chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / Treatment of COVID-19; Rebound with symptoms after finishing full course of paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: En5318), in left arm, on 22Feb2021 as dose 2, single (Lot number: En6200), in left arm and on 03Jan2022 as dose 3 (booster), single (Lot number: Fl3198) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Known allergies: Foods" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; VIT D [VITAMIN D NOS]; METFORMIN; IBUPROFEN. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 12Aug2022, outcome "recovering", described as "Rebound with symptoms after finishing full course of paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech / Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient received other medication in 2 weeks. Known allergies to foods. The patient received Paxlovid as a treatment for Covid-19 from 03Aug2022 to 07Aug2022. On 12Aug2022, rebound with symptoms after finishing full course of paxlovid.  Follow-up attempts are completed. No further information is expected.
No Adverse event; Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose).    This case contains information for the second patient (second child) of the two patients described by the reporter.  No concomitant medications were reported.  The pharmacist states that, 0.25ml of vaccine was pulled out of the adult Red Cap vial and administered to patient. Pharmacist further states that this 2nd dose was a booster and the 2nd dose and patient only received 2 doses.  No treatment medications were reported.   Reporter did not allow further contact
This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The following information was received via a statement of injuries: On an unspecified date the subject received unspecified dose of LYMERIX. At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, swelling, headache, fatigue, flu-like symptoms, tingling sensation, shock-wave sensation, facial twitching, mental fog, confusion, forgetfulness, heart palpitations, dizziness, vertigo, sleep disturbance, light sensitive, loss of pigmentation of the eye, thyroid nodules, spasms in feet, heat sensitivity, nausea, night sweats, anxiety, depression, and decreased activities of daily life. She reportedly suffered from rheumatologic, neurologic, and/or cognitive impairment from an autoimmune, immune-mediated, or other biological mechanism "all caused by vaccination with LYMERIX including but not limited to those set forth above". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Initial unsolicited literature report received from healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090257. (Same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. A female patient, whose medical history and concomitant medications were not reported, had received a dose of Hepatitis B vaccine, a dose of Varicella vaccine and a dose of TD (batch number, route and site of administration were not reported for all vaccines) on unspecified date. On unspecified date after vaccinations, the patient experienced chorioamnionitis and was pregnant during vaccination. The last menstrual period and estimated date of delivery were not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
This spontaneous report was received from a female patient of unknown age regarding herself. The patient was allergic to every treatment she was given. On an unknown date in July 2015, the patient was vaccinated with a dose of ZOSTAVAX (dosage information, lot number and expiry date were not reported), subcutaneously. Concomitant medications was not reported. On an unknown date in July 2015, the patient experienced shingles and had been in pain since after the vaccination. The shingles had not gone away and it continued to spread. The patient reported that, on an unknown date, her mind was snapping, her emotions were crashing and it was stressful to be in pain for almost a whole year. On 17-JUN-2016, the patient visited the unspecified physician and she was told that, "it looked like shingles". On an unknown date, the patient underwent biopsy examination, human immunodeficiency virus (HIV) test, hepatitis test and numerous dermatology test and the results were negative. The outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Concurrent conditions, medical history of the patients were not reported. Since 16-MAR-2015 (therapy started date was estimated as an unknown date in 2015), improperly stored VARIVAX (Merck) (lot # K003423, expiry date: 06-MAR-2016) (dose, route unspecified) was administered to unspecified patients. Other suspect and concomitant therapies were not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
2nd injection 2/16/21- 10 minutes post injection, I felt a tingling sensation in my throat,  had a metal taste in back of mouth and entire throat that lasted roughly 3 days. Throat also felt like it had a globule and constricting sensations. (No SOB and VSS). Symptoms gradually lessened to intermittent occurring every few days to a week. But this week 4/1/21- symptoms became daily. Initial self treatment- Ibuprofen and Benadryl OTC- helped. Doctor appointment today 4/1/21 due to symptoms became daily again. Treatment today- Starting Omeprazole 20mg daily and a course of Methylprednisolone for throat closing sensation.
BODY PAIN; NAUSEA; FATIGUE; SLIGHT COUGH; CHILLS; ELEVATED HEART RATE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced elevated heart rate. On 08-MAY-2021, the subject experienced slight cough. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 140, 100. On 08-MAY-2021 03:00, the subject experienced body pain. On 08-MAY-2021 03:00, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from elevated heart rate, and had not recovered from nausea, body pain, slight cough, fatigue, and chills. This report was non-serious.
Tremors or shaking in the arm/hand/fingers. This did not occur until after the shot and was also noticed in my 13yr old who also had the same vaccine.
including any and all of it sequelae/as well as other severe and permanent health consequences.; Guillain Barre Syndrome (GBS); This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently unknown gender elderly patient of 70 year-old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 10-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number, and route not specified) for prophylaxis. As a result on or about 01-SEP-2015, the patient suffered Guillain Barre Syndrome (GBS). As a result of his receipted of zoster vaccine live (ZOSTAVAX), the patient had suffer severe personal injuries, pain suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate results of  defective design of zoster vaccine live (ZOSTAVAX), the patient suffered severe and permanent physical injuries, including but no limited to GBS, as well as other severe and permanent health consequences. The patient will continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. Also, injuries and damages were permanent and will continued in the future.The outcome of the event Guillain Barre Syndrome (GBS), and Ill-defined disorder was reported as not recovered.   Upon internal review, the event Guillain Barre Syndrome (GBS) was considered to be medically significant.
Pt experienced a strong aching pain with pressure upon injection. Currently, the pain is a constant throbbing pain that runs down her entire right arm.
Migraine severe onset few hours post vaccinations, lasted 3 full days and nights, onset of chest pain burning with numbness in left art started on 12/5/2021, continious, fatigue, no relieve from medications, pressure in the chest visited Doctor, test are pending, pain in the chest irradiating into jaw. No relieve by aspirin, bruise on the chin, no trauma unexplained
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. Patient took the booster dose as an expired vaccine. The expired vaccine was administered on 3 different dates, 4JAN2022 (20 patients), 6JAN2022 (29 patients), and 11JAN2022 (14 patients).  HCP stated that some patients had reported flu-like symptoms after receiving the vaccination. The number of doses/vials-63 doses, 3-4 vials. Date the vial was initially stored in the refrigerator-01-Dec-2021.
Minor rash, itchiness, soreness at injection site.  Ongoing for 8 days so far.
temp of 104, swelling from my site to below elbow, N+V, headache, body aches.
Pt. states that after receiving the 3rd dose of Phizer 12/22/2021, started experiencing symptoms 12/23/2021 early morning of loose stool, vomiting, headache, chills, fatigue, and injection arm pain. Vomiting and loose stools have subsided, no noted Primary visit/communications.
I had a sore throat & some blockage so I thought I just had allergies and treated it as so but then I was still feeling bad a few days later so I took home Covid test & it was positive so then I went to Hospital & was tested again & it was positive also.
the day after shot my left lower tooth came out and just under the gum line while I  were brushing my teeth .
Toned bumps decreased skin. 25 to 30 around injection site. Advised to call family physician.
Fever; Chills; body aches; swollen lymph node under left arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 14Apr2021 at 12:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation.The patient had no medical history. The patient did not receive any medications within two weeks of vaccination. The patient previously received DITROPAN for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 12:45 (at the age of 32-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 04:00, the patient experienced fever, chills, body aches and swollen lymph node under left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events fever, chills, body aches and swollen lymph node under left arm were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Left arm became very sore after and by that night it was red with a little welt. Sunday morning it had swelled more was hot to the touch and extremely sensitive. Monday it was larger with redness present on whole inflamed location and very hot to the touch. As of today (3 days post vaccine ) it is still very sensitive, still swollen, and hot the the touch. Swelling is about 4 inches wide and 3 inches tall localized to injection sight. I have not taken any ibuprofen and I am hydrated. I have not done anything to aggravate it.
liquid that came out...after their first dose was a lot; liquid that came out...after their first dose was a lot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (liquid that came out...after their first dose was a lot) and UNDERDOSE (liquid that came out...after their first dose was a lot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (liquid that came out...after their first dose was a lot) and UNDERDOSE (liquid that came out...after their first dose was a lot). On 09-Feb-2021, PRODUCT ADMINISTRATION ERROR (liquid that came out..after their first dose was a lot) and UNDERDOSE (liquid that came out..after their first dose was a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to events was not applicable as patient already took the second dose. No treatment information was provided.  This report refers to a case of Product administration error and underdose for mRNA-1273, lot # 026A21A  with no associated AEs.; Sender's Comments: This report refers to a case of Product administration error and underdose for mRNA-1273, lot # 026A21A  with no associated AEs.
Pt contacted the pharmacy to ask about side effects from COVID Vaccine. She noted that she had excruciating pain shooting down her left arm and through her neck. Dose was given on 9/26 at 1pm and pain started at 6pm. Her pain has increased in severity since symptoms started. Patient woke up crying due to pain and states her pain level is 10/10 when lying on the arm and a 6/10 without pressure on the arm. Pt has been taking 600mg ibuprofen and used several doses but is unsure how many total doses she has used. Ibuprofen has not helped with pain. Recommended that the patient consul PCP or visit urgent care to address pain. I then verified injection technique with administering technician which was confirmed to be correct according to our company standard operating procedures
Cerebral sinus thrombosis in the transverse sinus thing; Cerebral sinus thrombosis in the transverse sinus thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine. The following information was reported: CEREBRAL THROMBOSIS (medically significant), TRANSVERSE SINUS THROMBOSIS (medically significant), outcome "unknown" and all described as "Cerebral sinus thrombosis in the transverse sinus thing". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: Unknown results. Clinical course: Patient confirmed that she developed 'Cerebral sinus thrombosis' in the 'transverse sinus thing.' She also received the Moderna vaccine but the majority she received was the Pfizer COVID vaccine and the brain MRI that was performed was prior to the Moderna vaccine.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021); This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021)). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 11NOV2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
This case was reported by a consumer via other manufacturer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced fever, shivering and headache. On an unknown date, the outcome of the fever, shivering and headache were unknown. It was unknown if the reporter considered the fever, shivering and headache to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The case was reported by the Merck employee for the friend's mother. At night, the patient experienced really bad shivering like she had a fever all night long and a severe headache. No additional information was available. The lot number and expiration date was unknown to the reporter.
Face especially cheeks are extremely swollen to the point where I?m having a problem seen. I had  Fillers in my cheeks in September 2020
paresthesias of both feet followed by gradual numbness radiating up both legs to abd;numbness subsided w/in 6-8wks;feet remain numb;dx w/MS JUL95;