chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Swelling; Itchy; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Boostrix.  Additional details were provided as follows: The health care professional reported that the patient had redness, swelling and itching at the site of Injection with Boostrix.  The reporter consented to follow up. The batch number was updated from 43E47 to 43E4T as per sales data sheet. This was one of the 6 cases, reported by the same reporter.
Left shoulder, upper scapular and underarm and forearm pain tingling of the first two finger of the left hand.
Onset of pain and swelling in left arm around injection site several hours after injection. Patient was seen in ER on 8/31/17 for pain and local reaction. She continues to have intermittent pain and discomfort with reported intermittent swelling at site of injection for months following for which she made office visit in 2/2018. At that time topical LIDODERM patch and or cream were offered to help with reported ongoing intermittent pain at former injection site.
Flu symptoms, fever, aches, sore throat, headache, developed terrible cough, malaise, and tiredness.
Left arm very sore. ran a fever of 100.6 about 24 hrs after second vaccination. Joints ached (felt like having the flue).  I took Tylenol and the fever broke within 8 hours.  flue like symptoms lasted about 24 hrs.
This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced general body pain and leg pain. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the leg pain was unknown. It was unknown if the reporter considered the general body pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The physician reported that the patient had body aches for one week after receiving SHINGRIX immunization. The patient also experienced leg pain.
Received vaccinations at 11 AM on 02/27/2014. Received call from daycare to mom at 2 pm that child was lethargic, had blue lips and vomited. Saw doctor at 2:30 pm, physician felt it was reaction to DTaP. Instructed to NOT receive any more of this series. Entered in NDIIS as medical exemption.
Sore arm, fever (Max 100.5), body aches, chills, headache, fatigue, general malaise
This spontaneous report as received from a pharmacist referring a patient of unknown age and gender who on 14-MAR-2013 the patient was vaccinated with a expired dose of M-M-R II (lot# and expiration date not reported). No symptoms reported. Additional information has been requested.
Had a couple days of pain at injection site and developed fever to 102 last night and this morning had large, painful, indurated area at site of vaccines.
PATIENT BEGAN TO HAVE A SEIZURE WITHIN 5 MINUTES OF VACCINE AND WAS TRANSPORTED VIA AMBULANCE TO THE HOSPITAL
This spontaneous report was received from a physician via company representative regarding a male patient of unknown age. Medical histories, drug reactions and allergies were unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiry unknown) 1 shot(DF), intramuscular route. Concomitant therapies included TRUMENBA. On an unknown date the patient experienced red swollen skin all down his arm like cellulitis. The patient sought medical attention and contacted the physician. The outcome of the event was reported as recovered. The causality of the reported event was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
vials that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) had resolved.        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.   Concomitant medication was not provided Treatment information was not reported
Patient come to clinic to report that on 9/17/18 at 1:00 am his left arm where the pneumonia vaccine was given was painful and red. On 9/18/18 he went to urgent care where they gave him a steroid shot and KEFLEX antibiotics. They drew with a pen around the redness on arm.
1/13/15 pt. had tenderness and swelling along cervical and supraclavicular lymph node locations. 1/14/15 pediatrician diagnosed "thyroiditis" inflammatory. Blood work was all WNL. 1/28/15 Mother calls to report thyroiditis has resolved. No specific treatment.
Raised, red, itchy, fluid-filled bumps all over body. Low grade fever. Benadryl liquid. Diagnosis Chicken Pox.
expired dose administered to 3 patients; Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022). On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist stated that, they shipped out 5 vials of the Moderna vaccine to one of their nursing home facilities on 29-Mar-2022 evening. On 30-Mar-2022 morning, 3 doses of the Moderna vaccine were administered to 3 staff members at the facility. After administration, it was found out that the doses given had expired on 17-Mar-2022. At this time, no adverse reactions have been reported by any patients.  Vial did not undergo any temperature excursions.  Treatment medications were not provided.
This spontaneous report was received from a pharmacist regarding a male patient of unknown age. No historical or concurrent conditions were reported. On 04-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L012215, expiry 13-JAN-2017). No concomitant medications were reported. On an unknown date approximately in 2015, the patient experienced tightness at injection site as well as a burning sensation and pain throughout the entire deltoid region after receiving the PNEUMOVAX 23. The patient also experienced an elevated body temperature as high as 102F shortly after receiving the PNEUMOVAX 23 on an unknown date in 2015. The patient was prescribed prednisone for the soreness and tightness in the arm on an unspecified date. The pharmacist has requested a lot # check for PNEUMOVAX 23. The outcome of the events were reported as fully recovered. Causality assessment was not provided. Additional information has been requested.
Patient developed flu-like symptoms the day after vaccination. She also states that she broke out in fever blisters all over her mouth.
body aches; very tired; pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back). At the time of the report, MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BACK PAIN (pain in the back) to be possibly related. No further causality assessments were provided for MYALGIA (body aches) and FATIGUE (very tired).
Urinary Tract Infection; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 19Feb2021, as dose 1, single, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after the administration of first dose of vaccine, the patient experienced Urinary Tract Infection. The patient was prescribed with an antibiotic for treatment by her physician. But she has not started the prescribed medication. Patient wanted to know whether it was kay to take antibiotics after the first dose or before taking the second dose of BNT162B2. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Left arm, upper, outer aspect with swollen, warm tender area of induration 5 cm x 4 cm. Mildly pruritic. No vesicles. No pustules. No (L) axillary nodes -  Meds 1) XYZAL 5 mgm po qhs for 7 - 10 nights 2) BACTRIM DS tabs 1 po BID x 10 days.
This spontaneous report as received from a healthcare professional refers to a 67 year old patient of unknown gender. On 16-MAR-2015 at 11:30 hrs, the patient was in the office to receive a dose of ZOSTAVAX. However, the medical assistant inadvertently reconstituted the ZOSTAVAX with a vial of GARDASIL (instead of the sterile diluent) and administered it to the patient (dose, lot numbers and expiration dates were not reported). Additionally, the reporter thinks, that the dose was given intramuscularly, but she was not sure. No symptoms reported. Concomitant medication was not reported. Follow up information has been received on 21-APR-2015, which reported that the patient with diabetes mellitus, hypertension and hearing loss, who received the first dose of ZOSTAVAX (lot # K018173, expiration date not provided, reconstituted in a vial of GARDASIL (instead of the sterile diluent, reported as a first dose) (Lot # reported as K009482, expiration date not provided), subcutaneously in the left upper arm, on 16-MAR-2015 at 11:30 a.m. It was mentioned that the patient did not seek medical attention. Additional information is not expected.
Bronchitis, Symptoms lasted for 3 weeks, Treatment - steroid, cough suppressant,
Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). On 06-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071231:Crosslink (MOD21-071889)
See neurologist note. Pt reports affected speech and episode of prolonged dystonic tongue posturing. Non specific paroxysmal spell post receipt of FluMist. "Glared over" "not himself", pursing lips, holding lips square; talking with tongue thrust behind front teeth, problem finding words, involved talking but not eating. Diagnosis: Prolonged dystonic tongue posturing. Problem resolved after about 5 weeks (prior neurology exam).
Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle and knee soreness, headache, very sore left arm, flu-like -ache in nipples Arm soreness declined over two weeks, ankle and knee soreness currently persist, fatigue lasted one week, other symptoms stopped after third or fourth day Treatment was acetaminophen, increased water intake and rest
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
I experienced my legs hurting so bad to where I could not walk, shooting pain in both my legs, hot flashes, knees are very swollen and body aches.
Received Janssen vaccine on 3/20/21.  Symptom onset 7/8 with a cough.  Tested positive on 7/8/21 for Covid-19
This spontaneous report was received from a medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (dose, strength, and route of administration were not reported) (lot # M042599, expiration date 17-JUN-2018) for prophylaxis. According to the reporter, PNEUMOVAX 23 doses were exposed to the following temperatures excursions: 5 hours and 9 minutes between 0 degrees Celsius (C) and a maximum of 2 C, and for 20 hours and 22 minutes below 0 C with a minimum at -3.7 C. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. Additional information has been requested.
Large, slightly raised red rash appeared 12 days after vaccination around/near the injection site.
Extreme dizziness- ongoing since injection. Weakness, fatigue, blood results show increase in calcium levels and albumin levels. Urgent Referral to ENT in process.
Client received incorrect formulation of Pfizer vaccine. Client is 12 years old and received the pediatric formulation of the Pfizer vaccine. Client should have received the adult formulation of the Pfizer vaccine. The parents of the client were notified of the error by the vaccination POD manager.
Anaphylaxis and shock, fever, liver damage, itching, fatigue, digestive, rheumatoid arthritis, depression. Medical records state sweat, hypertension, edema of face, vomiting. msv. 12/31/09 Blood test and liver biopsy confirm damage which there were no prior indications of from vaccine date. Iam very ill. I am unable to work or return to a normal life. Depression and fatigue accompany fevers and joint pain, etc.
Approximately 1/2 to 1 hour after receiving IM dose of FLUVIRON, patient got chilled and began shaking and could not stop. Patient had difficulty trying to talk and was pale. After about 45 minutes to 1 hour, symptoms disappeared. Blood pressure elevated during episode.
After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks; Patient had redness in both legs; she received the MODERNA shot on her side; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks), ERYTHEMA (Patient had redness in both legs) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (Blood pressure), Blood cholesterol abnormal (Cholesteol), Disorder sleep (Trouble sleeping), Panic attacks and Panic disorder (panic disorders). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, SIMVASTATIN (ZOCOR) for Blood cholesterol abnormal, LISINOPRIL and METOPROLOL for Blood pressure abnormal, MELATONIN for Disorder sleep, FUROSEMIDE (LASIX M) for Diuretic therapy, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS (SENEX 3) for Panic attacks, ALPRAZOLAM for Panic disorder, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side). On an unknown date, the patient experienced INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks) and ERYTHEMA (Patient had redness in both legs). On 08-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side) had resolved. At the time of the report, INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks) had resolved and ERYTHEMA (Patient had redness in both legs) outcome was unknown.            Patient stated that a time ago she took another vaccine (pneumonia) and she had an adverse reaction who disabled from being vaccinated again in the arm.  After receiving each dose, she had an infection from the injection site to the knee that lasted 3 weeks, and redness in both legs. She went to the Hospital and she received like 50 antibiotics (she doesn't remember the names of the antibiotics). 50 unknown antibiotics to treat the infection.   This case was linked to MOD-2021-404978 (Patient Link).
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of RECOMBIVAX HB (lot#M033334, expiry date: 11-AUG-2018) (route: intramuscular) that was exposed to 52.2F for 3.5 hours. No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
vomiting x1, dizziness, diaphoresis; patient felt immediately better after vomiting
Pt recvd 3 doses of Engerix-B vax then went to give blood 14FEB92 & was found to test pos for antibodies to Hep C; test is being repeated; pt has been asyptomatic for hepatitis sx all along; disc surgery has been deferred;
Maladministration after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3dz45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On 25th January 2022, the patient received a Kinrix vaccine which was expired on 15th January 2022, which led to expired vaccine used. The reporter consented to follow up.
This spontaneous report was received from a vaccine coordinator, and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHa, dose:0.5 ml, lot # U022728 expiration date: 16-JAN-2023 as prophylaxis (route of administration and anatomical location were not provided). On 28-DEC-2021, the doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) had a temperature excursion (product storage error) of 8.1 degree Celsius for 2 hours 58 minutes and 0 seconds. No additional adverse event reported.