chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid 19; covid 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 330336BD) at the age of 28 years 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) in 2 weeks included: MICRONOR; BUPROPION HCL. There was no known allergy reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Negative, notes: Tested negative for covid 19 with at home antigen testing 2 days after completion of paxlovid course; (unspecified date) Negative, notes: Again negative 6 days after completion of paxlovid; (unspecified date) positive, notes: Tested positive again on at home antigen test 8 days following completion of paxlovid; (unspecified date) positive, notes: Day 16 since first positive test Antigen test positive; (unspecified date) Unknown results, notes: COVID 19 Treatment; (24May2022) positive, notes: Remain positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-Viral details: Product: Covid 19 treatment, Brand: Paxlovid, Treatment Start date: 10May2022, Treatment Stop Date: 14May2022, Indication: Treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Pt devel flu-like sx following vax w/Hep B vax; The illness required the pt to stay home from work;
Information has been received from a physician concerning a 13 month old pt who on approx 19Jun05 was vaccinated with a dose of varicella virus vaccine live. On 19Jul05 the pt presented to the doctor's office with breakthrough. Thirty days post vaccination, approx 19Jul05, the pt experienced 5-6 lesions scattered around the body. The lesions were not only at the injection site. There was no fever present. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Developed large local reaction on deltoid area evidenced by swelling, redness and "hardened" area. Complained of local itching. Afebrile.
The family noticed redness, swelling, tenderness about 24 hours after the vaccine around the injection site. The area really has not changed. When seen on 12/01/03, area 10 x 14cm indurated, warm, erythematous.
Lichen planus. Multiple bumps and skin rashes all over skin causing itching and burning. Very noticeable everywhere. Redness and purple bumps
Medical assistant mixed the Shingrix with  the wrong dilutent. She mixed the powder form w/ Sterile Diluent, instead of Lyophilized ge antigen. No adverse reaction occurred.
The patient experienced localized swelling and redness, about the size of the palm of his hand, over his left bicep. He described it as mildly painful and developed approximately 24 hours after he received the vaccine. Pt elected to monitor for spreading before consulting his doctor. He was not experiencing any shortness of breath or reactions elsewhere.
Severe pain in hips and lower back like passing a kidney stone, severe bone pain in chest area, could not sleep for 2 nights and then slept 12 straight hours, headache and blood pressure spike on 3/14 resulting in ER  trip with bp at 204/100.  Anxious and nervous with low appetite.
10AUG evening of vax; pt felt hot, no temp taken, APAP given; 11AUG woke up hot, limp, c/o stomach pain, shivering, sweating while walking had a syncope episode; taken to ER & t102.8 ax, MD gave APAP & findings WNL; pt hot, weak & anoxeric
I passed out on the toilet and hit my head on the floor and have not gotten my period since I got the shot even though I am currently supposed to be having it.
Pt. claims his arm is still sore months after getting his flu shot. On 1-16-2012 he said he went to the doctor and he had a torn rotator cuff. I called his primary care Doctor's office to inform them per person at doctor's office. He was in the office week before his flu shot for muscle pain in his arm. She thinks this may be the reason for the sore arm. The shot was given in deltoid no where near his rotator cuff.
patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.; This is not normal; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (This is not normal), HEADACHE (Severe headache) and HEADACHE (patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (This is not normal) and HEADACHE (Severe headache). On 04-Sep-2021, the patient experienced HEADACHE (patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.). At the time of the report, FEELING ABNORMAL (This is not normal) outcome was unknown, HEADACHE (Severe headache) had resolved and HEADACHE (patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.) had not resolved.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Patient experienced severe headache started on the second vaccination, and lasted for more than 5 weeks. Severe headaches from 1 in the morning to 6 in the morning, everyday. Patient said that it was not normal. On 04 Sep 2021, patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10). Patient had to put pressure with his hand on the left side the cranium. Patient said that he went through hell and back on Saturday. His girlfriend was ready to call the paramedics, that was how bad it was. Patient said that he never had this in his life. As of now, patient had pulsating headache on the left side of my cranium, about 2 inches of the left eye, with 0.5 / 10 pain level.   This case was linked to MOD-2021-310582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up contains no new information.
tooth cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disorder tooth.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced HYPERAESTHESIA TEETH. At the time of the report, HYPERAESTHESIA TEETH outcome was unknown.            No relevant concomitant medications were reported. Patient stated that they were going to give her novacaine to the area where the tooth was getting pulled.
NEEDLES SUCK IT BURNED; VOMITED; ACHY; CHILLS; 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 not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced burned, vomited, achy, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burned, chills, vomited and achy was not reported. This report was non-serious.
hand from arm of vaccination swelled; wrist swelled; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand from arm of vaccination swelled) and JOINT SWELLING (wrist swelled) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PERIPHERAL SWELLING (hand from arm of vaccination swelled) and JOINT SWELLING (wrist swelled). The patient was treated with CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hand from arm of vaccination swelled) and JOINT SWELLING (wrist swelled) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment for the events included ice on the swelling.
arm soreness; dizziness; arm was hard; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness), INDURATION (arm was hard), PYREXIA (Fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness), INDURATION (arm was hard), PYREXIA (Fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GLUCOSE, POTASSIUM CITRATE, SODIUM CITRATE ACID (PAEDIALYTE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness), INDURATION (arm was hard), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   This case was linked to MOD-2021-106463 (Patient Link).
pt presented to ED via EMS with dyspnea and low O2 saturation, placed on non-rebreather; positive for COVID; hx of stage III CKD, DMT2, Alzheimers; condition worsened, placed on BiPAP; condition continued to deteriorate, pt died in the hospital
PT RECEIVED PFIZER VACCINE X 2 DOSES ON 3/4/21 AND 3/27/21.  Patient found down in hotel room on 8/12.  Patient tested positive for covid pcr on 8/12. breakthrough covid vaccine case
This spontaneous report as received from a nurse professional refers to a 11 year old male patient with asthma. On 20-OCT-2003 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # 0867m, exp. ??-AUG-2004) for immunization. On 24-APR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 1783u, exp. 06-NOV-2009) for immunization. Concomitant therapies included fluticasone propionate, ADVAIR, ZYRTEC and SINGULAIR. On 26-SEP-2013 the patient was diagnosed with chickenpox by his physician. The patient was home sick for 3 days broke out in rash and had draining pustules which started on his face, and then the rash moved down, onto his body. The patient had office visit. The outcome of chickenpox was reported as not recovered/not resolved. Additional information has been requested.
Posterior Hip Focused Point Pain after laying down for extended period - Left side Only.  Pain relief achieved with Percocet and Flexeril.  Pain does not manifest during the daytime with activity, only at night when laying in bed for extended period of time.
patient was 9 years old and the Quadracel was given, no adverse event; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a nine years old female patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA and expiration date  09-Oct-2020) via an intramuscular route in the right arm on 04-Oct-2019.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) received on 04-Oct-2019 and she did not experience any side effects.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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.
Rt upper arm 2in x 2in reddened hard area warm to touch. Denies pain c/o.
pt came into clinic stating lt arm has been killing her;LDM-red area extends to about 8-10cm diameter w/grayish dark area in ctr about 1" diameter;hard nodule area felt hot to touch;high fever & lump under arm, sore to touch;itches;
Nauseau, Vomitting and Diarrhea and headache started approximatly 27 hrs after vaccine and last for 24 hours.
sore arm; body aches; Tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Tachycardia), PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia) and MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Tachycardia), PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient experienced the event Tachycardia and body aches started 4-8 hours after receiving each dose and lasted 12-24 hours. Patient was concerned with an allergic reaction.   This case was linked to MOD-2022-670602 (Patient Link).
Achey/nausea same afternoon Fever/flu symptoms 8pm throughout night Fever/chills/ sweating moderate midnight to 6am Fever flu symptoms next day Fever achey sunday morning Sore arm bordering on unusable throughout and current
This spontaneous report was received from a medical assistant referring to a 4 year old female patient. It was reported that she was a healthy kid. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with a dose of M-M-R II for prophylaxis (dose, route, frequency, lot/batch number and expiration date were not reported) and a dose of PROQUAD for prophylaxis (dose, route, frequency, lot/batch number and expiration date were not reported). On 14-DEC-2016, the child was in for her second round of included M-M-R II and 0.5 ml, by unknown route, lot # L039613, expiration date 08-OCT-2017, for prophylaxis and that same day also received the second dose of PROQUAD 0.5 ml, 0.5 ml, by unknown route, lot # L031601, expiration date 18-FEB-2017, also for prophylaxis. At the time of this report the patient was fine and was unknown if she would continue to take M-M-R II or PROQUAD. Additional information has been requested.
I can't quit coughing; so sick; got the flu; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who can't quit coughing and so sick and got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site for prophylactic vaccination  On an unknown date the patient can't quit coughing (cough) and so sick (illness) and got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event.
Headache; Muscle ache; chills; extreme tiredness; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female 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 04Apr2021 at 13:00(at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021 at 16:00(at the age of 71-year-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 05Apr2021 at 06:00, the patient experienced headache, muscle ache, chills, extreme tiredness and joint pain. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events  headache, muscle ache, chills, extreme tiredness and joint pain was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
cramping & nausea devel w/in 10 mins of inject; discomfort cont x 5 hrs w/onset of vomiting x 1; mild sore throat devel in this time also; diffuse myalgias; also devel w/in 1 hr of inject;
High Fevers 105.1, complex Febrile seizures, cellulitis on injection site and a rash. encephalopathy
Nausea, vomiting, tired, 103.5 fever, lack of appetite, headache, muscle pain, chills, feeling unwell, arm pain
Muscular and pain throughout entire body, head to toe, all over weakness, Temperature spiked to 101.3, dizziness, nausea.  Lasted about 30 hours.  Treatment: Slept, took Tylenol 500 tablets 6 hours apart to reduce fever, 1 each time, only two.
Myalgia chills, body aches Narrative:  Treated with OTC ibuprofen
GOT EVERY SINGLE SYMPTOM; This spontaneous report received from a patient 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced got every single symptom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got every single symptom was not reported. This report was non-serious.
Information has been received from a physician concerning a 12 month old male with an egg allergy, questionable, dairy allergy, and no pertinent past medical history who was vaccinated with a dose of varicella virus vaccine (lot 644032/1059M). It was noted that the child received no other vaccinations that day, At the time of vaccination, the child had a mild upper respiratory infection with symptoms including a clear runny nose and a mild cough which was not being treated with any medication. The day after vaccination, the child went to day care in the morning, and the day care called the child's mother to inform her that the child was having difficulty. The child had a fever and the mild upper respiratory infection developed into severe respiratory distress. The pt was admitted to the pediatric intensive care unit and was intubated for apprx. 36 hours. No signs of an allergic reaction such as rash, urticaria, anaphylaxis, hives, or stridor were noted. A chest X-ray was within limits and showed no pneumonia, pneumonitis, or effusion. Laboratory tests showed no infection. The fever that had originally occurred with the worsening of the upper respiratory infection defervesced over a few days. The pt was hospitalized for three days. The reporter indicated that the intensivist thought the respiratory distress was of viral etiology, however, the parents questioned whether it was a reaction to the vaccine or as a result of the egg allergy. The reporter noted that he was unsure of the cause of the severe respiratory distress and fever. It was indicated that the child completely recovered from the events. Additional information has been requested.  A 15-day follow up report received 08/07/2003 adds: Follow-up info was received from the physician which indicated that on 04/13/2003, the day prior to vaccination, the pt had "very mild upper respiratory signs and symptoms." On 04/15/2002 the pt presented with respiratory distress and diffuse wheezing and was admitted to the intensive care unit. The pt received ventilatory support for 24 hours. A chest X-ray was negative and viral cultures were pending. The event resolved over 72 hours and it was noted that the pt recovered on 04/19/2003. No further info is expected.