chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid-19; have been vaccinated with two shots; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19; have been vaccinated with two shots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19; have been vaccinated with two shots). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19; have been vaccinated with two shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided. The patient recently tested positive for covid-19. The patient had been vaccinated with two shots, but have yet to get a booster.  Company comment:  This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of SARS-CoV-2 test positive , that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of SARS-CoV-2 test positive , that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concomitant products included ADACEL and PREVNAR. On 16th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On 16th June 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient received ADACEL and PREVNAR on the right deltoid. The patient who was administered the SHINGRIX vaccine subcutaneously, which led to intramuscular formulation administered by other route. The reporter indicated that she called the consumer's physician and left a message regarding what happened. Unable to obtain additional information.
My pain started a few days after the shot it was in the upper arm and a few days later into my back and into my breast - had to take TYLENOL extra strength to sleep. Im still in some pain today. No fever.
Developed rash after vaccine. No trouble breathing. Benadryl 25mg PO x 1 given. Pt discharged home with family in stable condition.
pt became nauseated, vomiting and abdominal pain on 12/27/20 came in to be seen on 12/30/20 labs, ct and exam were performed determined pt had gallbladder flare up  pt then sent to hospital where they removed gallbladder
Red arm worsened over a day; Itchy arm worsened over a day; Swollen arm that worsend over a day; Arm sore for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore for two days), VACCINATION SITE ERYTHEMA (Red arm worsened over a day), VACCINATION SITE PRURITUS (Itchy arm worsened over a day) and VACCINATION SITE SWELLING (Swollen arm that worsend over a day) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm sore for two days). On 27-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red arm worsened over a day), VACCINATION SITE PRURITUS (Itchy arm worsened over a day) and VACCINATION SITE SWELLING (Swollen arm that worsend over a day). On 22-Apr-2021, VACCINATION SITE PAIN (Arm sore for two days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red arm worsened over a day), VACCINATION SITE PRURITUS (Itchy arm worsened over a day) and VACCINATION SITE SWELLING (Swollen arm that worsend over a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information provided as, the patient used an antiitch cream that did not help.
Patient developed cellulitis. She was seen by a physician and given an antibiotic. The site of the cellulitis was not improving, so the patient went to her local ER and was given another stronger antibiotic. The second antibiotic treated the cellulitis. Her arm is currently healed, but she is still experience some tingling in the area. She reported some swelling and redness after vaccine, but did not report the cellulitis until coming back to the pharmacy for additional vaccines needed.
24 hrs after vaccines developed fever, arm pain & local swelling, then generalized rash (not hives), shortness of breath, wheezing. Also was unsteady when walking, disoriented, had a severe headache and neck pain. Nebulizer at home & dose of BENADRYL helped. Still not back to herself as of 48 hrs (24 hrs after symptoms) but improving. Mom feels she is acting mildly disoriented.
First dose gave me Covid arm in left arm.  Second dose gave me severe itching, rash, red bumps. in both arms but injection arm was more severe.  Finally went to the dermatologist after 9 days.  Iced in here in Texas and without power so had to wait. Received topical to assist in itching. At 2+ weeks still have some red bumps but no itching.  Never had fever or any other issues.
Chest Pains, Trouble Sleeping, Trouble Breathing, Fatigue, Insomnia, Anxiety, Immense Pain, Possible Arythmias, Fainting
Has a two lines of rash, which is itchy with a few; Itchy with a few pimples; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash and pimples. On an unknown date, the outcome of the itchy rash and pimples were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and pimples to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The age at vaccination was not reported. The patient experienced two lines of rash, which was itchy with a few pimples. On the day of reporting, the patient would be seing the doctor. No additional information was provided. The reporter did not consent to follow-up.
Vaccine that was administered was 4 days beyond use date. Patient was informed and reported  feeling tired and  had some aches and pains. Those symptoms have since resolved. Patient's doctor was called and made aware of the situation.
Note from client that administered vaccine:  THIS PATIENT GIVEN HIGH DOSE FLU VACCINE BY ME TODAY. I HAVE CALLED EMPLOYEE IN BILLING DEPARTMENT TO ADJUST THE AGE PARAMETERS SO I CAN PUT THE VACCINE IN FOR THIS PATIENT AS I WAS NOT ABLE TO BECAUSE OF AGE PARAMETERS. ALSO, THE BILLING WAS REMOVED SO THIS PATIENT WILL NOT BE CHARGED FOR THIS VACCINE. HER INSURANCE WILL DENY PAYMENT DUE TO HER AGE. I CALLED THE PATIENT TO NOTIFY HER OF THE MEDICATION ERROR. I APOLOGIZED AND INFORMED HER THAT SHE WILL NOT BE CHARGED FOR THE VACCINE NOR WILL HER INSURANCE BE BILLED. PATIENT UNDERSTOOD ALL. I WILL PUT AN INCIDENT REPORT IN FILE CABINET AND UPDATE PROGRESS NOTE AS NEEDED.
Sore arm, headache, eyes itchy, breathing difficulty, nausea. Similar reaction to allergic reactions I have with cats.
no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 9 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the right deltoid at a dose of 0.5 milliliters (ml), once (lot number: W002596, which was verified to be valid, with an expiration date: 24-JAN-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Patient received flu shot at off-site IMZ clinic on 10/24/18. Reports that immunization felt different than other immunizations that she has previously had. Considerably more painful than previous immunizations. Arm was more sore than usual following injection and not just at injection site. Describes a pain in her shoulder joint with loss of range of motion. She also has pain when using her arm to pick up light items such as soda bottles. Pain has been consistent for the past 2 weeks and she has become concerned that this could be something serious. She Googled her symptoms and fears that her discomfort could be from the immunization being administered too high in the arm. She has not sought medical attention, but is wondering if she should.
Headache,  muscle pain on the site  of injection,  chills, nausea, fever. Started time 01.03.2021 8:15pm.
pt recv vax 22AUG95 & w/in 1 wk exp dec sense of smell & taste;
Sore arm at injection site 3hrs after given, at 8:30pm started to feel weak, became pale, started having all over body/muscle aches, chills, fever of 100° and nausea. Took some aspirin...helped a little bit but still only got around 4 hrs of sleep. Woke up still with sore arm, body aches, headache, and still weaker than normal. Took some more aspirin....it's been around 4hrs now and body aches and weakness are almost gone. Still have the sore arm and slight headache.
c/o h/a, fever, vomiting, pain, edema, redness inj site on lt thigh 10cm size;
irritation in the throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset Jul2022, outcome "unknown", described as "irritation in the throat".  Additional information: Received the Pfizer COVID-19 vaccine yesterday and one day later he shows irritation in the throat, she wants to know if this could be due to the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information about medical history, concurrent conditions, drug reactions and allergies was specified. The pharmacist reported that on an unknown date, over 4 years ago an unspecified Pharmacy provided patient with ZOSTAVAX (lot#, dose, route not reported) to carry to Physician's office for administration. Patient states at that time the healthcare worker questioned whether it was too warm, but administered it anyway. No concomitant medications were reported. There was no stability check done at that time. Patient has not experienced any adverse effects. The patient did not seek medical attention. There was no product quality complaint. The outcome was unknown. Additional information has been requested.
he woke up shaking like crazy; he has joint pain (ankle, elbow); temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (he woke up shaking like crazy), ARTHRALGIA (he has joint pain (ankle, elbow)) and PYREXIA (temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TREMOR (he woke up shaking like crazy) and ARTHRALGIA (he has joint pain (ankle, elbow)). 11-Mar-2021, the patient experienced PYREXIA (temperature). At the time of the report, TREMOR (he woke up shaking like crazy), ARTHRALGIA (he has joint pain (ankle, elbow)) and PYREXIA (temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100 (High) high, 100.3 (High) high, 101 (High) high and 101.3 (High) high.         No concomitant medications were reported.  The patient self-treated with ibuprofen, twice.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
I received my Moderna booster shot on Thursday, Dec 2 2021. I started to feel ill by 11:00 pm that evening. I was pretty sick with symptoms (low-grade fever, muscle aches, fatigue, stomach pain) that lasted throughout Friday and Saturday. Saturday morning, I experienced a new symptom; I had trouble breathing where I could not process oxygen. At one point, my oxygen level was an 86. I experienced this breathing issue for about an hour. On Sunday I no longer had fever nor fatigue, but around 4pm started coughing. I still have an intermittent cough as of today Dec 15 but every day, I cough less. I felt perfectly fine prior to receiving the booster. My symptoms were similar to what I had experienced with receiving the first 2 vaccines except the breathing issue processing oxygen. I was taking deep breaths to try and compensate for the fact I could not process oxygen well. This was alarming hence why I am filling out this form.
pt recv vax NOV97 & started to have sinus infect w/coughing;it seemed to the pt that gets these sinus infect only when eats the foods is allergic to;dx fibromyalgia in NOV97;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated improperly stored dose of PROQUAD (therapy type rHA) (lot # R015742 with expiry date of 02-DEC-2019) subcutaneously for prophylaxis. It was reported that, data logger was in use but it did not alarm and excursion was discovered later. No adverse effects were reported. The vaccine was stored at the temperature of 6 Fahrenheit to 14 Fahrenheit (5.9 Fahrenheit) for 20 minutes. No previous temperature excursion was reported. The call was due to data logger. No product quality complaint was filed.
Chills, hot flashes, nausea, fever, headache- 24 hours Took Tylenol Symptoms Continued with Tylenol
A couple of days after the vaccine injection, I lost my taste, my mouth felt extremely dry, wired taste. The symptom lasts till today.
No additional AE/; one of her very experienced was administering the vaccine into the deltoid of a 17 year old patient when she was sprayed with the dose.; This spontaneous report was received from a nurse, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.  On 01-AUG-2023, while a very experienced nurse was administering hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe injection, product quantity: 1, lot #1775808, expiration date: 20-AUG-2023, into the deltoid of a patient (dose was not provided), she was sprayed with the dose (occupational exposure to product). She stated that "it seemed like the hub wasn't on like it normally was, the hub looked crooked" (syringe issue and accidental underdose, captured in MARRS#2308USA001096).  The gauge and size needle and syringe used were 25 gauge, 1 inch. The reporter stated that it did not spray from the insertion site where the needle was within patient arm, it came from the defective prefilled syringe.  No injuries and no adverse event were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA001096:
Redness and edema at site in left deltoid. Temp of 101.2 po. 650mg of Tylenol given.
Swelling; extreme soreness; inability to sleep due to pain; reported twice to doctor's.  Still sore after over a year. several weeks of severe arm pain; now milder discomfort & weakness still exists.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 80 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Feb2021 as dose 2, single (Lot number: EN9810), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Other medical history: none at this time. Past cancer patient.; "Known allergies: pecans" (unspecified if ongoing), notes: Known allergies: pecans. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
excessive swelling at vaccine site. Mother states she didn't look at it last night, but noticed it this morning. Mom states is is about 2.5 to 3 inches in circumference and about 1/2 inch raised. No discoloration and minor soreness described. Mom called their family practice provider and was instructed to put ice on. Patient has not complain of pain or discomfort.
Information has been received from a medical technician concerning a female employee who on 20-APR-2007 was preparing to administer Zostavax (Merck) (lot # 656395/0162U), she pulled back on the syringe plunger and the vaccine splashed into her eyes. She complained of a burning sensation in both of her eyes, they were immediately flushed at an eyewash station and the was referred for evaluation by an ophthalmologist. The results of the evaluation were pending. There were no lab studies performed. There was no product complaint involved. No further information was provided. Additional information has been requested.
Skin reaction; This case was reported by a pharmacist via call center representative and described the occurrence of skin reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that a patient received a dose of Shingrix and had skin reaction. The reporter reported that patient's demographic details were collected while pharmacist was talking only about gender and mentioned skin reaction since he/she did not know further information. The pharmacist was on a hurry and the call got disconnected while trying to reach the patient was on the other line. Pharmacist's first and last name was asked but he put reporter on hold instead of providing this information. The reporter did not consent to follow-up.
Heart rate 94 - 112 times two nights; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 11Jan2021 18:45 at a single dose on left arm for COVID-19 immunization. Medical history included COVID. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. No other vaccines in four weeks. The patient received other medications in two weeks prior to COVID vaccine (unspecified). The patient experienced heart rate of 94 - 112 times two nights on 11Jan2021 at 20:00. The patient underwent lab tests and procedures which included nasal swab (COVID test type post vaccination):  unknown on 12Jan2021 (reported as result pending).  COVID test name post vaccination was PCR. The patient is recovering from the event.  Information on the lot/batch number has been requested.
On 2/23/21, the day following the 2nd Pfizer vaccine, noticed pustules in left arm interior to elbow w/ itching and burning.  On 2/25/21, made appt at urgent care as PCP not available.  Photographed pustules, sent to Dr. for evaluation. Dx as Shingles. No treatment suggested or attempted.  On 3/2/21, seen by Dermatologist for f/u. Biopsy done d/t unusual presentation. Results confirm Shingles. Also experience severe lymphodema, causing extreme pain. Engaged in PT.