was given a Tdap in LD and a PPD (Tubersol) placed on left forearm by an Employee Health RN.   Patient developed a red arm shortly after the injection was given and then at approximately 17:00 she developed chills,  sore joints, sore arm, and a headache that would not go away.  This progressed to a high-grade fever, rigors, delirium, and low oxygenation.  She went to the Emergency Room at 22:00 that same evening.  She was given several bags of IV fluids and oxygen.  She underwent a CT scan, chest x-ray, and lab work.  All came back negative.  They could not identify an infective or other source for her symptoms.  Was discharged to home at 04:00 AM on 6/15/2019, was to return if she did not start to feel better.  She presented to Employee Health on 6/17/2019 for the TB read, but is not able to return to work yet, do to weakness and intermittent fevers.
No symptoms reported; expired dose of M-M-R II was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 26-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, intramuscular, lot number S020962, expiration date 07-JUL-2021, for prophylaxis. No adverse events of symptoms were reported.
Patient received 2nd dose of Moderna vaccine on 3/31/21 (Moderna, Lot 006B21A).  Patient was hospitalized with covid pneumonia on  8/13/21.
This spontaneous report was received from a pharmacist and refers to an approximately 68 year old male patient. Medical history and concomitant medications were unknown by the reporter. On an unspecified date in 2015 (reported as one year ago), the patient received ZOSTAVAX (lot number unknown). The day after the patient received ZOSTAVAX, the patient sought medical treatment at a facility because he broke out in lesions on his forehead. He was treated with an unspecified antiviral medication. The lesions lasted for an unknown amount of time but at the time of the report the patient was "fully recovered". Additional information has been requested.
NOT BEING ABLE TO EAT; NAUSEA; DIARRHEA; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN),vaccinated at right arm, dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included varicella zoster vaccine. On 28-MAR-2021, the subject experienced headache. On 28-MAR-2021 03:00, the subject experienced diarrhea, nausea. On an unspecified date, the subject experienced not being able to eat. The action taken with Covid-19 vaccine was not applicable. The patient recovered from diarrhea, and nausea on 29-MAR-2021, was recovering from headache, and the outcome of not being able to eat was not reported. This report was non-serious.
Has large patch of red bumps from wrist to his elbow on the same arm as injection; Has large patch of red bumps from wrist to his elbow on the same arm as injection; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash and papular rash. On an unknown date, the outcome of the red rash and papular rash were recovered/resolved.   It was unknown if the reporter considered the red rash and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's comments: The case was reported via interactive digital media. The reporter was patient's wife. The patient experienced large patch of red bumps from his wrist to his elbow on the same arm as injection after receiving 2nd dose of Shingrix, but patient felt fine. The reporter asked was it fine.
Neurological issues; This case was reported by a consumer via interactive digital media and described the occurrence of neurological disorder nos in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neurological disorder nos. On an unknown date, the outcome of the neurological disorder nos was not recovered/not resolved.   It was unknown if the reporter considered the neurological disorder nos to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported aby the patient for herself or himself. The age at vaccination was not reported. The patient got the shingles vaccine shot and now suffering side effects and taking medicine to see if can overcome the neurological issues occurred after the vaccine for shingles. Also stated that to read the side effects before get it.
cuts; accidental exposure; Exposure via skin contact; Product Complaint; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of hand in a male patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis. This case was associated with a product complaint.   On 13th June 2019, the patient received Shingrix. On 13th June 2019, immediately after receiving Shingrix, the patient experienced laceration of hand, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of hand to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reported that another one of their pharmacist noticed that the vial of the adjuvant vialof Shingrix was broken, he noticed this as he was trying to reconstitute the vaccine trying to reconstitute the vaccine. The reporter reported that the pharmacist's hands got cuts from the vial, which led to inadvertent exposure to vaccine and exposure via skin contact. The pharmacist threw away the vial. No product available for return. The reporter confirmed that the dose was wasted and not given to a patient. The company was providing credit to wholesaler for one full dose of Shingrix. The company asked was the package or carton or blister tray damaged upon receipt, was there any evidence of leakage or product in package/carton (ex. wet PIL, powder in box), were there any glass pieces still in the vial or carton or evidence of holes or glass pieces missing, was there product still present in the vial and if cracked was it a single hairline crack or is it extended and branched. The pharmacist said no it was thrown away and there was liquid in the vial when the pharmacist was reconstituted. The pharmacist told the vial was shattered from top to bottom.
Patient came back to the Flu clinic site approximately 15-20 minutes after receiving a flu vaccine injection. Patient stated she did not feel well and felt like she had shortness of breath, swelling of her tongue and itching. The second nurse at the flu clinic noticed patient had "hives" on her upper back. Nurse at the clinic called 911, fire and rescue showed up a few minutes later and transported patient to hospital.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that because their facility was not been able to download the digital data logger, they have been put on hold by the State at the movement and were not administering the Moderna COVID-19 vaccine to the patients until an assessment was made by the State. The reporter also stated that there had been no power outages that would have impacted the Moderna vaccine. The reporter stated that however, because their facility was unable to download the digital data logger, they treated this issue as a temperature excursion. It was also reported that the data logger which was unable to download was for the months of Dec-2021, Jan-2022 and Feb-2022. Reporter stated that no adverse reactions were reported by any patients.  No concomitant medications were reported.  No treatment medications were reported.
A 14 month old pulled away during Pediatric Covid vaccine injection. We are not sure how much of the vaccination the child received.
Information has been received from a licensed practical nurse concerning a 16 month old male who on 04-DEC-2006 and on other unspecified date was vaccinated PO with the first, second and third dose of Rotateq (no lot# given). On 08-FEB-2008 the patient "tested positive for rotavirus." It was also reported that on approximately 08-FEB-2008 "the patient had been feeling bad for 3-4 days and had experienced diarrhea." The patient sought unspecified medical attention. Lab diagnostic studies were performed but the specific test was unknown. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
pt recvd vax 19JAN93 on 29JAN93 mom noticed warm to touch in AM; pt taken to hosp 8PM by ambulance p/sz; p/5 hrs in ER discharged on Pediaprofen for fever & betapen for throat infect;
Was scheduled to receive the second dose, but the sight was closed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Was scheduled to receive the second dose, but the sight was closed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (Was scheduled to receive the second dose, but the sight was closed). On 13-Feb-2021, PRODUCT AVAILABILITY ISSUE (Was scheduled to receive the second dose, but the sight was closed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided.  No treatment details were provided.    This case was linked to MOD-2021-023438 (E2B Linked Report).; Sender's Comments:  MOD-2021-023438:Same reporter
This spontaneous report was received from a physician via company representative referring to an elderly (reported as over the age of 65 years) female patient with neoplasm malignant. The patient's medical history was not provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (route, dose, frequency, lot number and expiration date were not reported). Concomitant medications were not provided. On an unknown date, (reportedly as approximately one year after vaccination), the patient developed shingles (herpes zoster). Furthermore, on an unknown date (reported as approximately one year after developing shingles) the patient saw the physician in the office and was administered the second dose of ZOSTAVAX. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of herpes zoster was unknown. The primary reporter did not provide the causal relationship between ZOSTAVAX and herpes zoster. Additional information has been requested.
12/27/2005 vaccinations, 12/29 DX DM RX Amoxil, Given vaccination left leg, Febrile 01/05 to 01/16, X Diffuse Myositis, no osteomyositis, positive bilat knee effusions, right hip effusion, felt reactive arthritis no septic.
Pt recvd a series of 3 doses of Engerix-B & exp no adverse exp however did not convert; plan to revaccinate;
Patient was given Moderna 0.5ml dose as Booster instead of recommended 0.25 ml dose .  Patient had no adverse effects from dose.  She ahd one day of left am pain and fatigue.
I HAVE TWO PIMPLES ON MY RIGHT ARM ABOUT THREE INCHES APART ON  7/26 AND TWO MORE ONE NEXT TO EACH OTHER ON THE LEFT ARM ON THE 27TH WHEN I WAKE UP. tHEY WERE ALSO ITCHING
Patient noticed skin being red, itchy a few days after injection. After scratching he noticed a raised red rash this morning. Symptoms come and go.
Patient is a 54 y.o. male patient of MD with history of hypertension who presented to Hospital with shortness of breath, fatigue, recent COVID positive home test, found to have multifactorial pneumonia.   Acute respiratory failure with hypoxemia Abnormal CT chest  Multifocal pneumonia Respiratory failure in setting of pneumonia, likely combination of bacterial with component of COVID CTPA on admission without PE, though showed extensive bilateral lung opacity involving all lobes, most confluent in the left lung Initially required 4L supplemental O2, weaned to room air quickly Urinary antigens negative Sputum culture with mixed flora MRSA swab negative Pulm followed Initially on vanc/zosyn, transitioned to levofloxacin, planning 7 day course total Repeat CT chest in 6-8 weeks with outpatient pulmonology follow up   Sepsis, POA Lactic acidosis Due to pneumonia with leukocytosis, tachycardia, lactic acidosis on admission Blood cultures 2/2 with staph hominis, suspect contaminant Repeat blood cultures without growth at 48 hours Treated with antibiotics as above   CoNS positive blood cultures Blood cultures on admission 2 of 2 staph hominis, thought to be both contaminants given collection timing and not clinically relevant TTE does not show evidence of endocarditis ID followed Repeat blood cultures negative at 48 hours   Covid-19 Virus Infection Date of onset of symptoms: 3/10 Symptoms present on admission: Shortness of breath, fatigue Date of covid positive test: 3/12 on home antigen test, 3/15 here Vaccination status: vaccinated without booster Imaging: CTPA as above Oxygen requirements on admission: 4L nasal cannula Current oxygen requirements: room air Medical therapy: received steroids while admitted, discontinued on discharge given on room air and only briefly required oxygen;, was taking Paxlovid at home Consultants following: pulm Anticipated special isolation end date: 3/20   AKI Metabolic acidosis Admit Cr 2.1, baseline normal, suspect prerenal with ACEi use and was taking Paxlovid Improved renal function, back to baseline Resume ACEi/diuretic on discharge   Elevated LFTs In setting of COVID, though possibly related to remdesivir Improved to near normal Repeat 1 week   Hyponatremia Na 123, in setting of diminished intake, but was 126 Normalized   Anemia, normocytic Hgb 12.5, baseline wnl  Without evidence of active bleeding Iron studies with anemia of chronic disease Repeat as outpatient   Essential hypertension  Home regimen: amlodipine and lisinopril/hydrochlorothiazide  Held ACEi/diuretic during admission Resume home regimen on discharge
Chest pain. tightness and sharpness in the center of chest. This lasted for three days. treated with ibuprofen.
Facial flushing and redness , also redness noted on chest. v/s 136/84, 82, 100% RA, Alert and oriented x4, patient observed for 30 minutes with resolution of redness to chest and face. patient refused transport.
Vaccines were given. Patient was sitting on the bed, appeared well. He asked for a glass of water. I left to fill a glass. When I returned, patient was on the floor. He was awake and talking. Could not remember exactly what happened. His mother was at his head. Patient remained on the floor resting for < 5 min. sat up and drank water. No apparent distress. Physician evaluated. Pt steady on feet before leaving clinic. No questions.
Patient had a vasovagal syncope and started sweating. We laid patient on the floor, and gave him some water. Paramedics were called. After a few minutes, patient felt better. Paramedics took his blood pressure and did some checks. After that, he left on his own.