chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry cough; sinus congestion; shortness of breath; headaches; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Dry cough), SINUS CONGESTION (sinus congestion), DYSPNOEA (shortness of breath) and HEADACHE (headaches) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Allergy were reported as none.    On 01-Apr-2022 at 3:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022, the patient experienced COUGH (Dry cough), SINUS CONGESTION (sinus congestion), DYSPNOEA (shortness of breath) and HEADACHE (headaches). The patient was treated with FLUTICASONE PROPIONATE (FLOVENT) at an unspecified dose and frequency. At the time of the report, COUGH (Dry cough), SINUS CONGESTION (sinus congestion), DYSPNOEA (shortness of breath) and HEADACHE (headaches) had not resolved.            No concomitant medication were reported.
Patient admitted to Hospital on 7/30/21 with pneumonia due to COVID-19 infection.  The patient was fully vaccinated with a 2 dose series of Moderna COVID-19 vaccine on 2/21/21 and 3/17/21.
Three days after first injection high fever, presenting signs of peripheral Neuropathy, chest pains equaling ER visit. Second injection within 24 hours extreme all over body pain, fatigue, increased chest pains, difficulty breathing, veins ruptured in left leg presenting as a blood clot. Had to have a Doppler test. Continuous chest pain, severe back pain, loss of feeling in hands and feet, loss of balance, dizziness, continuous migraines, difficulty walking or holding items
Initial information received on 04-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old male patient who received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation on an unknown date. On 04-Mar-2019, the patient received a single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA (expiry date: 17-Jul-2020) via unknown route in left thigh. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown whether adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. Follow-up information was received on 05-MAR-2019 from other health professional. No new information received. List of documents held by sender: none.
PATIENT RECIEVED VACCINE ADMINISTRATION AT APPROXIMATELY 1220 ON 4/29/19.  APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION PATIENT HAD RASH ON SCALP, HEAD/FACE, BACK, UPPER CHEST AND ABDOMINAL AREA. NURSE WAS IN ROOM WITH PATIENT AT THE TIME AND IMMEDIATLY NOTIFIED CHARGE NURSE.  CHARGE NURSE URGENT CARE  WITHIN CLINIC AND PATIENT AND PARENT ESCORTED TO TREATMENT ROOM FOR OBSERVATION, EVALUATION AND IF NEEDED, TREATMENT.    PATIENT WAS THEN DISCHARGED FROM DEPARTMENT AFTER EVALUATION FROM PROVIDER.
Information has been received from a health professional concerning a 4 year old female with no allergies and no medical history, who on 10/11/2001 was vaccinated with a SQ 1st dose of varicella virus vaccine live. It was noted that the child was well at the time of vaccination. On 11/18/04 the pt experienced a case of classic varicella, multiple with greater than 30 lesions. It was reported that the outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additonal information is not expected.
Sister is having buzzing in both ears after first vaccine; This is a spontaneous case received from a contactable consumer (sister) via from a Pfizer sponsored program database.   A female patient of unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced buzzing in both ears after first vaccine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitants were reported. On 19-MAY-2014, the patient was vaccinated with ROTATEQ INJ, lot J015062, expiration date 13-OCT-2015 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received CERVARIX. Previously administered products included GARDASIL. In September 2014, the patient received CERVARIX. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced wrong vaccine administered and off label use. On an unknown date, the outcome of the wrong vaccine administered and off label use were unknown. It was unknown if the reporter considered the wrong vaccine administered and off label use to be related to CERVARIX. Additional information received: Father reporting his son was given a GARDASIL vaccination a few months ago, and instead of giving the GARDASIL second dose, his son received CERVARIX. Note: Father mentioned at the end of the call that he was a pharmacist.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with a dose of ROTATEQ (2 ml, orally, lot# and expiration date were not provided), that underwent a temperature excursion. No adverse effect reported. This case is linked to MARRS# 1502USA009813 (same patient link). Additional information has been requested.
pt was seen @ clinic by pediatrician;had no prev hx of rxn to vax;mom states @ 11PM pt began vomiting & by 1130 had sz;911 was called pt transported to hosp
3 painful, swollen lymph nodes on left clavicle and left side of neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number em9810, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 06Feb2021 11:00 as DOSE 2, SINGLE for Covid-19 immunization in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ek9231, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 15Jan2021 18:00 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient experienced 3 painful, swollen lymph nodes on left clavicle and left side of neck. Since the vaccination, the patient has not been tested for COVID-19. The patient was not treated for the events. The outcome of the event was reported as not recovered at the time of report.  No follow up attempts are possible. No further information is expected.
Localized nodule at injection site - 50 cent size up to small lemon nodule - red, itching - within 24 hrs of injection.
she had developed symptoms and tested positive to COVID-19; she had developed symptoms and tested positive to COVID-19; This is a spontaneous report from a contactable physician (patient). A female patient of unspecified age received BNT162B2 first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She tested negative on 18Dec2020. She received the first dose of the COVID 19 vaccine on 20Dec2020. On the following Friday (25Dec2020), she had developed symptoms and tested positive to COVID-19. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
No additional aderse event reported; VARIVAX that was administered to a patient a few days before his 12 month; This spontaneous report was received from an office manager and refers to a 11-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-NOV-2007, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). There was no additional adverse event reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX, lot #L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp chickenpox w/8-10 crusted lesions today;
missed the window for a second dose, do I need to start the vaccination process over; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the window for a second dose, do I need to start the vaccination process over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 (missed the window for a second dose, do I need to start the vaccination process over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the window for a second dose, do I need to start the vaccination process over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Reporter did not allow further contact
Initial information reported on 08-Nov-2013. A 51  year old female patients whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number UH920AC, expiry date unknown) intradermal at left deltoid on 11-Jul-2013. Patient experienced large lump at injection site that was painful to touch and some fluid lead from injection site. List of documents held by sender: none.
Information has been received from a medical assistant concerning a 66 year old male who on 11-JUN-2009 was vaccinated with VARIVAX (Merck) (lot #664018/0475Y) instead of ZOSTAVAX (Merck) (human error not a product quality complaint). No adverse effects had been reported. The outcome was unknown. The patient hadn't sought medical attention. Additional information has been requested.
Left arm swelling 7.5 inches (6" from deltoid to elbow); right arm size 6.5 inches.
I have a swollen lymph node on the back right side of my head. This could also be due to dental work but I was not sure so I am reporting anyway. I also had some swollen lymph nodes in my neck that have gone down completely. I also experienced the regular side effects as stated on my information pamphlet. General fatigue for an entire week and body aches. The lymph node on the back right side of my head is going down but has not completely gone down. I'm watching it closely bc I am not going to the hospital, they never treat me right there.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB. No adverse effect was reported. Temperature was 74.3F for 28 hours and it was administered. There was no previous temperature excursion. This is one of the three cases received from the same reporter. Additional information has been requested.
It was reported that a female pt received a Fluzone SV '99-'00 vaccination in her right forearm. Within 1 minute of vaccination, the pt developed itching and an elevated, red wheal the size of a dime. As well as local itching, flushed face and blood pressure increased to 156/84. The pt was given Allegra and Axid and was told if she had any difficulty breathing to go to the ER. Follow Up #1 06/04/02: During internal auditing  of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added Vasodilatation and Hypertension).
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Starting the night of the vaccine (Tuesday), the patient noticed redness in the area and started to feel achy.  On Wednesday, She felt sluggish, sleepy, and feverish along with worsening body aches.  On Thursday the area of redness on the arm had increased, but the body aches and the arm was less sore.
grandma states pt fainted by time got to the car p/vax;came back into clinic pt alert, pale w/cool, clammy skin;put head between legs;BP 100/76;
COVID+ 1/23. Pt presents to ED 2/8 with low hemoglobin and fever. Pt does not appear to be in any respiratory distress. 2/10 no acute issues overnight. Denies chest pain, shortness of breath, abd pain, no fever or chills and c/o back pain. COVID test negative upon arrival. Patient is a&o x3.vital signs are stable. Patient continued to be on IV antibiotics, s/p cath and colostomy intact, PEG tube in place. 2/13 pt medicated for elevated blood pressure with losartan and norvasc as ordered. 2/14 pt still very elevated BP, order to give hydralazine. Pt discharged to residential facility 2/16.
on afternoon 10FEB95 w/grandma pt awoke from nap; fever noted &given APAP but vomited; then had episode of unresponsive, limpness for less than 5 mins; brought to ofc t102.4 R; alert, good cry & cold; exam neg;
This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 13-JUN-2017, the patient was vaccinated with an improperly storage dose of VARIVAX (dose and route were not reported) lot number M045204, expiration date 11-NOV-2018. The temperature excursion was from -14 degrees celsius to -10 degrees celsius (-9.5 degrees celsius) in a time frame of 327 hours in total (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1707USA000678, 1707USA000679, 1707USA000680, 1707USA000681, 1707USA000682).; Sender's Comments: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000681: US-009507513-1707USA000682.
Swollen lymph nodes on head - preauricular nodes.; This is a spontaneous report from a contactable Other healthcare professional. A 44-year-old female patient received BNT162B2 (BNT162B2; Lot number: UNKNOWN) in the left arm on 06Mar2021 at 12:15 (at the age of 44-years-old) as single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, since vaccination. Concomitant medication included Levothyroxine (MANUFACTURER: UNKNOWN) from an unknown date to an unknown date for an unknown indication. On 11Mar2021, the patient experienced swollen lymph nodes on head - preauricular nodes, swollen began 5 days post vaccine and still present 11 days later. It was unknown if patient received any treatment for swollen lymph nodes on head - preauricular nodes. The clinical outcome of swollen lymph nodes on head-preauricular nodes was not recovered not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt c/o rt leg w/pink line going towards outer side of thigh 1" from dot where needle went in 1";no temp, nl also sudden crying hard for 5min then grad decline like heart broken about 1.5 to 2hr p/vax;APAP given;also hyperactivity & irritabl
Headache, Myalgia, Diarrhea, CHILLS Narrative:
Pt erupted in lesions 6 days post vax. Pt was seen by PMD 13 days post vax. Physician swabbed an active lesion and sent specimen to the National Varicella lab for typing. Pt had diffuse lesions all over the body. Conversation with PMD on 14th day post vax and noted lesions were crusted. No treatment was rendered by PMD.
The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vaccine, immediately after injection, I felt numbness/tingling in lips, upper & lower & inside left of head/brain area, and also brief very sharp pains in my upper body randomly throughout my arms and chest. Intermittent sharp pain in center of chest.- scale 2/10  After the first 15 min, I sat outside the tent, and noticed a numbness in my left leg and foot and sharp pain in my left big toe -  (03/21/21  left big toenail showed  a light discoloration). Symptoms subsided within an hour, yet a residual minor numbness in my lips, continued, and intermittent sharp pain in center of chest. 2/10  On March 7, Sunday following the vaccine, at 11:00 am I felt definite numbness on the left side of my face. I touched it to determine if I could detect  a sensation with my fingers, and I felt the numbness as I  touched my face as well. My right side of my face was normal.  Residual numbness to  left face/head intermittently. including today more noticeable March 22, 2021.