chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath/difficulty breathing; dizziness; rapid heartbeat; as if someone was sawing my arm off; pain in her injection arm all the way down to her fingers; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain in her injection arm all the way down to her fingers), HEART RATE INCREASED (rapid heartbeat) and FEELING ABNORMAL (as if someone was sawing my arm off) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M049(?)) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain in her injection arm all the way down to her fingers), HEART RATE INCREASED (rapid heartbeat) and FEELING ABNORMAL (as if someone was sawing my arm off). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain in her injection arm all the way down to her fingers), HEART RATE INCREASED (rapid heartbeat) and FEELING ABNORMAL (as if someone was sawing my arm off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) 120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided no treatment information provided
No additional information provided; The patient was administered an improperly stored dose of PNEUMOVAX23 on 10/31/2019; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 31-OCT-2019, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S004548 with expiration date in 12-AUG-2020 (route of administration, strength and anatomical location not reported).  The pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 47.3 degrees Fahrenheit (°F) for the time frame of 20 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:  manufacturerstate: ; manufacturercountry: ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA000302:
Vertigo, disequilibrium, presyncope, light headedness and severe nausea. Continued for three days now. Rest is only treatment attempted.
pain in her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm".  Additional information: The patient wanted to know if she could take Tylenol for the pain in her arm but did not want to be transferred. She decided to call someone tomorrow to see if she can take Tylenol. Was not able to read ISI or IVR due to reporter hanging up. It was unknown if the reporter is a Healthcare Professional (HCP) or not and Is the reporter the prescribing HCP or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came to vaccination site to recieve second dose of Pediatric Pfizer vaccination. After shot was given and in observation, patient's parents alerted paramedics he was experiencing chest pain. No shortness of breath, difficulty breathing, neurological symptoms reported. Patient stated minimal chest pain, specifically 3/10 and felt like someone was putting pressure on his chest or sitting on it. Vital signs at 3:35 PM were as reported: blood pressure 110/63, heart rate 93, SPO2 98%, respirations 20. Patient was sitting in booster seat, with mask on and no difficulty breathing and answering questions independently. An  EKG was taken that showed no abnormalities.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of influenza in a currently 47-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included BACTRIM allergy. On 10 October 2005 the subject, at the age of 41 years, received a dose of FLUARIX (1 ml, unknown route, unknown arm) and experienced overdose. The subject was administered a 1 ml dose of FLUARIX instead of the indicated 0.5 ml dose. At an unspecified time after vaccination with FLUARIX, the subject experienced influenza and vaccination failure. According to the healthcare provider, the subject said she got the flu after getting the vaccine. The healthcare professional noted that the subject received FLUARIX or FLULAVAL, but lot number provided was for FLUARIX. The healthcare professional answered no to the seriousness criteria. This case was assessed as medically serious by GSK. At the time of reporting the influenza was resolved.
Toxemia from vaccine. Flailing nerve pain all over body, numbing in hands and feet, cramping in intensities and uterus, difficulty walking, swollen joints.
positive COVID test result; positive COVID test result; cough; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 16Dec2020 (at the age of 49 years old) as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 21Dec2020, the patient experienced a strange cough. The patient reported that she received the first dose of COVID vaccine on 16Dec2020 and that she was then exposed to her husband who tested positive on 17Dec2020. Due to a strange cough, she was tested on 21Dec2020, which resulted in a positive COVID test result. The outcome of the events strange cough and positive COVID test was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Information has been received from a registered nurse concerning a 5 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) at one year old and a couple of years later developed shingles. Patient had not received the second dose yet. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Temp 102 x2 days, extreme fatigue,  difficulty walking due to all over joint and muscle pain,  hot flashes 42-50times per day until one week ago , dizziness and nausea during hot flashes, all over body bloating ....especially abdomen, still have  joint pain and bloating .  Hot flashes were thru the day and night.  Soaking clothes and causing severe dizziness and nausea.   Vomited a few times.   Hot flashes at night woke me up just before coming on and so I rarely slept for more than 40 min at a time for  a month.   Depression and mood swings were  difficult to deal with.     Elevated ALT
Pt vax 3rd hepta B on 18Jul90.  HBsAB showed titer 1.7RU.
Shortness of breath & jawline tingling on the day of the injection, itchy rash on neck and chest, which spread to legs after several days
There is no adverse event to report -- Just reporting the patient was given the wrong dose. Patient should have been given orange top vial(5-11 y/o) -- Instead patient was given adult dose, grey cap, 0.3 ml. Attempted to call patient's parents but was unsuccessful.
NO ADVERSE EVENTS. tested positive despite initial positive tests 9 months ago and  had both vaccinations. Tested COVID positive at PIMC 06/26/2020 Pfizer COVID vaccinations given Jan 01/06/2021 and Feb 02/03/2021. TESTED POSITIVE 5/15/2021
redness and swelling below injection site of Kinrix Vaccine. roughly 1.5 inch in diameter.
Patient was given flu vaccine per provider. Patient has received flu shot in the past with no interactions to date. Nurse administered flu vaccine to right deltoid. Patient was anxious but tolerated injection well. Patient stated to her mother ?mom I didn?t cry? mother responded you did great. Mother was also getting flu vaccine and b12 per provider at this time. Patient raised her right sleeve and was looking at the band aid when she stated to her mother that she was going to pass out. Nurse advised mother to stay with her and nurse went across the hall to get Dr. Patient became unresponsive as nurse and Dr. entered the room. Skin became diaphoretic and cyanotic. Dr. and nurse assessed the patient and they ordered Epi to be administered. Staff was alerted additional help was needed and Epi Single dose 0.3 mg x1 was administered at approximately 320 pm. EMS call and EMS alerted after Epi pen injection. Mother was removed from the room. O2 was applied to patient via NC as ordered by Dr. patient?s O2 sats unstable 4L O2 NC to patient. EKG applied with abnormal rhythm AED and crash cart were accessible. Patient?s BP at 3:32 PM manual 156/64 P 43. Ems arrived to transport patient at this time patient became verbal and consciousness was improving. Ems took over care the patient and patient was to be transported to hospital.
High fever; on exam had tremorous, jerky movements; No family hx of convuls or allergy;
mild non-pitting edema of rt hand, non elsewhere;full ROM w/mild pain in the rt arm;diffuse muscle tenderness entire rt upper arm;sx began approx 2 days ago;
Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; shaking/shaking and could not hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of headache (received 1st dose on an unknown date, refer case US2021AMR028691).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and tremor. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and tremor were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and tremor to be related to Shingrix.  Additional details were provided as follows: The case reported by patient herself. The age at vaccination was not reported. The patient received shingrix and had intense symptoms of bad headache, chills, shaking and could not hold a cup to drink. The patient also experienced muscles and joints ache, painful bilateral lower back pain and cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. The patient received Pfizer Biontech covid-19 vaccine and experienced bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028691:Same reporter
12 minutes after vaccine had left sided chest pain and mild shortness of breath.  In the evening the same day developed chills and diffuse muscle pain. Following was lightheaded, waves of Tachycardia (resting HR 50s would go as high as 120s at rest).  Symptoms came in waves of chest pain, SOB, lightheaded and tachycardia throughout. Patient seen in clinic 1/7/2021 with symptoms slightly improved.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.11.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 9AM, 10AM, 11AM, 2PM and 3PM with temperature was 32, 32,32, 35 and 35 respectively, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
No adverse event; Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7248B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022 at 9:15 PM, 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 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    The patient ID. The concomitant medication was not reported. The treatment medication was not reported. 113 bivalent doses administered after the BUD to patient of 12 and up. The information was unknown whether the patient received other vaccines in the 4 wees prior to COVID-19 vaccination.
4 to 5 patients received shot past 30-day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Treatment was reported by reporter.
Symptoms day of injection:  Evening hours  (around 7pm) felt sore arm, low grade fever and headache. Lasted until following day and then felt tired for 3 or 4 days following. 1 Week later: Friday afternoon April 23rd  around 1 pm, I felt very light headed. Then around 3:00pm I started to get vertigo. The dizziness lasted until around 7:00pm and then stopped. Around that same time I started to develop a fever. The fever lasted until Saturday afternoon April 24th until around 2 or 3 pm. Then felt tired the remainder of the day.  Sunday I felt good.
Racing heart, dizzyness,  shaking, heavy breathing.... Sort of like an anxiety attack.  Started about 35 minutes after shot Directly after shot  I felt a rush of blood  and felt uneasy.  They watched me for about 20 minutes but the severe symptoms started about 35 minutes after shot
9 y/o female with sx of fever (felt warm), muscle pains, runny nose & sore throat, tenderness following Vaccine adm x 2d.
redness, pain, itchy, hot, hardness and little bumps like pimples at injection site on my right upper arm
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown ages and genders who on an unknown dates were vaccinated with an improperly stored (incorrect product storage) doses of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
24hr p/vax devel hives over 30% body in no acute distress used DPH;hives gone in 24hr;22AUG97 hep #2 given no side effects;
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient received an improperly stored dose of VARIVAX (Merck) injection, lot # L030158, expiration date: 11-AUG-2017 (dose and route of administration was not reported). There were no concomitant medications provided. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came in today Saturday 09/30/23 stating that her left arm is completely swollen.  She doesn't know if it is related to the vaccine but wanted for me to reported
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 19th April 2018, for tolerance refer case US2018187700). On 15th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain and injected limb mobility decreased. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, shoulder pain and injected limb mobility decreased were unchanged. It was unknown if the reporter considered the injection site pain, shoulder pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient received SHINGRIX on the left arm. The patient experienced severe pain at the injection site and shoulder. She could not even lift her arm. The patient had denied permission to contact their physician. The patient was referred to her physician. No further details were provided.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietna at the time of the vaccination and no adverse reaction reported since given vaccine.
pt recv vax 8APR97 & 9APR97 pt devel redness & swelling on arm around the inj site as well as chills & sweats;
Pfizer BioNTech COVID-19 Vaccine EUA:  Patient with office visit for follow up s/p heart transplant received entire multi-dose 1.8mL vial of Pfizer BioNTech Bivalent vaccine on 10/14/2022. Pt has no reported significant reactions. No harm came to patient.
A 20 year female developed 6cm X 10cm erythema and swelling around injection site, extending below elbow. Treated with antihistamine with initial resolution of condition. No previous reaction. Still recovering.
MD order HPV for pt, she recieved her first dose 10/26/06, 2nd dose on 1/5/07, 3rd dose on 4/27/07