chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Enlarged knuckles; increased arthralgia in knuckles; This case was reported by a consumer via call center representative and described the occurrence of finger arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced finger arthritis and arthralgia. On an unknown date, the outcome of the finger arthritis and arthralgia were unknown.   It was unknown if the reporter considered the finger arthritis and arthralgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's Comments: The reported had a friend who reported experiencing same symptoms, except friend was still able to fit their rings over the middle knuckles. The reporter did not want to provide friend's information.  The reporter was advised to had friend call in to provide details. The reporter did not consent to follow-up. This case has been linked to the US2022144909 case reported by the same reporter.; Sender's Comments:  GSK-US2022144909:Same reporter
Light headed, soreness at injection site, headaches, tiredness, chills, fever of 100.6, body aches.
On or about February 6, 2022 at approximately 5:00pm I started experiencing pain in my left ear, left side of my throat was sore, and left side of my neck was sore. During the early morning hours of February 7, 2022 I was awakened with a feeling like something was in my left eye. I woke up on February 7, 2022 at 6:30am to get ready for work and noticed that the left side of my face was numb, I could not shut my left eye, and the left corner of my mouth was downturned. I went to local Memorial Hospital Emergency Room where I was diagnosed with Bell's Palsy at approximately 8:30am on February 7, 2022.
I started getting symptoms of upper respirator problems like congestions and sore throat. I had fever, body aches, and a headache. I took an at home COVID-19 test that was positive. I contacted my doctor and did a telehealth visit. I was prescribed Paxlovid. I can not tell if Paxlovid helped. It made me dizzy and I had a bad taste for 5 days. I am still experiencing tiredness. I went back to work Monday but I feel fatigued with voice hoarseness and sinus problems.
Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
12/24, I woke up with arm soreness and headache. 12/25, I had a headache, fatigue, arm pain radiating down to my elbow and into my right side. 12/26, I had all the above along with swelling under right axilla. 12/27, all of the above along with pain in right ribs, swelling worse under right axilla, fever of 100.3 (up to 101.2), body aches, and joint pain. The symptoms all continued as 12/27 into 12/28.
4 hours post vaccination patient complains of headache, lower leg numbness and dizziness.
rash stared on the right side of back at the waistline,  has no traveled to the front right side
injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; injection site pain which is swelling, red, and hot; just wants to itch; caller's arm is itchy; they both don't have energy to cook or anything and sleeping a lot.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 02Aug2021 (at the age of 59-years-old) (Batch/Lot Number: FA7484; Expiration Date: 30Sep2021) as dose 2, 0.3ml single for covid-19 immunisation. Medical history included heart murmur, laryngitis and had shoulder surgery from an unknown date and unknown if ongoing The patient stated she had shoulder surgery and she was scratching and trying to pull the tape off. The patient previously experienced known allergies: Penicillin and Tape. The patient stated she is usually allergic to a lot. The patient's concomitant medications was not reported. Patient previously took first dose of BNT162B2 (at the age of 59-years-old) (lot number: EW0181, expiration date: 30Aug2021) on 12Jun2021 for covid-19 immunisation and experienced Choking, Sluggish, Worn out, Tiredness, Coughing, Feeling abnormal and Hoarse voice. The patient experienced injection site pain which is swelling, red, and hot on 02Aug2021. The patient stated that she just wants to itch and scratch it, it's red and swollen. She also stated that arm was itchy and she wanted to scratch it so bad. The patient and her mother had nothing with the first one they were just tired and sluggish and worn out all a week. This improved then they got second dose and now they feel they've been run over by a car. They both don't have energy to cook or anything and sleeping a lot. The patient received treatment regarding the events. The outcome of the event just wants to itch, caller's arm is itchy and they both don't have energy to cook or anything and sleeping a lot was unknown. The outcome of all the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101002323 Same reporter/product, similar event, different patient
Syncope episode 15 mins after receiving vaccine. Pt reported feeling anxious and has history of syncope with blood draws.
Information has been received from a physician concerning a female with a history of shingles two years back who on approximately 12-APR-2007 was vaccinated SC with a dose of Zostavax. On approximately 26-APR-2007 two weeks after vaccination, the patient experienced shingles. It was reported that "patient insisted on receiving vaccine even though she had a case of shingles 2 years ago". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Received full third shot past 12 hour post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received full third shot past 12 hour post puncture) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 022M20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received full third shot past 12 hour post puncture). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received full third shot past 12 hour post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-371847 (Patient Link).
blood clots in lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-125941 (Bristol-Myers Squibb Company).  This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (blood clots in lungs) in female patient of an unknown age who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criteria hospitalization and medically significant). The patient was treated with Heparin for Pulmonary thrombosis. The action taken with Eliquis(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS outcome was unknown. The patient received apixaban for prophylaxis stroke (atrial fibrillation). The patient inquired that if it was safe to take the Covid 19 vaccine with Eliquis. She reported that she had been on Eliquis for at least 2 years or may be 3 because she did not want to deal with the lab work which she later stated was associated with warfarin. She had received both Covid 19 injections and after that within a month she had blood clots in his lungs. The patient stated that she was sick for 4 days in bed and that she could not get enough oxygen. She was taking Eliquis for afib, that she began to get worse all the sudden and her daughter had to call an ambulance for her and was hospitalized for 6 days, placed on a Heparin drip. The patient stated that she never had any problems before with Eliquis that she began this medication because with warfarin there was a time issue and she was frequently having to get stuck. She said that she had to wonder because the blood clots in the lungs came on so suddenly after 2 years of successful use with Eliquis if there was any correlation or association with the use of Eliquis with the Covid 19 vaccine. She mentioned that Eliquis has a 99.9% success rate in doing what is needed for patients, and that she wanted to know why this happened all of the sudden when she had experienced no problems before. For Eliquis(Unknown), the reporter did not provide any causality assessments.  Causality Assessments: Drug = ELIQUIS Event = Thrombosis pulmonary Per Reporter = No Information Per Company (Bristol-Myers Squibb) = Not Related.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: This patient had pulmonary thrombosis after receiving apixaban therapy and COVID-19 vaccine. Based on the limited information available regarding event details with relevant medical history and therapy details, it cannot be ascertained with reasonable possibility that apixaban contributed to the reported event.
Very sore bumps under skin in anterior side of left shoulder which is the shoulder the vaccine was administered in. Hurts to move left arm.
day after immunization generalized malaise and myalgias and pain and 4 cm swelling at injection site, nausea and vomiting and mild reported vertigo.  sx control prescribed with fluids, prn promethazine suppositories for nausea and vomit, and medrol dose pak as systemic symptoms, prn ibuprofen recommended for aches and call if sx worsen in any way or not improving.
RED PAPULAR RASHES AROUND INJECTION SITE. AREA AROUND INJECTION SITE IS REDDISH. RASHES WERE VERY ITCHY.
pt recv vax & exp chickenpox-like rash w/greater than 50 lesions that was pimply & boiling;
fever; big lump under left armpit; swollen neck left armpit; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 18:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 18:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 13:00 the patient experienced fever, big lump under left armpit and swollen neck. The patient did not receive any treatment for the event. Events had not resulted in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, big lump under left armpit and swollen neck left armpit was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
2 inch red mark, lump under area 2 inch area, hot to touch - still there 48 hours later slightly better, lump a little smaller.  applied heat on 1-5-2021 for soreness in arm - told that at time of injection, applied cold compress evening of 1-6-2021.
Received COVID - 19 booster dose too early. Notified patient of early dose, not having any symptoms.  She will contact her doctor if she started having any side effects.
Information has been received from a physician concerning a healthy 78 year old female patient with no pertinent medical history and no known drug reactions/allergies who about three weeks ago, on approximately 14-OCT-2011, was vaccinated SQ with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included aspirin and metoprolol (strength and manufacturer unspecified) and unspecified herbal medication. The physician reported that, about three weeks ago, on approximately 14-OCT-2011, after receiving ZOSTAVAX (Merck), the patient experienced acute renal failure and interstitial nephritis and was hospitalized for three days. It was also stated that the patient had lost 20 pounds since the injection. The events did not improve and at the time of the report the patient had not recovered. The patient was seeing her physician and nephrologist on 04-NOV-2011. Acute renal failure, interstitial nephritis and weight decrease were considered to be immediately life-threatening and disabling by the reporting physician. Additional information has been requested.
Exacerbation of Hashimoto's thyroiditis, elevated TPO antibodies, fatigue, lethargy, insomnia
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
This literature marketed report was received from the authors in a published literature article titled as stated above, regarding an infant male patient, which age was reported as "0.48 years", from an initial group of 204 patients (84 female and 120 male patients; enrolled in a study, which aim  was to evaluate the safety of live virus vaccines and the characteristics of the recipient population that are associated with successful live virus vaccination (LVV) post liver transplant (LT).  On an unknown date, the patient received a LT, along with an immunosuppressive regimen of sirolimus (dose, route and frequency were not reported). It was reported that, pre-transplant, the patient's IgG of the corresponding vaccine was not available.  On unknown dates, 4.9 years after the LT (discrepant information),  the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis, along with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.    On an unknown date, the patient experienced an injection site reactions with erythema and swelling following co-administration of both vaccines; that was considered a side effect from the 2 vaccines.  At the reporting time, the outcome of vaccination site reaction, vaccination site swelling and vaccination site erythema was not reported. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports obtained from the same literature article.; Sender's Comments:  US-009507513-2201MEX008251: US-009507513-2202USA001021: US-009507513-2202USA001023:
Received COVID vaccine on 12/19/2020. On 12/20, she experienced chills and fever (100.9) and body aches (shoulders, HA). UC visit on 12/21 and doing much better, essentially normal.  Clinical Impression: Post-vaccination syndrome.  Tested for COVID and flu on 12/21, received negative results on 12/22
Shortness of breath  Headache  Stuffy nose Fever Chills Fast heart rate  High blood pressure
Information has been received from a office medical assistant concerning a 21 year old female patient who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot# 661846/1312X). There was no concomitant medication. Three days later the patient experienced a fever, body aches and a headache that lasted for about three days and then subsided. Then on 16-SEP-2009 the patient was vaccinated with the second dose of GARDASIL (Lot# 662404/0312Y). There was no concomitant medication. About three days later the patient experienced fever, body aches, and headache that lasted for three days and then subsided. The patient had not sought medical attention. At the time of report the patient's status was recovered. Follow up information has been received from a medical assistant concerning a 21 year old female patient with no pertinent medical history, no known drug allergies and no illness at the time of vaccination who on 15-JUL-2009 was vaccinated IM into right hip with the first dose of GARDASIL (Lot# 661846/1312X). Then on 16-SEP-2009 the patient was vaccinated with the second dose of GARDASIL (Lot# 662404/0312Y) (dose and route not reported). The patient informed that after second injection she had reaction beginning 3 days after each injection consisting of fever, body aches and headache. Onset was sudden and then abruptly subsided. No lab diagnostic study was performed. At the time of the report, the patient had recovered. Additional information is not expected.
I gave the patient the Rotavirus vaccine.  Pt did not have a reaction or a problem.
Blood pressure has gotten much higher then normal. 150/101 and normally it runs 117/75. I haven't felt well since I got my booster.
7/30/13 received VARIVAX and MMR. Mom called 8/10/13 stating 4 days after vaccines given had fever and vomiting. Total fever x 6 days TM 102-103. DX with by M.D. friend and started Z-max. Rash onset 8/9/13 and spreading. Referred to ER for evaluation.
On 1/14/2003 arm started getting sore (left arm).On 1/14/2003 evaluated, swelling noted in arm. Headache, general malaise, stiffness at base of neck, some nausea and very tired.  On 1/16/2003 skin blotchy red below injection site. On 1/17/2003 continues to be swollen and painful.
Lost 95% vision in his right eye; Nerve damage in right eye/Optic nerve damage; Blood clots that cut off blood flow to optic nerve/Blood clotting; Dizziness; Seeing lights when he closed his eyes "bright blue arches of lights"; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Mar2021 as single for COVID-19 immunisation. Medical history included influenza A from an unknown date and unknown if ongoing (was diagnosed with Influenza A but as more information came out, we suspected it was covid), COVID-19 from Jan2021 to an unknown date (had Covid-19 infection before getting the vaccines in Jan; had an antibody test on an unspecified date in Feb2021 that confirmed he had it, he got it and survived). The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown) via unspecified route of administration on 24Feb2021 (at the age of 66years) as single for COVID-19 immunisation. In May2021 (2 months after getting the second dose of the vaccine), the patient began experiencing dizziness, seeing lights when he closed his eyes "bright blue arches of lights", lost 95% vision in his right eye due to blood clots that cut off blood flow to optic nerve, and nerve damage in right eye. It was a sudden onset just within 2 months period after getting the vaccine so the patient can't explain it any other way, it was either the infection or the vaccine. He didn't know if this blindness was because of the vaccine but he was waiting to find out. The patient was in the hospital and had multiple tests done and that's where they detected the optic nerve damage and the blood clotting on an unspecified date on 2021. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
After my second dose vaccine, I woke up with body aches, headaches, chills, fever, I felt like I had the flu.  I took my temperature it was 101.6F. The following day, my fever was 102.6F and still felt fatigued, joint aches, chills, severe headaches and could not read a book due to the headaches. Throughout the day, still had the fever and it was 100.7F and I had tons of fatigue, sweating with severe headaches, body aches, I had these symptoms for a total of 10 days. The following Monday 02-01-2021, I did a Covid-19 test which was negative and I resumed back to work on 02-03-2021.     For my 1st vaccine dose which I received 12-29-2020 my symptoms were not as bad as the second dose and I experienced fatigue, headaches and one week later I was diagnosed with shingles and a rash.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored VARIVAX (Merck). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.