chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19/Sick/Congested; Treatment of COVID-19/Sick/Congested; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJU989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in 2019 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19/Sick/Congested". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccinated and double boosted, patient took their 1st vacation since 2019. Left on 20Apr2023. They woke congested on 30Apr2023, the morning they were flying home. Took home test and both tested positive. Started Paxlovid on 01May. On 12May, she felt like she had a head cold, but no other symptoms. Tested positive 14May. Spouse tested negative on 14May. Though they got sick, she was reporting "country" below because this report was about the rebound.
6 days later I started to feel lethargic and couldn't stay awake. The next day I became so weak and had low grade fever. The next day I thought I had covid because of the chills, sweating, weakness, dizziness, dry mouth, malaise, trouble staying awake. I had a covid test it was negative. The DR at the facility told me that I was having severe adverse reaction to the vaccine. It has been 6 days and i am still not well.
Nausea, loss of appetite, muscle aches, headache, pain in upper back at right shoulder blade, chills, diarrhea. Appearance of rash - small raised bumps on both upper arms and lower legs, slightly itchy, on Thursday afternoon and worsening on Friday. I felt pretty ill on Friday - listless, tired and no appetite. I felt much better on Saturday and the rash began to improve without spreading further. The rash still exists today - on 07/04/2010 but does not itch or hurt- rash consists of small raised red and some white bumps.
Fever; body pain; chills; felt horrible; weak; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02Apr2021 at 15:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 05:00, the patient experienced fever chills felt horrible weak body pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever chills felt horrible weak body pain was resolved in April2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Less than one month after the vaccine symptoms began: felt like a pulled muscle in the left groin, fatigue, unable to ride a bicycle due to pain.  Lump developed in right groin in November. Difficulty walking due to pain. Had Omicron in December 2021 and the deep coughing caused bilateral hernias. (large, hard bumps bilateral groin area). Hernia repair on February 2, 2022. Large lumps growing and more painful. In April, Dr (surgeon) said he will do a CT if symptoms continue. In May, diagnosed with a DVT right inguinal vein. Right leg swollen and painful. CT showed cancer metastases to pelvic bone, fracture pelvic bone, ymph system and right lung. Primary site unknown. Radiation to pelvic bone, chemotherapy.  Cancer incurable. Life expectancy 3 to 12 months.
It started with being very cold and could not warm up.  Then during the night I got a fever but could not get up to check it and when I was able to check it it was 103.  I was having trouble breathing and was paranoid.  I thought I was hallucinating and was thinking who is the president and what year is it and did my temperature really say 103.  Plus I was thinking my husband was wanting me to die and I was afraid to tell him I wanted to go to the hospital.  We do Not have that kind of relationship.  Then I got a headache. By morning I was feeling better but was very weak all day and a little weak on Saturday.  Friday I pretty much slept all day.  I did better on Saturday and by Sunday I felt normal again.
NauseaVomiting Fatigue,soreness on the injection site,redness, swellin Narrative:
Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09598, -09599, and -09600. A two-month-old male patient had received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 12 hours after vaccination, he developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic, partial and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was noted as delayed. The patient also developed behavioral issues with autistic-like features. Brain MRI results were normal. At 20 years of age, patient was diagnosed with Dravet syndrome based on his clinical phenotype and his SCN1A (neuronal sodium channel alpha-1 subunit) testing which showed the deletion of one copy of all 26 exons. Parental SCN1A testing was not possible for this patient because he had been adopted. EEG findings at the time of diagnosis revealed focal discharges and slowing. Outcome was not recovered. Documents held by sender: None.
Patient received Fluzone HD on 9/9/2013 around 4PM. About 3 hrs later, felt like allergic reaction throat tighten. Check into emergency room, got treatment and went home around midnight.
Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the "patient fainted after receiving Gardasil". Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
pain in arm; had little rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and RASH (had little rash) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and RASH (had little rash). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CLONAZEPAM (KLONOPIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm) and RASH (had little rash) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090694 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090694:case for second dose
Did not have an adverse reaction.  Patient was given an H1N1 vaccine and was given 0.5cc instead of 0.25cc for age.  No adverse reactions following administration.
Fever over 105, Jerking, vomiting, intermediate crying, stop walking, less active, and not eating. Used Ibuprofen oral suspension for these incidents which lower his temperature. He slowly developed a rash under his skin, through out his head, neck, stomach, and back. The rash has covered those areas but hasn't turned into boils. We have tried to use cortisone and aquaphor but has not seen any changed in the past 4 days.
FEVER, BODY ACHES, CHILLS, LIGHTHEADED AND NAUSEA
5/17/02 reports 16x9cm warm, erythematous over R arm, per Dr's nurse which began morning of 5/17. Nurse reports per Dr to treat for cellulitis. Duracef 500mg/5cc, 3/4 tsp PO bid X 10 days.
PATIENT REFERES PALPITATIONS AND CHEST PAIN AFTER VACCINATION. PULSE: 80 B/P: 140/100 PATIENT WAS REFERRED TO THE HOSPITAL FOR REDUCING B/P AND OBSERVATION BUT PATIENT'S FATHER INSISTED ON TAKING HIM TO THE CLINIC.
Chills; fever; fatigue; tiredness; nausea; Little bit of vomiting; This case was missing the following minimum criteria: there is unspecified event. Upon receipt of follow-up information on (22Dec2020), this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable other HCP reporting for herself.  A 51-year-old female patient received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on 21Dec2020 at  single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unknown date the patient experienced the following symptoms chills, fever, fatigue, tiredness, nausea, little bit of vomiting, the outcome of all the reported events was unknown. The patient stated that before receiving the vaccine, she was in contact with her husband who discovered to be positive to COVID 19. The patient is now concerned because she does not know if the symptoms she is experiencing are caused by the vaccine or by the illness.
Patient received vaccines around 10:00 am and called around 11am stating his face and lips were swollen. Dr advised to give BENADRYL and come in, mom had no BENADRYL so she came in to office.
10JUN93 9PM fever, 10PM shaking chills, 11JUN93 6AM scratchy throat, ears, stomach cramps & 2 episodes of diarrhea; 11JUN93 cough devel w/extreme rhinitis very stiff neck, back & headache; cough & rhinitis cont; measles like rash; swollen
chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 040A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included ROSUVASTATIN, ATENOLOL, EZETIMIBE and ESCITALOPRAM for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Apr-2021, CHILLS (chills) and HEADACHE (headache) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-083204 (Patient Link).
got deathly sick; Initial information was received on 22-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who got deathly sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In 2008 the patient was vaccinated with a first and second dose of GARDASIL at the proper schedule. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. On 23-JAN-2014, the patient went to the office for the 3rd dose of GARDASIL. Dose, route and lot number were not reported. No adverse effect reported. Additional information has been requested.
patient out of recommended dosing window more than 48 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (patient out of recommended dosing window more than 48 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (patient out of recommended dosing window more than 48 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (patient out of recommended dosing window more than 48 days) outcome was unknown. Not Provided      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.  Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: F/U Received, Contact information was provided.
4 days after getting my second dose, I broke out in hives all over my body. they were not itchy, just red and hot. This has never happened before in my life, so I   called 911.
NO ADVERSE EVENT NOTED OR REPORTED. Jynneos 0.1 ml administered ID with no production of wheal; therefore an additional dose of Jynneos 0.1ml, ID administered with production of wheal.
sore arm; diarrhea, one time, every other day, at night; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (144508).  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea, one time, every other day, at night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within less than 5 min after administration, the patient  looked pale, temporary lost of vision, and weak to sit up straight.  After asking more questions about his health  and mediations, he informed about taking cannabis before the vaccination. By the paramedics came, he looked better and his vision came back.  He was communicating and able to walk around.
Pt recvd vax 31AUG92 & 3SEP92 pt exp dull, warm ache in rt arm; pain was sharp on movement; pt recovered;
INPATIENT PROGRESS NOTE    Date of Service 10/31/2023  Hospital Day(s): 4        Patient is a 91 Y female with PMH of Afib / coumadin, Eczema, HTN, S/P PPM,  Hypothyroidism, Pulmonary Nodule, RLS, RA in Remission, Venous Insufficiency / Venous Stasis. Patient was on duricef for 7 day on 10/18/29023. Completed antibiotic therapy, but did not improve. Admitted for Left LE cellulitis. Started on IV vanc/zosyn, now on ceftriaxone and vanc. Incidentally found to be covid positive   Subjective: - Seen at bedside with sons - reports tenderness of left leg with touch and movement     MAR reviewed.     Physical Exam: Patient Vitals for the past 24 hrs:
This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored VAQTA, lot number M027879, expiration date 24-JAN-2018, and lot number M047658, expiration date 28-OCT-2017, (dose, dose number, route and anatomical location were not reported), for prophylaxis.  The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012120: US-009507513-1703USA012118: US-009507513-1703USA012119:
All symptoms began within around 12 hours after dose, and have not improved. Severe headache: intense, painful pressure that worsens with any movement, especially leaning down. It frequently becomes disorienting and unbearable. I cannot retrieve things from the floor/lower shelves without help, due to severe discomfort. Sometimes the pain radiates down the base of my skull and back of my neck, particularly the left side. This is the most bothersome symptom by far. Ibuprofen does improve it but doesn't remedy it completely. Fatigue: I am constantly tired but cannot sleep soundly. I wake up frequently (every few hours), which results in "sleeping" (staying in bed) for much longer periods than normal, while only getting poor quality sleep. Nausea: I have very low appetite, and when I try to eat anything, I quickly begin to feel nauseous. Throughout the day, I often feel nauseous and take Pepto to feel better. Chills/Low-Grade Fever: This was the first symptom that appeared. It has improved each day, but I do still experience it. It is most noticeable at night, when I will shiver and sweat while feeling like I'm both freezing and also overheating. I check my temperature when this happens, and it is usually around 101 degrees Fahrenheit.  I take ibuprofen to reduce the fever. I sometimes feel chills during the day, but never as badly as at night.
Patient states legs have hurt like when she had COVID since receiving the Janssen Vaccine. States she thought this was normal but it has lasted over a month. Pt advised to seek medical evaluation
This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 02-SEP-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed within recommended storage temperature since then. The highest temperature the M-M-R II could have been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/pt recv vax pt exp 4 bouts of severe vomiting, high fevers, severe abd pain; no response to ATB
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration reported was 07-May-2021.  No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-363032 (Patient Link).
The patient developed itching in the arm near the injection site about 20 to 30 minutes after receiving the vaccine.  She took a loratadine since that is what she normally takes after getting a vaccine due to the itching.  We also gave her an ice pack to place on the arm.  We had her to stay in the pharmacy waiting area for about 45 min to an hour to monitor her reaction.  She began to feel better after taking the loratadine and applying the ice pack.
Patient vaccinated on Friday 2/6/2009 at 11:45am and then approx. 12 hours after vaccination at 1:30am, patient had 102.5 temp with chills, sweats, aches and head pressure for approx 8 hours. Treated with Tylenol 1000mg x 2, and 400mg with Motrin x 2.
Following the administration of the vaccine the patient started to feel lightheaded and started sweating. He reported feeling like he was going to faint. He sat in the pharmacy counseling room with his head down. He was given a damp paper towel to apply to his face and neck. He also mentioned that he hadn't had lunch so he received some orange juice. He started to feel better within 5-10 minutes. He remained in the store for about 30 minutes before expressing his symptoms had resolved. He left accompanied by his girlfriend.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 4/19/2021 and 5/17/2021. Presented to ED 12/29/2021 with new onset lethargy, SOB,  and COVID + on 12/25/2021 from ER. Admitted for severe Covid PNA. Started on supplemental oxygen and steroids. PMHx colon cancer and HTN. O2 requirements escalated. DNR upon admission.  Patient expired on 1/2/2022.