chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 75 year old female consumer with a history of shingles who on 12-MAY-2010, was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included "pain pills". The consumer stated that the ZOSTAVAX (Merck) shot did not relieve her pain. The consumer also reported that her myalgia remained after getting the ZOSTAVAX (Merck) shot. She received a dose of ZOSTAVAX (Merck) on the advice of a physician. At the time of the report the consumer was recovering. The consumer sought unspecified medical attention. Additional information has been received from consumer. The patient reported that she had developed shingles on an unspecified date in 2008. The patient was completely free of pain for 2 years after receiving the ZOSTAVAX. However she developed shingles again on an unspecified date in September 2013 and again on 27-FEB-2014. The patient stated that her legs became paralyzed and then she took VALTREX (also reported as manufacturer unknown) and then realized that she is getting shingles again. The patient sought medical attention for the events. The outcome of events was recovering. The causality of the events with the suspect product was unknown. No product quality complaint was reported. Upon internal review the event legs paralysis was considered as medically significant. Additional information has been requested.
Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiry date unknown) via an unspecified route of administration on 28Jan2021 11:45 AM in left arm at single dose for COVID-19 immunization. Medical history included acne and no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included adapalene (DIFFERIN, topical cream) cutaneous for acne. The patient experienced metallic taste in mouth on 28Jan2021 12:00 PM and no treatment was received. The outcome of the event was not recovered. The event was reported as non-serious and no results in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect involved.
Nausea prevented me from sleeping. The next morning (11/17/2015) I woke up at 6AM with extreme nausea and after attempting to vomit but being unable to, went back to sleep. Then, I woke up again at 8AM with extreme nausea and vomited. I felt faint and still nauseous but slightly better after. I did not have any appetite and did not eat, but drank a glass of water. At 9AM I vomited the water. I felt extremely weak and faint, but no longer nauseous. The rest of the day I had no appetite and did not eat anything. I almost became very faint and dizzy, cool, pale and clammy around 1PM. I did not actually go unconscious because I sat down in time. Around 3PM I started getting chills and my body ached. Specifically, my knees and pelvis joints were severely aching. All afternoon and into the evening the chills and aches became worse and I ran a fever. I went to sleep that night and took an ibuprofen to diminish the aching. I woke up the next morning (11/18/2015) feeling normal. Nothing happened since.
Patient was given a dose of Fluzone MDV from a vial that was at 18.6 C for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144005, 2019SA144006, 2019SA144007 and 2019SA144005. (same reporter).  This case involves a 10 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was at 18.6 C for 6.5 hours.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the patient received a first 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AE and Exp. Date 30-Jun-2019 via intramuscular route in the left arm.  It was an actual medication error due to incorrect product storage.  It was reported that patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I started out with runny nose, sore throat, intermittent cough, tachycardia HR 110, O2 levels stayed at 96. No fever. Extreme fatigue that lasted 5 weeks, shortness of breath. Walking and carrying on a full conversation I would be short of breath.
Pt was stable in PICU and preparing for discharge. Received immunizations and within 24 hours, became hypotensive, tachycardic, febrile-shock state. All septic workup was negative. Required ionotropic support X 48 hours. Returned to baseline. From the acute event, child will not recover from the congenital problems. She is presently still on vent at hospital for rehab.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up include data updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
RT ARM AND SHOULDER VERY PAINFUL....TOP OF SHOULDER PAINFUL TO TOUCH.  ENTIRE UPPER ARM  PAINFUL AND PAINFUL TO MOVE.   INJECTION SITE IS NORMAL.   GENERAL FEELING OF MALAISE.  EVEN TWO DAYS POST VACCINATION.
This case was reported by a physician to a sales representative and described the occurrence of swelling injection site in a female subject aged between 10 and 49 years old who was vaccinated with Twinrix for prophylaxis. Medical history included no allergies to yeast or neomycin. The subject's concurrent conditions and concurrent medications were not reported. On an unspecified date in 2007, approximately 2 weeks prior to 23 May 2007, the subject received 1st dose of Twinrix (unknown, right arm). In 2007, less than one day after vaccination with Twinrix, the subject experienced swelling injection site, swelling arm, swelling of fingers and unable to close hand due to swelling. The physician described the events to the sales representative as swelling at the injection site that proceeded to travel down the arm to the fingers. The swelling of the fingers prohibited the subject from forming a fist with that particular hand. The subject was seen at a physician's office. The physician considered the events were disabling. At the time of initial reporting, it was noted that the events resolved "48 hours later." The physician considered the events were probably related to vaccination with Twinrix.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277419 and 2018SA277420 (same reporter). This case involves a female patient (age unknown) who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6301NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to  vaccine underdose. It was reported that 3 of the 0.5 ml prefilled syringes leaked around the hub during administration. Two different nurses found that when they were going to give vaccine with needle already attached,it leaked from base of the hub with 3 different prefilled syringes and were unable to deliver full dose (syringe issue). It was unknown whether product technical complaint was registered or not for the syringes. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt devel pain in the hands (arthritis-like), ankles, & knees & muscle aches 2 to 3 days p/receiving Influenza vax; Pt was being treated s/ASA; Aches & pains continued intermittently;
acute pericarditis, R sided chest pain, sharp and stabbing, 8 out of 10 when taking deep breath, constant since waking up this AM, non-exertional, no trauma, no falls, also has  upper back pain , pain is not radiating (no chest to back or back to chest pain).
CHILLS, LOSS OF TASTE/SMELL, MUSCLE PAIN, FATIGUE
SUSPECTED COVID-19 INFECTION; BRAIN FOG; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sharp pain in ear, and covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced brain fog. On 12-APR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) Positive. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, and suspected covid-19 infection. This report was non-serious. This case, involving the same patient is linked to 20210449934.       .; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
This is a spontaneous report from a contactable consumer reported for herself. This 76-year-old  female consumer patient received the first dose of PREVNAR 13 for immunization at single dose on 03Apr2018 via unspecified route of administration in the left arm. Relevant medical history included Blood pressure and a mass in her upper half of her right lung since Oct2017 and ongoing, She states that when first diagnosed this mass measures 5.5 cm or mm. She states that it now measures 9.something. It has not been diagnosed as cancer because she has not had the biopsy. Concomitant medication included amlodipine for blood pressure since 05Apr2018 and ongoing at 500 mg, 1x/day.  The night after having the shot she woke up and had a lot of pain in her back and in the lower part of her lungs. It really hurt and she thought this was weird. The two events were recovered on the same date. The caller received her PREVNAR 13 vaccine in the doctor's office and doesn't have the lot number, NDC number, expiration date. The reporter also mentioned that she noticed she had more energy from 04Apr2018. Information on the batch number has been requested.
Narrative: 67yo male patient died at HOSPITAL of diabetic crisis per RN notes on date of pt's death. See RN note: Brief history and current status: Patient was at a facility and the CG wnet to get him up and he was on the side of the bed shaking so she checked his blood sugarand it was low so she gave him orange juice and peanut butter and after about10 minutes she took his sugar again and was up to 140 and the patietn was stillshaking alot so she called ems and upon arrival the patient went non responsiveand was taken to Hospital and was goin gto a step down unit yesterday if they could get a bed and the CG went to see patient and was still in ICU and he blood pressure was elevated and he was sleeping so she went home and 30 minutes they called and told her that his HR dropped into the low 30's and she needed to get up there and she did and he passed away shortly after her arrival. Pt had received covid vaccines on 3/13/21 & 5/11/21. This death is not related to covid vaccines.
Patient was given the flu shot then she left with her son. A few minutes later, the son came back and reported that his mom has pain in her hip and she can't walk. We took a chair where she was, so she can sit down. She rested in the chair for a while, then they left the store.
headache the same evening but gone the next morning. Ongoing injection site pain and mild achiness in joints
Rash under skin, non red 10pm 11-28-06 on stomach/back/shoulders. Turned red (bumps) and extended down arms to hands and 12-4-06 extending to legs.
No adverse effects observed. Father instructed on after care. Look for fever, soreness in thighs. Possible mild case of flu in next 2 weeks.
Since I have had the second vaccine, I have had body aches from the very beginning and horrible headaches. It got worse at the end of July. I was hot and cold. I felt extremely delirious - I felt like I was almost drunk. My fever got up to 102. I started sweating and then go to chills; every thing was aching and extreme fatigue. It was horrible. There were 3 or 4 days when I would be down and out and then it would clear up for a couple of days. And then it would start up again with all of those symptoms again. My husband was experiencing those very same things and having it come and go. Got COVID test - negative - Did one at Pharmacy (home test) and then got the actual second test at lab- negative result. Did blood panels - nothing was coming back irregular. The only thing in my life and my husband's life is the vaccine and we are not sickly people. I have had a few doctor visits. I was given a steroid pack; antibiotics and told to rest. Those did not help with the cycle of symptoms. I am still having this cycle of getting sick with all of these symptoms and then it going away and then it coming. My husband is still getting this as well. The doctor's not sure how to proceed - everything came back normal. She said if it gets worse where I can't breathe to go to the ER.
pt recvd vax; c/o itchy eyes, started about 11am; obvious hives; dizzy & mouth dry;
pt recvd vax;pt was shaking;to er;pupils dilated;MD stated rxn to vax;no tx given; on 12dec95 mom stated pt ok;
I have had reasonably well controlled hypertension for a number of years.  Since my vaccination, my blood pressure has been elevated while taking the same meds.
Rheumatoid arthritis flare up; Dizziness; Increase white cell count; Swollen lymph nodes; blood pressure increased; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Chronic lymphocytic leukemia since 2018. Concomitant products included LISINOPRIL for Hypertension.   In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg. In February 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 mg. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), DIZZINESS (Dizziness), WHITE BLOOD CELL COUNT INCREASED (Increase white cell count), BLOOD PRESSURE INCREASED and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and WHITE BLOOD CELL COUNT INCREASED (Increase white cell count) had resolved, DIZZINESS (Dizziness) and BLOOD PRESSURE INCREASED outcome was unknown and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, White blood cell count: 3000 (Inconclusive) had gone down 3000. On an unknown date, White blood cell count: 3000 (High) was up 3000.     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.   treatment medication were not provided   This case was linked to MOD-2021-111543, MOD-2021-111543 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
0300 (20 hours post) runny nose, sore throat, coughing 0700 (22 hours post) sore throat, body aches, mild plegm in nose.  12:00pm body aches, no fever, tiredness , sneezing, nasal drip, sore throat   Did 2 Covid tests (BinaxNow) both negative Feels like the second Covid vaccine
Patient is experience severe muscle spasms and myalgia in shins with extreme pain in toes of the right leg (previously injured leg, chronic pain). She has tried to take lyrica, but has not seen a doctor yet. Plans on following up next business day.
pregnant patient received a Fluarix vaccine; Allergic rash all over body, went to the ER; Allergic reaction; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of allergic rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 32P2F, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Additional patient notes included Prior to receiving the Fluarix vaccine, the patient was not allergic to anything.   On 3rd October 2022, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. In October 2022, less than 2 weeks after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic rash and allergic reaction. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the allergic rash and allergic reaction were recovered/resolved and the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   It was unknown if the reporter considered the allergic rash and allergic reaction to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter reported an allergic reaction in a patient from a flu clinic that she had conducted. The pregnant patient received Fluarix vaccine in her right deltoid and had an allergic rash all over her body, reporter stated that the patient went to the emergency room on that evening. The reporter stated that the patient was prior to receiving Fluarix vaccine she was not allergic to anything. No information was reported on the pregnancy The reporter did consent to follow up by phone.
Fever, muscle aches, upset stomach the next morning after the shot. Tylenol did not reduce the fever and muscle aches  and aches but ibuprofen worked well
After 03/16 I had pain in my joints. Burning around my bra line. Extreme fatigue. In April, I was hospitalized. I had symptoms of a stroke. Losing weight and hair.
Patient complained she was feeling dizzy after about 10 minutes post vaccine. She was about to fall down and could not stand straight on her leg. I helped her sit on the floor (so as not to fall down). Patient was also sweating all over. I removed patient's jacket, so she could get some fresh air. I called 911. The ambulance came about 10 minutes after. They checked the patient for blood pressure and oxygen (vital signs) and said she was okay. Patient also said she was okay when the ambulance came. She was allowed to rest for few minutes, then she went home.
After his initial dose didn't feel so great; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 26 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "After his initial dose didn't feel so great".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;screamed loudly same eve w/ T 102;turned white & became limp;to er,pt has recovered; er MD felt mild rxn to  DTP & suggested giving apap regularly for a while;recvd series of vax & tolerated them;