chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered to patient 12 hours post puncture; the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient 12 hours post puncture) and PRODUCT STORAGE ERROR (the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture). On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient 12 hours post puncture). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient 12 hours post puncture) and PRODUCT STORAGE ERROR (the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. The vial was initially stored in the refrigerator on 14-Dec-2021 and was first punctured at 8:00 am or 9:00 am.Pre-drawn syringe was refrigerated.
Pt received Engerix-B and experienced rhinitis, serious eye draining.  Third day following the vaccination she had onset of macular apaular rash w/pruritus on scapular region.  Rash extended to chest.  Dr evaluated felt rash was unrelated.
Vial was stored in the refrigerator post expiry; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator post expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the vial was stored in the refrigerator on 04-APR-2022.  The vial did not undergo any temperature excursion.   This case was linked to MOD-2022-551714 (Patient Link).
Information has been received from a physician concerning a 44 year old white female, weight 209lb, height 54 inches, with hypothyroidism and lipid disorder and no known drug allergies and a history of chicken pox in childhood and chronic recurring bouts of shingles who on the morning of 25-MAY-2007 was vaccinated with the first dose of ZOSTAVAX subcutaneously in the left arm.  Concomitant therapy included VALTREX.  In February, 2008, therapy with VALTREX stopped.  (Also reported VALTREX used through 31-AUG-2007).  On 15-May-2008, the patient developed shingles on her back and trunk, chills and myalgia.  The patient rated her pain a 7 on a scale of 0 (least) to 10 (most).  The shingles lasted for 7 days.  The maximum temperature was 99.2F.  The patient restarted VALTREX.  Subsequently the patient recovered.  The patient sought unspecified medical attention.  The reporting physician considered the recurrent shingles to be an other important medical event.  Additional information has been requested.
Patient stated her right arm at/around the injection site was swollen, red, and painful. The arm was painful to the point she could not sleep on her right arm or apply pressure to it.  She knew all of these were common and likely side effects; however, she became concerned because these side effects lasted for approximately 4 days. I did visually confirm the patient?s arm was swollen and red on 12/21/2020.  I recommended tylenol to help with the pain and for her to contact her MD additional guidance. Patient stated her side effects had resolved when she returned to the store on 1/3/2021. I did not get an exact date of resolution.  She was never able to see consult her MD .
Small white oval area around vaccination site, also slight swelling at first a day or two post vaccination. Continues to be a white area despite tanning around area on arm. No swelling at present time 3 weeks post 1st vaccine dose.
immed devel of diffuse somewhat splotchy erythematous rash w/scattered erythematous papules over face, primarily forehead;resolved w/o tx over 20-30min;
Nausea, vomiting, fever, chills for one day.  Fatigue, flu-like symptoms for 2 days.  Insulin-resistance and high blood sugar for 3 days.
Patient came to store on January 30 indicating she was 2 days in pain and showing her swollen arm. She said she went to the doctor and he indicated that she should come to Pharmacy so we could help her. She indicated she took 2 MOTRIN and her arm was less swollen but it still hurt. Called her the next day to see how she was but she indicated that she still felt pain on her arm.
Pt presented at ED by ambulance 01/11/2022, with fever and shortness of breath. Stated he had been experiencing SOB, mild cough and HA for 3 weeks. Had Moderna booster 01/10/2022, and reports 01/11/2022 he felt "horrible".  Determined to have severe sepsis and acute or chronic respiratory failure with hypoxemia. Admitted. Tested + for COVID.
Sudden Death after a headache episode Post shows Cerebellar tonsillar and bilateral uncal herniation in the setting of "mild" cerebral edema No fever No rash
devel fever 3 days post shot, lasted until 8 days post shot;also had rash, sore throat;main concern was inability to walk devel 6 days post vax; fever to 105;had nl x-rays but inc WBC & sed rate to 85;morning stiffness;viral toxic synovitis
Localized swelling, treated with BENADRYL and hydrocortisone cream. Much improvement in 3days.
I am 3 months post partum. The day after  I received my shot, my pelvic area had a odd feeling. Almost like my uterus felt a dull very very mild pressure. Day 2 after receiving my shot, I started to bleed. I am exclusively breastfeeding and I have never had a period start this early with all of my other children. Normal is 7 plus months for me. This period was also not a normal period. I had zero cramps. I felt nothing. I never have had a period with zero cramps. Lasted for 7 days.
Fussiness & screaming after immunization. Muscle felt hard & knotted. TYLENOL & warm bath given. Fell asleep approx 4:54 PM.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with RECOMBIVAX HB (strength, dose, lot# were not reported) intramuscular which were stored improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.
This initial spontaneous report was received on 09-FEB-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-FEB-2012 the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) (by an unspecified healthcare professional) at an urgent care facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-APR-2016, the patient was treated (by an unspecified healthcare professional) at a healthcare facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
I received my Moderna booster shot yesterday and 5 hours later I suddenly started experiencing significant pain in my left shoulder and down the back of my left arm (primarily between the shoulder and elbow). It feels/behaves exactly like bursitis. Since it started, I have had very limited mobility in my left arm and shoulder, and any movement causes pain. It is currently 22 hours since I had the booster and the condition is unchanged. I have taken two Tylenol since it started -- I know that I'm supposed to avoid taking things that can affect the efficacy of the booster shot.
Weakness, Joint and muscle aches, fever, left arm near injection site became warm and the next day, the "Covid-rash" presented on the upper area of my left arm area.
Arm hot; large red circle; This is a spontaneous report from a non-contactable consumer. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Jun2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not know about any medications received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jun2021 at 14:00, after three days of vaccination, the patient experienced arm hot and large red circle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of arm hot and large red circle was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Fever, Chills Narrative: Per nursing report: "C/o took 2nd Moderna vaccine on Monday [3/22]. The next night after receiving the vaccination and the next day 3/23/2021 states began to have body aches, chills and a temp of 101.5. Today 3/24/2021 states feels somewhat better, remaining a little sore and achy but no fever as of 2100 on 3/23/2021."
Itchiness at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) was resolving.        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.   Treatment for the events included acetaminophen, ibuprofen and diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
Presented with severe urticaria 10 days after booster. Redness, itchiness, swelling, warm to the touch - all over body from scalp to bottoms of feet. First visit to ER was given 2 steroid injections and prescribed Medrol dose pack and hydroxyzine for 6 days and Pepcid for 7 days. Symptoms kept calm but still itchy. 24 hours after finishing last prescription, hives came back again. Went back to the ER on 2/14 where I was prescribed prednisone for 10 days and Allegra 12 hour antihistamine. This course of treatment has helped better than the first but still have minor itchy from time to time. Currently done with prednisone but still taking Allegra and have an appointment with an allergist.
pt recv vax 14MAY96 5PM then went home ate&drank;slept 7PM-730AM&woke moaning/breathing heavily&vomited;15' later lips blue <1min,jaw shivered then turned limp&eyes rolled (no sz activity) ragdoll&heavy breathing;went to hosp ER
Patient stated he felt light headed with blurred vision. 1:50 pm BP 140/96  pulse 86 1:56 pm 98/69  pulse 86 2:24 pm 93/73 Pulse 81, alert 0x3 with NAD ( No Apparent Distress) color pink No SOB, No rash  ER instructions are given. Left at 2:28 pm went home in NAD.
A non-serious spontaneous report of half dose of FLUMIST was received from a healthcare professional concerning a ten year-old. On an unreported date the nurse forgot to pull the clip off the second half of the dose and the patient only received half a dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Numbness and tingling begin very suddenly in left leg at top on the inside. Couldn't walk for 3-4 days, pain subsided. Once pain lessened in leg, neck and shoulders became very limited in range of motion (accompanied with very intense migraine). Saw a Chiropractor, however, symptoms didn't lessen. After 1 week of pain in shoulders and neck, the pain subsided and then moved into my right rotators cuff area. I couldn't lift or move my arm AT ALL. Had to use my left arm to lift my right arm, but only with excruciating pain! Once pain subsided on right now, moved to left arm with same symptoms and no movement. Pain was so bad it left me in tears and would begin spasming uncontrollably. Had to take a muscle relaxer for it to stop from spasming. Pain subsided after a 4-5 days and then went back to right arm, followed by more right leg pain. Another 3-4 days of pain and everything went away. From Oct 8 - Mid November (1 month work) I had what I thought was impingements taking place. No further pain has surfaced in the same manor since.
Patient received Moderna first dose in error; advised to get second dose Pfizer. Patient presented for 2nd dose, again given Moderna. Observed for 30 minutes with no difficulty.
Patient called the pharmacy on 10/29/2021 and stated that about 45 minutes after his 2nd COVID vaccine was administered he experienced an increase in heart rate and palpitations. He has continued to have palpitations and an increase heart rate. Patient states that his chest also continues to "weird" but could not elaborate. Patient was advised to go to urgent care or ER.
I know people who have had the second shot and got real sick; 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 ILLNESS (I know people who have had the second shot and got real sick) 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, the patient experienced ILLNESS (I know people who have had the second shot and got real sick). At the time of the report, ILLNESS (I know people who have had the second shot and got real sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Fussiness, high pitch crying, unable to soothe/comfort, decreased sleeping in a breastfed infant.
Within 1 minute of vax, the pt experienced a localized red 7 x 7cm area on outer right thigh. The pt was given Benadryl and the redness lasted approximately 45 minutes.
Patient stated she noticed arm getting red and area spreading from injection sign extending to the ante cubital area. Patient reports no soreness or itching, just redness.
13Nov90 pt vax w/ 2nd hepta B; exp gen hives. Exp itching on neck, shoulders, arms & back, redness noted; small hives on neck.  Tx w benadryl.
Tinnitus; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03921A, 03921A, 001B21A and 031L20A) for COVID-19 vaccination.     Patient had no allergy.  Concomitant products included ATORVASTATINE [ATORVASTATIN] for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced TINNITUS (Tinnitus) and COVID-19 (COVID-19). At the time of the report, TINNITUS (Tinnitus) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.         Patient was afraid and concerned about next shot. Patient would like to know if other people had reported having tinnitus and if there was a treatment for it. Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 76-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately two and a half weeks after receiving the fourth dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately two and a half weeks after receiving the fourth dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Dizziness, Headache,  tired, sore left arm,  Narrative:
rash measuring 3 inches wide and 4 inches long at the injection site; Redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (rash measuring 3 inches wide and 4 inches long at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 72-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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE RASH (rash measuring 3 inches wide and 4 inches long at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (rash measuring 3 inches wide and 4 inches long at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
Multiple raised reddish-purple closed lesions anterior lower extremities from upper thighs to ankles  worse on medial aspect. Lesions are pruritic. BENADRYL 25-50mg po q 6-8 hrs, MEDROL dosepak. Follow up scheduled pending.
After 5-10 minutes. I started to feel tingling around my mouth and throat. Tingling in my chest, trouble breathing. After sitting there for an hour my heart rate was evaluated 100 beats/min. My temperature and blood pressure was high. I started to feel dizzy. I felt I was having an allergic reaction. My oxygen was low.