chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; 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 PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 51-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 19-Nov-2021 at 4:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 4:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight.   This case was linked to MOD-2021-402935 (Patient Link).
Patient states she" was in bed 72 hours with Fever of 100:5, chills, shaking, extreme body aches headache and nausea. Her left arm literally felt broken and I could not move without severe pain for 3 days but today I can move a few inches. The same thing happened with my first shot."
Approx 5 min after receiving dose #1 of MENACTRA pt began C/O redness and feeling itchy around injection site. Pt was monitored in office by nurse. Bandaid removed. Redness/itching did not spread. Inhaler used when pt felt 'lump in throat'. BENADRYL given in office. Pt 'felt fine' and returned home w/mom after 30 + min of monitoring w/no change or worsening of symp.
After four days, in the morning, I got itchy, eyes, and throat and tongue. My eyes got swollen and red until the next morning.
On evening of vaccination, 11/22/06, client reports that she had so much pain in her Rt deltoid that she was unable to lie on Rt side. When awoke on 11/23/06 at 0400 hours, was unable to get out of bed due to body aches/stiffness and legs were numb. Could not get up w/o assistance; was helped to shower where she stood for a prolonged period in the hot water. Required assistance to dress and do any activity that required bending; unable to stand from a seated position without assistance.  Continues, 8 days later, to have pain in lower back that keeps her from bending over.
Shortness of breath when taking long walks Rapid heart rate even when not exercising and resting.
Vaccination in late a.m. 10/27/06. patient well. That evening, some myalgias, fever, fatigue, headache. Same symptoms worse next morning plus difficulty breathing, dizziness, injection site red, hot, swollen painful. Patient confined to bed x1 week due to symptoms.
Moderna COVID-19 Vaccine EUA arm swollen, red & firm a little below the injection site;  size of reaction = 5.5 X 6.7 cm.
Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness.  Chills and extreme fatigue lasted 4 hours.  Low grade fever lasted 12 hours.
Feeling warm; Strong flow of urine; Body aches; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), DYSURIA (Strong flow of urine), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced FEELING HOT (Feeling warm), DYSURIA (Strong flow of urine), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, FEELING HOT (Feeling warm), DYSURIA (Strong flow of urine) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Moderate swelling, redness, tenderness at injection site and distal to it. Newly diagnosed.
Injection site bruise(bleed a lot at injection ) Itchy, red, swollen(harden) right below the injection site
5/21/09 Fever 101.8, eating ok, not acting sick, no rash, given TYLENOL for fever. Recommended if not better in a few days or if worse to be seen
A couple of hours following the injection I experienced fatigue. About 6-8 hours after shot had fever onset, which lasted a few hours. Day 2 just some fatigue. On day 3 started experiencing rash/hives and extreme itching all over body, especially throughout the night on 4th night. Took antihistamine which helped alleviate for time being. I?m currently on day 5 and there are still some hives present. I will continue antihistamine if needed.
COVID Vaccine Breakthrough Case  Moderna Dose 1 2/12/21 (03IL20A) Moderna Dose 2 3/12/21 (001B21A) COVID Negative 9/23/21 COVId Negative 9/26/21 COVID Positive 10/5/21  9/23/21: Patient is a 76-year-old male with a past medical history of anemia, CAD history of CABG, hypertension, myelodysplastic syndrome, history of MSSA cellulitis comes in with chief complaint of hypotension, malaise, subjective fever.  Patient also has a dental infection.  Reportedly follows with Dr. for myelodysplastic syndrome has labs drawn 2 to 3 times a week.  He went for lab draws this morning was noted to be hypotensive, febrile and felt weak with chills.  Outpatient providers as sent patient to ED for further evaluation. In the ED/blood work demonstrated hyponatremia of 125, pancytopenia, elevated CRP.  Patient received IV fluids, ceftriaxone, azithromycin, acetaminophen.  Blood pressures responded appropriately. Chest x-ray with faint left basilar opacity concerning for infiltrate.  Cultures were collected and request was made to admit to medical service for further management.  At bedside patient is sitting up comfortably in bed, denies any current lightheadedness, dizziness previously had chills but none currently no chest pain or palpitations no cough no abdominal pain though reports he did have some diarrhea few days back, has had some generalized malaise over last 2 weeks which has been getting worse.  Reports p.o. intake has been down as well.  Otherwise denies chest pain, palpitations, abdominal pain, paresthesia or swelling of extremities.  Denies tobacco, alcohol, marijuana/recreational drug use, over-the-counter medications.  Reports he has been compliant with prescribed medications.  No sick contacts or recent travel outside the area, family history reviewed unremarkable.  10/20/21: 76-year-old gentleman presented to the emergency room with history of fever and generalized fatigue.  Patient was noted to be neutropenic and has pneumonia.  Patient was started on empiric antibiotic therapy for pneumonia.  He was later on, a few days ago, found to be COVID-19 positive. Patient received dexamethasone, antifungal, multiple antibiotic therapies. Further evaluation with a bone marrow biopsy showed that the patient has developed acute myeloid leukemia.  After discussion with the oncologist, patient was recommended to be transferred to the another facility for further urgent management of leukemia.  However, the patient declined to go to the other facility and was debating and contemplating hospice and comfort management.  While patient was making the decision, patient opted for comfort measures.  Comfort measures were initiated.  Patient eventually passed away peacefully with his family at the bedside.  Patient passed away on October 19, 2021, at 2115.
Had flu like symptoms, felt myalgias, felt feverish, though did not take temperature; also had fatigue, mild lightheadedness and headache.
Cellulitis left arm since 10/18/2005 - after receiving pneumococcal vaccine.
redness; Swelling; Injection site itching; a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (Swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-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 15-Mar-2021, the patient experienced ERYTHEMA (redness), SWELLING (Swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot). At the time of the report, ERYTHEMA (redness), SWELLING (Swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot) had resolved.            Action taken with mRNA-1273 in response to the events was considered as not applicable.  Treatment medication include triple antibiotics and antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: FU received on 27 April 2021. New events ( redness , erythema and injection site erythema ) were added , reaction onset date was added and outcome of event injection site pruritis was changed from unknown to recovered.
feeling off along with some headache; feels kind of off; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose for COVID-19 immunization. The patient 's medical history and concomitant medications were not reported. The patient was administered with first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced sore arm. The patient received the second injection yesterday (11Jan2021). With the first one, the patient didn't feel any side effects other than a sore arm. He received the second vaccine yesterday at about 3pm. Last night, everything was fine. This morning (12Jan2021) at about 9 a.m., he started getting a little bit of a headache. He just felt kind of off. He thought that it was one of the side effects. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
12/2/21 @6:33 LOC while seated at post-vaccine table for < 1min.  No head impact. Patient reported hand numbness, nausea.  Laid flat and elevated legs.  Vitals WNL : 104/70, HR 78, Pulse ox 99%. Patient accompanied with partner who reports this type of thing happens about every 2 weeks. Patient is alert and oriented x 3.   Patient reports hx of dissociative seizures, POTS, and notes she had increased anxiety prior in the day. She reports she may have had a seizure earlier in the day.  She notes she had very little to eat or drink today.  She appears extremely thin - she states she has ongoing issues with nausea that prevent her from eating well. She is followed by a neurologist.   Carpopedal symptoms resolved within 15 minutes. Offered patient sips of water, she tolerated this well. Vitals remained stable throughout observation.  Took laying/sitting readings as follows: 100/72, HR 60 o2 99%; 102/70 HR 62 O2 99%.  Patient denied dizziness with position changes.  She left the clinic by 7:15 pm, accompanied by her partner who drove her home. They were advised to call 911 with any concerns. Advised f/u with neurologist to discuss recent seizures and work with a provider regarding nausea issues.
11/14/2010 Started with slight stuffy nose- by 11/15/2010 significant sinus pressure/congestion/pain; slight fever (100.0 F); headache; dry unproductive cough; general aches and malaise.  Still exists 11/16/2010, very little relief although fever is gone.  One day of school missed at this point.
neuropathy; having unusual reaction; shooting pain in an abdomen towards ovaries; extreme pain in spinal cord , it hurts badly;hand hurts like hell; numbness in both feet; tingling in both feet; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a 41-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 Neuropathy (Neuropathy 7 years ago) and Myelitis transverse (Patient had scar on spinal cord and caused by transverse myelitis.).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION COMPLICATION (having unusual reaction), PAIN (shooting pain in an abdomen towards ovaries; extreme pain in spinal cord , it hurts badly;hand hurts like hell), HYPOAESTHESIA (numbness in both feet) and PARAESTHESIA (tingling in both feet). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), VACCINATION COMPLICATION (having unusual reaction), PAIN (shooting pain in an abdomen towards ovaries; extreme pain in spinal cord , it hurts badly;hand hurts like hell), HYPOAESTHESIA (numbness in both feet) and PARAESTHESIA (tingling in both feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient got a 4th dose of pediarix Vs the infarix; Patient got a 4th dose of pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 21-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9Pz, expiry date 24th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2022, the patient received the 4th dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 5th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient received Pediarix in Left Vastus Lateralis. Nurse reported that, the patient got a 4th dose of Pediarix versus the Infanrix.   The nurse stated that, the patient was not exhibiting any adverse reactions. The reported consented to follow up. Additional supportive information: The patient got a 4th dose of Pediarix versus the Infanrix, which led to wrong vaccine administered and extra dose administered.
From initial info received on 6/29/05 from a physician, regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt received a dose of Menactra, lot U1657AA, IM in the left arm at 14:00 on 6/29/05. 90 minutes post vaccination, the pt developed red, blotchy patches over her elbows and knees. She was seen by a physician and treated with Benadryl 50mg per os. The pt recovered from this event.
Narrative: COVID infection following COVID vaccine series 01/25 Pfizer, dose healthcare professional #1 02/16, Pfizer, dose #2 09/27 COVID swab, result: detected 09/22 pt cc: chills, cough, fatigue, fever headache, loss of taste or smell, myalgias, sore throat exposure: unknown clinically resolved
This spontaneous report was received from a registerd nurse referring 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 unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M031574 with expiration date of 11-NOV-2018; lot # M037771 with expiration date of 21-FEB-2019 and lot# M039642 with expiration date of 03-JUL-2018) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000929: US-009507513-1702USA000364: US-009507513-1702USA000364.
Sore arm and heat radiating from injection site only a few hours after vaccination. Full body muscle aches and pains as well as uncontrollable shivering during the night. Fever in the morning and continued pain the next day.
herpes zoster rt back dermatome distribution;initial itching @ 24hrs by 72 hrs rash w/vesicles;MD visit started 10 days Acyclovir;pt was febrile & very painful;skin scarring;
Information has been received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date of 2011, the patient was vaccinated with one dose of ZOSTAVAX (strength, route, lot# and expiration unknown). On 23-APR-2015 the patient inadvertently received a second dose of ZOSTAVAX (strength, route, lot# and expiration unknown), which caused extra dose administered. No adverse effects reported. Additional information has been requested.
injection site pain; my neck was stiff 2 days after receiving my second dose; my left arm began to become sore as if it had been injected into the left arm again; This is a spontaneous report from a contactable Nurse reported herself. A 50-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 30Jan2021 at 18:30, (at the age of 50 year and patient was not pregnant at the time of vaccination) as 2nd dose SINGLE DOSE for covid-19 immunisation at hospital. Medical history included hypertension, type 2 diabetes mellitus from an unknown date and unknown if ongoing, covid-19 and musculoskeletal stiffness from Nov2020 to an unknown date. Patient had known allergies. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient's historical vaccine includes first dose of BNT162B2 via intramuscular, administered in Left arm on 06Jan2021at 12:00 PM for COVID-19 immunization and experienced the event vaccination site pain and left arm began to become sore. The patient experienced my left arm began to become sore as if it had been injected into the left arm again on 30Jan2021, injection site pain and my neck was stiff 2 days after receiving my second dose on 01Feb2021 at 13:00. It was reported that, she received 1st vaccine in left arm and second in right arm. About 10 minutes or so after receiving the second vaccine, my left arm began to become sore as if it had been injected into the left arm again. That went away later that night. She started injection site pain the next day which lasted only a few hours, while with the 1st injection it lasted 3 or 4 days. This afternoon she noted that neck was stiff 2 days after receiving my second dose. The only reason mention that was when she was sick with covid-19 in November, the stiff neck was one of the first symptoms noticed. Since vaccination patient not tested for covid-19. Therapeutic measures were not taken as a result of the events. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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 have been completed and no further information is expected.
RASH started next day. At first, was sick for 3 weeks, achey, cough, nose running. No fever. For 2 months, still has severe bilateral hand pain, arms hurt, finger joint pain, pain in all muscles, PRURITIC  RASH, rough patches on her chest, not on back, legs.
Fatigue Severe-chills Extreme joint pains/aches Fever up to 101.1 (normal temp resides@ 96.5  Muscle twitching specking
Swelling - size of baseball, Redness, pain, and extreme constant itching lasted about 9 days and is currently subsiding.  Still some pinkness (about 2 1/2 inches wide and 5 1/2 inches long down from vaccination site on upper arm near shoulder and still some mild itching.   Treated  with ice pack and Benadryl (antihistamine) .
No additional AE reported; Improperly Stored / Administered Vaccine; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. The concomitant medication included sterile diluent (lot# T029529, expiration date: 16-APR-2023).   On 03-APR-2023 (at around 10 AM), the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot #W036929, expiration date: 19-MAY-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  On 02-APR-2023, vaccine was exposed to temperature excursion of 26.6 degrees Fahrenheit for 2 hours and 8 minutes. It was reported that the previous temperature excursion took placed on 01-APR-2023, of 14 degrees Fahrenheit to 46 degrees Fahrenheit (18.1 degrees Fahrenheit) for 1 hour and 20 minutes. No additional adverse event reported (no adverse event).
Hospital Principal Problem (Discharge Diagnoses): Altered mental status, unspecified altered mental status type
Patient woke up at 08:00 with left sided-facial paralysis and decreased sensation.