chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up with a scratchy throat, no voice, and coughing. I had a lot of mucus and drainage in the back of my throat. I also had a headache. I had chills and body aches, but I didn't have a fever. I went to urgent care. They gave me promethazine and coughing pearls. They gave me a COVID-19 test. The result was negative. They told me it was a common cold, but I didn't' get better. I took MUCINEX and SUDAFED. I took raw honey and sucked lemons. Nothing helped. I went to the emergency room because I couldn't breathe. They didn't really do anything before sending me home. They told me time would help. I already had an appointment scheduled with my doctor. She prescribed an antibiotic. She told me to get plenty of rest, to drink plenty of fluids, and to use cough drops. They took X-rays of my lungs and tested my thyroid. She said my right side of my sinuses were totally clogged and that it would take time to get my voice back.
Soft lump underneath my arm; pain [in arm]; hard for me to sleep on my right side; a lot of pain underneath my arm; 2 inches by 2 inches/3 inches by 2 inches now; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Soft lump underneath my arm), PAIN IN EXTREMITY (pain [in arm]), VACCINATION SITE INDURATION (hard for me to sleep on my right side), AXILLARY PAIN (a lot of pain underneath my arm) and VACCINATION SITE SWELLING (2 inches by 2 inches/3 inches by 2 inches now) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Soft lump underneath my arm), PAIN IN EXTREMITY (pain [in arm]), VACCINATION SITE INDURATION (hard for me to sleep on my right side), AXILLARY PAIN (a lot of pain underneath my arm) and VACCINATION SITE SWELLING (2 inches by 2 inches/3 inches by 2 inches now). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of UNK, bid. At the time of the report, AXILLARY MASS (Soft lump underneath my arm), PAIN IN EXTREMITY (pain [in arm]) and AXILLARY PAIN (a lot of pain underneath my arm) outcome was unknown and VACCINATION SITE INDURATION (hard for me to sleep on my right side) and VACCINATION SITE SWELLING (2 inches by 2 inches/3 inches by 2 inches now) had not resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up document received. Contact details of primary reporter updated, new reporter information added. New events added. Conmed added.
1st Shingrix shot about 3 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter asked, if they need to restart the series or just 2nd dose needed. This case has been linked to US2022AMR044658, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR044658:Same reporter.
Taste of medicine in mouth/throat - 1:30pm Swelling and numbing of right side of face begins - 2:30pm Benadryl taken - 2:53pm Numbing spread to both sides of throat, difficulty swallowing - 3:15pm 24/7 Nurse Hotline at Medical Center called - 3:16pm Nurse hotline advised to call 911 immediately  Paramedics arrive - 3:23pm Bell?s palsy symptoms begin - 3:25pm Transported via ambulance to Emergency Room - 3:26pm Bell?s palsy worsens, facial contractions continue  Prednisone given in emergency room  Prescription of Methylprednisolone Tablets, USP is prescribed for 6 days, 21 pills, 4mg each  Continue use of 25mg of Benadryl as needed  Follow up with neurologist recommended and scheduled for 04/09/2021 Day 2, 04/08/2021 - slept off and on, felt terrible, facial twitching, forehead pain from twitching, right eye uncomfortable.  Day 3, current day, waiting to see neurologist, right eye pain increasing and blurriness of vision in that eye.
BODY ACHE; RASH; FEVER; TIREDNESS; HIVES ALL OVER BODY; 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: 206ASIA, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced rash. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced hives all over body. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body ache, tiredness, hives all over body, and rash. This report was non-serious.
Patient presented to emergency department with complaints of low blood sugar feeling weak and shaking.  He also complains of right quadrant abdominal pain, nausea, lightheadedness and fatigue.  Denied vomiting.  He also has intermittent blood in stool which he described as red/maroon color blood mixed with stool few times a week for last several months. Patient was admitted for symptomatic anemia likely secondary GI bleed and, hypoglycemia. Patient has asymptomatic COVID-19 infection and was not noted to be hypoxic.  He was saturating very well on room air.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left 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 was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: Paxlovid relapse after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 18Jul2022 to 24Jul2022 for COVID 19.  Clinical course: The patient received other medication in 2weeks Ssri, other medication in 2week brand Lexapro.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heart Attack; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a elderly 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, less than 2 years after receiving Shingrix, the patient experienced heart attack (serious criteria death and GSK medically significant). On an unknown date, the outcome of the heart attack was fatal. The reported cause of death was heart attack.   It was unknown if the reporter considered the heart attack to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient was over 75 years. The patient received Shingrix at some point had a heart attack and died. The reporter did not give consent for follow up. This is 1 of 3 cases reported.; Reported Cause(s) of Death: Heart attack
C/O soreness and swelling and pain in L arm using ice and Advil prn, sometimes with good effect, sometimes not.
Received vaccine @ 2:15pm At 9:00 pm client describes having a hard time breathing/ heart beating fast/ headache and extreme lethargy. called ER did not go had no transportation. Symptoms seemed to be subsiding by 11:00 pm but remained very tired client stated.site has very large red area around it and sore to the touch.advisedto seek medical attention for follow up of symptoms.
joints are very sore and achy/Joints really hurt after second dose; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Jun2021 (at the age of 78-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included lung cancer (she was diagnosed with lung cancer about a year ago and was still in treatment). The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, 1st dose, single for COVID-19 immunization and was ok. The patient stated that she received the second dose of the Pfizer BioNTech Covid-19 vaccine on 13Jun2021. On an unspecified date, the patient experienced joints are very sore and achy. She had an effect from the second dose. She did not know what to take and wanted to ask Pfizer what she could take. The patient stated that now her joints are very sore and achy. The patient stated that her HCP referred her to Pfizer to see what she can take for joint soreness. The patient asked what she can take for soreness in her joints. The patient stated that first one was ok, and with the second one, her joints really hurt. The patient declined to receive any further information over the phone regarding her side effects in relation to the Pfizer Covid-19 vaccine. Referred to healthcare professional for further guidance. The outcome of the event was unknown.  Information on the lot/batch, further information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number MJ432, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 19th November 2018, less than a year after receiving FLUARIX QUADRIUVALENT 2018-2019 season, the patient experienced pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site erythema and injection site warmth to be related to FLUARIX QUADRIVLENT 2018-2019 season. Additional information received as follows: The healthcare professional reported that the patient who received the dose of Fluarix QIV on Monday developed arm soreness, redness, and warmness at the injection site which was ongoing, till the time of reporting.  The patient had reportedly had flu vaccines in the past without adverse reactions which had lasted for so long. No further details were provided regarding the event. The reporter did not give consent to follow-up.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 11:03 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 11:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Arthralgia Fatigue, Loss Appetite Narrative: Symptoms started day after injection,  Persisted for a couple of days.
Patient received the vaccine on 6/7/18; Pt called today to report that she had a severe leg pain a day or 2 after she received the vaccine. She was referred to a specialist to check if she had DVT but it was ruled out. The primary care told the patient that the leg pain, was a nerve pain due to the vaccine and put her on steroids which is helping with the pain now.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:18 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.17 for dose administered on 02-Mar-2021 and 70.25 for dose administered on 30-Mar-2021 . No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 AM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021 . Batch number 019B21A underwent temperature excursion on 30-Mar-2021. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
got a Covid really made me sick; got a Covid really made me sick; The initial case was missing the following minimum criteria: reporter. Upon receipt of follow-up information on 16Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got a Covid really made me sick".  Additional information: Patient recently got booster about 3 weeks ago, they take patient out for about 3 or 4 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"Received second Injection 1-26-21 Next day experienced mild headache, moderate muscle and neck pain, skin extremely sensitive to the touch, and fatigue. This resolved about 36 hours after the injection.  Was feeling fine until today 2/3/21 (one week after injection) . New symptoms developed as I am now feeling like I have tightness in my lungs when I breathe with mild difficulty. (kind of like when I have a chest cold). Also my throat feels funny like my trachea hurts.I have been reporting daily with the CDC app as suggested and have reported these symptoms as well."
Dizziness and pain in right arm that began at time of immunization.  Decreased range of motion in in right shoulder.  Patient still experiencing pain and limited range of motion in right shoulder.  MRI completed on 11/13/23 which showed Full-thickness slitlike nonretracted tear of the posterior supraspinatus/anterior infraspinatus junction with background tendinopathy of the supraspinatus and infraspinatus. Severe subacromial/subdeltoid bursitis. Mild supraspinatus and superior infraspinatus muscle edema.
This spontaneous report as received from a pharmacist via company representative refers to a 11 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose 1 and 2) (dosing details were not reported) for prophylaxis. On an unknown date in May 2017 the patient was vaccinated with third dose of GARDASIL 9 (dosing details were not reported) for prophylaxis. On an unknown date in June 2017 the patient developed a "white sore on his tongue the size of a dime". On an unknown date in 2017 "the sore resolved on its own". On an unknown date in July 2017 the patient again developed a "white sore on his tongue the size of a dime" which again "resolved on it's own". On an unknown date the patient was seen by an unspecified physician in regards to reaction and had "multiple labs done and all were normal". The reporter stated that "the patient is fine now". Causality assessment was not provided. No product quality complaint was involved.
Information has been received from a registered nurse concerning an "11 year old" male patient who on 22-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot # 666863/0467Z). On 23-JUL-2010 the patient returned to the office with discomfort and redness (unspecified where). At the time of the reporting, the patient's status was unknown. This is one of two reports from the same source. The patient's brother's experience has been captured in WAES 1008USA03167. Additional information has been requested.
Ended up positive for COVID about a week ago. Fever at 104.2, runny nose, fatigue, congestion and headache.
No adverse effects were reported; Received a dose of MMRII taht was reconstituted with a expired diluent; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 02-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) one dose, for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported). The vaccine was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) lot #M016884 and expiration date 04-DEC-2018 (strength, frequency, and route of administration were not reported). No adverse effects.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA002598: