chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24) 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.    In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I have a nurse that administered a moderna dose today but the 30 day expiration date was on 8/24) had resolved.            Concomitant medication was not provided treatment information was not provided   Reporter did not allow further contact
Patient left clinic with mom and when arrived at a fast food restaurant and he was itching all over and had developed hives. He then presented to the ED, where he received epinephrine and dex for anaphylaxis, and now is being watched for 4-6 hours.
Shaking, fever 100.5,  anxiety,  nausea, vomiting, diarrhea, body aches, skin pain, myalgia,  joint aches, insomnia, anorexia
On  Thursday 01-21-2021, I started to have chills and headaches. On Saturday 01-23-2021, I had a dry cough which was uncontrollable. I also had SOB and my cough persisted. I went to see my PCP and he prescribed Prednisone and an inhaler which  helped my symptoms.  I say, I got better within a week from my chills and headaches although my cough lasted over a month.
My father died on Oct 4, 2021 24 hours after testing positive for covid, despite being vaccinated twice in March and then April 2021. He came into contact with another individual a 4 days prior who also was fully vaccinated, but then became ill and tested positive for Covid.
Shortly after receiving vaccines Lot UH746AC Sanofi Pasteur flu vaccine (exp 6/20/13) in left deltoid about flu vaccine below left lateral shoulder felt a numbness pain level #3 to #1 in intensity as of 2pm 10/1/12 F.U. 10/2/12 yesterday eve tingling went away but when she raised lft arm, area surrounding injection site is sore.
5/8/2021:  large raised rash 5/29/2021 to present:   dizziness, sensation of moving while sitting still, lightheaded
Patient received the second dose of zoster recombinant vaccination series on 8/24/21 and developed hives. Patient returned to the ER two days later due to the hives and itching. Patient was given methylprednisolone  dose pack and diphenhydramine to help with the itching and hives.
Information has been received from an office manager concerning her daughter with no pertinent medical history and no known allergies who on April 2009, was vaccinated with the second dose of GARDASIL. There was no concomitant medication. In April 2009, two days after administration of the second dose of GARDASIL, the patient experienced migraines, syncope and aches. It was reported that the patient's symptoms "come and goes and go with different durations". On an unspecified date a computerized tomography was performed; results were not reported. The patient's mother stated that her daughter had to miss one month of school. At the time of reporting the patient had not recovered. The reporting office manager considered that migraines, syncope and aches were disabling. Additional information has been requested.  11/16/09:  Neurology consult received for date of service 5/8/09.  Dx: HA's and  Migraine HA's Assessment:  Initially she sees spots that resolve, then she becomes dizzy, followed by HA pain.  Pain starts in R frontal region, with eye pain then becomes diffuse throughout her head.  She experiences nausea, photophobia, feet and ankles become tingly with diffuse weakness and fatigue.  All sx. resolve once the HA resolves. HA's occur monthly.  Hx. of migraines for one year lasting hours to days. Migranes intensified after a concussion with a brief loss of consciousness 1 yr. ago.  Tension HA's occur up to a couple of times per wk.  Most recent migraine lasted for a few weeks. Taking Frova, Amitryptyline and Compazine prn.   11/24/09 ER records received for date 4/14/09, 4/24/09, 4/28/09, 4/29/09. DX: migraine. Chief c/o migraine HA, nausea, x2 wks. Assessment:WNL, pt tx, and dc w/ sx resolved.ER visit on 4/29/09 DX: migraine HA. Pt c/o ongoing HA/migraine x3wks. HA moves to different locations of head. Pt states sharp pain/pressure, nausea, light/sound sensitive. Pt. states have blacked out a couple of times.
pt recv vax 21AUG96 & 19DEC98 pt to MD w/upper resp infect; tx w/med to be taken 3 times a day for 10 days; 29DEC97 pt presented to clinic w/rash; pt mom told that it was chickenpox; rash never blistered or devel scabs; did not have chickenpox
I experienced a breakthrough case of COVID-19 with nasal congestion, chills, coughing, mild fever and body aches.
Patient was admitted on 2/6/2022 with chief complaint of chest pain. The patient had an ablation in late December 2021 and presented to the ED in early January for worsening palpitations. He was cardioverted in the ED and discharged home, but states that his symptoms have worsened again since being diagnosed with COVID-19 on 02/04/22. He reports respiratory symptoms and diarrhea with his COVID infection. Early in the morning 02/06/22 he states that he developed chest pain and diaphoresis while sitting in a chair, similar to his prior episodes of afib. Manual pulse check was 170. He took Tylenol and attempted breath holding, which did not improve his symptoms. He called EMS and was transported to the ED for further evaluation.  On arrival in the ED the patient was afebrile 97.8F, 115/73, respiratory rate 18 and saturating 100% on room air. He was found to be in afib with RVR. The ED physician discussed therapeutic options with the patient including electrical cardioversion vs medical management, and the patient elected to have electrical cardioversion. He was cardioverted with synchronization at 300J of biphasic energy, which converted the patient to a regular rate afib. During the procedure the patient was sedated and experienced mild respiratory depression requiring jaw thrust support. Repeat EKG demonstrated atrial fibrillation with a normal rate. On Labs patient had a mildly elevated 2.1 (baseline 1.9), troponin, CK, and CKMB were within normal limits. Magnesium 1.6, which was replaced. CBC was within normal limits, and INR was 2.5. Chest x ray showed mild interstitial vascular congestion with interstitial infiltrates that had developed since the prior exam.    Patient was admitted for AFib with RVR. Due to patient's recent positive BK virus PCR and elevated quantitative level of 154 on 1/17/22 a repeat quantitative level was ordered.  Ultimately patient's heart rate was able to be managed on 120 mg b.i.d. Of sotalol.  Patient did have elevated creatinine at the beginning of hospitalization.  This improved with fluids.
Pt stated a history of fainting with vaccinations. Had her lie down for vaccination, and stay supine for 10 minutes after vaccination. She then stated she was "ok", sat up, "I'm OK", stood up, "I'm OK", and walked out. Came back to the nurse's office within 2 minutes saying she wasn't feeling well. As the school nurse was leading her to a exam room, she fainted. Then she had a seizure lasting approx 30 seconds. Lost control of her bladder. She regained consciencousness but was weak. Stayed in nurse's office for half hour more, then was escorted to her dorm room.
Per patient email on April 14, 2021: "I experienced pretty serious abdominal pain that I felt in my reproductive area as well. I did have muscle pain in my hips and legs. But I did not really have a headache besides just fogginess. I received my vaccine at 9:00am and they started around 6:00pm. I left work early and went home where I slept and woke up the next day feeling back to normal."
Pt reports to nurse that her arm has been sore.  When asked what might be causing it, pt stated that she had gotten her pneumonia shot there on the previous day.  Rt. shoulder is very swollen, hot, red and tender, with complaints of pain with any movement.
Information has been received from a 73-year-old female consumer with hypertension, sulfonamide, codeine and morphine allergies and a history of breast cancer who on 02-APR-2007 was vaccinated with a first dose series of 0.65ml of zoster vaccine live (Oka/Merck). Concomitant therapy included "several medications that the patient could not name at the time of the call." Subsequently, 10 days after vaccination on 12-APR-2007 the patient developed a rash over her entire body. Medical attention was not sought. There were no lab studies performed. It was reported that the patient had not contacted her physician thus far. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Follow-u8p information was received from a physician, concerning a 72 year old retired female with many medications allergies who on 02-Apr-2008 was vaccinated with the first dose 0.5 ml of ZOSTER (Merck) in the left deltoid. The onset date of the rash in 12-Apr-2008 on approximatel 25-Apr-2008, the patient recovered. Additional information is not expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), NDC number, lot number, expiration date: Unknown has vaccination card somewhere but not at the time of the call), administration date: Feb2022, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "Moderate breathing issues"; MYALGIA (non-serious) with onset 2022, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "Significant fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "Temperature was 102 degrees Fahrenheit.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient Had the 2nd booster shot about 3.5 weeks ago. Had a total of 4 doses of the Pfizer COVID-19 vaccine. The 1st dose caller received was in Mar2021, then got the 2nd dose caller thought 6 months later, then had the 1st booster, then had the 2nd booster 3.5 weeks ago. Problem was patient had no reactions to any of the 3 other doses of the vaccine, but with the 2nd booster had an adverse reaction. Patient had a temperature, chills, muscle aches, significant fatigue, and moderate breathing issues which have not gone away and have been going on for 3.5 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 12-month-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 2D24J, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The nurse administered FLULAVAL QUADRIVALENT to a patient in the thigh. The reported batch number 2024J was corrected to 2D24J as per sales data review. When she withdrew the syringe after vaccination the needle detached from the syringe and fell to the floor. When she went to reattach the needle to the syringe the tip lock part of the prefilled syringe broke off. The reporter also reported that, the patient experienced pain with the vaccination. Clarification has been raised to confirm if this case was associated with pharmaceutical product complaint.
Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that continued with any exertion. It continued for several days. I called PCP and was seen. Chest Xray & bloodwork was done. Was called to go to E.R. for CT scan of lungs. Pulmonary Embolisims were seen and a blood thinner was given. Heart monitored for previous Afib (ablation performed 5 yrs ago). CT scan w/dye was done of abdomen, Right leg ultrasound with compare L, MRI w/contrast done of abdomen/pelvis. No reason has been found for cause of several blood clots in both lungs - sub arteries. Am being followed up by Vascular Doctors in 2 weeks.
No reaction, signs or symptoms, pt white blood cell count dropped to a dangerously low level.
Sinus sickness 8/13. Tested 8/16  Results 8/18  Hospitalized 8/19  ICU 8/21  Intubated 8/22.   Tracheotomy 9/10. Physical therapy rehab facilty 9/22 - 10/1 outpatient physical therapy through December 2021
I had my vaccination on 10/14/2022. On 03/26/2023 I had hoarse voice but not painful. On 03/27/2023 I had a sore throat headache flu like symptoms fever chills. I tested COVID-19 Positive on 03/27/2023. I called my physician on 03/28/2023 and asked if I turned down the Paxlovid prescription. I still have fatigue with continuous cough on 04/17/2023.
Scratchy throat on July 12, 2022.  Tested positive for COVID on July 13, 2022. Communicated with health care provider on July 14 regarding general care and treatment options. OTC medications and Pavlovid. I opted to continue to treat with rest, fluids and isolation. Took one dose of Mucinex 12 hr. Symptoms were mild to moderate and include decent cough, low grade fever (highest about 100F) days 2-4, nasal congestion, slight headache (sinus congestion). Symptoms are greatly reduced by day 7 but have not completely resolved.
I was having low blood pressure, which I have never had before. I had 2 instances that this happened, but on one of them, I passed out. When I had the check-in, it asked me if I have had any health issues lately and that is when I thought that this could be linked and decided to report it. I went to the emergency room, and they gave me some fluids, thinking that I was dehydrated. They really didn't do too much.  No medications were prescribed.
This spontaneous report as received from a registered nurse refers to a 5 year old patient. Illness at the time of vaccination was none. On 29-APR-2013, the patient was vaccinated with a second dose of VARIVAX (H018457, expiry date was 05-OCT-2007, dose were not reported) subcutaneous in the right leg. On 30-APR-2013, the patient had a localized reaction of quarter sized red raised area to right lateral leg. The outcome of the reported event was unknown. Additional information has been requested.
Severe dizziness that presented at 8am on 4/26/21 with sharp intermittent vertigo (like starting to pass out) that subsided quickly approximately 5 times over a 20 minute period.  This graduated to constant dizziness and cloudiness and severe shaking while outdoors.   Arrived at ER at about 10am  and "room spinning" vertigo began shortly after and at about 11am there was about 5 episodes of severe vomiting over about a 2 hour period.  Dizziness did not decrease until enough medication was administered to stop the vomiting and allow a dose of Meclizine 25mg PO to be administered and take effect and decrease the dizziness to barely manageable.  Left the hospital in this state at about 6PM.  Today is 4 days later and dizziness continues as manageable only with Meclizine 25mg every 8 hours.
Sudden Fever then 3 minute Seizure  Called 911 drove to Fire Dept.  Rode in Ambulance to Emergengy Room. Gave Tylenol and Motrin to bring down fever.
A report was received from a health care professional on 12/15/03 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on the same day. On 12/15/03 the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Low grade temp of 99.1 and two back-to-back seizures. This occurred 10 days after getting MMR.
weakness ache all over headache fatigue sore arm pain at injection site  mild sore throat
SEVERE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ10802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache. This report was non-serious.
headache, body aches, tiredness, fever, hypothermia, severe chills, hot flashes
Received notification that patient was admitted to the hospital for weakness, fatigue, and chills.  Positive COVID 19 test result at the Hospital.  Reported that patient was admitted for 1 day d/t dehydration and has been discharged home.
Patient fainted after inj of GARDASIL. Patient became pale, diaphoretic within seconds after admin. Regained consciousness within 60 seconds. No injury. 911 called. No treatment needed.
Injection site reaction - swelling, redness and itching (currently 3 days post vaccine) alternating using cortizone cream and benadryl cream on the site
Patient received the orange cap/pediatric formulation 0.2mL instead of the age appropriate purple top 0.3 mL dose.  I called Pfzier and medical rep cited a CDC recommendation that patient should receive the 0.3 mL purple top dose 21 days from first injection.  No additional doses needed.
Bells Palsy developed 7/18/21.  Patient prescribed prednisone 60mg for one week
Cataracts stage 4 / 2 years ago my cataracts were very mild; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: CONDITION AGGRAVATED (non-serious) with onset Jan2021, outcome "not recovered", described as "Cataracts stage 4 / 2 years ago my cataracts were very mild". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: Follow-up (13Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pain all over; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain all over) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain all over). At the time of the report, PAIN (Pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported "FELT LIKE RINVOQ WAS NOT WORKING." Treatment of events was not reported.
I got the "high dose" inactivated vaccine. Day later started low fever; didn't measure. Next day (Wed) fever went up to 102 in early evening.  Took Ibuprofen; went down overnight. This afternoon (Thursday) back up to 101.
Prolonged amount of soreness of the left shoulder - 9 days. The shot was high in or near shoulder joint and tendons.
MMRV was given on 12/6/2021. On 12/8/2021 upon review, it was noted that the patient was 19 yrs old which is out of the age range for the labeled use of MMRV vaccine (Labeled use is 12 months - 12 years of age).  Spoke with patient, no side effects or adverse reactions from vaccine.  Spoke with the NC Immunization Branch who says the dose will not need to be repeated, may continue with the next doses of single antigens (MMR, Varicella) in 1 month.  Incident report filled out for medication administration error, and staff has been educated on appropriate use of vaccines.
My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER  due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .
No adverse event occurred.  Patient received incorrect vaccine.  Patient should have received  COVID-19, mRNA, LNP-S, PF, 3 mcg/0.2 mL dose, tris-sucrose (Pfizer PEDS 6m-4y (maroon). And patient received COVID-19, mRNA, LNP-S, PF, 10 mcg/0.2 mL dose, tris-sucrose (Pfizer PEDS 5y-11y (orange).
Morning after I had 2nd shot I felt  woosy and passed out on kitchen floor. Called 911 and went to ER. They said I was 4th person  they?d seen who passed out
Uneventful night, woke this a.m. warm to touch, axillary temp 99.5F, totally nonverbal, pale, disoriented, too weak to get out of bed. (These symptoms were not present yesterday.)
Local swelling and redness from shoulder to elbow. Treated with Benadryl, resolved.
Slight swelling,red around injection site (about 4inches by 2 inches) and itchy one week after receiving vaccine.  Cortisone cream eased the itch.  Day 3 of reaction the itching is subsiding, still a little swelling and pink around area but not bothersome.
I had diarrhea, acid, reflux. abdominal pain, headache, and fever of 102. I tested positive for COVID-19. My doctor prescribed me PAXLOVID on the 12/22/2022. I was symptom free and then my symptoms came back again on the 29th. I had lower intestinal distress, headache, and fatigue. I tested positive for COVID-19 on the 30th. I started feeling better on the 01/03/2022 but I am still positive. I still have light respiratory distress.