chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a 24 year old male patient. The patient did not have any concurrent condition, medical history, concomitant medication, drug reaction or allergy. On 14-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (strength, dose, lot number and expiration date were not reported); on 01-SEP-2016 and on 31-MAR-2017, the patient received the second and the third dose of the hpv GARDASIL 9 (both with a Lot # reported as lot M014929 and expiration date of 27-MAY-2017) intramuscular, in the left deltoid area (strength and dose were not reported) all of them for prevention of human papillomavirus (HPV). On 31-MAR-2017 (also reported as 30-MAR-2017), the patient experienced mild injection site pain at the time of the administration of the third dose of GARDASIL 9. On 10-APR-2017, the patient visited the physician because he had severe left shoulder pain, which was further described as "radicular pain radiating to the left thumb and forefinger," as a result, the patient was unable to elevate or abduct his left arm away from his body. Upon examination, the physician noted that the patient had a weakened rotator cuff and atrophy of the deltoid muscle. The physician stated that the arm pain and inability to move the arm were from a "recent onset", but due to the degree of the deltoid atrophy that he observed, the physician suspected that the atrophy started to occur 2 weeks ago, soon after the administration of the third dose of GARDASIL 9. As a result of those symptoms, the physician reported that he suspected a C5-C6 brachioplexopathy and a brachial neuritis. The physician placed to the patient's arm in a sling and it was considered to start the patient on high-dose of corticosteroids. No laboratories or studies were performed.  Additionally, the physician reported that he had seen brachial neuritis commonly in other unspecified patients after the administration of other unspecified vaccines, including an unspecified influenza vaccine. No additional information provided regarding those other unspecified patients. At the time of reporting the patient had not recovered from vaccination site pain, rotator cuff syndrome, atrophy of the deltoid muscle, C5-C6 brachioplexopathy and brachial neuritis. The reporter considered the events to be significant disability or incapacity. The causal relationship between all the events and the suspect vaccine was not reported. Additional information has been requested.
Diagnosed with PMR; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed with PMR) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Diagnosed with PMR). At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed with PMR) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-529262, MOD-2022-529267 (Patient Link).   Reporter did not allow further contact
Pt came to clinic to receive his 2nd dose of the Pfizer vaccine. He received the dose in his left deltoid however when the plunger was pushed the vaccine squirted out of the syringe and down the recipients arm. The needle may not have been screwed tight enough on the preassembled syringe.  CDC Covid19 Administration Errors and Deviations reviewed. Vaccinator was unable to determine how much vaccine actually went into the pt's arm. Recipient and vaccinator thought less than half of the dose made it into the arm. Per CDC pt was revaccinated in the right deltoid.
Left arm stiffness could not lift; Left arm stiffness could not lift; Bad reaction to covid shot; Vaccination site induration; Chest pain; Neck pain; Back pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced BACK PAIN (Back pain), CHEST PAIN (Chest pain) and NECK PAIN (Neck pain). In August 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift), IMMUNISATION REACTION (Bad reaction to covid shot) and VACCINATION SITE INDURATION (Vaccination site induration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In 2021, BACK PAIN (Back pain), CHEST PAIN (Chest pain) and NECK PAIN (Neck pain) had resolved. In August 2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift), IMMUNISATION REACTION (Bad reaction to covid shot) and VACCINATION SITE INDURATION (Vaccination site induration) had resolved.            No concomitant medications were reported.  On 01-AUG-2021, the patient received Booster dose/ 3rd dose of Moderna vaccine.  Reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Report called in to agency by mother: Child received a dose of MMR vaccine and a dose of mumps vaccine 2-3 weeks apart (both given 11/2003); one dose given in one foreign country and the other in another foreign country. Child diagnosed with brain tumor (anaplastic arthrocytoma grade 3) on 5/2009. Mother believes brain tumor may be associated with receipt of 2 doses of MMR vaccine at an interval of <28 days. Child is still alive.
fatigue; headache; body aches; fever; This is a spontaneous report from a contactable consumer (patient herself).  A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: unknown), via an unspecified route of administration on 10Feb2021 08:15 (at age of 44-year-old) at single dose in left arm for COVID-19 immunisation. Medical history includes diabetes mellitus. There was no known allergies. No other vaccine was received in four weeks. Concomitant medication included empagliflozin (JARDIANCE), metformin for diabetes, semaglutide (OZEMPIC), atorvastatin (LIPITOR), sertraline. The patient experienced fatigue,  headache, body aches, and fever on 10Feb2021 14:00. No treatment was received for the events. There was no COVID prior vaccination or no COVID  tested post vaccination. The events did not result in emergency room visit or physician office visit. The outcome of events was resolving.  Information on the lot/batch number has been requested.
The patient's spouse stated that they experienced extreme flu-like symptoms, including chills, malaise and muscle aches. It lasted only one day, but the spouse says that it kept them in bed for the day.
Narrative:  83 yo male with PMHx of esophageal cancer (SCC) with extension to larynx s/p IMRT and chemotherapy, CHF, OSA, HTN, HLD, DM, h/o depression, h/o migraines, CKD stage 3a, Non-ischemic Cardiomyopathy with decreased ejection fraction, hypertriglyceridemia, BPH, and prosthetic left eye. Patient was previously receiving Hospice care. Per medical record patient passed away inpatient at MC. Death was caused by respiratory and cardiac arrest related to esophageal SCC and debility plus related acute renal failure. Vaccines do not seem to be related to event.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-OCT-2013 at 17:30, ZOSTAVAX lot # J004268 was exposed to -14C for an estimated total time out of range of 10.0 hours. On 25-OCT-2013 at 18:30, ZOSTAVAX lot # J004268 was exposed to an exact T not recorded but noted as equal to or >12 C for an estimated total time out of range of 10.5 hours. On 28-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J004268, Exp. Date: 12-JUL-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Dizziness light headed and dizziness Narrative:  c/o lightheadedness and dizziness after 2nd vaccine. Dizziness and headache lasted until 2/23/21. Stated she took off from work 2 days. Called by clinic on 2/23/21. States headache is resolved, per phone update 2/23/21.
The events I experienced, I had heart palpitations and fluttering. I was send in to a walk in clinic they did an EKG I had AfIb,  and then they sent to an emergency room. I was a referred to a cardiologist  for more testing.
This case was reported by a healthcare professional via other manufacturer sales representative and described the occurrence of injection site rash in a child female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  On 15 December 2008, the subject received 1st dose of HAVRIX (unknown, left thigh).  At an unspecified time after vaccination with HAVRIX, the subject experienced injection site rash.  The subject was treated with steroids.  At the time of reporting the event was resolved.  The nurse in the office reported to a sales representative (Merck) that a subject had an injection site reaction after vaccination with a vaccine manufactured by GSK.  The subject developed a rash over injection site of her left thigh.  She was prescribed topical steroids.
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration in left arm on 31Jul2017 13:00 at 0.5 ml single for dr. recommended. She received the vaccine at Physician Office. No additional vaccine was administered on same date. Medical history included colon cancer from 2009 and got blockages because of the adhesions in her stomach and was in the hospital 3 weeks prior to getting the shot, compromised immune system, urinary tract infection. There was no family medical history relevant to AE. Prior vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient experienced very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills on 02Aug2017, fell twice while getting up, scratched her arm when she fell, bruising, didn't remember a lot from the past 2 weeks on an unspecified date. She stated that she had the worst reaction and thought she was dying. She was so sick and couldn't bring herself to go to the hospital. She stated she didn't remember a lot from the past 2 weeks. She said she fell twice. She scratched her arm when she fell. She hit the side of her dresser. She has bruising as well. She had a history of colon cancer and got blockages because of the adhesions in her stomach. She questioned her doctor before she took it the shot. She called him after she got the shot and he told her to take MOTRIN and BENADRYL. She started taking Cephalexin 500mg four times a day for a urinary tract infection on 02Aug2017. She would like to know if this medication and the shot were contraindicated for each other. She didn't take relevant tests. She was too weak to visit Emergency Room. On 14Aug2017 (yesterday) was the first day that she felt like getting up and going to the living room. She had an appointment with Doctor on 15Aug2017. The outcome of events very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills was recovering, outcome of other events was unknown.
INJECTION SITE PAIN & REDNESS, ARM PAIN. TIREDNESS, HEADACHES, MUSCLE + JOINT PAIN. CHILLS, FEVOR, NAUSEA, VOMITING, FEELING OFF/UNWELL.
TM was supposed to receive dose # 2 of Moderna COVID 19 vaccination.  Inadvertently rec'd Pfizer COVID 19 vaccination during visit. TM remains asymptomatic day 2 ( today) after receiving.
Initially Left shoulder pain followed by left shoulder stiffness and weakness. Limited range of motion of left shoulder joint and strength is 4/5 of the left deltoid. No rash or swelling at the joint or injection site. Treating with exercising the joint. May need orthopedic referral if no improvement.
within 15 mins, started burping weirdly, about 6 hours later, could hardly breathe, both symptoms were taking turns recurring
pt recv vax 29AUG94 & 30AUG94  pt exp a non-specific rash @ the inj site & on his face;
Fever of 101.3, joint pain throughout body, pain in kidney area, severe headache; Joint pain throughout body; Pain in kidney area; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 14Apr2021 at 11:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN) all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 17Mar2021 at 11:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 03:00, the patient experienced fever of 101.3, joint pain throughout body, pain in kidney area and severe headache and on the same day, the patient underwent body temperature test and the result was 101.3 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fever of 101.3, joint pain throughout body, pain in kidney area and severe headache was recovered on unknown date on Apr2021.   No follow-up attempts are needed. No further information is expected.
Swelling at site of injection, fatigue, nausea, fever, pain at site of injection, neck pain.
Client given MMR & Varicella vaccine on 3/12/13. Started with severe itching on 3/13 and got progressively worse with hives. Went to ER on Monday 3-18-13. Advised it may be allergic reaction. Rx BENADRYL.
Second hematoma in eye; hematoma; This is a spontaneous report received from a contactable consumer (reporting on herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration in Arm Right 05May202115:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing arthralgia. The patient's concomitant medications were not reported. Previously patient received Tetanus Vaccine and experienced sore arm in 2016 or 2017. Patinet received the first dose of the Pfizer Covid 19 vaccine on 5May2021 and developed a hematoma in the right eye 3 days later on 08May2021.  A few days later she developed a second hematoma in the right eye on 12May2021. Her vision has not been effected. she was concerned that this may happen somewhere else in her body if she gets the next dose. patinet at risk of it just causing more kinds of things like that if she get the second dose. Patient saying it called a subconjunctival hemorrhage- its kind of like a bleeding disorder right. Asking If she miss her dose do we have a certain window that we can get the second dose. She wants to know if someone can give her some guidance.  She was hesitant to get the second shot. States it was like a vessel on the white part of her eye burst.  States it did not effect her eye sight. States she didn't think much of it, but then her sister got the Covid shot and also developed a hematoma in her eye. Patinet states she was wondering why they had the same reaction. She was supposed to be going to get her second shot but was concerned if this was something that could happen somewhere else in her body. Outcome of the events were recovering.    Information on batch/Lot number was obtained. Further information has been requested.
Get the vaccine. Mine had expired; got shingles / Suspected vaccination failure; got shingles; nerve damage; pain that never ends; Get the vaccine. Mine had expired; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get the vaccine. Mine had expired; got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles), nerve damage (Verbatim: nerve damage), pain (Verbatim: pain that never ends) and expired vaccine used (Verbatim: Get the vaccine. Mine had expired). The outcome of the vaccination failure and expired vaccine used were unknown and the outcome of the shingles, nerve damage and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2023 This case was reported by the patient via interactive digital media. The reporter reported got the vaccine as his/her vaccine had expired and got shingles now had nerve damage with pain that never ends. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
I experienced menstrual spotting outside of my menstrual cycle for about a week after I received this vaccine.   After determining that many other women receiving a COVID vaccine experiencing this I was advised I should report this event.
trouble with our voice/couldn't hit high notes/could no longer speak in a high tone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "trouble with our voice/couldn't hit high notes/could no longer speak in a high tone".  Additional information: Reporter seriousness for trouble with our voice was unspecified  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021756268 same reporter/drug/AE, different patient.
12/30/2021 presents to ED for "shortness of breath". PMHx of "anxiety, diabetes, coronary artery disease, bronchiectasis"
Child screaming unconsolably for 1 hour and then would not bear weight but had normal exam.
10 minutes after receiving his vaccination, he developed lightheadedness. He was taken to a private section of the arena and monitored.
Severe local reaction including redness, warmth, severe itching, hives (localized).  Continued through 7/2/08.  Treated with Keflex, Prednisone and local treatment.
She c/o dizziness about 5 minutes after vaccination, skin was pale, diaphoretic. She also c/o "not being able to see," for a few seconds. She was brought to observation area, allowed to lie down on cot, vital signs taken, wnl. She was observed for 30 minutes, left with parent.
Hives and welts not controlled with Benadryl Cream or oral tabs. Went to ER as spread was significant and had IV solumedrol. Hives  led up. Within an hour of discharge they started coming back and were not controlled with Benadryl still. Hives were apprearing in new locations and spreading rapidly again. Went back to ER for further treatment.
Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (she was diagnosed with lymphoma in perhaps in February2021/March 2021.) since 2021.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK AND BODY) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) outcome was unknown.            Concomitant medications not reported by the reporter.   This case was linked to MOD-2021-357742 (Patient Link).
About 1-2 weeks after vaccination, itchy skin lesions started to appear on my lower back and legs. Itching subsided after dermatologist prescribed topical creme. But the marks still remain as dark spots all over lower back
Death on 2/8/2021 unknown signs and symptoms at time of death; multiple co-morbidities
i am a heart patient with an implanted defibrillator, It had never fired in 8 years, 36 hours later at 1:33 a.m. it fired because my heart beat had elevated to 300 beats per minute. Since that event my heart has been in atrial flutter continuously. I am now scheduled for an ablation procedure to hopefully return my heart to normal rhythm. I am confident the heart event was a result of receiving the Moderna vaccine.
It was her 2nd dose, and she said her throat was itchy and she was having a difficult time swallowing. No nausea or vomitting, no cough or hives or redness at the site. Just subjective stated she had a hard time breathing and swallowing. When asked for history of anxiety she did say yes. This happened maybe after 20-25 minutes of receiving the vaccine.  While on the phone with EMT, we informed them we would use an epipen and they were aware. Once they arrived, they found no signs of anaphylaxis but still took her to the emergency room.
sx dizziness, nausea, blurred vision, h/a;cont to worsen throughout day;crushing chest pain, numbness, feelings of being very cold then passed out;amb called;upon arrival pt appeared pale & pulseless;CPR started;dx as Coronary Artery Spasm