chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little bit of pain in the arm; Rash itches; Rash on the abdomen, chest and lower back; Chills; Headache; Fever; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of pain in the arm), RASH PRURITIC (Rash itches), DIZZINESS (Dizziness), ASTHENIA (Weakness) and RASH (Rash on the abdomen, chest and lower back) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 11-Mar-2021, the patient experienced RASH PRURITIC (Rash itches) and RASH (Rash on the abdomen, chest and lower back). On an unknown date, the patient experienced PAIN IN EXTREMITY (A little bit of pain in the arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 10-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit of pain in the arm), RASH PRURITIC (Rash itches), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Rash on the abdomen, chest and lower back), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a rash on the abdomen, chest and lower back, it's not that strong, is slight but it's red. Rash itches. Had a little bit of pain in the arm. The patient had experienced dizziness and weakness.  The concomitant medications were not provided.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment was given to the patient. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
the rph found that we injected vaccine expired by one day , so pharmacy contacted pfizer and pfizer said it is ok and no need for revaccination
Fever; A spontaneous report was received from a consumer, concerning a female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, after vaccination the patient had experienced fever. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   Outcome of the event fever was not reported.; Reporter's Comments: Based on the 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.
Breakthrough case admission after 2 vaccines Janssen 4/1/21 Lot# 1808978;  Moderna 11/18/21 Lot# 077C21B
Late localized reaction. Redness, pain, itching, hot to the touch. Redness is about 6? long and about 5? wide. Reaction started at vaccine site 9 days after vaccine administration.
Body aches; Headache; fever; joint pain; This is a spontaneous report received from contactable consumer via Pfizer sponsor program. A 46-year-old female patient received bnt162b2 (COVID-19 Vaccine, Solution for injection), via an unspecified route of administration in Sep2020 (at the age of 46-year-old) at dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that after receiving what would eventually be revealed as the actual vaccine during a clinical trial that started Sep2020, she experienced fever, joint pain, body aches, and headache. Patient reported that, "when I started getting my first shot, I had a systemic reaction- fever, joint pain. My body wasn't feeling great. I had done research, so I knew it could happen. It wasn't great to have a fever, it's one thing to learn about it (ahead of time), another thing to experience in your body." "When we got unblinded. I was not quite as surprised. I was so happy, but I had suspicious because how I felt when I got the shots. Body aches, headaches. The mind is very powerful and the placebo effect exists, but I could not cause a fever. It was a huge relief to know that yes, I had gotten (the vaccine)." Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt developed strange taste and tingling in her mouth 10 min. after receiving flu vaccine. Was given 25mg of BENADRYL 14:45. Symptoms subsided.
At injection site 16cm by 17cm erythematous patch w/ about quarter size vesicular patch to center.
This case was reported by a physician and described the occurrence of arm soreness in a female subject of unspecified age who was vaccinated with Twinrix for prophylaxis. The subjects medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received primary course of Twinrix (unknown dose). The lot number and expiration date were not provided. An unspecified amount of time after vaccination with Twinrix, the subject experienced arm soreness. The event resolved. No additional information is available.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022 at 7:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022 at 7:34 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
expired dose engerix-B vaccination; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number HN5BA, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of  engerix-B vaccination, which led to expired vaccine used. The reporter consented to follow up.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 02/09/21,pfizer,Lot#EL9264 2nd dose: 03/02/21,Pfizer,Lot# EN6202 Diagnosed covid positive:04/26/21 Exposure:Travel Symptoms:Asymptomatic
Suspected vaccination failure; Got shingles after the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles after the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-Jun-2023 This case was reported the patient via interactive digital media. The patient got shingles after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
LEFT SIDED SWOLLEN LYMPH NODES IN AXILLA, LEFT ARM NUMBNESS, SWELLING, PAINFUL TO TOUCH, THROBBING OVER LEFT EYE ORBIT Narrative: EMPLOYEE REPORTS THAT SHE INTENDS TO SEE PCP WHICH IS WHAT THIS LPN RECOMMENDS
About 5 inches lower on the same arm the patient has a palm size red rash that is semi painful at touch and warm to touch.  No treatment currently.
10 hours post vaccine developed headache body chills and weakness. Along with pain at injection site. 12 hours post vaccine developed low fever 100.8, worsening chills, body aches, and headache and insomnia.
Started having fever Thursday morning around 100 degrees. Continued with Tylenol q 6 hrs. By 17:00 PM, temperature 101.3 F. Seen by PA. No other signs or symptoms of vaccine. reaction. Pt has caries but according to mom, no fever with cavities before. Was dx'd with UTI
both of her legs became like jelly/jelly like feeling in both legs; unable to move,unable to get up/ can not reposition herself,spends many nights on floor; same feeling every night since the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONTROL OF LEGS (both of her legs became like jelly/jelly like feeling in both legs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032120A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASENAPINE MALEATE (SAPHRIS), ZOLPIDEM TARTRATE (AMBIEN), CARBAMAZEPINE (TEGRETOL), DISULFIRAM (ANTABUSE), VALBENAZINE TOSILATE (INGREZZA), TRAZODONE, CLONIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and CHLORPROMAZINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced LOSS OF CONTROL OF LEGS (both of her legs became like jelly/jelly like feeling in both legs) (seriousness criterion medically significant), GAIT INABILITY (unable to move,unable to get up/ can not reposition herself,spends many nights on floor) and VACCINATION COMPLICATION (same feeling every night since the vaccine). At the time of the report, LOSS OF CONTROL OF LEGS (both of her legs became like jelly/jelly like feeling in both legs), GAIT INABILITY (unable to move,unable to get up/ can not reposition herself,spends many nights on floor) and VACCINATION COMPLICATION (same feeling every night since the vaccine) had not resolved.            Patient was fine during the day however, after taking her evening medications she experiences the same jelly like feeling in both legs.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-125373 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
injection site redness 4-5 inches; itchiness; feels warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Pain since an unknown date. Concomitant products included MINERALS, VITAMINS, CALCIUM, CRANBERRY, and TYLENOL for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Pain since an unknown date. Concomitant products included MINERALS, VITAMINS, CALCIUM, CRANBERRY, and TYLENOL for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
Information has been received on 20-NOV-2017 from a lawyer and a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 25-MAR-2015, 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 29-FEB-2016, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. 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 and pain and suffering and other damages. Additional information has been requested.
Administerd Flu Vaccine in R Deltoid 11/6/2006; Presented with swelling under groin area of R arm 11/7/2006; Afebrile; Denied Tenderness @ swollen Area. Private MD visit 11/8/2006. Rx Valtaren SR
The pt delivered on 11/4/01 and was given Rubella vaccine on 11/6/01, the day of discharge. Noted Bell's Palsy on (R) the next morning, 11/8/01. Still with palsy.
Slight tenderness at injection site that lasted for two days.  By the 10th day after taking the 1st shot, I began experiencing debilitating dizziness that lasts during waking hours; it?s nonstop. I never had dizziness or vertigo prior to taking the vaccine.  My blood pressure has been reasonable; 130/70.
No related effects noted; initial TE; new short date exp. date 7/19/2023; This spontaneous report was received from a non-medical healthcare worker referring to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, Concomitant therapies and historical drugs were not reported.  On 06-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, single dose, lot #W031815, expiration date: 05-OCT-2024, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). Due to the previous temperature excursion for 1 hour 22 minutes (product storage error), new short expiration date date was 19-JUL-2023 (expired vaccine used). No related effects noted (no adverse event).  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA002813:
42 yo female with c/o itching to neck/throat, sensation of throat swelling/SOB, dizziness ~1:43 pm.  She has prior h/o anaphylaxis to IV contrast and appeared to be very anxious.  Pt was given Benadryl 25 mg PO, water, and rested in a recliner.  BP 140/80, HR 88, o2 sat 100%.  911 was called as pt's symptoms were not improving and she had travelled to vaccination clinic alone by bus.  She remained A&Ox3, was speaking in full sentences, and no swelling or erythema to throat visualized.
PATIENT EXPERIENCED ITCHY THROAT, AND FELT LIKE THE TONGUE WAS SWOLLEN AFTER 30 MINUTES GETTING THE SHOT PHARMCIST GAVE PATIENT 1 DOSE OF EPIPEN 0.3 MG AND PATIENT FELT BETTER, NO 911 CALL NEEDED
Narrative:  COVID fully vaccinated, admit for encephalopathy and falls found to be COVID positive with UTI
Breakthrough case admission after 3 vaccines Pfizer 3/19/21 lot# ER2613;  Pfizer 4/9/21 lot# EW0158;  Pfizer 11/15/21 lot# FG3527;
Anorexia, nausea, asthma, myalgia. Asthenia. Fatigue. Injection site pain, soreness, redness.
Patient experienced pruritus and lip tingling approximately 20 minutes after injection. Benadryl 50mg IM administered.  Patient's symptoms did not worsen and left on her own.
No additional Adverse effects were reported; patient received improperly stored PROQUAD; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-MAR-2020, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter (ml), once, lot # S027463, expiration date 02-MAR-2021) (dose detail and route of administration were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot number R032353 and expiration date 10-JUN-2021).  According to the reporter, the temperature excursions were ranged from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (-14 degrees Celsius to -10 degrees Celsius) (-14.3 degrees Celsius) for 54 minutes, which was detected by a digital data logger. There was no previous excursion reported. No additional adverse effects were reported.
This spontaneous report was received from a medical assistant concerning to a 16 months old female patient. On 30-NOV-2012, the patient was vaccinated with a dose of 0, .5 ml M-M-R II in his left thigh (Lot#H012142; Exp date: 29-JUN-2014). No other co-suspects were reported. No concomitant medications were reported. On 12-DEC-2012, the patient had fully body rash, 12 days after onset of therapy. No treatment information was reported. Medical assistant stated that rash was fading; the patient was recovering. Doctor diagnosed the rash was due to the M-M-R II vaccination. This is one report of several reports from the same source. Additional information has been requested.
rash going down her arms; This is a spontaneous report from a contactable consumer.  A 26-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced rash going down her arms on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
On December 30, 2020 at 1745 the patient was accessed since the patient complained of "lymph node swelling." On December 31,2020 the patient was reassessed as he the swollen lymph nodes, patient reported he was having trouble swallowing and it started the night of December 30 ,2020. The provider performed a physical exam and did not appreciate any swollen lymph nodes, but his tonsils were palpable and seemed slightly enlarged. Patient was then treated with Benadryl 25 mg intramuscularly once and prescribed 50 mg PO Benadryl every 8 hours for 4 days as needed if tonsil swelling occurred. The patient did not require any additional oral Benadryl after Benadryl intramuscularly was administered once on December 31, 2020.
Lips went numb approx. 15 min post vaccine. S/S lasted < 30 min.
At 10:45 AM pt c/o feeling "hot" states gas "hot flashes"  Offered water to drink, with resolution of symptoms.  No nausea or itching.  BP 110/72, HR 66, SO2 93
Information has been received from a company representative concerning her daughter a 7 year old female with pollen allergy who in approximately July 2007, was vaccinated with VARIVAX (Oka/Merck). In July 2008 the patient experienced chicken pox after vaccination approximately 1 year ago. It was a mild case on the trunk area. Subsequently, the patient recovered from chicken pox. The patient sought medical attention. Additional information has been requested.