chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She believes she was bit by a spider, fainted twice; Crazy reaction to a spider bite/believes she was bit by a spider; Chills; Hives on the face; Rash on arms/full body rash; The swelling has gone down around the bite and I can see two holes looking like a bite.; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program, COVAX US SUPPORT. A 74-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 301308A; Expiration date was not reported) on the left arm on 27Sep2021 (11:30) as dose 3, single, with route of administration unspecified, for COVID-19 immunization. Medical history included eczema (diagnosed since she was a child). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 13Jan2021 (when the patient was 73 years old) for COVID-19 immunization, and had rash on her torso; and the second dose (Lot number: EL9265; Expiration date was not reported) on 03Feb2021 (when the patient was 73 years old) for COVID-19 immunization, and had hives on her face and arms. On 28Sep2021, the patient had hives on the face, and rash on arms/full body rash. On 01Oct2021, the patient had believed she was bitten by a spider, and fainted twice; had a crazy reaction to a spider bite; and had chills. On an unspecified date in 2021, the patient had swelling that has gone down around the bite and could see two holes looking like a bite. The events, "believed she was bitten by a spider, and fainted twice" and "crazy reaction to a spider bite", had resulted in to an emergency room visit and physician's office visit. The patient's EKG was okay; bloodwork was okay; and still had to sit in the waiting room for 10 hours. The patient took cetirizine HCl (ZYRTEC) as treatment for hives and rash. The outcome of the events was recovered on an unspecified date in 2021 for hives and rash; and was unknown for all the other events.
Initial report received from a non-healthcare professional on 5 NOVEMBER 2014. A 54-years-old female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of FLUZONE QIV, (batch number, expiry date, dose number, route and site of vaccination were not reported), on 09-OCT-2014. It was reported that three week after vaccination the patient had elevated liver enzymes, AST and ALT. Illness at the time of vaccination was none. Pre-existing physician diagnosed allergies and birth defects were unknown. Corrective treatment and laboratory data were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Headache, fever, body aches and pains, nausea, disorientation, extreme thirst weakness all over, could not sleep loss of appetite
Had 2nd dose 6 months after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd dose 6 months after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd dose 6 months after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd dose 6 months after the 1st dose) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Pt.'s Father states that after receiving the 3rd dose of Moderna 12/17/2021, started experiencing symptoms 12/24/2021 of hives throughout the body with severe itchiness. Emergency Room visit 12/30/2021 with recommendations of Benadryl (noting Allergic Reaction). Urgent Care visit 01/02/2021 recommended follow-up with Primary for Epi-Pen prescription. 01/08/2022 Emergency Room visit (Blood Work, Chest X-Ray), chest pain, hand swelling to the wrist, treated with Prednisone and discharged. Pt. still continuing the experience symptoms.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Knot to Lt arm-erythematous, warm to touch; approximately 1 1/2 inches.
Flu like symptoms, myalgias, arthralgias, fever of 104, headache. Recovered in 10 days. Had blood work and chest x-ray.
09/21/2019 - Fever, Headache, Chills, Injection Site Pain (no redness or swelling) symptoms increased in terms of headache and pain between 21 to 26 September 09/26/2019 - Continued low-grade fever, headache, chills,  injection site pain with redness, hot to touch and swelling extending to a 5-inch x 7-inch oval pattern from injection site down toward the elbow (Margins marked at home, a photo was taken) 09/27/2019 - went to Urgent care prescribe 50 mg prednisone per day x 5 days, sulfamethoxazole TMP DS tablets  10 days bid; Naproxen Sodium 550 mg bid as needed for pain.   (Margins - increased from previous day marked) 10/1/2019 - Rash remains slightly visible [Note: margins increased through 09/28/2019 with swelling and redness extended down to elbow crease]; last day of prednisone and several more days of antibiotic remain. Photos were taken through 30 September 2019
DIFFERENT KINDS OF PAIN EVERYDAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced different kinds of pain everyday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from different kinds of pain everyday. This report was non-serious.
NEARLY DIED; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received two doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, administered for covid-19 prophylaxis. On an unspecified date, the patient was nearly died within days after both her second dose (unspecified manufacturer) (Dose number in series 1). The outcome of the nearly died was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was nearly died days after her booster and was hospitalized for unspecified number of days. (Dose number in series 2). It was reported that "My mother caretakes an old woman. She was hospitalized and nearly died within days after both her second dose and again days after her booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nearly died and revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20221247101 and 20221247130.; Sender's Comments: V0: 20221247073- nearly died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Today I jumped in pool at 5 feet and started to swim towards the stairs.  When I went to catch my breath as I am too  lazy to pop up my head,after each stroke,  at around 4 feet I popped up my head and could not feel the bottom of the pool. I found myself drowning. It happened so sudden and lasted like 5-8 seconds.  One second I was swimming and the next  I was like in a dream where the water was going into my throat, my body wasn't moving.  My  mouth wasn't closing.    All i know was I could hear these sounds coming from  my throat like when you are dreaming and want someone to wake you up.  I was aware I was drowning but didn't know why or how.  Suddenly I snapped out of it and stood up and walked to the stairs.  I was confused on what had just happened to me because it seemed like I had woken up from a nightmare. There were two ladies sitting by the pool.  i asked them if I had been making weird sounds and they said yes.  The one lady said she was ready to get up and jump into the pool when she then saw me get up and walk.
Started feeling flushed, pain at injection site, radiated down right arm, right shoulder, and up right side of neck. Itching of lips, nose and eyes. I took Benadryl el." 25mg and Tylenol extra strength 2 tabs" at approx. 12:15pm. 4:20pm mild itching of lips.
Received Covid vaccine booster dose on 11/1/21, signs and symptoms of covid began on or about 11/18/21. Signs and Symptoms included general malaise, chills, intermittent low -grade fever, SpO2 of 79% on room air, cough and shortness of breath. Testes as COVID + on 11/25/21, hospitalized 11/25/21 - 12/4/21, left the the hospital against medical advice (AMA).
generalized rash, wheal/flare type rxn;modest swelling of hands & feet;treated in ER w/Epi & decadron & DPH;
Patient received Janssen vaccine, despite not being 18 Patient should have been given Pfizer vaccine. Patient developed mild "cold" symptoms after vaccination
12 hours after inoculation I started feeling intense pain at the inoculation site and the left arm joint. I developed a high grade fever of 102° @ 2am minor body aches and pains, no sweating. I self administered 500 mgs. of Acetaminophen every 4 hours as needed for a total of 4 doses. The high grade fever broke 6 hours later into a low grade fever ranging from 99.7° to 100.3° minor body aches. Minor pain and discomfort at the inoculation site and arm joint. The low grade fever broke and I returned to normal temperature Monday morning at 11am.
Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed an injection site reaction that resolved on its own; and for about 1-2 weeks after the vaccination the patient complained about sickness and nausea.  The patient underwent blood work, laboratory tests (unspecified) and only a liver function test showed an elevation.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
The following symptoms started within 12 hours of the injection and continued for 8 days : Swollen tonsils, Sore throat, Headache, Malaise, Sharp pain in rib cage (right side), Stuffy nose, Fatigue. Ibuprofen, Vitamin C, and Iron were taken throughout the week.  The following symptoms started 13 days after the injection and continue today: Urticaria all over the body. Symptoms are slightly relieved with Diphenhydramine and Cetirizine but do not go away completely.
Resident received flu vaccination at 1:30 pm on September 30,2008. The morning of October 2,2008,6:00 am, resident had seizure like activity lasting 10 seconds. She had jerky movement of upper and lower extremity and had small bite mark on her lower lip.
Fever above 100 degrees (began at 100, increased to 101.1 the following day), stuffy nose, dry cough, body aches
Reached 102.8 temp on Tylenol, hives on neck and chest, blotchy on arms, lethargic, blank glassy eyed stare, unresponsive at times, restlessness as well. Some symptoms lasted 3 days.
Symptoms started with a low temperature for several days - 5-7 days. It was about 99.1 to 99.4. I had a sore throat. It felt really, really raw. It was swollen a little bit - like I had a hard time swallowing. I had a headache now and then. I had aching in my arm; elbow area. And I had a lot of congestion and pressure in my sinuses in my nose/sinuses and in my chest (I was coughing for a couple of days). I did not consider them severe symptoms. Had a doctor appt that was schedule for tomorrow but I've felt better so it is cancelled. Had a flu vaccine - on October 1st, 2021. I don't know the name of it - I had a double dose. I had it a clinic - I had it on my left arm/injection.
Day after vaccine pain in left arm and behavior was fearful at every movement. Behavior changed and was angry and kicking and hitting walls repeatedly with hands and feet. hypersensitivity to noises, decrease facial expressions, and increased bowel accidents. Cough started 2 days later. 5 weeks  later In middle of night with continued cough and severe wheezy cough, extremely high temperature 105, and was making forceful jerking movements while not able to respond to parent. Eventually woke up.  Called doctor and they said gove Tylenol for temp movements were from high temp. Next morning eyes were dark. Cough persisted for a week and visited doctors who diagnosed her with pertussis. Since then diagnosed with Autism, Sensory Disorder, OCD, and Anxiety.
Holding throat, crying and coughing, "saying I can't breathe." Wheezing.
Patient received vaccine in upper right extremity. Patient sat in waiting room for 15 minutes post injection. After 15 minutes, patient stated they felt weird. Stated their lips were tingling and their body felt shaky. Denied any SOB or chest tightness. Patient was observed for another 15 minutes. Vitals WNL. No signs of distress. Patient was cleared to leave.
Soreness in his arm; Worsening of an imbalance he had since he had a stroke 30 years ago; Not able to walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm), BALANCE DISORDER (Worsening of an imbalance he had since he had a stroke 30 years ago) and GAIT INABILITY (Not able to walk) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     The patient's past medical history included Stroke (Medical history reported as he had a stroke 30 years ago). Concurrent medical conditions included Blood pressure high and Anxiety depression.    On 25-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm) and BALANCE DISORDER (Worsening of an imbalance he had since he had a stroke 30 years ago). 25-Mar-2021, the patient experienced GAIT INABILITY (Not able to walk). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm), BALANCE DISORDER (Worsening of an imbalance he had since he had a stroke 30 years ago) and GAIT INABILITY (Not able to walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood thinners, high blood pressure medications, and anxiety / depression medications. Treatment information was not provided.
Patient seen in Emergency room 03/05/19 with fever, abnormal movement episode, cough and congestion. The primary encounter diagnosis was Febrile seizure. Mother reported mild dry cough and nasal congestion over the previous 1-2 days; woke that AM with tactile fever. Pt was reported to have arched her back and became stiff with arms stretched out. No eye rolling noted. Unsure if arms stiffened. Entire episode lasted 3-4 seconds. No LOC. No SOB noted. No obvious color change reported during event. Child appeared to have less energy afterwards. Measured temp 101.5F at home after the event. Parents attempted to give Tylenol, but child vomited the med. 4 episodes of NBNB emesis between episode and when seen in the ED. Also reported to ED staff to have recent flu-like illness for about 1-2 weeks at the time seen in the ED.
Rash around injection site of few inch diameter, rash on bilateral shin/calf few days later, rash below nape of neck week post-vaccination.
Patient had a fainting episode after receiving a dose of Janssen Covid-19 Vaccine. Patient walk out of the consultation room, and immediately reported feeling lightheaded and fell backwards landing on his buttocks first and then hitting is head. The pharmacy staff called 911 and they came within about 5 minutes. The patient quickly recovered and was sitting up by the time the medics arrived.  The patient refused service, citing feeling much better.
Numbness and tingling, sometime burning in my hands and from the knee down to the bottoms of my feet. It has been increasing over the past month.
sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 024M20A, 007B21A and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.            Concomitant medication information was not provided by the reporter.               Patient received the second booster in her left arm shoulder deltoid muscle.              Treatment information was not provided by the reporter.   This case was linked to MOD-2022-546520, MOD-2022-546519, MOD-2022-546515 (Patient Link).
Patient stopped breathing during next feed. He required stimulation to resume breathing rhythm. He continued to struggle with saturation levels every hour for the next day. His seats would drop during every feed for the next 2 weeks. He had regular spells while sleeping. He had to be given suck therapy to relearn how to coordinate breathing and eating.
received the ActHib component out of the Pentacel vaccine, reconstituted with the diluent out of an ActHib box (0.4 percent saline).; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Infant patient who received the HIB component out of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and, reconstituted with the diluent out of box (0.4 percent saline) of vaccines HIB (PRP/T) VACCINE [ACT-HIB].  ActHib component taken from the Pentacel box and used was UJ020AAA expiration 09 Oct 2020; diluent that was used to reconstitute, from the ActHib box, was U6338AA expiration 21 Aug 2020; ActHib vial that was not used (but whose diluent was used) was UJ075AA expiration 27 Nov 2020; and Pentacel diluent that was not used (but whose ActHib vial was used) was U6215AA expiration 09 Oct 2020  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong technique in product usage process.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received vaccine on 5/3/00 and then had a headache, diarrhea, myalgia with nausea and vomiting. Temperature was up to 100.2. Malaise persisted for 1 week. Had induation of 15cm X 8cm.
sore arm; fatigue; felt a feverish sensation; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Sanofi Pasteur quadrivalent influenza vaccine (Sanofi Pasteur quadrivalent influenza vaccine) in 2017. Past adverse reactions to the above products included Adverse event with Sanofi Pasteur quadrivalent influenza vaccine.    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, the patient experienced MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation). At the time of the report, MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        My allergist/immunologist and cardiologist were very pleased my COVID vaccinations went so well.  Patient was having hereditary alpha tryptasemia genetic trait, confirmed by a Gene-by-Gene genetic test.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received includes Added reporter details (Non-significant information).
1st dose on 1/15/2021 I had only mild symptoms of arm soreness, tiredness and headache.  2nd dose on 2/12/2021 I had greater symptoms.  Continued to have arm soreness and tiredness.  However, strong headache persisted for several days.  My family was concerned and almost sent me to the hospital on 2/21/2021 due to my flushed face and appearance of being ill.  Most concerning, from that date, my diabetes blood sugar readings have become excessive for more than two months following.  My doctor has had to add Jardiance to my other medications to try and control it.  I am still not in the desired range to match where I was prior to my COVID vaccination.