chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild pain/stiffness in the affected arm; mild pain/stiffness in the affected arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613) at the age of 42 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease", start date: 1992 (ongoing), notes: The condition has been stable for the past 30 years - taking levothyroxine. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown" and all described as "mild pain/stiffness in the affected arm".  Additional information: The patient has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. specific relevant test for thromboembolic events with thrombocytopenia: unknown. adverse events for thromboembolic events with thrombocytopenia include specific relevant tests above: "n/a".
SORENESS OF LEFT ARM; BODY ACHES; HEADACHE; BURNING SENSATION ON INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. 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 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported has been requested On 08-MAR-2021, the subject experienced burning sensation on injection site. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. On 11-MAR-2021, the subject experienced soreness of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-MAR-2021, and burning sensation on injection site, and headache on 11-MAR-2021, and was recovering from soreness of left arm. This report was non-serious.
I have been getting the flu shot since it's been around and never had anything more than the normal pain for a few days. This time was different. There was no pain at the time of the vaccine like I usually get. I didn't get the normal pain or swelling that usually follows this vaccine either. A few days later (around 09/11/2015) I started feeling pain in my upper shoulder when I moved my arm backwards. Since then, it has gotten worse and the range of motion of my arm has gotten very limited to the point that I want to cry every time I move it around. I can't reach for things, I can't lift things and I practically can't do anything with this arm without wanting to scream or cry. What's worse is I don't know if my flu shot is even effective.
6 1/2 hours after the shot she had the following symptoms and was unable to work the following day. Headache, body aches, nausea, and chills.
Injection given on 8/1/07, on 8/1/07 eve patient complain of redness, pain at injection site. Swelling, redness noted.
Sore arm; Mild Headache; This is a spontaneous report from a contactable nurse. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0 151) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously took Demerol, Darvocet (Darvicette), Morphine, Vancomycin, Reglan and experienced drug allergy. 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 vaccination. On 10Apr2021, the patient experienced sore arm and mild headache. The 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 sore arm and mild headache was resolved on 10Apr2021.   No follow-up attempts are needed. No further information is expected.
complaints related to Chrone's disease have increased after vaccine.; GI complaints after vaccination.; headache on and off; nausea; rash all over body  itchy; redness at injection site; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (complaints related to Crone's disease have increased after vaccine), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease (No reported Medical history).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (complaints related to Crone's disease have increased after vaccine.), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site), HEADACHE (headache on and off) and NAUSEA (nausea). At the time of the report, CONDITION AGGRAVATED (complaints related to Chrone's disease have increased after vaccine.), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site), HEADACHE (headache on and off) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient asked about delayed reactions and if she can go for the second dose of vaccine? Concomitant drug information was not provided.  Treatment information was not provided. Gave consent for safety team to follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received vaccines 9-30-11, ct had severe swelling of lips & face on 10-1-11. Ct seen & treated in ER with prednisone & BENADRYL. Dx with angio-edema.
Around 7pm on 5/14/21 after receiving the second dose of the Pfizer Covid-19 vaccination, I started having a mild headache, and body aches followed throughout the night until approximately 7pm on 5/15/21.  The aches were mostly in my feet (toes) and upper body.  I took a Tylenol to relieve the aches and it helped.   Soreness in the arm started approximately one hour after getting vaccinated (around 10:30am) and continues until today (5/18) but the pain has lessened.
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient. Patients sister reported that her brother had a stroke after he received the vaccine,  She stated she already reported it and was not going to report that here in her call. No consent was obtained.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected serious adverse event of special interest, Cerebrovascular Accident. The event was medically significant. The event occurred in on an unknown interval after receiving an unspecified dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected serious adverse event of special interest, Cerebrovascular Accident. The event was medically significant. The event occurred in on an unknown interval after receiving an unspecified dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Within 90 minutes vomiting, increased temperature, weakness, nausea and hives. Vomited several times within next 1 hours. Contacted clinic that administered vaccine. Rested and took diphenhydramine by mouth once able to keep small amounts liquid down.
Fever Pain at injection site Very sore arm hurts to move my arm Chills that lasted 6 hours Muscle aches for 8 hrs
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 16-JUL-2016, the patient was vaccinated with a dose of VAQTA (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. This is one of several reports that received from the same source. Additional information has been requested.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 3:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Apr-2022 at 3:21 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.
This is a spontaneous report from a contactable pharmacist via a sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot # L36482, expiration date Oct2016), intramuscular at 0.5 ml, single in the left arm on 16Jun2015. Medical history included chronic obstructive pulmonary disease, type 2 diabetes mellitus (DM II), hypertension (HTN), hypercholesterolaemia. Concomitant medication included simvastatin 40 mg 1x/day for cholesterol, alendronate sodium 70 mg weekly for osteoporosis, metformin 500 mg 2x/day for DM II, metoprolol ER 25 mg 1x/day for HTN, PROAIR COPD as needed, lisinopril 5 mg 1x/day for HTN. On 17Jun2015, the patient went to Emergency Room (ER) for arm redness from deltoid to elbow. ER diagnosed it as cellulitis. Patient visited Primary Care Physician (PCP). PCP diagnosed redness as injection site reaction. The patient returned several weeks later to report resolution with no sequel. Follow-up (03Nov2015): New information obtained from a contactable pharmacist includes: details of vaccine administered, medical history, concomitant drugs, diagnosis, onset and outcome.
pt recv vax; screaming for 2 1/2 hrs day vax given; no fever p/ resolution;
In error, patient was given 1st dose of Moderna vaccine after receiving the Janssen vaccine on 04/09/2021
Developed a fever  Body felt hot/cold Temperature went up to 101 Body aches I took Tylenol.
The patient experienced severe arm pain, hives and a fever one day after immunization, worsening the next day. The patient was treated with Medrol dose pack, Benadryl, Tylenol and cool compresses.
First pix noticed on legs 5/15/01. Saw private physician on 5/17/01. No treatment was given. Mom used over the counter calamine lotion. Child was covered head to toe with pox.
Information has been received from a Registered Nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 30-MAR-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # K008871, exp. date:19-DEC-2015 (dose, dose number, route and application site were not reported). Concomitant therapy was not reported. The temperature excursion for the PROAQUAD (Merck) was found to be supported with in-house stability data. No adverse symptoms reported. Additional information has been requested.
Within a few hours after extreme lethargy. With serious nausea that lasted almost 4 weeks. First week and a half I could barely get the energy to pick up my arms. Felt dizzy often when attempting to walk which increases nausea. Could barely eat anything during the weeks after. No other illnesses that could be linked to these issues.
Patient slumped in chair after vaccination against her mother. Mother guided her to the ground. She came to quickly when pharmacist entered room. EMS evaluated patient's vitals and cleared patient. Patient had been outside in extreme heat for volleyball in the morning, had minimal water and a light lunch/snack.
COVID-19 Vaccine EUA; The original injection site tenderness resolved after two days.  On day 7, I woke up with a very itchy upper arm at the injection site.  It was also red and swollen.  Day 8 is still swollen (firm) and reddish, but not quite as itchy. I take Claritin daily,  so it may be helping.
Tingling in all four extremities, chest tightness, throat tightness, pharyngeal Edema , Nausea, lightheadedness
Both knees ached and became swollen and has continued to this date with the recent addition of both wrists hurting.
complains of heart racing. Had patient site down checked bp 151/92 and pulse now 72. Patient reported heart rate  no  longer racing and has history of high BP
The patient was brought to the ED by EMS on 9/2/23 for shortness of breath and difficulty breathing. Additionally, she reported a cough that has been ongoing for about a week. She is a current smoker. She tested positive for COVID-19 by PCR. Ultimately, the patient was admitted to the hospital on 9/2/23 - 9/8/23 for acute hypoxemic respiratory failure due to COVID-19 infection with superimposed bacteremia pneumonia. Initially, O2 sats were at 84% and so she was placed on 4L O2 via NC. Of note, the patient has received the primary COVID vaccine series and three boosters.
Parent took child to get vaccinated on 08/10/2021. Patient was given Rotavirus vaccine that parent believes was expired at the time of administration. Patient's heart stopped 30 days later on 09/10/2021.  Parent doesn't have lot number bc she stated that the clinic attempted to hide the paperwork from the patient's visit on 08/10/2021. Parent received documentation on 11/02/2021 but it still doesn't list lot number to vaccine.
Incessant fatigue regardless of sleep, muscle weakness, unexplained weight gain, and hair loss
Pt presented to health department for vaccines for school. Pt requested Hep A, HPV, and MenB. Pt reports allergy to Rocephin with a reaction of Hives. Pt denies any history of any anaphylactic reactions. Pt lost consciousness for Approx 1 minute almost immediately after receiving vaccines. Pt did not fall. Pt did not hit his head. EMS was called. Vitals stable.  Pt observed for approx 20 minutes. Pt drank sprite and ambulated to car with father.
Hives; Itching; Rash; Scratches on her arms/Scratches all over her body; Was her first ever dose of the Pfizer Covid 19 Bivalent vaccine. Was a primary dose; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 as dose 1, single (Lot number: GJ3270) at the age of 76 years intramuscular, in left deltoid for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (medically significant) with onset 27Apr2023, outcome "recovered" (28Apr2023), described as "Hives"; PRURITUS (non-serious) with onset 27Apr2023, outcome "not recovered", described as "Itching"; RASH (non-serious) with onset 27Apr2023, outcome "recovered" (28Apr2023); SCRATCH (non-serious) with onset 27Apr2023, outcome "not recovered", described as "Scratches on her arms/Scratches all over her body"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Apr2023, outcome "unknown", described as "Was her first ever dose of the Pfizer Covid 19 Bivalent vaccine. Was a primary dose". Therapeutic measures were taken as a result of urticaria, pruritus, rash. Therapeutic measures were not taken as a result of scratch. Clinical course: Reporter stated that patient received her first ever dose of the Pfizer Covid 19 Bivalent vaccine. Was a primary dose. Was her first vaccine ever of the Covid vaccine. Treatment received Benadryl for Hives, Itching and Rash. Investigations: No, Other Products: No. Reporter stated events pruritus, rash, Scratch as not serious and event urticaria as serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the event hives cannot be excluded based on the plausible temporal relationship and product profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Had a mild headache at time of vaccine, unknowingly had a mild fever at the time, so did not take temperature. Went home to take a nap. Woke up two hours later with fever, stronger headache, chills, and muscle ache. Four hours later, the chills decreased, but the headache, fever, and muscle ache still persisted. 14 hours later (the next day), no chills, no headache, face still feels warm, but no fever. Muscle ache only in the location of the injection site.
Patient had flushing/sweating,  ringing in ears, nausea. Stable, released from vaccination site.
Fever of 102.2 F; Chills; Body aches; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 102.2 F), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040D21A, 007M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (diabetes medication) and Blood pressure high (high blood pressure medication).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 102.2 F), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 102.2 F), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 f (High) Fever of 102.2 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; first dose on 01Apr2021/second dose on 15Apr2021; showed some kind of elevation in antibodies for allergic reaction; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Apr2021 at 12:00 (Batch/Lot number was not reported; at the age of 54 years old) as dose 2, single for COVID-19 immunisation. Medical history included vitamin B deficiency controlled with monthly shot, anemic, and high BP. Concomitant medications included ibuprofen (MOTRIN) and losartan potassium (LOSARTIN).  The patient previously took Vicodin and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 54 years old) in the left arm on 01Apr2021 at 12:00pm for COVID-19 immunisation.  The patient reported that she broke out in horrible itchy rash along with blistering and oozing spots all over the entire body on 19Apr2021. The only place it did not appear was on her face.  The patient went to urgent care twice within two-week span because got worse and worse. The patient was sent for bloodwork after visit in 2021, and doctor said the patient showed some kind of elevation in antibodies for allergic reaction. In 2021, the primary care doctor referred the patient to a dermatologist and was biopsied newest spot on the knee, sent it to pathology for review, also more lab work was done for third time showing an unknown conclusion. At that point of 3rd round of steroids, antibiotics, creams, ointments, the patient was referred to (University name).  At visit, doctors said they never seen a severe reaction like the patient has. The patient showed pictures of the progression of her awful reaction to this and brought all the past results from other doctors which had no clue how to diagnose because vaccine being too new. In summary, the patient was one of the unlucky few, a guinea pig. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Other treatments included drugs, anti-itch pills, steroids, creme, and ointments. The patient is recovering from the events. The events were assessed as serious (Disability or permanent damage).   Information on the lot/batch number has been requested.