chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible sneezing/continuous sneezing day and night; runny nose/nose was running profusely/sniffles; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 at 17:00 (lot number: EN6198) as single dose for COVID-19 immunization. Medical history reported as none. No allergy medication. Concomitant medications were not provided. Patient received his first Pfizer Covid vaccine dose on 26Feb2021, and the next five days were unremarkable, but he had terrible sneezing, sniffles and runny nose and it resolved after 5 days. Stated when he had the 1st dose of the vaccine, everything went fine but from day 1-5 after the 1st dose he had continuous sneezing day and night and his nose was running profusely after the 1st dose. The patient HCP did not know he had this problem. The outcome of events was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Intermittent pain and pressure in the right ear which has continued 3 days after the injection in addition to expected side effects (pain in arm, headaches, body aches)
Get dizzy; So weak to lift my arms/ cannot walk because he is to weak; Trouble breathing/ shortness of breath; So sick now i don't think i'm gonna make it; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021. The most recent information was received on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak to lift my arms/ cannot walk because he is to weak), DYSPNOEA (Trouble breathing/ shortness of breath), ILLNESS (So sick now i don't think i'm gonna make it) and DIZZINESS (Get dizzy) in a male patient of an unknown age 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ASTHENIA (So weak to lift my arms/ cannot walk because he is to weak), DYSPNOEA (Trouble breathing/ shortness of breath) and ILLNESS (So sick now i don't think i'm gonna make it). On an unknown date, the patient experienced DIZZINESS (Get dizzy). At the time of the report, ASTHENIA (So weak to lift my arms/ cannot walk because he is to weak), ILLNESS (So sick now i don't think i'm gonna make it) and DIZZINESS (Get dizzy) outcome was unknown and DYSPNOEA (Trouble breathing/ shortness of breath) had not resolved.            Concomitant product use was not provided by the reporter. The patient stated that the breathing is getting better but not so good. Treatment information included goes twice a week for breathing therapy.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received  includes additional event, updated outcome of the event, dosage details (received 2 shots) and narrative were updated. On 06-Aug-2021: Followup Received includes : updated patients home Address received.
patient presented with vomiting, nausea 55 minutes after receiving vaccine. symptoms resolved after the episode.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Healthcare worker reported that unspecified doses of improperly stored RECOMBIVAX HB (therapy type, lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
Red ring on the leg; Bruise; Slight pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red ring on the leg), CONTUSION (Bruise) and VACCINATION SITE PAIN (Slight pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Vaginal irritation. Concomitant products included CLOBETASOL for Vaginal irritation, CLONAZEPAM and ANTIBIOTICS for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red ring on the leg), CONTUSION (Bruise) and VACCINATION SITE PAIN (Slight pain at the injection site). At the time of the report, ERYTHEMA (Red ring on the leg), CONTUSION (Bruise) and VACCINATION SITE PAIN (Slight pain at the injection site) outcome was unknown.            ? Treatment information was not provided.  ?    This case was linked to MOD-2021-021525 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Initial Additional-1 / NNI
Reddened, swollen area to inject site; lt deltoid approx 1in in length; no fever noted;
1/21/22 pt brought to ED with SOB and altered mental state; diagnosed positive for COVID on 1/18/22; EMS called on 1/20/22 due to pt being less responsive; was given O2 and improved; ED was deferred; 1/21/22 pt's O2 sats were decreasing (79% on RA) and he had a worsening mental state; poor oral intake, non-productive cough; in ED pt was hypertensive and desaturating into 80s% on O2; O2 was increased; admitted; given ABX, steroids, remdesivir; transferred to PCU; COVID pneumonia; on BiPAP; unable to place NG tube; pt transitioned to comfort care; IVs and ABX were dc'd and he was transferred to GIP hospice service where he passed away
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, therapy type, route of administration, lot# and expiration date were not reported). Administered dose of RECOMBIVAX HB was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on an unknown date. Digital data logger was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & w/in 24 hr of vax pt exp h/a, nausea & arm & neck stiffness;these sx resolved w/in 24 hr;
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: Patient became unresponsive (eyes rolled back). Attempted to obtain response and 911 was called. Patient returned to responsiveness in less than 1 min and was confused. Unaware that they had lost consciousness. BP/Pulse was check and was low. EMTs arrived within 5 min and patient BP/Pulse and returned to normal upon recheck. Patient declined further treatment or transport. Mother was present in store and provided food and water. Observed for an additional 20 min. Patient left on own ambulation.
Severe headache, body aches, diarrhea, nausea, low BP, high heart rate, chest pain
Patient reported entire upper right arm became painful, warm to touch and very red the morning after receiving vaccination. She was treated with augmentin 875mg BIDx10 and as of 4/5/19 she reports the redness and warmth are resolving but arm continues to be painful and tingly.
about 1 1/2 hrs later pt got blue lips & got pale; this lasted about 10-15mins; pt was seen immed & observed x 30 mins was sl pale on presentation BP was 90/60; pulse 130;
Patient presents to ED on 10/30/13 with a chief complaint of bilateral lower extremity weakness with muscle and joint pain beginning two days ago upon awakening in the morning. He had been jogging two days prior to symptom onset and experienced only mild soreness the day following running. For the past two days, he has been having trouble balancing and has been requiring a cane for ambulation. He denies fever, chills, shortness of breath, nausea, headache, and dizziness, and he is not currently taking any medications. Recent medical history consists of a colonoscopy on 10/3/13 and an upper respiratory infection five weeks ago, from which he recovered within ten days. The patient also received a flu shot (Fluarix Quadrivalent) on 10/14/13. Pertinent labs/tests (urinalysis, chemistry, CBC with differential, DVT work-up, and lumbar MRI) are performed and determined to be insignificant. The patient is diagnosed with weakness and myositis and is discharged home with Medrol Dosepack prescription. The patient presents back to the ED two days later (11/1/13) with complaints of worsening weakness in calves and reports falling to the floor when trying to squat. He continues to require a cane/walker for support. On neurologic exam, he is ataxic with absent reflexes. An EKG and LP are completed, and the patient is admitted to hospital. Neurology is consulted and reports that the test results are concerning for Guillain Barre Syndrome (GBS).  IgA level is 228, and patient is started on IVIG 35 grams once daily for a total of 5 days, beginning on 11/2/13. Patient also receives IVF, diphenhydramine, prophylactic-dose enoxaparin, acetaminophen, and baclofen. Nerve conduction studies on 11/6/13 are consistent with acute acquired demyelinating neuropathies such as GBS. The patient is followed by physical therapy throughout his stay. Although he is stable, there is little improvement noted after the five IVIG treatments. The patient has also been experiencing new episodes of hypertension (indicating some possible autonomic dysfunction) for which he is given IV beta-blockers. No changes in respiratory function, bowel or bladder function, cognition, or vision are noted. The patient does complain of some difficulty sleeping at night due to leg discomfort.  On 11/6/13, the patient is admitted to the hospital's inpatient rehabilitation facility for physical therapy, occupational therapy, and neuropsychology. He is currently in a wheelchair requiring maximal assistance. His right lower extremity is slightly stronger than his left. Right Knee Exam (RKE) is graded at 3/5 (joint can only be moved against gravity; inability to move against resistance). LKE exam is graded at 1/5 (only a trace or flicker of movement is seen or felt in the muscle). Patient remains in the rehab center as of 11/13/2013.
I noticed that I had several red tender lumps located on the back of my lower leg calf and one place on the right leg.  Then there has continued to be more between my ankles and knees.
approx 10 min p/ vax,had v,lightheadedness & hives that resolved 22aug85;10sep85 had asthma & arthralgia;26feb86 had arthritis of lt knee & on 14May86 asthma;16Oct86 herpes simplex genitalis while pregnant;recurrent asthmatic attacks;
Immunization site immediately turned white in center and red surrounding; area itching. About 3 inches in diameter; decreasing about quarter size after about 10 min. Face also flushed. 25 mg Benadryl given po. Client instr. to remain in clinic assessed x 20min
TOOK UNREFRIGERATED DOSES; DID NOT TAKE THE LAST DOSE; This spontaneous case report was received from a consumer (PVX2019-227) on 24-Jan-2019. The report describes a female consumer who "took unrefrigerated doses" and "did not take the last dose". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the first dose of Vivotif on 15-Jan-2019 then took two more doses which are unrefrigerated. She did not take the last dose.   The action taken with Vivotif with respect to the events "took unrefrigerated doses" and "did not take the last dose" was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "did not take the last dose" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "did not take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "did not take the last dose" was considered as not applicable.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a rash that consisted of less than 50 lesions.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient reported various side effects such as: arm immobilization, hardness of the area (deltoid), warmness and develop dark spots in the left deltoid, all on an unspecified date. Patient visited her pediatrician and was informed to wait 4-5 days to observe progress. Eventually, the spots disappeared as well of other side effects. patient completely recovered from the events on an unknown date.
A report has been received from a Physician concerning a 10 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent  started on an unknown date. The patient experienced motor ticks. The outcome of motor ticks is unknown. The report was considered to be non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: 8020) at the age of 34 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PAROXETINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Versed, reaction(s): "Known allergies: Versed", notes: Known allergies: Versed. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: day 1 of Covid-19; Positive, notes: day 2 of Covid-19; Positive, notes: day 3 of Covid-19; Positive, notes: day 4 of Covid-19; Positive, notes: day 5 of Covid-19; Positive, notes: day 6 of Covid-19; Positive, notes: day 7 of Covid-19; Negative, notes: negative for 2 days; Negative, notes: negative for 2 days; Postive, notes: on day 15th. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid started on 04Nov2022 till 09Nov2022.  Clinical Course: I tested positive for Covid for 7 days then negative for 2 days and then positive again. I am still testing positive on my 15th day after my initial positive test.
15 min after receiving  vaccination patient became nauseous and became pale.  She then became overcome with dizziness and had to immediately sit down for 30 minutes.    After sitting her nausea and dizziness had improved enough to stand up  and she was feeling better again.
Client verbalized feeling very weak after receiving the vaccine.  According to client he is diabetic and did not absorb anything to eat prior to receiving the vaccine.  Client was given a bottle of water and evaluated by  Fire Rescue.  Client's spouse accompanied home and he was released by paramedic at 9:40 am.  Per Paramedic no further evaluation needed.
Fainted 5 minutes after injection. Blood pressure 96/50. Fainted a second time 15 minutes after injection. Blood pressure 57/26.
Tremors of hands, feet, and legs; when he tries to move or get up in bed at night, he is frozen and can't move; muscles are weak; he has trouble with balance especially when he gets up; excessive sweating, he just gets soaked some nights; Chest pains; it is lung pain; shortness of breath; Muscle cramps; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and one patient. This is the first of two reports. A male patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) as a single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease. Concomitant medications were unknown. The patient had some fairly serious symptoms since his shots and stated he had both vaccines a few weeks apart and after the first vaccine started his symptoms out mildly. The patient experienced tremors of hands, feet, and legs. When he tries to move or get up in bed at night, he was frozen and can't move. The patient experienced muscles are weak and he has trouble with balance especially when he gets up, and it is more pronounced. The patient had excessive sweating; he just gets soaked some nights but stated he doesn't run a fever. The patient had chest pains, thinks from the lungs pain, not heart and associated shortness of breath. The patient stated when he couldn't turn over, he was laying on his side and that didn't help his breathing. The patient had muscle cramps. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021370302 same reporter/ suspect/different patient, similar events
Day after vaccine in left arm, large red long streaks appeared not at injection site but around arm running toward under arm. Also next 3 days sneezing all day and nose ran clear water all day also arm was sore and painful. Under arm tissue still sensitive, tender.
2 hrs p/DTP/HIB/OPV administered pt devel hypotonic unresponsive episode assoc w/pallor; t99.4 R; Seen by MD; had redness & swelling @ inject site;
I had the Moderna booster in my left arm at your office on Friday, Nov. 19th at about 2:30pm. Around 2:45am (Sat.), I noticed my feet were hurting when standing or walking. I noticed the left foot had some swelling and took an antihistamine (10mg Zyrtec allergy tab). The bottoms also must have been swollen at that time because it felt like I was walking on balloons. Several minutes later, my rib cage area felt as if it was icy and churning. The sensation felt as if my entire below-the-shoulder to the bottom of the rib cage area was actually physically thrashing about. My lower rib bones felt painful and broken. This sensation lasted about half an hour to 45 minutes. Simultaneously, I experienced intense stomach.
On 2/6/06 Mom in clinic c/o child had rash, hives, itching on Saturday. 2/4/06 Mom treated with 2.5 HIC cream ? on 2/4/06. Macular erythematous, lesions on face. Mom reports was on back and legs. ?  temp. Denies new foods cream soups, detergent ?. No urticaria. Will see tomorrow.
discomfort in the area of vaccination; limited range of motion as well; This spontaneous report has been received from a nurse concerning a 43-year-old female patient. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided) as prophylaxis.  On 28-MAR-2022, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided). On the same date, she experienced discomfort in the area of vaccination and limited range of motion as well (vaccination site discomfort) (vaccination site movement impairment).  It was reported that the patient went to the healthcare providers office again on 11-APR-2022, 10-MAY-2022 and 11-JUL-2022. It was at the last date that the vents were documented. The outcome for vaccination site discomfort and vaccination site movement impairment was reported as not recovered.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.
A 26 year old female patient experienced anorexia, nausea, fever and myalgia while receiving RabAvert.  The patient received RabAvert 1ml into the arm for post exposure prophylaxis on 07/27/2004.  She had a history of acid reflux disease for which she took ranitidine and also took Ortho Tri-cyclen concomitantly. The patient was exposed to bat feces and received her first dose of RabAvert on 07/27/2004.  Following the injection she experienced a lack of appetite, nausea, a low grade fever to 99.5 maximum, and muscle aches all over.  She was taking Advil for the symptoms as needed.  The muscle aches diminished and the other symptoms remained at the time of this report.  The patient was scheduled for her second dose of RabAvert on 07/30/2004 and planned on completing the series.  She also had an appointment with her family physician on 07/30/2004.
Received Moderna COVID vaccines on 2/3/21 and 3/12/21. Tested positive for COVID-19 by PCR on 4/19/21. Patient is asymptomatic, was tested due to upcoming appointments at our facility.
Father brought child back to office 2 days later. (L) upper arm red with purplish middle. Stated it look better than day before.
I had a pericardial infusion. I started had trouble breathing. It was serve chest pain.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient had what seemed to be a coughing fit immediately afterwards, but after 5 minutes it had resolved. No signs of anaphylaxis, patient was able to verbally communicate that she could breathe fine.
THE PATIENT RECIEVED THE VACCINE AFTER EXPIRATION DATE.  THE PATIENT REPORTS NO ADVERSE EVENTS.
6/25/07: received MMR, varicella & Hep A vaccines in thighs  7/3: diarrhea x4, excessive drooling  7/4: runny nose, drooling  7/5:fever increasing to 103.6F despite tylenol/ibuprophen  7/7: pediatrician checked ears, etc. said treat fever 7/8: unable to move left elbow ER visit x-ray, aspirated pus, surgery to clean joint, IV vancomycin and rocephin started; noticed red spot on left thigh and corner of mouth and on tongue 7/11: culture grew gram-neg-rod, identified as alcaligenes faecalis 7/13: received PICC line & discharged with rocephen 900mg/day for 2 weeks 7/23: vomiting 6x 7/24: fever 102.8F  7/26: seen by infectious disease MD who encouraged reporting 7/30: to see orthopeadic surgeon follow up surgery site, expected removal of PICC line 8/2/07-records received-Child noted to not use left arm. Fever 103.Impression:X-ray revealed evidence of elbow joint effusion, infected left elbow. Septic arthritis. Irrigation and debridement.
Patient inadvertently received a monovalent Pfizer Covid-19 dose as a booster instead of the recommended bivalent booster dose.  Patient notified and has chosen not to get bivalent dose.