chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DVT symptoms occurred after first dose and was undiagnosed; soft tissue injury; muscle pull and ankle strain; muscle pull and ankle strain; This is a spontaneous report from a contactable nurse. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 23Feb2021 at 13:30 (Batch/Lot Number: EN6200) at a single dose for COVID-19 immunization. Medical history included a family history of diabetes - his mother had diabetes. The patient's concomitant medications were not reported. DVT symptoms occurred in Feb2021 after the first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Found to have GI bleed and thrombocytopenia at 4k. Hemoglobin at 6.9,  stable at baseline. Given patient's recent history of left pelvic rami and left sacral fracture, CT abdomen was done and ruled out retroperitoneal bleed. Patient refused colonoscopy due to her age. Hematological workup for thrombocytopenia was unremarkable. Concern for immune thrombocytopenic purpura (ITP) given recurrent drop in platelets to < 10 despite persistent platelet transfusions. Currently being treated empirically for ITP w/Decadron 40 mg x 4 days. Due to lack of response, patient now on IVIG (10/21-10/22).
TRANSIENT CEREBRAL ISCHEMIA 4/8/2023 TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/8/2023 TRANSIENT CEREBRAL ISCHEMIA
Achy joints (not just in shoulders with shots - though it is worst there), sore lymph nodes (at back of neck), sore throat, aching ears, loss of appetite (not very hungry), mild headache, mild fever (1 degree).
Site of injection began itching rather intensely within 10 min of administration. A six-inch oval real of raised, redness developed within 24 hrs. Hot to the touch. Remained reddened from 10/24/02 until approx 11/19/02. Never had a fever nor any respiratory symptom.  Follow up on 12/03/03: nothing answered.
Golf-ball sized lump under arm; pain in right breast all the way down midway to ribs and all the way down to right arm and right-side of back. Pain extends down right-side more and more every day. Intermittent fever.
Headache, Fever, NauseaVomiting, chills, diaphorisis Narrative:
The pt experienced a knot and red area with heat to the left thigh injection site. Was able to walk.
Information has been received from a physician concerning an 18 year old female who in May 2008, was vaccinated with her first dose of GARDASIL 0.5 mL, IM. In approximately May 2008, after receiving the vaccination, the patient experienced lymphadenopathy. The patient called the physician in August 2008, about 10 days before her schedule appointment to say her lymph nodes were swollen. The physician said to wait the 10 days and then come in for her second dose. She come in 10 days after her call but was still sick so the second dose was not given. The physician "ran a bunch of testing, including bloodwork, and ruled out mononucleosis." Patient came on 02-SEP-2008 for a follow-up, but the physician still has to send her for a biopsy. Additional information has been requested.  On 03-Nov-2008, Dr reported that the patient was seen by Infectious Disease specialist, and was diagnosed  with mononucleosis. The patient's status was reported as recovered.
PATIENT FAINTED AND HAD A 20SEC SEIZURE SEVERAL MINUTES AFTER RECIEVING VACCINE.  PATIENT HAD EXTREME ANXIETY ABOUT BEING VACCINATED BEFORE HAND AS WELL AS HAD NOT EATEN DAY OF.   PATIENT SYMPTOMS SUBSIDED AND HSOPITLIZATION WAS NOT REQUIRED.
C/o lethargy, AMS. MRI to r/o CVA. Covid lab (negative) but Tx for covid pneumonia per medical record
pt recv vax; fever 10 days p/ MMR; T 104; blotchy red rash all over; glands in neck; dx of Roseola; fever lasted 2-3 days;
Mom reports @ 12noon pt was eating lunch & 'eyes started quivering", & lasted until p/lunch off & on; fever of 100; Had another episode in the evening of the eyes quivering; also sleepiness & fussiness;
Pt developed severe pain 10/10 and swelling at injection site, pt states pain started soon after injection and got much worse from day of injection. Pt given Methylprednisolone Pak and TYLENOL #3.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in the refrigerator on 04-NOV-2021.Vial did not undergone any temperature excursion. No adverse event was reported. No treatment medications were reported.
Within 15 minutes of injection experienced cramping, diarrhea and nausea.  Observed for 30 minutes.
Pt devel rash 3-4 days 99-100 temp, h/a, pain in fingers & hands knees;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 13:00 as dose 1, single (Lot number: EL9269), in left arm, on 04Mar2021 at 13:00 as dose 2, single (Lot number: 2N6205) and on 30Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 at 10:00 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Negative, notes: Paxlovid rebound. After completing the five days of Paxlovid, I tested negative on 13Jun22; (19Jun2022) Positive, notes: On 19Jun22, I tested positive again. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Paxlovid rebound. After completing the five days of Paxlovid, patient tested negative on 13Jun22. On 19Jun22, patient tested positive again.  No follow-up attempts are possible. No further information is expected.
"Nut" on the elbow after getting the second dose of Moderna COVID-19; High temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING ("Nut" on the elbow after getting the second dose of Moderna COVID-19), PYREXIA (High temperature) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced JOINT SWELLING ("Nut" on the elbow after getting the second dose of Moderna COVID-19), PYREXIA (High temperature) and CHILLS (Chills). At the time of the report, JOINT SWELLING ("Nut" on the elbow after getting the second dose of Moderna COVID-19), PYREXIA (High temperature) and CHILLS (Chills) had resolved.            No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The follow up received contain significant information :outcome of the events changed from unknown to recovered.; Reporter'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.
Left leg with area of swelling, heat, redness about 7cm; localized reaction only.
Did not has enough strength to pull herself up; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Did not has enough strength to pull herself up) and INJECTION SITE PAIN (Pain at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (Did not has enough strength to pull herself up) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, ASTHENIA (Did not has enough strength to pull herself up) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Chills; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 83 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Jan2021 (Lot number: EN5318) as dose 1, single and intramuscular, administered in arm left, administration date 17Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM taken for intervertebral disc degeneration, arthritis (ongoing); GABAPENTIN taken for neuropathy peripheral (ongoing); LORATADINE taken for hypersensitivity (ongoing). The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Chills only after 1st and 2nd.  No follow-up attempts are possible. No further information is expected.
Pt. received vaccine at employee vaccination clinic at 1pm on 12/18,  and received phone call from patient at 6:20pm at the vaccination clinic on 12/18. Patient reported Redness on thighs, arms, chest, throat and face, no redness below her knee or on her trunk. Reported itching all over where there was redness. She described tingling and burning down her right arm (compared to nerve pain) and cold hands. Patient was on her way to store to pick up Benadryl, advised patient to take 50 mg of Benadryl and to report to the emergency room or call 911 if symptoms did not resolve or worsened to involve any difficulty breathing.   Called patient on 12/19 at 8:30am to follow up. Patient reports worsening symptoms overnight including developing leg cramps in calves, restless legs, chills without a fever, and a scratchy throat. Patient called family friend (ER Physician)- patient was instructed to take 60mg of prednisone, 1 tab of zyrtec, 2 tablets of magnesium. She currently reports fatigue, scratchy throate and headache with other symptoms resolving around 10pm on 12/18. Instructed patient to call on call physician at PCP office for a predisone taper prescription.
A report was received from a physician concerning a male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient started receiving a treatment with nasal FLUMIST. On an unspecified date the patient developed influenza like illness. Action taken on FLUMIST was unknown. At the time of reporting the outcome of the event of influenza like illness was unknown. According to the reporter the report was considered to be non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, limbs stiffness and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, limbs stiffness and pain in arm were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, limbs stiffness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web form. The age at vaccination was not reported. The patient received SHINGRIX early in the morning and by afternoon her arm was hurting badly and continued throughout the day. By the evening of the day of vaccination, her arm was red and swollen from the hand to the shoulder and she could hardly squeeze her fingers. The patient stated it was painful. It took nearly a week for the pain and stiffness to resolve. The symptoms occurred on her non- dominant arm. The patient consented to follow up. Unable to reach healthcare professional (HCP) for healthcare professional address, information about administration address or the patient and vaccine lot number or information.
Started with soreness in shoulder which progressed worse each month, until health provider contacted; then Orthopedic specialist; received steroid injection; no help or relief 6 months later.
Rapid heart beat, high blood pressure, chest pain, full body aches- ER visit for chest pain Nitro administered, chest ultrasound, blood work.  Full body work up
itching; redness; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus and erythema. On an unknown date, the outcome of the pruritus and erythema were recovered/resolved.   It was unknown if the reporter considered the pruritus and erythema to be related to Shingrix.   Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got her 1st Shingrix vaccine in an unknown arm.  The patient had itching and redness for over a week until it resolved. The reporter did not consent to follow-up.
Approximately 30 mins after having seasonal flu vaccine became SOB, burning throat & wheezing, runny nose. Given nebulizer to relieve symptoms & IV SOLU-MEDROL.
Onset of fever, tmax 102 in the evening on 7/20/2020. Had well child exam the same day in the morning, received vaccines. Was well at the exam. seen in the office today, fever 103.8. exam essentially negative. observing with symptomatic care at this time.
(L) Shoulder jt effusion asp 30 cc 9/6/20 re asp 9/8/20 30 cc + injection steroids  C+S neg
Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-MAR-2023 This case was reported by patient via interactive digital media. The patient got shots 2nd time and it was so painful, cost almost 400 dollars.  The patient stated that it was worth it. Follow up was not possible, as no contact details were available.
pt started crying approx 1 1/2hr p/vax & cried cont for 6hr;
Headache Body Aches Chills Fatigue Took tylenol 650mg X 1
24hrs after 1st dose, shortness of breath, hard to breathe, dry barking/bronchitis cough, sore throat, neck hurts, bad pelvic pain, lower abdominal pain,
4-27-17 Patient noticed redness, tenderness and swelling in (R) bicep area, warm to touch. Followed up with health care provider who felt it may be cellulitis, however not sure if it was related to vaccination since it was in a different area than vaccination site. Patient was prescribed 10 days of KEFLEX. 4-28-17 Patient noticed numbness in left side of body and went to ER. Medical team determined that MS, which had been in remission for 35 years, had reactivated. Patient is now being treated with strong doses of steroids and reports that she is doing better and will continue to follow up with her health care provider.
Stated itching around armpit area on same arm as injection. After going home stated that the itching stopped under the arms but moved to both legs. Suggested to take diphenhydramine.
pt recvd vax 27OCT95-devel pain, swelling, & clear blisters around inj site by 29OCT95;mom giving DPH & APAP for pain & usual comfort measures
Within few hours of vaccine, client called with complaint of fever to 101, seen in ER within about 8 hrs, was vomiting, had headache, cough (history of asthma). Was treated for dehydration with IV Tordol for headache, Zofran for nausea, cough medicine, on bedrest for 2 days.
Hospitalization for syncope, COVID + 1/1/22-1/3/22. Treated with dexamethasone, zinc daily vitamin D3 daily and vitamin C daily
This initial spontaneous case, was received on 27-Oct-2017, from a pharmacist concerning a 27-year-old, adult, female patient. This is second of 3 reports. On 05-Oct-2017, the patient was administered with FLUVIRIN (batch number: 179701P, dose: 0.5ml, route of administration: intramuscular and anatomical location: left deltoid). On 07-Oct-2017 after 3 days of vaccination, the patient had soreness in his arm. On 14-Oct-2017, the event was resolved. The reporter assessed the case as non-serious. Follow up information was received on 28-Nov-2017. Event onset date was added (07-Oct-2017). Outcome was updated from not recovered to resolved (14-Oct-2017). Narrative was amended accordingly.
Swelling. Redness. Hot sensation. Skin peeling (like a sunburn). Lasted about a week and a half.
The day after chills and a general feeling of upset stomach. Early the next morning diarrhea that lasted until the next morning. Now just a feeling of upset stomach, unsettled.
Headache, Myalgia, Fever, NauseaVomiting, CHILLS; SORE THROAT
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus.  Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
Vaccines (HPV and Quadrivalent Flu) administered 11/5/18 and 11/6/18 with 2 brief (1-2 mins) episodes of AMS with emesis. Still slightly pale and clammy.
I have a tooth filling needed to be replaced. After vaccination the pain in my tooth pain which is normally non existent went to a 10. For 2 days I couldn?t sleep or be in a prone position. 800 mg ibuprofen and Tylenol. After that back to normal. 2nd dose is scheduled tomorrow and dentist next week.
Lost of sense of taste for just less than a day (18-20 hours), but was noticeable.
Hives started on hips, then spread to stomach, then to extremities, then head. ER visit 07/01/18 at 10:00 AM--instructed to give ALLEGRA and BENADRYL cream, which did not help and hives continued to get worse. Mother initiated oral BENADRYL (1st dose given 3:30 PM). Two phone calls to ER after that- mother was told nothing more they could do and to keep giving BENADRYL. No wheezing or breathing difficulties. Doctor appointment at 9:00 AM on 07/02/2018 with physician at clinic; steroid shot given. Prednisone prescribed if more lesions noted. BENADRYL continues to be given every 4 hours. Lesions on stomach appear bruised, while lesions on back appear bright red.
DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2148) was received from a pharmacist on 21-Aug-2019. It described a female consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer was scheduled to take the last dose of Vivotif on Saturday (24-Aug-2019). However, she would be travelling to the endemic area on the same date.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete immunization one week prior to traveling" was considered as not applicable.
Death Metastatic adenocarcinoma Intertrochanteric fracture of left femur
This spontaneous report was received from a pharmacist and refers to a 28 year old patient of unknown gender with a medical history of asthma. There was no information about concomitant medications, drug reactions or allergies provided. On 31-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX (lot# K010016, expiration date 05-AUG-2015, dose, site and route of administration were not reported). The patient had not experienced any adverse effects. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # K008410, expiry date 26-FEB-2016. Temperature 12 degree centigrade for 4 hours and there was no previous excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.
A spontaneous report has been received from a Health Professional concerning a female patient. Patient relevant history, concurrent disease and concomitant drugs were not provided. On 02-Oct-2015, patient received nasal FLUMIST (intranasal), 0.2 millilitres and 2 hours later the patient mother called the office to report her son's left side of the face was swollen and he was congested. Reporter enquired to Dr. responded that she rec BENADRYL but the patient was not experiencing difficulty swallowing. The outcome of events congested and left side of the face was swollen was unknown. The reporter considered events congested and left side of the face was swollen to be non-serious.