chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP is not sure patients have been administered from expired vaccines/ only few patients were involved/6 patients received expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is not sure patients have been administered from expired vaccines/ only few patients were invnolved/6 patients received expired doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP is not sure patients have been administered from expired vaccines/ only few patients were invnolved/6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is not sure patients have been administered from expired vaccines/ only few patients were invnolved/6 patients received expired doses) 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.   Reportedly, other vaccine history was unknown.  No concomitant medications were reported.  On 04-Nov-2021 and 01-Dec-2021, the vial as initially stored in the refrigerator. The vial had not undergone any temperature excursions. The vial thawed on the same day of administration of vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-497407, MOD-2022-497396 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow-up information contains individual Patient demographics and suspect vaccine dosage details(Significant box not checked as regulatory clock is getting updated as per FRD)
Admitted 10/30/2022 with chief complaint SOB. Onset of symptoms was gradual starting several days ago with been gradually worsening course since that time. Reports SOB at rest and exertion, associated productive cough, weakness.  Active Problems: Essential hypertension, benign Centrilobular emphysema (CMS/HCC) Diastolic CHF (CMS/HCC) COPD, moderate (CMS/HCC) Adenocarcinoma of left lung (CMS/HCC) Other hyperlipidemia  Acute hypoxic respiratory failure, Acute on chronic diastolic heart failure,  COVID-19 infection pneumonia, Acute systolic heart failure, Hypoxia is multifactorial, DDX, radiation pneumonitis, HF, COVID or a combination of these.  Pulmonology consulted. Patient clearly expressed that he does not want to be intubated. Inpatient hospice. Continue Lasix 40 mg IV b.i.d. and spironolactone. Continue atorvastatin, Coreg. Continue PPI Dexamethasone 6 mg iv daily  11/6/2022: Cause of death: Acute hypoxemic respiratory failure due to COVID-19 infection and acute combined congestive heart failure. Confounding factors include left lung adenocarcinoma, valvular heart disease and acute kidney injury.
Next day rash down arm to elbow burning itchy blisters lasted 1 month.
Pt developed nausea, and dizziness shortly after injection. She was noted to be pale and diaphoretic. She denied any other symptoms. Initial BP 60/40, HR 65, SP02: 99%. Pt improved over the course of 20-30 minutes. Repeat BP 100/80. No signs/symptoms to suggest anaphylaxis.  Her symptoms completely resolved and she elected to drive home.
Patient stated she had no symptoms until the next morning when she awoke to soreness at right deltoid. Patient stated she looked at her arm and saw approximately a 6 inch in diameter firm nodule that was hot and red at the vaccination site. Today the nodule is approximately 3 inches in diameter and firm.
covid-19; covid-19; symptoms returned (cough, fatigue, congestion). Tested positive again for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (manufacturer unspecified), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 06Aug2022, outcome "unknown", described as "symptoms returned (cough, fatigue, congestion). Tested positive again for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Tested positive again for COVID-19. The patient received PAXLOVID from 26Jul2022 to 30Jul2022 for treatment of COVID-19. Symptoms of COVID-19 had initially improved for approximately one week after taking PAXLOVID. On Day 8 (06Aug2022), symptoms returned (cough, fatigue, congestion) and the patient tested positive again for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash on her forehead, bumps on her forehead looks like shingles. Her eyes turn red, left eye, nose is red, eyebrow lining is red.
Patient had vasovagal reaction starting about 2 minutes after vaccination and took about 15 minutes to resolve. Symptoms included tunnel vision, nausea, sweating, shakiness, ringing in the ear. I had patient wait an additional 15 minutes in the pharmacy once he felt better. Checked blood pressure about 20 minutes after vaccination and reading was 122/83 with pulse 65. Patient felt better after the additional 15 minutes and felt like he was ready to leave. Checked in on patient again via phone around 1:30 pm and he was feeling fine.
Muscle aches and inability to move the arm for two days along with redness and swelling. Short course prednisone.  Tylenol prn - states allergy to Ibuprofen Ice
Developed an itchy patch on my left upper thigh.  The next morning I had another patch of the same itchy bumps on my right side of my waist.  That night I had another batch on my right underarm.  More spots show up everyday.
On 11/8/2021, I went to get my Pfizer COVID-19 booster at my PCP's office. At first, I had just swelling and pain at the injection site, but that's nothing unusual for me. I then rapidly developed a fever of 102-103. I then had severe swelling in both armpits, and this didn't go away until about a week later or longer. I took Tylenol every four hours to treat the fever, but the fever always returned. I also quickly developed severe pain in all of my joints. I woke up in the early hours of 11/9/2021. I had a high fever, severe diarrhea, a headache, and ceaseless vomiting. I then went to the ER, because I had become dehydrated, and the Tylenol wouldn't bring the fever down. At the ER, I was given Zofran, which stopped the vomiting. I was given several IV bags to treat the dehydration. I think they also gave me Tylenol. I was eventually discharged and sent home. They prescribed me Zofran to take at home. The fever ended up lasting for about a week before it finally resolved.
On 11/27/11, patient came into the pharmacy stating she had arm discomfort, mobility impaired. She went to her MD 8-10 days after vaccination. MD thought it was from injection near a nerve. He referred her to a neurologist for further consultation and testing.
Sore arm at injection site; body aches/pain; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in right Arm on 06Mar2021 at 16:30 (at the age of 53 years old) as 1STDOSE, SINGLE for covid-19 immunisation. Medical history included high blood pressure, diabetes and covid. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient did not receive any other vaccines within four weeks of the vaccination. Concomitant medications included metformin (METFORMIN, bisoprolol (BISOPROLOL), citalopram (CITALOPRAM), lisinopril (LISINOPRIL) and prilocaine hydrochloride (PRILOC) taken for an unspecified indication, start and stop date were not reported taken as other medications in two weeks. On 07Mar2021, the patient experienced sore arm at injection site, body aches and pain. The patient not received treatment for events. Post vaccination, the patient not been tested for covid. Outcome of the events was Unknown.  No follow-up attempts are possible. No further information is expected.
This infant had swelling of the face consistent with allergic reaction approximately 16 hours after receiving her vaccine. She was given Benadryl.
muscular aches and pains, chest discomfort, headache, neck tightness, joint swelling, fatigue, dizziness, periods of sweating
On Monday, I woke up feeling weak, with chills and a cough. I thought I had a cold and took regular medicine that didn't help. On Wednesday I went to the hospital and was diagnosed with COVID. They sent me home but I got worse and returned to the hospital on July 17th. I was admitted and treated for COVID. I could hardly breathe and I was discharged on July 27th. I was given oxygen tanks to take home. I had trouble breathing, I lost my sense of smell and taste, and I had coughing fits. I would be exhausted if I did too much activity. I still have fatigue and coughing fits.
Patient reported that after dose 1 she was observed due to stated allergies.  Approximately 10 minutes into this observation she reported tingling around her lips that resolved within approximately 20 minutes.  She does not feel she was anxious and hyperventilating when this occurred.  She was released and went back to work.  Within approximately 30 minutes of being back to work her coworker commented that she had hives on her forehead.  These were described as two blotchy areas and were slightly pruritic.  They resolved without treatment within approximately one hour.
Received Expired Dose of Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment drugs were reported
Moderna covid-19 vaccineEAU Headache, severe body aches and spine joint pain, severe fatigue for 3 days.
This spontaneous report as received from a pharmacist via company employee refers to a patient of unknown gender and unknown age. It was reported that on an unspecified day in February 2014, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, dose number, lot/batch number were not reported). On an unknown date, approximately in 2014 (couple of week ago), the patient was diagnosed with shingles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Lymphadenopathy- swollen, painful right armpit; Lymphadenopathy- swollen, painful right armpit; level of pain at injection site; Body aches; fever; chills; This is a spontaneous report from a non-contactable consumer.  This 36-year-old female consumer (patient) reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247),  into the right arm on 12Feb2021 at 12:00PM (at the age of 36-years-old) at single dose for COVID-19 immunization. the patient had received first dose of vaccine on 22Jan2021 12:00 PM in right arm. Medical history was none, no known allergies. Other medications included Escitalopram. On 13Feb2021 the patient experienced  level of pain at injection site, body aches, fever, chills, Lymphadenopathy- swollen, painful right armpit. The outcome of the events was recovering  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Classical Bell's Palsy symptoms, right side of the face. Treatment began with valtrex and prednisone on 03/23/2021. No decrease (or increase) in symptoms so far.
Two ,two weeks of topical steroids rogaine , daily , vitamins for hair, special shampoo.  Hair stopped traveling after steroids.  Baldness crown forehead, and sides.
Sore throat and fatigue noticed on September 18.  Since I work in hospitals and facilities, I was screened by employee health staff and I took a PCR COVID test at my doctor's office.  I discussed contagion and the appropriate protocol for returning to work with staff at my doctor's office.
Injection site became very hot to the touch.  Large palpable knot is present at site as well.  Sore to touch.
2nd dose 6 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after first dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and COPD.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after first dose) outcome was unknown.            No concomitant medications were reported.  Patient received booster dose in August 2021, after he received it, he said he did not think he should had gotten it. He said he thought he got the immunocompromised 3rd dose, but he was not sure which one it was.  No treatment medications were reported.
On 12/1/21 --Significant swelling of patient's lips began approximately 16 hours after vaccine administered. Progressed over next 90 minutes, at which time he went to school nurse. Lips were 3 times normal size, apparently from swelling of mucus membranes. No other food, chemical, or environmental exposures experienced. Given diphenhydramine 12.5 mg at 11 am.  Did not seem to progress in the 1-2 hours after that. No tongue or throat swelling or trouble breathing. No urticaria.
15-year-old patient received their first dose of the COVID-19 vaccination. Was in Post Vac 20 mins and then he stated he was feeling "weird". Nurse brought patient over to stretcher to lie down. Patient denied any symptoms of allergic reaction. No signs of allergic reaction noted. Took vitals and they were all within normal limits and a neuro check that was within normal limits as well. Patient was given juice and water. Captain notified of patient condition. He stated he was feeling better within 15 mins of lying down. Nurse raised the head of the stretcher and he began to feel "weak and shaky." Nurse lowered the head of the stretcher and continued to monitor him. Vital signs and neuro check all remained within normal limits. He felt better again lying flat, but when the head of the stretcher was lifted again, he began to feel "weak and shaky". Nurse alerted the captain and mom wanted to be taken to the hospital. 911 was called for transport to facility. Mom and sister drove to the hospital and patient was taken to facility ER via ambulance in no acute distress.
Severe shingles rash along T8 on left abdomen with minor rash on adjacent dermatomes. Itching, pain, and blistering. Ibuprofen for pain and topical calamine lotion.
positive COVID test on 8/14/21; presented to ED from infusion center where she's been receiving antibody infusions since 8/18/21; presented with increasing fever, chills, cough, SOB, and diarrhea; hx of diabetes mellitus type 2; acute hypoxemic respiratory failure due to COVID
This case was reported by a nurse via a company representative and described the occurrence of abnormal liver test (NOS) in a female pt who received Engerix-B and Havrix. The pt received Engerix-B and Havrix on unknown dates. At an unknown time after  receiving both vaccines, diagnostic tests revealed abnormal liver test (NOS). The pt was evaluated by a health care provider. The event was unresolved at the time of reporting.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) which was diluted with MENACTRA (dose, lot # and expiry date were not specified) in the same syringe. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Pt had second vaccine on January 13.  Was diagnosed with COVID on 02/10/2021
Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. In approximately June 2016 (reported  as "27-JUN-2016 or 28-JUN-2016"), the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M004116, expiration date 12-OCT-2017, dosing details and route were not provided). The vaccines were exposed under 28 Fahrenheit degree (F) for 3 hours and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality issue was involved. Follow up information has been received from the licensed practical nurse and a office manager on 01-SEP-2016 referring to a female patient of unknown age. The patient received a revaccination with GARDASIL 9 on 28-JUN-2016. It was unknown which shot in the series these revaccinations was. This is one of several reports received from the same reporter. Additional information has been requested. General, patient and narrative are updated.
Severe muscle pain started at 4:00 a.m. on Saturday, 02/06/2021 and continued through Sunday, 02/07/2021.  No fever, just pain throughout entire body.  Eased considerably by morning of Monday, 02/08/2021.  No medical help sought; simply slept a lot through it.
Red rash on torso; Jittery; Cold then hot; Sore; Worst flu she's ever had; Nausea worse than nausea from chemo; Headache so bad thought head was going to explode; Felt like she had been hit by a mac truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by a mac truck), INFLUENZA (Worst flu she's ever had), FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot) and PAIN (Sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by a mac truck). On 20-Apr-2021, the patient experienced INFLUENZA (Worst flu she's ever had), NAUSEA (Nausea worse than nausea from chemo) and HEADACHE (Headache so bad thought head was going to explode). On 21-Apr-2021, the patient experienced FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot) and PAIN (Sore). On 22-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on torso). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by a mac truck), INFLUENZA (Worst flu she's ever had), FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot), PAIN (Sore), RASH ERYTHEMATOUS (Red rash on torso), NAUSEA (Nausea worse than nausea from chemo) and HEADACHE (Headache so bad thought head was going to explode) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
Approx 7 to 10 days after shot - felt very "weird" malaise - headache - nausea - weak - tired - runny nose - slight cough - terrible digestive issues - abdominal pain - nausea continuous without vomit or diarrhea - no appetite last 1 month.
We had patients who were administered the vaccine that underwent temperature excursion; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (We had patients who were administered the vaccine that underwent temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (We had patients who were administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported.  The information about allergies, acute illnesses, chronic or long standing health conditions, information about other medications (prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was initially stored in refrigerator on 03-Nov-2021 and moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.   No treatment medicines were reported.
Pt developed high fever and had generalized tonic-clonic convulsions witnessed by a nurse in ER on 10/30/2001.