chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left radial artery left arm blood clot; Dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4485445-00.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for hidradenitis. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PERIPHERAL ARTERY THROMBOSIS (medically significant), outcome "recovering", described as "Left radial artery left arm blood clot"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". The action taken for adalimumab was unknown.  Clinical course: on unknown dates, the patient experienced left radial artery left arm blood clot and dizzy. Moderna covid-19 vaccine (Elasomeran) and pfizer biontech covid-19 vaccine (Tozinameran) were also considered suspect. Patient was waking up in mornings and dizzy. it was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. It was reported that the non-serious dizzy with Humira (Adalimumab). there was no reported medical history.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of left radial artery left arm blood clot and dizzy was not provided. Agency's opinion is that the events of left radial artery left arm blood clot and dizzy are not assessable.  The reporter's assessment of the causal relationship of "left radial artery left arm blood clot" and "dizzy" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.
lymph nodes are swollen; the whole side of her body is very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "lymph nodes are swollen"; PAIN (non-serious), outcome "unknown", described as "the whole side of her body is very sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fluad given to patient that is 63 years and 11.5 months old. Not yet 65 years of age
On Feb 3 I experienced tiredness to a level that I had to take a half sick day from work.  From 11 am cst till next morning at 9am I had cold chills and hot flashes.  After that all adverse effects have disappeared.  On 2/3 I had a regular scheduled appointment with Dr.
Information has been received from a nurse concerning a 20 year old female patient who on 08-JAN-2007 was vaccinated with the first dose of GARDASIL (lot # 655619/1427F) 0.5 ml intramuscularly.  On 22-JAN-2008 the patient received her second dose of GARDASIL (lot # 659657/1487U) 0.5 ml intramuscularly.  On 08-JAN-2007 the patient experienced migraine headaches after the first dose.  After the second dose, the patient experienced migraine headaches again.  The patient also had the first two shots over a year apart.  As of 11-FEB-2009, the patient had not received the third dose.  The patient sought unspecified medical attention.  Additional information has been requested.
Redness at injection site; Swelling at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 8-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2018-2019 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of FluLaval Quadrivalent 2018-2019 season (intramuscular) .5 ml. On an unknown date, less than 2 weeks after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced injection site erythema and injection site swelling. The patient was treated with amoxicillin trihydrate (Amoxicillin). On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FluLaval Quadrivalent 2018-2019 season.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient received private dose of FluLaval. The patient experienced redness and swelling at injection site. No co-administration of other vaccines. The reporter stated that adverse event was a result of vaccine. The reporter denied permission to follow up. This case has been linked with case US2019AMR164466 reported by the same reporter.
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Extreme weight loss; Burning tongue; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101619191 (pfizer).  A 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Apr2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: looks like BP7534, Site: left arm), administration date: 25Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Tiredness". The following information was reported: WEIGHT DECREASED (non-serious) with onset Apr2021, outcome "not recovered", described as "Extreme weight loss"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Burning tongue"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea". The events "extreme weight loss", "burning tongue" and "nausea" were evaluated at the physician office visit.  Additional information: No additional vaccines administered on same date of the Pfizer suspect. The events result in physician office visit. The patient did not receive any other vaccinations within four weeks prior to the first  administration date of the suspect vaccine. Caller stated that his "sister took the vaccine maybe 2 months ago (second dose), maybe 3-4 months ago, no actually 4 months ago". Caller said that they've "notice significant changes like extreme weight loss, burning tongue. several, different, tired all kind of crazy stuffs that we think are related." Caller is asking if we can help and what to do. Caller mentioned " can send her somewhere to lab that we can get tested out to any relation on what's going on, where do you want me to tell my sister to go so you can all test her and see what's goin on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild soreness around the injection site that started the morning after the injection.; This is a spontaneous report received from a contactable consumer (patient).   A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and gastroesophageal reflux disease (GERD) from unknown dates. The patient had a history of allergies to sulfa-based antibiotics from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 08:00, the patient experienced mild soreness around the injection site that started the morning after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of mild soreness around the injection site that started the morning after the injection was resolving.   No follow-up attempts are needed. No further information is expected.
Pt recvd 1 dose of Engerix-B & 6JUL92 exp difficulty breathing; 7JUL92 also exp exertion on standing, tightness of breath, substernal pain, h/a, dizziness, felt faint & was unable to work; seen in ER; lungs were checked, & EKG was neg;
My period was regular and lasted 5-7 days (although heavy) before the vaccine. The first period after the vaccine, my period lasted 3 weeks with 10-12 days being so heavy that I bled through multiple outfits a day even while using heavy duty pads and changing them every time I used the bathroom.
Not 100 percent it was vaccine but unknown reason for what happened has lead me to report to be safe.  I noticed arthralgia in my wrist joints first. Then with a 6 hour period the swelling in right wrist and left knee became so bad I couldn't use my hand or walk. High dose steroids has helped allievate symptoms but also had high WBC and other CBC flags.
Breaking out all over / face; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Breaking out all over / face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Breaking out all over / face). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Breaking out all over / face) outcome was unknown.            Treatment Antibiotic Topical treatment   This case was linked to MOD-2021-162048 (Patient Link).   Reporter did not allow further contact
Patient received H1N1 vaccine on 11/25/9 per father. Pt face on left side became paralyzed Dec 6, 2009. Today is 1st time patient seen by provider since onset of paralysis. Vaccine given by State Health Department at school. Dx: Bell's palsy.
Received 3 immunizations in the left thigh, which is tender to the touch, red, warm and swollen. Patient is afebrile.
Myalgia, Fever, Woke up with fever, chills, tiredness Narrative:
3/16 Morning after vaccination noted red dot and itching left upper arm. 3/17 10 am Left upper arm warm, red, swollen to elbow denies pain or itching. 3/18 8:30 am - warm, red, swelling continues to sl. below elbow, 3/22-11 9:30 am - swelling, redness resolved.
Back upper left arm has been red, swollen and very painful in area that received the Varicella vaccine.  Went to clinic and seen by NP on 4-19-22.  States vaccine wasn't given deep enough and prescribed Cephalexin 500mg bid x 10 days. States no difference noted and states  area burns.   Patient also received Hepatitis B pediatric dose in error.  Received 0.5 ml in Right Deltoid and received 0.5 ml in Left Deltoid when nurse realized had only given half of the required dose due to not administering an adult dose.   Complaint of pain and swelling was not noted in either arm in the  area that Hepatitis B vaccine was administered.
24 after vaccine local swelling, redness, and tenderness. Symptoms began 2 hr after having IM injection.
Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is day 5, I believe it is swollen lymph nodes. If not better I will go to Dr next week
Patient received the Tdap and Menveo vaccines, then mother request to get the Bexsero also. The Bexsero was then administered and patient immediately had a vasovagal syncope episode. She was out for a few seconds and then woke up. She was pale, clammy, and nauseated. We monitored her vitals while she drank some water and juice, then ate some cookies. Patient reported she had not had much to eat or drink beforehand. Within 30-40 min, she walked out of the clinic feeling back to normal.
This spontaneous report as received from a licensed practical nurse (L.P.N) refers to a patient of unknown age. On 10-MAY-2013 the patient was vaccinated with COMVAX (lot # 1513AA, expiry date 06-MAY-2013) (intramuscular, 0.5 ml, strength not reported). It was reported that the patient was inadvertently administered COMVAX that had expired on 06-MAY-2013. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
At 5:30am on 2/03/12 awoke fussy, with temp 101.3, began shaking in Dad's arms, generalized seizure activity lasted over 20 minutes (as long as 30 min) given IM VERSED by ambulance personnel and brought to ER. CBC, electrolytes, blood culture, urine culture, CXR normal no further seizures/seizure activity.
Information has been received from a licensed practical nurse concerning a currently 21 year old female patient with no medical history and no allergies who on 11-AUG-1983, at 15 months of age, was vaccinated with a first dose of MMR II (lot # not reported - unavailable). On 15-DEC-1993 the patient was vaccinated witha  second dose of MMR II (second generation) (lot# not reported-unavailable) and it was reported that the patient had a cold at the time of that vaccination. Concomitant therapy reported be birth control. It was initially reported that the patient experienced a 'fine red rash after the vaccination." Follow up information reported that as a child the patient had a rash after receiving the first dose of MMR II (second generation). The patient's mother felt the rash was from a viral illness. It was reported that the rash resolved. laboratory evaulation on 27-AUG-2001 revealed a titer that was positive for Rubella and Rubeola. Mumps was not checked. Laboratory evaluation on 21-APR-2003 revealed that 'mumps antibodies Igg-negative." Treatment for the negative mumps titer was vaccination subcutaneously on 08-MAY-2003 with a dose of MMR II (second generation) (lot# 644708/1125B). It was reported that the patient tolerated the vaccination on 08-MAY-2003 without any difficulties. Follow-up information reported that the patient was recovered.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (lowest recorded temperature) for 468 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
cold; high fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and PYREXIA (high fever) in a female 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 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 NASOPHARYNGITIS (cold) and PYREXIA (high fever). At the time of the report, NASOPHARYNGITIS (cold) and PYREXIA (high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 100.3F.         No concomitant medications reported.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L017757 with expiration date of 08-APR-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 8 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002718: US-009507513-1708USA005078.
Information has been received from a 30 year old female Licensed Practical Nurse who on 07-AUG-2007 was in the process of administering Zostavax (Oka/Merck) (Lot #658081/0743U) when the needle fell off and the vaccine squirted into her eyes.  There was no concomitant medication.  She rinsed out her eyes and she reported having a headache since the accident.  As of 07-AUG-2007, the patient had not recovered from her headache.  Additional information has been requested.
Redness, swelling, warmth, soreness. Physician's assistant saw patient and diagnosed infection, prescribed antibiotic.
Sore arm; Fatigue; mild headache; worsening of existing eye symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, FATIGUE, HEADACHE, and EYE SYMPTOM in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0403214 and 0183214) for COVID-19 vaccination.     The patient's past medical history included Vision abnormal since an unknown date.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-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 MYALGIA, FATIGUE, HEADACHE, and EYE SYMPTOM. At the time of the report, MYALGIA, FATIGUE, HEADACHE, and EYE SYMPTOM outcome was unknown. Not Provided.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient reported that he had some vision problem in the past and does the vaccination have anything to do with the worsening of the existing eye symptoms.  No concomitant medications were provided.    No treatments medications were provided.   This case was linked to US-MODERNATX, INC MOD-2021-080482. Sender's Comments:  US-MODERNATX, INC MOD-2021-080482: 1st dose of vaccine.
Muscle or body aches  Headache  Sore throat  4/22/2021Hospital Course   G2 P1001 admitted for scheduled Repeat LTC/D and Bilateral salpingectomies. +GDMA2 on Metformun + Insulin +CHTN on Labetalol 100mg po bid with superimposed preeclampsia w/o severe features Uncomplicated surgery and recovery
Painful and itchy hives on multiple places of body after booster that doesn't seem to go away; Painful and itchy hives on multiple places of body after booster that doesn't seem to go away; Painful and itchy hives on multiple places of body after booster that doesn't seem to go away; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away), PRURITUS (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) and PAIN (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away), PRURITUS (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) and PAIN (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away). The patient was treated with LORATADINE (CLARITINE) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away), PRURITUS (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) and PAIN (Painful and itchy hives on multiple places of body after booster that doesn't seem to go away) had not resolved.            No Concomitant product use was reported.  The patient stated that they received the booster shot on 07-Dec-2021 and then last week, hives started coming up on multiple places of the body and they were painful and itchy, and they don't seem to go away.  The patient went and talked to their healthcare provider who wasn't aware of these cases of hives and they first thought the patient had the COVID arm, but this seemed to be more than that as the hives were spreading across the body parts. After talking to their healthcare provider last Friday on 24-Dec-2021, the patient was advised to take Claritin, but it doesn't seem to take effect.   This case was linked to MOD-2021-427701, MOD-2021-427771 (Patient Link).
I received the injection in my shoulder joint and immediately I knew something was wrong. It was not in the deltoid and was extremely painful. It felt like someone was shoving a pencil in my arm. Since then, I have experienced a loss of ROM and severe pain (all over my upper arm constantly with a shooting pain if I try to move my arm). I am in extreme pain and still cannot move my arm.  I have tried doing some range of motion exercises, but it is not helping. The pain is keeping me from sleeping and working. I went to my primary care doctor and they said the symptoms would go away in a week, but I am very worried that it would be a SIRVA issue.