chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 56.87.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,  9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
A few days I broke out into a rash on my stomach and face & was itching all over my body. I went to the dermatologist and he said it was contact dermatitis
This child developed a fever, erythema and swelling developed on her left deltoid (6 x 7 cm) and a smaller area of erythema on the right deltoid.
Patient stated that he started to have dull headache, body ache and general discomfort on Tuesday after vaccination on Monday, and symptoms improved over 3 days. Then on Thursday he started experiencing mild sore throad. Patient was able to ean and drink normally. Patient checked body temperature and stated no fever.
Constipation, chills, intestinal/stomach cramping, many liquid bowel movements, fever, extreme fatigue & lethargy, body/joint aches, mental fogginess, headache, all lasting one day. Liquid bowel movements, intestinal cramping lasting into day 2.
Half hour post pt left boyfriend called back stating pt's tongue was starting to swell & have blisters on tongue.  Told boyfriend to return to clinic.  Dr examined pt & ordered 50 mg of BENADRYL IM.  Let pt set for half hour & then rechecked pt.  Tongue s/s were getting better but now was c/o left eye itching & pt & felt it was BENADRYL kicking in.  BP at recheck was 104/82 (5:50 pm).  When pt left at 1800 pt BP 108/76 was c/o eyes (bil) burning but felt ok.  Symptoms resolved.
Received DTap #4 and Polio in Left Deltoid and left arm on 08/15. By 08/17/2005 the shot area is red and has abrasion. Left deltoid is swollen, red, firm and tender. Mom says it has gotten better over the last day.
4cm area of erythema and warmth around site of DaPT injection left deltoid.
sore arm @ inj site devel into red, hot, swollen spot size of quarter;progressed to size of half dollar-hotter & redder & then progressed again larger, hotter, redder;pt devel temp up to 102.4-dx cellulitis;devel varicella type lesions;
Initially, I only experienced soreness near the injection site. However, 10 days later, I started experiencing mild sore throat and fever, headaches, and moderate aches and muscle weakness. Day 11 after the vaccine, I noticed a red, asymptomatic ring around the injection site. I have never had a reaction to any vaccine or shot before. In total, I experienced fever, sore throat, muscle weakness, fatigue for 4 days after the symptoms started.
Rash around forehead that spread down beside eyes onto cheeks and over mouth. Rash then clumped together in hive-like splotches. Then swelling above and below eyes. Gave him 5 mls hydroxyzine. Within an hour the rash had diminished by half although the eye swelling remained the same. Urgent care is closed but taking him in the morning.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medciations, pertinent medical histories, drug reactions and allergies. On unspecified dates, 17-JUL-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot# K007262, expiration date 25-NOV-2015, doses, route and site of administration were not reported). The vaccines were exposed to temepratures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Achy, faint feeling, muscle weakness, unable to inhale air, dark colored urine, fever, shivering, took 2 extra strength Tylenol.
Immediately after injection pt became pale passed out slight jerking noted. Pt laid down cool comp. applied. Dr called in pt then became more alert and aware and oriented. Pt rested for 1/2 hr. Monitored and check by Dr then was able to leave office.
No Adverse event; Received Expired first primary dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No Adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine).    No concomitant medications were reported. The vial was stored in an unbroken carton in the refrigerator. Vial size was reported as 5.5 mL. The vial was initially stored in the refrigerator on 01-Sep-2022. The vial did not undergo any temperature excursions. No treatment details were reported.
Half hour after shot experienced minor itching on neck, head, face and torso.  Took 2 benadryl over the counter and itching is slowly subsiding.
Patient presented to ER on 10/6 with numbness in right arm after influenza vaccine on 10/3/2018, patient presented to ER on 10/8 with numbness on his whole right side arm and leg as symptoms worsened.
Numbness and tingling in ear canal, over scalp, face, arms, legs, fingers and toes. Numb feeling in mouth and tongue. Pressure headaches. Muscle twitching. Tinnitus.
Information has been received from a 65 year old female patient with pertinent medical history of SYNTHROID used and adverse drug reaction to TEQUIN, who on 06-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. The patient stated that she developed scaly skin and vaginal herpes in December 2010 after she was given ZOSTAVAX (Merck). It was reported that the patient had unspecified labs/diagnostics tests. At the time of reporting, the outcome of the events was not reported. The patient sought unspecified medical attention. No further information is available.
Information has been received from a registered nurse concerning a 12 year old female who on 10/19/99 was vaccinated with a first dose of Hep B vaccine. Following vaccination on the same day, the pt developed macular rash in upper arm in the area of injection. The rash was itchy. On the second day of event a fine rash was evident from the elbow to the shoulder. Subsequently, the pt recovered completely from symptoms. It was noted that no medication was required to treat the rash.
Patient is 42-year-old male with complaints of hives  new onset shortly after getting the Anthrax #2 and smallpox.  He says the rash came on within approximately 3 weeks of getting the vaccine.  He reports that he first noticed the rash on lower legs about 45 days into the deployment.  He reports that "everyone had intestinal problems".  No parasites that he knows of.  He says that the rash spread to chest and rest of body.  He took benadryl and this would help his symptoms to resolve quicker.  If he didn't treat it, the rash would go away over a matter of hours.  Complete resolution with no hyper pigmentation or hypopigmentation.  Stopped Malaria prophylaxis  4th of July time frame.  Rash did not go away.  He returns today --- approximately 10 months after the above episodes.  He got a booster Anthrax vaccination with a flare of his chronic urticaria.  The flare began approximately 2 weeks after getting his most recent vaccination in March.  A/ Chronic urticaria with initiation after #2 anthrax and smallpox vaccination and now possible flare after #4 vaccination.  #3 with mild flare but patient was taking daily antihistamine to suppress the chronic urticaria --- given time frame ... not clear association
Patient had sore arm that turned into cellulitis. Patient had dr visit and was diagnosed with cellulitis and was prescribed cephalexin 500mg capsule four times daily for 10 days.
Continuous Headache  starting 2/21/2021 .still active today 4/23/2021
Headache: start date, time  - 08April2021, 03:00; status - ongoing; severity - mild Muscle ache: start date, time - 08April 2021, 03:00; Status - ongoing; severity - moderate; location - total body Fever: start date, time - 08April2021, 03:00; status - ongoing; severity - mild (99.8) Fatigue: start date, time - 08April2021, 03:00; status - ongoing; severity - mild
pt recv vax 16JUN95 & 25MAR96 pt exp mild case of chickenpox w/less than 50 lesions;10APR96 pt had recovered;
I have Multiple Sclerosis.  I took both the Moderna Booster & the Flu vaccine on the same day as my internist said it is fine to do so.  Reluctantly I agreed.   I was fine until approximately 9pm when I felt flu like; warm, fatigue and nausea.  I went to get out of bed around 10pm  (which I can do on my own) but I collapsed as I lost all function of my legs.  It was an awful night and very scared.  By late morning the feeling began to return to my legs.  I feel that I have lost some strength in my legs as a result.  I became very angry when I received literature that stated: "redacted" I feel that this blanketed information should be removed from all literature and should be considered VERY IRRESPONSIBLE to put In writing unless those who wrote this statement have Multiple Sclerosis and have taken the flu vaccine and the Covid-19 Booster as the same time and did not have any reaction.  I doubt very much that any studies such as this have been conducted to date.
First few days of symptoms (3/23 - 3/25) Chills, headache, pain in lymph nodes Ongoing since 3/23 - COVID arm (swelling, itchiness, rash of increasing size)
Feels like her heart is going to stop, chest tender and heavy, sharp pains in chest, can't sleep.
1st dose Pfizer, 2nd dose Moderna; "every joint in her aunt's body was hurting"; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer, 2nd dose Moderna) and ARTHRALGIA ("every joint in her aunt's body was hurting") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer, 2nd dose Moderna) and ARTHRALGIA ("every joint in her aunt's body was hurting"). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose Pfizer, 2nd dose Moderna) and ARTHRALGIA ("every joint in her aunt's body was hurting") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reportedly, the patient was in her 70's.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-048805 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048805:Crosslinked case
Within 4 hours I started experiencing an Optical Migraine, became nauseous. By 3AM had a fevers of up to 101.3, uncontrollably shaking, cold sweats. My left arm had a burning sensation throughout, had itching at the site of injection, and the last three fingers on the left hand were tingling, pain radiating up into the left back side of my neck up into my skull. Was very tired and foggy. All symptoms lasted until the next day when they started to go away. The burning sensation in the arm, fingers tingling, tiredness, nausea and headache lasted throughout that 2nd day. By day three the headache, tiredness, and pain in the arm and neck were still in place. By day 4 only experiencing soreness in arm at injection site, mild headache.
took to MD 25OCT due to bruising all over; had bruises 1-2 by then-kept bruising more; lip & forehead swollen & bruised; no fever; sent to hematologist that afternoon;
SICK FOR TWO OR THREE DAYS; This spontaneous report received from a patient via a company representative concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levofloxacin, lorazepam, and omalizumab.  On an unspecified date, the subject experienced sick for two or three days. The action taken with covid-19 vaccine was not applicable. The outcome of sick for two or three days was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose from 24-APR-2017 to 09-MAY-2017 of GARDASIL 9 with Lot # M037770 with an expiration date of 01-JUN-2019 and lot # M043731 with an expiration date of 22-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 47 Fahrenheit degrees (°F) to 77 °F range for a time frame of 28 minutes. The temperature excursion was recorded by a data logger and it had previous temperature excursions on 19-APR-2017 of 32 °F to 35 °F by 29 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009720: US-009507513-1705USA009720.
Pt presents to ED with worsening dyspnea. Patient has had persistent dyspnea since COVID infection in February and was placed on home O2 in September due to exertional hypoxemia. Over the past three days, wife states that he has had frequent desaturations into low 80s when getting up to go to bathroom or other activities, which causes patient to become anxious and tachypnic. Patient's wife states his mental status fluctuates when he has desaturations and this has been happening more frequently. He does report of pleuritic chest pain and dry cough however these are not significantly worse over the past month or so. This evening, patient and wife state that he was becoming anxious, short of breath and felt as if he needed to come in. He denies any fevers/chills, night sweats, chest pain, productive cough, nausea/vomiting, abdominal pain, nausea/vomiting or diarrhea   -Tested positive on 11/19. Previously diagnosed 2/2021 and underwent treatment. Received 2 doses of Moderna vaccine. -Has had extensive work up outpatient with pulmonary for chronic hypoxia after initial COVID-19 diagnosis. Recently started on steroid taper for organizing pneumonia. Bronch with biopsy 10/8 with chronic inflammation. -CT PE on admission with interval increase in GGOs throughout lungs with bronchial wall thickening, bronchiectasis, and peribronchial fibrotic changes; no PE. -Other infectious work up negative. Urine histo negative. Beta glucan and autoimmune work up negative -S/p course of Remdesivir until 11/24 and IV cefepime until 11/23 -S/p 14d course of baricitinib until 12/2 -As per rehab facility, patient will benefit from pulmonary rehab but denied by 1st facility and accepted at another facility for rehab -Also OPD referral for pulmonary rehab -Oxygen requirement stable on 4L NC currently (baseline~3-4L PTA at home) -Continue prednisone 40mg until outpatient local clinic follow up in 1mo -Continue PPI and PJP ppx with bactrim while on high dose steroids -Continue mucinex for cough, encourage incentive spirometry and PEP therapy -Discussed with IPAC, isolation removed on 12/11 (21 days from positive date)  Discharge Disposition/Condition Disposition: Rehab facility  Condition: Stable (s/sx potential problems absent or manageable)
Patient received the PNEUMOVAX in office on 10/18/16 during a Adult Physical. That evening the (R) arm where injection was given - became swollen, painful with itchy rash. Returned to office on 10/20/16 after tried Antihistamine/Ibuprofen. No cellulitis - had soreness with ROM, red swelling at site.
Stevens-Johnson Syndrome; This is a spontaneous report from a contactable consumer, reporting for herself.   A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 31Mar2021 at 14:45 (Batch/Lot Number: ER8737) as a single dose (at the age of 57 years old) for covid-19 immunisation.  Medical history included pain from an unknown date and unknown if ongoing, and stevens-johnson syndrome from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydrocodone bitartrate, paracetamol (NORCO) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride taken for an unspecified indication, start and stop date were not reported; calcium taken for an unspecified indication, start and stop date were not reported, and multivitamin taken for an unspecified indication, start and stop date were not reported.  The patient previously took sofosbuvir and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced stevens-johnson syndrome on 14Apr2021 with outcome of recovered on an unspecified date in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient reported "bumps" on the right side of his face that he did not think were there earlier that morning.
The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022; Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/ 3 booster doses administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine expired on 20-May-2022 and initially stored in refrigerator and administered on 27-May-2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the reporter noticed the box did not have a expiration date so she scanned the code and noticed the expiration date was 20-May-2022. The vial was initially stored in the refrigerator on 27-May-2022. The vial did not undergo any temperature excursion. No treatment medications were provided.   This case was linked to MOD-2022-587906, MOD-2022-587910 (Patient Link).
Presented to Family Medicine for another reason. Site of Td was evaluated per patients request 4 inch area of erythema noted. Mild tenderness. Pt is afebrile bodyaches, chills. Pt reports in 1996 had reaction to Td with swelling and blisters at site
Both hands burning and hurting, fingers tip became very sensitive. Feet burning and tender, shortly after burning ankles became stiff. The signs and symptoms started about 2 wks after second shot, medications prescribed and switched because they became ineffective; medication raised to a comfort level. Symptoms still occurring.