chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still feeling dizzy; Head is not feeling right; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Still feeling dizzy) and HEAD DISCOMFORT (Head is not feeling right) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 027A21A and 030l20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced DIZZINESS (Still feeling dizzy) and HEAD DISCOMFORT (Head is not feeling right). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Still feeling dizzy) and HEAD DISCOMFORT (Head is not feeling right) outcome was unknown.            No concomitant medication was mentioned.
This is a spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis Reference #: PHEH2016US029422_NS). A contactable consumer reported for himself. A 65-Year-old male patient of an unspecified route received PREVNAR 13 at single dose on the right arm and influenza vaccine on the left arm both via an unspecified route on 18Oct2016 for immunization. The right arm where he received pneumococcal 13-val conj vac (dipht crm197 protein) appeared swollen. The outcome of the event was unknown.
Patient fainted approx. 1 hour after receiving H1N1 injection.  She hit her head when falling to the floor.  EMS was called and transported her to the local hospital emergency room.
Hallucinations, auditory and visual. Onset at early morning hours. 2 days in a row. Will be making appointment with primary care.
Dad states that patient started running 104 fever the night shots were given. Dad not sure how long fever lasted due to sleeping. Itching, pain, swelling started the next morning. Dad notes swelling has continued to get worse and area grow larger. Dad states he gave her ibuprofen one time. Fever resolved. Swelling and pain continued as of today (4/3/23).
Headache; blurry vision; fevers; body ache; chills; Second dose on 07Jan2021 (19days) after firts dose on 19Dec2020; This is a spontaneous report from a contactable physician (patient).  A 40-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date not provided), via an unspecified route of administration left arm second dose on 07Jan2021 07:45 at singled dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation (first dose, Anatomical Location: Arm Left and lot number EJ1685).  On 07Jan2021, the patient experienced Headache, blurry vision, fevers, chills, body ache. The patient did not received treatment for the events. Second dose on 07Jan2021 (19days) after first dose on 19Dec2020. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Since vaccination patient was not tested for COVID-19.
Narrative: Pt is a 90y.o. male who died on 02/10/2021 w/ h/o vascular dementia, afib/flutter s/p ablation, pacemaker, DM, htn, facility resident-Tested positive for Covid 1/29. Pt received Moderna Covid-19 Vaccination 1/2 on 01/14/2021. Pt presented to ED on 02/02/2021 following positive covid-19 test on 01/29/2021. Patient was evaluated for bamlanivimab treatment, given Bam, and discharged. Pt presented to ED on 02/06/2021 with decrease IN MENTAL STATUS OVER 1 WEEK (PER REPORT FROM NURSE). PT UNABLE TO STATE NAME, WHERE HE IS. On 02/07/2021 palliative care was consulted and pt admitted to inpatient care. Infectious Disease consult on 02/10/2021 reported blood culture obtained and grew MRSA in 1/2 samples drawn 24 minutes apart on 2/6. he was started on Vanc and Ceftriaxone due to a positive urine culture for K. pneumoniae. Pt died on 02/10/2021 with physician reporting Death was caused by: PEA arrest secondary to sepsis. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
This case was reported by a pharmacist and described the occurrence of abnormal taste in mouth in several subjects of unspecified age and gender who were vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On unspecified dates several subjects received unspecified dose of Fluarix (unknown).  At an unknown time after vaccination with Fluarix, the subjects experienced a latex taste in mouth.  At the time of reporting the outcome of the event was unspecified.
A non-serious, spontaneous report of administered expired FLUMIST was received from a health professional concerning a six-year-old male. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.
Patient had significant bruising at injection site (approximately 3 inches in diameter). The bruising started shortly after the shot and is still there 3 weeks later. She is also on Warfarin.
Soreness at injection site, difficulty lifting lingering painfulness >3 weeks. Physical therapy.
The patient received vaccination and after approximately 5-10 min. he felt unwell and was sweaty. There was a possibility he would faint. After paramedics arrived, he was diagnosed as having vasovagal syncope. Paramedics cleared patient for release.
Information has been received from a physician concerning an adult female who in October 2006 was vaccinated with a dose of MMR II. In October 2006, the patient and developed redness, swelling, and itching at the injection site. The patient was seen in the physician's office three days after the vaccination for these symptoms and was treated with an unspecified antibiotic. No laboratory or diagnostic studies were performed. The patient outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Arm discomfort at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm discomfort at the site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm discomfort at the site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm discomfort at the site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 103 (High) 103 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-034872 (Patient Link).
Patient transferred from outlying hospital on 3/30/21 due to increasing oxygen demands and increased level of care.  Patient was admitted to outlying hospital with COVID-19 infection with shortness of breath, cough, fever, weakness, fatigue with decreased oral intake on  3/28/21.  Patient required oxygen and was treated with remdesivir, steroids, and antibiotics.  Patient was discharged to home with oxygen.
MUSCLE SORENESS RADIATING INTO SHOIULDER AND NECK AND KNOT ALMOST 1 MONTH POST INJECTION.
About 9 1/2 centimeter of redness and warmth around injection site on right upper deltoid. no fever noted.
PATIENT REPORTED AN ITCHY RED REASH ON THE BACK OF HIS LEG(S) SEVERAL HOURS AFTR RECEVING HIS FIRST VACCINE; I RECOMMENDED ORAL BENADRYL, TOPICAL BENADRYL CREAM AND/OR AND HYDRCORTISONE CREAM; OTHER RECOMMENDATIONS INCLUDED A COLD COMPRESS AND CALAMINE LOTION AS INQUIRED BY THE PATIENT; PATIENT REPORTS NO SWELLING OF THE TONGUE, LIPS, MOUTH AND NO DIFFICULTY BREATHING
Information has been received from a registered pharmacist concerning a 46 year old female patient with pertinent medical history reported as none and no known drug allergies who on 01-SEP-2009 was vaccinated  with a dose PNEUMOVAX 23 (lot # 661529/0868X) 0.5ml, intramuscularly into left deltoid. She may have received a prior dose of PNEUMOVAX 23 at least 5 years ago. There was no concomitant medication. On 01-SEP-2009 after administration of vaccine the patient experienced pain, redness, swelling and warmth at the site of injection. The patient stated she felt excruciating pain when she rolled on the arm while asleep. The patient sought medical attention via phone. Her symptoms had improved on 02-SEP-2009. At the time on the report on 02-SEP-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow-up information has been received regarding a case in litigation concerning the 46 year old female patient with asthma and no pertinent medical history or allergies. The patient's concomitant therapy included an influenza virus vaccine (unspecified) administered on 01-SEP-2009. No further information is available.
Patient felt nausea, cold chills, evening of 3/31/12. Area of vaccination felt "extreme heat" and was swollen. Patient went to Emergency Room at 6pm 3/31/12. Swelling was enlarged. Patient was given a prescription for KEFLEX and OTC BENADRYL. Diagnosis treated for cellulitis.
Nausea, vomiting, fever, chills lasting 36 hours, malaise lasting 4 days.
After receiving the shot pt is sitting outside the pharmacy area. After about 10 minutes she informs me, that her finger nail beds are turning orange. This had affected both of her hands. Did not spread to her feet. PT was not complaining of any trouble breathing or itchiness. I observed the pt for a total of 30 minutes. PT stated she is not having trouble breathing and I said its ok to go home. Informed pt to fill out V-safe and if the coloring does not go back to normal in a day reach out to her PCP.
This spontaneous report was received from a nurse regarding a female patient of unknown age. There was no information on pertinent medical history and drug reactions or allergies. On 20-JUN-2012, the patient was vaccinated with first dose of GARDASIL strength reported as 120, units reported as Y (dose, frequency, route, product lot#, expiry date not reported). No concomitant therapy reported. The nurse reported that on an unknown date in OCT-2014 (reported as in office now), the she was in office to receive her second dose of GARDASIL. No adverse symptoms reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Site: Swelling at Injection Site-Mild, Additional Details: came for second dose vaccine on 7/5.reported swelling under right armpit area/side of breast that appeared 3 days after receiving first dose and that this has happened to him once in the past as well. Pt went to md for visit and was told it was nothing and gave abx which he didnt take.Swelling noticeable, but does not cause pain/affect his daily activity.RPh asked patient if he wants to get it checked by his pcp before receiving second dose, pt refused and wanted 2nd dose.monitoring 30mins
Got slight rash on inner upper thigh of Left leg stated that it was itichy and had a tingle feeling just like when she had shingles before
States in Oct2021 PTT was too high to operate; Was diagnosed with Lupus anticoagulant; This spontaneous case was reported by a consumer and describes the occurrence of ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant). At the time of the report, ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED (States in Oct2021 PTT was too high to operate) and ANTIPHOSPHOLIPID ANTIBODIES (Was diagnosed with Lupus anticoagulant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Activated partial thromboplastin time: high (High) PTT was too high. In October 2021, Antiphospholipid antibodies: diagnosed with lupus anticoagulant (Positive) diagnosed with Lupus anticoagulant.         No concomitant medication was reported. No treatment medication was reported.  States in Oct-2021 patient was supposed to get knees replaced Patient declines to provide further personal medical history was reported.   This case was linked to MOD-2022-515380 (Patient Link).
Patient said there is a bump at the area of injection, redness and warmth and that the redness was spreading around her arm.
J&J Dose 5/15/21 (lot NA) COVID Positive 1/10/22  1/10/22: The patient is a 64 year old male with past history of hyperlipidemia, obesity, depression, and obstructive sleep apnea who was admitted with hypoxia secondary to suspected COVID-19 pneumonia.  History is obtained from chart review as well as discussion with the patient and the ED provider.  Patient has a history of sleep apnea although he has not uses CPAP in some time.  He has received 2 COVID-19 vaccinations.  Started feeling poorly approximately 1 week ago.  Has had a productive cough as well as shortness of breath, fatigue, and diarrhea.  Has had some nausea but no vomiting.  He presented to the ER today and O2 saturations on room air were noted to be 79%.  He is currently on 2.5 L of oxygen. He has had some fevers and chills during the 1st part of his illness but none the last few days.  He denies any chest pain, abdominal pain.  He does not smoke or have a history of lung disease.  1/14/22: Patient is a 64-year-old male admitted to hospital for acute hypoxic respiratory failure due to COVID-19 pneumonia, patient was treated with supplemental oxygen medical therapy including antibiotic Decadron and remdesivir, as time progressed patient clinically improved. Patient will be discharged to home with supplemental oxygen 4 L at rest and 6 L with activity, Decadron and antibiotics for completion.  Patient also referred to program at home.
blood clots that had apparently broken up and gotten stuck in my lungs; A spontaneous report was received from a consumer who is a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clots that had apparently broken up and gotten stuck in lungs/thrombosis/pulmonary embolism.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Mar 2021, five days post-vaccination, the patient reported he had a significant event in which his wife had to call an ambulance and rush him to the hospital. It was discovered that he had blood clots that had broken up and got stuck in his lungs. The patient reported he was put on heparin and apixaban blood thinners. The patient stated he is scheduled for further testing.   Treatment included, heparin and apixaban.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, blood clots that had apparently broken up and gotten stuck in my lungs/thrombosis/pulmonary embolism, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
scarlet fever from neck to toes; diagnosis of strep throat; finger and wrist stiffness; snapping joints; fever; lymphadenopathy; fatigue; myalgia in both hips; arthralgia; This spontaneous case was reported by a physician and describes the occurrence of SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints) and ARTHRALGIA (arthralgia) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ARTHRALGIA (arthralgia), FATIGUE (fatigue) and MYALGIA (myalgia in both hips). On an unknown date, the patient experienced SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints), PYREXIA (fever) and LYMPHADENOPATHY (lymphadenopathy). At the time of the report, SCARLET FEVER (scarlet fever from neck to toes), PHARYNGITIS STREPTOCOCCAL (diagnosis of strep throat), MUSCULOSKELETAL STIFFNESS (finger and wrist stiffness), JOINT NOISE (snapping joints), ARTHRALGIA (arthralgia), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (myalgia in both hips) and LYMPHADENOPATHY (lymphadenopathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse refers to her 84 years old mother with hypertension and no drug reactions or allergies who approximately one year ago, in 2011, was vaccinated with a dose of PNEUMOVAX 23 (dose and lot number not reported) at her unspecified primary care physician's office, following an initial dose of an unspecified pneumococcal vaccine about 26 years ago, in approximately 1986 (dose, route and lot number not reported). No other co-suspects were reported. Concomitant therapy included high blood pressure medication. The registered nurse reported that approximately one year ago, in 2011, she believed that PNEUMOVAX 23 was administered intradermally-like tuberculin skin test -as there was a bubble under the skin of her mother's arm. The registered nurse reported that the administration site was at the back of the arm, not in the deltoid muscle and that her mother's arm turned red and swelled, in almost total circumference, from elbow to shoulder. Ibuprofen and compresses were given as a treatment for the experience. No lab diagnostics studies were performed. The patient recovered on an unspecified date, it was reported that the swelling tool many weeks to subside. The relatedness for patient's arm turned red and swelled in almost total circumference, from elbow to shoulder and there was a bubble under the skin was unknown for PNEUMOVAX 23. Additional information has been requested.
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender 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 first 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 VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA218718, 2018SA223733, 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves five-year-old (five year six months) patient of an unknown age who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported 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 holders compliance with the requirements set out in Directive 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. Documents held by sender: none.
shot were given 15OCT93 mom stated pt became ill about 5 hrs later took to clinic had sz, t100.7; to hosp was admitted for 3 days; MD wants pt to have DT for future vax;
Had a reaction / Redness; This case was reported by a consumer and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient had second Shingrix shot and had a reaction. The redness had almost cleared up but not completely.  The patient wanted to know how long should wait before getting a covid vaccination?