chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medications were not reported.  113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as 51 doses from Lot AS7140C and 60 doses from Lot AS7148B.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946: Case
Patient received his 1st Pfizer dose at 6:45pm today 02/16/2022 and started fainting at 6:55 pm while waiting for 15 minutes observation. Patient was conscious but had visible flushing /paleness on his face and showing signs of weakness. I applied a cold compress to the patient's face and neck and he recovered within 5 minutes.
patient received Pneumovax 23 on Monday overnight right arm swelled  was inflamed and had pain.
Information has been received on 31-MAR-2017 from a physician via a company employee regarding a 60 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The physician, currently 67 years old and who is also the patient, reported to the company employee that he was vaccinated with ZOSTAVAX (lot number and expiration not reported) subcutaneous for prophylaxis when he was 60 years old. The physician reported that ever since he received the vaccine, once or twice a year he gets a mild case of shingles somewhere on his body, usually on his torso. The physician has not sought medical attention and has not been hospitalized. The physician reported that it always resolves on its own.   No further information has been provided. The causality of shingles was not reported. Additional information has been requested.
Swelling in left shoulder from elbow to collar bone on left side. Tender to touch. Decreased range of motion. Tissue stiff/tight.  (Negative for redness, fever, SOB)
Received Tdap immunization 10/25/06. Seen by infection control nurse on 10/26/06 and referred to occupational vaccine clinic. c/o redness, tenderness and discomfort at injection site. Severe reaction to immunization (cellulitis rt deltoid). Keflex 500 mg x 28: 8mg once QID ordered/taken by emz Resolved by 11/1/06
About 10 minutes after vaccine given, patient began to experience tachycardia, lightheadedness and a headache.  Vitals showed heart rate within normal limits, slight hypertension.  Patient took Xanax shortly before her vaccine.  Symptoms resolved.
Since the time of vaccination have experience increasing psin in both the left and right upper arms, across my shoulders which has affected my range of motion.  Extreme pain in the mornings; increasing pain in both the left and right upper arms, across my shoulders; increasing pain in both the left and right upper arms, across my shoulders which has affected my range of motion; Extreme pain in the mornings with very limited mobility in upper body.; joint stiffness and tightness; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 07Jun2021 at 13:45 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included colecalciferol (D-3) and calcium (MANUFACTURER UNKNOWN) and unspecified multivitamin; all for unspecified indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO183) via an unspecified route of administration in the left arm on 17May2021at 13:00 (at the age of 64-year-old), as a single dose for COVID-19 immunisation.  On 07Jun2021 at 14:00, since the time of vaccination, the patient experienced increasing pain in both the left and right upper arms, across shoulders which had affected range of motion, extreme pain in the mornings with very limited mobility in upper body. Tried to treat with heat therapy and Tylenol but little relief. In pain daily to varying degrees, patient also experienced joint stiffness and tightness. Therapeutic measures were taken as a result of the events and included treatment with heat therapy and Tylenol. Since the vaccination, the patient had been tested for COVID-19. On 13Jul2021, the patient underwent lab tests and procedures which included COVID-19 virus test and the result was negative. The clinical outcome of the event increasing pain in both the left and right upper arms, across shoulders which had affected range of motion, extreme pain in the mornings with very limited mobility in upper body and joint stiffness and tightness was not resolved at the time of this report.
In the same area as my shingles virus, which is well on its way to healing, I developed a rash about 6 or 7 hours after the vaccine.  The rash is small red markings that look like hives and it is unbelievably itchy.  I took benadryl which reduced the itching within 4 hours, but did not appear to impact the rash.  Today is day 1 after my vaccine, so I am watching the rash to see if and how it progresses over the next 48 hours.
Nausea, dizziness, extreme chills, headache. 2 days now.1802068
Acute appendicitis, onset morning of 1/1/2021  (Reporting this because Pfizer covid vaccine had 3-4x higher risk of appendicitis, although data not reported for Moderna covid vaccine)
Fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown.), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2022, outcome "unknown".  Additional information: Patient reported fever and chills after receiving the bivalent vaccine. Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Vaccines given 10/15/08, developed swelling, redness, hot to touch on left deltoid area. No streaking or signs/symptoms infection. Mother applying cold compresses giving TYLENOL, swelling decreased on 2nd day, non-tender.
itching; Felt bad; nervous; couldn't drive; rash on the same arm of the vaccination; short of breath; sore; tired; kind of felt nauseated; slept for most of the day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore), FATIGUE (tired), NAUSEA (kind of felt nauseated), SOMNOLENCE (slept for most of the day) and DYSPNOEA (short of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DS9E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea ( I have sleep apnea and I use a CPAP (since 2015/2016)  ) since 2015, Hypertension since 2013 and Type 2 diabetes mellitus since 2013. Concomitant products included HYDROCHLOROTHIAZIDE, METFORMIN, LOSARTAN, METOPROLOL, LATANOPROST, COLLAGEN, ACETYLSALICYLIC ACID (ASPIRIN 81), GLIMEPIRIDE, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced MYALGIA (sore), FATIGUE (tired), NAUSEA (kind of felt nauseated) and SOMNOLENCE (slept for most of the day). On 06-Sep-2021, the patient experienced DYSPNOEA (short of breath). On 08-Sep-2021, the patient experienced VACCINATION SITE RASH (rash on the same arm of the vaccination). On an unknown date, the patient experienced PRURITUS (itching), FEELING ABNORMAL (Felt bad), NERVOUSNESS (nervous) and MOBILITY DECREASED (couldn't drive). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) for Rash, at an unspecified dose and frequency. At the time of the report, MYALGIA (sore), FATIGUE (tired), NAUSEA (kind of felt nauseated), SOMNOLENCE (slept for most of the day), VACCINATION SITE RASH (rash on the same arm of the vaccination), PRURITUS (itching), NERVOUSNESS (nervous) and MOBILITY DECREASED (couldn't drive) outcome was unknown, DYSPNOEA (short of breath) had not resolved and FEELING ABNORMAL (Felt bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that she have a History of allergic reaction to Blood Pressure medication.
He developed a rash on his left forarm area that was itchy and when lotion was applied it burned slightly.  It has not gotten worse since yesterday.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 23-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004707: US-009507513-2207USA001345: US-009507513-2207USA004698: US-009507513-2207USA004697: US-009507513-2207USA004714: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004712: US-009507513-2207USA004709: US-009507513-2207USA004691: US-009507513-2207USA004700: US-009507513-2207USA004710:
rash on body-itches-appeared approx 8PM on 11/2/99;on concurrently septra for ear infect;AM to take DPH until itching sx goes away;
After getting Moderna booster, a few weeks later, the lymph node in my underarm on that side became swollen. It is still swollen, now 3 months later. Planned ultrasound March 4.
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site reaction, pain in arm, injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site reaction and pain in arm were recovering/resolving and the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site reaction, pain in arm, injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The caller was a patient who left afterhours voicemail. The age at vaccination was not reported. At the beginning of the week from the date of reporting, the patient experienced a sore arm for 2 days and since then redness has continued around the injection site 4 inches by 2 inches in size and that it remains tender to the touch. The caller stated that she was going to have physician look at it as soon as she can get an appointment. The caller's phone number was not provided in the voicemail message. No other details was provided.
This spontaneous report as received from an emergency medical technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concurrent conditions was provided. The reporter stated that on an unknown date, the patient might have been vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot number M027884, expiration date: 19-APR-2019 or lot number M032147, expiration date: 14-APR-2019, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. It was reported that the vaccine underwent a temperature excursion in the range of 9 degrees Celsius to 25 degrees Celsius for 47 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter (linked with MARRS# 1703USA009932 and 1703USA009933). Additional information has been requested.; Sender's Comments: US-009507513-1703USA009932: US-009507513-1703USA009933:
GENERALIZED RASH, SWEATING 38 HOURS AFTER INJECTION,  SELF MEDICATED WITH DIPHENHYDRAMINE. WENT TO EMERGENCY DEPARTMENT AND WAS PRESCRIBED PREDNISONE
Top of head to bottom of feet for itching. difficulty breathing, lung pain, headache, dizziness, disoriented-unable to maintain balance, growly voice, body aches
46 y/o male with no past medical history, who presents with dizziness post vaccination. Patient states that this is his second vaccination in the two-dose series. Patient denies previous reaction to the first vaccination. Patient received the vaccination to the Left arm. NP and Paramedics at bedside. Patient vitals within normal limits (119/76 BP, 97% RA, 96 HR, Resp 12). Patient placed in Trendelenburg and water provided. Patient monitored for 15 minutes with resolution of symptoms. Patient was cleared by the NP to be discharged home. Patient discharged in stable condition.
Had Iz's on 2-9-10, woke up 2-10-10 with red area on L thigh, area got bigger as day went on per parent. Brought into clinic on 2-11-10, area was 10 x 10 cm circular, red area, recommended warm compress and return to clinic if needed.
Patient was given the High-Dose formulation prior to reaching the age of 65yrs. An inquiry was made to patient 5 days after his vaccination and to alert him of the error. Patient did not have any adverse reactions outside of the typical chills the evening after his dose. He indicated that he felt no worse than normal after his influenza vaccination.
Narrative:  38 yo female reported low grade fever, myalgia, and diarrhea on 2/18/2021. This was attributed to the second dose of covid19 vaccine on 2/15/2021. Pt received her first dose on 1/18/2021 with no adverse events. of note, pt denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Vaccine was administered both times without adverse events seen during observation period.
Patient has had major site pain and redness which has now developed into arm pain radiating from shoulder to hands. Pain started approximately 1 week after vaccine
3-4 minutes after vaccine, they "passed out" while seated in chair. head went back, eyes closed, hands went into a fist. They came to about 15 seconds later. Immediately started talking  & was sweaty. Offered water & sprite (they had not eaten today).  Sat for 20 minutes with no further incident.
Received vaccine 1 week ago and was fine normal injection site pain that resolved in a day or two, woke up this morning 1 week later with a large red swollen welt at the injection site. It?s very warm to the touch and has not subsided yet. It is also quiet itchy.
pt recv vax 14AUG96 & 10DEC97 pt devel chickenpox approx 20-25 lesions were present when pt was seen on 11DEC97 by MD;
Ataxia of both legs and pain at injection site was the adverse event. He was admitted to hospital for 3 days until the ataxia symptoms improved. LP performed and meningitis panel done, blood and urine cultures done, CBC, CMP, Trileptal level.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-DEC-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2013, the patient was treated for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
missed 2 dose of moderna vaccine scheduled on 9 May; Sore throat; Sleepy; Arm pain; Tiredness; I had chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (Sleepy) and MYALGIA (Arm pain) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever), SOMNOLENCE (Sleepy), MYALGIA (Arm pain), FATIGUE (Tiredness) and CHILLS (I had chills). On 08-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (Fever), SOMNOLENCE (Sleepy), MYALGIA (Arm pain), FATIGUE (Tiredness) and CHILLS (I had chills) had resolved. On 11-May-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2 dose of moderna vaccine scheduled on 9 May) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient was immunized with the second Moderna vaccine in the left arm (not in this clinic) on 04/16/21.  ON 04/27/21 she suffered a CVA.  She is now being treated with statin and plavix
Refroze the vaccines after receiving them and administered them to patients; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) with product storage error.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date not provided) for prophylaxis of COVID-19 infection.   A pharmacist called to report the vaccines were refrozen after receiving them. He stated he thought that they were frozen, but they were shipped refrigerated. He reported that he administered 108 patients with the refrozen vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, product storage error, was considered resolved.; Reporter's Comments: This report refers to a case of Product storage error for mRNA, where refrozen vaccine was administered. There were no reported AEs associated with this case of out of specification product use.
I was eight weeks pregnant and on 3/30 exp miscarriage. My estimated date of delivery was 11/10/21.
I had a long gap following the vaccination, a normal period immediately after was normal, but July 8th I started a menstrual cycle that continued until 08/04/2021. It was so heavy for 2 weeks that I had to use 3x of protection at the same time-tampons, pads, and adult diapers and still had to change them out a few times a night. I scheduled an appt but they could not see me until the bleeding stopped. Saw OBGYN Sept. 24th 2021. I am supposed to get a biopsy but haven't been able to as of yet, but my periods were completely normal after the fact. Until my recent 3rd dose (01/2022). I had an unusually long gap between cycles (03/2021 and then nothing until 5/7/21) but was normal.