chrisvoncsefalvay/vaers-outcomes huggingface dataset:
in discomfort and pain; arm fell asleep; in discomfort and pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (already received the first dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, numbness of upper extremities and discomfort. On an unknown date, the outcome of the pain, numbness of upper extremities and discomfort were recovered/resolved.   It was unknown if the reporter considered the pain, numbness of upper extremities and discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 06-Nov-2022 Reporter's comment:  This case was reported by a patient via interactive digital media. The patient already received first dose of Shingles vaccine. The patient never had pain after a first dose. The patient now experienced that arm fell asleep (numbness of upper extremities) and had discomfort and pain for about two days. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Broke out in itchy, red splotches on left trunk, under both arms and left waist area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis/psoriasis and penicillin allergy. Concomitant medications included adalimumab (HUMIRA), pravastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and methotrexate (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took flu shot and shingles shots on unknown dates and did not experience any reactions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 18:30 (32 hours after Pfizer vaccine), the patient broke out in itchy, red splotches on left trunk, under both arms and left waist area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with BENADRYL and application of a hydrocortisone cream. The clinical outcome of the event broke out in itchy, red splotches on left trunk, under both arms and left waist area was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
patient inadvertently vaccinated on day 16 post Dose 1. patient informed, no s/s immediately reported.
devel bilat swelling of knees 6APR96 AM;cont on 7APR96 used ice packs for relief;knees tender no c/o pain;11APR96 has swelling into rt ankle, rt thumb & dorsum of hand;dx arthralgia etiology questionable & has a hx of arthritis knee & wrist
Mild dizziness day 1 after vaccines, at night feverish arm pain.  2nd day Headaches, fever, fatigue, chills and body aches and numbness on left side of body leg and back feeling of sciatica pain, 3rd day, all of the above and bottom  4am woke up to lip itching and swelling. Took one Tylenol went back to sleep.  Blood pressure elevated 121/98.  Woke up at 8am swelling went down so i didnt feel the need to go to the doctor. Fever subsided just headache and minor body pains so took one lisinopril.  3pm blood pressure check 125/91.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "may have occurred between 05-AUG-2016 and 20-SEP-2016"), the patients were vaccinated with GARDASIL 9 injection, lot # L043214, expiration date 30-AUG-2017, (dosage number, route and anatomical location of administration were unknown), which were improperly stored. The temperature of excursion was 11.3 C and the time frame was 965 hours 19 minutes cumulative since 05-AUG-2016. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
REPORT GIVEN BY HIS WIFE.  DAY ONE: ITCHING IN ODD AREAS OF BODY (UNDER ARMS AND BACKSIDE). NEXT DAY FEELING TIRED. FRIDAY HE DID FEEL WELL AND O2 LEVEL 91% - 88%  THEN A RASH WAS NOTED FROM NECK DOWN TO LEGS. WIFE TOOK HIM TO THE  HOSPITAL SATURDAY MORNING. IN ER FOR ALLERGICE REACTION, BUT THEN TOOK A TURN FOR THE WORSE AND WAS PLACED ON BI PAP MACHINE FOR ABOUT 5 HOURS. DISCHARGED AFTER 5 DAYS IN HOSPITAL. ALLERGIST CALLED I N TO CONSULT-
A report has been received from a Physician concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient reported received expired FLUMIST which started during 2014. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Red/swollen/hot at injection site and down arm   Patient can barely move arm within 1 day of getting the vaccine
This spontaneous pregnancy report as received from a consumer refers to a 17 years old female patient. The patient's history of previous pregnancies and live births is not known. On May 2012, the patient was vaccinated with dose 2 GARDASIL. Concomitant medications included JOLESSA, sumatriptan and trazodone hydrochloride. On 24-AUG-2012, the patient found out she was pregnant after getting the second dose of GARDASIL. No treatment was given. Blood test was performed (results not available). The outcome of the event was unknown. The event was not related to GARDASIL. Additional information had been requested. Follow up information received, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. This case was lost follow up. The pregnancy outcome was lost to follow up. Additional information is not expected.
This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes on 03-FEB-2017. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1704US A010916:
felt weak; bones sore; felt cold; vomiting; diarrhea; flu like symptoms; bones stiff; arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 30th September 2020, for tolerance refer case US2021AMR008922).   On 5th December 2020, the patient received the 2nd dose of Shingrix. On 6th December 2020, 1 days after receiving Shingrix, the patient experienced weakness, bone pain, feeling cold, vomiting, diarrhea, influenza-like symptoms and stiffness. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, weakness, bone pain, feeling cold, vomiting, diarrhea, influenza-like symptoms and stiffness were recovered/resolved.   It was unknown if the reporter considered the pain in arm, weakness, bone pain, feeling cold, vomiting, diarrhea, influenza-like symptoms and stiffness to be related to Shingrix.  Additional details were provided as follows: On 6th December 2020 morning, the patient felt weak, her bones were sore and stiff, had diarrhea and vomiting, felt cold and flu like symptoms. Her arm was sore again for 2 days. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021021112:same reporter US-GLAXOSMITHKLINE-US2021AMR008922:same reporter
Day of injection large knot at injection site. Lasted 6 days ,  9 days after injection bright red rash approximately 2inches below injection site, tender and hot to touch,  2inches by 4inches. Continues to grow: now 13 days post injection rash has grown  to 5 inches by 7 inches. Lighter in color, now reddish blue. Has been itchy since appearance. No temp, left arm has been sore but not painful.
Can not get the 2nd shot; difficulty breathing upon minimal exertion; pain everywhere; fatigue (slept for 5 days); chills; fatigue (slept for 5 days); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot), DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)), CHILLS (chills) and FATIGUE (fatigue (slept for 5 days)). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can not get the 2nd shot) had resolved and DYSPNOEA (difficulty breathing upon minimal exertion), PAIN (pain everywhere), HYPERSOMNIA (fatigue (slept for 5 days)), CHILLS (chills) and FATIGUE (fatigue (slept for 5 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   This case was linked to MOD-2021-079973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Event added. On 31-Jul-2021: Follow-up information included no new information. On 04-Aug-2021: Follow-up information included no new information.
left arm sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included coxarthritis (received hip replacements). Previously administered products included Shingrix (1st dose received on an unknown date and did not experience any side effects). Concurrent medical conditions included finger arthritis.   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose of Shingrix either on 8th or 9th January 2020 on left arm. Later that night, the patient's left arm became sore. Till the time of reporting, the patient's arm was sore and she could hardly lay on that arm. The patient stated that she had a physician's appointment on friday of the reporting week to have her arm checked out and stated that she would be getting an x-ray on the left arm. The patient required emergency visit. The reporter did not consent to follow up.
did fine, my arm was a little sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "did fine, my arm was a little sore".  Additional information: The patient received first dose on 18Apr2021, second dose was scheduled on 09May2021. She was asking if she could change her appointment to 03May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Intermittent arm swelling, redness and warmth that lasted for 2 days.  Better with cold compress.  Then developed some hives/rash.  Seen in office and diagnosed with scarlatina.
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route of administration were not reported, lot # M035487 with expiration date: 23-FEB-2019). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004591: US-009507513-1704USA004333: US-009507513-1705USA004590: US-009507513-1705USA004589.
tumor grow to the size of a soft ball/ grow a tumor that size that fast (history of ongoing multiple myloma); She steadily declined every day after getting the shot and died May 3rd./ she could not get out of bed without help; This is a spontaneous report from a contactable consumer (patient's son). A non-pregnant 83-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose in her left arm, on 03Mar2021 10:00, at the age of 83-year-old of vaccination, for Covid-19 immunization. The patient had a history of ongoing multiple myloma. Concomitant medications included lenalidomide (REVLIMID), gabapentin, and acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had multiple myeloma and was informed in late February that her blood work numbers indicated her cancer had come out of remission. She received the Covid shot on 03Mar2021. Within 3 weeks she had a tumor grow to the size of a soft ball. She steadily declined every day after getting the shot and died 03May2021. Before the shot she was walking 2 mi per day by the end of March she could not get out of bed without help. The reporter considered that the events started on 04Mar2021. Unspecified chemotherapy was received for her condition. Her condition resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was the reporter's belief that no one grew a tumor that size that fast without help. The reporter believed that the combination of the timing of the cancer coming out of remission and getting the Covid shot was the cause of her fast decline.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: tumor grow to the size of a soft ball/ grow a tumor that size that fast; She steadily declined every day after getting the shot and died May 3rd./ she could not get out of bed without help
Fever, irritability, lack of appetite, vomiting. Temp. 102F - 103F for 3-4 days with an ER visit on 3/28/06 with a bulging fontanel. No treatment, seemed to get better after 4 days.
Arm was sore for a couple of days, "I just don't feel well" Chills. Difficulty getting warm. Runny nose. Pt was still not feeling well on 11/21/2017.
Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.
Female kid received Infanrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number T753J, expiry date 01-FEB-2021) for prophylaxis.   On 21-MAY-2021, the patient received the 2nd dose of Infanrix. On 21-MAY-2021, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Female kid received Infanrix expired dose).  The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 23-AUG-2023. Medical Assistant reported that on 21st May 2021, a female kid received Infanrix expired dose which led to expired vaccine used. This shot was the second one in the Dtap series. The reporter consented to follow up. Call Notes was reported as follow up accepted.
Headache, Myalgia, Arthralgia, Fever, chills/ fatigue Narrative:
racing heart (130 beats per minute, resting); could not stand up because the body pain was so intense; fever (T-104.4F); chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (racing heart (130 beats per minute, resting)), MYALGIA (could not stand up because the body pain was so intense), PYREXIA (fever (T-104.4 F)) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (racing heart (130 beats per minute, resting)), MYALGIA (could not stand up because the body pain was so intense), PYREXIA (fever (T-104.4F)) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (racing heart (130 beats per minute, resting)), MYALGIA (could not stand up because the body pain was so intense), PYREXIA (fever (T-104.4F)) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: negative (Inconclusive) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-027834 (Patient Link).
pt recvd vax 10FEB93 & devel a rash on torso & arm; pt recovered; No further details were provided;
Local swelling, redness, itching. Cold pack applied w/ some relief. Some headache.
Information has been received from a physician concerning an 18 year old female who sometime in April 2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. Subsequently, the patient claims that ever since she received the vaccination, she gets her "period every 13 days" as opposed to every 28 days which is considered normal for her. Unspecified medical attention was sought. The patient's outcome was reported as unknown. No product quality complaint was involved. Additional information has been requested.
Raised erythema size of a silver dollar matching area swab by alcohol. Just warm to touch and red and raised.
Dizziness, Headache, Sedation, Myalgia, Arthralgia, diaphoresis and chills and fatigue Narrative:  Moderate due to "I couldn't function, i was totally out of it"
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 13-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
low grade fever, increased rhonchi in bilateral lungs, increased Edema on 1/21/23, treated with routine nebs, IV merrem, increased oxygen
Overnight on Jan 28 the injection site has become itchy, hot and slightly achy. Some slight visible blotchiness as well.