chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inadvertently administered an expired Moderna Covid-19 vaccine to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Dose administered after 30-day Use By Date or after manufacturer date of expiry. No vial under went any temperature excursions   This case was linked to MOD-2022-457918 (Patient Link).
Pt vaccinated with DTP/OPV/HIB developed inconsolable crying 3 hrs after shot, lt leg swollen.
Pt with no active medical problems other than diet controlled diabetes had his Moderna COVID vaccines 02/16 and 03/16/2021. He presented to the hospital with c/o 2 mo (since around 4/14) of progressive fatigue and weakness which progressed to dizziness and now shortness of breath the past month and was found to have profound pancytopenia. He had no history of alcohol use, b 12 or folate deficiancy, no recent illness, no medications, HIV and hepatitis testing were negative. He does not smoke. He had no prior history of problems with his white blood cell count, red blood cell count or platelet count. He admitted that shortly after his second vaccine he began to feel fatgiued with symptoms progressing afterwards. Upon admission his hemoglobin was 6.7 and he was given 2 units of blood. His D-dimer was elevated at 1224 and a CTA of the chest was negative for PE.  His PT/INR PTT were within normal limits EKG showed no acute ischemia and normal sinus rhythm.  Fibrinogen was 246.  His iron was 238 saturation of 77 TIBC of 309 and ferritin of 941.    His hemoglobin A1c was 6.0.  He was seen during his hospital stay by Hematology/oncology . vitamin B12 and folate levels were normal.    He has no prior history of malignancy.  Patient's ultrasound of the abdomen showed no splenomegaly.  Again vitamin B12 and folic acid levels were normal.  A peripheral blood smear was done which was concerning per oncology for an underlying bone marrow condition. Ultimately his bone marrow biopsy showed Acute myeloid leukemia with blasts and monocyte features.
Ringing in ears, bad headaches off and on until 12/5 and ongoing  high blood pressure and resting pulse with continued ringing in the ears.  Did not realize blood pressure was high until doctors visit 12/1.  was prescribed migraine medicine and asked to continue recording blood pressure.  Have been prescribed blood pressure meds starting 12/9.  Had always previously had low blood pressure and been diagnosed at one point as having syncope due to low BP and normal resting pulse in 55 - 65 range
pt recvd vax & exp fever 106, confusion, combative behavior 6hrs post vax; admitted to hosp & sedated;
Case number PHEH2013US021169 is an initial spontaneous report received from consumer on 08 Oct 2013: This case refers to a 36-years-old female patient. Her medical history and concomitant medications were not reported. Past flu vaccinations were well tolerated. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on an unreported date in Sep 2013. The reporter stated that patient received vaccine at 10 AM. By 8 PM patient was feverish, had nausea, vomiting, disoriented, weak, and passed out. The reporter informed that events resolved within 2-3 hours. The reporter stated that these events were not informed to the physician. The reporter considered these events as serious. The causality was not reported.
Pneumococcal Polysaccharide Vaccine administered Monday afternoon Respiratory discomfort Tues. evening. Deep cough with phlegm Wed. morning Temp of 100.2 with chills and worsening cough Wed. evening; ibuprofen taken at bedtime Worse cough with phlegm, chills, temp on Thurs; ibuprofen taken morning & evening - difficulty sleeping due to cough Fri - worse cough, loss of voice, minor chills; ibuprofen taken in morning at time of this report filing Similar reaction when the same vaccine was received 10/10/2011; laryngitis with complete loss of voice for one week. No similar symptoms encountered over the intervening years.
Information has been received from a health professional concerning an approximately 10 year old white female who on  28-OCT-1996 was vaccinated with a dose of Varivax. Subsequently, the patient experienced a generalized rash with < 50 lesions. This case was documented or evaluated by a physician. The child was not hospitalized. There was no other information provided. Additional information has been requested.
Injection site was posterior side of left upper arm. 2 days after injection, area was still itching, red, blotchy, raised, slightly distended (2.5 inches wide, ~4-5 inches long). Advised to ice area, take diphenhydramine, possibly use a topical steroid.
12 hours after injection, fever, chills, aches, headache, nausea, vomiting, sore throat lasting for 3 days.
Patient received vaccine 9/16/16. Patient reports sore arm on 9/16/16 and 9/17/16. On 9/18/16, patient's arm was red, sore, with warmth. On 9/19/16, the patient came back to pharmacy. Arm was visibly red, but patient reports improvement. Patient did not require any treatment.
This spontaneous report was received from a healthcare professional, referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unspecified date in October 2015, (reported as "between 05-OCT-2015 and 26-OCT-2015) the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (route, dosage, strength and lot# were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
BLURRED VISION; CONSISTENT HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraine, non-smoker, non-alcohol user, and allergy to sulpha drugs, and other pre-existing medical conditions included: The patient had no any history drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 7821287, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, treatment medications included: ibuprofen. On 01-JUL-2021, the patient experienced flu like symptoms. On OCT-2021, the patient experienced consistent headache. On an unspecified date, the patient experienced blurred vision. Additional treatment medications (dates unspecified) included: sumatriptan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 03-JUL-2021, and had not recovered from consistent headache, and blurred vision. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
pt was given routine vax @ approx 2PM; mom reported that pt became inc fussy throughout the afternoon & evening; by 8PM temp was reported to be 102-103 & uncontrollable screaming x 4 hrs;
Pt recvd 2nd dose of vax & exp arthritis in one or more joints five out of seven days per wk; had warmth & swelling of the lt wrist & palindromic rheumatism;
This spontaneous report was received from a health care professional, via the Agency and refers to an approximately 61 year old female patient. Information regarding the patient's pertinent medical history or concomitant medications was unknown by the reporter. The patient's previous drug reactions/allergies included sulfonamide and penicillin (reported as sulfa and pene). On 18-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 1 dosage form (DF) for prophylaxis (dose number, anatomical site of administration, lot number and expiration date were unknown by the reporter). On an unknown date, following the vaccine administration, the patient experienced an unspecified serious reaction. No further information or clarifying details were reported. It was unknown by the reporter if the patient received any treatment; if any laboratory or any other diagnostic studies were performed to her, or if she sought for medical attention regarding the adverse event. The outcome of serious adverse reaction was unknown. The action taken with PNEUMOVAX 23 was not applicable.  The causal relationship between PNEUMOVAX 23 regarding unspecified serious reaction regarding was unknown by the reporter. Upon internal review unspecified serious reaction was medically significant.
Patient was given Moderna Bivalent Booster 0.25mcg not 0.5mcg. Patient was given wrong dose.
Stomach pain a few minutes of eating or drinking anything.; This case was reported by a consumer and described the occurrence of stomach pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2022 11:15, the patient received the 1st dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the stomach pain to be related to Shingrix.     Additional Information: GSK receipt date: 08-DEC-2022 Reporter's comment: The patient had the first dose of Shingrix on Sunday at 11.15 am.  The patient said on the day of reporting as thursday, 6 am and he/she was still having stomach pain within a few minutes of eating or drinking anything.  The patient asked was this normal. When should he/she get it checked out.
Chills, fever- low grade, fatigue, nausea and flu like symptoms and body aches which lasted 48 hrs. Immediately stopped and completely better. Then 20-25 days later when she got congestion sore through head ache and fever that turned into bronchitis.  Called the telehealth Dr. and they prescribed medicine and symptoms worsen then she went to urgent care face to face with the Nurse, prescribed Doxycycline 100mg twice a day and received two shoots antibiotic and steroids.
4-5 hrs p/recvd DTP became pale, hypotonic, perfusion dec (6SEG refill in gums); contacted MD; adm to hosp for observation;
started with Shortness of breath and chest tightness while walking to prepare for a hiking trip towards the end of march 2021.  SOB and chest tightness continued.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifies, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Tdap administered 4/20/16 - developed redness and swelling 4-23-16 - came back to clinic 4-25-16. Treated for localized reaction to immunization. Cannot R/O cellulitis.
1hr p/vax pt had pounding heart & pain between shoulder blades; stopped spontaneously p/30mins; VSS when returned to ofc; began 1 hr p/shot;
Headache, Myalgia, Arthralgia, Fever, injection site swelling, redness and pain both doses, lymphnode swelling for 2 weeks after first dose, fatigue, fever to 103 with  second dose Narrative  Other Relevant History:
Information has been received from a physician concerning a 16 year old female who was vaccinated IM with GARDASIL vaccine (yeast) 0.5 ml. The physician reported that a patient developed redness and swelling from the right side of her face to her wrist after she received GARDASIL vaccine (yeast). The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Fatigue for 48 hours starting 2 hours post vaccine, pain and swelling at injection site (72 hours +), fever for 24 hours starting 12 hours post vaccine, headache for 24 hours starting 12 hours post vaccine
About 20 minutes after injection I had immediate onset of severe kidney pain to the point of not being able to sit or stand without assistance. Now, 2 days later, the pain has gone from a 10 to about a 6 but is still severe with movement.
8 min after receiving the vaccination, client was sitting in waiting area. States after he sat down, he thought about being glad the shot was over.  He began to get dizzy and blacked out.  Fell out of chair.   Unconscious for approx. 15 sec.  EMS on site and attended to him.  States he did not eat today. Had some snacks, but planned to eat after shot.   Admits to being nervous prior to shot.  Mother was present.   States he has never passed out after vaccines or medical treatment.  Mother believes that this was a reaction to the vaccine.  Ambulance was called, however, family refused further tx.  Client received ice for back of head which hit the floor when he fell out of the chair.   Client left after being released from paramedics.  Client was taken home by family.
Information has been received regarding a case in litigation concerning a 24 year old female with no relevant medical history or allergies who on 25-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included vitamins (unspecified). On 27-AUG-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 27-AUG-2008, also reported as starting the day of her second shot of vaccine, the patient experienced hair falling out in handfuls. The patient also reported that she was breastfeeding her 6 month old daughter. The patient's daughter developed a rash on her face. No medical attention was sought. The patient's event persisted. This is one of several reports received from the same source. Additional information has been requested.
breathing had gotten more difficult; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing had gotten more difficult) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL from August 2021 to an unknown date for Pulmonary arterial hypertension.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathing had gotten more difficult). At the time of the report, DYSPNOEA (breathing had gotten more difficult) had not resolved. Not Provided          On an unknown date in 2021, 3 weeks ago patient took Moderna vaccine and his breathing had since gotten more difficult. The patient had reached out to physician.  No treatment medication was reported by reporter.   Reporter did not allow further contact
The next day. Exhausted, chills, head ache, muscle pains. Sore arm at injection site
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021 at 3:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2021 at 3:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.18.  No concomitant medications were reported.  The vial was initially stored in the fridge on 05-Jan-2021, moved to clinic on 06-Jan-2021 and proposed beyond use date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 06-Jan-2021, at 03:00 P.M, the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
This greatly accelerated symptoms from after first shot and sent me to ER next morning where was kept on pain med IV for 4 days and received MRI. Discharged home with pain meds, muscle relaxers, and nerve pain med.
Pt recvd MMR vax as a child; pt currently exhibited a lack of response as a child; pt currently exhibited a lack of response to mumps; no further details were provided;
feeling sleepy; not the hungry/ appetite came back; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feeling sleepy), DECREASED APPETITE (not the hungry/ appetite came back) and PAIN IN EXTREMITY (arm was sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SOMNOLENCE (feeling sleepy), DECREASED APPETITE (not the hungry/ appetite came back) and PAIN IN EXTREMITY (arm was sore). On 20-Feb-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, SOMNOLENCE (feeling sleepy) and DECREASED APPETITE (not the hungry/ appetite came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Patient was fully Vaccinated with Moderna with first dose 5/20/21 and second dose 7/30/21. Patient  was admitted 11/5-11/12 for COVID 19 (cough and fatigue and myalgia and shortness of breath and some chest tightness for the past week). Patient is discharging today
Vomiting, fever, shaking, sore muscles, painful in the lower back, headache.
Right upper arm swelling, red, flaccid, violasis upper arm to elbow.  Treated with Motrin/Tylenol.