chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Welts on both arms appeared in a straight line on both arms several days after 1st dose, which I now think are related to the vaccine; This is a spontaneous report from a contactable consumer (patient himself).  A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FF2589), via an unspecified route of administration, on 30Sep2021 14:30 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient did not have a medical history and concomitant medications were provided. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Welts on both arms appeared in a straight line on both arms several days after 1st dose (Oct2021), which he now thinks are related to the vaccine. The event was reported as non-serious. No treatments were given for the event. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the event.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101440822 Same reporter, different vaccine dose (2nd dose), different event
Covid; A spontaneous report was received from a nurse on 19OCT2022 along with additional information received on 20OCT2022 and 21OCT2022. It described a 61-year-old male patient who was diagnosed with Covid (PT: COVID-19) following administration of oral Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: 3003783, expiry date: 31AUG2023; National drug code (NDC): 69401-000-01) for immunisation. It was reported that on 15OCT2022 (Saturday), the patient took the first dose of Vivotif following which he was admitted to an emergency room due to high temperature and was diagnosed with Covid. Reportedly, the patient was given Paxlovid as a treatment medication and was advised to discontinue taking Vivotif. It was confirmed that on the same day (15OCT2022) the patient was back at his home. Furthermore, it was reported that the patient was left with one pill of Paxlovid, the next dose of which would be on 20OCT2022. Additionally, the reporter confirmed that the patient was fine and just congested and again wanted to start taking Vivotif.  The patient was recovering from the reported event, at the time of this report. Therapy with Vivotif was withdrawn with respect to the reported event.  The patient had no medical history, or allergies and was not on any concomitant medications.  No additional information was reported.  Company comment: It was reported that a patient took the first dose of Vivotif for immunisation and was diagnosed with Covid (COVID-19). In response to the event, he took Paxlovid and Vivotif was discontinued. Further information regarding the event, medical history and concomitant medication is limited. Considering the limited case information, the causality of COVID-19 is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took the first dose of Vivotif for immunisation and was diagnosed with Covid (COVID-19). In response to the event, he took Paxlovid and Vivotif was discontinued. Further information regarding the event, medical history and concomitant medication is limited. Considering the limited case information, the causality of COVID-19 is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.
12 cm x 11 cm area; warm, red, indurated to (RT) arm at injection site. Non-tender; full ROM. Tx: cool compresses; PRN BENADRYL. Return to office or call if: severe pain, fever; increased redness after 48-72 hours.
pt had a positive COVID test on 8/24/22 in General Hospital, was placed on BiPAP; transferred to Regional Medical Center for higher level of care; pt had worsening SOB, O2 desaturation in the 80s on 2L O2 via NC; nausea/diarrhea, poor oral intake; CXR showed right sided infiltrates Left perihilar infiltrates; respiratory status worsened requiring intubation and mechanical ventilation with proning; multi-system organ failure; transitioned to comfort care with palliative extubation; pt passed away in the hospital
In early February I had a headache and a runny nose which began to be congestion. I also had a low-grade fever for about 3 days and scratchy throat. I tested negative for COVID-19. I spoke to my doctor and he said go to the emergency department if it did not get better. I still have a little bit of a headache as of today and I am sneezing a lot.
A report has been received from a physician concerning a 32 years old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 10-Oct-2012, the patient received nasal FLUMIST. On 11-Oct-2012, the patient developed right sided Bells Palsy with left sided nerve deficiency and bilateral double vision. Patient was getting progressively worse. The symptoms began with tongue numbness, then face numbness and progressed to facial drooping. The patient was hospitalized on 18-Oct-2012. At the time of reporting, the events of Bells Palsy, left sided nerve deficiency and bilateral double vision were ongoing. The reporting considered the events to be serious due to hospitalization.
patient states she had Redness, swelling, warmth, tenderness to the touch and pain with not  contact to the upper outer Right deltoid near the injection site, about 4 1/2 inch area, also large inflamed lump above the elbow 4 inches and 1/3 around the arm.
Patient received a Td 10/9/02, left deltoid with problems. Mom called today (10/14/02) and said the area was reddened with a bump; denied any warmth or pain at site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), on 23Mar2021 at 11:30 as dose 2, single (Lot number: EP7534), in right arm, on 08Oct2021 at 13:15 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 28May2022 at 13:15 as dose 4 (booster), single (Lot number: FN2908) at the age of 61 years, in right arm 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: "CLL - leukemia" (unspecified if ongoing); "malignant melanoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Sep2023 at 21:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: From 11Sep2023 to 16Sep2023 patient Paxlovid as treatment of COVID-19. The patient had fever, headaches, body aches, nausea, lung congestion heavy, intense fatigue, light sensitivity, sneezing, coughing, brain fog.
Subsequently post vax, laboratory evaluation revealed negative seroconversion. It was noted that this was the six time taking it over the course in two years.
flu; Initial information received on 26-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, route and frequency: not reported) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination. Information on Batch number will not be available for this case  On an unknown date the patient developed a non-serious "flu (influenza)" (unknown latency) following the administration of influenza vaccine.  It was reported that "Only time I ever took a flu shot I was sick for a week with the flu never again that was 35 years ago".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
upper body inflammation; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization.  The following information was reported: INFLAMMATION (non-serious) with onset 04Apr2021, outcome "recovered" (2021), described as "upper body inflammation"; PAIN (non-serious) with onset 04Apr2021, outcome "recovered" (2021), described as "pain".  Additional information: Patient received 2nd dose of Covid vaccine on 27Mar . 8 days later he started experiencing upper body inflammation and pain and that lasted a couple of weeks. He is wondering if there have been any other reported incidents of this from the Covid vaccine. Relayed RA information and transferred. Faxed due to long hold times.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fainted 2-5 minutes after the injection. Came to quickly and recovered enough to walk out after a short rest.
Patient was administered a 3rd dose of the Shingrix vaccine. Patient claimed no adverse effects.
This spontaneous report as received from a female Nurse patient of unknown age concerning herself. On 16-SEP-2014 (also reported as 2 days ago) the patient was vaccinated with PNEUMOVAX 23 lot # K007821; expiry: 06-JUN-2015, dose 1 in the right arm. No concomitant medications reported. Approximately on an unknown date in September 2014 the patient experienced swelling on arm, swelling looks cellulitic, arm is red and injection site so swollen that her right arm is 4 cm (centimeters) larger in circumference than her left arm. She stated that she received the dose two days ago. She stated that the injection site was so swollen, that her right arm was 4 cm larger in circumference than her left arm. She stated that she saw her physician and that they used a doppler to rule out a blood clot. She stated that she was started on KEFLEX. The nurse stated that this swelling looks cellulitic. The nurse stated that she would like to request a lot check on with lot K007821 expiry: 06-JUN-2015. She stated that she would like to be contacted concerning the results of the lot check by email or by a call on her cell phone. the outcome of arm is red, injection site so swollen that her right arm is 4 cm larger in circumference than her left arm and swelling on arm, swelling looks cellulitic is unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received concerning a female patient of unknown age from her mother. The patient was vaccinated with a first, second and third dose of GARDASIL (lot number, expiry date, dose and route unspecified) on 21-DEC-2009, 17-JULY-2012 and on 21-NOV-2012 respectively. No adverse experience was reported. Additional information has been requested.
Pt called to discuss reaction after flu vaccine today. C/o (L) shoulder itching with hives. Hives starting to go away + area red; no swelling, no pain, no SOB, no swelling of lips/tongue or throat.
This spontaneous report as received from a physician refers to a male patient of unknown age. Relevant medical history and concomitant medication were not provided. On 26-DEC-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU at a pharmacy. Lot number, dose, route and frequency were not provided. The following morning, on 27-DEC-2013, the patient awakened with a shingles-like rash on his buttocks and hips. The patient was examined by the physician who stated that the rash appeared to be shingles. The physician prescribed an unspecified antiviral medication for the patient, who filled the prescription on 30-12-2013. The prescription packet was accepted by the physician, and he will contact the patient to see if the patient will come back to his practice for collecting the specimen. The outcome of shingles was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been requested.
This case was reported by a consumer and described the occurrence of arm soreness in a 69-year-old female subject who was vaccinated with Flulaval for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included sulfa allergy. Concurrent medications included Toprol XL, Aspirin, Multivitamins, Calcium salt and Glucosamine. On 15 October 2007 at 16:15 the subject received unspecified dose of Flulaval (unknown, left arm). The subject was not able to specify which vaccine she received. On 15 October 2007, less than one day after vaccination with Flulaval, the subject experienced arm soreness. Two hours after vaccination the subject developed hives that spread to her whole torso. By day five, the subject's torso was covered mainly in the front and stopped under the arms and under the breasts; it was not on her neck. The hives were also no her calves. The subject was treated with Benadryl and Poison ivy lotion. Six weeks later, in November 2007, the events were resolved. This case was reported by a consumer, and subsequently confirmed by a physician, that described the occurrence of arm soreness in q 69-year-old female subject who was vaccinated with FLULAVAL (Glaxosmithkline). On 15 October 2007 at 16:15 the subject received unspecified dose of FLUVAL (unknown, lef arm). The subject was not able to speciy which vaccine she received. On 15 October 2007, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness. Two hours after vaccination the subject developed hives that spread to her whole torso. By day five, the subject's torso was covered mainly in the front and stopped under the arms and under the breasts; it was not on her neck. The hives were also in her calves. The subject was treated with BENADRYL and POISON IVY lotion, Six weeks later, in November 2007, the events were resolved. Follow-up information was received on 30 January 2008 via a physician, which conflicted with the original report, According to the physician, the arm soreness, hives, and itching occurred on 20 October 2007, five days after the subject was vaccinated with FLULAVAL. As of 22 October 2007, the events were resolved. The reportinf physician considered the events to be related to FLULAVAL vaccination.
On evening after vaccination, chills, body aches, felt feverish but no fever, and took Tylenol for pain. Two days after, severe jaw pain and swelling began, felt light headed. Redness and swelling at injection site. Jaw pain continued for two weeks and required 4 Tylenol does each day. Used warm compress on swollen jaw.  Then examination by dentist and oral surgeon with 3-D full mouth X-Ray showed no dental problems that would cause pain. Then went to PA at Dr 's office for examination. Swelling of cheek and neck and collar area indicated swollen glands. Did CBC panel blood draw (waiting for analysis, expect result 10/11/2021). Prescribed Prednisone to treat swelling.
L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic; L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 33-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 13Oct2021 12:00 (Lot number: FF2589) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (medically significant), UPPER LIMB FRACTURE (medically significant) all with onset 16Oct2021 04:00, outcome "recovered" (19Oct2021) and all described as "L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic". The events "L arm from shoulder to elbow hurt/ahead like a broken bone went to walk in clinic" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram (EKG): (Oct2021) good, notes: left side hurting. Therapeutic measures were taken as a result of pain in extremity, upper limb fracture.  Follow-up attempts are completed. No further information is expected.
This report was identified from a line listing obtained on request by the Company from the FDA (HA# F108235301 and 10823530) under the Freedom of Information Act on 20-JAN-2016 referring to a 11 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On 23-JAN-2015, the patient experienced abdominal pain upper, rash, vomiting, tonic clonic movements, staring, pyrexia, paraesthesia, oropharyngeal pain, nausea, malaise, loss of consciousness, hypoaesthesia, fatigue, eyelid oedema, diarrhoea and chills. No treatment was given for the adverse events. The outcome of eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia was reported as not recovered. The reporter did not assess the relatedness of the events with GARDASIL. The agency considered eyelid oedema, vomiting, pyrexia, nausea, malaise, fatigue, chills, diarrhoea, abdominal pain upper, tonic clonic movements, oropharyngeal pain, rash, staring, paraesthesia, loss of consciousness and hypoaesthesia as a medically significant events. The originally reporter was not provided. Additional information is not expected from the agency as follow up information cannot be obtained.
weakness; fatigue; server dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Pneumonia Vaccine) for prophylaxis.   On 15th October 2022, the patient received Shingles vaccine and Pneumonia Vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced weakness, fatigue and dizziness. On an unknown date, the outcome of the weakness, fatigue and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the weakness, fatigue and dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-DEC-2022 Reporter's Comment: This case was received from consumer via interactive digital media. The reporter stated that on 15th October 2022 the patient got a shingle shot and a pneumonia shot and had been going through weakness fatigue, server dizziness. The patient stated physician would not listen they keep ordering test. The reporter believes it's from the shingles shot. Additional supportive information: The follow up would not possible, as no contact details were available. It was unknown if the reporter considered the weakness, fatigue and dizziness to be related to Pneumonia vaccine.
shoulder and joint pain; stiffness in joints and shoulder; stiffness in joints and shoulder; This is a spontaneous report from a contactable other hcp.  A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231), via an unspecified route of administration on 11Jan2021 at single dose at left upper arm for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The first dose of the vaccine BNT162B2 was administered on 19Dec2020 at 42 years old.  Caller stated she received the 2nd dose yesterday of the covid vaccine and experienced shoulder and joint pain, and this morning she has stiffness in joints and shoulder. The patient reported that last night, her shoulder joint started hurting but it was mild. This morning, it is very painful. Caller was looking at where the medication was injected on her, and she thinks the product may have been injection too high on her arm, like it was directly under the acromion process, and she is concerned the product may have been injected directly into her shoulder joint, instead of into the muscle. She thinks that injection was given to her too high, it may went to the joint not the muscle. Caller confirmed that she had no other vaccines on the same day as her COVID vaccine. The outcome of the event shoulder and joint pain was unknown while not recovered for the other events.   Information on lot/batch number has been requested.
Information has been received from a physician concerning an 18 or 19 year old patient with no family history of deep vein thrombosis (DVT) and previously healthy who was vaccinated with a first dose of GARDASIL.  5 days after the vaccination, the patient came in the hospital with a right upper extremity DVT that required "Lyticx".  At the time of this report, the outcome was unknown.  Additional information has been requested.
swelling; red circle; tenderness; redness; hot to touch; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (red circle), TENDERNESS (tenderness), ERYTHEMA (redness) and FEELING HOT (hot to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and PROTEIN SUPPLEMENTS for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), ERYTHEMA (red circle), TENDERNESS (tenderness), ERYTHEMA (redness), FEELING HOT (hot to touch) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm). At the time of the report, SWELLING (swelling), ERYTHEMA (red circle), TENDERNESS (tenderness), ERYTHEMA (redness), FEELING HOT (hot to touch) and TYPE IV HYPERSENSITIVITY REACTION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was unknown
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (dose#, dose, strength and lot # were not reported, intramuscular). The patient experienced "fatigue" on unspecified date after injection of GARDASIL. The patient had called doctor's office for medical attention. Additional information has been requested.