chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow up consists of non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Patient states that over the last 2 weeks he Z of progressively worsening weakness, patient states he usually gets around well with a walker, he has not been doing this, no recent falls.  His cough is shortness of breath have been stable, his p.o. intake has decreased
I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time I arrived to work, my temperature was greater than 101 degrees Fahrenheit and I was told to go home. By the time I arrived home (40 minutes later), extreme chills and body aches. I have never experienced anything like it. The fever, chills, and body aches persisted throughout the day despite Tylenol. Fever broke around 2AM on 12.24.20, slept and felt perfectly fine later that morning.
This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to report adverse side effect from the COVID-19 shot. Patient reported that this shot made him/her very devastated, stated "have itchiness in our ear to our bottom of our feet". Further reported that he/she had kidney failure from the shot, got chronic fatigue, had nausea, headache and was not doing well and stated "if I die from the shot I want to document that we were having adverse drug event from the Pfizer shot that we had". The outcome of the events was unknown. Information on the lot/batch number has been requested.
About 45 minutes after inject upper lip and chin tingle and itches.  about 45 minutes after injection was have tickling sensation in throat which followed into voice lost, chest tightness, decrease in expiration efforts, occasional coughing , increase breathing and heart rate.  Use albuterol inhaler and called for the on call doctor.  took zyzal, zertex, benadryl, Prednisone, and use nebulizer
Headache, neck and joint pain, fatigue, mild fever ( <100), loss of appetite. Symptoms lasted for 24hrs.
vaccines were administered to patients; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-JAN-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T013540, expiration date 17-OCT-2021, 0.5 milliliter 1 dose, subcutaneous (SQ) route (formulation and anatomical location were not reported) for prophylaxis. The reporter did not have cumulative and complete temperature excursion information. It was unknown if a data logger was involved to capture the temperature excursion.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2102USA004608:01865322 US-009507513-2102USA004759:01865321
Initial misuse report received from a healthcare professional (Pharmacist) on 06 FEBRUARY 2014. A patient  (age and gender not reported) whose medical history and concomitant medication were not reported,  had received TDAP (batch number, dose, route and anatomical site of administration were not reported) instead of TB test. No adverse event was reported. List of documents held by sender: none
Muscle and joint pain; so dizzy that she has to sit down because feels like she's going to fall if she remains standing; Muscle and joint pain; Couldn't get out of bed; Upset stomach; Nausea; Horrible headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't get out of bed), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain) in a 48-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 was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced MOBILITY DECREASED (Couldn't get out of bed), ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle and joint pain), NAUSEA (Nausea), HEADACHE (Horrible headaches) and PYREXIA (Fever). On 28-Jun-2021, the patient experienced DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing). On an unknown date, the patient experienced ARTHRALGIA (Muscle and joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at a dose of 500 milligram every four hours. On 27-Jun-2021, MOBILITY DECREASED (Couldn't get out of bed) and PYREXIA (Fever) had resolved. On 28-Jun-2021, MYALGIA (Muscle and joint pain) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing), ARTHRALGIA (Muscle and joint pain), NAUSEA (Nausea) and HEADACHE (Horrible headaches) outcome was unknown.            This case was linked to MOD-2021-239789 (Patient Link).
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was reported.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a chemo treatment starting 03Mar2021 with a pump until 05Mar2021. Patient was in the hospital 06Mar2021 until 09Mar2021.
pt recv vax & 10 days later had small round (measles) bright red cont to get worse for 3 days;eyes were almost swollen shut & was very sick;pt was sick a total of 6 days-spots for 4 days;
2 hours after injection experienced expected AE of fevers and fatigue. 1 day after injection experiencing some cough, congestion, shortness of breath. Felt like her throat was closing- did not seek medical attention on this day. She also developed cold sores to her lips. She was evaluated 3 days after injection and her symptoms were improving.
Extreme muscle spasm in lower back to where patient couldn't walk without assistance. Occurred about 2 hours after vaccine. Patient had current prescription for FLEXERIL which helped.
Large itchy red blister developed by 2nd day. After a week, it has not gone down.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Feb2021 (Lot number: EN6198, Expiration Date: Jun2021) at the age of 61 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "heart medicine" (unspecified if ongoing). Concomitant medications included: PLAVIX taken for cardiac disorder; METOPROLOL. The following information was reported: GAIT INABILITY (non-serious) with onset 24Feb2021, outcome "recovered", described as "I cannot even walk, everything was stunning and I had to go straight to bed". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable nurse via a Company sales representative. A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA intramuscular in the upper arm on 13Apr2016 at 0.5 ml single and a single dose of pneumococcal vaccine (unknown trade name) via an unspecified route of administration on an unspecified date, both for immunization. The patient medical history and concomitant medications were not reported. On 13Apr2016 the patient experienced low grade fever, chills, some joint pain, she was very pale and on 14Apr2016 she was not feeling well. The patient underwent laboratory tests and procedures which included full blood count that was negative on 14Apr2016. No treatment was given due to the reported events. Outcome of the reported events was unknown at the time of this report. The reporter believed that there was a causal relationship between the vaccines and the side effects.
no signs or symptoms reported; temperature excursion on VAQTA/VAQTA was administered to three patients; 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 02-MAR-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), dose: 0.5 milliliter, lot# T013546, expiry date: 28-OCT-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There were no previous excursions related. Data logger was not involved. No adverse events were reported.   This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA007895: US-009507513-2103USA007597:
I developed shingles. I now suffering with postherpectic neuralgia. I haven?t gotten my second dose because of this.
pt waited in store over 30 minutes before exiting. on his way out of the store, he started having trouble breathing. pt then came over to pharmacy to let pharmacist know. pt was seated, bp was checked >190/100, EMS was contacted, and pt was given water. pharmacist stayed with pt until ems arrived to take him to the hospital. he believed it was just another copd exacerbation like he experienced a few weeks ago.
On 02/27/2023, I woke up with a very stuffy head and a headache which I'm not prone to. That continued on through Monday and Tuesday. Wednesday, I did not have the usual COVID-19 cough or anything, but I was still very stuffy and still had a headache. I controlled off and on with TYLENOL. After having that for 3 days with very unusual symptoms such as the headache and stuffiness, I took an at home Binax COVID-19 test which was positive. I took myself to the urgent clinic because of my age, asthma, and symptoms. They listened to my lungs, and he did prescribe me an antiviral which I filled. Thursday, 03/02, I lost my sense of taste and smell. I couldn't taste or smell anything all day long. Friday 03/03, I got a little bit of my taste back and I got more of that back along with smell throughout the day. It didn't come back completely for about a week. I haven't had any symptoms or problems since then.
rash abd&neck-going away no tx;taking ATB&mefloquine simultaneously no h/a;pt left for South America;
Sore arm ,  fatigue, flu like symptoms,  fever, chills body aches. 2 days
red, welts on chest, back, abdomen, arms too beginning 02/16/2001. Treated with OTC Benadryl. Cleared up on 12/17/2002
Vaccine administered 6 days after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 6 days after 1st punctured) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 6 days after 1st punctured). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 6 days after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-333903 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received: included no new information.
27AUG achiness;28AUG fever (unmeasured);chills, achiness & testicular swelling;30AUG subsiding sx;3SEP some testicular swelling remaining & saw primary MD;4SEP or 5SEP sx ceased;
Patient vaccinated by both IPOL and KINRIX / No AE; Initial information received on 26-Jun-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via call center via Agency (reference number- 00657668).  The case was linked to 2021SA215597 (same reporter).  This case involves a 4-years-old male patient who vaccinated with double dose of polio vaccine from suspect IPV (VERO) [IPOL] (strength: standard, frequency: once, batch number: 26-Jun-2021 and expiry date: 25-Jul-2022 via intramuscular route in right arm) and fourth dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [KINRIX] (batch number and expiry date not reported) (extra dose administered) on 26-Jun-2021 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administered (latency: same day).  Reporter calling to find out if there are any known side effects for someone who got 2 doses of polio. Caller wants to know what to look for since it was given today at the clinic to twins. It was reported as dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml.  At the time of reporting, no adverse event was reported.  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.
Erythema and swelling measuring 110 mm on right subcutaneous area of right arm. Warm to touch. Large knot.
I had a rash, and soreness of the arm that lasted for a week. Felt very fatigue. Lasted 2 days.
Initial unsolicited case received from a nurse ates on 08 Nov 2016. This case involves a female patient (age not reported) who was immunized with a dose of FLUZONE HIGH DOSE (Batch number: UI659AB Expiry date: 29 Mar 2017, dose and route of administration was not reported) in right deltoid on an unspecified date and time frame. The patient medical history and concomitant medications were not reported. On an unknown date reported as two days after vaccination the patient presented with a tender hematoma radiating down right upper arm. The patient required emergency room or doctor visit. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of the documents held by the sender: none.
22hr p/vax pt devel fever 101, h/a, stiff neck, nausea, pain in legs;parent had to pick put up @ school;T103 ax 130PM 20MAY98;saw family MD about 4PM;dx probable HBV rxn & advised not to complete the HB series;
A physician reported that a male pt received his third dose of Hib-Titer and subsequently developed an injection site reaction. No further details were available at the date of this report. Follow-up information received from the physician on 11/22/99 indicated that the pt had a rash at the injection site. He recovered.
The next day following the shot (05/22/2021), the patient had a rash covering his entire body. He said it was itchy and red. The patient went to urgent care and received a steroid shot and steroid pills for 6 days. Called the pharmacy on 05/25/2021 to tell about the reaction
Acute encephalitis and seizures.  Patient is currently in ICU sedated and on mechanical ventilation.   MRI is "unremarkable",  lumbar puncture, analysis of spinal fluid is "unremarkable" chest x-rays normal.  Lab results pending.   He has  no known insect bites and has not been near wooded areas, and has routine pest control for the home.  After 24 hours in the ICU  it remains unclear what is causing encephalitis.   I am not certain what flu shot he had, so the information reported above is based on the fact that he advised in regular conversation last week that he had the "high dose flu vaccine"  on Saturday 9/19/2020 at about 11:15 in the morning, and your website lists only the Sanofi one as "high dose".  His wife reports that he was "very cranky and out of character" all day  Saturday, 9/26, and then he was disoriented and incoherent on Sunday morning 9/27/2020 and admitted to the ICU, and having seizures by midday, Sunday 9/27 requiring intubation.  He remains intubated while tests are pending.  I am making this report based on the VAERS guidance "VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in specific country. "
On 19DEC2022 I tested positive for COVID-19 my symptoms were mild on 21DEC2022 I had an earache in my left ear and my bottom lip was turned up a little bit, my doctor prescribed a Steroid Methylprednisolone on 27DEC2022. The next day I woke and my face was droopy I had vision and hearing problems on the left side I did a telehealth visit with my Doctor I was diagnosed with Ramsey Hunts disease, he prescribed Valtrex and told me to quit taking the steroid he had prescribed and he prescribed anther stronger steroid. I also have Gabapentin for pain due to the Shingles.
I had no problems and no symptoms, I could tell I was short of breath at times. I saw a cardiologist my calcium levels were high so I had a stress test and I was diagnosed with Afib. I'm going to have an ablation in about 3 weeks.
Tiredness; Chills; Headache; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 08May2021 at 09:45 (at the age of 63-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 were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 15:30, as a single dose for COVID-19 immunisation. On 08May2021 at 23:00, the patient experienced tiredness, chills, headache and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, chills, headache and felt unwell was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
1st shot-nothing  2nd shot- shaking all over in 1st 15 minutes, progressing over the next few hours: muscle spasms/jerks, chest pain, SOB, bad right  side pain in upper arm/shoulder, neck, jaw, face. Hard facial spasms, felt like I was in fight/flight physically- but not mentally, dizzy, very nauseous, hearing in right ear would drastically reduce for 30-60 seconds, heart palpitations, stuttering at times, difficulty finding words at times. Was driven to  ER & evaluated (they said nothing was wrong with me-made to feel like I was faking).Called my doctor?s office the next day-symptoms were persistent but less than the previous day.She wouldn?t see me since I was seen in ER. I went to urgent care & got an appointment the following day with a new provider, .  She sent me to ENT, who says it appears Mennier?s was triggered. Started on high dose Prednisone 60 mg tapered dose. My hearing showed some loss in lower frequencies. I feel slightly, very slightly better each day. Extreme fatigue Has also been an issue.