chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 18-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot #J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional information has been requested.
The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 046A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information provided.  Nurse administered an expired dose of the Moderna Vaccine to 8 patients. Lot number 049E21A, number of doses/vials 8 doses o The vial was initially stored in the refrigerator on 08 Sep 2021 and the vaccine was administered on 14 Oct 2021. The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-366988, MOD-2021-367143, MOD-2021-367474 (Patient Link).
Information has been received from a physician concerning her "11 months" old daughter who on an unspecified date was vaccinated orally with her 2 ml second dose of ROTATEQ.  According to the reporter, after receiving the second dose of ROTATEQ the patient experienced 16 days of diarrhea.  At the time of the report the patient had recovered.
Headache; Chills; Sweating; Nausea; Feel awful; Woke up in middle of night; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and FEELING ABNORMAL (Feel awful) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night). At the time of the report, HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.   Reporter did not allow further contact
Since 5/25/21, I have been having pain in my left arm and the pain is not subsiding. The pain is spreading to my shoulder, upper back and left leg. On a scales of 1 - 10, the pain is level 6. The pain is very troubling.
Debilitating, non stop pain in place where shot hit a nerve. Can't carry or lift a dish without pain. All topicals for pain relief, ice packs, message, 4 bottles BIO PROZYME, red clover, agonizing movement to prevent frozen shoulder.
Patient started to sweat, patient then became unconscious after 3 minutes. No reaction from outside stimulation
Patient was given a full dose flu shot by accident.  Patient mom notified.  I checked with pharmacy said she should be fine.
This spontaneous report as received from a Registered Nurse refers to a 65 year old female patient with a medical history of fibromyalgia, Hashimoto's thyroiditis, lymphadenectomy, breast cancer in 2010. The patient had a drug reaction or allergy to penicillin. The patient had experienced nausea and vomiting after taking erythromycin in the past. On 20-AUG-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous in the right arm; dose number and dosage unknown; lot # J001003 exp 24-APR-2014). Concomitant therapies included tramadol, sertraline, ARMOUR THYROID TABLETS, ATIVAN and FLONASE. The nurse reported that approximately on 27-AUG-2013 (reported as: one week after receiving ZOSTAVAX) the patient stated she developed "a searing ache and throbbing in her right upper arm and right shoulder, and joint and neck pain" after receiving ZOSTAVAX. The nurse stated the patient received ZOSTAVAX in her right arm, but also developed achiness in her left upper arm after receiving the vaccine. On 20-SEP-2013 the patient developed "puffiness" at the injection site. It was recommended by an unspecified healthcare provider that the patient be treated with "moist heat and pressure point therapy". The patient was reported as recovering from the adverse events. Additional information has been requested.
One month after vaccination I developed a rash on my face.   It comes and goes and continues to this day.
3/5/04 103 degrees. Right deltoid red, swollen and hot to touch. Pular equal decreased ROM of right shoulder. 1) Augmentin susp 600/5 1 1/2 tsp po BID X 10 days. 2) Prelone syrup 15/5 6 cc po BID X 5 days. 3) RTC- 3 days for recheck. Pt did not return for follow up.
Myalgia, malaise, joint pain - started 48 hours after vaccine with yellow fever - seen 4 days after vaccine.  Treated with rest and Tylenol.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant therapies was provided. On 29-JUL-2013, the patient was vaccinated with the first dose of GARDASIL. On 02-APR-2015 the patient was vaccinated with the second dose of GARDASIL; route and site of administration, lot# and expiration date were not reported for either of vaccination courses. There was no adverse event reported. Additional information has been requested.
Full body rash -- mostly located in both shoulders and also included patches on the buttocks, both thighs, lower back, and left hand. Rashes began as patches of dry skin about a week after vaccination, and then progressed into itchy rashes over the course of three weeks. Rashes eventually faded and left areas scared and chronically dry.  Appendix also became inflamed approximately three weeks after vaccination and an emergency appendectomy was required to remove the organ after patient went to urgent care for intense stomach pains. Not known if this is related to vaccination.
Redness, swelling, mild induration, warmth on left anterior thigh starting on 3/8/18, continues to appear some today (3/9/18) per mother.
Vaccination site bruising; Bruise is purplish in color; Bruise a bit swollen, about a size of a nickel; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising), INJECTION SITE DISCOLOURATION (Bruise is purplish in color) and VACCINATION SITE SWELLING (Bruise a bit swollen, about a size of a nickel) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), INJECTION SITE DISCOLOURATION (Bruise is purplish in color) and VACCINATION SITE SWELLING (Bruise a bit swollen, about a size of a nickel). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising), INJECTION SITE DISCOLOURATION (Bruise is purplish in color) and VACCINATION SITE SWELLING (Bruise a bit swollen, about a size of a nickel) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medicines was not reported by reporter   treatment information was not provided
pt says she got the flu like symptoms but then developed a raised, red itchy rash on her arms, legs, and chest.  Pretty much all over her body.  She is taking Benadryl which seems to help but as soon as it wears off the rash comes back.  Pt will contact her PCP if her symptoms do not subside.
she experienced problems with breathing, loss of energy and looks weird all the time.; tired, her breathing was a bit worse/she experienced problems with breathing, loss of energy and looks weird all the time.; tired, her breathing was a bit worse/she experienced problems with breathing, loss of energy and looks weird all the time.; tired, her breathing was a bit worse/tired; This is a spontaneous report from a contactable consumer (Patient) from a  sponsored program. A female patient (age:80 units: not provided) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included blood clotting after the miscarriage, blood transfusion, throat surgery, takes baby aspirin, has COPD, infection, breathing problems had pneumonia after the lung surgery, allergy to morphine or Percocet, heart problem . Patient experienced tired, her breathing was a bit worse. Upon follow-up received on 15Feb2021, the medical history included C-section, blood disorder, Lung cancer and Lung surgery (From: 1993 to: Unspecified), Throat cancer and throat surgery (From: 1997 To: Unspecified), blood disorder, the blood not clotting. Again, mentions she had this blood issue in the past, but wondering if she should get the second dose. The patient underwent lab tests included her red corpuscles (does something). Upon follow-up received on 16Feb2021, it was reported that patient experienced problems with breathing, loss of energy and looks weird all the time. The outcome of the events was unknown.  Follow-up (05Feb2021): New information received from spontaneous report received from a contactable consumer (patient) includes: Relevant medical history added, Lab data added.  Follow-up (16Feb2021): New information received from spontaneous report from a sponsored program. A contactable consumer reported: Event added (loss of energy and looks weird all the time).  Information on the lot/batch number has been requested.
pain in his left arm which shot up to left side of his neck; pain in his left arm which shot up to left side of his neck; trouble lifting his arm; This spontaneous report was received from a pharmacist referring to a male patient of 67 years-old. The patient's current conditions included prostate cancer, diabetes mellitus and high cholesterol. The patient's medical history was not reported. Concomitant therapies included treatment for prostate cancer (it was unspecified if it was completed or currently continued), unspecified cholesterol medicine and metformin. On 10-OCT-2018, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, anatomical location, route and lot number with expiration date were not reported) for prophylaxis. On 05-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the left arm (dose not reported) (lot number S005857 with expiration date of 03-DEC-2020) for prophylaxis. On the evening of 05-NOV-2019, the patient developed pain in his left arm (pain in extremity) which shot up the left side of his neck (neck pain). The patient also complained of trouble lifting his arm to remove his shirt (Injected limb mobility decreased). The patient visited the pharmacist on 06-NOV-2019 and reported these events. The pharmacist did not show that whether patient ever had Prevnar 13. The events did not recover. The patient did not receive any treatment for the events. Causality assessment was not provided.
Foggy mind; Fast heart beat; High BP; Chills; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/100 (High) BP150/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089068:Case for husband
14 hours after the shot, I began to have tenderness and pain in the shot area, experienced fatigue, headaches, muscle/joint pain, and extreme chills.  About 18 hours after first experiencing these symptoms, I began to feel better.  36 hours after the shot i was experiencing no symptoms.
later the night of the vaccine and next day, both arms very sore and hurt to raise them up, started getting night sweats/fever 3/26, but did not take actual temperature.  left arm/shingrix is still sore, but feels better.  right arm/pneumo 23 still very sore/feels like bad bruse/6 inch raised area, but not red/hot to the touch.  he said he was going to give it anther day or so and see if it gets better.
Patient was given pfizer as a second dose. First dose was moderna. Pt swore that he recieved pfizer as second dose. Pt had no adverse reaction from second dose. Denies any issues
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. On an unspecified date in 2014 (reported as one year ago), patient received the first dose of GARDASIL (dose/frequency and route unspecified). The patient received second dose of GARDASIL on 02-APR-2015. No adverse effects were reported. Outcome of the event, inappropriate schedule of drug administration was unknown. Reporting health professional considered product the event to be not related to GARDASIL. Causality assessment was not provided. Additional information has been requested.
Hives, itching. Majority of hives located on the left side of patient's body.
Patient became very hot and sweaty after dose.  He felt light headed and had to lay down.  He was given a glucose tablet and Gatorade. He did not have any symptoms of anaphylactic allergy.  Emergency responders came and took his blood pressure and blood sugar. Both were a little low.  He was not taken to the hospital, he walked out of the pharmacy with his parents
received SHINGRIX prior to having shingles/suspected vaccination failure; had Shingles on inner thigh, shingles lesions reoccur; debilitating neuropathy pain; had a 50lb weight loss; pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cortisone shot for post herpetic neuralgia and pain and prednisone for post herpetic neuralgia and pain.   The patient's past medical history included lung cancer.   On an unknown date, the patient received Shingrix, cortisone shot at an unknown dose and frequency and prednisone at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, weight loss and pain. The patient was treated with gabapentin and morphine. The action taken with cortisone shot was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure, weight loss and pain were unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, weight loss and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The reporter was the sister of the patient. About 2 years ago from reporting, the patient had shingles on his left inner thigh and the reporter believed that the patient received the Shingrix vaccine prior to this. The patient continued with debilitating neuropathy pain and shingles lesions occasionally resurface. The reporter stated that the patient had received Cortisone shots, Prednisone, and Nerve Blockers in the past and currently took Gabapentin and Morphine to control the pain. The patient had a 50 lb weight loss since having shingles. It was unknown if the reporter considered weight loss to be related to Cortisone shots, Nerve Blockers and Prednisone. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2023012633, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023012633:SAME REPORTER
ADACEL TDAP booster received (8/28). Onset muscle weakness 2 days after shot (8/30/18), diarrhea, fatigue, weakness. Reported to pharmacist. On (10/4/18) received flu vaccine. On 10/27-10/28, back pain, muscle weakness, tingling in arms, tingling in feet and legs. burning sensation in chest and abdomen. Extreme weakness. Ears ringing. Left Eye ball pain when looking sideways. On 11/2/18 went to primary care physician to report symptoms. Had MRI of thoracic and lumbar on 11/2/18. Know significant disc issues reported on MRI. Referred to Neurologist (12/4/18). Legs and feet continue to tingle. Received brain and c-spine MRi on 12/8/2018.
wrong vaccine was inadvertently administered; 9 month old was given Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant stated that, the wrong vaccine was administered as a 9 month old male patient was inadvertently given a dose of Kinrix as part of his primary DTaP series, this was supposed to be his 6-month dose, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M007764, expiration date 30-JAN-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. Data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 hours following the vaccine, I noticed decrease sensation in my chin, nose, and toes. I have a diagnosis of nonlength dependent small fiber neuropathy, it is unclear to me whether the vaccine caused a flare in symptoms or if it is a progression of my disease so I am reporting just in case. I smoked my neurologist and they said there is no treatment they could give me regardless so I did not go to the emergency room