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 PROQUAD (Lot #: N021728, Exp Date: 06-FEB-2019) (Lot#: N022972, Exp Date: 19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-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 MERCK STERILE DILUENT (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-009507513-1805USA006787: 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-009507513-1805USA009919: 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.
I began feeling extreme pain, nausea, fatigue and headache within a few hours of the shot.  The joint pain and fatigue increased and has persisted as of Monday (day 5 following first dose) becoming extreme at times.  I have severe headache on and off.  I threw up 2x a day from Thursday-Sunday.  My lips began tingling on and off on Wednesday evening April 7 and that has continued ever since.  I have also had tingling in my extremities especially my legs and feet, but also my left hand.   Fatigue has not improved and as of today, I began to get worse (onset of chills and fever as of 4/12).
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th May 2019, the patient received the 2nd dose of Shingles vaccine. In May 2019, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patients husband. The age at vaccination was not reported. On 13th May 2019 yesterday from the reporting date, the patient had 2nd dose of Shingles vaccine. The patient was having a common side effects. The patients husband inquired, how long does the side effects last after the injection. This case has been linked with the case US2019AMR096010, reported for patient's husband.
No adverse event; most recent dose of the vaccine she received was a pediatric presentation of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS7164B, 038A22A, 004F21A, 040A21A and 039K20-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine).    Concomitant medications details were not reported by the reporter.  Reporter stated that has not reported any symptoms with those most recent dose. No additional doses, medications or treatments have been administered in response to the event.
temperature excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # 1637648, expiration date 19-JUN-2022 (anatomical location and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 14.7 degrees Celsius for 19 hours and 14 minutes.  Data logger was involved. There were no previous excursions reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA004766:
Treatment of COVID-19; Treatment of COVID-19; Comirnaty Dose Number 5 / Moderna Dose Number 4; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Autoimmune small vessel vasculitis" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; XELJANZ; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [VITAMIN D NOS]; VITAMIN B12 NOS.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Comirnaty Dose Number 5 / Moderna Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Positive, notes: Paxlovid started on day 1 of positive test; (29Nov2022) Negative, notes: Negative test with significant symptom improvement on day 8 after starting paxlovid; (03Dec2022) Positive, notes: Return of symptoms with positive test day 12 after starting paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Paxlovid rebound: Paxlovid started on day 1 of positive test. Negative test with significant symptom improvement on day 8 after starting paxlovid. Return of symptoms with positive test day 12 after starting paxlovid (7 days after completing 5-day course of paxlovid). Paxlovid treatment start from 21Nov2022 to 26Nov2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Had erythematous maculo-papular rash that began 3 days after the injections, on both thighs and arms. The rash worsened over the next 17 days and th macules have coalesced into patches. The maculo-papular rash spread to lower extremities and onto the dorsum of both feet.
Vaccine administered by RN, patient without any symptoms for several minutes, RN left room, then MD was called in by mom and per MD chart note :  "Mother called out from room after patient received HPV and flu vaccine.  Upon entering room, patient noted to have full body convulsions with loss of consciousness.  Patient also lost bladder control.  Episode lasted ~30 seconds from time I walked in room.  Patient became alert without intervention.  AAO x 3 immediately after event.  Color appeared normal.  RN and MA in room and monitored patient as documented below.  I reviewed with mother that syncope is a rather common occurrence after vaccines at this age.  I suspect patient had a hypoxic seizure.  I reassured that this should not lead to any future seizure activity or long term sequelae.
Headache, sore throat, chills, body aches, diarrhea. About 12 hours duration.
It started as a horrible cough with headache, sinus pain and brain fog. My mind was not working very well. I had no shortness of breath, but I did have fever, fatigue, and congestion. I had some change in my taste as well. I had no go at all. The coughing started the night before and I tested myself for COVID-19 on the side of the road and it was positive. They recommended that I take Paxlovid. My symptoms began improving on day 2 and by day 3 when I started the Paxlovid I was getting better. The thing that lingered is fatigue and a lingering cough, but I feel like I am back to normal.
Patient complained of left arm hurting after receiving  Hep A vaccine but stated he was okay to receive the Hep B vaccine. Moved client to exam table before administering other vaccine, after receiving Hep B vaccine he complained he was not feeling well, severe throbbing HA, unable to hear out of right ear, syncope like episode with decreased LOC. BP 112/80 @ 1319, BP 122/80 @ 1319, 118/74 @ 1327, @1351 BP 118/76, R. 16 P 82. Treatment: Pt laid back on exam table with head lowered and feet elevated, wet paper towels to back of neck, fan blowing to keep him cool. EMS called stayed with patient until EMS arrived @ 1354, @1356 VS y EMS BP 130/82 pulose Ox 83% blood sugar 91. EMS applied O2 and transported to ER at 1405. At 1555 client and his father returned to home to get shot record and VIS that he left behind, and to schedule appointment for other vaccines.
Left thigh very red, swollen and warm to touch. Child was very fussy on 7/16/02. Left leg was tender to touch on 7/16/02.
Soreness in arm, aches, vomiting (though this could have been from food poisoning, we are not sure)
Pain in both wrists, elbows, hips, shoulders and back a month ago.  Feels weak. Spoke to MD - he recommended ibuprophen and will follow-up in a month.
This spontaneous report was received from a medical assistant referring to a 21 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # M036059 and expiration date 03-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32° Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009229 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009229 is being deleted from our files and the case is consolidated into case # 1711USA004082 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Rash on pt's face. Breathing fine. All vital signs WNL. CDC called. Pt monitored 20 minutes. Rash diminished at this time.
black out for vision for 2 minutes; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 12 years 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: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "black out for vision for 2 minutes"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: Patient can't get the second shot since she experienced a reaction of black out for vision for 2 minutes and dizziness. Caller asking why they can't get the second shot for her son.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 12 hours had fevers, chills, sweat, myalgia, HA, and axillary LN (size of golf ball). These sx eventually improved. 72 hours latter diffuse macularpapular rash on trunk, inguinal region, back.
Day of vaccine, had body aches and chills, which continued until the next day.  First week in April, noticed hip and shoulder pain which became chronic and debilitating and persisted through June.  On June 9th was started on prednisone and diagnosed with polymyalgia rheumatica with high CRP.
no additional ae; patient was administered expired M-M-R; This spontaneous report was received from a physician assistant and refers to a 12-month-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 19-OCT-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) lot number: S031483, expiration date: 07-OCT-2021, for prophylaxis (exact dose and rout of administration were not provided) (expired vaccine administered).  No temperature excursion was reported. No additional adverse event were provided.
The patients Right ankle was swollen, the patient could not bear weight, ambulate, or have a bowel movement. Patient had a 105F fever, lost all DTR's.
I could not walk, fainted three times in a 15 hour period. I blacked out and could not see anything while becoming light headed 3 times. I was not dehydrated as I have hydrated a lot. I also was extremely tired for 5 days, once my other more normal symptoms (fever, chills, sweating, achy, headache ) resided.
received mistakenly Boostrix vaccination instead of HepB.; newborn infant / 40 week gestation / received mistakenly Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a infant patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A Health Care Provider reported that a newborn patient with 40 weeks of gestational age was administered Boostrix vaccine instead of Hepatitis B which led to wrong vaccine administered. As the patient was a newborn it led to inappropriate age at vaccine administration. The reporter asked were there concerns or was it solely that it would not count towards completion of vaccine schedule. The reporter was concerned and enquired if it would not count towards completion of vaccine schedule. The reporter consented to follow up.
Information has been received from a consumer concerning her 11 year old granddaughter who on 09-AUG-2007 was vaccinated with Varivax (Oka/Merck) (lot# 657619/0605U). Concomitant vaccinations included HAVRIX and ADACEL. Ten days after the vaccination, in 19-AUG-2007 she developed her first seizure. The reported indicated that on, 30-AUG-2007 (also reported as 28-AUG-2007), and 26-SEP-2007, the patient experienced tonic clonic seizure. It was indicated that the seizure on 26-SEP-2007, resolved after two minutes. The patient was seen by a neurologist. The first week of September 2007, therapy with LAMICTAL was begun. The dose of LAMICTAL was titrated to 2 tablets a day. The reporter indicated that at that time, no definitive diagnosis had been provided and the seizures were considered to be unresolved. Current patient status was not reported. Seizures were determined to be an other important medical event. Follow up information is not expected.
Arm ache; Pain in the lymph nodes on the same arm of injection; Swelling in the lymph nodes on the same arm of injection; Shoulder pain; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache), LYMPH NODE PAIN (Pain in the lymph nodes on the same arm of injection), VACCINATION SITE LYMPHADENOPATHY (Swelling in the lymph nodes on the same arm of injection), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm ache), LYMPH NODE PAIN (Pain in the lymph nodes on the same arm of injection), VACCINATION SITE LYMPHADENOPATHY (Swelling in the lymph nodes on the same arm of injection), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Arm ache), LYMPH NODE PAIN (Pain in the lymph nodes on the same arm of injection), VACCINATION SITE LYMPHADENOPATHY (Swelling in the lymph nodes on the same arm of injection), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle ache) outcome was unknown. Not Provided          Medication for high Cholesterol was reported in Concomitant medication. No Treatment information was provided.; Sender'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.
During immunizing, after injecting the plunger, the needle separated from the syringe. Visually inspecting, majority of dose was injected, however through naked eye exam I can see  some dose drops on patients arm.
sore muscles/muscle aches; weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore muscles/muscle aches) and ASTHENIA (weakness) in a  patient of an unknown age and gender 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, the patient experienced MYALGIA (sore muscles/muscle aches) and ASTHENIA (weakness). At the time of the report, MYALGIA (sore muscles/muscle aches) and ASTHENIA (weakness) outcome was unknown.            No concomitant and treatment information was provided by the reporter.
03/16/21 - 1st Pfizer Vaccine 03/20/21 - Trouble with floaters in left eye 03/22/21 - Appointment with Optometrist - Floaters in both eyes & lens implant in right eye had slipped.  Scheduled appointment with Dr. (Opthamologist) 03/29/21 - Appointment with Dr.  - Confirmed floaters in both eyes and the lens in the right eye had slipped.  Scheduled surgery for right eye on 04/20/21. 04/06/21 - 2nd COVID vaccination 04/10/21 - When I woke up, the floaters in my left eye were worse - eyesight in left eye was very poor 04/12/21 - Called Dr. office to report, but have not received a call back. 04/12/21 - Early evening, there was only a bit of light getting through to my left eye, so I went to bed.  Ultimately, I am unable to see at all out of left eye.