chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heavy arm; Little lethargic; A little soreness on both sides below his earlobes; Pressure in ears, like a clogged ear, ears need to pop like being on an airplane; Puffiness (both sides under his ear/jawline area; Slight swelling (both sides under his ear/jawline area); A sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavy arm), LETHARGY (Little lethargic), EAR PAIN (A little soreness on both sides below his earlobes), EAR DISCOMFORT (Pressure in ears, like a clogged ear, ears need to pop like being on an airplane) and SWELLING FACE (Puffiness (both sides under his ear/jawline area) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Demerol), Drug allergy (Allergic to Benadryl), Allergy to topical drugs (Allergic to topical iodine), Seasonal allergy and Complex regional pain syndrome Type II (CRPS Type II vagus (affects left arm)). Concomitant products included POTASSIUM, PROPRANOLOL, LISDEXAMFETAMINE MESILATE (VYVANSE), VITAMIN D NOS and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (Heavy arm), LETHARGY (Little lethargic), EAR PAIN (A little soreness on both sides below his earlobes), EAR DISCOMFORT (Pressure in ears, like a clogged ear, ears need to pop like being on an airplane), SWELLING FACE (Puffiness (both sides under his ear/jawline area), SWELLING (Slight swelling (both sides under his ear/jawline area)) and PAIN IN EXTREMITY (A sore arm). At the time of the report, LIMB DISCOMFORT (Heavy arm), LETHARGY (Little lethargic), EAR PAIN (A little soreness on both sides below his earlobes), EAR DISCOMFORT (Pressure in ears, like a clogged ear, ears need to pop like being on an airplane), SWELLING FACE (Puffiness (both sides under his ear/jawline area), SWELLING (Slight swelling (both sides under his ear/jawline area)) and PAIN IN EXTREMITY (A sore arm) had not resolved.            On 09-Feb-2021, the patient received their second dose and stated they had a heavy arm at the time of report and a sore arm and was a little lethargic post receiving the vaccine. The patient also mentioned that they were experiencing a little soreness on both sides below their earlobes and also experienced slight swelling and puffiness on both sides under their ear/jawline area.   The patient also experienced pressure in their ears like a clogged ear and stated that it was like their ears need to pop like being on an airplane.  No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-029277 (Patient Link).
Started running fever (unmeasured by mother) that evening, woke up next morning (9/22) with red and swollen knees and ankles.  Today, 9/24, the child is unable to walk due to excessive pain.  Mother states she cries whenever she is moved.
Employee began experiencing tingling in roof of her mouth, watery eyes and itchy throat. She was taken to ED for further evaluation and treatment.
Swelling, tenderness, redness, pain and itching on left upper arm next day after the injection
MMRV and varicella given on the same day. No reaction noted Per physician no action required.
Information concerning 15 to 20 pts who were vaccinated with a 3 dose series of hepatitis a virus vaccine revealed that the pts failed to seroconvert. The pt sought unspecified medical attention. No further information is available.
Pt recvd DTP/HBOC/OPV 12JUN92 & w/in 24hrs exp fussiness & low grade fever; tx included APAP & runny nose & low grade fever off & on; 1 wk later fever & coughing; 1JUL92 med cont; 7AM found dead in crib;
Blurred vision while looking at computer screen, nystagmus, nausea, vertigo & headache. 48 hours after vaccination nausea, vertigo and headache still persist.
Sx- muscle aches in neck, chest, arm, and back; nausea, migraine x2. Sx continues into the following morning.  Tx-ibuprofen
patient presented to emergency department on 12/2/21 with shortness of breath patient was admitted for further management of covid-19 patient was found to be covid-19 positive on 12/2/21 patient did require treatment for symptoms associated with covid-19 - treatment included remdesivir and baricitinib patient was discharged to rehab facility on 12/7/21
I was out working in my garage, and I was going into my basement and lighting in there is dark and my left eye responded normally but my right eye did not adjust correctly to the change in lighting, and I could not see as I should, this was the first thing I noticed. Then I thought that my contact was blurry and to try and fix that I cleaned them and that did not help, I changed it and that did not help either. This caused me to reach out to my eye doctor. The issue makes it seem like I am looking through a smoky room or that things are blurry, and I cannot see normally. I was able to get into my doctor on April 26th and he did some tests both on my eye and on what I am seeing. I was diagnosed as having a central venous occlusion in the right eye and then glaucoma in both eyes. They have given me a treatment that includes shots of bevacizumab 0.2mg and I have six shots of that thus far and my seventh shot which was aflibercept 1 mg. They also gave me eye drops which do help as well. Now when I have flare up and that retina in the right eye is swelling up, I can work to adjust my vision and see through the blurriness, but it takes concentration and work on my end. I am answering that I am recovered because I do go in to get the shots which help for seven weeks but by the end of the seven weeks my eye does get cloudy and blurry, but the shots do work and help with the blood clot that is in my eye. I was also told that this should heal, and I will not need these shots forever.
Vomiting, lethargy, swelling, colic, developed CMPA and reflux after oral vaccination.
0.5 ml MENACTIA/MENINGOCOCCAL vaccine given IM R Deltoid. Rash broke out around inj site MD notified. 25mg DIPHENHYDRAMINE given PO per MD order.
6 HOURS AFTER EVENT, PT STARTED FEELING A LOT OF PAIN ON ARM SHOT WAS GIVEN. PT WENT TO BED. THE NEXT MORNING, PAIN WOKE HER UP AND EXTENDED TO ALL OVER HER BODY. SO PT STARTED TAKING IBUPROFEN. PAIN WAS SEVERE IN HER NECK AND COULD NOT BREATHE PROPERLY SO SHE TOOK A SUDAFED. AFTER AN HOUR LATER, PAIN WAS A LITTLE MORE MANAGEABLE. PT TOOK MORE IBUPROFEN AND PAIN IS STILL THERE. PT WILL MONITOR HER PAIN AND WILL SEE HER DOCTOR IN THE MORNING IF PAIN HAS NOT SUBSIDED.
3cm erythematous macula/indurated and warm. Prevnar is the one that has reacted.
Fever and irritability, starting about 4 hours after vaccination.  Temp to 103.7 (ax).  Generalized clonic seizure 16 hours after onset of fever, lasting 1 1/2 minutes.  Back to her normal self by 24 hours.
12/09 Lymph nodes above clavicle itchy and swollen, lump under armpit and left and, had a recent GI tract local anesthetic and thought it may be reacting to the booster. Chest cavity was sore and achy and had an itchy lump on left side neck. Irritability from pain and swelling. Went to ER thinking it may be heart related. EKG, blood work, urine sample, and Orthostatic test was done, and all came back normal. Gave bed rest and instructed for at-home treatment. Took Tylenol for the pain and swelling.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator (a RN). The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The RN then alerted the lead APRN, who escalated the situation to the manager. The manager then contacted  Quality.  The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a ?near miss? event and is being reported out of an abundance of caution.
Numbness and temporary paralysis of right-side of face, with twitch in left eye.
Pt c/o headache and dizziness post-vaccination. BP-144/91 P:95 O2 sat 100% at time adverse event began. No loss of conciousness witnessed. Juice given. Pt monitored closely by nursing staff for 30+ minutes. BP 117/70 P:66 prior to discharge. Pt stated feeling better other than a dull headache when discharged home with mother at 1225pm.
Injection leaked out of the syringe over his arm and on to the floor; Injection leaked out of the syringe over his arm and on to the floor; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reports an injection leaked out of the syringe over his arm and on to the floor/ Syringe leak, Underdose.  The patient's medical history was not provided by reporter. Concomitant medications were not provided by reporter.  On unknown date, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On 11 Mar 2021, prior to the onset of the events, the patient received the second of the two of their planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the injection leaked out of the syringe over arm and on to the floor/underdoes, Syringe leak.  Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the events was not applicable as patient has taken both doses of the vaccine.  The outcome of the events, under dose and syringe leakage due to error, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Underdose and Syringe issue for mRNA-1273, lot # unknown with no associated AEs.
Relapse of covid after taking paxlovid. I tested positive for covid on 12Apr.; Relapse of covid after taking paxlovid. I tested positive for covid on 12Apr.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "Relapse of covid after taking paxlovid. I tested positive for covid on 12Apr.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not received Other medication in 2 weeks. Treatment start date: 13Apr2022 Treatment stop date: 18Apr2022. Relapse of covid after taking paxlovid. Patient tested positive for covid on 12Apr. (Name) taking Paxlovid on 13Apr and took full five day course. Tested positive for covid on 17Apr and the negative on 18Apr. Felt fine except for vague lingering congestion from 18Apr-27Apr. On the morning of 27Apr tested positive for covid and evening of 27Apr covid symptoms returned.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sinus congestion; Sinus pressure; 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 SINUS CONGESTION (Sinus congestion) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUS CONGESTION (Sinus congestion) and PARANASAL SINUS DISCOMFORT (Sinus pressure). At the time of the report, SINUS CONGESTION (Sinus congestion) and PARANASAL SINUS DISCOMFORT (Sinus pressure) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medications were OTC drugs, steroids and antibiotics.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Confused, Body Aches, Constricted pupils, grey tone to skin, black under eyes, clammy, fever. 48 hours later, projectile vomiting, stomach pain, confusion, lethargy.
MODERATE RASH, ITCHING REPROTED  AROUND VACCINATION SIGHT.   COVID ARM
Patient received first dose of COVID vaccine with the Pfizer product on 7/21/2021, then later received the Moderna product as the second dose in the series on 8/12/2021. No adverse events were reported following these administrations and the patient later received a booster dose of the Moderna product as well.
The arm that I got the injection in was itchy with no rash or other noticeable skin reaction and my right ankle was very itchy like an allergic reaction and 3 red dots appeared in a line in the same place I felt the itchiness.  They appeared on 4/12 and are still visible today (4/20).  They look like 3 mosquito bites in a row but it's still too early for mosquitos to be out.
Tingling/numbness left arm with tremor-especially index finger of left.  Presently still symptoms.
Felt like a cold coming on, cold symptoms; Fever got up as high as 100.5; Cold symptoms; Runny nose; Body aches; Cough; Feels sick; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th December 2021, 2 days after receiving Shingrix, the patient experienced general body pain and cough. On 7th December 2021, the patient experienced runny nose and cold symptoms. On 8th December 2021, the patient experienced feeling cold and fever. In December 2021, the patient experienced feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the general body pain, cough, runny nose, feeling cold, fever, cold symptoms and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, cough, runny nose, feeling cold, fever, cold symptoms and feeling unwell to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix around 3pm in the afternoon and he felt fine on Saturday (4th December 2021) and on Sunday (5th December 2021).   2 days after receiving vaccine, the patient began to experienced body aches and cough. 3 days after receiving vaccine, the patient had runny nose and the patient also said that it felt like a cold coming on. 4 days after receiving vaccine, the patient had cold symptoms and fever and felt cold. On an unknown date, the patient stated that he still felt sick The patient said that his fever got up as high as 100.5 degree Fahrenheit. On 9th December 2021 (day of the call), the patient said that he still had a low grade temperature of 99, body aches which were not as bad as they initially were, and cold symptoms. .   The patient was taking Tylenol for his symptoms.  The patient also commented that he heard that the second dose was worse. The patient was given medical advice disclaimer. The patient was referred to health care professional. The case was linked with case US2021AMR253585, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252836:Same reporter US-GLAXOSMITHKLINE-US2021AMR253585:Same reporter. Hearsay case.
SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 12:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Passed out every time he stood up; Gallbladder infection; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out every time he stood up) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out every time he stood up) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Mar-2021 due to CHOLECYSTITIS INFECTIVE and LOSS OF CONSCIOUSNESS. The patient was treated with Surgery for Cholecystitis infective. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out every time he stood up) and CHOLECYSTITIS INFECTIVE (Gallbladder infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Laboratory test: abnormal (abnormal) Gallbladder infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  This case concerns a 67-year-old male hospitalized with serious unexpected events of loss of consciousness and cholecystitis infective. Event onset 17 days after first dose mRNA-1273. Underwent surgery. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 67-year-old male hospitalized with serious unexpected events of loss of consciousness and cholecystitis infective. Event onset 17 days after first dose mRNA-1273. Underwent surgery. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose) 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 INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose).    No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Reporter did not allow further contact
Vaccine administered 6/27, approximately 10AM. 1. "spacey" and weak after lag of 30 minutes, headache began, weak, fell asleep. 2. next AM (24 hours later) severe nausea light headed, weak, anorexia: metallic taste (6 days +) extreme soreness, redness, swelling at site.
Tested positive for COVID; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Sars-covid 2-antibody test: Positive.     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.   No relevant concomitant medications were reported. No treatment information was provided.