chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM (SORE UPPER ARM AT INJECTION SITE); FATIGUE; This solicited pregnancy report received from a patient concerned a 34 year old white female. The patient was enrolled in a non-company sponsored study. The patient's weight was 76.19 kilograms, and height was not reported. The patient's concurrent conditions included: attention deficit hyperactivity disorder, body mass index increased, asthma, and non alcohol user, and other pre-existing medical conditions included: The study participant had no obstetrical history and no history of tobacco and recreational drug use. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for covid-19 immunisation. Concomitant medications included cetirizine hydrochloride, famotidine, fluticasone propionate, iron, minerals nos/vitamins nos, and paracetamol.  On 06-APR-2021, the patient experienced maternal exposure during pregnancy, sore arm (sore upper arm at injection site) and fatigue.  On 21-JUL-2021, the patient experienced marginal cord insertion. Laboratory data included: Ultrasound scan (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm (sore upper arm at injection site) on 08-APR-2021, and fatigue on 07-APR-2021, and the outcome of marginal cord insertion and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm (sore upper arm at injection site), and fatigue was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211055909-COVID-19 VACCINE AD26.COV2.S-Marginal cord insertion. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. 20211055909-COVID-19 VACCINE AD26.COV2.S-Maternal exposure during pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild
Acute onset of dementia, intubated est 1 mo after vaccination Deceased 7/3/21 at Hospital
02/18/2021 just cold chills, cold to the touch all over, run a low grade fever, headaches, fatigue and sleepiness, loss of apatite, lethargic  -that lasted 10-12 hours. Remain fatigued, chills and headaches for the next 8 days. About three /four weeks post shot I then felt bad again, across my torso and shoulders. 04/26/2021 I went to see my family Dr. I had regular bloodwork done a week before. He sent me for additional blood work. I have been to three specialist Infection disease, Rheumatology, Gastroenterology. I have been put on Celebrex 200mg 2x daily, and Enalapril 2.5mg once a day. On the  04/27/2021 ended up in the ER, with BP 176/107.
REceived shot at 9:30 am, symptoms started at 7:30 - severe fatigue, chills, ache, which continued till next day at 1:30 pm. Urgency with poor voiding started about 11:30 pm on day of vaccination, hematuria started next morning. Still continuing
Patient had a history of febrile seizures; one day after his shots (based on MD's account) he developed a fever of >101 F and he started shaking prompting 911 call, seizure persisted despite rectal & IV diazepam, phenobarbital was given, patient was intubated.
Hives; Tachycardia; Felt needle pricking stuff; Felt like her skin was crawling on back, chest and neck; Arthritis in both hands; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), TACHYCARDIA (Tachycardia), PARAESTHESIA (Felt needle pricking stuff), FORMICATION (Felt like her skin was crawling on back, chest and neck) and ARTHRITIS (Arthritis in both hands) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), TACHYCARDIA (Tachycardia), PARAESTHESIA (Felt needle pricking stuff), FORMICATION (Felt like her skin was crawling on back, chest and neck) and ARTHRITIS (Arthritis in both hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives), TACHYCARDIA (Tachycardia), PARAESTHESIA (Felt needle pricking stuff), FORMICATION (Felt like her skin was crawling on back, chest and neck) and ARTHRITIS (Arthritis in both hands) outcome was unknown.            Concomitant medication information  was not provided  by the reporter.  The treatment history was not provided.   This case was linked to MOD-2021-252746 (Patient Link).
little bit tired; temperature of 100.5F; headache; joint aches; chills; lethargic; cough; body aches; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), COUGH (cough), PAIN (body aches), FATIGUE (little bit tired) and ARTHRALGIA (joint aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included FAMCICLOVIR, LOSARTAN, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMINS [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced LETHARGY (lethargic), COUGH (cough), PAIN (body aches), ARTHRALGIA (joint aches), CHILLS (chills) and HEADACHE (headache). On 28-Mar-2021, the patient experienced PYREXIA (temperature of 100.5F). On 29-Mar-2021, the patient experienced FATIGUE (little bit tired). The patient was treated with PARACETAMOL (TYLENOL) on 27-Mar-2021 at a dose of 3 dosage form and NAPROXEN on 28-Mar-2021 at a dose of 220 milligram. On 28-Mar-2021, CHILLS (chills) and PYREXIA (temperature of 100.5F) had resolved. On 29-Mar-2021, PAIN (body aches), ARTHRALGIA (joint aches) and HEADACHE (headache) had resolved. At the time of the report, LETHARGY (lethargic), COUGH (cough) and FATIGUE (little bit tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 100.5f (High) 100.5F Temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-060992 (Patient Link).
Pt. reported extreme pain - unable to move arm & unable to go to work for a few days - self medicated with OTC pain meds & ointments. Pain started Sunday night - unable to rest or lay down that night - could not work Monday.
Patient was admitted to Hospital on 1/15/22 with chest pain and shortness of breath  2 days following his Covid vaccine booster.  Patient was admitted and being treated for myopericarditis.
Experienced mild pain in right arm pit lymph node last night around 5:30PM. Woke up this morning with more pain than last night. The pain reminds me of the Small Pox inoculation I'd received. I am self-reporting this morning, I will report again if/when I feel better. I will also report if I end up having to seek medical attention.
PATIENT EXPERIENCED PAIN/SWELLING AT STARTING ON SUNDAY APRIL,11 2 DAYS AFTER INJECTION,  MORE PAIN THAN WITH OTHER VACCINES.  MONDAY MORE PAIN HAD DEVELOPED AND EXTENDED DOWN THE REST OF HER ARM.  I SPOKE WITH PT ON APRIL 10, TALKED ABOUT POSSIBLE REMEDIES BUT EXPRESSED THAT SHE MIGHT WANT TO CONSIDER GOING TO THE DR JUST IN CASE THERE WAS INFECTION AND TO RULE OUT ANYTHING ELSE.  PATIENT WENT TO ER AFTER PHONE CALL, THEY GAVE HER A ROCEPHIN AND STEROID SHOT,  A PRESCRIPTION OF KEFLEX AND INSTRUCTIONS TO FOLLOW UP IF NOT BETTER AFTER 72 HOURS
Pt she's experiencing bruisitis and swelling on her arm and elbow. states she has a hematoma on elbow.
Itching all over the body got worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRURITUS (Itching all over the body got worse) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hard of hearing since an unknown date and Chemotherapy (Patient on chemo since NOV2020.) in November 2020.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itching all over the body got worse). At the time of the report, PRURITUS (Itching all over the body got worse) had not resolved.            No concomitant medication provided.   No treatment information provided.  Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine.    This case was linked to MOD-2021-053344.
The patient received both of their Moderna vaccines. The first was on 1/20/21 and the second was on 2/17/21. The patient was asymptomatic for COVID-19 symptoms but was tested on 3/29/21 as others on the unit had tested positive. On 3/31/21 test results came back as positive for COVID-19.
1 small hive-like welt about 1.5-2inches below the injection site, red, raised, itchy, Non-blanchable
01/11/2000 received vax and subsequently developed a "swollen arm and the area around the injection site had a fine blistering effect. The pt was instructed to use warm moist soaks and take analgesic of choice. Follow up form the pt's mother indicated that the pt had no further problems."
Mom States he woke up stating arm was itching and she looked and it was red and swollen where MMR injection was given,subQ in left arm.
Headache; Chills; Sore in both arms; Received two doses at once; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the parent.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (1st booster, Unknown Manufacturer), administration date: 21Jan2022, when the patient was 13-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Oct2022, outcome "unknown", described as "Received two doses at once"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore in both arms".  Additional Information: The patient was the caller's 14-year-old daughter who received two doses of the Pfizer BioNTech Covid 19 Bivalent Vaccine instead of one dose. Stated that the doses were given at the same time to her daughter, one dose in each arm.Caller stated that this wasn't her daughter's first Covid Vaccine though. Stated that her daughter had a booster, 21Jan2022. This was the first of the Bivalent Booster.Caller stated that she called her daughter's doctor and they said to just watch for tachycardia or other symptoms. Caller states that her daughter just had a headache and some chills, she was better today, just sore in both arms. Caller states that they were just worried about long term effects.Caller mentioned that she was calling on behalf of her daughter who had the Bivalent Vaccine last saturday and unfortunately they gave 2 doses of the bivalent. She has had Covid vaccines before, but instead of receiving one dose of the booster, she accidently was administered two doses of the bivalent. The pharmacist said to especially watch her the first 24 hours and be very careful, and signs of needing to go to the ER. Luckily she's been okay, just a headache, or something like that, sore arms, kind of like a flu shot. She was given double the dose.   Follow-up attempts are completed. No further information is expected.
The first dose of Moderna COVID-19 vaccine was administered to a recipient under the age of 18.
Swelling of the Left Side of the Brain Encephalitis, Herpes Simplex Virus Encephalopathy Spinal Tap    Removed Cerebrospinal Fluid (CSF tests for infections) Aciclovir Drip for about 10-21 days
Within 15 minutes of the first dose I experienced itching on my face, which intensified with time.  By later in the day, I had itching on my upper body.  In addition, I experienced fatigue, swollen glands and generally felt "bad."  Within a few days, I started to have joint pain throughout my body, which continued for several days.    After my second shot, I experienced some itching, but less than with the first shot.  However, within 2 days, I had joint pain throughout my body.  The pain was "matched" on both sides and I had pain in my knees, hips, shoulders, elbows, wrists and knuckles.  There was no swelling in the joints and they were not "hot" to the touch.  I did not have fever.  The pain was intense enough that I began to take 15 mg. of  Meloxicam (an anti-inflammatory drug) daily, supplemented by regular doses of Tylenol to reduce the pain.  I was able to complete daily tasks, but found it difficult to do so.  The amount of pain that I experienced interfered with my ability to go to sleep and stay asleep.   The joint pain continued for 2 full weeks after the second shot and gradually began to get better by the third week after the second shot.  I saw my primary care doctor during the 3rd week and because I have a family history of rheumatoid arthritis, she ordered a series of labs to test for RA, as well as other conditions that could cause continued joint pain.   All came back negative.  My joint pain continued to improve as time passed, with almost all of the pain gone by the first week of June.  I am now able to do daily activities and take no medication for inflammation or pain.
It started of with itiching and developed into a very painful rash and in places small blisters. there is a strip about 2-3 inches wide going half way around my abdomin. If no changes happen today will be seeing the hospital tomorrow
Injection was given before the recommended 24-28 days. First dose was given 3/1/21
inability to lift her arms or legs; Lethargic; Weak; Shaky; overall Malaise; Flu-like symptoms; feel tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose on 21st July 2019 and experienced events, refer case US2019220473).   On 15th November 2019, the patient received the 2nd dose of Shingrix. On 15th November 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 16th November 2019, the patient experienced influenza-like symptoms, mobility decreased, lethargy, weakness, tremor and malaise. Rechallenge with Shingrix was positive. On 18th November 2019, the outcome of the influenza-like symptoms, tiredness, mobility decreased, lethargy, weakness, tremor and malaise were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, mobility decreased, lethargy, weakness, tremor and malaise to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. On Friday, the patient received Shingrix and started to feel tired.  The next day on Saturday he was in bed all day with flu-like symptoms, including the inability to lift his arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. On Sunday, he started to feel better.  All symptoms had resolved and he went in to work. The reporter was unable to provide any additional details and her husband was not home at the time of the call. This case has been linked with the cases US2019220473 and US2019220457, reported by same reporter.
This patient had swollen axillary lymph nodes of the right arm, headache, malaise, diaphoresis, and fevers.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that she and her daughter received the second dose of the Pfizer Covid-19 vaccine on Saturday, 8May2021. Caller reported that on Saturday she had a very high fever of 102, reduced down to 101, then down to 100 and then 99 and she took two tylenol every 6 hours two times and she used Vicks salve on her chest and back. Caller reported her daughter only had a sore arm. Reporter asked is it part of the side effects to have a fever and does it get worse and if you have a low grade fever under 104 is all you are expected to do is take two Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue, severe migrating arthralgias and myalgias (sometimes with swelling and erythema) for the past 9 months. Have tried NSAIDS and steroid injections.  Follow up 06/04/2001: "Patient has not recovered from adverse event.  Fatigue, migrating joing, muscle pain, confusion, digestive problems, light-headed, ears ringing... 35-40 days plus several days left work early or come in late."
Visual disturbances. Unable to read and see things close.  Optometrist diagnosis and prescribed corrective lens
Systemic: Fainting / Unresponsive-Mild, Additional Details: PT DID NOT LOOSE CONSCIOUSNESS, BUT FELT LIGHT HEADED AND FELL TO FLOOR, BLOOD PRESSURE AND PULSE WERE NORMAL, NO FEVER.
Swelling from R thigh to the R ankle in the 24hr following the vaccine.  Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.; Swelling from R thigh to the R ankle in the 24hr following the vaccine.  Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.; Swelling from R thigh to the R ankle in the 24hr following the vaccine.  Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.; This non-serious spontaneous case was received during the Reporting System monitoring on 12-Jul-2022 with the following Primary ID 2213945-1. The original narrative from the sender is the following:  Swelling from R thigh to the R ankle in the 24hr following the vaccine. Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.  No further information is expected.
High fever, soaking sweats, worse headache I've ever had which didn't respond to Tylenol, dizziness, pain all over body and skin, inflamed, very painful lymph node under left arm.
Pt presented around two weeks after shot and resolving erythematous macular rash that started two days after shot.
Moderate to severe pain in lower back, hips, thighs and shoulders.  Ruled out: Back injury, COVID (Delta variant), Lyme and other tick-borne diseases.  Diagnosis: Polymyalgia, Rheumatica (PMR).  Treated with prednisone from which I am tapering off.
Macular rash on trunk starting within 2 days of Td shot. No wheezing or serious allergic findings antihistamine tx given.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 14-MAR-2014 the patient received an improperly stored dose of PNEUMOVAX 23 (lot # J009723, expiry: 30-JAN-2015) single dose vial. No adverse event reported. No PQC involved. Additional information has been requested.
Event: On 6/16/2021 it was identified post vaccination that one of Medical Assistants inadvertently administered an expired vaccine. The patient did not have any adverse reactions to the vaccine while at my lab. The vaccine was last punctured on 6/7/2021 at 4:26 p.m. and was kept refrigerated in accordance with the vaccine requirements. Action Taken to mitigate future events: 1. Conducted a Safety Stand-down/retraining with all Lab staff. 2. Punctured vile will immediately be labeled with date and time. 3. Expired vaccines and diluent will be removed immediately to avoid inadvertent administratio
This spontaneous prospective pregnancy report was received from a physician concerning to a 27 year old female patient. The patient's current conditions included heterozygous for factor 5. The patient was allergic to nitrofurantoin (captured in MARRS# 1704USA009571). Concomitant therapies included vitamin B complex, omega-3 marine triglycerides, and magnesium (unspecified). On 14-FEB-2017, was the patient's last menstrual period. On 06-MAR-2017, the patient had a urine pregnancy screen which resulted as negative. On 10-MAR-2017, the patient was inadvertently vaccinated with a dose of VARIVAX lot # M040139 with expiration date of 28-SEP-2018 for prophylaxis (the dose, strength, and route were not provided) while she was unknowingly pregnant. On 15-MAR-2017, the patient had a new urine pregnancy screen which result was positive. The estimated date of birth was reported for 21-NOV-2017. The initial exposure to VARIVAX was at week 3 of gestation. The pregnancy outcome was pending. Additional information has been requested. Sender's Comments: US-009507513-1704USA009571.