chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost sense of smell; Lost sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste). At the time of the report, ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.  Company comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious  events of anosmia and ageusia. The events occurred after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious events of anosmia and ageusia. The events occurred after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chills, low grade temp, excessive fatigue, redness and swelling at injection site, muscle pain.
adverse reactions:feeling diaphoretic; adverse reactions: felt dizzy and like she was going to fainting; adverse reactions: hands started to tingling; This case was reported by a nurse via call center representative and described the occurrence of diaphoresis in a 30-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   On 28th March 2022, the patient received the 1st dose of Engerix B. On 28th March 2022, less than a minute after receiving Engerix B, the patient experienced diaphoresis, felt faint and tingling of extremity. On an unknown date, the outcome of the diaphoresis, felt faint and tingling of extremity were unknown.   It was unknown if the reporter considered the diaphoresis, felt faint and tingling of extremity to be related to Engerix B.     Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The nurse reported that a patient vaccinated with Engerix-B and within seconds started feeling diaphoretic, felt dizzy and like she was going to fainting also her hands started to tingling. This was the first time that after being vaccinated had some adverse reactions. The reporter consented to follow up. Additional Supportive Information: This case is linked with case US2022055950 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022055950:same reporter
Arm swelling has increased today, as has the pain.  I have a large lump at the injection site which is itchy.  It is reddened but there doesn't  appear to be a rash.
severe h/a, tunnel vision, ears stopped up, high pulse, faintness, sweaty palms, shaking hands & legs; began 2 hrs p/vax recvd shot of Vistoril all sx relieved x/h/a;
Pt fainted, hit head during fall, suffered scalp laceration, required sutures, on way home began throwing up, and sent to ER for concussion protocol.
Patient returned one day later with complaint of upper swollen, red, puffy, and warm to the touch. She also complained of neck stiffness.
Information has been received from a physician concerning an 18 year old female patient who on an unknown date was vaccinated intramuscularly with the third 0.5ml dose of GARDASIL (lot # not reported). The physician reported that the patient who received the entire series of GARDASIL was HPV positive after completing the three dose series. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's status was unknown. Follow up information has been received from the physician concerning the female patient with no illness at time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 06-APR-2007 was vaccinated intramuscularly with a 0.5ml dose of GARDASIL (lot # 656049/0187U, expiration: 29-SEP-2009) and on 22-MAY-2007 was vaccinated intramuscularly with another 0.5ml dose (lot # 657621/0387U, expiration: 02-FEB-2010) and on an unknown date was vaccinated intramuscularly with another 0.5ml dose (lot # not reported). On 21-JUN-2011, 4 years after vaccine Pap smear showed positive for HPV, high risk (16/18/31/33/35) and low risk (6/11/42/43/44). Colposcopy showed positive for HPV. At the time of reporting, the patient's status was unknown. Pap smear positive for HPV, high risk (16/18/31/33/35) and low risk (6/11/42/43/44) was considered to be an other important medical event by the reporter. Additional information has been requested.
Patient was admitted from the ED with Chest pain on 10/21/2021 which he tested positive for COVID-19
Smallpox vaccine placed LT deltoid 05 June 07. Post 4 days increasing swelling and pain. Possible infection was seen by Lt Col who ordered Ibuprofen.
Large redness area (4 1/2 inches x 4 inches) on left arm with swelling and soreness.
Here with Mom for lethargy and concern for adverse reaction to Td vaccine, which she received on 4/24. Her arm was red, and spreading intermittently. She was seen on 5/1 by Dr. for concern for allergic reaction. Mom gave BENADRYL once on 5/1 when the redness spread to her chest, which helped. No BENADRYL since that time. She has been napping every day for ~2 hours since she received the vaccine. This morning she wouldn't wake up per Mom. She is awake now and walked to and from the car. No fevers. She threw up on the way to the office, but Mom reports that she does get motion sickness. No diarrhea. Decreased appetite today, she took two sips of water in the car and then threw up. No rash now. +Abdominal pain today. No dysuria. Last BM was yesterday, which was normal. No sore throat. No ear pain. No sick contacts at home. She is in school. Mom reports that she was limp for ~36 hours after she got DTaP at age 2 months.
Patient was diagnosed with Covid-19 on 6/30/2021, and subsequently died on 7/8/2021. Covid-19 was listed as a contributing factor on his death certificate.
got diarrhea too; started to get sick; "it was kind of powerful for me"; Fever; Nauseous; Chills; The injection really hurt; feeling dizzy; having cold sweats; being frozen and couldn't get warm; Had to go to bed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), COLD SWEAT (having cold sweats), FEELING COLD (being frozen and couldn't get warm), SOMNOLENCE (Had to go to bed) and DIARRHOEA (got diarrhea too) in a 90-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.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced DIZZINESS (feeling dizzy), COLD SWEAT (having cold sweats), FEELING COLD (being frozen and couldn't get warm), SOMNOLENCE (Had to go to bed), ILLNESS (started to get sick), VACCINATION COMPLICATION ("it was kind of powerful for me"), PYREXIA (Fever), NAUSEA (Nauseous), CHILLS (Chills) and VACCINATION SITE PAIN (The injection really hurt). On 28-Oct-2021, the patient experienced DIARRHOEA (got diarrhea too). On 26-Oct-2021, VACCINATION COMPLICATION ("it was kind of powerful for me") and VACCINATION SITE PAIN (The injection really hurt) had resolved. At the time of the report, DIZZINESS (feeling dizzy), COLD SWEAT (having cold sweats), FEELING COLD (being frozen and couldn't get warm), SOMNOLENCE (Had to go to bed), DIARRHOEA (got diarrhea too), ILLNESS (started to get sick), PYREXIA (Fever), NAUSEA (Nauseous) and CHILLS (Chills) had not resolved.            Concomitant drugs were not reported. Treatment medications were not provided.
Information has been received from a MA concerning a 7 year old female who on 09/16/96 was vaccinated with a first dose of varicella virus vaccine live. On 09/16/96 the pt was also vaccinated with a first dose of MMRII. On 06/19/03 the pt was seen in the physician's office with a "typical" presentation of chickenpox that began on 06/12/03.  It was described as an itching rash spreading to her back, underarms, legs, stomach, face and hairline (everywhere). A physician exam identified vesicles and an "impression" was made of varicella. There was no fever. The pt was treated with Aveeno baths, calamine lotion and Benadryl. It was also reported that 3 other pt's were vaccinated with a dose of varicella virus vaccine live and developed chickenpox (WAES # 0306USA02442, 0306USA02866 & 0306USA02867).  Additional information has been requested.
My initial reaction within 5 minutes after vaccine injection I was sitting in waiting/observation room and had 2 major dizzy spells. Felt like I was going to faint and heart rate felt elevated. This subsided somewhat. Stayed in waiting room for 30 minutes. When I left facility heading home as someone else was driving me, I had another sudden side effect attack but much worse. The side of my mouth/chin area started to flutter and then that was followed immediately by shortness of breath, minor feeling of throat closure, very dizzy and extremely rapid heartbeat.
immun 31AUG; 1SEP had elevated temp of 101.8 ax w/APAP; red blotches on trunk & legs; rt leg swollen & lg bruise; cont APAP & used ice to site;
Patient was 34w4d pregnant with EDD of 5/23/22.  Patient had agreed to Covid-19 Booster Vaccine and screening questionnaire was filled out and reviewed. Vaccine was retrieved from refrigerator and vial was reviewed and it was unopened. Lot number was reviewed but expiration was not reviewed due to no expiration on the vial. Vaccine form was filled out but no expiration date was wrote down. Immunization was reviewed by an additional staff member and verified that Immunization was good to give. Vaccine was given with no complications. When logging vaccine my EMR flashed an alert that the vaccine was expired. Verified on the box that the vaccine expired on 4/11/22. Called Pfizer who stated that the vaccine was only good for 2 days pasted used by date if not opened.
Vomiting, fatigue, muscle pain, fever, and soreness at the site of injection, Took TYLENOL, iced area, and drink fluids.
approx 18 hrs p/DTP had fever to 103 ax @ 20 hrs became pale w/perioral cyanosis-massive swelling of rt leg down to knee; painful-wouldn't walk; examined 3OCT92 still had sifnificant swelling of thigh & knee of warmth & erythema;
Patient had swelling and redness after injection. She has pain in her arm and arm weakness. It hurts to hold a coffee cup, fold cloths, and drive. She has an appointment with her physician 9/21/18.
It started with a feeling as though I was getting a sore throat.   I took an Emergen-C drink and went to bed at normal time.  I also had more drainage than normal from my head.  During night I felt a fierce sore throat.  Next day, sinus headache, slight sore throat, additional drainage from head.  Last meal that day was lunch.  Going to bed, I vomited.  Next day, sinus headache, drainage, cough and yellow phlegm from lungs--a cough.  Took Tylenol during these times.  Vomited before bed.  Next day I took Alka-Seltzer Plus Cold meds in a.m. and again in afternoon.  Felt better.  Ribs very sore from coughing.  Appetite began returning.  Congestion much improved.  Following day (today) still congested but improved.  No meds so far today.
The patient was hospitalized in February 2022 d/t a fall at home, and urinary tract infection.  She tested positive for Covid-19 during rehab stay and was returned to the hospital.  She required assistance with eating and was non ambulatory and was placed in a nursing facility.  She developed SOB with saturation in 70s on 03/09/2022 and was hospitalized again.  She continued to decline and has required high flow oxygen and bipap.  The family ultimately chose comfort  focused care with Hospice Patient expired on 03/17/2022.
low level anaphylactic reaction half an hour after first shot; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 66-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on 21Mar2021 (at the age of 66-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Mar2021, the patient had a low level anaphylactic reaction half an hour after first shot. Patient's second dose was scheduled for 21Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
approx 2wks p/vax pt exp severe rash from head to toe & fever; pt  to MD; pt now suffers from PDD; perfect development until about 18-21 mon; parent feels the MMR has caused PDD;60 day follow-up dated 09/29/00 states the pt suffers from PDD - Autism.
74-year-old woman with a past medical history significant for breast CA 2010 status post RT and lumpectomy, dyspnea with associated weight loss and fatigue for the last 6 to 8 months, and hypertension who presented to the hospital for an outpatient bronchoscopy with EBUS.  She underwent HRCT outpatient was found to have a large right pleural effusion and underwent thoracentesis on 9/16/2022 which revealed lymphocytic with negative cytology.  The CT also revealed pulmonary nodules with right middle lobe atelectasis mediastinal lymphadenopathy requiring her to be scheduled for the EBUS bronchoscopy today.  Prior to the bronchoscopy the patient was reportedly in her normal state of health.  She denies shortness of breath was any different from her typical shortness of breath for the past 6 months.  She also denied chest pain, fever, chills, abdominal pain, nausea or vomiting.  She denies recent travel or sick contacts.  She has never required home oxygen.  She reports no history of lung disease ( other than recurrent pleural effusions recently) or cardiac disease.  She has never smoked tobacco and only drinks alcohol socially.  Post bronchoscopy today the patient experienced episode of bradycardia with heart rates in the 20s to 30s, atropine was given and the patient also received 4-5 chest compressions by anesthesia.  She was reportedly hypoventilating throughout the procedure with low tidal volumes.  The patient was also initially difficult to arouse postprocedure but she did became more alert and was able to be extubated and transitioned to supplemental oxygen via nasal cannula.  Given the above scenario the patient was admitted to internal medicine for ongoing monitoring. COVID-19 positive.  Medical team consulted, discussed with them.  Patient is agreeable and wishes to start remdesivir if appropriate per recommendations.  Decadron ordered by pulmonary medicine.  Will monitor LFTs and HR. Discussed with medical team, plan to stop Remdesivir and isolation precautions as COVID-19 positivity is likely related to old infection.   Elevated D-dimer in the setting of recent procedure, and chest compressions.  Bilateral lower extremity venous duplex is ordered showing chronic DVT.  VQ scan abnormal.  Patient will need anticoagulation for at least 3 months and prefers to be on Eliquis despite the high cost does not want to be on Coumadin.  Patient understands that she needs to follow-up with cardiology and her primary care provider for ongoing medication refills past the first 30 days.
1/14/21  severe chills , fever of 101.9, treated with ibuprofen throughout entire day,  sweats, headache, fatigue, body aches, nausea, soreness at injection site 1/15/21  headache, fatigue, body aches, nausea, dizziness, soreness at injection site, numbness and soreness of right 5th metacarpal; took ibuprofen for headache 1/16/21  headache, dizziness, fatigue, nausea, body aches, numbness and soreness of right 5th metacarpal 1/17/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal; took Tylenol for headache 1/18/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal 1/19/21 tiredness, nausea, numbness of right 5th metacarpal
Pt continues to be very symptomatic in the setting of a complex chest pain syndrome that is atypical in its description but has been persistent since she developed Covid or receive the Covid vaccine and is limiting her daily activities.  She is in extensive cardiac work-up and this has effectively ruled out obstructive epicardial coronary artery disease, cardiomyopathy, infiltrative disease, conduction system disease, or pulmonary hypertension.  The only significant finding we have is that she has a mild increase in her index of microvascular resistance in the setting of a normal coronary flow reserve suggesting that she does have an element of microvascular disease but it is also plausible that this does not explain all of her symptoms, especially since she found almost no relief with nitrates and several days on a calcium channel blocker.  It is also possible that many of the symptoms are due to endothelial inflammation that occurred secondary to either Covid or the vaccine and that these are slowly resolving over time as there does appear to be improvement in her biventricular function and return to normal size.
Neck stiffness, pain, Severe headache/ migraine overnight the night of receiving vaccine 1. Following 2 days chills, fever 101.5, nausea, headache, joint pain, neck stiffness/pain, dizziness, difficulty concentrating. Swelling like a golf ball at injection site,  purple skin and painful arm  for 10 + days. Can feel a solid border of  about 3 inch diameter around where the golf ball type knot was . Still sore when touched and visible bruise today.
Information has been received from a physician concerning a "12 year old" female with no known drug allergies and known drug allergies and no past medical history who on 26-MAR-2008 was vaccinated with her first of three doses of GARDASIL (lot# unspecified, sit not reported.). Concomitant therapy included MENACTRA. The physician reported that the patient fainted after receiving the vaccination. Subsequently, the patient recovered. No additional information was provided. Additional information has been requested. Follow-up information received from the office worker on 12-May-2008 indicated that she was unable to identify the patient who had this event. No additional information is expected.
pain at injection site (still a little sore to the touch), headache, muscle pain, tiredness and fever 101 (highest)  all lasted 1 day except for injection site tenderness
All over Stiffness/Upper arm stiffness; Blurred vision/Visual changes; Could not focus on anything; Dizzy; Muscle rigidity/Joint rigidity/All over rigidity; Felt like having Mono; Felt like moving cement; Could not do anything; Pain in the arms; Achiness; Enlarged lymph nodes; Extreme fatigue; Muscle soreness; Weakness; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), ASTHENIA (Weakness), DISCOMFORT (Discomfort), MUSCULOSKELETAL STIFFNESS (All over Stiffness/Upper arm stiffness) and MYALGIA (Muscle soreness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and VITAMIN B COMPLEX for Supplementation therapy, LAMOTRIGINE (LAMICTAL XR), METHYLPHENIDATE HYDROCHLORIDE (CONCERTA), ETHINYLESTRADIOL, LEVONORGESTREL (JOLESSA), LACTOBACILLUS NOS (CULTURELLE), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), ALPRAZOLAM (XANAX SR) and DIAZEPAM (VALIUM) for an unknown indication.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced FATIGUE (Extreme fatigue), ASTHENIA (Weakness), DISCOMFORT (Discomfort), MYALGIA (Muscle soreness), LYMPHADENOPATHY (Enlarged lymph nodes), MUSCLE RIGIDITY (Muscle rigidity/Joint rigidity/All over rigidity), INFECTIOUS MONONUCLEOSIS (Felt like having Mono), FEELING ABNORMAL (Felt like moving cement), MOBILITY DECREASED (Could not do anything), PAIN IN EXTREMITY (Pain in the arms) and PAIN (Achiness). On 03-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (All over Stiffness/Upper arm stiffness), VISION BLURRED (Blurred vision/Visual changes), DISTURBANCE IN ATTENTION (Could not focus on anything) and DIZZINESS (Dizzy). At the time of the report, FATIGUE (Extreme fatigue), ASTHENIA (Weakness), DISCOMFORT (Discomfort), MUSCULOSKELETAL STIFFNESS (All over Stiffness/Upper arm stiffness), MYALGIA (Muscle soreness), LYMPHADENOPATHY (Enlarged lymph nodes), VISION BLURRED (Blurred vision/Visual changes), DISTURBANCE IN ATTENTION (Could not focus on anything), DIZZINESS (Dizzy), MUSCLE RIGIDITY (Muscle rigidity/Joint rigidity/All over rigidity), INFECTIOUS MONONUCLEOSIS (Felt like having Mono), FEELING ABNORMAL (Felt like moving cement), MOBILITY DECREASED (Could not do anything), PAIN IN EXTREMITY (Pain in the arms) and PAIN (Achiness) 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.   second dose was scheduled on 30 may 2021. no treatment was provided.
Woke up approx 5am with body aches, fever, sweating, chills, scratchy throat. Patient took 800mg ibuprofen. Went back to bed, woke up approx 9 and face "felt funny", went back to bed. Woke up at 10 am and could not see out of right eye, right upper eyelid, right cheek down into neck swollen. No pain. Ice pack applied and 5mg Zyrtec taken per patient report.
Shortness of Breath; Swelling in leg; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and PERIPHERAL SWELLING (Swelling in leg) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) and PERIPHERAL SWELLING (Swelling in leg). At the time of the report, DYSPNOEA (Shortness of Breath) and PERIPHERAL SWELLING (Swelling in leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021, no new significant information
8 hours later bad chills then fever of 101. It was over within 12 hours Three days later had a strange like feeling of flittering near heart area...has happened 3 times since Blood pressure has increased at least 20 points or more since vaccine Swelling in fingers and toes
Bi-parietal throbbing headache X 10 days.  Normal exam, normal labs.  Headache slowly resolved over the next 10 days.
No adverse events reported by patient.  Report filed because Pfizer Monovalent was given in error instead of Pfizer Bivalent.