chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started as flu like symptoms (diarrhea, original weight loss of 11 pounds, achy/sore muscles and joints, exhaustion.  The diarrhea eventually went away and she regained the lost weight; however, the achy/sore muscles/joints, chronic pain and exhaustion have never gone away. Patient was eventually diagnosed with fibromyalgia, although we have no family history of fibromyalgia, nor had she ever had any related symptoms prior to the Gardasil vaccination. 8/29/08-records received for DOS 4/9/08-initial clinic visit, Fibromyalgia by history.  Travel out of country August 2007 and developed GI upset and nausea. Developed diffuse joint pain. Presently on Lyrica. Office visit 5/13/08-for follow-up. Assessment chronic insomnia improved. New diagnosis by psychologist dysthymia and may have ADD as well. Office visit 7/30/08-C/O decline in mood state and diffuse body pain over past 2 weeks. Irritable not sleeping well. 1/26/2010 Her health condition has not improved since the report I filed without your agency, infact it has continued to deteriorate. After seeing numerous doctors/specialist, she was finally diagnosed with fibromyalgia. Sine that diagnosis in December 2007, she has consistently been on numberous medications in an attempt to manage her symptoms, which include chronic pain, fatigue, leg and body cramps, achy muscles, joint pain, and reoccuring diarrhea. Regardless of the medications she ahs seen very little improvemtn and continues to live her life in pain. In addition to the medication, she has attended physical therapy and regulary sees a therapist regarding depression and dealing with chronic pain.
fever; swelling at injection site; redness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, less than a day after receiving Shingrix, the patient experienced fever, injection site swelling and injection site erythema. On 2nd March 2020, the outcome of the fever, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the fever, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported from physician's (MD) office. The patient received Shingrix in the right arm. Outcome of adverse events fever, injection site swelling and injection site erythema was reported as recovered in the database while mentioned as recovered/resolved with sequel in the source document. The reporter gave consent to follow-up.
Information has been received from a registered nurse concerning a 26 year old female patient with a drug allergy to DEMEROL who on 27-JUN-2008 was vaccinated with the first dose of GARDASIL (lot# 660555/0279X) (dose and route not reported). The patient received her second dose of GARDASIL (lot# 661764/0650X) on 25-NOV-2008 and the third dose of GARDASIL (lot# 662300/0100Y) on 12-JUN-2009. The patient had shoulder pain that radiated to her back toward her shoulder blades after the third dose of GARDASIL was given on 12-JUN-2009. The patient had no adverse reactions after the first two doses. The patient was treated with "two CELESTONE injections and anti-inflammatory medications". The patient had sought unspecified medical attention. At the time of reporting, the patient had recovered. Additional information has been requested.
patient had an injection site reaction with redness and soreness after he was administered PNEUMOVAX 23; patient had an injection site reaction with redness and soreness after he was administered PNEUMOVAX 23; This spontaneous report was received from a currently 76-year-old male physician referring to himself. The patient's pertinent concurrent conditions included lymphoma. The patient had previous seasonal allergy and allergies to cats and dogs, also it was reported that the patient had a previous injection site reaction to testosterone cypionate. His concomitant medications included testosterone cypionate, omeprazole (PRILOSEC), rosuvastatin calcium (CRESTOR), unspecified chemotherapy and radiation.   On an unspecified date in April 2019,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, number of administered dose, vaccine scheme frequency, lot number and expiration date were not provided). After the patient was vaccinated, he experienced injection site reaction with redness and soreness (injection site erythema and injection site pain).  The patient did not seek medical attention, no treatment was given to the patient and no laboratory diagnostic or studies were performed. The patient recovered from the event couple days after pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered.  As the patient reported having an adverse reaction to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23), therefore the causality was being considered as related.
Left shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left shoulder pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis and Kidney transplant.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ARTHRALGIA (Left shoulder pain). At the time of the report, ARTHRALGIA (Left shoulder pain) had not resolved.            No concomitant medications were provided. No treatment medications were reported.  The patient had left shoulder pain since 3rd week of May2021 until at the time of the call.
urinary retention; transverse myelitis; difficulty walking; weakness; Traumatic LP; This serious case was reported by a consumer and described the occurrence of urinary retention in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 6 days after receiving Arexvy, the patient experienced urinary retention (Verbatim: urinary retention) (serious criteria GSK medically significant), myelitis transverse (Verbatim: transverse myelitis) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), weakness (Verbatim: weakness) and traumatic lumbar puncture (Verbatim: Traumatic LP). The outcome of the urinary retention, walking difficulty, weakness and traumatic lumbar puncture were not reported and the outcome of the myelitis transverse was resolving.   It was unknown if the reporter considered the urinary retention, myelitis transverse, walking difficulty, weakness and traumatic lumbar puncture to be related to Arexvy.     It was unknown if the company considered the urinary retention, myelitis transverse, walking difficulty, weakness and traumatic lumbar puncture to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced difficulty walking, weakness, urinary retention, traumatic LP, C-spine MRI with enhancement across spinal cord consistent with transverse myelitis; underwent plasma exchange with improvement. No confounding apparent but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149213, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149213:Same reporter
After first dose: Diarrhea, left arm joint immobility, weak grip in left hand for 1 week; drowsiness for 1 week; very thirsty for 1 week, craving sugar/sweets (normally don?t eat any sweets) After second dose: random bruising on arms, legs, shoulder, rash, body felt heavy, constipation, longer than normal menstruation (normal 4-5 days; this lasted 8+ days); craved oily foods before period ( not normal for me at all); cognitive decline - feels like my memory doesn?t work
extreme chills, fever 102 degrees, soreness, muscle aches, which have lasted over 24 hours, except for the fever. I was thinking about calling 911 but I didn't.
Arm discomfort; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 11:00 (Lot number: ER8727) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim", notes: known allergies: Bactrim.  The following information was reported: LIMB DISCOMFORT (non-serious) with onset 28Mar2021, outcome "recovered" (2021), described as "Arm discomfort". Therapeutic measures were not taken as a result of limb discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medication the patient received within 2 weeks of vaccination which included multivitamin. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Began menstruation the day after I received the vaccine. This period arrived 10 days early, with heavier flow and cramping compared to usual. Previously my menstrual periods had followed a predictable  26-28 day cycle. My cycle has now returned to normal.
14 hours after shot, woke up at 4:00am with raging chills, at 5:15am extreme nausea started followed by violent vomiting that resulted in almost passing out twice. Had two rounds of violent vomiting. The following symptoms continued nonstop for the next 18 hours until I went to bed for the night, some coming in greater or lesser intensity in waves : raging chills, feverish, total body sweats, lightheaded, racing heart, splitting headache, extreme joint pain (especially in wrists and hips), extreme muscle fatigue, nausea, unable to regulate body temperature, bulging lymph node in armpit, bloodshot eyes, feeling of burning organs on inside from neck to waist, and an unscheduled menstrual period. Day 2 symptoms persisted though not as intense, preventing me from completing normal daily activities. Nausea, fatigue, muscle pain, joint pain and headache being the worst along with random sweats and chills. Day 3 symptoms a little better, still present, interfering with normal daily activities.
Tinnitus / ear ringing Prior to vaccination, minor, mainly in left ear. After vaccination, ringing became stronger, still concentrated in left ear.
patient has redness, swelling, and is hot to the touch at the injection site. mother states that she is warm but does not know if has a fever. mother says that she has thrown up a couple of times. she gave her benadryl and put hydrocortisone on the area and that did not help much. i told her to contact her pediatrician.
Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 47 year old (age at the time of vaccination 46 year old) female. The patient's weight was 123 pounds, and height was 59 inches. The patient's pre-existing medical conditions included: Patient has no medical history and no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, 1 total, administered at left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient had bloodwork and tested negative for COVID antibody (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000197563. This case, from the same reporter is linked to 20211028354.; Sender's Comments: V0:20211028400-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Post vax, the pt developed fever of 102.6 and was treated with children's Motrin.
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient experienced rash after 1st dose. The patient asked if she/he get the Shingles 2nd dose when the rash clears up .
APPROXIMATELY 11 HOURS AFTER RECEIVING VACCINE CLIENT WOKE UP WITH A  RED RAISED , WARM,  PAINFUL SMALL AREA AT SITE OF VACCINATION. THIS AREA HAS GOTTEN BIGGER AND MORE PAINFUL WITH INCREASED REDDNESS AND RAISED AERA. 04/14/2021 CLIENT PRESENTS WITH THESE S/S,  AREA MEASURES 5 INCHES BY 7.25 INCHES.
Had vomiting 4 hours after vaccine, had constipation then diarrhea.
On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swollen lymph nodes in throat, sore throat, and very large swollen lymph node in left arm pit. This lasted thru Sunday Mar 28. On Mar 29 I woke up to severe, frequent watery diarrhea and stomach gurgling along with burping and general gastro discomfort.
Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine). At the time of the report, VACCINATION COMPLICATION (Physician states patient experienced  localized reaction following 1st dose of Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Physician advised patient not to have 2nd dose of Moderna COVID19 vaccine. Treatment details were not provided.   Reporter did not allow further contact
Felt like arm was going to "fall off" for 18 hours after receiving COVID vaccine; Felt like arm was going to "fall off" for 18 hours after receiving COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A 33-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient felt like arm was going to "fall off" for 18 hours after receiving COVID vaccine in 200. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
-fatigue -severe muscle aches -headache  -nausea -dizziness/syncope -hot flashes/chills
Two times my smart watch has alerted me of high resting heart rate. Both times the resting heart rate was around 115 bpm. The first event lasted 6 hours and the second event about 2 hours. No other symptoms occurred and I would not have known about the elevated heart rate without my smart Watch. I had never had an elevated heart rate at rest before getting the vaccine. The first events date was 4/19/21 and the second event was 6/23/21.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVommiting,   Chills, pain at the injection site   Narrative:
Previously, she received 2 doses of Daptacel DTAP; Large pancake-size area of redness; Large pancake size area of warmth; Huge fluid filled blisters; This non-serious case was reported by a nurse and described the occurrence of localized erythema in a 3-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL (DTAP VACCINE)) for prophylaxis.   Previously administered products included Daptacel DTAP with an associated reaction of no adverse event.   On 04-MAY-2023, the patient received Infanrix. On an unknown date, the patient received DAPTACEL (DTAP VACCINE). In MAY-2023, 24 hrs after receiving Infanrix, the patient experienced localized erythema (Verbatim: Large pancake-size area of redness), localized feeling of warmth (Verbatim: Large pancake size area of warmth) and blister (Verbatim: Huge fluid filled blisters). On an unknown date, the patient experienced interchange of vaccine products (Verbatim: Previously, she received 2 doses of Daptacel DTAP). The outcome of the localized erythema, localized feeling of warmth and blister were not reported and the outcome of the interchange of vaccine products was unknown.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth and blister to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the localized erythema, localized feeling of warmth and blister to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023 Previously the patient received two doses of Daptacel DTAP on an unknown date and did not had a reaction. The nurse reported that one of the patients received an Infanrix DTAP vaccine and within 24 hours, she developed a large pancake-size area of redness and warmth followed by huge fluid filled blisters forming around the perimeter of the red area.  The reporter stated that this was an uncommon reaction, and that the reporter was trying to determine if patient had an allergic reaction to an ingredient that would be in Infanrix DTAP but was not present in Daptacel DTAP. The reporter asked had GSK seen this kind of reaction before and did GSK know what ingredient might had caused this reaction. The reporter stated that any help provided would be greatly appreciated. Previously the patient received 2 doses of Daptacel DTAP which led to interchange of vaccine products.
mildly itchy; rash all over, Rash in torso,Rash in groin; Tired; "Covid arm"; Red swollen arm; Red swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Red swollen arm), PRURITUS (mildly itchy), ERYTHEMA (Red swollen arm), RASH (rash all over, Rash in torso,Rash in groin) and FATIGUE (Tired) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Red swollen arm), FATIGUE (Tired) and VACCINATION SITE REACTION ("Covid arm"). On 29-Mar-2021, the patient experienced PRURITUS (mildly itchy) and RASH (rash all over, Rash in torso,Rash in groin). At the time of the report, PERIPHERAL SWELLING (Red swollen arm), PRURITUS (mildly itchy), ERYTHEMA (Red swollen arm), RASH (rash all over, Rash in torso,Rash in groin), FATIGUE (Tired) and VACCINATION SITE REACTION ("Covid arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Dizziness post vaccine, came back to clinic and ate snack bc she had not eaten that morning. BP 130/80, felt better with food. 2 similar episodes the following day, no further epidose after 48h.
More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.       No concomitant drug were reported.   Patient received Treatment drug Tylenol and Excedrin for the events which occurred after booster dose.   This case was linked to MOD-2021-430178 (Patient Link).
This spontaneous report as received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of 0.5ml of improperly stored GARDASIL 9 either with lot number L040054 with expiration date of 26-DEC-2017 or L037554 with expiration date of 25-DEC-2017 (strength and route of administration were not reported), which was stored at 1.1 Celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Day after vaccinated child's right arm, area of vaccination swollen, hot, hardened, no pain, does complain of some itching.  IZ received in this arm (DTaP and IPV) on 4/9/03.  No fever.