chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 3 days, a peppery itch began on chest and lower back. After one more day, the itch became dots and began forming a rash that was moving along the entire torso, neck, shoulders, front and back. After another day or so, the rash extended to fingers, hands, feet and toes  but not the entire arm and leg. The forearms, bicep area as well as calf sustained some rash as well. The rash can best be described as raised bumps with a white and hard center, some having small quantities of liquid. More than 50% of my body was engulfed with this inflammation, itching, rash that was completely incessant. The rash has continued to grow  and is currently neither regressing or aggressing and has left scarring on my body The treatment has been aggressive high-dose prednisone (at first a methylprednisolone 5-day taper pack); however, the rash continued to grow and forced  a cycle of prednisone as follows (6- 10mg tabs for 3 days; 4- 10mg tabs for 3 days; 3- 10mg tabs for 3 days, 2-10mg tabs for 3 days, 1- 10mg tab for 3 days; 5mg for 3 days). Triamcinolone .1% cream not more than 14 days.
PATIENT RECIEVED MODERNA 0.5 ML DOSE INSTEAD OF INDICATED BOOSTER DOSE OF 0.25 ML.
606 doses were given after expiration date; Vaccine expired on 03-OCT-2021 and placed in refrigerator on 04-NOV-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-OCT-2021 and placed in refrigerator on 04-NOV-2021) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-OCT-2021 and placed in refrigerator on 04-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-OCT-2021 and placed in refrigerator on 04-NOV-2021) 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 did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Patient experienced a syncopal episode while in clinic. The episode was addressed while the patient was in our care.
PATIENT RECEIVED HIS VARICELLA #2 VACCINE, WAS NERVOUS BUT RESPONSIVE AFTER THE SHOT AND APPROXIMATELY 1-2 MINUTES AFTER THE VACCINE HE PASSED OUT AND FELL OUT OF THE CHAIR HE WAS SITTING IN. HE WOKE QUICKLY AND SAID HE WAS FINE BUT WE CALLED THE DOCTOR IN TO EXAMINE HIM AND HAD HIM DRINK JUICE AND SIT WITH AN ICE PACK ON HIS NECK FOR ABOUT 15 MINUTES. HIS VITALS WERE STABLE SO HE WAS ABLE TO GO HOME.
Woke up Thursday morning screaming. Screamed for 2 hours I took him to the doctor he had a low grade fever. Doc said all was normal for just having shots. I checked his temperature at 2:15 and it was 102.4 called the office back was told again it was normal as long as his fever didn't reach 105. Also gave him fever reducer at this time.So I put him down for a nap he woke up around 4 and his fever was 103. About 6:15 I took him to urgent care and his fever got up to 104.3 they said he tested positive for flu I didn't feel like this was right so I took him to a different urgent Care Friday around 1:30 they retested for flu it was negative and they told me it was just from the shots. Saturday morning he woke up still with a fever of 102.2 I took him to er and they ran test blood work chest x-ray and flu strep and rsv test all came back normal.fever broke Saturday afternoon. He was also given I've fluids in the ER because he was dehydrated Sunday afternoon he started getting a rash and by Monday from his neck down was covered.
This spontaneous case reported by a consumer, describes the occurrence of injection site pain (arm sore after the injection) and injection site joint swelling (bright pink circle around the injection site about 1 inch in diameter) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038K20A) for COVID-19 immunization. No medical history reported. On Feb 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced injection site pain (arm sore after the injection) and injection site joint swelling (bright pink circle around the injection site about 1 inch in diameter). At the time of the report, injection site pain (arm sore after the injection) and injection site joint swelling (bright pink circle around the injection site about 1 inch in diameter) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Products known to have been used by the patient within two weeks prior to the event, not reported. Treatment information not provided.
This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report however; patients were 65 years and older. The pharmacist reported that, the patients experienced increased pain at injection site with SHINGRIX vaccine - multiple complaints.
This is a 62-year-old female, with a significant PMH of uterine cancer s/p HSY, HTN, HLD, GERD, Former tobacco smoker, Rosacea (on topical Ivermectin/Brimonidine), H/O CTS, Arthritis (on chronic Mobic), s/p lumbar discectomy, Morbid Obesity, presented to hospital on 12/03 with headache/shortness of breath. Patient states that the day before Nov. holiday she was noted to have a headache. On Nov. holiday, patient had headache/chills and was noted to be positive for COVID-19. On 11/30 she went to the ED because her headache was stabbing/piercing but she was not short of breath at that time. Patient was given Toradol and discharged on Norco. Patient's SpO2 was running between 86-87%. Upon exertion, HR was as high as 120. Patient noted to have fever/nausea without vomiting. Patient had diarrhea which resolved. Patient was noted to have poor appetite. Patient still having headaches and now shortness of breath specially with exertion. CRP 14.6. CXR: Bilateral infiltrates. Patient was admitted with Acute hypoxemic respiratory failure secondary to COVID-19 pneumonia. Patient was given supplemental oxygen, Decadron, Remdesivir. She was discharged in stable conditions.
2cm x 3cm wheal erythemic reaction pinprick outside of reaction occurred approximately 18 hrs after vaccine.
no symptoms near injection. started getting white raised spot on the lower arms that is itchy. progressively worsened onto stomach and legs. now improving. now mostly around elbows and armpit and all over legs. not large hives or welts but smaller- like insect bites.
On 6/13/01 patient noted to have a baseball sized knot at site. It was red in color and she had a fever at the site. Patient also had a fever to the touch. The area was very tender to the touch. On 6/14/01, the site was 3.5" by 3" and much better. The patient was treated with Motrin, ice and Benadryl cream.
dyshidrotic eczema- symptoms began in march.  Hands were red and itchy.  Skin became dry to the point of bleeding.   I first thought it was due to environmental, went back to work in the school at the start of March.  Symptoms continued after getting out of school for the summer(mid-June).  Went to the doctor late July.  Doctor said I had dyshidrotic eczema.   Never had skin issues until March 2021.
On 1/1/2020, I developed a rash on my palms that was pruritic. On 1/2/2020, the rash progressed to involve the soles of my feet, hard palate, and the rest of my body. The rash is papular and pruritic and has continued until 1/4/2020 without improvement. No associated fever or systemic symptoms.  My daughter did have a febrile illness 2 days prior to the development of my rash.
Patient was given incorrect vaccine, Not approved strength for age based on changes made with Bivalants Patient also received second dose on incorrect 6/19/23
This case was reported by a consumer (the subject's daughter) and described the occurrence of sore throat in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced sore throat and malaise. At the time of reporting the outcome of the events was unspecified. The consumer reported that both she and her mother received FLULAVAL on the same day and experienced the same symptoms. The consumer has asked for information regarding FLULAVAL in people with auto-immune disease. She did not provide any further information. See case ID A0952198A for details of the other case.
I chose Meningococcal Conjugate because the Meningococcal ACWY Vaccine is not listed. A couple of minutes after my son received the shot he fainted falling to the floor. He reports getting light headed and then he fainted
breakthrough covid-19 infection; symptoms began mid-August 2021, tested positive by PCR on August 23, 2021 symptoms included fatigue, nausea, dizziness, shortness of breath, fever, chills
Information has been 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. On or about 01-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
Administration of vaccine began at 10:46am.  At 10:48, patient was observed to be pale, complained of being light headed, and was observed to be diaphoretic. Pediatric resident was called at 10:48 and was in attendence through observation event.  She was placed in a supine position on stretcher. BP 102/63; HR was 69.  Improved quuickly; at 10:55; feet were placed down; BP was remeasured at 107/70; HR 77.  She was positioned in sitting position on edge of stretcher; BP was 109/62 sitting.  She was positioned to standing at 11:00; color was observed to be pink; standing BP was 109/66.  She was discharged to home at 11:20am with parents.
There was no adverse event, Patient did not have any reaction or pain, Im reporting a vaccine given by error.
This case was reported by a physician, via a GSK representative, and described the occurrence of diarrhea or vomiting in a 2-month-old female subject who who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); Sanofi; unknown; unknown given on 8 June 2010; "PCV 13" (non-gsk); non-GSK manufacturer; unknown; unknown given on 8 June 2010. On 08 June 2010 the subject received 1st dose of ROTARIX (oral). Less than one week after vaccination with ROTARIX, between 08 June and 13 June 2010, the subject experienced diarrhea or vomiting. The subject visited the Emergency Room on 14 June 2010. Relevant test results included stool sample positive for rotavirus. A the time of reporting the diarrhea or vomiting had resolved and the outcome of the stool positive for rotavirus was unspecified.
Second day sudden symptoms. Overall sickness, extreme cramps! Nausea and diarrhea. I was so sick it was hard to get home from work.  The diarrhea lasted about 2 hours. The second day I still have some pretty good cramps. And still feeling pretty sick. I will not be getting a second shot.
pt received flu shot at work, was given on the top of his left arm, shoulder, not in the deltoid area per pt and pt's wife who is a nurse, pt stated immediately had a warm sensation that went down left arm, pain immediately in shoulder, area became red, hot and at his appointment today 11-4-2019, states he is unable to raise arm up due to the pain in shoulder area
This spontaneous case, initially received on 20-Sep-2018, from a pharmacist, concerning an 89-year-old, elderly, male patient. The patient's historical conditions included syncope, constipation, ingrown toe nail, foot pain, corneal mild neovascularization, skin lesion, onychomycosis of toe nail, shoulder pain, peripheral oedema, low back pain, neck pain, obsessive-compulsive disorder (OCD), mood disorder dysthymia, hearing loss, polyp of colon, diverticulosis, sleep apnoea, atherosclerosis and visual impairment (on an unspecified date). The patient's current conditions included acquired blindness in one eye, atrophy of optic disc, epiretinal membrane, multiple environmental allergies, osteoporosis, degeneration of intervertebral disc, hyperlipidaemia, hypertension and chronic obstructive pulmonary disease (COPD) (reported as medical history). The patient's concomitant medications included FLONASE, hydrochlorothiazide, tramadol, calcium, PROAIR, TYLENOL, MICROLAX, vitamin D, Albuterol, Spiolto combo inhaler with tiotropium, Alendronate for unknown indications. It was reported that the vaccine underwent first time temperature excursion reaching 34 F (Fahrenheit) for 15-20 minutes (explicitly coded as incorrect product storage). On 19-Sep-2018, the patient was administered FLUAD TIV [egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: 250796 and expiry date: 31-May-2019] that underwent temperature excursion. The patient had not experienced any adverse effects after administration. The reporter assessed this case as non-serious. This case 201803916 was cross-linked with the case 201803915 reported by the same reporter. Follow-up received from reporter (combinedly processed with follow-up received on 23-Oct-2018) on 12-Oct-2018: The reporter confirmed the start date of vaccination as 19-Sep-2018. The historical condition previously reported as dejou impairment was confirmed to be visual impairment. The narrative was amended accordingly.
Left side of her face felt uncomfortable; Left arm felt uncomfortable; Left side of mouth felt uncomfortable; Swelling on left side of face; Numbness on left side of face; Swelling on left side of mouth; Numbness on left side of mouth; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face) and HYPOAESTHESIA (Numbness on left side of face) in a 63-year-old female 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-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face), HYPOAESTHESIA (Numbness on left side of face), MOUTH SWELLING (Swelling on left side of mouth) and HYPOAESTHESIA ORAL (Numbness on left side of mouth). At the time of the report, FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face), HYPOAESTHESIA (Numbness on left side of face), MOUTH SWELLING (Swelling on left side of mouth) and HYPOAESTHESIA ORAL (Numbness on left side of mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with MMR II (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information is not expected.
Body soreness, fatigue. Severe headache, cough. Shoulder pain/soreness.
Did not receive the full dose/ Syringe cracked, lot of leakage; Syringe cracked, lot of leakage it is possible that it got on the patient's skin since it leaked out.; it is possible that it got on the patient's skin since it leaked out. Syringe cracked, lot of leakage; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a adult patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: The pharmacist stated that a nurse was attempting to administer Havrix to patient and cracked the syringe when placing the needle on. The patient did not receive the full dose as there was a lot of leakage around the needle.  It was possible that it got on the patient's skin since it leaked out. The reporter did not know how much of the dose the patient received. The reporter confirmed that the syringe was not cracked upon receipt (no PQC). The patient demographics, lot number, expiration date was not available at this time. The reporter consent to follow up. Additional supportive information: The patient did not receive the full dose of vaccine as there was a lot of leakage around the needle, which led to Incomplete dose administered. It was possible that it got on the patient's skin since it leaked out, which led to exposure via skin contact and inadvertent exposure to vaccine.
This spontaneous report was received from a registered nurse via a company representative referring to a female patient of unknown age, non pregnant. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date the patient was vaccinated with a dose of GARDASIL, intramuscularly, for prophylaxis, (dose, frequency, lot number and expiration date were not provided).        On an unspecified date in 2013, the patient experienced multiple sclerosis. The patient sought medical attention during an office visit. There was no hospitalization and no life threatening situation.  No product quality complaint (PQC) was involved. At the time of reporting, the outcome of multiple sclerosis was unknown. The causal relationship between GARDASIL and multiple sclerosis was not provided.  Upon internal review, multiple sclerosis was determined to be medically significant. Additional information is not expected as no consent to contact the physician was provided.
Started to feel engorgement sensation in (L) axilla area -> surrounding axilla area and upper (L) arm inner aspect became painful & remained swollen. This same reaction happened last October 2009 when patient received the flu vaccine for the first time. The reaction appeared about a week after the flu vaccine was given and she went to her private physician who was concerned due to the edema and closeness to the left breast. A full work up was done with negative results. Patient did not tell her physician at the time that she received the flu vaccine in her left deltoid because she did not feel it was related. It was only after she received the flu vaccine on 1/14/11 that she felt the same symptoms coming on & remembered that she just received the flu vaccine that day. The symptoms occurred quicker this time.
Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 44 years old female patient who received 0.5 ml dose of FLUZONE QUADRIVALENT on 10-Jan-2019,which was expired last year (lot UI876AB expiry date: 20-Jun-2018 via intramuscular route in the left deltoid). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to expired vaccine used. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Right arm pain in injection site immediately after administered with an itchy rash. Progressively worsened by spreading to Right side of neck, chest and back.
1/16/05-Began with stiffness and aching in the neck and shoulders. 01/29/05-Experienced left thigh "bone" pain "feels like it is coming out." Fingers became swollen that night. 1/30/05-Pain in both legs, hands, numbness in arms, hands and legs. 2/1/05-Pain continues, SOB, heaviness in chest, lightheadedness, dizzy, temperature is 98.3 but extremities cold, complained of feeling like she can snap her bones. Aches all over, all joints. Advised to go to ER by PMD.