chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines / exposed to negative 43 degrees Celsius / some / were administered after the temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. The action taken with Bexsero Pre-Filled Syringe Device was unknown. The action taken with Infanrix Pre-Filled Syringe Device was unknown. The action taken with Kinrix Pre-Filled Syringe Device was unknown. The action taken with Pediarix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug 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 applicable for this report. The nurse calling regarding the vaccines Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix, and Pediarix exposed to negative 43 degrees C. The nurse stated some of the vaccine were administered after the temperature excursion, however at the time of call unknown which vaccines were administered which patients. The reporter consented to follow up.
pt recv vax 26MAY98 2PM & onset 28MAY98 rash on ear lobes progressing to face & neck;then on upper anterior chest;none @ inj site;blotchy, erythematous & finely macular;tx w/medrol dosepak & DPH;
Immediate scalp and ear itching went away within the hour. Over the next several weeks after the injection had problems with breathing, aerobic function, swelling in legs and torso, and trouble walking. I had noticeable discoloration in my legs for several weeks. I had lymphedema and venous insufficiency and they were both under control. However, over the last nine-plus months I have not been able to keep it in control. Additionally, I have new varicose veins, broken capillaries, small hematomas, and reddish splotches on the top of the left foot.
Patient received the vaccine from either lot #024C21A or #007C21A. It is not known which lot. Both lots were out of the freezer for 4 to 18 days (more than the recommended 30 days). Moderna expects vaccines to remain sufficiently efficacious. Patients did not have any negative outcomes so far.
No adverse event; VAQTA, was administered after a temperature excursion.; This spontaneous report was received from a  Health Care Professional and refers to a 4-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.
After receiving the vaccine, that night, I didn't feel good at all. The next morning I had a fever of 104, body aches and severe chills. I also got a rash all over my body, from head to toe. I had them symptoms for at least four days and the rash for about eight days. I was dizzy and weak. I wasn't able to work for five days. It felt like I had the flu. I was really feeling bad. I couldn't do a thing. I was out of town and had to get my grandson to fly and come get me. I couldn't do a thing for myself.
Knot; Red/Pink; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Knot), VACCINATION SITE ERYTHEMA (Red/Pink) and VACCINATION SITE SWELLING (Swollen) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 21-Feb-2021, the patient experienced MASS (Knot), VACCINATION SITE ERYTHEMA (Red/Pink) and VACCINATION SITE SWELLING (Swollen). On 22-Feb-2021, VACCINATION SITE ERYTHEMA (Red/Pink) and VACCINATION SITE SWELLING (Swollen) had resolved. At the time of the report, MASS (Knot) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: Patient went to the hospital and said that at the hospital they told her that vaccine was given too high-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came in for second dose of Pfizer and said that when 1st shot was administered, it was given too high, causing arm pain, and pain radiating to chest.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    No Medical History information was reported.   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported. This case concerns a  62-year-old, female patient with relevant medical history of concomitant Influenza vaccination, who experienced the unexpected non-serious event of Malasie and the expected non-serious event of Headache. The events occurred approximately 1 day after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of concomitant Influenza vaccination remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-370266 (Patient Link).; Sender's Comments: This case concerns a  62-year-old, female patient with relevant medical history of concomitant Influenza vaccination, who experienced the unexpected non-serious event of Malasie and the expected non-serious event of Headache. The events occurred approximately 1 day after the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of concomitant Influenza vaccination remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Dark urine; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (denies past medical history.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain). At the time of the report, CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
a severe rash that started around the injection site and grew to cover my arm from shoulder to hand, then spread to my back and stomach.  The rash was blisters looking like poison ivy and very itchy.  I was treated with two round of steroids over 9 days and 7 days of antibiotics.
1/8/11 - 12:30 P.M. Headache, nausea, chills, rash itching - at vaccine site, 2:30 PM shingles started breaking out different sites on my body - mild case - for 3 to 4 weeks. No treatment.
Varivax given 12/19/2003, Atypical varicella 5/18/2005
This spontaneous report as received from a physician refers to a 78 years old female patient. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) on 27-AUG-2012. Lot number 00768AE was an invalid lot number for ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. Physician reported patient seen in the office with a swollen right arm at the injection site one week after receiving ZOSTAVAX on 04-SEP-2012. Reporter noted there were no other immunizations provided at the time of ZOSTAVAX administration. The outcome of swollen right arm at the injection site was unknown. The patient went to physician's office and sought medical attention. Additional information is not expected.
mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301421B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (mild sore arm). On 03-Dec-2021, PAIN IN EXTREMITY (mild sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received 2 dose of vaccine intramuscular injection on 31 DEC 2021 lot ,059H21A, expiration date unknown, No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2022-448142 (Patient Link).
A physician reported that a 4 month old female pt received IPOL, Acel-Imune, Hib-Titer and Prevnar vaccines on 2/16/01. Reportedly, the pt had a seizure, 24 hours, post vax, and had 4 more seizures over 2.5 days. The pt was hospitalized. From follow-up information received on 3/7/01, it was reported that the pt was hospitalized for 4 days. Additional pt, vaccine, vaccine administrator and responsible physician information was also provided.
Pt. got 1st Pfizer vaccine on 8-6-21 Friday here at the health facility. Came back on Monday 8-9-21 during event here by public health, told them he needed his 2nd dose Pfizer. They gave pt. another dose of vaccine prior to checking his vaccine card.
Low grade fever of 99 degrees; A little nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever of 99 degrees) and NAUSEA (A little nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure high.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PYREXIA (Low grade fever of 99 degrees) and NAUSEA (A little nauseated). On 01-Feb-2021, PYREXIA (Low grade fever of 99 degrees) and NAUSEA (A little nauseated) had resolved. Not Provided          Additional concomitant product used included high cholesterol medications NOS.   This case was linked to US-MODERNATX, INC.-MOD-2021-054525 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054525:2nd dose
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a rash. Reportedly the pts sibling had a case of varicella at the time. One day later the pt developed chickenpox.
COVID-19 Treatment; COVID-19 Treatment; booster; offlabel use; Location of injection: Leg Left; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left leg for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 01Feb2022; DESLORATADINE, start date: 01Aug2017; EFFEXOR, start date: 01Aug2021. Past drug history included: Zofran, reaction(s): "known allergies: Zofran"; Dilaudid, reaction(s): "known allergies: dilaudid". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Apr2022, outcome "unknown", described as "Location of injection: Leg Left"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; OFF LABEL USE (medically significant), outcome "unknown", described as "offlabel use". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/31/21 thru 1/1/22 had body aches and headache, which resolved.     Starting on 1/8/22 he began having shortness of breath,  body aches, fatigue, chest pressure over sternum, constant headache, pain in left thorax and left medial/upper arm that moved around and described as a deep ache.   As a result of these symptoms on 1/10/22 had a COVID-19 PCR test, which was negative.  He also developed petechial rash on thighs and fingers that did not itch.  His fingers and toes developed a tingling/numbness/burning sensation.  He did not have any fever but he did have some chills and night sweats.    No cough, sore throat, runny nose.    Did have a single mildly loose stool, but no diarrhea, nausea, vomiting.    No urinary symptoms.   Left shoulder pain, hurts to raise arm.    Chest pressure has been constant for past 6 days.
redness at injection site and some bruising after vaccine. On 1/5/21 started exercising 20 - 30 min. into exercise routine began having  a debilitating headache. Lasting 24 hrs  even after taking taking Tylenol and Ibuprofen.  Also checked my B/P and it was around 120/68.  Then on 1/7/21 with exercising had a minor H/A with exercising relief after taking Tylenol. Then yesterday with exertion I had another debilitating headache which lasted whole 24 hrs. I had to lie down and take Ibuprofen 400 mg and took pseudophed last night. Patient did notify his doctor and awaiting call back still today has a mild headache today in left temple area and behind eyes. Still no blurred vision no tingling of face or armes.
Systemic: Diarrhea-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
01-14-12 Fever, body aches and weakness. Max temp 102 degrees.
Started feeing itchiness in throat, lips and heaviness in chest two mins after shot. Known egg allergy with hives and itching throat. Gave Benadryl 50mg Im at 1151. HR 135, RR 20, 02 100% BP135/90. After 5 min 1156 HR 105, PB 120/80 feeling a little better. 1211 BP 130/90. HR 120's, still feeling tingling in hands, mild nausea. no rash. 1300: O2 97% Room air HR 109 RR 22 BP108/87 Left arm. Pt states improvement in tinglingness. numbness in bilateral fingers. denies tingling in abdomen. pt. states improvement in throat tightness.  1323: O2 100% HR 111. Same tinglingness/numbness in fingers.  1335: 02 100% HR 102
13JAN97 745AM pt had sz-lasted 10-12min;1st responders called-hosp for 6hr;fever broke in amb t101.7;fever 101.6-100.5 til 15JAN97 then broke out in all body rash-red, raised, pimpled-currently afeb w/rash;
Information has been received from a health professional concerning a 2 year old female pt with no known drug allergies and no past medical history who on 08/18/1997 was vaccinated with a third dose of hep B vaccine. There was no concomitant medication. It was reported that the pt's mother was concerned about mercury in the vaccine. It was also reported that the mother felt the child had possible autistic symptoms starting 05/27/1999 with repetitive movements, hyperactivity and "shuttering." On 08/11/2000, the child had pacing and mouth movements. On 11/29/2000, he had difficulty with fine motor skills, but his gross motor and speech were okay. In January 2001, he saw a neurologist. At that time he had "shuttering" but a negative exam. On 08/16/2001, the school doctor stated he had a developmental and language delay and special ed classes were recommended. It was reported that the pt's primary physician did not feel the child was autistic. Follow-up info from a nurse indicated that the pt had been seen by a physician a couple of times, but the child has not been diagnosed as austistic. Upon internal review, "possible autistic symptoms" were considered an other important medical event. Additional info has been requested. Follow up info from a doctor's office indicated that the mother was only ding some research on her own and inquiring about the vaccinaitons and "not saying that her child's condition has anything to do with a reaction to the vaccinations." No additional info is expected.
Narrative: Positive COVID-19 result after completion of COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 05/17 tested for COVID for pre-colonoscopy testing->tested COVID positive patient declined daily calls and never reported symptoms
A nurse reported that several pts received an injection of flu shield and subsequently developed "flu-like symptoms." No further info was available at the date of this report. This is 1 of four pts from this facility who had an adverse experience following receipt of flu shield. The reporter was unable to specify the number of pt who experienced this event. Additional reports will be generated when identifying info is provided.
a little tired; This is a spontaneous report from the Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age started to receive first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, formulation: solution for injection) via an unspecified route of administration on 19Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Apr2021, the patient had her first shot on Monday with her husband (withheld), and now they experienced an adverse reaction. She got a little tired and her husband is having fever, sore and achy muscles. Asking if that is a normal side effect. The outcome of the event a little tired was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received FLULAVAL (batch number 7754S, expiry date June 2016). On 16th November 2015, the patient received FLULAVAL .5 ml. In 2015, less than a month after receiving FLULAVAL, the patient experienced injection site pain. On 16th November 2015, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain and wrong injection technique were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL. Additional details were provided as follows: This case was reported by a pharmacist, who himself was the patient. The patient complained that her arm was hurt after receiving FLULAVAL QIV vaccine. The patient also believed that the FLULAVAL vaccine was administered in the bursa sac, which led to wrong injection technique. On 2nd December 2015, the patient visited the orthopedic and received Cortisone shots. The patient wanted to know whether she needs to be revaccinated. The reported batch number (77545) for FLULAVAL vaccine did not exist and was updated to 7754S as per the sales database.
24hr p/vax pt devel erythema & edema of the thigh the shot was given;also had an effusion of the lt knee same as the thigh;
REC'D FLU VACCINE @9AM. @ 10:30AM SAME DAY BEGAN TO BREAK OUT IN HIVES [5] ON THE SAME ARM AS VACCINE WAS ADMINISTERED. BENADRYL 50MG ADMINISTERED AND CLIENT HAD NO FURTHER COMPLAINTS.
Area became red, swollen and hard. Pt experienced headache, shoulder and neck pain. Pt prescribed Cephalexin QID and Benadryl prn. Pt instructed by MD to avoid further Td vaccination.
Patient recvd HPV (2nd dose) at 8:30am. Patient stated to his mother that he felt light-headed while walking out of the clinic shortly after 8:40am. While attempting to get into the car, patient fainted and fell backwards, hitting the back of his head on the pavement.
Temperature of 99.8, RR increased to 20, full severe body aches, BP 138/80 (my Normal is 100/70), sore throat, and runny nose. I felt like I had the flu.
Developed itching and hive-like rash 24 hours after receiving flu shot at public  clinic         Taking Benedryl PO every 4-8 hrs with relief       Referred to primary MD