chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine after the BUD; Vaccine stored in refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the BUD) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 23-Dec-2022).    No concomitant medications were reported.  Vial size was reported as.4 ml per vial. The vial was initially stored in the refrigerator 23-Dec-2022. The vial did not undergo any temperature excursions. The patient received vaccines on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17Feb2023 and 21-Feb-2023.  No treatment medications were reported.  This case contains information for the 15th of 42th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
fever 103-wouldn't come down w/Ibuprofen or APAP was taken to ER;extreme tenderness @ inj site, no redness;had diarrhea, then refused to eat;JUN total 4oz fluid;taken back to ER;UA done pt sl dehydrated sent home w/instruction;
Swelling on the right eye; Redness; Sore to the touch on the right cheek; This case was reported by a nurse via call center representative and described the occurrence of eye swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 1st dose of Shingrix. On 30th January 2020, 1 days after receiving Shingrix, the patient experienced facial pain. On 31st January 2020, the patient experienced eye swelling and erythema. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the eye swelling, facial pain and erythema were unknown.   It was unknown if the reporter considered the eye swelling, facial pain and erythema to be related to Shingrix.  Additional case details were reported as follows: One day after vaccination experienced the patient sore to the touch on the right cheek. On 31st January 2020, 2 days after receiving Shingrix the patient swelling on the right eye, redness. The patient went to urgent care and received a steroid shot and also prescription for steroids. The reporter consent to follow up. This case has been linked with case US2020115716, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115716:same reporter
2 days p/shot pt devel knot; no fever; knot in rt thigh 30x35mm; parents putting warm compresses on area; (area reddish pink) non-tender;
Information has been received from a health professional concerning a 70 year old female who, "today", on 04May2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 651280/0803R). The patient came into the office stating she needed the varicella virus vaccine live (Oka/Merck) however, the nurse stated that the patient was mistaken and she needed the zoster vaccine live (MSD). It was reported that the event was a staff error. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I am breaking out with hives all over my body; Tightness of the chest; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "I am breaking out with hives all over my body"; CHEST DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "Tightness of the chest".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Area is swollen, hard, softball size area after vaccine.  Itchy, no pain.
Irregular bleeding/period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Irregular bleeding/period) in an elderly female patient 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular bleeding/period). At the time of the report, MENSTRUATION IRREGULAR (Irregular bleeding/period) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient stated she had completed the primary vaccination series and received 2 Moderna boosters. The experienced bleeding/period after getting the moderna Covid-19 vaccine.  Treatment information was not provided.
Headache; severe sinus pressure on right side of face; Runny nose; Body aches; Intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 11:15 (Lot number: EW0179) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "adhd" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; WELLBUTRIN; BENADRYL. Vaccination history included: Bnt162b2 (lot number=EW0179, administration time=05:15 PM, dose number=1,, vaccine location=Left arm (reported as Arm Left), No events reported), administration date: 23Jul2021, when the patient was 30 years old, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Headache"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "severe sinus pressure on right side of face"; RHINORRHOEA (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Runny nose"; PAIN (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Intense fatigue".  Additional information: Facility where the most recent covid-19 vaccine was administered was noted as doctor's office/urgent care. No name of drug was reported for relevant past drug history. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, patient had not been tested for covid-19. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Hospitalization prolonged was noted as no. It was unknown if patient received any treatment for the events. Device date noted as 15Aug2021. Patient received Zoloft, Wellbutrin, Benadryl within 2 weeks of vaccination.    Follow-up attempts are completed. No further information is expected.
After receiving the vaccine I started having flu like symptoms, and then I started itching with hives that must have been going on through the night because my chest is scratched up, then diarrhea and nausea started. I've not been able to eat for a couple days now. I ended up in the ER and was given IV fluids and slept all afternoon.
Pt is a 22 year old.  He reports awakening with "a severe sore throat, swollen tonsils and coughing up yellow mucus" the night after receiving his first anthrax and smallpox vaccinations.  He lists a history of "an allergy to eggs as a child", but has since been able to eat eggs without problems.  He also reports "allergy to trees, pollen, molds and cats".  He has received "many other shots" without problems.  His symptoms following his anthrax and smallpox immunizations are listed below. ANTHRAX: RA: Localized swelling, redness and tenderness at site.  Swollen throat and tonsils and glands in my neck the evening following his immunizations.  Also "felt like my tongue was swollen."  He denies chest pains, shortness of breath, fever, chills, nausea or vomiting.  He was seen at medical clinic 10/02/03 with diagnosis of strep throat and treated with an antibiotic, decongestant, Tylenol and saline gargles.  2 days later he had swelling in both his hands with "loss of feeling" in his right hand; an itchy generalized rash "little red dots on my arms, hands, chest, back and legs", diarrhea (times 2 days), joint pains (left foot and big toe) and fatigue "feeling tired and wanting to sleep all the time".  Strep and Mono cultures were negative.  The antibiotic was stopped 10/06 and he was treated with atarax with good results (rash completely resolved 10/15/03).  SMALLPOX:  LA: Swollen, warm to touch.  Swollen glands, in my neck and under my left arm.  Denies shortness of breath, fever or chest pains.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J014219, expiration date 05-OCT-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 168 hours, with the lowest recorded temperature of 34 degrees (1.111111111 degrees Celsius) and another lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward they gave out and I was on the floor unable to get back up on my own without staff assistance. I was very sweaty very dizzy and disorientated. not knowing who was around me. I had pain at injection site, no headache no body pain. Very tired slept took tylonal.
The morning after my shot (on Sat), on Sunday at about 6am, I woke with palpatations and high pulse, measuring 225/ 115  111pulse ....called 911 and taken to Emerg Room.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 14-OCT-2017, the patient was vaccinated with unknown dose of PNEUMOVAX 23 (route of administration, lot#, expiry date not reported) for prophylaxis.  On 15-OCT-2017, the patient came back to the pharmacy with a hot, swollen arm. Relevant lab data was unknown. The outcome of the events and causality assessment were not provided.
This spontaneous report was received from a consumer and refers to a male patient who would be 5-year-old currently. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient died after receiving the hepatitis b vaccine (recombinant) (manufacturer unknown). The cause of death and information concerning autopsy were not reported. Causality assessment between the death and the hepatitis b vaccine (recombinant) (manufacturer unknown) was not provided. This is one of several reports from the same reporter.
Information has been received from a health care professional concerning a 7 year old female who on 08Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 07Mar2004 the pt experienced shingles that were red and itchy and painful. She also reported a sore throat and a fever. The pt did not go to the hospital nor receive any treatment. The reporter also indicated that another pt experienced adverse reactions following vaccination with chickenpox. Additional information has been requested.  This is in follow up to report previously submitted on 05/14/2004, information has been received from a health care professional concerning a 7 year old female with asthma (diagnosed at 2 years old) who on 10/08/1997 was vaccinated in the left upper leg with a first dose of varicella virus vaccine live (lot 624340/0962E) There was no illness at the time of vaccination. follow up information indicated that on 03/01/2004 the patient broke out on her left arm with bumps that started out as red dots. The dots turned into blisters and were in a linear pattern down her forearm. The patient indicated that they itched very bad, and were painful to the touch. After about a week, the dots started to fade. The physician indicated that it was mild shingles. It was noted that the patient had never had the chickenpox disease. The outcome was reported as recovered. The reporter also indicated that another patient experienced adverse reaction following vaccination with chickenpox (WAES0403USA01393). No further information is expected.
Hives, 12.5 mL BENADRYL given, DECADRON 0.6 mL.
TOOK THIRD DOSE OF VIVOTIF WITH FOOD; This spontaneous case report (PVX2019-1887) was received from a nurse on 22-Jul-2019. It described an adult female consumer who "took third dose of Vivotif with food" (PT: Product administration error), while being on Vivotif for an unknown indication.  Case report: The consumer took the third dose of Viovtif with food might be on 21-Jul-019.   Action taken with Vivotif was not applicable.  The clinical outcome was unknown.  Company's Comment: The causality of the event "took third dose of Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose of Vivotif with food" was considered as not applicable.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 18-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L011529, expiration date: 03-JUL-2016), which was improperly stored for 15 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
On 7-17-2012 patient received Tdap IM to left upper arm 0.5 cc. 11/27/2012 He returned to clinic for routine diabetes follow up and reported continuing pain at injection site limiting ROM.
Intermittent moderately high fever T max 104F followed by watery lined mucoid diarrhea and poor appetite.  Fever lasted till 1/25/2012. Fine maculopapular rashes on trunk was noted when fever abated.  He was also noted to be unsteady and would easily fall when walking.
Rash, itching, soreness & swelling beneath the injection site.  Appeared 9 days after the vaccine . Rash & soreness lasted 7 days then disappeared.
Initial information has been received from a registered nurse concerning a 27 year old patient with an unspecified age, pertinent medical history or drug reactions/allergies. On 19-OCT-2012 the patient was vaccinated with the first dose of GARDASIL intramuscular (dose, frequency lot number were not reported). On 20-DEC-2012, the patient was vaccinated with the second dose of GARDASIL intramuscular (dose, frequency lot number were not reported). On 19-APR-2013, the patient received the third dose of GARDASIL intramuscular (dose, frequency lot number were not reported). No other co-suspect medications were reported. No concomitant medications were reported. The patient was vaccinated with the first and second doses of GARDASIL when the patient was 26 years of age. On 19-APR-2013, the patient was administered the third dose of GARDASIL when the patient was 27 years of age. No adverse effect reported. Action taken was not applicable. The events were not related to GARDASIL. Additional information has been requested.
Onset of fever, chills and sore throat on 6/8/00. Onset of weakness in hands and legs on 6/11/00. Admitted to the hospital on 6/14/2000 and still hospitalized at the time of this report. Treatment with IVIG. Dx Guillain-Barre.
Patient received vaccine on 11/8/2021. Patient reports injection site soreness worsening 2 days after receiving injection. Patient describes soreness as "a million needles" in entire right arm, into hand, and fingers. Patient followed up with Primary Care Physician. PCP referred patient to orthopedic specialist. Patient had MRI done. MRI showed "fluid" per patient. Patient got a second opinion from patient's employee's health center via phone visit with Dr.. On 7/29/2022, patient followed  up with Dr., sports medicine specialist. Per patient Dr. stated he could not rule out that the vaccine injection has caused "muscle damage." Plan is to refer patient for physical therapy.
This spontaneous report was received from a nurse and refers to a currently 27-year old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unspecified dates, when the patient was 17 years old, she received 2 doses of GARDASIL (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. Nurse reported the patient did not receive a third dose of GARDASIL. The patient was in the office then and would like to complete the  Human papillomavirus (HPV) series with GARDASIL 9. Nurse reported the patient had not yet received dose of GARDASIL 9. No adverse effects were reported. The outcome of the events was unknown.
Pt is not sure which vaccine caused reaction. Pt experienced chills 3 hrs after vaccine, then 5 hrs after that had fever and sweating. In the morning pt had chills again. Her arm was slightly swollen around the area of the shot. It proceeded to get bigger and redder from the tip of shoulder to elbow. She reports it was red and sore. Pt was treated w/ IM ROCEPHIN x 3 days and PO cefuroxime 500 BID x 6 days.
On Day 2 (the day after the vaccine), I had a fever that wavered between 100 and 101 and was not very responsive to Tylenol.  Also had aches and chills for the entire day.  On day 3 (2 days after the vaccine), my fever dropped to between 99.3 and 100 and I was not achy, but have had a malaise and heaviness in my chest that has been persisting (I'm now on day 5).
Subject was administered vaccine and developed LUR cellulitis which required PO antibiotic intervention for 10 days
Left arm sore; scratchy/sore throat; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The concomitant medications were not taken by the patient within two weeks prior to COVID-19 vaccine. The past drug history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 15:15, the patient experienced left sore arm/swollen arm, scratchy/sore throat, fatigue and body aches. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen arm, sore throat, fatigue and body aches were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Three weeks after the shot I started to experience severe headaches and trembling in my right arm, forearm to hand. The headaches have increased and I?m missing about a day of work each week, and having headaches nearly everyday. I went to my primary, then to a neurologist. He did MRIs of my head and neck, nerve testing and EEGs to check for seizures and everything came back clean. Next he sent me to my psychiatrist to check the meds I?m on.  He doesn?t believe they are a cause but lowered the doses to make sure and no relief.
This case was reported by a physician via sales rep and described the occurrence of aphasia 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, less than a year after receiving SHINGRIX, the patient experienced aphasia, fatigue, watering eyes and weakness. On an unknown date, the outcome of the aphasia, fatigue, watering eyes and weakness were unknown. It was unknown if the reporter considered the aphasia, fatigue, watering eyes and weakness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient received SHINGRIX and sometime post the vaccine dose the patient experienced extreme fatigue, eye watering, could not speak and weakness.
arm is swollen; arm is sore; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th February 2023, the patient received the 2nd dose of Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the 2nd shingles vaccine on Friday.  The patient's arm was swollen and sore.