chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he tested positive with the rapid test/not feeling well; he tested positive with the rapid test/not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Oct2022, outcome "recovering" and all described as "he tested positive with the rapid test/not feeling well". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical course: The patient reported not feeling well on 02Oct2022, and it was getting worse so he went for a COVID-19 test on 04Oct2022. He tested positive with the rapid test and his doctor prescribed him PAXLOVID. The patient stated he was doing okay now except he got a cough and fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm the next day; weren't feeling well; got what they expected; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) in a patient of an unknown age and gender 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 PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected). At the time of the report, PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
One week and one day after the shot, a red welt developed below the injection site/bruise.  Slightly swollen, sensitive to touch, red.  Felt like a large knot.
Medical assistant reported that a 4 year old patient inadvertently received 4th dose (w038864  7/16/2025) of RECOMBIVAX.  The medical assistant did not provide the lot numbers for the previous 3 doses of RECOMBIVAX.   No additional AEs were reported.; No additional AEs were reported.; This spontaneous report was received from Other Health Professional and refers to a 4-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot #W038864, expiration date: 16-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced Medical assistant reported that a 4 year old patient inadvertently received 4th dose of RECOMBIVAX. The medical assistant did not provide the lot numbers for the previous 3 doses of RECOMBIVAX. No additional AEs were reported. No further information provided. No PQC.
01/19/2021 patient received  Moderna Vaccination. Later that evening patient began having abdominal pain.  He took 2 tums and reported that he felt much better and slept well.  On 01/20/2021 patient was seen by home health skilled nurse.  All vital signs within normal limits with no complaints at skilled nurse visit.  On 01/22/2021 patient participated in therapy with no complaints. Home Health notified today 01/26/2021 that patient was admitted to hospital on 01/22/2021 for abdominal pain.
Symptoms started with a cough and then an itchy throat. Then throat became really sore, and developed a fever (eyes felt burning). Then a nasal congestion with runny nose and headache. This lasted overnight and the symptoms were almost completely gone by 10/10/2012 at 11:00 AM.
Information has been received from a physician concerning a 65 year old male who on 05-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #661577/1161X). On 05-NOV-2008 the patient experienced tenderness, swelling and pain at the injection site. The pain became severe and stemmed from the shoulder up through the neck. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Follow-up information received from the physician indicated that the patient with asthma, hypolipidaemia, gout, diabetes mellitus and allergies to erythromycin and niacin received a dose of PNEUMOVAX 23 (Lot #661577/1161X) IM into the left arm on 06-NOV-2008 (previously reported by the physician as 05-NOV-2008). Concomitant therapy included influenza virus vaccine (unspecified) IM into the right arm on 06-NOV-2008. The patient experienced pain at injection site on 16-NOV-2008, 10 days after the vaccination. The patient also had difficulty ROM (range of motion). On 14-JAN-2009, one magnetic resonance imaging (MRI) of the left shoulder was performed. The changes on MRI suggested degenerative changes. The patient had an orthopedic evaluation after the MRI. The reporter considered tenderness, swelling and pain at the injection site, pain severe and stemmed from the shoulder up through the neck, difficulty ROM to be other important medical events. Additional information has been requested.
Very red, swollen arm from site of injection almost to elbow, starting about 2-3 hours after vaccine administered - went to own M.D. 48 hours later as rash and swelling kept getting worse - M.D. made diagnosis of cellulitis and put on clindamycin for 10 days.
Sore arm the first couple of days.   After about 7 to 10 days I started feeling sort of dizzy.  Equilibrium is a little off. Sometimes vertigo.  (maybe 3 episodes of vertigo)
Caller is a Caregiver calling about her mother who is losing hair since receiving this last shot, the newest Moderna booster on November 2022.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALOPECIA (Caller is a Caregiver calling about her mother who is losing hair since receiving this last shot, the newest Moderna booster on November 2022.) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient was never diagnosed with COVID-19 and had good health.  Concurrent medical conditions included Allergy.  In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Caller is a Caregiver calling about her mother who is losing hair since receiving this last shot, the newest Moderna booster on November 2022.). At the time of the report, ALOPECIA (Caller is a Caregiver calling about her mother who is losing hair since receiving this last shot, the newest Moderna booster on November 2022.) had not resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was not like this with the last shots. The patient had a lot of hair loss.   The reporter did not know lot number or any previous dose information.  No treatment medications were reported.  Reporter did not allow further contact
Headache, Myalgia, Fever, NauseaVomiting, anorexia  Narrative:
4/26: pain at injection site, containing to strengthen as day progressed.  8pm: swollen lump nodes in neck, fatigue.  4/27: 4am; fever, chills, body aches, fatigue. Pain at injection site and swollen lump nodes in neck and left arm pit. Continues throughout the day, off and on fever every couple of hours.  6pm; fever gone, chills gone, extreme fatigue gone.  4/28: 4am; swollen lymph nodes, neck and left armpit.  Painful injection site and left armpit lymph node. Minor body aches.
didn't sleep well the night of injection, about an hr ago my stomach started cramping and it went to my throat like i was gaging and it went through your arms and into your head.
Anaphylaxis  3 min after receiving injection experienced tightness in the throat and was taken to ER  Narrative:  Employee reports that he experienced anaphylaxis 3 mins after receiving injection and was taken to ER and given IV steroids and pepcid
Feeling paralyzed; Numbness in both arms and both hands; Couldn't shave or brush his teeth; Weakness; This spontaneous case was received on 14-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-03649) and concerned a male patient of unknown age.  The patient's medical history and concomitant medications details were not reported.  On 02-Oct-2020, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: left arm and route of administration: intramuscular) for flu prevention. The batch number reported was 276546, expiration date: 25-Jun-2021.  On the same day, some hours after vaccination with Flucelvax QIV, the patient started feeling paralyzed and numbness in both arms and both hands.  On an unspecified date in Oct-2020, the patient started therapy with prednisone on his own. He couldn't shave or brush his teeth. The patient developed weakness.  On an unspecified date in Oct-2020, the patient recovered from the event of 'paralysis'.  At the time of initial reporting on 14-Oct-2020, the patient had not recovered from the events 'numbness of upper extremities' and 'weakness', as it was reporter he was better, but still felt weakness and numbness in both arms.  The outcome of the events 'loss of personal independence in daily activities' was not reported.  The reporter did not provide the causality assessment.  The event of 'paralysis' and 'loss of personal independence in daily activities' was considered as serious due to criterion of medical significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: The patient developed paralysis and hypoesthesia several hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The events of the loss of personal independence in daily activities and asthenia occurred on an unknown date within same month, making temporal relationship compatible. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed paralysis and hypoesthesia several hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The events of the loss of personal independence in daily activities and asthenia occurred on an unknown date within same month, making temporal relationship compatible. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Vomiting and fever. Had Vaccine mid-afternoon on the 10th. Had a fever that evening and through the night. Early morning complained of stomach ache and then got up at 8 am and vomited. Still has a fever.
Reaction occurred sometime between administration of vaccine on 7/31/12 and NP phone call follow-up of labs on 8/3/12. Myalgia, Fever & Pain, Swelling, Chills, Malaise.
Partial deafness on her right ear; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Rx 1420942-00), via an unspecified route of administration in right arm, on 12May2021 at 03:15 PM (15:15) (at the age 34 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 14May2021, the patient felt partial deafness on her right ear for several weeks. The adverse event resulted in disability or permanent damage. No treatment was administered for the event.  Since the vaccination, the patient has not been tested for COVID-19. At the time of last observation, the patient had not recovered from the event.
I was diagnosed with temporal arteritis which is inflammation of the arteries in the temple area which resulted in a sudden onset of double vision. The following week, I saw my doctor who suggested I see a rheumatologist. He has been treating me with Prednisone and Actemra that is administered intravenously twice a month, in hopes that will replace the need for steroids. Around 11/17/2022, I had a fairly large doses of Prednisone administered intravenously which helped block the progression of that disease. Since then, I 've been treated with changing strength of Prednisone as well as the infusions. I was a participant in trials for AstraZeneca which began in 2020. I received the active vaccine and had no incidents with any of the AstraZeneca doses. However, my rheumatologist does not believe this health event to be vaccine related. I received my second dose of that in 01/2021 and did not receive my third dose, which was Pfizer until late 2021.
Bell's Palsy; postherpetic nervous system involvement; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 09-MAR-2017, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered blisters and rash over the left upper eyelid and left upper nose area and was diagnosed with shingles and postherpetic nervous system involvement. Patient also suffered blurred vision and weakness on her left side and was diagnosed with Bell's Palsy. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using Company's product. Patient also expenences mental and emotional distress due  o resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be disabling.
PT IS REPORTING EXTREME EXHAUSTION AND VERY PALE TO COLOR 6 DAYS POST VACCINE.  PT STATES HE WAS DIAGNOSED WITH COVID IN NOVEMBER 2020, BUT HAD NO SYMPTOMS AND RECEIVED NO TREATMENT FOR COVID.
Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited 15min with no symptoms)-upon return patient c/o initial tingling to lips and then itching across face. Treated with 25mg Benadryl, monitored for 40 min. Vital signs remained stable and patient stated that she felt better upon leaving the center.
Arm is tight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm is tight) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20, 029K20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Arm is tight). At the time of the report, VACCINATION SITE INDURATION (Arm is tight) outcome was unknown.            No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-369389, MOD-2021-369392 (Patient Link).
Patient admitted for Headache and fever, found to be COVID-19 Positive upon admission, post vaccination.  Pt received both COVID vaccines-Moderna- last dose was 04/22- developed COVID.   Allergies (drug/food and reaction):__Niacin Date of Vaccination 1 :__3/25/2021- Moderna-Lot 018B21A Date of Vaccination 2 :__4/22/2021- Moderna ?lot 046b2A Clinic Administering Vaccine: County Health department Injection site: Unknown (Arm)  Hospital Admission 6/3/2021 for headache and low grade fevers Positive covid test 6/3/2021 Discharged 6/5/2021
Patient received Moderna vaccine on 2/23/21 and presented to hospital on 03/02/21 with symptoms of covid-19 infection. Tested positive at birth center on 03/01/21 and began feeling symptomatic on 02/28-03/01. Patient is symptomatic and has had maternal tachycardia, fever, fatigue, myalgias, cough, shortness of breath. Of note, there is associated fetal tachycardia. Patient is preterm and today is a 22 y/o G2P0010 at 34+4. Has thus far received adequate prenatal care with no pregnancy complications.
No other adverse events reported; Caller reports that seven doses of improperly stored GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications past drug reaction or allergies were not reported.  On 07-JAN-2022, the patient was vaccinated with one (1) improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T039467 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 20-MAY-2023) for prophylaxis (product storage error).   The vaccine previously underwent a temperature excursion of 33.4 degrees Fahrenheit (F) for 2595 hours. There was no previous temperature excursion. No further information provided.   No other adverse events were reported (no adverse event).  This is one of seven reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007812: US-009507513-2203USA007915: US-009507513-2203USA008053: US-009507513-2203USA008063: US-009507513-2203USA008097: US-009507513-2203USA007997:
Diarrhea, Both Eyes Itchy & the Eyelids a Bit Swollen
Arthralgias and edema x 2 weeks tx prednisone taper, pain and nausea med and DOW
FLU LIKE SYMPTOMS, HEADACHE, SORE THROAT FOR TWO DAYS. AS OF TODAY THE 22ND AM STILL LETHARGIC AND HURT ALL OVER.    HAD THESE SYMPTOMS WITH ALL 3 MODERNA SHOTS.
Extreme fatigue,  constant headache that Tylenol and Ibuprofen would not help.  Chills,  fever,  night sweats.... from 6:00 p.m. to noon the following day.
lack of energy; Temperature dropped to 97.1; chills; dizzy; joint stiffness; muscle stiffness; soreness; peripheral neuropathy; pain at injection site; tingling sensation; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years before day of reporting, on the upper left thigh) and neuropathy (experienced neuropathy in this area about 3 to 4 times since having shingles).   On 28th September 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. On 28th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), injection site pain and tingling sensation. On 29th September 2020, the patient experienced loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain. On an unknown date, the outcome of the peripheral neuropathy and tingling sensation were not recovered/not resolved and the outcome of the injection site pain, loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain were recovered/resolved.   It was unknown if the reporter considered the peripheral neuropathy, injection site pain, tingling sensation, loss of energy, body temperature decreased, chills, dizziness, stiff joint, muscle stiffness and pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional case details were reported as follows: The patient reported case for himself. The patient received first dose of Shingrix vaccine in the left arm and the high dose flu shot at the same time in the right arm. The patient reported peripheral neuropathy in upper left thigh and a tingling sensation that was fairly pronounced at night when goes to sleep and that began after receiving the vaccine and was still ongoing but not as severe. The patient reported pain around the injection site that began on 28th September 2020 after receiving the Shingrix vaccine and was resolved. The patient reported on 29th September 2020, had soreness, muscle and joint stiffness in the left wrist and hand and these lasted until the weekend after the vaccine was given and was resolved. The patient reported on 29th September 2020, had felt dizzy, had chills, temperature dropped to 97.1, and a lack of energy that lasted until the weekend after the vaccine was given and was resolved. The reporter consented to follow up.
PATIENT PRESENTED WITH A RED MARK UNDER HER DELTOID ANGLING TOWARDS THE BICEP ABOUT 4 INCHES BY 1 INCH AND REPORTED ITCHING ASSOCIATED WITH THE REDNESS.
Swollen lymph node on left clavicle.  Patient given Keflex 500mg qd for 5 days.  Swelling decreased.