chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case : 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
Red swollen welt around vaccination site radiating pain in neck and shoulder. Visibly swollen, sore axillary lymph nodes in same side arm only. Headache, achiness.
No Adverse event; temperature excursions; 2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 year old patient reeived MODERNA COVID-19 VACCINE, BIVALENT).    Concomitant medications were not reported.  The 5 patients were administered with the Moderna Covid 19 vaccine after these vaccines had surfer multiple temperature excursions. The case is for the 4th patient out of 5 patients. Treatment medications were not reported.
got sick as hell; Initial information was received on 30-Nov-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory Authority (under reference number - US-SA-SAC20211206000078)..  This case involves Adult and unknown gender patient who experienced got sick as hell (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got sick as hell (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
shingles; Information has been received regarding a case in litigation from a lawyer and the pt on 02-OCT-2020, referring to a 65 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On November 2018, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown). The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: shingles on an unknown date in December 2018, that was permanent and lasting in nature. The outcome of shingles was reported as not resolved. The causality assessment between shingles with zoster vaccine live (ZOSTAVAX) was reported as related.  The adverse event of shingles was considered a disabled event.
Was diagnosed with a one of the best neurosurgeons/know of two people that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2023, outcome "unknown", described as "Was diagnosed with a one of the best neurosurgeons/know of two people that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis". The event "was diagnosed with a one of the best neurosurgeons/know of two people that that have recently got it that have been diagnosed with it after they received the covid shot/myasthenia gravis" required physician office visit. Clinical course: reporter mentioned that she knew her twin brother knew the patient that that had recently got it that had been diagnosed with it after receiving the COVID shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201185389 same reporter/product, different patient/events.;US-PFIZER INC-PV202300186627 same reporter/product/event, different patient;US-PFIZER INC-PV202300186632 same reporter/product/event, different patient;
Pt reported feeling pain and seeing redness right after the IMZ was given, as the day progressed the area became warm and swollen. That evening pt's arm was red, hard, swollen and a bruise was beginning to form. Pt could not sleep on that side. The bruise grew to approx 1 inch below shoulder to 1 inch above elbow. The arm stayed red, hard and swollen. The pt reports that the redness & hardness went down after 2 days. She came into the pharmacy to report this on day 5, she still had minor swelling in the arm and the bruise was turning green and yellow but was still very large. Pt was concerned she was having an allergic rxn to the bandage we used for the IMZ. I told her I wasn't sure that was what happened but I would file a report and investigate her concerns.
Information has been received from a medial assistant concerning a 4 year old male who received the second dose of MMR II (rHA) (Lot # 655380/1326F), 0.5 ml SQ on 04-Aug-2008. The patient received his first dose of MMR II on 02-Sep-2005. On 06-Aug-2008, the patient developed cellulitis. The patient was seen on 07-Aug-2008 and was prescribed AUGMENTIN. The patient had an appointment today but did not show up for the follow-up. It is reported that the patient is recovering from the event. Unspecified medical attention was sought. No product quality complaint was involved. A lot check has been requested. Lot check results for 655380/1326F: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
Injection site erythema and swelling and soreness staring approx. 18 hours post injection.  Ice applied to site on day 1 and 2 post injection.  Swelling and pain decreased by day 3 though a knot remained.  Erythema had significantly diminished by day 6 and remains presently.    The erythema returned along with the knot approx. the size of a large grape on the evening of day 7.  Area is warm to the touch and intermittently itching.   Area of erythema is approx. the size of a half dollar coin.  No soreness at site at this time.
This is a spontaneous report from a contactable consumer (patient, self-reported). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after her first dose of the vaccine, she had arm soreness, tired, chills, fever, body aches and pain for 2-3 days and then went away. The patient also received the second dose of vaccine on Friday morning and at evening she reported that she had a sore arm, nausea and feeling tired. On Saturday and Sunday, she reported that she was feeling tired and dizzy. Today, she was no longer tired but still had dizziness. There was no information about blood pressure changes as a side effect. Outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician assistant referring to female patient in her late 30's. The patient's had no pertinent medical history. In approximately November 2015, reported as month ago, the patient was vaccinated with VARIVAX (Merck), I shot (strength, dose, route, lot number and expiration date were not provided). Concomitant medications were not reported. On an unspecified date, in November 2015, after 7 to 10 days of vaccination the patient experienced herpes zoster, reported as shingles. Patient sought medical attention and she was treated with antivirals. The patient recovered with no longer effects on an unspecified date. At the time of the report, relatedness between herpes zoster, reported as shingles and vaccination with VARIVAX (Merck) was not provided. Additional information is not expected as no contact information from the physician was given.
Patient's mother called the office stating patient's arm was swollen. Denied redness or rash.
pt recv vax 9DEC97 & 10DEC97 1 day p/vax pt devel elevated liver function tests, clay colored bowel movements & colored urine;dx allerg rxn to vax causing extensive itching & scaling over body;
Received the flu shot on 10/7.  The shot itself hurt much more than a normal flu shot I've had in the past.  For the next 5 days, I was not able to raise my arm beyond shoulder height without significant pain.  On 10/12 I noticed my shoulder felt a bit better but since then, the pain has not changed and even though I have full range of motion, it hurts at any movement above 90 degrees and any front and back motion. Went to my PCP on 10/19 due to the sustained pain.  My PCP diagnosed with me rotator cuff tendonitis and prescribed an anti-inflammatory medication to take for 14 days.  She also suggested Physical Therapy.
Patient states: Beginning in afternoon of 12/7/09, 2 red spots then a speckled reddened area developed on the underside of the right arm from the wrist to 3/4 of the way to the elbow. Area is itching and warm to touch - "texture of eczema" per patient. Took ZYRTIC, BENADRYL and prescription cream.
Information has been received from a physician concerning a 2 month old female who was vaccinated with an oral first dose of Rotateq vaccine (human-bovine). Subsequently the patient vomited. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt presented to medical staff after complaints of mild itching and chills after covid 19 vaccine. She complains of itching and tingling feeling on bilateral lower extremities. Her vitals are within normal limits 118/81, HR 91, spO2 96%, RR 18. She was given orange juice. Her symptoms are minimal and not progressing.
Took the shingles shot, got shingles after 3 years/Suspected vaccination failure; Got shingles; This 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the he/she received Shingles vaccine and they told him/her that it would be last for 5 years. The patient stated that he/she experienced Shingles after 3 years of receiving shingles vaccine. The patient reported that the medical business was fallen considerably just because of that they said we should take the vaccine and it did not guarantee it would work and he/she was a living proof. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Lymph node inflammation above left clavicle (painful). Pain & swelling at injection site.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 30-MAR-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at his primary care physician's office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately April 2016 [reported as "shortly after" receiving the ZOSTAVAX], the patient began to experience tingling and numbness, accompanied by burning, originating in his hands and radiating outward thereafter. Shortly thereafter, the patient developed a painful rash and blisters on his upper back and shoulders. On or about 13-APR-2016, the patient presented to his primary care physician, and was diagnosed as suffering from shingles. It was planned that the patient would follow-up with a neurologist. The patient presented to a neurologist (exact date not provided), who performed an electromyogram/nerve conduction study (EMG/NCS) which indicated nerve damage. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This 79   year old  female received the Covid shot on  2/18   and went to the ED on  2/26  and was admitted  on 2/26 with chest pain and abdominal pain and again to the ED on 3/14 and admitted on 3/14 with hyperkalemia, acute renal injury, chest pain and died on 05/04/21 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
1.5 inches below puncture are swelled, turned red, temp at swelling site 102.5. Blood pressure spiked to 187/110. Severe chest pain that subsided after laying down 5 minutes. BP dropped to 162/90 but would not go down.
At 9pm on the day vaccine was given patient experienced severe pain in L arm, headache & nausea.  She also had pain & numbness the next day so she contacted me & her physician.  When the doctor called her back the next day, the pain had subsided & doctor told her less than 10% of patients get nausea from vaccine.
Information has been received from a physician and a licensed practical nurse concerning a 62 year old female patient with ibuprofen and penicillin allergy and a history of meningitis viral in 1982 who on 30-DEC-2008 was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX (lot # 663012/1163X). Concomitant therapy included "10-12 medications". The patient received PNEUMOVAX in the past with no reactions. On 30-DEC-2008 the patient experienced itching, pain and slight rash at the injection site (left deltoid). The patient sought medical attention by phone. At the time of reporting the patient was recovering. This is one of three reports received from the same source. Additional information has been requested.
I noticed that I felt tired one day. I have the ability to take an EKG on my phone, so I did, and it was abnormal. this went on for several hours and then normalized. I went out in the yard to do some yard work and it happened again and then it normalized again. I went to the doctor, and they did an EKG there and it showed up again there. Then, on 4/8/23, I tested positive for COVID-19. I had a cough, congestion, and chills. I contacted my doctor and was prescribed Paxlovid. I am still dealing with these symptoms at this time.
Numerous papules scattered throughout body, mainly on trunk; also on arms, legs, face and feet.
Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old male patient who received a single dose of vaccine FLUZONE QUADRIVALENT (lot number not reported) via unknown route in unknown administration site on 10-Dec-2018. It was reported that the Visiting Specialist Pediatric Clinic drew up the vaccine from the single dose vial on 03dec2018 and put it back into the fridge until administration. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Overwhelming feeling of a sudden rush of warmness; Frequent Chills; Extreme exhaustion; Jittery
Fever of 102F going upto 105F. Treated with Tylenol 500mg every 6 hrs  and Motrin 400mg 2 doses 8 hrs
Employee reported dizziness that started approx. 15 min. after receiving the flu vaccine.  She rated the severity of dizziness as a 7 on scale of 1-10.  The employee was seen in the ED department and prescribed Antivert.  Currently she is still dizzy, 24 hrs later, and continues to take the Antivert as prescribed.  She reports treatment has decreased the dizziness from a 7 to a 2 on scale of 1-10.  The employee also has a knot about the size of a quarter and warmth at the injection site, no redness.  The employee also reports achy joints the day after the vaccination.
DTAP was ordered, TDAP was mistakenly given.  Patient did not have any adverse reaction. Physician was notified.
Fever if 104.2 the morning of April 12. Full body aches and sharp pains.
Tdap and MCV4 vaccine given in (L) arm on 8/3/15-mother came in with child on 8/4/15-(L) deltoid area red and very swollen-seen in urgent care prescribed medication.
No side effects until third day. Then migraines, tiredness, dizziness, nausea.
The patient experience cholestasis 4 days after receiving the vaccine. They had itching on their hands and when they went in they bile levels were 3 times normal and had elevated liver enzymes. They were induced by the doctors to protect the pregnancy.