chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (19Aug2023) Negative, notes: Day 9; (21Aug2023) Positive, notes: Day 11. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 11Aug2023 to 15Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 16-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was exposed in refrigerator to temperatures of 0 Celsius degrees for 168 hours and 1.1 Celsius degrees for 920 hours with lowest temperatures recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Had a muscle "knot" at injection site starting on day 2. Arm was sore but not extremely painful. Knot lasted until day 9 (1/21/21). On day 9, the knot had resolved but upper warm was very red, warm to the touch and itchy. Took 1 diphenhydramine 25mg tablet at night. Redness had improved in the morning and had not spread. Still have some redness in the same pattern  on 1/25/21. Was told to report the adverse event through workplace who facilitated the vaccine.
bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis that was acting up because it was cold; arthritis that was acting up because it was cold; chest hurts, left center of chest sharp pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included blood pressure and arthritis. Concomitant medications included unspecified blood pressure medications and some "probiotic type thing". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, Thursday night, the patient had a lot of muscle aches and pain and has body aches from her toes to top of her head which were persisting. She thought it might be her arthritis that was acting up because it was cold but states it is more than that. Her chest also hurts, not constantly, towards the left center of her chest, what were like sharp pains but it was not normal. She is still having the chest pain, states it is not  anything she can clock by time, it goes and comes back, only lasts a very short time,  it hurts about a minute or two and then goes away. Last night (18Jan2021), she also developed a bad headache that went away when she slept but now that she is awake it is coming back. At the time of report, the outcome of the events not recovered.  Information about lot/batch has been requested.
patient states she had pain and immobility in her shoulder.  She says that today (November 27) the pain is starting to diminish but she is still unable to lift her arm higher than her chest.
couldn't pee; shut his kidneys down; UTI; got very sick; This is a spontaneous report from a contactable Consumer (patient friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced couldn't pee, shut his kidneys down, UTI and got very sick on an unspecified date. The reported stated that I heard people are getting observed for 15 minute after getting it. A friend of mine got the vaccine and got very sick. It shut his kidneys down and couldn't pee and got an UTI. He is a lot younger than me and on TV news hearing that the vaccine developed by Astra Zeneca reporting cases of 30 different people with blood clots not sure if it's connected to the vaccine and will investigate that. I'm 81 and I'm scared to get it. I do have allergies. I have high blood pressure and beginnings of emphysema. Years ago when I got the flu vaccine (it was a live vaccine) and I got the flu from the vaccine. Now they use dead virus and since then I didn't have a problem. Reporter also stated, Pfizer used to carry a body and hand cream which they discontinued. It is not made anymore and when I asked before they said I could get it on (E-commerce Company) and/or (Pharmacy) both selling old remaining stock if it's not being produced. It was called pacquin plus cream. It was so nice and worked well and smelled nice. It's hard to believe they discontinued it. I don't know why they did. It worked so well. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This is a flu shot reaction. Patient is having a "laugh" that feels like a cough but there is no tickle in her throat. It comes out as a laugh. It persisted until dinner, and then reoccurred in the middle of the night. It presented again the following day, during the morning hours at school. It has not resolved and we have not sought treatment yet. It was administered at her school by the dept of health. We received no information on the shot type.
received a boostrix dose and then realized about a tag alert; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received the 1st dose of Boostrix 1 ml and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 12-Apr-2022 Reporter's comment: The medical assistant stated that a patient at their medical office was administered a dose of Boostrix vaccine on the date of reporting (today) into his right deltoid that had been stored outside of the recommended temperature range. After administration then realized about a tag alert. The health care professional reported that did not get consent from patient to contact. Did not consent to follow-up. Additional Supportive Information: The patient received a dose of Boostrix that had been stored outside of the recommended temperature range, which led to incorrect storage of drug. This case was found as duplicate of case US2022064048. All the information from the case US2022064048 was merged into this case. The case US2022064048 was deleted and this case stand as case of record for this patient.
Area was "itching" on afternoon of 7-10-12; on 7-11-12 at 6:00 p.m. mother noticed area to be very red and hot with slight amount of "puffiness", firm to touch in center of reddened area with few small clear vesicles noted. Low grade temperature.
On 03/15/2023, I felt like I had a cold coming.  I had a runny nose and a lot of phlegm.  On 03/17/2023, I took the COVID-19 Test and it was positive. I stayed isolated and depressed for five days. I did really well with it, I was just worried I would give it to someone. The doctor prescribed Paxlovid but I did not pick it up.
Patient called the pharmacy on Monday, March 15th2, 2021 and said that her arm was very red and hot to the touch. She said that it seemed to be getting worse and even moving toward the armpit. It did not start until several days after getting the vaccine. I advised her to contact her family physician. The family physician called in a prescription for Cephalexin 250 mg  four times daily for 10 days. She began taking the antibiotic Monday evening and I followed up with the patient Wednesday morning, 3/17/21. She said it was no longer as sore or red or hot to the touch. She was seeing her doctor again on Thursday morning to follow up.
Severe exhaustion started 24 hours after getting second booster Planter facitious started 24 hours after getting second booster.   I also got planter fac after getting my 1st booster covid shot back in October.   I know it started around my booster shot but don't have a real time frame.    I have never had this in my life and seems strange to get it right after each booster shot.
This spontaneous report was received from a healthcare provider regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unknown dates in January 2016 (also reported as since 11-JAN-2016) unknown number of patients were administered with improperly stored doses ROTATEQ (lot # L013192, expiry date 19-JAN-2017) dose, route unknown. Concomitant medications were not reported. It was reported that there were no previous temperature excursion to the product. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 82916100) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) and BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    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 HEADACHE (headaches) and NAUSEA (nausea). At the time of the report, HEADACHE (headaches) and NAUSEA (nausea) 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.   Treatment information was not provided.
Pt said arm hurt for 3 days then moved into his shoulder. One month out shoulder still hurts.
Malaise, tired night after immunization. Raised redness and warmth at injection site.
STEMI HEART ATTACK; This spontaneous report received from a consumer concerned a 31 year old male. The patients height, and weight were not reported. The patients concurrent conditions included elevated cholesterol, and other pre-existing medical conditions included patient was not having a family history of heart issues.May be patient was genetically more prone to heart attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 in the morning, the patient experienced stemi heart attack (life-threatening), patient was rushed to Emergency Room at 3:00AM in morning and the patient was hospitalized. The patient experienced permanent heart damage and patient received angiogram and stent in artery was performed for the diagnosis. Laboratory data (dates unspecified) included: Angiogram (NR: not provided) not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stemi heart attack was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210504947-COVID-19 VACCINE AD26.COV2.S-STEMI Heart Attack . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
rash looking like measles over my chest, stomach, back and underarms lasting for 2 weeks
Haven't felt well since I received 5th vaccine, balance was effected experience vertigo.  The night of 12/14/2022 started feeling  pain in my left chest the pain continued the next pain progressed across chest into both shoulder to scapula.  The 11/16/2022 the pain traveled to rib on the left side of my body.  Prescribed Tylenol
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medicines were not reported. The patient was vaccinated with the second dose of GARDASIL (dose, route, lot # not provided) approximately in August 2014 (reported as "a year before"). On 12-AUG-2015, the patient was in the reporter's office to receive the third dose of GARDASIL injection (lot #, expiry date, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Right eye was found to be swollen at 0600 the morning after receiving the vaccine. It completely resolved within 2 hours
(R) upper arm - Varicella injection site. Given SQ. Pt presents next day with 9.5cm x 5.5cm raised, red whelp. Warm to touch. No fever, labored breathing. Pt c/o pain and itching at site. BENADRYL topical cream applied.
Red, swollen and hot to the touch at injection site. A little rash with two or three strikes running down arm. Took Benadryl and ibuprofen.
Pain in shoulder; difficulty with some movements, such as bending and lifting as if taking off a shirt. Pain has not subsided since vaccination.
After taking his shot he said his arm felt like it was arm fire it was burning. The burning went away but he felt unbearable pain in his muscle in his arm.
tested positive for COVID in Aug2023/Felt like had Covid again after receiving the vaccine; tested positive for COVID in Aug2023/Felt like had Covid again after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "AFib" (ongoing), notes: Diagnosed before 2007, but had cardioversion in 2007; "sinus and congestion issues in the fall" (unspecified if ongoing); "Covid-19", start date: Aug2023 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Pneumonia vaccine, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Oct2023, outcome "unknown" and all described as "tested positive for COVID in Aug2023/Felt like had Covid again after receiving the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive.  Additional information: it was reported that the patient had Covid again after receiving the vaccine. After patient got vaccine thought had COVID again, but patient did not. The event lasted until a couple of days ago, feeling better. Lasted 8 to 10 days. Patient said some of the people at work felt like that too, no further details provided. The patient had COVID-19 vaccine 12 plus, adult new formulation because it had had been over 9 months and figured coming into season again and doesn't want COVID at his age. It was further mentioned that the patient tested positive for COVID-19 in Aug2023. Patient had sinus and congestion issues in the fall. Patient didn't test at that time, then 2 days later was getting worse, clearly had COVID, didn't get a positive COVID test until 2 days after caller did. Patient had lingering sinus things. Clarified and confirmed had prior Pfizer COVID vaccines, had first 2 doses and then a booster and maybe another booster. Confirmed all doses were the Pfizer COVID vaccine. NDC numbers, lot numbers, expiration dates were unknown as the reporter did not have products or information at time of call. Had sinus problems every Sep, which was part of the delay in patient going to urgent care when tested positive for COVID in Aug2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
hands and neck are swelled up; huge red rash on every joint; Neck swelling; threw up; couldn't able to eat; knee joints, elbows and ankles swelled up; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (couldn't able to eat), JOINT SWELLING (knee joints, elbows and ankles swelled up), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint) and SWELLING (Neck swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, PANTOPRAZOLE, TIZANIDINE HCL, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), LEVOTHYROXINE and VITAMIN D3.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced JOINT SWELLING (knee joints, elbows and ankles swelled up). On an unknown date, the patient experienced FEEDING DISORDER (couldn't able to eat), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint), SWELLING (Neck swelling) and VOMITING (threw up). At the time of the report, FEEDING DISORDER (couldn't able to eat), JOINT SWELLING (knee joints, elbows and ankles swelled up), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint), SWELLING (Neck swelling) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines include Prednisone, Anti-histamines, Benadryl  Action taken with mRNA-1273 in response to the event was unknown
1 1/2 hours after receiving the MMR vaccine he called by phone and said he felt like he was going to "black out" but did not. He also complained of "tingling all over". He reports BP at that same time was 140/98 and he had not eaten all day. After eating an early lunch he still felt tingling in his hands and feet and just "felt bad" BP 128/86. He says he went home after lunch rested,took a nap, and symptoms were gone when he awoke.  12/11/08 he reports swelling in the left side of his neck/ear area. He saw a ENT physicain. Physician was not sure if in was vaccine related or not.  He recovered from this also.
Initial literature report was published on 29 November 2005. The article was a case report of a 7 month sold boy, who developed acute transverse myelitis after DTP immunization. A 7 month male without any significant past medical history, was admitted on an unspecified date, to a hospital for leg weakness. He received Dtap vaccine lot U0952AA 17 days prior to admission. Based on the clinical course and MRI findings, the diagnosis of acute transverse myelitis was made. Previous Dtap doses given at the age of 2 and 4 months were well tolerated. he had an upper respiratory tract infection 2 weeks prior to admission. He initially developed constipation for which he was admitted to the local hospital and fleet enemas were given. Subsequently, he developed urinary dribbling, priapism, and lower extremity weakness. he had no breathing or feeding difficulties. He was than transferred to the reporters hospital. So far, his developmental milestones had been normal. Birth maternal and prenatal history had all been unremarkable. Family history was negative for neuromuscular disease or for any recent illnesses. His parents and 7 year old sister had been well. He had no known dug allergies and was not on nay medications. On admission, he was alert, smiling, and was focusing and tracking well. He was not dysmorphic and he did not have any neurocutaneous stigmata. Pulmonary, cardiovascular, and abdominal examinations were normal. A detailed examination of his back did not reveal any abnormalities. He had priapism and urine was intermittently dribbling from the urethral meatus. He had flaccid paraplegia and he exhibited a triple flexion response to noxious stimulation of the lower extremities. Deep tendon reflexes were +1 on lower extremities and +2 on the upper extremities. Plantar responses were equivocal and no clonus was elicited. He had no abdominal reflexes. Cremasteric reflexes were present bilaterally. Anal tone was patulous and no anal wink was elicited. Laboratory evaluation included a complete blood count showing an increased white blood count of 16000 with 67% neutrophils. Comprehensive metabolic panel, erythrocyte sedimentation rate, urinalysis, and C reactive protein were all normal. Cerebrospinal fluid analysis showed two red blood cells/pl, seven white blood cells/pI with four lymphocytes and three monocytes, glucose of 63 mg/dl and a total protein of 30 mg/dl. Cerebrospinal fluid oligoclonal bands were negative and IgG index. The patient's MRI features showed preservation of cord architecture with a homogenously abnormal signal of T2 weighted images, patchy gadolinium enhancement and the lack of vascular channels made a neoplasm and arterio venous fistulas unlikely. Follow up MRI performed 3 months later also showed resolution of the above abnormalities (dema and signal) although the spinal cord appeared of smaller caliber. Urologic symptoms improved with steroids but motor function was never fully regained.  The reporter was not able to discover an associated agent despite an extensive diagnostic workup.
On 04/06/2021, he experienced these symptoms: chest pain, fatigue, shortness of breath, paleness, and dizziness.  On 04/08/2021, he went to the ER. It was discovered that he had a blood clot in the lower left leg, a bilateral embolism in both lungs, and a partial bowel obstruction. He was put on Eliquis, steroids, and breathing treatments.