chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Administered after frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 11-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was 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 reporter given FluLaval after being frozen at minus 0.45C for 15 minutes, which led to incorrect product storage. The reporter consented to follow up. This is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230173:Same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter
Initial report was received on 07 September 2013 from a consumer who is also the patient. A male patient (date of birth not reported) had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later, reported the area was red and swollen, he had enlarged lymphnodes and he had two red, raised lines going to his underarm. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Patient developed Bell's Palsy to left face on 4/24, seen in ER for evaluation and then saw me (PCP) on 4/27.   She is on treatment for this and starting to recover
stomach pain; diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant and treatment medications were provided
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. In May 2017 (reported as "within the past week (prior to 12-MAY-2017)"), the patient was vaccinated with a dose of VARIVAX injection, lot # M039318 with expiry date 20-SEP-2018, subcutaneously (exact dose was not reported) for prevention of varicella. The vaccine was administered together with sterile diluent (DILUENT MERCK), lot # M034911 with expiry date 05-MAY-2019 (exact dose was not reported). On an unknown date in May 2017, 3 to 4 days following the administration of VARIVAX and sterile diluent (DILUENT MERCK), the patient experienced an injection site reaction consisting of redness, swelling, warmth and discomfort at the injection site. The patient sought medical attention by visiting the physician, however they did not require treatment. The outcome of the events and causal relationship between the events and suspect therapies were not provided. The reporting nurse requested a lot check on the administered products. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007174:
Severe chills, shakes, shivering, fever (101.3 F), lightheadedness, nausea, sleeplessness
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In May 2016, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Mom reports child had fever up to 102 degrees 24 hours starting 7/8/02. States on 7/10/02 at11:30pm, child awoke screaming with headache. States she alternated Advil 1 1/2 tsp and Tylenol 1 1/2 tsp every 2 hours and every 2 hours he would wake up screaming. States child was seen by MD on 7/11/02 and MD states child "had brain swelling from MMR." Other symptoms lethargy and eyes were slight sensitive. States by 7/12/02 he was feeling much better.
This spontaneous report as received from an other health professional refers to a female patient of unknown age. The historical drug included Penicillin. The patient's current conditions included back pain, osteoarthritis, rheumatoid arthritis and type 2 diabetes mellitus. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapies included insulin glargine (LANTUS), insulin aspart (NOVOLOG) and metformin (manufacturer unknown). On an unknown date, the patient experienced allergy. The outcome of the event was unknown. The causality assessment was not provided by the reporter. Additional information has been requested.
pt recv vax & devel redness, warmth, and/or soreness to the inj site;no tx was necessary;pt recovered;
This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 63 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional received SHINGRIX and developed shingles over his left shoulder approximately 9 weeks later. The health care professional was the patient, he did not have lot number or expiry date of SHINGRIX given.
Injections given in both thighs. Redness and swelling around injection sites. Skin hot to touch. Child reported soreness.
About an hour after my vaccine I noticed what looked like spider bites on my right thigh. It later turned into hives. I was not very big. They were itchy and still there the following day. I then noticed more hives on my left wrist so I went to Urgent Care about 24 hours after my vaccine. The doctor confirmed it was hives and gave me a prednisone injection. She also gave me a 5 day prednisone script. The hives cleared up after a couple of days.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unspecified dates, patients were vaccinated with improperly-stored doses of ROTATEQ oral liquid, (strength and dose were not reported) administered orally (lot # L042214, expiration date 14-JUN-2017/ lot # M019708, expiration date 25-OCT-2017) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperature excursions: 51 hours between 32 degrees Fahrenheit (F) and 35F, and for 14 hours and 15 minutes between 47F and 77F (60F). No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1705USA000387:  US-009507513-1705USA000339:
ABDOMINAL PAIN GETTING WORSE AFTER EATING; FEELS LIKE FOOD POISONING; ACHES AND PAIN IN THE BODY; SHORTNESS OF BREATH; FELT HOT AND COLD; PAINFUL TOES; NUMBNESS IN THE LEFT FOOT; ACHINESS IN THE JOINTS; FEVER WAS BURNING UP; BREAKING OUT WITH HIVES IN BOTH ARMS; WANTED TO THROW UP AFTER EATING BUT COULD NOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included: addiction, and other pre-existing medical conditions included: The patient had no health issues and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced abdominal pain getting worse after eating. On 08-AUG-2021, the patient experienced feels like food poisoning. On 08-AUG-2021, the patient experienced aches and pain in the body. On 08-AUG-2021, the patient experienced shortness of breath. On 08-AUG-2021, the patient experienced felt hot and cold. On 08-AUG-2021, the patient experienced painful toes. On 08-AUG-2021, the patient experienced numbness in the left foot. On 08-AUG-2021, the patient experienced achiness in the joints. On 08-AUG-2021, the patient experienced fever was burning up. On 08-AUG-2021, the patient experienced breaking out with hives in both arms. On 08-AUG-2021, the patient experienced wanted to throw up after eating but could not. Laboratory data included: Body temperature (NR: not provided) normal, Oxygen saturation (NR: not provided) normal, and Pain scale (NR: not provided) pain was at 8/10 (joint ache). Treatment medications included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aches and pain in the body, achiness in the joints, shortness of breath, fever was burning up, felt hot and cold, breaking out with hives in both arms, numbness in the left foot, and painful toes, had not recovered from abdominal pain getting worse after eating, and feels like food poisoning, and the outcome of wanted to throw up after eating but could not was not reported. This report was non-serious.
Initial symptoms: Low grade fever; severe dizziness; severe nausea; headache. Since 7/13: fainted 4 times; severe headaches with episodes that are seizure-like; regular, reoccurring low grade fevers; visual and auditory disturbances; difficulty concentrating; heart palpitations; severe fatigue. Cardiologist says she now has POTS related symptoms.
patient experienced a seizure approximately one week later after the first dose of GARDASIL 9, then with second dose she experienced a seizure; patient experienced a seizure approximately one week later after the first dose of GARDASIL 9, then with second dose she experienced a seizure; This spontaneous report was received from  a Physician via employee and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2016, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, two dose series, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2016, approximately one week later after the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced seizure. Outcome of the event was unknown.  On an unknown date, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), then with second dose she experienced a seizure on an unspecified date (reported as the following day), as well. The outcome of the second episode od seizures was not recovered as it was reported that the patient continued to experience seizures. Both events of seizures were treated (treatment was unspecified) and the patient sought medical attention for both events.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding first episode of seizure was Not Applicable wit positive rechallenge and due to second episode of seizure it was not applicable.   The causal relationship between both episodes of seizure and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review both episodes of seizure  were determined to be medically significant.
HARD KNOT ON LEFT ARM; CHILLS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once total administered on 03-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAR-2021, the subject experienced chills. On 03-MAR-2021, the subject experienced slight headache. On 05-MAR-2021, the subject experienced hard knot on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight headache on 04-MAR-2021, and had not recovered from hard knot on left arm. This report was non-serious.
Per pt, sweats at night, chills, redness at injection site after receiving 1st dose of vaccine
On Friday, October 31, 2014, the medical center was administrating flu shots. I received the flu shot that Friday afternoon with no immediate symptoms. Starting Saturday, I developed a rash around my mouth, a lump at the injection site, and my lips swelled to three times their size. This reoccurred Sunday and Monday with swelling, rash, itching and burning around my mouth area. The nurse reported the incident to Employee health. After several days the symptoms have lessened.
Started as hoarseness, red itchy eyes with pus, hacking cough, headache, fever, chills, difficult in swallowing, swollen throat. Actually vomited (foam) and no energy.
Information has been received from an office manager concerning an 82 year old female who on 17-NOV-2006 was vaccinated with first dose of Pneumovax 23 (lot # 651356/0089F) intramuscularly in left deltoid at 1330 hours.  Concomitant therapy included LIPITOR, aspirin, metformin, LANTUS, ALPLAX and therapy unspecified.  Subsequently, in November 2006, the patient experienced redness, burning, and itching of left upper arm.  The patient sought medical attention.  The patient was treated with BENADRYL and KEFLEX.  The outcome of events was not reported.  No further information is available.
bouts of pancreatitis; Pain; not eating much; feels like crap; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PANCREATITIS (bouts of pancreatitis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (bouts of pancreatitis) (seriousness criteria hospitalization and medically significant), PAIN (Pain), HYPOPHAGIA (not eating much) and VACCINATION COMPLICATION (feels like crap). At the time of the report, PANCREATITIS (bouts of pancreatitis), PAIN (Pain), HYPOPHAGIA (not eating much) and VACCINATION COMPLICATION (feels like crap) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use and treatment information not provided.  A parent reported on behalf of the patient. The patient has bouts of pancreatitis. Ever since he got his first shot, he's been suffering. Caller stated he was released from the hospital last Friday or the Friday before that. He still had pain and was not eating much. He was told to eat a soft diet. Caller stated ever since then he has felt like crap. Patient demographics and vaccine information was not provided. Caller stated the pancreatitis was not caused by the vaccine.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-036788, MOD-2021-036788 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
This spontaneous report has been received from a pharmacist and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately May 2015 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX 1 dose (route of administration, lot # and expiration date were not reported) reconstituted with sterile diluent (MRK) injection (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as recently), the patient had a negative antibody titer. No treatment was given for the adverse event. The patient sought medical attention by office visit. No product quality complaint was involved. The outcome of the event was not recovered. The relatedness between the event and suspect therapies was not reported. Additional information is not expected because there was no consent to contact the reporter.
Prickly, itchy rash on legs, spreading to feet and toes Yellowing hard tips on rash.
He felt dizzy, nauseated and he noticed diffuse redness.  He was seen later that night in an ER and treated with Benadryl.  He was discharged home.  The day after vaccination at about 1 PM he began to feel weak, dizzy and nausea.  At 1:30PM he had a witnessed syncopal event.  He was brought into our clinic and treated with intravenous fluids and intramuscular phenergan.  At 4:30 PM he felt much better and was discharge home.
Information has been received from a licensed practical nurse concerning her 6 year old Caucasian male relative with asthma and sulfa allergy who on 6/3/96 was vaccinated with the first dose of varicella virus vaccine live (site unknown) (lot # 616997/1656B) SC. In April 2001 the patient developed varicella with many lesions and a fever of 104 degrees F. It was reported that the patient recovered. Additional information has been requested.
skin reaction that has grown rather large 4in by 3in still hanging around; itching mildly; has some heat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (skin reaction that has grown rather large 4in by 3in still hanging around), PRURITUS (itching mildly) and FEELING HOT (has some heat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Migraine. Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX), BREXPIPRAZOLE (REXULTI) and CARVEDILOL for Depression, GABAPENTIN and RIZATRIPTAN for Headache, ALPRAZOLAM (XANAX) for Sleeplessness, BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBIT/APAP/CAFFEINE PLUS), AMITRIPTYLINE and TOPIRAMATE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (skin reaction that has grown rather large 4in by 3in still hanging around), PRURITUS (itching mildly) and FEELING HOT (has some heat). At the time of the report, VACCINATION SITE REACTION (skin reaction that has grown rather large 4in by 3in still hanging around), PRURITUS (itching mildly) and FEELING HOT (has some heat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included ice on the itching site.
1-31-17 - size 2 Quarters red, inflamed, sore, no itching, no rash around it, hot. - noted after shower 2-1-17 - worsened today, discussed cold compress and ibuprofen to help w/soreness and swelling
sore arm at site of injection - day after; swollen underarm lymph nodes of arm that was injected
pt recv vax; had sz on 20aug95, lasting several mins;warm to touch; T 104.3 at er;dtap given approx 60 hrs a/ febrile sz;