chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 19-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 15th AUGUST 2016, the patient received the 2nd dose of BEXSERO .5ml. On 15th AUGUST 2016, immediately after receiving BEXSERO, the patient experienced pain in arm and injection site swelling. On an unknown date, the outcome of the pain in arm and injection site swelling were unchanged. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. The reporter considered the injection site swelling to be related to BEXSERO. Additional details were provided as follows: The case was previously reported to a doctor. This case was reported by the patient's father. On 15 JUNE 2016, the patient received 1st dose of BEXSERO without experiencing any issues. On 15th AUGUST 2016, the patient received her BEXSERO booster (time unknown) on her left arm.  The patient's father stated that he had called the pediatrician's office for medical advise but had not heard back yet, sho he would call again, as the patient leaves home for school and she would  not return until break. The paperwork the patient received did not list lot number or expiration date.
12 hours post vaccine- 101 fever body aches  18 hours post vaccine - fever broke. Sweating for hours  27 hours post vaccine- right side of my upper lip started swelling significantly.  28-hours post vaccine - swelling in both lips bilaterally with facial swelling/ numbness and tingling on right side only.   Went to urgent care and got a kenalog shot and was given and dose pack later by my pcp. Took 50 mg of benadryl Q6 since event.   This morning 48 hours post vaccine swelling is gone but now have itching in my hips / lower torso with some fine rash.
Information has been received from a registered nurse concerning a 11 year old male patient who on 22-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 666863/0467Z), 0.5 mL (route of administration not reported). Concomitant therapy included BOOSTRIX. It was reported that on 23-JUL-2010 the patient experienced localized reaction, discomfort, swelling, redness at the injection site after receiving VARIVAX (Merck) (unknown whether this was the first or second dose). At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome 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 assessment was provided for WRONG PRODUCT ADMINISTERED (dose was administered to an adult patient from pediatric vial  instead of bivalent vaccine).    No concomitant medications were reported. The reporter was not aware of any adverse events after the vaccine was given.  No treatment medication was reported. This case contains information about 21st patient out of the 26 patients.
This spontaneous report as received from a consumer refers to her 16 years old son with no pertinent medical history or drug reactions or allergies. The patient was vaccinated intramuscularly with dose 1, 0.5 ml of GARDASIL (lot number not reported) on 25-JUL-2012. The patient's mother reported that on 25-JUL-2012 the patient received the dose by the medical assistant who was the nurse practitioner in the doctors office. The mother was upset that she did not receive more information on GARDASIL. The mother stated that she and her son were told they could leave the office right after the injection was given. The mother left with her son and later on her son had a seizure (medically significant). The mother took her son to the hospital. The patient was given a CAT SCAN (result not provided) but was not admitted to the emergency room at one hospital. The ER doctor recommended the patient schedule an EEG. The mother also stated she did not think she would take the patient back to get the remaining schedule doses of GARDASIL. The outcome of seizure was reported as recovered. The relatedness for seizure was not provided for GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
the patient "experienced seizure like activity for five minutes and her eyes rolled up in her head".; the patient "experienced seizure like activity for five minutes and her eyes rolled up in her head".; fever of 101.3F; This spontaneous report has been received from a nurse referring to an 18-month-old female patient who had no concurrent conditions, medical history, concomitant therapies or drug allergy or reactions.          On 12-AUG-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R030115, expiration date reported as 29-DEC-2019; strength: vial 25/0.5 (unit not provided); dose was not reported) intramuscularly for prophylaxis (also reported as scheduled vaccine).         On 13-AUG-2019, the patient experienced seizure like activity for five minutes and her eyes rolled up in her head. The patient also had a fever of 101.3 Fahrenheit (F). The patient was taken by emergency medical services to an unspecified hospital on the same date. The patient received rectal acetaminophen (TYLENOL). On that date, the patient went home. It was unknown if there were diagnostics or studies performed. The patient sought medical attention. The outcome of the events was unknown. The causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.  The reporter considered all the events to be medical significant (reported as need intervention to prevent serious criteria).
administration of an expired dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number c9gm4, expiry date 15th November 2021) for prophylaxis.   On 2nd January 2022, the patient received Shingrix. On 2nd January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 69 or 70 years The patient was given an expired dose of vaccine. No further events were reported . The reporter agreed to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002051:same reporter US-GLAXOSMITHKLINE-US2022002054:same reporter
No additional AE's; a temperature excursion for VARlVAX; the patients dob: 23-JUL-2021; This spontaneous report has been received from a registered nurse (also reported as medical assistant), referring to a 7 weeks old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter to report a temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX). Per the reporter, varicella virus vaccine live (oka/merck)(VARIVAX) experienced an excursion of (4 degree Celsius (C)) for 20 minutes on 07-SEP-2021 during transport and (4C) for 20 minutes on 09-SEP-2021 during transport. On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot#U002394 with expiration date: 22-JAN-2023; dose: 1 (units not provided), strength and route were unknown) for prophylaxis (product storage error and product administered to patient of inappropriate age). No additional AE reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under 10C below zero to 8C (4C) for 20 minutes and 10C  below zero to 8C (4C) for 20 minutes. There previous temperature excursion was under 10C below zero to 8C (4C) for 7 hours and 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005632: US-009507513-2109USA005639: US-009507513-2109USA005641: US-009507513-2109USA005648: US-009507513-2109USA005651: US-009507513-2109USA005701: US-009507513-2109USA005705: US-009507513-2109USA005730: US-009507513-2109USA005742: US-009507513-2109USA005744: US-009507513-2109USA005752: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005881: US-009507513-2109USA005891: US-009507513-2109USA005901: US-009507513-2109USA005902: US-009507513-2109USA005910: US-009507513-2109USA005918: US-009507513-2109USA005945: US-009507513-2109USA005964: US-009507513-2109USA006765: US-009507513-2109USA005776: US-009507513-2109USA005618: US-009507513-2109USA005662:
postherpetic neuralgia; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around November 2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles.        On an unknown date the patient experienced postherpetic neuralgia.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations not present prior. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. Plaintiffs sustained severe, serious, progressive, incurable, and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of postherpetic neuralgia was assessed as not recovered.   The reporter considered postherpetic neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, postherpetic neuralgia was considered as disabling due to "severe and permanent injuries".
Fever   Shortness of breath   Chills  Unable to move my arm  My arm was swollen and red around the area where the vaccine was injected.  Sore throat
Patient received her shots on Feb 25, 2011. On Thursday March 3rd patient seemed like she was coming down with a cold. We bathed her and she ended up throwing up what little food she ate for dinner. On Friday March 4th patient seemed OK during the day according to her daycare, but at home that night she seemed lethargic and was running a 100.4 fever. Was given a little infants ADVIL and was put to bed at 8:15pm, checked her at 10:15pm, and then at 3:15 am when she had already passed in her sleep.
I experienced extreme fatigue for two to three days, body aches, low grade fever, and chills. I went to the doctor and was told that I the symptoms would subside after a while. After a few weeks, I finally started to feel normal but the fatigue continued for an additional week and a half.
December 1, 2021 Vaccine vial transferred from Freezer to Fridge January 6, 2022 Vaccine administered.
onset of fever 101-102.5 5-6 hr p/vax fever cont for 5 days w/a high of 105.7 R through APAP & Advil;started on Ceclor on 5OCT;had blood cult & CBC done on 6OCT rash appeared 7OCT;dx roseola;
The day after the injection, I woke in a state of extreme exhaustion and weakness. I have been barely able to function and almost a month later, I am still very tired and weak and staying at home, also have swollen glands that are painful under my ear lobe.
-Approximately one hour after receiving the 2nd dose of the Moderna Covid vaccine on 2/3/21, I noticed a  heat wave kind of sensation from my back , up through the back of my head, and very mild dizziness. -Between 3:00 and 4:00 pm I noticed I was becoming very tired, and having some difficulty concentrating  and recalling information. I noticed my arm had started to become mildly achy, and body was beginning to ache mildly as well. -About 7:45 pm I was experiencing significant fatigue and "brain fog" during conversation with my son. Stopped in the middle of things and went to bed, needing to hold handrail to walk upstairs due to extreme fatigue and mild dizziness. -Between 3:00 and 4:00 am I woke up thinking I was feeling vibration of loud sound - but it was heart rate of 150 bpm. Temperature was 102 F.  Chest was heavy and tight.  8/10  pain with head ache and body ache.  Heart rate remained high for at least 15 minutes, so my husband took me to the Emergency Department. They ran EKG, took labs, and chest x-ray. My heart rate started to come down during this time. I was told there were no problematic findings. My heart rate was between 100-106 by the time I left. Fever had come down to about 100.  Began to get extreme nausea - was given Zofran. -In bed the entire day 2/4/21.  -2/5/21, continued to experience mild to moderate fatigue and brain fog, difficulty with recall and new learning. Had to leave work early. Continued same symptoms throughout evening, able to sleep in segments. -2/6/21: As of today, I am continuing to experience fatigue and some brain fog, for example, I wrote down my only son's birthday incorrectly. This is not remotely normal.
Shortness of breath requiring 911 call. Also fever, chills/cold feet, new onset diarrhea and cramps, severe weakness.
fever; chills; her hands were shaking; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (first booster; unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "her hands were shaking"; HEADACHE (non-serious), outcome "unknown".  Additional Information: The reporter said that she got the new vaccine yesterday afternoon (27Sep2023). Reporter mentioned that this was her fourth booster. She had a bad reaction last night - she had a fever, chills, and her hands were shaking. She also had a headache. She noticed that she had those bad reactions after taking her second booster shot in Apr2022. The caller wanted to know if those were the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300163318 same reporter/patient/events, different dose number;
Red at injection site; Itchy at injection site; Swollen at injection site/ Raised its head up again at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site/ Raised its head up again at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site/ Raised its head up again at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) had resolved and VACCINATION SITE SWELLING (Swollen at injection site/ Raised its head up again at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.  Treatment was not provided/ unknown.
pt recv vax & became irritable for 48hr;pt was very clingy & devel a fever;pt recovered & recv no further doses of pertussis vaccine;
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program  Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Flu type reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu type reaction) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu type reaction). At the time of the report, INFLUENZA LIKE ILLNESS (Flu type reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Got full dose for their 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Got full dose for their 2nd booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Got full dose for their 2nd booster). At the time of the report, ACCIDENTAL OVERDOSE (Got full dose for their 2nd booster) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that reporter's 2 friends took the 2nd booster dose on 31-Mar-2022 at a pharmacy and were informed that they got a full dose for their 2nd booster and were told that this recommendation was from Moderna. Reporter mentioned that these friends were not immunocompromised. Reporter had an appointment for her 2nd booster dose at another pharmacy and when she called them, she was told that the 2nd dose was half the dose and she was told they never heard about the 2nd booster dose being given at full dose. So, she was contemplating on going to that pharmacy which gave a full dose.  No treatment medication was provided by the reporter.
About two months after second Pfisher,  COVID shot on May  24, 2021, I became ill with COVID like symptoms. Got negative COVID results from store. Same day my doctor said it could be pneumonia, ever since, I've felt sick, exhaustion, feverish, low energy, low oxygen,  nausea. Treated for pneumonia did not help.
Apx 08:31 pt c/o not feeling well, feeling flush, pale skin and feeling like fainting. Apx 08:37 started c/o weakness, chest heaviness, dizziness and increased feeling to faint.  08:41 2L Oxygen started via nc, EKG completed-results unreliable due to poor quality  resulting from pt stated having muscle tremors. stated having nausea. 911 activated.  08:53 pt c/o bilat hand tingling and coldness. 08:57 Fire on scene, paramedics transfer to ED. ED did chest X ray,  ECG, Labs-CBC,CMP, Lipase,, Troponin, Pregnancy. Given normal saline and Ondansetron IV and Potassium Chloride PO. Discharged from ED 11:36
Felt like she had the flu; Couldn't walk; Hard to get up and down; Whole body hurts; Coughing; Sore throat; Chills (feels very cold); Fever; Bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), GAIT DISTURBANCE (Couldn't walk), ASTHENIA (Hard to get up and down), PAIN (Whole body hurts) and COUGH (Coughing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and COPD.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HEADACHE (Bad headaches). On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), GAIT DISTURBANCE (Couldn't walk), ASTHENIA (Hard to get up and down), PAIN (Whole body hurts), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills (feels very cold)) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu), GAIT DISTURBANCE (Couldn't walk), ASTHENIA (Hard to get up and down), PAIN (Whole body hurts), COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills (feels very cold)), PYREXIA (Fever) and HEADACHE (Bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Thyroid problems and stage 3 liver disease are the medical history reported by the patient. Treatment medication: Alka seltzer flu medicine.