chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.; The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.), PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.), PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.), PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 vaccine after the 30 day BUD between 6JUN2023 to 9JUN2023.) and PRODUCT STORAGE ERROR (The dose was placed into the refrigerator initially on 4-MAY-2023 and administered between  6-JUN-2023 to 9-JUN-2023.).    No concomitant medication was reported. The dosage text of the suspect product was reported as unknown. It was reported that 9 adult patients were received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023. The dose was placed into the refrigerator initially on 4-MAY-2023. There were no reported symptoms and no additional doses medications or treatments administered in response.    This case contains information about patient 7th out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case US-MODERNATX, INC.-MOD-2023-729624:Patient 7
Shortness of breath, chest pain, chest pressure,  Each episode would last for a few hours after activity or pressure on chest.
Hives around mouth; swelling of lips; dizziness; anxiety; sever chills; moderate fatigue; arm pain; severe stomach cramps; diarrhea; This is a spontaneous report received from a contactable consumer or other health care professional (patient).  A female patient (non-pregnant) of unknown age received bnt162b2 COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported /Lot number EN8727, expiry date not reported) via an unspecified route of administration, administered in Arm left on 29Mar2021 11:00 AM as dose 1, single for covid-19 immunization at Workplace clinic. Medical history and concomitant medications were not reported. Patient had known Allergies with insect stings. Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. On 29Mar2021 05:00 PM, the patient experienced with hives around mouth, swelling of lips, dizziness, anxiety, sever chills, moderate fatigue, arm pain, severe stomach cramps, diarrhea. Seriousness was reported as No. No treatment was received for the events caused. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Patient felt faint and passed-out 10 min after receiving her first vaccination. She was not alert for about 30 seconds. Then she was alert with normal breathing, HR and speaking. Patient was given juice and water. She received a ride home, instead of driving herself.
Patient was here for Flu vaccines and it was processed for Pfizer pediatric dose. Mom filled and signed out VAR for Pfizer vaccine. Mom asked after the vaccine was administered  to verify flu vaccine was given. Patient felt very dizzy and felt like passing out after Covid 19 pediatric dose was administered. We had to call emergency number . Patient was feeling ok in 5 min and her vitals were normal when paramedics came and checked her out. Mom chose to take her to hospital to get her checked. Next day dad called and patient was feeling fine.
Patient received varicella 0.5 cc SQ to right arm on 7-18-07. Patient presented on 7-20-07 with warmth and swelling to right arm. No pain. No fever in office. CBC obtained, within normal levels. No meds given.
Low fever, body pains, lethargic 1-3 days after the vaccine. 19 days later I developed a very painful blister that grew to not quite the size of a dime. It burned as if it were an actual burn. The pain/throbbing was enough to wake me from sleep.  The blister eventually burst and gradually went away. I kept the area clean and covered with a bandage the entire time using neosporin once the blister burst. The area still visibly shows where the blister was. I was instructed not to get the next dose of the vaccine which was due to be administered tomorrow. The doctor replied to my message this afternoon after having read my description and seen the photo of the blister I attached.
Patient complained of the sensation of little pricks (pin needle pricks) on both her hands (index, middle, and ring fingers) for an hour and then it stopped
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose and route were not reported), lot # K007825, expiration date 03-JAN-2016 and lot # K020214, expiration date 25-MAR-2016. Total number of doses administered was 29. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen eyes, increase heart rate, joint and head aches, frequent urination, insomnia, sore throat. Pt. did not take anything and symptoms subsided within a few hours,
Per mom - infant had temperature under 100 degrees.  Both legs were red, inflamed, swollen - the left leg more symptomatic (Pentacel) than right (Prevnar).  Infant had decreased appetite and was fussy for two to three days following immunization.
12 1/2 hrs p/vax devel t103.6 & then had febrile sz was seen in ER & released p/APAP control
Pt reports flu-like sx, fever on date of administration. Sx-improved with ibuprofen. In additional has continued redness, warmth, firm swelling 3-4" at site of pneumococcal injection. Treated as walk-in 10/11/13 - given Zyrtec for allergic reaction.
Pt. states she felt 'achy all over; chills; fatigue'; no nausea, vomiting, diarrhea; left arm red, swollen, hard and painful to touch; took Tylenol with relief
Patient stated she has a red, itchy are at her injection site. Approximately 4x51/2 inches thinks it is an allergic reaction and is taking BENEDRYL. She saw her dermatologist for a regular visit on 2/18 and he gave her DOXYCYLINE when he noticed the area. Has not worsened as of 2/19/10 3pm.
Vaccine administered in ICU with nurse at bedside with continuous monitoring because of previous reaction to vaccine 8/1/11.  Stacked symptoms began 8 min after administration with facial flushing, slow speech, slow thoughts.  Patient said "Uh Oh" and then facial numbness, light headedness, inability to speak, paralysis of extremities (all limbs) with rigidity, gazing at ceiling, apneic.  Patient intubated immediately.  Monitor Sinus Tach (116-120).  BP 193/111.  Patient extubated 8/4/11 at 3 pm.  Patient back to baseline with no deficits.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunization.  Medical history included COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) for unknown indication from unspecified date. The patient had no known allergies to medications, food or other products. 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 receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021 at 16:30, the patient experienced shingles. The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event and included treatment with medication. The clinical outcome of the event shingles was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
04.11.2021 12:15 p.m. Vaccination and immediate sore arm 12:45 p.m. Headache and continued sore arm 7:00 p.m. Chills, fever 100, took Advil and hot shower. Broke fever during shower.  11:00 p.m. Went to bed but chills returned.  Couldn't sleep.   04.12.2021 12:35 a.m. Went pee and felt nauseous with chills.  2:30 a.m. Went pee, drank a bottle of water and felt extreme pain in joints and chest. 3:00 a.m. Took 400 mg Advil.  4:15 a.m. Went pee and drank another bottle of water.  6:00 a.m. Woke up SO due to high fever of 104.4. checked repeatedly both ears.  Checked SO temp and he was normal.   6:30: In ER. 2 L of IV, tylenol, pain meds (tramadol) and sleep. Chills went away around 7:45 a.m. when the fever broke.  8:00 a.m. Another round of pain meds.  9:00 a.m. Last round of pain meds.  10:00 a.m. Discharge with temp of 99.8. 3:00 p.m. After rest and more fluids at home, fever broke.  7:00 p.m. Chills returned, mild headache, and joint pain. 8:00 p.m. Diarrhea. Flushed 3 times.  Lost a lot of fluid. 8:15 p.m. Took hot shower to help with chills.  9:00 p.m. Drank 15 ounces of water and Gatorade combined.  9:15 p.m. Fever 101.0 10:45 p.m. Fever 101.5  04.13.2021 12:40 a.m. Fever 102.5 and took 2 Tylenol 2:30 a.m. Fever 99.8  5:00 a.m. normal temp 98.7, still have headache.  11:00 a.m. normal temp 98.5, pain in leg and arm muscles and joints primarily ankles, knees and wrists.  Pain in lower abdominal area.  2:20 p.m. PCP appt. Blood drawn. Temp normal at 98.9 6:00 p.m. temp 100.0 8:20 p.m. 2 Tylenol, headache, joint/muscle pain 9:30 p.m. Temp 100.0 11:00 p.m. Normal temp 98.8  04.14.2021 12:05 a.m. Temp 105.5; took 2 Tylenol. 3:00 a.m. Temp 96.8/97.4 10:30 a.m. Blood draw to test for clotting 12:30 p.m. Blood results indicate clotting potential; went to ER for head CT scan to asses clotting in the brain. Headache still persists and pains in muscles.
Initially, mild pain at injection site only lasting 1-2 days. This adverse reaction that began nine days later started with a small red circle with a hard lump inside. By the next morning, the lump was gone and the red started expanding. It became very red and mildly hot. Very little pain This is eleven days later and the size is about a 2 by 3 inch oval, and it is fading.
I traveled and wore mask at all times. Contracted COVID-19 from friends that I was staying with. Symptoms began as persistent cough and diarrhea. Next day I had lost taste and smell, ran fever of 101, and horrible cough. Had telehealth appointment with doctor and was put on cough medicine and anti nausea meds. Day three I began sneezing and developed sore throat. Day 4 symptoms began improving. Day 6 slept horrible and temp was normal. Began coughing up dark phlegm. Also, began taking antibiotics on day 6. Day 7 slept better. Raw throat and nose from coughing and blowing nose. Day 8 feeling better and cough better. Developed an intense pain in left chest. Doctor ordered CT scan, and it showed congestion in pleural space and ground glass.
BROKE OUT IN HIVES(RASH) A DAY LATER AFTER RECIEVING THE VACCINE SHOT ( MODERNA). WENT TO THE CLINIC AND THEY GAVE ME ALLERGY MEDICINE. WITHDRAW BLOOD AND TEST RESULTS WERE NEGATIVE. THEY TOLD ME THAT THE RASH WAS TEMPERAILY AND WOULD GO AWAY.
skin on left arm erythematous 4-5 cm indurated area on left arm. Cellulitis 2 hours after shots.
Pt reported 4 inch x 2 inch hot, itchy, inflamed area around injection site for 4-5 days after injection. Pt now has a quarter size red spot on skin at injection site but has no pain at this site. Report per wife pt will not see doctor despite our recommendations because "it is not a big deal" pt just wanted to let pharmacy & mgf. know.
Headaches; dizziness; weakness; joint pain; tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262; Expiration Date: unknown) dose 1 via unspecified route of administered in Arm Left on 03Feb2021 11:45 AM as 1st DOSE SINGLE for covid-19 immunisation.  The patient medical history was essential thrombocytopenia. Concomitant medications included baby aspirin, lisinopril, pravastatin and tramadol. On 06Feb2021: 07:00 AM the patient experienced headaches dizziness weakness joint pain and tired. Outcome of the events was recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
This initial spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Since the temperature excursion on 16-JUN-2016, the patients were vaccinated with improperly stored doses and not supported of PEDVAXHIB injection (subcutaneously, lot # L051123 with expiration date 13-OCT-2018; dose and anatomical location were not reported). The vaccines had a temperature excursion of 27 Fahrenheit for 11 hours. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. Additional information has been requested.
Chronic pain in her neck which went away for a couple of weeks; 2nd shot not yet administered; Itching all over all over  for a couple of days; Her lip looked wierd; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over all over  for a couple of days), ORAL DISCOMFORT (Her lip looked wierd), NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (Itching all over all over  for a couple of days) and ORAL DISCOMFORT (Her lip looked wierd). On an unknown date, the patient experienced NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered). On 01-Mar-2021, PRURITUS (Itching all over all over  for a couple of days) outcome was unknown. At the time of the report, ORAL DISCOMFORT (Her lip looked wierd) and NECK PAIN (Chronic pain in her neck which went away for a couple of weeks) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd shot not yet administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.
Female patient developed fever, vomiting, body aches, sore throat, h/a & ear pain.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   This case was linked to MOD-2021-306137 (Patient Link).
spotting after a covid diagnosis 6 Jan 2022, lasting through March 2022, turnng to heavy bleeding. Diagnosed with Hyperplasia non atypia
EE received flu vaccine in l arm higher than in the past. EE felt pain in left arm/shoulder than increased over time as well as decreased ROM and weakness. EE was seen by provider and has had some slight improvement in symptoms. EE is scheduled for an MRI on 1/18/2021.
Arm pain for approx. 18 hours and extremely sore arm for 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 12:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), ascorbic acid (VITAMIN C) and vitamin d nos (VITAMIN D), HB medicine (MANUFACTURER UNKNOWN) and ; all were taken for unknown indication from an unknown date and unknown if ongoing. On 11Mar2021 at 01:00, the patient experienced arm pain for approx. 18 hours and extremely sore arm for 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm pain for approx. 18 hours and extremely sore arm for 24 hours was recovered on an unknown date in Mar2021.     No follow-up attempts are needed. No further information is expected.
Body ache from head to toe; flu GI distress; continued joint, muscle tendon stiffness.
MODERNA COVID 19 VACCINE BOOSTER  GIVEN INSTEAD OF PFIZER-BIONTECH COVID 19   NO  ADVERSE EVENTS FROM THIS  ERROR  . PATIENT INFORMED  AND  INFORMATION   TO REPORT ADVERSE SIDE EFFECTS
This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. Since 02-JUL-2015, unspecified patients were vaccinated with improperly stored (may have been exposed to temperatures outside of the recommended range) PROQUAD (Merck) (Lots # K023861, exp date 25-MAY-2016; L009208, exp date 31-OCT-2016; L005293, exp date 17-AUG-2016) (dose, route, frequency and strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reporter (MARRS # 1509USA003624). Additional information has been requested.
Lightheaded and nauseaus; patient states she gets lightheaded with blood draws. She received Transcend 15 grams glucose given at 01:57. BP 114/74 heart rate 79 pulse of 100% RA. 911 called and transport arrive and patient refused and chose to go to ER via personal vehicle.
Approx 6 hrs p/flu inject pt felt nervous; shortly thereafter pt noticed small red spots on lt arm (like mosquito bites) these becam very itchy & grew to nickle size whelps, they spread to rt arm & hand & to face; DPH taken;
very confused and didn't remember the first day, diarrhea, and nausea, couldn't move or walk; this was similar to when he had covid, chills, nausea and fever also. I was so weak I couldn't get into bed. I still have foggy thinking and blurry vision.
Post vaccination client became diaphoretic, and lightheaded with a syncopial response.  Clients legs raised, water provided, vitals taken and extended observation period.  After 20 minutes client stated feeling good.  Educated the client on adverse events and when to seek medical attn.  Client confirmed understanding.  Within 30 mins symptoms resolved and client left the site with a steady gait and in no apparent distress.
Starting on 07/15/2022, he had vomiting, fever and fatigue. The vomiting lasted for about half a day. He tested positive with an At-Home COVID-19 test on 07/16/2022. The fever persisted for 2-3 days. Fatigue persisted for 5-6 days.
Fever (about 101.5), headache, goosebumps, nausea, general fatigue
He had more than the usual amount of swelling, pain and redness in his arm. Size if reaction estimated at 6 by 10 cm. Improved with ice and observation.
Pain at injection site immediately.  Waited 15 minutes at the site and felt normal enough to drive. About 10 minutes into my drive home I started breaking out into sweats and felt faint to the point where I pulled over on a side street.   I called my spouse and laid back my seat and came close but did not lose consciousness. 5 minutes later I continued my drive and had to pull over once more and lay back before continuing my drive home.  I attribute this to an anxiety related event.  12 hours after vaccination I developed a fever and chills which subsided by introducing Tylenol. This did break overnight, however I experienced fatigue 24-48 hours post vaccination.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore right arm), feeling abnormal (not feeling good), feeling of body temperature change (feeling warm and freezing), pain (body hurting) and headache in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 043B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 21, 2021, patient experienced pain in extremity (sore right arm), feeling abnormal (not feeling good), feeling of body temperature change (feeling warm and freezing), pain (body hurting), headache and nausea. The patient treated with Motrin (ibuprofen), at an unspecified dose and frequency; and Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, pain in extremity (sore right arm), feeling abnormal (not feeling good), feeling of body temperature change (feeling warm and freezing), pain (body hurting), headache and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication reported.
Flu-like symptoms during the day; uncontrollable shivering most of the night; fever up 100 degrees; malaise and lack of energy on the second day.