chrisvoncsefalvay/vaers-outcomes huggingface dataset:
thumb swelled; This is spontaneous report received from contactable consumer  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262) via an unspecified route of administration on left arm on 22Jan2021 at single dose for Prevention of COVID-19 pandemic. The patient medical history included kidney problems. The patient concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266), via an unspecified route of administration on left arm on 12Feb2021 at single dose for Prevention of COVID-19 pandemic. On an unspecified date, thumbs swelled after he received his first COVID-19 Vaccine. The next week, patient had swelling in both of his hands. The following week, patient hand swelling got worse, and had pain with the hand swelling. The third week, the patient went to a doctor at a place where he could get an appointment the same day and then went to his primary care doctor. The patient continued to have hand swelling, and then he was taken to the Emergency Room. The events resulted in Emergency Room visit. The patient had to go to a Rheumatoid Arthritis specialist and then this morning patient woke up, and half of his face was swollen. The patient hands swelled after his second COVID-19 Vaccine, it progressed from a little bit of swelling to lot of swelling. The Pain of the hands on the scale of 1 to 10 is reported as 3 or 4. The relevant lab test included doctor did tests on patient for Rheumatoid Arthritis and Bursitis, and both tests were negative. The Emergency Room doctor did an ANA test that was inconclusive, and an ESR test that was negative. The patient's primary care doctor gave him more lab tests, and did another Rheumatoid Arthritis test, which was negative. The treatment included Prednisone and his hand swelling went down for 3-4 days. when patient stopped the Prednisone, the swelling in his hands came back. The patient primary care doctor provided the patient with Rheumatoid Arthritis medicine to take, but patient stopped taking the medicine after 2 days. The patient received the Colchicine twice because he was been told not to take it anymore. So, they repeated that (Colchicine) if it was arthritis then it would help and it would go down but it did not and they told him to stop taking it. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.  Follow up (02Apr2021):Upon follow up, new information included anatomical location details, lot details,treatment details like colchicine.
Swelling in the arm; Sore; Big red blotch formed below the injection site; itching; Hives; A lot of redness; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Sore), RASH MACULAR (Big red blotch formed below the injection site), PRURITUS (itching) and URTICARIA (Hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Sore), RASH MACULAR (Big red blotch formed below the injection site), PRURITUS (itching), URTICARIA (Hives), ERYTHEMA (A lot of redness) and INJECTION SITE PAIN (Tender to touch). At the time of the report, PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Sore), RASH MACULAR (Big red blotch formed below the injection site), PRURITUS (itching), URTICARIA (Hives), ERYTHEMA (A lot of redness) and INJECTION SITE PAIN (Tender to touch) had resolved.        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.   No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received on 20-Jul-2021 and included Outcome of all the events were updated from unknown to recovered.
Patient was having vaccines administered- HPV, then ADACEL, then VARIVAX - all left arm. During last injection (VARIVAX), patient stated, "I'm going to have a seizure" then all four extremities stiffened -> eyes rolled back about 15 seconds -> immed. recovered alert, crying
Right arm (vaccinated arm) has been in pain; Arm goes numb; Lose sensation on hand; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 16:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. 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. The patient did not receive any medication within two weeks of vaccination. On 30Mar2021 at 16:45, the patient experienced right arm (vaccinated arm) been in pain, arm goes numb and lose sensation on hand. It was reported that, patient was unable to lift it even half way up without feeling pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm (vaccinated arm) been in pain, arm goes numb and lose sensation on hand were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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. On or about 23-DEC-2011, a healthcare provider at a health system administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 23-JAN-2017, the patient was treated by a physician at a health system for shingles and postherpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, 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. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Patient received the first dose of the Pfizer COVID-19 vaccine and subsequently developed hives on her mouth, neck, and chest. Associated with mild chest discomfort and throat swelling, but not with shortness of breath. Patient was given epinephrine and Benadryl by medics and pharmacist on scene. Patient took Benadryl 25mg prior to vaccine. Patient was given Solu-medrol and Pepcid in ED. Normal EKG and no further allergic reaction noted.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of and VAQTA, lot number L015460, expiration date 20-JUL-2017 (dose, frequency and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA004510: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005550.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/17/2022 NAUSEA AND VOMITING
After vaccination, nurse observed seizure activity while patient sitting in chair. Tonic-clonic motion in arms.  Seizure activity lasted approximately 3-4 minutes. Skin pale, cool and clammy. Blood pressure 94/72, pulse 68. Respirations 16. O2 sat 97%. EMS called and patient was transported for evaluation. Follow up phone call to patient 4/7 at approx. 5 pm.  Patient resting.  Stated she had negative CT at the hospital and has neurology appointment tomorrow, 4/8. Follow up phone call will be placed 4/8 after neuro appointment.
"Several" pt exp non-response p/completion of a series of 3 Engerix-B vax; These pts are not HBV protected;
Information has been received from a physician concerning a 15 year old female with irritable bowel syndrome and with no history of drug reactions/allergies, who on 06-JUL-2007 was vaccinated with the first dose of Gardasil (0.5 ml). Concomitant vaccination on 06-JUL-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and MENACTRA. Other concomitant therapy included PRILOSEC. It was reported that within a few minutes the patient experienced sharp abdominal pain, and her blood pressure dropped from 100/60 to 90/65 and she felt faint. The patient remained in the office and lied down. It was reported that she felt better. Additional information has been requested.
Moderate swelling erythema shoulder to 2/3 down to elbow. Moderate itching. Persisted greater than 48 hours.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: per the pt he feels lightheaded and dizzy still having this problem and he went to pcp he prescribed meclizine , pt also was about to fall couple of times
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 20-JAN-2017, the patient was vaccinated with VAQTA (which had the lot # L030442, expiration date 19-DEC-2016 (expired product administered)) for prophylaxis (dosage details, route or strength were not informed). Information regarding concomitant medication was not provided.  No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
After the first dose of the vaccine I was very tired. After the second dose I was extremely tired. I started to have trouble breathing at night and I developed a cough one week after the second dose. After two weeks I went to an Urgent Care and they did not find anything on X-Ray. Two weeks later I was not improving so I went back because my breathing was worse. X-Ray showed Pneumonia in both lower lungs. I recovered a little over two weeks after antibiotics. I had Covid-19 in July of 2020 and I had not felt well since then. I was only working two days a week up until the time of the first dose of the vaccine. I was originally given a Benzoate capsules but those did not help. My breathing seems to better than it was for the time period since I got the Covid-19 last year. I still have a dry cough and I get short of breath on occasion. I use Flonase currently and I am able to work more now.
Patient experience rapid heart rate / tachycardia 36 hours after receiving vaccine.  Next day, Cardiologist diagnosed atrial fibrillation.    Patient now taking digoxin.   No improvement.   10 days following vaccine, at follow up appointment with doctor, doctor recommends cardioversion.   Patient continues to experience dyspnea and atrial fibrillation.
1/25/21 6:30 right arm started getting sore, 7:30 Pt reports getting really hot like she was on fire (no fever), 8:00  Pt felt light-headed, dizzy, nauseous, vomiting, diarrhea, and whole body started aching which lasted all night long. 1/26/21 body aches turned into pain which lasted for 2 hours. Pt took 2 Tylenol and 2 Ibuprofen at the same time at 4:15 pm. Pain finally started getting better 2 hours after that and turned into aching. Pt felt better at 6:00 pm. 1/27/21 Pt feels much better.
Shivering for 12 hours. Upset stomach with vomiting the following evening (02/18/2019).
Soreness around the injection site; Body soreness; Chills; Fever of 101.7; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number EW0153 and expiry date: 31Jul2021), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, approximately 16 hours after receiving the vaccine, the patient experienced localized soreness around the injection site, body soreness, chills, and a fever of 101.7. On an unspecified date, the patient underwent lab tests and procedures which included body temperature which was about 101.7. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
few hives/rash; few hives/rash; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the left arm on 11Jan2021 at 15:00 at a single dose in the hospital for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of report. The patient experienced few hives/rash on 11Jan2021 at 18:00, about 2 hours after getting the vaccine. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. Outcome of the events was unknown.
CHILLS; PERSISTENT HEADACHE; MUSCLE ACHE; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, persistent headache, muscle ache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, persistent headache, muscle ache, fatigue and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417710.
suffered an acute thrombosis of his left middle cerebral artery that required acute thrombectomy
Chills, muscle pain, joint pain, headache, fatigue, slight fever, skin tingling/sensitivity.  Water, Tylenol, sleep  At onset, really uncomfortable, flu-like symptoms.  Once awoke about 10:00am, 04/25/2021, chills were gone, but other symptoms present.  Fever reached 99.1 about 5:45pm.  At this time, slight muscle pain and headache (11:25am, 04/26/2021.)
p/vax pt devel fever of at least 102 w/cellulitis & swelling of the leg;
This case involves a 74 years old female patient who reported trouble lifting their arm, swelling, redness, pain and pain in their shoulder and then severe joint pain in their shoulder while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-May-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6853AA via intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date the patient developed a non-serious  event "trouble lifting their arm" (limb discomfort) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious  event "swelling" (vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "redness" (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pain" (vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pain in their shoulder and then severe joint pain in their shoulder" (arthralgia) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "severe joint pain in legs" (pain in extremity) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "The patient reported having swelling, redness, and pain and then trouble lifting their arm and then it moved to joint pain in their shoulder and then severe joint pain in their shoulder and then it was in their legs for the next few weeks". Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable. It was not reported if the patient received a corrective treatment for the events (swelling, redness, pain, pain in their shoulder and then severe joint pain in their shoulder, trouble lifting their arm, severe joint pain in legs). At time of reporting, the outcome was Unknown for the event swelling, was Unknown for the event redness, was Unknown for the event pain, was Unknown for the event pain in their shoulder and then severe joint pain in their shoulder and was Unknown for the event trouble lifting their arm.
Very tender lymphadenopathy; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (Very tender lymphadenopathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Very tender lymphadenopathy). At the time of the report, LYMPHADENOPATHY (Very tender lymphadenopathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.
Presented to ED for shortness of breath. Patient stated it had been constant and worsening. He had a productive cough with yellow sputum. He also stated he had intermittent diffuse anterior chest pain. Patient was hypoxic on room air 78-81%, hypertensive 197/107, tachycardic 117 and tachypneic 24. He was placed on a non-rebreather mask initially and changed to bi-pap due to work of breathing. COVID-19 test positive. He was started on Decadron. Venous blood gas showed worsening acidosis due to hypocarbia. Patient intubated. Current condition unknown.
29NOV93 mom states p/vax pt cried (screamed) inconsolably for close to 3 hrs; had vax around noon; crying started around 5PM; called pvt MD advised DPH; p/dose of DPH crying stopped; no other episodes of screaming;
ANEMIA; INSOMNIA; BODY ACHES; CHILLS; ARM SORENESS; TINGLING IN TOES AND FINGERS; NUMBNESS IN TOES, KNEES &  FINGERS; This spontaneous report received from a patient concerned a 41 year old female. 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021 16:30, the subject experienced tingling in toes and fingers. On 02-APR-2021 16:30, the subject experienced numbness in toes, knees & fingers. On 02-APR-2021 16:30, the subject experienced body aches. On 02-APR-2021 16:30, the subject experienced chills. On 02-APR-2021 16:30, the subject experienced arm soreness. On an unspecified date, the subject experienced anemia, and insomnia. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 03-APR-2021, had not recovered from tingling in toes and fingers, numbness in toes, knees & fingers, and arm soreness, and the outcome of anemia and insomnia was not reported. This report was non-serious.
Muscle pain. patient called pharmacy on 3/13/2015 stating that she has difficulty moving her left arm.
fluid on her heart caused by a virus; fluid on her heart caused by a virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on (lot number and expiry date unknown) at single dose for Covid-19 immunization. Medical history included low fever from 01Jan2021 (negative for covid on 01Jan2021). The patient's concomitant medications were not reported. On 14Jan2021, the patient was hospitalized for fluid on her heart caused by a virus on unspecified date. The patient was scheduled to take her second dose of the vaccine on Saturday (unspecified date). The patient would like to know if she would be able to get her second dose of the Pfizer Covid vaccine after the side effects she experienced post-vaccination on the first dose. Her family doctor has told her to wait 90 days. She was also scheduled to visit her cardiologist tomorrow. The outcome of the events fluid on her heart caused by a virus was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Severe ear ache, in right ear,  both ears stopped up could not hear, everything sounded muffled for about 4 weeks