chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SPONTANEOUS NOSE BLEEDS (GUSHING, ALSO LIKE STREAMS OF RIBBONS,THICK); This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pseudocholinesterase deficiency, scoliosis, ramsay hunt syndrome, diabetes, narcotics allergy, non alcholic, non smoker, and anaesthesia allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. he patient had no family history of any disease or allergy relevant to vaccination. the patient had no pre-existing acute illness in last 30 days prior to vaccination. the patient had no history of hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 08:30 on left arm for prophylactic vaccination. Concomitant medications included glimepiride for diabetes. On 13-MAR-2021 12:30, the subject experienced spontaneous nose bleeds (gushing, also like streams of ribbons, thick). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from spontaneous nose bleeds (gushing, also like streams of ribbons, thick). This report was non-serious.
rash under both breast the followingafternoon; Sweating and chills overnight; Sweating and chills overnight; This is a spontaneous report received from a contactable non-Health care professional. A 36-year-old non-pregnant female patient received BNT162B2 (BNT162B2), Lot Number: unknown, solution for injection, first dose, single on 15Mar2021 at 14:45, via unspecified route of administration in the left arm for Covid 19 immunisation. Medical history included mitral valve prolapse (MVP), irregular heartbeat, intravenous pyelogram (IVP) dye allergy. Concomitant medications included Zinc, vitamin D, and vitamin C for hair, skin and nails. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 23:00, she experienced sweating and chills overnight and on 16Mar2021 (following afternoon), she experienced rash under both breasts. The patient did not receive treatment for the events. The patient was recovering from sweating and chills overnight. The outcome of the event rash under both breasts was not reported. Information about lot/batch number cannot be obtained. No further information is expected.
Both of my arms from my shoulder down to my wrists have broken out in an itchy red rash; I also have some minor rash on both lower legs.; This is a spontaneous report from a contactable consumer. A 68-years-old (age at vaccination) male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EW0179) via an unspecified route of administration on 18May2021 at 10:15 am in left arm as dose 2, single for covid-19 immunisation. Patient's medical history included Known allergies: Penicillin (dates unspecified). Historical vaccine included that patient previously took first dose of COVID-19 Vaccine (BNT162B2, Lot number: EW0172) via an unspecified route of administration on 29Apr2021 at 10:30 am in left arm for covid-19 immunisation. Patient did not receive other vaccine in four weeks. Concomitant medications (Other medications in two weeks) included Pravastatin sodium (PRAVASTATIN) at 40 mg for unknown indication and omega q plus 100 for unknown indication. Patient stated that 'On 19May2021 at 08:00 am experienced both of my arms from my shoulder down to my wrists have broken out in an itchy red rash. I also have some minor rash on both lower legs. No treatment for the AE was given. Patient did not have covid-19 prior vaccination. Patient was not tested for covid-19 post vaccination. The seriousness criteria was reported as non-serious. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
flushed face, fatigue, sore left arm into left chest area, muscles aches, swollen left arm
Red, puffy, warm spot around injection, itchy, and painful. Instructed to use antihistamine and anti-inflammatory. Employee admitted to only taking at night and symptoms not resolving. Instructed to take around the clock and symptoms disappeared in 24 hours after following instructions.
COVID-19 resulting in inpatient hospitalization of a vaccinated patient.  Pt was also boosted with Pfizer on 11/7/2021.  Unknown lot number
Administering FLUZONE in (L) deltoid muscle & vaccine liquid squirted back out, the injection did not go in.
I had rapid weight loss and Sinus Tachycardia. I contacted my doctor and was diagnosed with Graves' Disease. I was prescribed Methimazole and Metoprolol. I am feeling better, but my Thyroid labs are still a little off but better.  I am still dealing with this at this time.
04/11/2022 vaccination, 06/21/2022 I had cough, body aches, fever, chills, headache, back ache. COVID-19 negative. 06/22/2022 COVID-19 negative. 06/23/2022 PCR positive. Dr. put me on PAXLOVID but then had to change because I am on PROZAC. Changed to 'mono-?'.
Lightheadedness/Dizziness; This is a spontaneous report from a contactable 29-year-old non-pregnant female Pharmacist (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EM9809), via an unspecified route of administration on 12Feb2021 time: 17:45 at single dose in left arm for covid-19 immunization. The patient medical history included depression and anxiety. Concomitant medications included fluoxetine, amfetamine sulfate (AMPHETAMINE SALTS), omeprazole, ethinylestradiol, norethisterone acetate (JUNEL). On 12Feb2020 at 17:45, the patient experienced lightheadedness/dizziness. The patient did not take any treatment for the event. The outcome of the event was recovered on an unknown date in Feb2021.
Patient stated he was dizzy about 5 minutes after injection. He then had mild confusion that lasted approximately 20 minutes.
temperature dysregulation (hot sweaty then chills) on day/night 1- took Tylenol and this went away by morning of day 2. headache day 1- took Tylenol and this went away that evening.  Swollen arm, injection site pain, radiating pain across entire shoulder blade, up into neck, and down arm for the past 3 days. No over the counter medication (Tylenol, advil, aleve) are helping to ease pain. Hot pad applied offered minimal time limited relief.
Large, red, hot hive around the injection site; Redness spreading to other parts of upper arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 17Apr2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 27Mar2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient previously also received sulfamethoxazole/trimethoprim (BACTRIM), cefaclor (CECLOR) and amoxicillin sodium (AMOXCIL), for unknown indication from an unknown date and experienced drug allergy. On 18Apr2021 at 12:00, the patient experienced large, red, hot hive around the injection site, with redness spreading to other parts of upper arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events large, red, hot hive around the injection site and redness spreading to other parts of upper arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Patient reports that approximately 1 week after receiving his flu vaccine he developed left middle finger DIP joint pain that spread to multiple joints (fingers,wrists, ankles, and knees)  severe PAIN 7/10 on pain scale that was worse at night and  tneuropathy in bilateral upper and lower extremities for at least 2 weeks that interupted his sleep. Reports still having pain however it has improved slightly currently pain 5/10.
Patient was given 0.5 mL of 0.9 Sodium Chlorine instead of the J&J Vaccine
Within 2 days child developed a rash and induration on his left thigh.  This gradually resolved over 3 days.  Around this time child's behavior changed: mother says he became very aggressive, would not be quitened down, would hit people, growl at parents.  She says this behavior is new and is convinced that it is related to the vaccine, possible MMR. Nurse follow up on 06/02/04 states: ADD: cellulitis (L) thigh.  Nurse follow up on 06/16/04 states: "No new information."
Mild Facial swelling: nose and under eyes, mild nasal congestion, mild fatigue, mild frontal headache, decreased appetite Duration ~7 days, began improving slightly after 5 days
pt recvd vax 9JAN95 & later that day area surrounding inj site was red;during the next 3 days, area became inc red & raised;no fever;MD visit on 12JAN95;pt had a 4cm round, sl red area, warm to touch around inj site; no treatment
muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced MYALGIA (muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg). On 07-Sep-2021, MYALGIA (muscle pain in my left leg. It like runs up and down, it'll stop to my knee, and then get to my lower leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not reported  Patient's second dose is due on 16-Sep-2021.
Redness/swelling/pain at injection site. Oval shape size of a plum tomato.
soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "soreness at the injection site".  Additional information: It was reported that she received the second dose of the Covid 19 vaccine 29 hours ago (at the time of report), it was reported that soreness at the injection site was the only symptom the patient was experiencing. Patient wanted to know if she should be worried about something and if it was okay to get her antibody titers in two weeks as suggested by her doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports 10/25/02 18:00 to approximately 23:30, itching all over her body with no rash or fever. 10/26/02 face bright red with rash and itching of face. Face also hot to touch. The rash and itching of face only occurs in the evenings according to the patient. No rash or itching of any other part of her body. Patient has been referred by her doctor to see dermatologist today. 11/1/02.
vaccine given on 10/2/07 .  4a-5 days later developed severe headache while doing a few squats.  Several days later developed a 102.6 fever-ended up having lumbar puncture and MRI brain.  10/30/07 Received ER medical records which reveal patient experienced high fever x 1 day & bilateral frontal headache pain w/nausea & photosensitivity x 5 days.  Had been seen at outlying ER w/fever 102.6 & LP was unsuccessful.  Tx w/IV antibiotics x 1.  Transferred to higher level of care for MRI & LP. Exam revealed minimal redness of tonsils w/minimal swelling.  No neck pain.  No neuro deficits. Refused further attempts at LP.  Neurosurgery consulted.  Began to spike fever again & did allow LP at that point under fluoroscopy.  D/C to home w/neurosurgery & MRI f/u for cyst FINAL DX: headache, resolved; right ventricle cyst; fever.
Woke up next morning with 102.2 fever and chills.  Lasted two days.  Couldn't hardly function for 4 or 5 days and still feeling really weak and achy six days later.
2-5-2019 @ 4:00pm Low grade fever, a couple small spots by mouth in late evening. 2-6-2019 @ 6:00am Low grade fever, small red spots/rash all over face and upper chest area. Scheduled same day doctor appointment for 8:30am. 2-6-2019 @ 9:00am Rash and symptoms identified as viral infection. 2-6-2019 @ 8:00pm Rash spread from face and trunk to arms and legs. Called pediatrician on call due to symptoms escalating and resembling measles rash. Doctor confirmed diagnosis as reaction to MMRV vaccine on 1-25-2019. 2-7-2019 @ 4:00am Measles rash advanced to complete body coverage. Spots had increased in size drastically. Patient was extremely uncomfortable. Took to emergency room; where diagnosis was confirmed as a vaccine reaction to MMRV. Patient was discharged at approximately 7:00am with no treatment plan (rest, time and TYLENOL as needed).
Dose given wasn't completely thawed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Dose given wasn't completely thawed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose given wasn't completely thawed). At the time of the report, PRODUCT STORAGE ERROR (Dose given wasn't completely thawed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Pnt. vomited within 6-8 hours after vaccination. Developed hives, aches and pain also. On 11/8/11 her nurse practitioner called to inquire about which vaccine was given to her. Patient's symptoms have subsided, still has hives but they are lessening.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant product use was not provided by the reporter.  On an unknown date, the patient received Moderna bivalent booster dose that had undergone a temperature excursion. The dose was administered before it was known if the vaccine was ok.  Treatment information was not provided.  This case contains information for 20th of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122: case
shingles; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that 2 weeks after receiving 2nd dose of vaccine patient developed shingles. Patient know 6 other people in age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. Patient had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in my body. This had been an extremely painful experience, but patient still would have gotten the C19 vaccine. Patient was told by the doctors to let Pfizer know of my reaction. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Choking, turning blue, limp with feeds; decreased appetite, lethargy; admitted and within 48 hours developed seizures (treated aggressively and ceased within 48 hours).
arm soreness; some fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 2, single (Lot number: EL9267) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "BPH" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN GLENMARK, start date: Jun2018; HYDROCHLOROTHIAZIDE, start date: Jun2001. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: amoxicillin. Vaccination history included: BNT162b2 (Vaccine administration date=11Feb2021,, Vaccine administration time=10:00 AM, vaccine lot number=EL9261,, Vaccine dose number=1,, Vaccine location=Right arm, Adverse event: , Mild reactions after each injection. Arm soreness, some fatigue.), administration date: 11Feb2021, for COVID-19 Immunization, reaction(s): "Arm soreness", "some fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Jul2022, outcome "recovering", described as "arm soreness"; FATIGUE (non-serious) with onset 09Jul2022, outcome "recovering", described as "some fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
11/07/2021 I began having a sore arm that night, a headache, vertigo, nausea, vomiting. All have stopped except nausea, headache, and sore arm where the injection was given.
bad mood; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4144750-00.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOOD ALTERED (medically significant) with onset 2021, outcome "unknown", described as "bad mood". The action taken for bnt162b2 was unknown; for adalimumab was dosage not changed.   Additional information:PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 2021, patient was in bad mood after Pfizer COVID vaccine injections. It was unknown if she was enrolled in a COVID 19 Vaccine Trial.   Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of LEFT KNEE REPLACEMENT SURGERY and BAD MOOD with HUMIRA(ADALIMUMAB) was no reasonable possibility.   Product-Reaction level Seq.No. : 1 Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), UNKNOWN  Causality  Bad mood (Mood altered) Action(s) taken with drug : Dose Not Changed Causality as per reporter (Drug/Vaccine) : No reasonable possibility Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility Dechallenge : N/A  Product-Reaction level Seq.No. : 2 PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN)  Causality  Bad mood (Mood altered) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Not Related Dechallenge : N/A  Did event abate after stopping drug? NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Limited information precludes a comprehensive causality assessment of event ,however due to possible temporal association the causal role of BNT162B2 Vaccine is assessed as related.Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate