chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medications were reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP stated the expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at this time. The second potential lot was confirmed to not be used. There are a total of 82 patients involved. HCP wants to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
About 2 weeks after started having daily outbreaks of hives/rashes on various parts of the body with skin writing
first booster had a stronger reaction than the other two; felt more tired; felt a little nauseated; 0.5 mL booster dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first booster had a stronger reaction than the other two), FATIGUE (felt more tired), NAUSEA (felt a little nauseated) and ACCIDENTAL OVERDOSE (0.5 mL booster dose administered) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5 mL booster dose administered). On an unknown date, the patient experienced VACCINATION COMPLICATION (first booster had a stronger reaction than the other two), FATIGUE (felt more tired) and NAUSEA (felt a little nauseated). At the time of the report, VACCINATION COMPLICATION (first booster had a stronger reaction than the other two), FATIGUE (felt more tired) and NAUSEA (felt a little nauseated) had resolved and ACCIDENTAL OVERDOSE (0.5 mL booster dose administered) outcome was unknown.            No Concomitant Medications were provided by the Reporter Patient had no allergy to medications, food and other products. Patient never had COVID positive test or diagnosis. Patient had no acute and chronic illness at the time of vaccination and up to one month before. Patient had no vaccine within one month prior to Moderna vaccine. It had been stated that could not provided information about the other doses or the lot numbers. The events did not cause the patient to seek medical care. just rested for a day  No Treatment Medications were provided by the Reporter   This case was linked to MOD-2022-550463, MOD-2022-550488 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2022: Live Follow-up received contains Significant information Reporter address added, Patient demographics added, new events were added
Vomiting, fatigue, unable to breathe, overheating, heart failure, pulmonary hypertension, and swelling of body until I couldn't walk or put on shoes. Acute on chronic combined systolic and diastolic heart failure HCC/CMS. Multiple subsegmental pulmonary embolism without acute cor pulmonale. Chronic diastolic heart failure. Diastolic dysfunction. Pulmonary hypertension
I had pain in my arm and a huge lump on the back of my shoulder and I still have that. I have contacted my doctor and they did an ultrasound and the results are not back.
Itching and swelling at injection site and redness on upper arm. Appeared a full week after the vaccine was administered. Has been continuing for three days.
This spontaneous report was received from a 60 years old male consumer reporting on himself with high blood pressure and high cholesterol and no drug reactions/allergies who on 26-JUL-201 was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose and lot # not provided). No other co-suspects were reported. Concomitant medications included hypertension and cholesterol medications (unspecified). On 28-JUL-2012, the patient developed redness, swelling and fever at the injection site. The patient wanted to know how long it would last. No treatment was given for the events. The patient's outcome was unknown. The relatedness for redness, swelling and fever at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
PATIENT EXPERIENCED BLURRY VISION, SWEATING, NAUSEA, AND HEADACHE. PATIENT WAS GIVEN WATER AND GUM. PATIENT WAS REQUESTED TO STAY FOR LONGER MONITORING. WAS DISMISSED ONCE THE BLURRY VISION, SWEATING, AND NAUSEA SUBSIDED.
fever; headache; severe body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (on an unknown date, the patient received the 1st dose of Shingrix, refer case US2019AMR209753).   On 14th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever, headache and general body pain were unknown.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient. The patient had severe body aches. The patient asked if fever headache and severe body aches were common.
labored breathing; irregular/strong heartbeat after minimal exertion, most noticeable while resting/sleeping; feeling of 'gravel/bubbles' in blood running through body; lightening bolt across shoulders blades, chest and upper abdomen; "propeller" like feeling inside arms, chest, growing larger, then dissipating;  split second loss of feeling in lower half of body as if it didn't exist;  unbalanced; dizzy, losing balance while simply standing still; increased tinnitus
pt had a seizure today. was found to be febrile 103.9 but no obvious source of fever.
Severe pain in left arm to the point she could not move her arm more than a couple inches. The site of injection is red with swollen from about inched from the shoulder to about 8 inches below the injection site and very bright red and warm. the area is itchy. Temperature of 102.2.
I had a very sore throat, lots of congestion, cough and overall fatigue. I did not feel well for the first 5 or 6 days, very under the weather. The first 2-3 days were the worst. My doctor prescribed Paxlovid because of my asthma. I have a lingering cough today.
Edema, redness, warmth and welts at side of varicella vacc immediately after vacc.
Red spot at site of injection. Approximately two inches in diameter. Present day of injection and continues to be present 3 days later. The red spot is hard and also itchy.
ED 11/21/2022 with altered mental status and fever - recently seen for infection in his spinal cord, tx with IV antibiotics line for prolonged period of time, remains on oral antibiotics -Patient did receive Decadron given his oxygen requirement in the setting of being COVID-positive. Admit diagnoses: Sepsis - fever, tachycardia; resolved; Covid positive; Weakness, malaise; Hypoxia; Fever and tachycardia on admission, resolved with sepsis fluid bolus and acetaminophen. Suspect fever and tachycardia are due to COVID-19 infection (positive PCR today). Hospitalized again 12/8/2022 with chills/nausea. Submitter does not have access to full medical record. If additional information is needed, please contact hospital noted above.
complete hair loss on the body and scalp which includes facial hair, scalp hair, pubic hair, eye lashes and eye brows.; This spontaneous report was received from a medical assistant concerning a male patient currently 12 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U028825, expiration date: 02-NOV-2023, administered as prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient developed complete hair loss on the body and scalp which includes facial hair, scalp hair, pubic hair, eye lashes and eye brows (Alopecia). At the time of reporting, the patient had not recovered from the event of alopecia. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as discontinued.   The causal relationship between the event of alopecia and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
stiff neck; This case was reported by a consumer via interactive digital media and described the occurrence of stiff neck in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stiff neck. On an unknown date, the outcome of the stiff neck was unknown.   It was unknown if the reporter considered the stiff neck to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient asked that was stiff neck a side effect. Additional supportive information: The follow-up would not possible, as no contact details were available.
About 14 hours post-injection, I began to have onset of mild chills and mild ?yucky? feeling that you get when you are ill. This lasted about 24 hours, and then completely disappeared. No fever. I took ibuprofen 400mg which helped initially, but repeat dosing of this did not assist as well that evening.
Discharge Provider: MD  Primary Care Provider :MD    Admission Date: 2/2/2023 Discharge Date: 2/6/2023   HOSPITAL COURSE:   She presented with fatigue, cough, shortness of breath.  Who has 2 to COVID pneumonia and acute exacerbation of chronic obstructive pulmonary disease.  She was treated with dexamethasone, remdesivir, nebulizers.  Debilitating cough is the main issue for her.   She also has hypothyroidism, hypertension, hyperlipidemia, coronary artery disease, CKD 3B, GERD, anxiety.   She was discharged with 2 liters/minute of oxygen.
Describes pain in the arm for 2 month. pt states pharmacist may have given it in the wrong place and Pysical Therapist says may have hit a tendon. Patient has been seeing PT and getting steroid injections that seem to bring the pain from 8-9/10 to 6/10. If not better will get MRI to see what is going on
Pt recvd 1st dose of Recomb & 2 wks prior to receiving 2nd dose of vax pt recvd 13 blood components via blood transfusion; following 2nd dose lab eval revealed pos anti-HBc titer & weakly post HBsAg titer; poss due to blood transfusion;
Per ER record- 2 month old male presented to ER per EMS in cardiopulmonary arrest at 0837 on 10/10/2020, According to ER report from Medical Center, EMS reported call came in approx 30 min prior to arrival  after mother awoke on the couch where she was sleeping with her older daughter and the patient. The patient was found apneic and without spontaneous pulse. He was unresponsive and cyanotic. Last known well time was reported around 0200 after breastfeeding. On arrival to ER pt is described as cyanotic, cold and rigid, no palpable pulse, no heart rate, no pulse, no respirations. Pulse oximetry is 0. Pupils were documented as fixed and dilated. There is a notation regarding "dried blood noted to both nostrils and dried blood surrounding his mouth" reported by EMS. Patient was pronounced deceased at 0842. Clinical impression documented-primary impression cardiopulmonary arrest in newborn, asphyxia in infant
1st. shot I felt Light headache starting same day about 4pm and same symptoms for about 4 days. 2nd dose, light pain on dose location on arm, slight headaches few days later.  About 4 Days later started feeling  nauseous for almost each day of and on.  Not normal for me, Still feeling nausea  today, not severe but bothersome.
Pt w/ h/o receiving flu shot w/o incident, latex allergy and no other known issues. Use latex free form vaccine. Upon receiving vaccine, pt experienced fainting and stomach indigestion. EMS called and took to ER. Mom explained after shot pt experience seizure once before after allergy shot.
It started with left arm pain and throughout the evening arm pain increased and I have been unable to move my arm.  Also, experience a burning feeling in the injection site but when touching didn't feel warm.  Had sweats and extreme cold feels along with mild fever, 89.6.  Body aches, lethargy, headache, and mild dizziness.  Currently taking Advil to help with symptoms and noticed mild improvements however still experiencing symptoms.
Pt with 7 cm x 5 cm erythematous, edematous nodule at injection site that starting the morning after the injection.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates in 2017 (reported as beginning sometime in January 2017), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M037248, expiration date: 21-FEB-2019) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  93.04 degrees Fahrenheit for 8 hours and 42 minutes on 24-JAN-2017. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012514: US-009507513-1703USA012512: US-009507513-1703USA011060:
I had the first dose of the vaccine on 8/25/2021. This was also the first day of my last period. Sometime shortly after I became pregnant. After conceiving or right around conception I received the 2nd dose. I received a positive pregnancy test about two weeks after the second dose and to my knowledge remained pregnant until it was discovered at my 9-week sonogram that I had an empty embryonic sac. I continued on to have a missed miscarriage. I am unsure when exactly the embryo stopped growing and became no viable. I will now continue on to have to have a D&C. I have two healthy children who were conceived on the first try naturally without complications. This was my first miscarriage ever and I completely believe it was due to the vaccine.
Patient said made her arm swell and red. Hospitalized for 9 days. Waited here for 15 min after shot. Must've been a delayed rxn.
I received the vaccine on my left side vaccine was given in my left arm the rash is on my left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 (Lot number: fc3182) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 29Aug2021, outcome "unknown", described as "I received the vaccine on my left side vaccine was given in my left arm the rash is on my left side".  Additional information: Reported Event: Patient got the covid Pfizer shot on Thursday patient had a rash on the same side that patient received the vaccine on her left side vaccine was given in her left arm the rash is on her left side. Date of start of reaction/event: 29Aug2021. In follow-up spontaneous report received from a contactable consumer (patient) reported for herself that: She got the covid Pfizer shot on Thursday on Monday patient had a rash on her left side... she had a rash on the same side that she received the vaccine on her left side vaccine was given in her left arm the rash was on her left side.  No follow up attempts are possible. No further information is expected.
Red circle one inch in diameter around site of injection along with soreness and itchiness developed one week after receiving the first vaccine. At the same time, soreness of the lymph node in the armpit of the vaccine injection site is sore
Extreme fatigue, lasted about a day and a half.  Arm sore, could barely raise it.  Nauseous for the day with periods of cold chills.
large red patch on left arm below injection site swelling of arm fever shivering all day chronic tiredness I had to stay home from work on 10/01/2019 due to adverse reaction to the Shingles vaccine.
2-3 hours after vaccines were given she broke out in a rash. She also had a fever and very fussy. She came in the office today for her rash that has spread all over her body. Treat with TYLENOL and watch closely.
tired; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: she also takes cholesterol meds but pretty healthy otherwise.; "High blood pressure" (unspecified if ongoing), notes: she has high blood pressure that she takes meds for. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary series completed with unknown manufacturer), for Covid-19 immunization; Flu vaccine (Caller also states she already got a flu shot without egg and had no problem with it.), for Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; CHILLS (non-serious), outcome "unknown".  Additional information: The caller stated that after her booster last year in Nov she was tired and little bit of chills, therefore she enquired if it will be alright to receive the bivalent booster Pfizer BioNTech covid 19 vaccine. Caller also stated she already got a flu shot without egg and had no problem with it. Caller reported that she had high blood pressure that she takes meds for, she also takes cholesterol meds but pretty healthy otherwise.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feel like crying; chills; fever of 100.6°F; Fatigue; Body ache; Arm was sore where they gave me the shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel like crying), CHILLS (chills), PYREXIA (fever of 100.6°F), FATIGUE (Fatigue) and MYALGIA (Body ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Melanoma. Concurrent medical conditions included Trigeminal neuralgia, Anemia, Disability and Palpitations.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 01-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 100.6°F), FATIGUE (Fatigue), MYALGIA (Body ache) and VACCINATION SITE PAIN (Arm was sore where they gave me the shot). On an unknown date, the patient experienced FEELING ABNORMAL (Feel like crying). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) at a dose of 1 dosage form every four hours. At the time of the report, FEELING ABNORMAL (Feel like crying), CHILLS (chills), PYREXIA (fever of 100.6°F), FATIGUE (Fatigue), MYALGIA (Body ache) and VACCINATION SITE PAIN (Arm was sore where they gave me the shot) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Event outcome updated to resolved.
23 days after the second does the the Pfizer\BioNTech vaccine, I experienced a nocturnal seizure. I was 21 weeks and four days pregnant with my first child (estimated delivery date of August 12, 2021). I was diagnosed with high blood pressure and prescribed labetalol at 100 mg twice a day 4 days before the adverse event. It was my first time being put on blood pressure medication. During the seizure, I fell out of bed hitting my head, face, shoulder, hip and ankle on the right side of my body. 911 was called and I was brought to the  ER and eventually transferred to  Hospital on the labor and delivery floor.  They ran a series of labs and tests which resulted in a three day stay. They determined that I have gestational diabetes and epilepsy which they believe had been dormant until the seizure.
On 5/9/03 child received MMR left arm and Varivax and Hep B right arm. He developed rash/pupular on neck and axilla on 5/11/03. On 5/29/03 came with fever 104.2 CBC and UA, blood culture negative. On 6/1/03 he had repeated seizures, seen in ER. Head MRI normal, spinal tap was normal.