chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever; Facial Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial Swelling) and PYREXIA (low grade fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     The patient's past medical history included Eye laser surgery. Concomitant products included DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN / POLY B / DEXAMETHASONE) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced SWELLING FACE (Facial Swelling). On an unknown date, the patient experienced PYREXIA (low grade fever). On 10-Feb-2021, SWELLING FACE (Facial Swelling) had resolved. At the time of the report, PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up was received on 14-Jul-2021, new event low grade  fever was  added.
received their first dose of menacwy on 15oct2019 and booster dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] on 02aug2022 with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old male patient who received their first dose of menacwy on 15oct2019 and booster dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] on 02aug2022 with no reported adverse event   The patient's past medical treatment included MENACWY TT on 15-OCT-2019. The patient's past medical history, vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE  On 02-Aug-2022, the patient received a 0.5 ml Booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7249AA, expiry date:  11-Mar-2024) via intramuscular route in the right deltoid as immunization.  On 02-AUG-2022 the patient developed a non-serious event "received their booster dose of menquadfi at 14 years old. they received their first dose of menacwy on 15-oct-2019 and the booster dose of menquadfi on 02-aug-2022 with no reported adverse event" (inappropriate schedule of product administration; latency: same day). No adverse reactions to report. There was no treatment.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 the 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.
Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-002362 (E2B Linked Report).; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002362:
Date and time of vaccination: (list both if they received both shots):   1-9-2021 approx at 1:03pm     LOT #  039K20A 2-6-2021 @ 12:53pm    LOT # 029K20A yes, itching, rash that is 2inches wide by 3 inches tall. texture is coarse, with welts
I had a fever, chills, sore arm, and was tired. This lasted 1 full day after receiving my vaccine.
My pulse went up to 142 the morning of the shot (Tuesday). I did drop down, but remained higher than normal for a couple days.  I woke up in the middle of the night (Tuesday-Wednesday) with a pulse just over 100 and my normal resting pulse is around 60. My face was bright red on Wednesday and it looked like sunburn. It was better the next day. I was very shaky. I do have an essential tremor that usually just affects my hand, but the night of the shot and the next day it was exaggerated to the point that even my legs were shaking. I also had the common side effects of a headache, muscle aches, sore arm, chills, and slightly nauseous.  Most of the side effects have improved at this point, although I still feel like I am recovering from the event.
No symptoms were reported by any of the patients; Improperly stored vaccines administered; MMR II Lot: S039309 Exp: 4-DEC-2021, but upon internal validation established as 31-MAR-2018; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 14-MAY-2021, the patient was vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S039309, which have been verified to be a valid lot number, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018) as prophylaxis (product storage error and expired product administered).  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003873: US-009507513-2105USA003871: US-009507513-2105USA003872:
She started coughing, fatigue, and had watery eyes. She was diagnosis with COVID-19.
administered an expired dose of Havrix to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HAV (Havrix 1440) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: 04-Oct-2022 Reporter's comment: The registered nurse stated that she administered an expired dose of Havrix to an patient. The consent was given for follow up via postal. The consent to follow-up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-month-old (gender unknown) patient received the fourth dose of PREVNAR 13 on an unknown date at an unknown age. Relevant medical history and concomitant medications were not provided. On an unknown date the patient developed Streptococcus Pneumoniae bacteremia that was not sero-typed and was hospitalized. At the time of the report the outcome of the event was unknown. Follow-up (06Oct2011): No follow-up attempts possible. No further information expected.
Extremely sick; Severe reaction; Sweats; She was down for 5 days; All my joints were hurting like I've never hurt before; Body aches; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), DEPRESSED MOOD (She was down for 5 days) and ARTHRALGIA (All my joints were hurting like I've never hurt before) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), ARTHRALGIA (All my joints were hurting like I've never hurt before), MYALGIA (Body aches), FATIGUE (Fatigue) and PYREXIA (Fever). September 2021, the patient experienced DEPRESSED MOOD (She was down for 5 days). The patient was treated with IBUPROFEN in September 2021 for Adverse event, at an unspecified dose and frequency and HYDROCODONE in September 2021 for Adverse event, at an unspecified dose and frequency. In September 2021, DEPRESSED MOOD (She was down for 5 days) had resolved. At the time of the report, ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), ARTHRALGIA (All my joints were hurting like I've never hurt before), MYALGIA (Body aches), FATIGUE (Fatigue) and PYREXIA (Fever) outcome 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.   This case was linked to MOD-2021-363473, MOD-2021-363475 (Patient Link).
FEEL CRAPPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced feel crappy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feel crappy was not reported. This report was non-serious.
Rash spread to entire thigh, fever (103) for 4 days, diarrhea, wouldn?t eat for 4 days, minimal fluid intake for 4 days, wouldn?t walk/run due to leg pain at injection site, fussy for 4 days.  Rash spread for 6 days.
2 hours after shot, fever 102 degrees F, ache/pain in limbs, tired, lump at site:(lasted 2 weeks) other symptoms lasted a day and a half.
Red, itchy area developed on arm near vaccination site on day 9 after vaccination. Not raised or warm.
Itch and burning sensation on left arm, and bruise at injection site.  Left arm has redish/pink color, with several small bumps, and dull aching pain.
chest is hurting; ill/sick; trouble breathing; wasn't able to function; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 30Jan2021 (Saturday morning), the patient woke up and was ill, she had trouble breathing, wasn't able to function and has been sick since. As of 03Feb2021, the patient's chest was hurting a bit less (onset date unspecified) and it was reported that the patient needed to go to the emergency room to know what was going on. The reporter told the patient she should be tested for the virus. The outcome of the events ill/sick, trouble breathing and wasn't able to function was not recovered; and the outcome of chest is hurting was recovering.  Information on the lot/batch number has been requested.
Feeling thirsty, unable to quench it; Coughing a lot; High fever of 102F; Feeling chills; Nauseous; Severe headache; A Spontaneous report was received from a consumer (reporting on self), concerning a male patient (age unspecified), who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed a high fever of 102° F, coughing a lot, severe headache, feeling chills, nauseous, and feeling thirsty, unable to quench it.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   The patient woke up at 2:30 AM on 06 Jan 2021 experiencing high fever of 102° F and feeling chills.  At 8:30 AM the patient's fever reduced to 100°F and he was feeling nauseous, coughing a lot, had a severe headache, and was felling thirsty, unable to quench it. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of high fever of 102° F, coughing a lot, severe headache, feeling chills, nauseous, and feeling thirsty, unable to quench it was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3 days after 3rd shot started feeling a little dizzy. 5 days after got extremely dizzy and fatigued and could not see due to eye balls ?moving up and down extremely fast?. Could not see at all as everything was ?jumping with eyes open. ? went to ER, thought maybe mini stroke. Next day, same thing happened. Couldn?t walk, no balance, super dizzy
Fever up to 101. Blisters on leg. Not eating/drinking. Fatigue.
Pt recvd HIB vax & 2 months following vax it was noted that pt had  devel a small nodule @ inject site;
rash all over her face; turned very red in the face; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 was received on unspecified date for covid-19 immunisation. On an unspecified date, patient had a reaction to second dose of vaccine, patient experienced rash all over her face and turned very red in the face. Patient reported that she heard if she had an adverse reaction to vaccine that means she was not protected. Patient would like to know if this information was true. Patient reported that she has already spoken to company about her symptoms yesterday. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a Licensed Practical Nurse refers to a 11 month old patient of unknown gender. No medical history was reported. On 23-JAN-2013, patient was vaccinated with dose 1 of PEDVAXHIB (lot#, expiry not reported) intramuscularly. The nurse reported that on an unknown date in 2013, the patient was vaccinated with dose 3 of PEDVAXHIB (lot#, expiry not reported) intramuscularly only one month after receiving the second dose of PEDVAXHIB (lot#, expiry not reported). No adverse events were reported. Additional information has been requested.
wheezing all lobes, responsive, pale with increased heartrate. Pulse ox 76, oxygen started open full, epi-pen 0.15mg given left thigh. Pt's pulse ox increased to 95%.
The next day, post vax, had red, indurated, itchy area on left anterior thigh (DTAP site) which was the size of a baseball. Resolved over the next 3-4 days.
Urticaria & wheezing w/in 1 hr of vax administratin; responded well to SQ epi x 1 & DPH; sent home p/1 hr observation & DPH for 1 wk;
Information has been received from a licensed vocational nurse concerning a 12 month old female who on 19-NOV-2007 was vaccinated with a dose of COMVAX (lot#657380/0377U). Concomitant vaccinations on 19-NOV-2007 included Varivax (lot #658932/1343U), MMR (lot# 657118/0865U), influenza virus vaccine (unspecified), poliovirus vaccine. Illness at the time of vaccination, included a mild ear infection that was treated with amoxicillin. On 27-NOV-2007 the patient was taken to the emergency room and was diagnosed with mild ear infection and also had a fever, mild unspecified rash and mild twitching symptoms. However, these symptoms were not treated. Therapy with amoxicillin was discontinued and therapy with amoxicillin (+) clavulanate potassium was initiated. In the evening on 27-NOV-2007, the patient was taken back to the same emergency room because the patient had 30 minutes of seizure-like activity (twitching). The patient was administered VALIUM and ATIVAN and performed unspecified blood work, chest x-ray and computed axial tomography (all within normal limits). The patient was hospitalized for 24 hour monitoring. During the night, the patient's rash worsened and covered the patient's body. On 28-NOV-2007, the patient was discharged from the hospital. On 29-NOV-2007, the patient follow-up with the pediatrician. Therapy with amoxicillin (+) clavulanate potassium was discontinued and the ear infection, rash and fever were gone. On 29-NOV-2007, the patient recovered. The reporting licensed vocational nurse considered fever, mild unspecified rash, mild twitching symptoms and seizure-like activity (twitching) to be other important medical events. The reporting licensed vocational nurse considered seizure-like activity (twitching) to be immediately life-threatening. Additional information has been requested. 1/30/08-records received for DOS 11/27-11/28/07-DC DX:Convulsions. Otitis media. Previously seen by physician for otitis media which did not resolve. Developed seizure activity with shaking and jerking of upper extremity and twitching. Active tonic colonic seizures observed in ED. Fever 102.
Patient came in tonight at described that she could still tell the exact site of injection from her flu vaccine received 09/26/2017. She mentioned that there was a pain and numbness that shot down about three inches from that site. She has a doctor's appointment to ask more clarifying questions. The point to which she pointed did not seem inappropriate for placement of the injection.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (0.5 ml, lot # L019996, expiration date 02-DEC-2016) subcutaneously. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
At approximately 10 minutes after receiving vaccination, patient reported difficulty breathing and felt like his throat was closing up. He became visibly anxious and sat on the floor in a tripod position. Patient was immediately assessed by medical personnel. Pt remained Alert and oriented x 3, PERRL, mouth and throat assessed without evidence of tongue, throat, or uvula swelling, patient tolerating oral secretions well, lungs CTA, resp with ease; no increased work of breathing. BP 158/82, pulse 80, Resp 18, FSBS 204, SaO2 97% RA. Pt had spontaneous improvement after 5 minutes with complete resolution of symptoms. Pt declined to be transported by EMS for further evaluation at local emergency department. Pt left facility accompanied by wife in stable condition after additional 30 minute observation and complete resolution of symptoms.
This spontaneous report as received from a company representative from an unknown reporter though a conference refers to a patient of unknown demographics. The patients current conditions or medical history were no reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, route, lot number and expiration date were not reported). On an unknown date, the patient experienced an unspecified adverse reaction. At the time of the report outcome of unspecified adverse reaction was unknown. Additional information has been requested.