chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 17-JUL-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Patient left a voicemail claiming that she could not move her arms and that she lost her vision. Upon visiting Dr., he phoned in LOTEMAX for her on 09-6-2018 at 11:12 AM for dry eyes.
Immediately after my Pfizer COVID-19 vaccine and my flu shot, I had site soreness and the next day I had increasing soreness that spread down through my arm. I was a little dizzy immediately after the shots as well. I had hives on the second day on my left arm but they cleared up pretty quickly. On the third day, I experienced a sore throat and swollen lymph nodes under my arm.  I also experienced some soreness in my neck. Around day 5 things got pretty bad so on day six I contacted a doctor. The throbbing in my neck was so intense that it was radiating through my jaw and in my ears. I haven't been able to sleep for a couple of days due to the pain. They advised an increased dosage of Advil and Ibuprofen and that I come in to see someone if I'm not improved in a few days. Things have been getting progressively better since yesterday but I have been experiencing excessive sweating although I don't feel hot and the skin on my palms has been peeling as a result of the sweating. I experienced similar issues after my other Pfizer COVID-19 vaccines. However, I did not have any issues with the doses of Moderna that I received.
Loss of appetite, red bumps on her face, that spread all over her body within 5 days.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Dizziness / Lightheadness-Mild
Patient received vaccine on 9/11/12 and 2 days later, she called pharmacy complaining that she has terrible pain in her neck, shoulders, wrist, arms, fingers, back and no strength in her arms, and feels very warm. Her temp was 101 F.
Patient received wrong booster dose. Patient received 0.5mL dose instead of 0.25mL dose.  24 hours post vaccine administration, patient states "feeling a little feverish and tired that night I received the vaccine, but feeling better now."
After being seen I went home and suddenly felt tired and feverish. I got up at 4 o'clock that even and my right arm was heavy and painful. I had spiked a temp of 103.6 at the time. My Friday 12/23/2016 my fever got worst. I spiked a temp of 104.3. I was take to the hospital and was take to surgery. I stayed in the hospital a few days.
7 days after the vaccination, injection site began to itch in the middle of the night, throughout the rest of the day became swollen at injection site, red, and hot to touch. Symptoms lasted 4-5 days, I also experienced joint pain throughout the arm during that time which lasted a few days longer.
At approximately +2 hours from time of vaccine, began experiencing severe (immobilizing) RIGHT FRONT rib pain. Pain level 6 of 10. Contacted doctor's answering service at +24 hours from time of vaccine to inquire about course of action. Ice was recommended. Doctor's answering service concluded rib pain to be unrelated to vaccine but rather to Cerebral Palsy and/or muscle strain from 10,000 meter indoor rowing event completed -10 hours from time of vaccine. I am very skeptical of this finding since I routinely row 10,000 meters, and average 40,000+ meters each week. No prior known incidents of right front rib pain.  Pain history:  +2 hours, 6 of 10  +24 hours, 6 of 10, unable to conduct normal activity, painful to walk/exercise  +36 hours until present, 6 of 10 but decreasing slowly. Still not able to return to normal routines
6 days after the injection I developed small bumps on the left upper arm that were very itchy and developed tiny blisters.  The next morning my arm was swollen from shoulder to elbow,red and warm to touch.  My scalp and skin felt crawly all over.  This went on for about a week.  Arm is still itchy and slightly red after almost two weeks since symptoms began.
An expired dose (expired on 4/11/22/) of Vaqta Hep A adult vaccine was given to a patient on 5/3/22; This spontaneous report was received from an unspecified reporter via Sanofi and refers to an adult patient of unknown gender and age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-MAY-2022, the patient was administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, expiration date: 11-APR-2022, administered for prophylaxis (strength, lot #, and route of administration were not provided).
diarrhea; dose 1, on 10Feb2021/ dose 2 on 10Feb2021 04:00; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 04:00 (Batch/Lot Number: EL9261) (at the age of 79 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no known allergies. There was no other vaccine in 4 weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Left Deltoid on 10Feb2021 (Batch/Lot Number: EL9261) (at the age of 79 years) for covid-19 immunisation. The patient experienced diarrhea on 13Feb2021 14:30 with outcome of recovering without treatment and dose 1, on 10Feb2021/ dose 2 on 10Feb2021 04:00 with outcome of unknown.   No follow-up attempts are possible. No further information is expected.
whole body Extremely Cold; chills; 101 F. fever; body aches; tired; extreme headache (migraine?); nauseous; can't eat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 209L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches), FATIGUE (tired), HEADACHE (extreme headache (migraine?)), NAUSEA (nauseous) and EATING DISORDER (can't eat). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches), FATIGUE (tired), HEADACHE (extreme headache (migraine?)), NAUSEA (nauseous) and EATING DISORDER (can't eat) outcome was unknown.            This case was linked to MOD21-061522 (E2B Linked Report).; Sender's Comments:  MOD21-061522:MOD-2021-056430 Cross-Linked with patient case
Onset of severe chills with headache at 8:45pm April 7th, approximately 7 hours following vaccination.  Chills, lethargy and "pounding headache" with reduced appetite continuing on April 8th.
Headache, chills and aches starting 12 hours after the shot. No fever though. Feel much better already after OTC medication (Advil).
Pfizer vaccine x 3. Tested positive for Covid on 05/03/2022. Admitted to a local Hospital on 4/30/2022. Expired on 05/14/2022 while still hospitalized.
Felt constant pressure on the left side of my chest so I was had to get a CT Scan then  Hospitalization and given blood thinners on the same day which was on 4/12/ 2021
On 8-28/01, at night time she acted like she was choking with her secretions. Her skin got splotchy. Acted as if she couldn't breath. Mucous from the mouth lasted 1 hour.
No adverse event; A temperature excursion; vial beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion), EXPIRED PRODUCT ADMINISTERED (vial beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion) and EXPIRED PRODUCT ADMINISTERED (vial beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion), EXPIRED PRODUCT ADMINISTERED (vial beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion) and EXPIRED PRODUCT ADMINISTERED (vial beyond use date).    Concomitant and treatment medications were not reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  A temperature excursion affected Moderna COVID-19 vaccines monovalent and bivalent lot #216K22A on 23-Jan-2023 - refrigerator - for only 15 minutes. 1 patient received a dose affected by a temperature excursion and after the vial beyond use date, on 25-Jan-2023. Date vial of monovalent was first thawed on 21-Dec-2022 with min temperature which reached 31°F  and max temperature which reached 42°F.  Duration of the excursion reported as 15 minutes.
Patient was light-headed, pale, nauseous, and dizzy a few minutes after receiving vaccine.
Vaccination was given high in the deltoid and resulted in pain in shoulder with use for 2 weeks.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning an adult pt who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had previously been vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced injection site pain. The physician reported that the pt sought unspecified medical attention. Additional information is expected.
Explosive diarrhea, abdominal cramping.  Feeling sick to my stomach.  Diarrhea is a light grayish brown color.
p/vax pt c/o having soreness @ inj site, whole arm ached, felt hyper, nauseated to the point of not being able to eat, h/a, dizziness, head congestion, fatigue & hives;welt type hives on arm/shoulder & @ inj site;saw MD;
Redness right upper arm above the elbow to deltoid. Pink above arm swollen, soft and with itchiness.
Consumer reports that 1 mo p/vax pt had sx of a cold; 10 days p/that exp stiff neck & could not move head; 10 days p/that exp 3 seizures; 13JAN92 hospitalized for 2 days; tx w/Dilantin; 20JAN92 hospitalized again 3 days for sz;
The patient is 16 months old and was due for Infanrix (Dtap) and was instead given Kinrix which is Dtap and polio. Meaning the child got an extra dose of polio that was inappropriate for their age.
Nausea, headache, fever, sore arm, large rash over injection site - within hours of injection, going into 3 days now.
awakened at 3:30AM with chills.  Freezing cold intensified such that I was not just shivering but shaking even though I had a heating pad and several quilts on me.  Splitting headache started by 7AM, muscle aches and nausea; extreme fatigue.  Chills changed to fever around 9AM.  My husband called the nurse at Hospital who said I could come in if my temp was above 100.  My temp was 102.3 at peak and broke before midnight on 4/3.  On 4/4 the symptoms began to ease.  On 4/5 the symptoms still easing...
This is not a big deal at this time.  The area of the vaccine is still slightly tender to the touch.  Last night it started itching and has a red place on my skin.
received PROQUAD vaccine that had undergone temperature excursion; No additional AE reported.; This spontaneous report was received from a nurse concerning a male patient of currently 4 years of age. No concurrent condition, medical history, or concomitant therapy was reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength and route were unknown; recombinant Human albumin; lot # U002539 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 24-JUL-2022) for prophylaxis following a temperature excursion (product storage error). Temperature were 13.8 Fahrenheit (F). The time frame was reported as 1 hour 48 minutes. There was no previous temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA001589: US-009507513-2110USA001664: US-009507513-2110USA001341: US-009507513-2110USA001533:
pt recv vax; few days later mom stated pt's arm devel half $ size swollen red area; 3rd day the size had reduced to size of quarter & is better;
Patient had the regularly reported pain and tenderness but on day 3 developed a red area she describes as roughly 6 inches X 8 inches in size and warm to the touch. Patient went in to see immediate care at her primary care physician's office and was diagnosed with cellulitis. She was placed on 7 days of an antibiotic. Returned to clinic on 6/27 and was prescribed an additional 3 days of same said antibiotic then on advice of physician's office, contacted us with all this information.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in hands, swelling in feet), SWELLING FACE (face swelled up like balloon), ERYTHEMA (spots on arm), PRURITUS (face itches) and PAIN (Hurts in hairline) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, LISINOPRIL for Blood pressure, DOXYCYCLINE for Infection.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in hands, swelling in feet), SWELLING FACE (face swelled up like balloon), PRURITUS (face itches), PAIN (Hurts in hairline), INSOMNIA (can't sleep), DRY SKIN (her face feels dry) and SKIN WRINKLING (caused wrinkles on face). On an unknown date, the patient experienced ERYTHEMA (spots on arm). The patient was treated with CORTISONE at a dose of 1 dosage form for 6 days. At the time of the report, PERIPHERAL SWELLING (swelling in hands, swelling in feet), SWELLING FACE (face swelled up like balloon), ERYTHEMA (spots on arm), PRURITUS (face itches), PAIN (Hurts in hairline), INSOMNIA (can't sleep), DRY SKIN (her face feels dry) and SKIN WRINKLING (caused wrinkles on face) outcome was unknown. Not Related      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 medication include allegra.
Information has been received from a health professional concerning a 72 year old female who on 29-OCT-2007 was vaccinated with PNEUMOVAX 23 (Lot # 658673/0990U or 658451/0963U) intramuscularly in the right deltoid.  On 02-NOV-2007 the patient developed swelling in the right deltoid, pain, fever and localized erythema.  The patient was advised to ice pack the site area.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  This is one of several reports from the same source.  No further information is available.
Approx.  24-28 after 12 pt. noted swelling redness & heat @ inj. site on left upper arm 4 cm X 2 cm area.  Instructed to use compresses & TYLENOL.  Should resolve in a week.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 21-SEP-2014 at a pharmacy, as recommended for routine adult maintenance and for the prevention of shingles. The patient used the ZOSTAVAX in the manner in which it was intended. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2016, the patient was treated at an urgent care center for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 06-SEP-2016, the patient was treated again for ongoing and worsening conditions, which were diagnosed as post-herpetic neuralgia with nervous system involvement. The patient has been prescribed valacyclovir hydrochloride (VALTREX), codeine, and betamethasone for management of her painful and chronic condition. 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. Additional information has been requested.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  It was unknown if the doses are first, second or third doses for the patients.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
facial swelling; Neck swelling; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional. This was a courtesy case received from Pfizer, Pharmaceuticals.  This case involves an unknown age and unknown gender patient who experienced facial swelling and neck swelling after receiving vaccine influenza vaccine.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Adhesive tape allergy with Reaction: Rash Severity: Moderate and Drug allergy with Reaction: Anaphylaxis, Drug Allergy Cortisone Reaction: Anaphylaxis Severity: Severe Sensitivity: Allergy Type: Drug Allergy Eliquis Reaction: Tongue swelling Severity: Severe Sensitivity: Allergy Type: Drug Allergy Vicodin Reaction: Nausea Severity: Mild Sensitivity: Intolerance Type: Drug Allergy OxyContin Reaction: Hallucinations Severity: Severe Sensitivity: Adverse Reaction Type: Drug Allergy Kenalog.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via subcutaneous route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient developed facial swelling (swelling face) and neck swelling (swelling) (unknown latency) following the administration of influenza vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Traveling pain/aches throughout body, inability to sit still and feeling restless, persisting pain and numbness from feet to hips. This has persisted nightly since 03/19/2021