chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, heat, and pain at injection site in left upper arm about 2 inch circumference, and pain at injection site requiring Tylenol every 4-6 hours.  Body aches, feverish, fatigue, blood sugar higher than usual, palpitations and decrease in appetite.  Symptoms continued through 4/18. 4/19 and 4/20 symptoms improving.  Still some redness (more diffuse) at injection site, but much better.
pt states her left arm was sore and hard after getting the vax and since has developed a red, itchy rash at the injection site that goes all the way around the left arm and  has started to move down the arm toward her elbow.  she has been using cold compresses on it.
I am repeatedly having small shingles outbreak on right side/back of ribcage.  I'm on a daily dose of 1 Valtrex a day for H1 and H2, and then have seen Urgent care 2x re my shingles outbreak and then take full recommended dose of Valtrex until it clears up...it happens every month or every other month.
Switching vision & lightheadness & felt flushed. vitals obtained; water  & juice given. started  feeling better,  continued to observe  & walked with pt  & rechecked vitals
localized rxn & itchy macular type rash across chest;resolved p/tx w/Depromedrol;last dose of vax 1988;
Onset of symptoms began morning of 11/17/05.  Diagnosis of Guillain-Barre Syndrome confirmed 11/18/05. Discharge summary states dizzy, hypertension,dysphagia, pain, apnea. Medical record states headache, paresthesia, weakness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (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 2022, outcome "unknown" and all described as "COVID 19 Treatment". 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 with paxlovid from 17Jul2022 to 21Jul2022  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Vaccine was diluted using the incorrect diluent. Bacteriostatic, normal saline was used instead of preservative-free, normal saline.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was inadvertently vaccinated with the fourth dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. The patient did not seek medical attention. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter declined any further contact.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 26-MAY-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916658, 20210916455, 20210916312, 20210916228, 20210915731, 20210916300, 20210916697, 20210916553, 20210916401, 20210916415, 20210916520, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916849, 20210916907, 20210915719, 20210916965, 20210917160, 20210915661, 20210915646, 20210915623, 20210915852, 20210916808, 20210915748, 20210917515, 20210917226, 20210916910, 20210916498, 20210916465, 20210916129, 20210917074 and 20210917163.
I went to urgent care because I thought I had an ear infection because I had tingling and numbness in my right ear. I tested positive for COVID-19. I started feeling tired and fatigued. I was prescribed a 5 day of PAXLOVID and have completed the 5 day course. I also had a breakthrough epileptic seizure and was admitted for 5 days.
Hospitalized (5.24.22);  COVID-19 positive (5.24.22);  Fully vaccinated PLUS booster BRIEF OVERVIEW: Hematologist/Oncologist: MD Primary Care Physician at Discharge: DO Admission Date: 5/24/2022 Discharge Date: 06/06/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Neutropenic fever (HCC)  COVID-19  HOSPITAL COURSE: The patient is a 69-year-old male with past medical history significant for squamous cell carcinoma of the right mandible and right posterior lateral tongue status post surgical resection.  Patient is currently receiving weekly cisplatin and concurrent radiation.The patient was recently admitted 5/3 -5/6/22 with sepsis secondary to right facial and neck cellulitis. Patient was seen in the office on the day of admission ( 5/24) for his weekly cisplatin and found to be febrile and tachycardic and sent to the emergency department for further evaluation.  In the emergency department he tested positive for Covid-19, patient was started on cefepime and vancomycin with Infectious workup.  CT neck 5/24/22 - interval decrease in size of several heterogenous masses right lateral neck suggesting favorable treatment response.  Some of these masses could represent superinfection which is improving.  No new or enlarging neck masses.  Persistent prominent right facial swelling and edema suggestive of cellulitis. ENT assessed the patient and did a  flexible laryngoscopy,  no  airway obstruction was noted, but he was noted to have a right-sided asymmetry in hypopharynx and lateral pharyngeal wall. Steroids were started to help with swelling.  They recommended  moisturized air and mucolytics. ID was asked to see and were concerned some of the erythema was radiation induced. He had repeat fevers and AMS. He was changed to merrem and neurology was asked to see for AMS. EEG was done showing encephalopathy. Neurology initially felt he needed a LP as part of the work up for encephalitis. But that resolved and the concern for encephalitis was resolved. Antibiotics were DC'd on 6/4. He was stable for DC on 6/6. He had RT prior to DC and was sent on a steroid taper of 4 Mg TID x3 days, 4 MG BID x 3 days and 4 mg daily x 3 days, then 2 mg daily x 3 days and stop. He has follow-up as listed above.
Patient was scared to get her vaccines mom informed us. Prior to vaccines Patient resisted to receive first vaccine and I was able to calm her down and she sat still to receive vaccines. After administartion Patient would hold her breath and mom and I would have to tell her to take some deep breaths and she would respond by talking or taking some breaths. Within a few minutes after vaccines I saw a change in her face color and asked her if she felt ok. She stated she needed to get sick. She laid on exam table and after 5 minutes felt better. BP was within normal limits. Mom stated she passed out when she got her ear pierced recently. I explained if she starts to feel not good then she needs to lay down or if she has anything life threatening go to ER.   7/24/23 10:00 PM - Mom reached out to me on my personal phone at 10:00 PM to call her. I called her and Cami vomited before she got in shower and almost passed out in shower. She  had ate dinner at a resaurant and then headed home prior to this. Their BP cuff was not working. Cami was laying down in bed and felt better, but not 100%. She just wanted to go to sleep and the mom was concerned. I explained usually any fainting/vomiting/etc happens within 5-10 minutes after vaccines. I also explained in the 12 years I have been working at LPCHD I have not had any reports of anything like this hours after vaccine. Mom wanted to know if she should take her to hospital. I explained that anything considered life threatening we send individuals to the ER. In this case i cannot recommend not to go to ER, but if she feels concerned and she does not improve she can choose to take her to ER. Mom said she would watch her for an hour and decide. I also explained common symptoms of BP problems are dizziness, headache, not feeling well, etc. I would follow-up in morning with mom.   7-25-23 10:00 AM  Mom states that Cami feels OK and slept all night. She will take her to doctor if it happens again.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 68-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX. On 4th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling and injection site hemorrhage were unknown. It was unknown if the reporter considered the injection site swelling and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Registered Pharmacist (RPh). The age at vaccination was not reported. The pharmacist administered a dose of SHINGRIX to a patient on right arm and noted when she went to put band aid over injection site, that there was almost like a bubble or swelling around the injection site just smaller than the size of a quarter. On the same day upon transfer the pharmacist additionally stated that the patient bled at the injection site, and that there was a mass like the vaccine just sat in her arm. The reported lot number (P45MA) for SHINGRIX did not exist and was updated to P45M9, according to the sales database.
Patient received a 3rd dose of Moderna. 1st dose on 1/7/21, 2nd dose on 3/4/21, and 3rd dose on 7/2/21.
Somatic reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced influenza-like symptoms with Shingrix. No further details were provided. The reporter consented to follow up. This case has been linked with case US2019199353, reported by the same reporter.
COVID-19; COVID-19; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4233376-00 (Agency).  A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 24Feb2021 (ongoing) (Batch/Lot number: unknown) at unk, citrate free for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. The action taken for adalimumab was dosage not changed.  The reporter considered "covid-19" related to bnt162b2. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 with bnt162b2 (BNT162B2) was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
approx 3-5min p/vax c/o feeling light-headed color pale, pulse 112/bounding-placed on floor;feeling better p/5min;then severe nausea w/retching c/o feeling hot, color dusky, c/o diff breathing-911 lightheaded when sitting/standing-nausea
Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
On 6/27/99, the pt experienced a twinge of a headache. On 6/28/99, he had a runny nose, headache on and off, and fleeting shivers. On 6/29/99, he experienced lack of appetite. On 6/30/99, he had a headache with any sudden motion. On 7/2/99, he had a fever of 103. On 7/4/99, he had a truncal rash without itching. There were three separate rash areas on the pt's left side described as 10" x 6" on left hip, 9" X 4" on left groin, and 4" x 1" on left chest. On 7/4/99, he was seen by a physician who started him on doxycyline.
pt recv vax 2MAY97 & pt reports knot devel under lt arm 7MAY97;8MAY97 5cm tender, firm, mobile nodule noted lt axilla;referred to MD;call from pt 9MAY97-saw MD r/t Td per MD will resolve w/o rx;
PATIENT EXPERIENCED PAIN, SWELLING, AND WARMTH AT THE SITE OF INJECTION STARTING THE DAY AFTER
Got a little sick; Information has been received regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (number US-009507513-1908USA001036) from a lawyer who provided Plaintiff Fact Sheet concerning a female patient of an unknown age. The pt had never smoked. The patient's concurrent conditions included therapy with chiropractor, fibromyalgia, diabetes, herpes zoster keratoconjunctivitis, unspecified tear film insufficiency, depression, anxiety, insomnia, nerve pain, pain, high cholesterol, osteoporosis, dry eye syndrome secondary, shingles and allergies. The patient's historical conditions included chicken pox (1958), back surgery (2005 and 2016) and neck surgery (2016). The patient's concomitant therapies included pregabalin (LYRICA), promethazine, azelastine hydrochloride, acetaminophen (TYLENOL), eszopiclone, pregabalin, celecoxib and valacyclovir hydrochloride.  On an unknown date in 2018, the patient was vaccinated with a dose of pneumonia vaccine (manufacturer unknown) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) administered by a physician.  On an unknown date, the patient got a little sick. The outcome of the events was unknown. The causality assessment was not provided.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1908USA001036:
Basically I started feeling anxiousness and thinking it was because we were remodeling, my fit bit kept alerting me that my heart rate was going up and down even at rest. I went to Doctor who sent me to Emergency room because my Doctor did an EKG and I was in full Afib and they admitted me that night. In the emergency room they were trying all different things to get my heart rate down. Finally meds start working leveling my heart rate. Then I went home and two days later I was sitting and having fluttering in my chest my heart rate was 150-160 I went back to the hospital. They ended up doubling my meds metoprolol. I was fine til just recently on vacation we were at lunch with our granddaughter I had a drink which I don't normally drink, we went to pool car back to Condo for dinner and I started having a flutter in my chest, I went to ER the doctor said it was perfect storm traveling being dehydrated from travel having one alcohol drink and being out in sun. He suggested drinking more water.
Patient left pharmacy and went to an assisted living complex to see someone. He then experienced dizziness, sweating and fatigue. Nurses took his vitals and glucose levels. All were normal. Symptoms resolved 30 minutes after with no treatment. Patient returned to pharmacy to inform me of event. Patient was of even temperament.
Tingles all over body, Chills, unable to get warm, Fever, Headache (Migrane), major Body Aches and numbness this was the day after the shot.  The Fever and Chills subsided after a day and a half, however I am still experiencing major headaches, head spins, fogginess, Nightmares, as well as tingling in the legs and slight numbness and feelings of slight chest cold.   I've called my Dr. today, waiting on response.
Patient said he can not move his arm for about 6 months for the vaccine that he received on 09/05/2018.
he had an equilibrium issue; lightheaded; he was wiped out; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 07:00 (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: FATIGUE (non-serious) with onset 26Mar2021 12:00, outcome "unknown", described as "he was wiped out"; BALANCE DISORDER (non-serious) with onset 29Mar2021, outcome "unknown", described as "he had an equilibrium issue"; DIZZINESS (non-serious) with onset 29Mar2021, outcome "unknown", described as "lightheaded". Additional Information: He had his vaccine first dose on Friday 26Mar2021 at 7 AM and by 12PM he was "wiped out." He felt like he had an equilibrium issue starting on 29Mar2021 and was feeling lightheaded. He wanted to know if these are normal side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel a severe inj site rxn w/swelling & pain;seen by MD;2-3wk post vax exp weakness in legs, tingling in hands & ascending paralysis;hosp 1JAN98;LP confirmed dx of GBS;hosp 3wk then rehab;
This RN was made aware that pt was supposed to receive a Shingles Vaccine however only the diluent was administered. This RN contacted the provider to report incident. Pt daughter notified. Verbalized understanding. No injuries reported.
Patient experienced fainting several minutes after receiving a flu immunization.  She was in the process of leaving our store and began to collapse but was caught by her father. Patient immediately revived and complained of nausea and fatigue.  Pharmacy staff called 911.  The patient did not appear to have trouble breathing and swelling was not observed.  EMS arrived and documented blood pressure to be low.  Patient condition continued to improve and patient left on their own ability.  Called to follow up with patient later on in the day and confirmed she is now doing well.
This spontaneous report as received from a newspaper via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, frequency and indication not reported). The representative reported that there was an article on the front page of the newspaper "today"(07-NOV-2013). She reported that the article talked about how GARDASIL caused two sisters to have premature ovarian failure. The outcome of the event was unknown. The case captured one of the two sisters, the other sister was captured in the case(1311USA007452). This is one of several reports from the same source. Additional information has been requested.
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 61-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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: The patient did not have any known allergies. The patient did not receive any other medication in 2weeks. The patient received Paxlovid as COVID 19 treatment from 11Oct2022 to 16Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.