chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a male 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) 1 total dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that her husband had blood clot after vaccination. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210508168-COVID-19 VACCINE AD26.COV2.SI-BLOOD CLOT. 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).
left arm feels useless; red left arm; warm left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (left arm feels useless), ERYTHEMA (red left arm) and FEELING HOT (warm left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LIMB DISCOMFORT (left arm feels useless), ERYTHEMA (red left arm) and FEELING HOT (warm left arm). At the time of the report, LIMB DISCOMFORT (left arm feels useless), ERYTHEMA (red left arm) and FEELING HOT (warm left arm) outcome was unknown. Not Provided          No concomitant medication was reported. The treatment medication was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: followup received with no newinformation
Fever of 100.2, feel weak and horrible.; Fever of 100.2, feel weak and horrible.; Fever of 100.2, feel weak and horrible.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 11:15 as dose 4 (booster), single (Lot number: GL0446) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), ASTHENIA (non-serious), MALAISE (non-serious) all with onset 22Nov2022, outcome "not recovered" and all described as "Fever of 100.2, feel weak and horrible.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, asthenia, malaise.  Additional information: It was also reported that patient had covid prior to vaccination. There was no covid tested post vaccination and no known allergies.
Patient described not feeling right. Looked pale and then vomited. (Mom returned to let us know patient is fine). After admin of vaccine RPh noticed immediate raised nodule at sight of injection. Told to wait in pharmacy for 15 minutes to make sure no reactions. After a few minutes patient complained of not feeling right and appeared pale, one minute later he vomited. RPh went to admin. EPI-PEN but Mom/and patient said he was feeling better and he did not want it. Tech called the EMS right away and they arrived shortly thereafter and agreed that patient was doing better. They took him to hospital for analysis.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 05Sep2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Sep2021 at 13:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with an unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolving at the time of the report.
A week after shot, I began feeling intense back pain which radiated to my right groin.  Back pain went away, but pain continued to my left need, shoulders, and then arms. Feels like those areas are inflammed,
Fatigue; Headache; muscle pain; chills; joint pain; fever; injection site swelling; nausea; painful lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Mrna, Lnp-s, Pf) in the right arm on 09Mar2021 at 10:30 (at the age of 57-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Mrna, Lnp-s, P) in the right arm on 30Mar2021 at 10:45 (at the age of 57-years-old) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included disc degeneration, arthritis, essential tremor, neuropathy, fibromyalgia and COVID-19. Concomitant medications included primidone (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), omeprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN). The patient had the history of allergy to Lyrica. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been had tested for COVID-19. On an unspecified date in 2021, the patient experienced fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea and painful lymph nodes. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea and painful lymph nodes were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
CMA pocket her index finger with an EPI PEN . she was training one of the New CMA at out office, trainer epi are in a specific drawer . She grab it she put her index finder in the top and pocked her self. Finger turned completely white  she got admitted to the ER
NO ADVERSE EVENT OCCURED.  PATIENT WAS UNDER AGE, HOWEVER PARENT CONSENT WAS OBTAINED
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender (First name could be a female or male).  Medical history, concurrent conditions, and concomitant medications were not provided. During 2013, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-MAY-2016, the patient was treated by a physician at a physicians group, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
This is a 50-year-old male who got his first Covid vaccine last Thursday, April 8 and then he said on Saturday he began to feel weak and off balance.  He also began to feel tremulous.  He apparently said that on Saturday his right leg was shaking so bad he could hardly walk.  He denies any numbness but again feels off balance.  He has fallen down several times since Saturday.  He apparently went to urgent care and then was sent to the emergency department for evaluation.  His blood pressure was noted to be 194/130 on presentation.  He does have an obvious tremor in his left arm.  His significant other says that he at times had slurred his words.  The patient does not know what type of vaccine he received on April 8.  The patient due to these symptoms presents to the emergency department now for evaluation.  He apparently drinks about 8 to 10 cans of beer per day and has done so for an extended period.  He denies any loss of vision.  Patient was not a candidate for alteplase.  He was admitted on 4/12 and discharged on 4/14. Discharge medications included aspirin, atorvastatin, clopidogrel, and losartan.
Swelling of the arm around the injection site which is burning; swelling of the arm around the injection site which is itchy; swelling of the arm around the injection site which is hot; swelling of the arm around the injection site which is red; swelling of the arm  around the injection site; high fever; Very bad migraines; felt very weak, couldn't get out of the bed; vomiting; severe body pain; didn't eat all day; diarrhea; arm was little sore; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Very bad migraines), VACCINATION SITE PAIN (Swelling of the arm around the injection site which is burning), EATING DISORDER (didn't eat all day), DIARRHOEA (diarrhea) and VACCINATION SITE PRURITUS (swelling of the arm around the injection site which is itchy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm was little sore) and FATIGUE (felt tired). On 12-Aug-2021, the patient experienced MIGRAINE (Very bad migraines), EATING DISORDER (didn't eat all day), DIARRHOEA (diarrhea), ASTHENIA (felt very weak, couldn't get out of the bed), VOMITING (vomiting), MYALGIA (severe body pain) and PYREXIA (high fever). On 13-Aug-2021, the patient experienced VACCINATION SITE PAIN (Swelling of the arm around the injection site which is burning), VACCINATION SITE PRURITUS (swelling of the arm around the injection site which is itchy), VACCINATION SITE WARMTH (swelling of the arm around the injection site which is hot), VACCINATION SITE ERYTHEMA (swelling of the arm around the injection site which is red) and VACCINATION SITE SWELLING (swelling of the arm  around the injection site). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, MIGRAINE (Very bad migraines), VACCINATION SITE PAIN (Swelling of the arm around the injection site which is burning), EATING DISORDER (didn't eat all day), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (swelling of the arm around the injection site which is itchy), PAIN IN EXTREMITY (arm was little sore), VACCINATION SITE WARMTH (swelling of the arm around the injection site which is hot), ASTHENIA (felt very weak, couldn't get out of the bed), VOMITING (vomiting), MYALGIA (severe body pain), VACCINATION SITE ERYTHEMA (swelling of the arm around the injection site which is red), PYREXIA (high fever), VACCINATION SITE SWELLING (swelling of the arm  around the injection site) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. The pharmacist advised consumer was having a reaction to the vaccine.
This spontaneous report as received from a other health professional refers to a 4 months old female patient. The patient was vaccinated with, .5 ml PNEUMOVAX on 04-DEC-2012. No other co-suspects were reported. Concomitant medications included ACTHIB and DTaP (unspecified), tetanus toxoid. On an unknown date the patient experienced inadvertently vaccinated with PNEUMOVAX 23. No treatment information was reported. The outcome of inadvertently vaccinated with PNEUMOVAX 23 is unknown. The relatedness for inadvertently vaccinated PNEUMOVAX 23 is unknown for PNEUMOVAX 23. No adverse effects was reported at this time. No other information was provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: NSAIDs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (non-serious), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Continue to have positive rapid test; Positive, notes: Continue to have positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication in 2weeks. Anti-viral details: Product- COVID 19 Treatment, Brand- Paxlovid, treatment start date- 24May2022, treatment stop date- 29May2022, indication- treatment of COVID-19. Adverse event: On 2Jun, I had a headache and a low fever (99.5) and some congestion. Continue to have positive rapid test. I completed the course of paxlovid treatment in the morning of 29May.
bad headache; swollen in his joints; his hands are swelling; he couldn't make a fist and he also had joint pain on both shoulders, fingers, and knuckles/ joint pains in his elbows; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 72-years-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 72 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "dilated cardiomyopathy" (unspecified if ongoing), notes: he had a heart condition called dilated cardiomyopathy that he before the shots which was 20 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (2nd dose), administration date: 22Feb2021, for COVID-19 Immunization; Bnt162b2 (1st dose), administration date: 02Feb2021, for COVID-19 Immunization, reaction(s): "Headache". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "not recovered", described as "his hands are swelling"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "he couldn't make a fist and he also had joint pain on both shoulders, fingers, and knuckles/ joint pains in his elbows"; HEADACHE (non-serious) with onset 18Oct2021, outcome "recovered" (18Oct2021), described as "bad headache"; JOINT SWELLING (non-serious) with onset Oct2021, outcome "not recovered", described as "swollen in his joints". Therapeutic measures were taken as a result of peripheral swelling, arthralgia.  Additional Information: Caller stated that he had all three shots. Stated that on 18Oct2021 or 19Oct2021, received the booster and that night had a bad headache. Stated that three days later, his hands swell and he could not make fist. He had joint pains in both elbows, shoulders, hands, knuckles and was swollen in his joints. He was told to take Advil. He woke up at 6am this morning and still could not make a fist. Wanted to know if this was normal, will it go away or should he see a specialist. He had never been diagnosed with arthritis. He was asked if was for the PFIZER COVID-19 shots. Clarified that the joint pains in both hands was his fingers. He had a heart condition called dilated cardiomyopathy that he before the shots which was 20 years ago. He also clarified the swelling in his joints as in his hands. He started with swelling in his hands 4-5 days ago. He stated that the joint pains in his right shoulder started two days ago. He stated that the joint pains in his elbows started about a week ago. He stated that the joint pains in his hands started a week ago. He stated that it was bad when he first woke up and if he took Tylenol then it was tolerable. He stated that the joint pains in his knuckles started a week ago. He stated that the joint pains in his left shoulder started a week ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diffuse unbearable joint pain, lower extremity edema, pain, fever. Treatment consisted of lab work, imaging, antibiotics, prednisone, ibuprofen. Condition lasted 2 months.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site bruising (bruise at the injection site) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site bruising (bruise at the injection site). At the time of the report, vaccination site bruising (bruise at the injection site) outcome: unknown. Action taken with mRNA-1273 in response to the event: not applicable. No concomitant medications or treatment details reported.
This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included Flu seasonal, pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th 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 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 details were provided as follows: The age at vaccination was not reported. The patient was administered Flulaval vaccine after a temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up.
Approximately 2 weeks after the vaccine was administered the child developed a raised rash on both arms. Over the next 2 weeks he developed a fever and a severe rash all over his body, which has been diagnosed either as Gianotti-Crosti Syndrome or Coxsackies A6. Parents applied cortisone cream with little to no help. He was taken to the doctor on 8/28/17, given both antibiotics and an antiviral and the areas were cultured.
With second dose of Moderna (lot 031M20A) given on 2/15/21 patient passed out 22 hours after vaccination. This occured again after booster dose being 21 hours post vaccination.
Transverse Myletis characteristed initially by intense pain in think and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness in lower extremities and numbness.
Left lymph nods swollen; Breaking out in hives on stomach and back; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 27Nov2021 14:45 (Lot number: 33030BD) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Other medical history: Thyroid; "Hoshimoto" (unspecified if ongoing), notes: Other medical history: hoshimoto. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EW973, Administration time: 01:15 PM, Vaccine location: Left arm, Dose number: 2), administration date: 05May2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Lot number: EW0153, Administration time: 03:00 PM, Vaccine location: Left arm, Dose number: 1), administration date: 07Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 14:45, outcome "unknown", described as "Dose number: 3"; LYMPHADENOPATHY (non-serious) with onset 29Nov2021 05:45, outcome "not recovered", described as "Left lymph nods swollen"; URTICARIA (non-serious) with onset 29Nov2021 05:45, outcome "not recovered", described as "Breaking out in hives on stomach and back". Therapeutic measures were not taken as a result of lymphadenopathy, urticaria.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Narrative: Pt is a 74-year-old male with metastatic prostate cancer treated with abiratirone and prednisone; small cell lung cancer with hepatic metastases, CD5+ B cell leukemia (mantle cell vs SLL/CLL), obstructive nephropathy due ureteral compression from retroperitoneal lymphadenopathy requiring bilateral ureteral stenting on 5/24/21 and bilateral percutaneous nephrostomy tube placement on 5/28/21. The patient passed away 8/3/21 while in Home Hospice. The pt had covid vaccines on 1/20/21 & 2/16/2021. Pt's death not related to vaccinations.