chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute onset supraclavicular lymphadenopathy left side clavicle; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0171) via an unspecified route of administration in the left arm on 01May2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LO ESTRIN FE) from an unknown date and for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0158) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 48-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 02May2021, the patient experienced acute onset of supraclavicular lymphadenopathy on left side clavicle. The clinical outcome of the event supraclavicular lymphadenopathy on left side clavicle was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
low grade fever; chills; fatigue; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (mild headache). On 11-Mar-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HEADACHE (mild headache), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 29-SEP-2015, the patient was inoculated with ZOSTAVAX, at a store pharmacy (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-SEP-2015, she was treated by a physician at an unspecified facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe Herpes Zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX.  Additional information has been requested.
34 year old female complained of shortness of breath. Onsite EMS responded. Vitals BP 138/89 HR 104 100% O2. Refused care, released against medical care.
received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose; received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose; received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 19:00 (Lot number: FK5127) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No: FK5127), administration date: 08Nov2021, when the patient was 11 years old, for COVID-19 Immunization. No additional vaccines administered on same date of the Pfizer suspect to the patient.  The following information was reported: OFF LABEL USE (medically significant), ACCIDENTAL OVERDOSE (medically significant), INCORRECT DOSE ADMINISTERED (medically significant) all with onset 29Nov2021 19:00 and all described as "received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose". There was no emergency room visit or physician's office visit due to the adverse events. There was no prior vaccinations (within 4 weeks) to the suspect vaccines.
The mother of patient noticed a diffuse papular rash on the anterior trunk & legs; no rash on back, hands or feet. No resp, no CU, no GI illness.
Cold symptoms.... lasted 1 1/2 weeks ... sore throat, stopped up nose, runny nose, cough, aches, no fever... undiagnosed COVID in Feb. 2020....but found out later was exposed to COVID... did have a test and was not flu.... unlike any flu/cold had before (in Feb 2020)
This spontaneous report was received from a health care worker regarding a 44 year old female patient. The patient's medical history included trigeminal neuralgia, dysphagia unspecified. The patient's current condition included multiple sclerosis and weakness. The patient had no known drug allergies. The patient was vaccinated with a dose of ZOSTAVAX approximately on 13-SEP-2012 (reported as one week ago) (lot #, dose and route not reported). Concomitant medications included AMITIZA, acetaminophen, VICODIN prn, TRILEPTAL, EFFEXOR and alprazolam. On an unknown date, the patient experienced exacerbation of multiple sclerosis symptoms (medically significant). The patient had a preexisting condition of Multiple Sclerosis and was vaccinated with ZOSTAVAX and it exacerbated her symptoms of multiple sclerosis, caused a flare up. The patient sought medical attention. The outcome of the event was reported as not recovered at the time of this report. Additional information has been requested.
pt received Moderna dose one as well as Fluarix (flu shot) on Thursday, Sept 9 at around 6 pm.  On or around Saturday, patient experienced diarrhea and chest tightness, overall ill feeling.  He reports feeling hungry or "empty" inside, but can not seem to eat and must take tylenol or motrin to function.  Pt also reports poor sleep, as chest/back pain keeps him up. He continued to have this chest/lung/back tightness on and off for about a week, then returned to pharmacy today (9/16/21) to report symptoms. Symptoms continue. Pharmacist recommended seeing family doctor or going to ER if family doctor can not be reached.
This spontaneous report as received from a registered nurse refers to a 2 month old female patient. On 29-APR-2013, the patient was administered expired ROTATEQ (lot # 0923AA; expiry date: 25-APR-2013) 2ml oral. No adverse effects were reported. The outcome of the event was unknown. This is one of three reports from the same reporter. Additional information has been requested.
Not sure if the vaccine caused these effects, but I have a very itchy rash all over my body in different parts. Lower stomach, leg, both arms, neck. Very reminiscent of poison ivy but I don't recall contacting any plants over the past 3 weeks.
uterine/menstrual type cramping from below my belly button down to my anus; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Not reported), via an unspecified route of administration, administered in Arm Right on 11Mar2021 as single dose (at age of 45-years old) for COVID-19 immunization. The patient concomitant medications were not reported. The patient did not have any known allergies and other medical history. Previously, the patient received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that about 1 PM today (11Mar2021), she began having uterine/menstrual type cramping from below her belly button down to her anus. Worst cramping she had in a long. No treatment was received for the reported event. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pt vaccinated w/DTP/OPV 21MAR went home took nap up 4PM sounded like she was choking-child was limp, lips pale-not responding; Temp 101R; Advised not to have any more DTP's;
Within 15 minutes I started getting tingling in both feet, within a few days my lower legs felt like they had compression socks on, felt heavy.  Tingling moved up to my hands, Lips tingle.  Involuntary movement of pointer finger on right hand. Muscle spasms, thigh pain. Symptoms got better in May and June. About three weeks ago my right top eye lid started twitching then the bottom eyelid.  Last week my left eye started twitching,  when I smile my face tremors at the end of my mouth.  Tingling started back left lower leg and foot both hands. Elbow pain, involuntary movement of multiple fingers on both hands. Arms and legs ache. Thigh pain.
Mild chemical smell and taste intermittent over 4 day period, believed to be vaccine.
Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain that went down my leg to my foot, feeling it going down my thighs and knees; Started with one side of the hip then both; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the second episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the third episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and ARTHRALGIA (Started with one side of the hip then both) in a 31-year-old female patient 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 the first episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the second episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), the third episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and ARTHRALGIA (Started with one side of the hip then both). At the time of the report, last episode of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain that went down my leg to my foot, feeling it going down my thighs and knees) and ARTHRALGIA (Started with one side of the hip then both) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Patient states her arm hurts really bad even a few weeks after vaccine. Was told by her doctor to take tylenol and ibuprofen.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JUL-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 3312 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Breathing difficulty when standing; chest pain; sore throat; swollen gland; back ache; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), via an unspecified route of administration in the left arm on 26Feb2021 at 10:15 (at the age of 75-year-old), dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 04Mar2021 at 00:00, the patient experienced breathing difficulty when standing, chest pain, sore throat, swollen glands, back ache. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.
Shivers, trembling, vomiting, general weakness, low blood pressure and slight fever. slept for 1.5 day  Took three time my Hydrocortisone medication.  Also took my BP medication and Tylenol.
Patient was given KINRIX on 5/3/2013 when he was 7 years old.
pt recvd vax;exp 2 febrile szs; T 104;apap given;to er;dx:acute otitis media;;poor apetite;adeq fluid intake;nl activity level;20jan95 f/u,persistent ear infect;atb given;
The patient believed that he did not receive the full 0.5 ml AFLURIA dose because some liquid was leaking from the syringe. The patient was fine. The nurse administering the vaccine stated the patient received the full dose, the syringe was not leaking. Outcome was not reported. Reporter's comments: The reporter stated that the patient was fine.
I am 9 weeks pregnant. First evening after receiving 1st dose of Pfizer, I felt sharp discomfort in my heart lasting 1-3 minutes, medially and inferiorly, while at work and resting at home, no exercise, no sob. That same night, I had heart flutters that woke me up from my sleep, it felt like my heart went out of rhythm and was trying to get back into normal rhythm. The next day (Day 2, 9/17/2021), I had sharp pains again with duration unchanged but occurred ~ ~4 times, at work and at home; no exercise, no sob. The 3rd day (Saturday 9/18/21), I woke up at 6am with sharp pains again and paged by OBGYN right away; was advised to call my physician if pain persists into the the next week. Day 4 (9/19/21), frequency had lessened. Day 5 (9/20/21) and Day 6 (9/21/21) sharp discomfort occurred less duration and frequency.
Entire arm became swollen and painful day after vaccine. Developed fever as well. Resolved on its own.
This spontaneous report as received from a other health professional refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with PROQUAD lot # M038229 (exp date 06-MAR-2018) and lot # N013865 (exp. date 31-OCT-2018) for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, the patients experienced incorrect product storage and no adverse event. Sender's Comments: US-009507513-1707USA007166.
mom reports fever for 2 days @ 2AUG98 followed by onset of rash;4AUG98 which progressed to vasculitis lasting 4-5days;CBC, platelets checked nl results;follow up child w/o problems vasculitis clearing-no complaints;
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ROTATEQ (route, dose and lot # were not reported) for prophylaxis that was improperly stored. No adverse symptoms reported. The outcome of patients received improperly stored vaccine ROTATEQ was unknown. This is one of several reports from the same source. Additional information has been requested.
rash that started on the left arm 2 days after the injection. monitoring the rash for now. it is asymptomatic outside of pink rash with slightly raised border
Exhaustion, Brain Fog, Confusion, Hives at the site of the injection. The first 3 symptoms were apparent for several weeks and the hives/allergic reaction on left arm lasted for over 24 hours.
I tested positive for COVID 9 days after receiving the vaccine; I tested positive for COVID 9 days after receiving the vaccine; Rhinorrhea; aches; fatigue; cough; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of the two reports.   A 68-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 21Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient had no known allergies. Concomitant medications included losartan (LOSARTAN), amlodipine (AMLODIPINE), and atorvastatin (ATORVASTATIN). On 28Dec2020, the patient had rhinorrhea, aches, fatigue, and cough. The patient had no COVID prior vaccination, and when tested post vaccination showed a positive result. It was reported that the patient was tested via nasal swab (PCR SARS) and showed positive for COVID on 30Dec2020, 9 days after receiving the vaccine. The patient had no other vaccines in four weeks. No treatment was administered for the events. The events had not resolved.   Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and SARS-COV-2 test positive cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001246 Same reporter, same drug, similar events, different patients.
Arm at injection site started to itch with a small rash.  After a few days it stopped itching but rash continued to grow.
I didn't have an symptoms at first, but I was exposed to COVID. When they tested positive I decided to take a rapid test and it came back positive. I was having cold like symptoms. Nose running, I was achy and tired. I didn't have much energy. I tested negative 8 days later. About a month later I noticed I lost vision in my right. I went to bed to see if it would get better in the morning. The next morning I woke up and it wasn't better. I call my treatment nurse and she told me to go to the emergency room. They did a head CT Scan, took blood, urinalysis. They sent me home and I had to make an appointment to see the ophthalmologist and he determined I had a stroke in my right eye.
On the evening of March 6, I developed sharp pain in my upper right quadrant.  I had a history of similar episodes over the previous decade, but this one required emergency room treatment.  I was given pain medication and sent home.  Twenty four hours I returned to the emergency room.  I was diagnosed with acute cholecystitis and admitted to the surgical service at the hospital.  The next day, my gallbladder was removed by laparoscopic surgery. The pathology report confirmed cholecystitis with cholelithiasis.   I was discharged on March 9, 2021.
gave a child the monovalent vaccine instead of the Moderna bivalent vaccine; Monovalent vaccine labeled as booster dose being given for the bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (gave a child the monovalent vaccine instead of the Moderna bivalent vaccine), PRODUCT LABEL CONFUSION (Monovalent vaccine labeled as booster dose being given for the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (gave a child the monovalent vaccine instead of the Moderna bivalent vaccine), PRODUCT LABEL CONFUSION (Monovalent vaccine labeled as booster dose being given for the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (gave a child the monovalent vaccine instead of the Moderna bivalent vaccine), PRODUCT LABEL CONFUSION (Monovalent vaccine labeled as booster dose being given for the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (gave a child the monovalent vaccine instead of the Moderna bivalent vaccine) and PRODUCT LABEL CONFUSION (Monovalent vaccine labeled as booster dose being given for the bivalent vaccine).    No concomitant medication was provided by the reporter. The pharmacist administered the dose out of the monovalent vial labeled for booster dose with the blue cap and the purple border and the labeling contributed to the mistake as she thought that she was administering the bivalent booster dose. No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2022: Follow up received included QE number.
Fever, decreased appetite, shaking, medial aspect of left foot with vesicular rash and mild local erythema. DX: Varicella Zoster.  TX: fever control with Ibuprofen, fluids, rest.