chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 28-APR-2019) for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # L006184; Expiration date: 13-DEC-2016 and Lot# L013188; Expiration date: 02-NOV-2016) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported, throat and head filling with mucus, roughly 45 minutes after receiving vaccine. She took a single dose of over the counter Benadryl. She developed a cough and some shortness of breathe. She used her personal rescue inhaler using 3 pumps and took a second dose of the over the counter Benadryl.  She did not seek emergency care. She reported that symptoms subsided, feeling back to normal within 4 hours of the first symptom.
Information has been received from a registered nurse referring to a 13 year old female patient. There was no concurrent condition or medical history reported. On 24-MAR-2016 the patient was vaccinated with GARDASIL 9 (lot # L037339, expiration date 09-FEB-2018) (0.5 ml, strength and route unknown). Concomitant medication included an unnamed hepatitis A vaccine. The patient's mother contacted the health department, staring her daughter had diarrhea, was throwing up and had petechiae on both ankles in March 2016. The reporter stated the child had follow up visit scheduled with her primary care doctor on 28-MAR-2016 (today). The outcome of the events was reported as not recovered. Additional information has been requested.
Fever, Chills, Body Aches, Shortness of Breath, Fatigue
Exhaustion, sore arm, sore muscles, weakness, chills lasting over 24 hours - not severe
Case number PHEH2015US020455, is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to a 75-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX, (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
Information has been received from a medical assistant concerning a 76 yr old female Caucasian pt with improving right lung pneumonia (since 30Aug04), chronic obstructive pulmonary disease, asthma and chronic bronchitis who on 28Oct04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Subsequently, on 28Oct04 at 4:00PM the pt c/o swelling, redness at injection site and was running a slight fever. The pt was treated with warm compress and acetaminophen (Tylenol) as needed. The pt recovered. The medical assistant requested a lot check of 649913/0577P. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. It was also reported that two other pt's had a similar reaction (WAES0410USEA04368 and 0411USA00342) and were vaccinated from the same lot. No additional information is expected.
After my first moderna vaccine I experienced dry skin and dark spots all over my body. On 03/30/2021, I received my second dose at work. Within a less than 2-3 days I noticed more skin rashes on my thighs, legs, and both arms. Also on my upper left arm where I received my vaccine. I?ve had these rashes for more than 1 month in a half, and don?t know what to do in order to clear my skin.
Diarrhea, runny nose sneezing.  10/12/2009 vomiting 9pm and 3am.
cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Rash development 4x4 inch on back of neck and shoulder base, small 2 inch section of left side, abdominal region, upper left chest base of neck 2x2 inch section and small bumps 3 inches below bellybutton( no growth there).   Taking Benadryl 4hr. And using topical hydrocortisone cream.
Vaccine they received was expired but it was given to 6 patients.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients.).    No concomitant medications were reported.  The vaccine they received was expired, but it was given to six patients. The caller wanted to call and reference what to do. Patient received monovalent. Six doses were administered. Vial size was not reported. On 16Feb2023, the vial was initially stored in the refrigerator. Vaccine administration dates of 24Feb2023, 28Feb2023, 01Mar2023, and 06Mar2023. The vial did not undergo any temperature excursions. No women were pregnant or post-partum at the time of administration.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804, US-MODERNATX, INC.-MOD-2023-715806, US-MODERNATX, INC.-MOD-2023-715730 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715785: US-MODERNATX, INC.-MOD-2023-715792: US-MODERNATX, INC.-MOD-2023-715804: US-MODERNATX, INC.-MOD-2023-715806: US-MODERNATX, INC.-MOD-2023-715730:
Patient experience shaking that occured for 3 to 4 hours after receving the vaccine. Patient stated the shaking occur for several hours. Patient stated he felt fine after the next day.
Pericarditis Went to the emergency room April 18 miss- diagnosed for phenmonia treated w ant biotics Returned to emergency room April 25 admitted April 25- 28 diagnosed pericarditis
Left upper arm swelling from injection site to just above elbow, warm to touch and red. Patient complaining of pain and itching.
floaters in right eye; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in right eye) and VOMITING (Threw up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003021A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VITREOUS FLOATERS (floaters in right eye) and VOMITING (Threw up). At the time of the report, VITREOUS FLOATERS (floaters in right eye) and VOMITING (Threw up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.
The patient's daughter called the pharmacy at 2:30 PM on 2/13/20 and said that her mom was in at 1:00 PM and received her second Shingrix vaccination. The patient had hives all over her body. The patient's daughter said that she gave her mom 50mg of benadryl and was not in distress, nor did she have any other symptoms.
severe fatigue within 12 hours, continued 72 hours fever (100-102 degrees) within 24 hours, continued 24 hours headache within 12 hours, continued 72 hours muscle pain within 24 hours, continued 48 hours
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 15:18, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.2 and 4.7 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
1. Chills, low grade fever, headaches, joint pains for about 3+days. 2. Observed rashes on Day 4 Tuesday, that got worse  and got more and lasted for several days, started fading around Sunday morning. 3. Random fast heart-beat, no pattern, just happened randomly from Tuesday for about 3 days.
This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a physician concerning a 16 week old female with no allergic or pertinent medical history who on 29-SEP-2008 was vaccinated po with a first dose of ROTATEQ.  There was no concomitant medication.  The physician mentioned a patient inadvertently received first dose at 4 months of age.  No adverse effects reported.  No laboratory diagnostics were done.  A product quality complaint was not involved.  Follow-up information was received on 29-OCT-2008.  The patient was given ROTATEQ at 4 months and 5 days of age.  At the time of this report, there were no known consequences.  No further information is expected.
CHICKENPOX LIKE RASH ON THE SITE OF THE INJECTION, EXTREME PRURITUS, FATIGUE , STIFFNESS IN LEFT HIP JOINT
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
developed hives all over arms and thighs, few spots on calf.  Slightly itchy at times.  Arms were not painful welts, but the leg welt are very painful, feel almost like bruises.  This along with generalized muscle aches and pains. Took an antihistamine with no relief, hives have been gradually fading but pain in legs still persistent.  no respiratory issues so did not go to ER.
Developed migraine headache the evening of the vaccine that persisted five days. Stomach pain developed within one day of the vaccine.  Severe nausea, vomiting, and diarrhea along with low-grade fever and chills began a little over 2 days of vaccine and lasted about 48 hours.
No Additional AE; PRIORIX sterile water/diluent was used to reconstitute PROQUAD; This spontaneous report was received from a pharmacist and referred to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were unknown by reporter.  On 18-APR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #W034211, expiration date: 24-APR-2024, administered for prophylaxis (strength, and route of administration were not provided); which was reconstituted with measles vaccine live (schwartz) (+) mumps vaccine live (rit 4385) (+) rubella vaccine live (wistar ra 27/3) (PRIORIX) sterile water/diluent (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided) (Product preparation error). No additional adverse event.; Sender's Comments:  US-009507513-2304USA008314:
Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023; no adverse event; a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023) and NO ADVERSE EVENT (no adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2023, 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 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-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 (a dose of the Moderna Bivalent vaccine was administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge on 24Jan2023 and administered to the patient on 07-MAR-2023).    Concomitant medication details not reported by the reporter. Vaccine was stored in the fridge on 24-Jan-2023. Treatment details was not reported by the reporter.
Prolonged crying, prolonged fever-excessive irritability adm to hosp as fever, r/o sepsis; LP done-4 mono; blood drawn x 2-no growth, cath urine clear; WBC 15,000 48 seg 4B;
Immediate itching left wrist, rt. shoulder, slight nausea. Symptoms diminished after 25 min. Nausea gone at that time.
Fainted immediately following HPV vaccine. Was sitting on exam table, gurgled, turned pale and was lowered to a lying position and head of table  was raised.  She aroused after approximately 15 seconds and stated she was fine and ready to go.  He father was brought into the room.  She sat up we gave her a cool damp wash cloth for her face and bottle of cold water. Pulse was regular.  She again stated she was fine and ready to go home. Father advised to  call 911 if any issues arise on way home.
Large area of Pain, redness & swelling at the injection site. Pain experienced in the entire left arm. Treated with Tylenol & Benadryl with improved symptoms in 24 hours but not complete resolution.
PAIN; SORE ARM; MUSCLE ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, pain, headache, sore arm and fever was not reported. This report was non-serious.
pt got headache @ 3 AM after second dose followed by swollen fingers on vaccine side. Next day  - 052121 - pt reported pressure in lungs (only when breathing in and out using full force) - during working hours.  pt using homeopathic remedies currently - states they are helping
IN 24 HOURS AFTER 2ND VACCINATION -, RED WELTS AND RASH ON TORSO (FRONT & BACK), ARMS, LEGS.  SYMPTOMS STILL PRESENT ON 02/26/2021
Headache and fever of 100.4. Fever lasted  about 36 hours. No fever since then.
Redness, swelling, hives, warm to the touch, and pain at injection site and surrounding area.
It first started after my first does, it was exasperated after my 2nd dose. Tingly and numbness on my face. Then I started getting neuropathy everywhere, including my tongue. My arms and legs have improved, I just have tingly and numbness on face. It got so bad I went to ER twice and I have PVC with my heart now. I saw dentist and oral surgeon to make sure it was not jaw related.
administered an expired Menactra by a nurse; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.(Physicians Assistant). This case involves a 17 years old male patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] by the nurse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient didn't get any other vaccine at the time of vaccination.   On 18-Apr-2019, the patient received second 0..5 ml  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5836BA(expiry date: 18-Mar-2019)  via intramuscular route in the arm nos.  It was of actual medication error due to  expired vaccine used.  It was unknown whether adverse event was occurred..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
they had Covid from their self testing; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (they had Covid from their self testing) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced COVID-19 (they had Covid from their self testing). At the time of the report, COVID-19 (they had Covid from their self testing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, SARS-CoV-2 test: (Positive) positive.         Patient was concomitantly receiving statin.  Patient received first dose on 04-Feb-2021 with lot number 013L20A. Patient received second dose on 05-Mar-2021 with Lot number 016M20A. Patient received first booster dose on 17-Sep-2021 with Lot number 037F21A. Patient received second booster dose on 13-May-2022 with lot number 005M21A.  Patient experienced bit of sniffles, felt crumy, little of tenderness in the arm. and had a bad cold, as symptoms of COVID-19 diagnosis.  No treatment drug was reported.
2 inch round red, swollen, hot, itchy spot at injection site lasted a few days after injection on 1/23/21, then went away except for faded brown bruise appearance for 1 week, then the 2 inch round red, swollen, hot, itchy spot came back again and  is still there today 2/3/21. 2/3/21 started taking  50 mg Benadryl  and Cortizone-10 cream.
pain , itching, edema, hives on shoulder  Recommended patient can use a hydrocortisone cream or Benadryl cream to help with sx
Child spent the day (of vaccination) with dad (10-21-11). Did not appear ill at time of vaccination. Evening: Child was hot, screaming 6 am- Mom took temp 106 degrees. Gave children's TYLENOL and went to ER. Temp there was 105 degrees. Dx Pneumonia. Child had history of high fevers (103 degrees-104 degrees). History of bronchitis/pneumonia 5/2011.