chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urgent Care visit; called out of work; felt like just gotten off a roller coaster; numbness on the inside of the arm all the way down to fingertips; light-headed; pain in arm; pain escalation; swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the inside of the arm all the way down to fingertips), DIZZINESS (light-headed), PAIN IN EXTREMITY (pain in arm), PAIN (pain escalation) and SWELLING (swelling) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced HYPOAESTHESIA (numbness on the inside of the arm all the way down to fingertips), DIZZINESS (light-headed), PAIN IN EXTREMITY (pain in arm), PAIN (pain escalation), SWELLING (swelling) and FEELING ABNORMAL (felt like just gotten off a roller coaster). On an unknown date, the patient experienced EMERGENCY CARE (Urgent Care visit) and JOB DISSATISFACTION (called out of work). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness on the inside of the arm all the way down to fingertips), DIZZINESS (light-headed), PAIN IN EXTREMITY (pain in arm), PAIN (pain escalation), SWELLING (swelling), EMERGENCY CARE (Urgent Care visit), FEELING ABNORMAL (felt like just gotten off a roller coaster) and JOB DISSATISFACTION (called out of work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-JUN-2021, no new information
Chills and Shakes started at time indicated, 2 hours later vomiting.  Vomiting only lasted 20  minutes. Second night, extreme sweating. Sunday still have some sweating and nausea but feel 90% better than Friday night.
I had severe arm pain and redness for 2 days following the injection, accompanied by fever (101 degrees), chills, and great fatigue.  All resolved by the third day. But on the tenth day after the vaccination, I woke to a sore left arm with a raised bright red rash in the bicep area approximately 4 inches wide and 7 inches long . The entire upper arm area was swollen. The pain, swelling, and redness gradually reduced over the next 6 days. By the 4th day, a swath about 2 inches wide extended from wider bicep rash down to nearly the elbow. Today is the 6th day  since the rash appeared. Most of the original area has cleared and the swelling is decreased, but the newer swath remains red, though lighter than originally.  During this time I felt unwell and tired, often with a slight fever of 99 (usual is 97).
patient extremely confused & lethargic. Patient was taken to the emergency room and admitted to the hospital.
Pain in arm.  I saw her in clinic a week after injection.  No injection site abnormality.  Pain in consistent part of arm.  Shoulder joint itself does not appear involved.
"Patient presents with SOB Abnormal Lab Results pt sent here from SNF due to H/H 7.1/21.6 creatnine 3.26.   sepsis secondary to Covid 19.  Tx.  Remdesivir in addition to steroids, antibiotics. discharged  to rehab "
She said she had itching from her scalp to her toes starting the night of the vaccine.  This was gone by Friday morning.  She took Benadryl for the itching and it resolved.
Narrative: Patient received 1st dose of Moderna vaccine. Patient was admitted to outside facility shortly thereafter for acutre renal failure. Unclear if result of vaccine or if patient was volume depleted. Outside records unavailable.
the syringe exploded and vaccine splashed in to the pharmacist face; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (the syringe exploded and vaccine splashed in to the pharmacist face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (the syringe exploded and vaccine splashed in to the pharmacist face). On 03-Jun-2021, ACCIDENTAL EXPOSURE TO PRODUCT (the syringe exploded and vaccine splashed in to the pharmacist face) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter
after receiving the flu vaccine patient started to feel "funny in left side of throat" able to converse with staff thru whole process. Dr notified. patient has epi pen with her, she thought she might have a reaction since she is sensitive to alot of meds. has had flu shot in the past without reaction.  Patient felt like she needed the epi pen so she administered it. vitals taken within normal limits. appeared to be in no apparent distress , was conversing with staff and watching videos on her phone. was made aware by Dr she needed to go to ER, she refused to have 911 called. she had staff call her daughter. patient was one on one until daughter arrived. vital again in normal limits. patient left with daughter again no apparent distress ambulating and talking with staff and daughter
"Covid arm"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION ("Covid arm") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION ("Covid arm"). At the time of the report, VACCINATION SITE REACTION ("Covid arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Gardasil 9 was given in place of Vaxneuvance. Called Merk and they have no record data on patient safety for ages under 9. Informed parents, parents were told to monitor at home. Plan is to call and check on patient later today and again tomorrow.
Initial report received on 12/5/05 from a health care provider. An adult female patient received an IM injection of Fluzone SV 2005-2006, lot number U1930AA, on an unspecified date. Number of previous doses was reported as one.  Within five minutes of receiving the vaccine, she had a seizure. An ambulance was called. However, the patient refused transport. There was no illness at the time of vaccination and no known pre-existing medical conditions. The patient will reportedly follow up with her physician. At the time of this report, the patient had fully recovered. (OMIC)
Within 2 or 3 hours of the vaccine I began having teeth and facial nerve pain.  This has been ongoing with intense fatigue.  Occasional dizziness, foggy thinking, and difficulty focusing.  I initially had a headache for a few days straight and now have frequent headaches and a feeling of pressure.  I've been awakened from sleep with a feeling of intense fear or dread which has never happened to me before. I have joint pain mostly in my feet, neck and back.  This has continued.  I also am having irregular menstrual cycles.
32yo female with PMH of new onset Type 2 DM (diagnosed by PCP yesterday),? brain fog for last couple of months? and tiredness presented for her first Pfizer vaccine today. She received the vaccine without incident. She presented to observation remained there without reports of adverse effects. She was about to be discharged at 2:50 pm, at which time when she reported feeling her heart racing.  She denied SOB, difficulty breathing. She was not pale or diaphoretic. She reported eating a small amount prior to the visit and had consumed a limited amount of fluid. She did not take her blood glucose level as she is awaiting a glucometer, which she ordered yesterday. She was offered water, and encourages to practice slow breathing.  She continued to feel the heart racing. Her BP was taken at 2:55pm noted to be 176/107, heart rate 119, O2sat 100% resp 22.  She was encouraged to continue to concentrate on relaxing and to breathe slowly.  Over the next 15minutes the patients heart rate and BP gradually decreased as she regained control. During this time, she reports she had not mentioned to the vaccinator that last night she has a similar episode of palpitations which resolved on its own without intervention.  3pm 174/96 HR 110 O2sat 100% Resp. varied, during the next 30 minutes as patient?s anxiety level waxed and waned. At 3:33pm her BP gradually decreased to 129/82, HR 85, O2sat 100%, Resp 20. Her color was normal. At this time, she was asked to stand which she did. Upon sitting down, she again began to c/o repeat onset of palpitations. At 3:37pm her BP was retaken, noted to be 139/94 HR 93, O2sat varied between 98 and 100%, depending on her ability to concentrate on breathing. She reported feeling anxious and reported a feeling of doom.  She requested she be sent to the hospital for evaluation. Paramedics were called.  She continued to have elevated BP at 150/93, HR of 102 to 110.  Around 4pm paramedics arrived. Patient was evaluated and taken to hospital. She was stable on departure.
Headache, Myalgia,  fatigue Narrative:  Other Relevant History:
Patient received 2nd dose pediatric Moderna at our clinic without issue. On 08.29.22, we found out that our pediatric moderna vaccine was past its beyond use date. It was taken out of the freezer on 6.30 or 7.1 which would mean this patient received an expired vaccination. Moderna was contacted & investigated this LOT number, expiration date, and its viability. We received that this dose was still viable and confirmed this with our physician Dr. I contacted the family to inform them of the error, the results of the Moderna inquiry and what Dr. stated. The family was extremely understanding and does not want to repeat their second dose of pediatric Moderna.
Tested positive with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive with Covid) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Diabetic.   On 06-Sep-2022, 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 received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 09-Sep-2022, the patient experienced COVID-19 (Tested positive with Covid). At the time of the report, COVID-19 (Tested positive with Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2022, SARS-CoV-2 test: Positive.         Products - Comirnaty, Pfizer-BioNTech COVID-19 Vaccine  [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to12 years -15/15 mcg per dose.  Concomitant product use was not provided by the reporter.  Six months was passed, after discussing with doctor, the patient wanted to get another COVID booster before traveling aboard for a month.  Treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:00 as dose 1, single (Lot number: HG4664) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Cataracts" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hiatal hernia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GH9703, Location of injection: Arm Right), administration date: 04Oct2022, when the patient was 48-year-old, for Covid-19 Immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: FF2589, Location of injection: Arm Right), administration date: 01Oct2021, when the patient was 47-year-old, for Covid-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Right), administration date: 08Jan2021, when the patient was 47-year-old, for Covid-19 Immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Right), administration date: 18Dec2020, when the patient was 47-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2023) Positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (COVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Infanrix administered to patient over 7; Infanrix administered, supposed to receive Tdap; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Interim Practice Manager stated that the Infanrix was administered to a over 7 years old patient. The patient was supposed to receive a Tdap vaccine. Lot number and expiration date was not available at time of call. The reporter consented to follow-up via mail. Additional Supportive Information: The patient received Infanrix instead of Tdap,which led to inappropriate age at vaccine administration and wrong vaccine administered.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 9th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is a physician. The patient stated that, his arm was sore and had no other symptoms and spent the evening (from 6:30 to 10 pm) emcee'ing a benefit event (not otherwise specified).
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/28/2021 and 2/23/2021. Presented to physician office on 8/9/2021 for evaluation of dry non-productive cough, clear runny nose x3 days. Was prescribed levofloxacin for acute sinusitis, benzonatate, albuterol nebs, and prednisone taper. Patient called provider back on 8/11/2021 stating symptoms are still persistent and a COVID test was ordered w positive result. on 8/12 the prednisone taper was discontinued and patient was prescribed dexamethasone 4 mg QD.  on 8/17/2021 patient presented to ED with shortness of breath and hypoxia. Pulse ox on presentation was 70% on room air.  Patient was treated with dexamethasone, Remdesivir, ascorbic acid, zinc sulfate,  and convalescent plasma. Patient status deteriorated and was switched to comfort care on 9/4/2021, expired at 1335.
Sore arm after each dose; very mild flu like symptoms after each dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 009C21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose) outcome was unknown.            Concomitant medication information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-406661, MOD-2021-406670 (Patient Link).
Vaccine administered at 11:45AM 9/16, and about 3hrs later she vomited once and had a temp of 102.8. Next day limped. Never had diarrhea and no contacts without symptoms. Family all well 3 days later.
Injection site started itching; Hard; Swollen; Quarter size red circle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE INDURATION (Hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Quarter size red circle) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE, AMLODIPINE, LOSARTAN, MONTELUKAST, VITAMIN D NOS, PRAVASTATIN, IBANDRONATE SODIUM (BONIVA), METFORMIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE INDURATION (Hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Quarter size red circle). On 05-Feb-2021, INJECTION SITE PRURITUS (Injection site started itching), INJECTION SITE INDURATION (Hard) and INJECTION SITE ERYTHEMA (Quarter size red circle) had resolved and INJECTION SITE SWELLING (Swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol.   Action taken with second dose of mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
This spontaneous report was received from a pharmacist via Pfizer sales employee (reference number 2016505520), referring to a patient of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown date, the patient was vaccinated with PNEUMOVAX and the reporter stated that on unknown date the patient received PREVNAR 13 (manufacturer Pfizer) (formulation, concentration, dose, frequency, route, lot number and expiration date were not reported). On unknown date, after the vaccination with PNEUMOVAX the patient experienced cellulitis and when the patient was given PREVNAR 13 the patient also had cellulitis after a few days. At the time of the report, the outcome of the event was unknown. A product quality complaint was not involved. The pharmacist stated that cellulitis was a result of vaccination with PNEUMOVAX and PREVNAR 13 was unknown. Upon internal review the cellulitis was considered to be medical significant. Additional information has been requested.
Patient given pfizer bivalent booster for correct age group but should have received moderna bivalent booster. No adverse side effects noted at this time.
This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 88-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 3rd July 2018, the patient received SHINGRIX. On 3rd July 2018, immediately after receiving SHINGRIX, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved. It was unknown if the reporter considered the numbness of upper extremities to be related to SHINGRIX. Additional details were provided as follows: On 9th April 2018, the patient received 1st dose of SHINGRIX and did not experience numbness. The patient received 2nd dose of SHINGRIX and ever since getting the 2nd dose, the patient had numbness in his arm that goes all the way down to his fingers. The numbness started right after the 2nd dose and patient was still experiencing the numbness all down his arms to fingers. No further information was provided.
About 8-10 mins after injection, pt complained of flushing, tingling in legs/feet and weakness.  after about 20 mins symptoms still present, so gave her 2 x  25 mg diphenhydramine tablets. Symtpoms resolved and pt left pharmacy after 1h20 mins of observation. followed by w pt at 8:06pm (several hours later) and she was fine but a bit tired and weak.
Mother called on 9/21/17 @ 10:48 am stating that patient had reaction on vaccine site given on 9/18/17. He had red raised bump bigger than size of a quarter and it is swollen. Mother was offered an appointment to bring patient in same day, but she denied and wanted Dr. to return her a call. She took the patient to urgent care towards end of day when Dr. returned a call. Mother witnessed a seizure (described as rolling of eyes backwards with sleepiness. Was evaluated at hospital but EEG was normal.