chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with first dose of PROQUAD (Merck) subcutaneous, Lot #J009886; Expiration date: 15-FEB-2015 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse originally called on 13-DEC-2013 requesting stability information for PROQUAD (Merck) that was improperly stored. During the call she was told that based on company stability data PROQUAD (Merck) would had to be used within 1 month by 13-JAN-2014. Nurse reported that improperly stored PROQUAD (Merck) was administered to patient on 12-FEB-2014. No adverse effect were reported. This is one of 3 reports concerning same reporter (MARRS #1403USA007675 and 1403USA012819). Additional information is not expected.
Information has been received from a registered nurse concerning a 20 year old female taking birth control and allergy to AMOXICILLIN who on 13-MAY-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL. The nurse reported that the patient was vaccinated IM with the second 0.5ml dose of GARDASIL on 17-JUL-2009 (lot# 658271/0558X). Concomitant therapy included NUVARING. On 17-JUL-2009 the patient experienced syncope post vaccination in the office, but did not fall. The patient was monitored at the office and recovered. The patient's mother called on 20-JUL-2009 stating her daughter was experiencing chest pain, heart racing and shakiness, which started on 19-JUL-2009. The patient was coming in the office for follow upon 27-JUL-2009 and the symptoms persisting. No lab diagnostics study was performed. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 20-SEP-2013 was vaccinated with VARIVAX (Merck), (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (Same reporter link). Additional information has been requested.
Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm was hot, swollen, red, itchy and bruising occurred. All was on left arm at injection site.
Friday after injection arm became extremely swollen & painful.  Saturday was started on PREONISONE.  Monday swelling decreasing also taking NAPROXEN.  Twice daily saw doctor on Monday swelling mild & mild pain in area.  7/8/09 Saw MD.  NAPROXEN continue pain present yet, warm to touch.  Some swelling (mild) start on DARVOCET stop NAPROXEN.  7/13 arm pain unchanged 7/13 - Patient admitted to hospital for unrelated issue seen by neurology & rhumetalogy; given FENTEYL for discomfort in arm.  Then 7/15 switched pain med to DILAUDID and MRI ordered.
Product integrity issues, No adverse event reported, Patient received product that was expired by 1 day.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 84th patient of the total 190 patients. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
pt recv vax & pt exp a vax related chickenpox type rash of unk severity;pt also devel a fever of 101 or 102 noc before;
On 03Jul2021, I contracted Covid, delta, variant; On 03Jul2021, I contracted Covid, delta, variant; This is a spontaneous report from a contactable nurse (Patient). A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9262 and Expiry date was not reported) dose 2 via an unspecified route of administration in arm Left on 23Jan2021 09:00 (age at vaccination was 53-year-old) and dose 1 (Lot number: EL3246 and Expiry date was not reported) via an unspecified route of administration in right arm on31Dec2020 13:15 as single dose for covid-19 immunisation. The patient had no known allergies. Medical history included Hypothyroid, PFO, HCP from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had tested for COVID-19. Concomitant medications in two weeks were included levothyroxine sodium (SYNTHROID), asa (ASA), riboflavin (RIBOFLAVIN), ergocalciferol, retinol (VITAMIN A + D), zinc (ZINC), magnesium (MAGNESIUM), topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. The patient was hospice that continues to take masking precautions, hand hygiene. On 03Jul2021 16:00 she contracted covid, variant. Due to events patient visited Emergency room/department or urgent care. Treatment received for the events was Promethazine, Albuterol inhaler, Tessalon pearls. The patient underwent lab tests and procedures which included PCR nasal Swab positive on 03Jul2021. The outcome of the event was recovering.; Sender's Comments: Based on the information in the case report, a possible causal relationship between events Covid-19 and suspect drug BNT162B2 cannot be excluded
breakthrough seizures; sinus infection; She also missed her 2nd appointment on 5APR2021 due to sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (breakthrough seizures) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SEIZURE (breakthrough seizures) (seriousness criterion medically significant), SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (She also missed her 2nd appointment on 5APR2021 due to sinus infection). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (She also missed her 2nd appointment on 5APR2021 due to sinus infection) had resolved. At the time of the report, SEIZURE (breakthrough seizures) and SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant medications reported. Treatment included antibiotics for the event sinus infection.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (seizure and sinusitis), a causal relationship cannot be excluded.
Patient was given injection, then fainted immediately. She faded in and out of conciousness 3 times. Ammonia stick was used to bring her to, Epi-pen was not used. Gave her glucose tablets to raise her blood sugar. She visited medical facility. Patient experienced a Vagal reflex response. Patient was woozy until the following day, but felt fine after 24 hours.
Case previously recorded as MA2009-4575. Case report received from a physician, via Novartis Medical Communication, on 17 NOV 2009. Patient (gender unknown) under 3-year old was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008308.
I felt an immediate "anaphylaxis-like" reaction right away.  I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue.  I did take an antihistamine (Xyzal) prior to the vaccine.  I took Tylenol and Zofran  for nausea.  The swelling subsided after  2 days,  and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA .  I still have nausea and he prescribed Zofran for that.   I have small-medium lost my appetite and my taste and smell have change and also itchy eye.  But I have noticed increased saliva excretion.
COVID test Positive/ Treatment of COVID-19; COVID test Positive/ Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 06Jan2022 as dose 3 (booster), single (Lot number: 041J21A) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID test Positive/ Treatment of COVID-19". No adverse event from the vaccines. After taking Paxlovid and then testing negative for four days, patient started to get symptoms again and tested positive for Covid again on 14Aug2022. On 18Aug2022, patient still test positive and have mild to moderate symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included COVID 19 Treatment, Paxlovid from 04Aug2022 to 08Aug2022.
Left upper arm muscle pain, tingling finger @ X s X 4 wks.  Pain increasing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 at 06:15 as dose 1, single (Lot number: EH9899), in left arm, on 10Jan2021 at 06:15 as dose 2, single (Lot number: EKG231), in left arm, on 06Oct2021 at 06:15 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "autoimmune hypothyroidism" (unspecified if ongoing); "chronic allergic rhinitis" (unspecified if ongoing), notes: chronic allergic rhinitis. Concomitant medication(s) included: LEVOTHYROXIN; ALLEGRA; FLONASE SENSIMIST ALLERGY RELIEF. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022 at 12:15, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Negative, notes: 07:00; (23Jul2022) Negative, notes: 09:00; (27Jul2022) Negative; (28Jul2022) Negative; (30Jul2022) Positive, notes: 20:00; (01Aug2022) Positive; (02Aug2022) Positive; (21Jul2022) Positive, notes: 12:15. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details:COVID-19 Treatment,brand=Paxlovid,treatment start date 28Jul2022,treatment stop date 05Jul2022, other medication in 2 weeks product reported as Levothyroxin, Flonase Sensimist, subcutaneous immunotherapy for allergy desensitization. other medication in 2 weeks brand reported as Allegra 180. started Paxlovid at 1800; 22Jul2022 - two doses paxlovid; 23Jul2022 - two dose paxlovid, neg antigen test at 0900; 24Jul2022 - two doses paxlovid; 25Jul2022 - 2 doses paxlovid; 26Jul2022 - final dose paxlovid 0800; 27Jul2022 negative antigen test; 28Jul2022 - mild runny nose, negative antigen test; 29Jul2022 - mild congestion; 30Jul2022 - congestion worsened suddenly in the evening and sneezing and sinus pressure started, positive antigen test at 2000; 01Aug2022 positive antigen test and worsening congestion and rhinorrhea; 02Aug2022 congestion and clear rhinorrhea improved and positive antigen test this morning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
This spontaneous report as received from a nurse refers to a 6 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Swelling, pain, redness and heat at injection site. Also generalized achy ness. On exam, indurated warm 8 x 6 cm area L deltoid.
Information has been received from a registered nurse concerning a 6 year old female who was vaccinated on 6/21/99 with a dose of varicella virus vaccine live (lot number was unavailable). The patient was seen in January 2004 with a few pox after exposure. The child was noted to have chicken pox breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live and developed chicken pox breakthrough/shingles (WAES0404USA00205, 0404USA00418, 0404USA00419, 0404USA00420, 0404USA00421, 0404USA00422, 0404USA00423, 0404USA00424, 0404USA00425, 0404USA00426, 0404USA00427, 0404USA00428, 0404USA00429, 0404USA00430, 0404USA00431, 0404USA00432, 0404USA00433, 0404USA00434, 0404USA00435, 0404USA00436). No further information is expected.
I had expected chills and muscle aches for first 24 hours. At 36 hours I had nausea and at 48 hours I had severe nausea, diarrhea, stomach cramping, chills. I felt improved Thursday but then felt similar again Thursday night. If I eat my stomach cramps and eventually have diarrhea. I had aching and stomach cramping yesterday still 10 days post vaccine. I?m unclear if this is vaccine related.
100.6 temperature that lasted  approximately 16 hours. Severe Headache that lasted 16 hours Severe body aches that lasted 16 hours. Nausea that lasted 16 hours.
rolled head back & began petit mal seizures approx 20min p/vax;cont sz for about 20min;seizure several times;taken to ER;
Feels like I have a cold; Sweaty; Hot; Sneezing; Oral Temperature of 98 Degrees F; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Feels like I have a cold), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), SNEEZING (Sneezing) and PYREXIA (Oral Temperature of 98 Degrees F) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C2119) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for Allergy, MULTIVITAMINS [VITAMINS NOS] and VIT D [VITAMIN D NOS] for an unknown indication.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced NASOPHARYNGITIS (Feels like I have a cold), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), SNEEZING (Sneezing) and PYREXIA (Oral Temperature of 98 Degrees F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NASOPHARYNGITIS (Feels like I have a cold), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), SNEEZING (Sneezing) and PYREXIA (Oral Temperature of 98 Degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Body temperature: 98 (High) oral temperature of 98 degrees F ( patient's baseline temperature is reportedly 97 degrees F).     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.
Initial unsolicited report received from healthcare professional (patient) on 03 NOVEMBER 2014. This case is linked to case 2014SA033390 (same patient). A female patient, whose medical history and concomitant mediations were not reported, had received a dose of INFLUENZA (batch number, dose number and route of administration were not reported) in arm on 10 OCTOBER 2014. The patient received FLUZONE (batch number UH909AA intramuscularly in left deltoid) on 1 OCTOBER 2013 previously and experienced soreness at the injection site and left upper arm muscle spasm which was extended upward to her shoulder and down to her elbow. It was reported that on an unspecified date, after receiving influenza vaccine, the patient experienced soreness with muscle tightness. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from a health care professional on 22 JUNE 2015. It was reported that, patient's symptoms got better and after the amend attempt to work out with weights or other equipment activities, patient's muscle pain was back and it was hard to know if it was still affected by the vaccine the pain seems extreme from the activity. At the time of report, patient was recovering from event sore with muscle tightness (in initial report it was unknown). No new additional information reported. Documents held by sender: none.
In June I had COVID-19. In July I noticed as I would take my blood pressure it would higher than normal. I made note of this as I had a routine exam coming up. When I went in for my routine exam my blood pressure was taken at the beginning of the exam, it was noted that my blood pressure was high. My doctor took my blood pressure at the end of the exam hoping it would have come down. I was prescribed medication to help correct my blood pressue.
This non serious case was received on 24 February 2009 from a health care professional. A nine year old patient received the INFLUENZA vaccine (manufacturer and lot number not reported) on an unspecified date. On an unspecified date the patient was diagnosed with flu strain B. No further details were provided. Recovery status was not provided. Follow-up information received 24 March 2009 from a health care professional. Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious. The patient received a left deltoid injection of FLUZONE SV 2008-2009 (route not reported), lot number U2828AA on 20 November 2008 and 96 days later, he developed Flu Strain B with symptoms of headache, stomach pain and fever on 24 February 2009. A rapid flu test had been performed in the doctor's office and TAMIFLU was prescribed as corrective treatment. The patient had no illness at the time of vaccination. At the time of the report, the patient's recovery status was unknown. According to the reporter, the patient had a past history of "Flu" at eight-years of age  following receipt of an unspecified INFLUENZA vaccine (manufacturer, lot number, route/site and date of administration not reported). No additional information was provided. List of Documents held by Sender: none.
Approximately 12 hours post vaccination, patient experienced a mild fever (~100 degrees F) and swelling of the lips. Patient stated that lips swelled to a size approximately 25% larger than normal. Symptoms mostly resolved the following day without treatment. Six days later the lip still seems a little swollen and dry but is not noticeable to the casual observer.
9cm X 7cm raised, tender, erythematous area on anterior left thigh on 8/29/00. On 8/30/00, 3" diameter area raised at injection site and 2nd area medial 3" X 4.5" with a separate 1cm bulla in center.
approx 8PM temp to 104.5 ax & pt became limp; MD notified instr to give another 1 1/2 dorppers of Tempra & put in bath water; temp gradually came down over next 2 hrs then pt ok;