chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little arm pain) in a 72-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little arm pain). At the time of the report, PAIN IN EXTREMITY (Little arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients; This non-serious spontaneous safety report, with reference number 02268180 / 02268162, was received by the partner on 14-OCT-2022 and forwarded on 17-OCT-2022, from a non-healthcare professional.   Due to the nature of the event the causal relationship between Vaxelis and the event "unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients" was not applicable.   Further information is expected.
This case was reported by a physician via call center representative and described the occurrence of shivering in a 57-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shivering and malaise. The patient was treated with NSAID. On an unknown date, the outcome of the shivering and malaise were recovered/resolved. The reporter considered the shivering and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: The specific date of vaccination for 2nd dose of SHINGRIX was not given. The patient took an unspecified NSAID which helped to resolve symptoms. The symptoms lasted for a day and a half.
Dizziness & Headache Narrative:  Per nursing report: "Employee presented to EH with complaint of headache and dizziness."  Other Relevant History:
Patient recieved MMR vaccine at approx. 4:00pm on 9/11/2002.  She contacted the nurse who administered the vaccine at 5:00pm to report that the palms of her hands were red and itching.  This started within 10 minutes of recieving the vaccine
Patient is a 100 y.o. female with a history of dementia who presented to Hospital 9/23/2023 from her ALF with fever, poor p.o. intake and increased cough with ambulatory COVID test positive. She was found to be mildly hypoxic in the ER. She was admitted as a DNRCC. Patient was weaned from oxygen, but reportedly spontaneously turned blue and ceased to breathe. She ultimately passed on 9/24/23 at 1038 AM.   1. COVID 19, lethargic only no encephalopathy: Noted decreased p.o. intake, lethargy and worsening cough on 9/22. Ambulatory and ER testing +ive for COVID. Vaccinated x3. Mild hypoxia. CXR non acute. Inflammatory markers ordered. Initiated Decadron, gentle IVF for 1L as appeared dry on exam.  2. Acute hypoxic RF: Secondary to above. Admitted on 2 L. Weaned to RA. 3. Elevated troponin: Noted on admission high sensitive troponin of 37. Suspected demand ischemia in the setting of above. EKG without acute ST changes. No ischemic work-up per goals of care. 4. End stage dementia, functional quadriplegia: Per history, patient nonverbal at baseline, bedbound and did not perform any ADLs. Cargivers provide pureed diet and crushed meds. Admitted at baseline. 5. Severe malnutrition with cachexia POA: BMI 15.62. Due to end stage dementia.
A one inch 25 gauge vanish point needle was properly inserted into the left deltoid muscle. Upon pushing the syringe the needle retracted before dispensing the 0.25 mL booster dose of Moderna vaccine. I observed what appeared to be the entire dose spill down the patient left arm. The patient also confirmed he felt the liquid spill down his arm. I immediately informed patient, another Registered Nurse, and my manager of the malfunction. Patient verbalized understanding and was amicable. I informed we would contact him when we had more definitive answers about the situation.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 7-year-old male patient who received FLUARIX QUADRIVALENT (batch number A2Z34, expiry date 30th June 2017). Concurrent medical conditions included allergic reaction. On 3rd November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 5th November 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting and exhaustion. On 6th November 2016, the patient experienced eye rolling. In November 2016, the patient experienced injection site pain, injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching, injection site swelling and eye rolling were recovered/resolved and the outcome of the injection site erythema and exhaustion were unknown and the outcome of the vomiting was recovering/resolving. The reporter considered the injection site pain, injection site itching, injection site swelling, injection site erythema, vomiting, exhaustion and eye rolling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. Allergic reaction to Pez candy product, when he was around three years old and the patient's lips got red. On 3rd November 2016 at 17:30, the patient received FLUARIX QUADRIVALENT on the right deltoid. On 4th November 2016 (Friday), approximately 18 hours after vaccination, the patient experienced hurting and itching all day in his arm. When the patient's mother looked at patient's arm, she described that the area around the injection site was raised up to 1/4 of an inch and there was a fiery red area that was circular, approximately 5 inches in diameter. The patient's mother called the Minute Clinic and was told to ice it and give him BENADRYL. On 5th November 2016, the area was less raised, pink with a white area in the center the size of a fifty cent piece and by the 12:00 noon, redness and raised area were fully resolved, however the patient began to start vomiting. He initially was vomiting every 15 minutes for 8 episodes, then went to sleep and vomited on and off throughout Saturday into Sunday. The reporter described that the patient would pass out from exhaustion after vomiting which she clarified as he went right back to sleep. On 6th November 2016, 3 days after vaccination, on Sunday, after one episode of vomiting, the patient's eyes rolled back into his head. The reporter called his physician and was told to give him bland diet and keep him hydrated. The patient was referred to his physician.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: After 3 hours patient said feeling better.
Started on May 29th with severe headache, and up until last Monday, 6/12/06 went to doctor with headache and earache. Was also told that he had irregular heartbeat. Was referred to cardiologist who did EKG and Echocardiogram which were found to be normal. Headache free since 6/15/2006 when started prescription for headache.
Fever, shaking chills, body aches, headache, weakness.  Unable to get out of bed for 24 hours.   Weakness and fatigue lasted for a week and then gradually wore off.  I experienced the same on my second dose of moderna.  The booster, my 3rd moderna was slightly better as I did not have shaking chills and the other symptoms wore off after a few days.  The reason I am reporting this now, so long after the fact, is that I do not like reading that the vaccine causes mainly mild reactions.  Some people have a mild reaction, but many people I know have had an experience like mine.  It was the sickest I remember ever being.  Mind you, I'm still glad I had the vaccines, but you need to know it's not a mild reaction in many cases.  Thank you.
I was positive for COVID-19 30APR2022, I started feeling sick. I tested then went to the doctor they gave me steroids, I was achy all over, my throat was hurting, also very short of breath but no fever.
The patient had received the Pfizer COVID-19  vaccination on his first two vaccinations in the series.  The wife had requested that he receive the Pfizer vaccine again on his behalf.  The patient inadvertently received the Moderna COVID-19 vaccination.  We reported this to his facility staff and his wife was notified as well.  We followed up with the wife to discuss the error and what was being done to prevent this in the future.  No adverse effects were reported on follow up.
Case number PHEH2016US024500, is an initial spontaneous report received from a pharmacist on 21 Sep 2016. This report refers to a 34 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported)  at a dose of 0.5ml intramuscularly on 20 Sep 2016. On 21 Sep 2016, the patient experienced arm swelling and was very hot to touch. The patient also experienced erythema on an unknown date. The outcome of the events arm swelling and very hot to touch was reported as unknown for the event erythema was not reported. The seriousness and causality of the events was not reported.
2 hours after vaccination 11-23-20 patient said she started with vomiting, diarrhea, body aches/joint pain, fever, blurry vision, even hallucinations, and insomnia.  11-26-2020 on the night of holiday she was treated in the ER with possible cellulitis.
Initial unsolicited report received from a pharmacist on 27-Sep-2018. This case involves a two-month-old patient (gender not reported) who was vaccinated with a dose of 0.5 ml PENTACEL lot number not reported via unknown route in the left thigh on 26-Sep-2018. The patient's medical history was not reported. Concomitant medications included PREVNAR 13, and ROTAVIRUS VACCINE for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution (it was reported that the ACTHIB (lot number: C5515AA, expiry date: 15-Sep-2019) portion had been reconstituted with sterile water rather than IPV (lot number: C5422AA, expiry date: 15-Sep-2019)). No information on 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 holders 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. List of documents held by sender: none.
Patient reported having Shingles 4-5 years ago on the right torso. Received second Shingrix shot in left arm in July. Ten minutes later, patient felt "like epinephrine was in my brain" for duration of 30 seconds. About 3 days later she experienced twitching in right eye and top of right foot. That night, the foot twitch turned to spasm for a duration of 12 hours, patient reported the foot was kicking up and down.
second Moderna COVID-19 vaccine at this time: 28May2021; experienced soreness after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna COVID-19 vaccine at this time: 28May2021) and PAIN (experienced soreness after first dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 049C21A) for COVID-19 vaccination.     Concomitant products included TRAMADOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna COVID-19 vaccine at this time: 28May2021) and PAIN (experienced soreness after first dose). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna COVID-19 vaccine at this time: 28May2021) had resolved. At the time of the report, PAIN (experienced soreness after first dose) outcome was unknown.            Concomitant drug included blood pressure medication and cholesterol medication.  Treatment medication was not reported.  Company Comment: This report refers to a case of inappropriate schedule of Product administration for mRNA-1273, lot # 045A21A with an AE. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-277233 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received and contains non-significant information. On 05-Aug-2021: In follow-up information 2nd dose detail has been updated  & AE- terminology has been updated as "dose omission issue"(Patient has not received second dose of Moderna COVID-19  vaccine after 42 days) to "inappropriate schedule of vaccine administration" (second Moderna COVID-19 vaccine at this time: 28May2021 ).; Sender's Comments: This report refers to a case of inappropriate schedule of Product administration for mRNA-1273, lot # 045A21A with an AE. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No adverse event; temperature excursion and also reported that the vaccine, VAQTA was administered; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-AUG-2022, a dose of hepatitis a vaccine, inactivated (VAQTA) lot # U033212, expiration date: 07-NOV-2022 (strength, and route of administration were not provided) was administered, following a temperature excursion (product storage error). No additional adverse events had been reported (no adverse event). No additional information was provided.
Arm/Hand swelling and pain, hemoptysis, rhabdomyolysis, hepatic abnormality.
patient received dose from expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial did not undergo any temperature excursions as per the reporter.   This case was linked to MOD-2021-360687 (Patient Link).
Pt received 5th anthrax vaccine. Local reaction occurred 3 days later. Marked by severe swelling, redness. Moderate pain at injection site. Swelling ~ 5 inches also 10/21, but pt reported it was nearly 6 inches at its "peak" of swelling 10/20. Pt was taking Naprosyn for wrist pain until 10/20.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Post Whipple surgery" (unspecified if ongoing), notes: Other medical history: Post Whipple surgery; "Chronic Lyme disease" (unspecified if ongoing), notes: Other medical history: Chronic Lyme disease; "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Other medication in 2weeks product = Thyroid meds. Concomitant medication(s) included: PANTOPRAZOLE, start date: 01Jul2018, stop date: 23Nov2022; GABAPENTIN, start date: 01Jul2018, stop date: 23Nov2022. Past drug history included: Ciproflaxin, reaction(s): "Known allergies: Ciproflaxin", notes: Known allergies: Ciproflaxin; Creon, reaction(s): "Known allergies: Creon", notes: Known allergies: Creon; Statins, reaction(s): "Known allergies: Statins", notes: Known allergies: Statins. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks, vitamin (Still taking from 01Jul2018 to 23Nov2022). Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid started on 25Nov2022 to 30Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving vaccination, syncopal episode while sitting in the chair.  Mom held child from falling to the ground and slowly placed her on the floor.  LOC for less than 2 minutes.  Alert and talking, ice pack to forehead and fluids offered.  Placed in wheelchair and sent to med evaluation for further evaluation.  Mom present at all times.  VS taken 104/80 HR 72 Resp 16, diaphoretic with c/o's of lightheaded and foggy feeling.  Lying on cot with Gatorade/water offered.  Pt has never passed out with a vaccination in the past, had carrots for breakfast and little fluid intake. Very anxious with getting the shot.  Discussion with mom & pt. importance of hydration eating when the next dose given,  it will be in the med evaluation area lying down.  Pt alert an ambulatory with 1/2 Gatorade and 1/2 eater prior to discharge with mom.  Discussed s/s of reaction and call pediatrician with any further concerns.  Verbalized understanding, discharged ambulatory with mom.
weakness; diarrhea; bad headaches; woozy; disorriented; fever/fever up to 102; chills; uncontrollable shaking for next 6 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 10:00 (Lot number: EL9267) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "aprox. 4 year remission from Non Hodgkins Lymphoma" (unspecified if ongoing), notes: aprox. 4 year remission from Non Hodgkins Lymphoma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Administration time: 10:00 AM, vaccine location: Left arm, lot number: EL9262,), administration date: 26Jan2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "woozy"; DISORIENTATION (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "disorriented"; PYREXIA (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "fever/fever up to 102"; CHILLS (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "chills"; TREMOR (non-serious) with onset 16Feb2021, outcome "recovered" (Feb2021), described as "uncontrollable shaking for next 6 hours"; ASTHENIA (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "weakness"; DIARRHOEA (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "diarrhea"; HEADACHE (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "bad headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, disorientation, pyrexia, chills, tremor, diarrhoea, headache.  Additional information:  Reaction/event as reported by primary source: 1 hour after, woozy & disorriented. 3 hrs after: sudden onset of fever & chills, uncontrollable shaking for next 6 hours. On second day, fever up to 102, weakness and diarrhea, bad headaches. 3rd & 4th day : Headache, weakness & continued diarrhea. On 5th day weak but improved.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse and a pharmacist concerning a currently 21 year old male patient who on 15-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot#667912/0933Z). It was reported that the patient developed reaction to PNEUMOVAX 23. At the time of this report, the patient's outcome was not reported. The physician is concerned about this lot number and was hesitant to give other vaccinations with the same lot number. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667912/0933Z were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse who stated that the 21 year old patient with sulfa allergy on 16-OCT-2010 called the pharmacy to report arm swollen, hot, red, tender shoulder to elbow. At the time of the report, it was unknown if the patient had recovered. The patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.