chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight arm soreness; This is a spontaneous report from This is a spontaneous a report by contactable female consumer (patient) reported from a Pfizer-sponsored program . A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced slight arm soreness. The outcome of the event was unknown.  Information of lot/batch number has been requested.
felt sick when he got the first 2 dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick when he got the first 2 dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick when he got the first 2 dose). At the time of the report, ILLNESS (felt sick when he got the first 2 dose) outcome was unknown.        No Concomitant medication details were provided. No Treatment medication details were provided.   This case was linked to MOD-2021-398877, MOD-2021-398918 (Patient Link).
They both began to have flu like symptoms on 03May.; she noticed that her legs began aching; she experienced swelling on her leg, felt foggy and not feeling well./had swelling in her legs to where her knee high panty hose were cutting off her circulation; she experienced swelling on her leg, felt foggy and not feeling well.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient in her 60's received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "she experienced swelling on her leg, felt foggy and not feeling well./had swelling in her legs to where her knee high panty hose were cutting off her circulation"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she experienced swelling on her leg, felt foggy and not feeling well."; INFLUENZA LIKE ILLNESS (non-serious) with onset 03May2021, outcome "unknown", described as "They both began to have flu like symptoms on 03May."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she noticed that her legs began aching".  Additional information: It was reported that in her 60's. She and her husband both received the first covid vaccine dose on April 23rd. The 2nd dose will be on 14May2021. On 03May as per the caller she experienced swelling on her leg, felt foggy and not feeling well. They both began to have flu like symptoms on May 3rd. The caller reports that her symptoms were not as severe reporting that she felt mostly "Foggy" and like she had a light flu, but she was still able to work and go shopping. But she did report that when she was out shopping she noticed that her legs began aching and she realized that her knee high panty hose, which are normally loose and falling down were tight and digging into her legs because her legs were swollen. When she got home she elevated her legs and it eventually went away. She reported that this was concerning as she didn't see it on the list of side effects and their symptoms appeared over 1 week after having the vaccine. Asking was this normal. She also asks if the symptoms can be delayed after the first dose. She had a side effect after the first dose of the vaccine. Should she get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
urinary tract infection; experiences vertigo "usually when I get up" / vertigo while sitting and throughout day; headache the day of receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (experiences vertigo "usually when I get up" / vertigo while sitting and throughout day), URINARY TRACT INFECTION (urinary tract infection) and HEADACHE (headache the day of receiving the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Not provided and not provided) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (headache the day of receiving the vaccine). On 13-Feb-2021, the patient experienced VERTIGO (experiences vertigo "usually when I get up" / vertigo while sitting and throughout day). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, VERTIGO (experiences vertigo "usually when I get up" / vertigo while sitting and throughout day), URINARY TRACT INFECTION (urinary tract infection) and HEADACHE (headache the day of receiving the vaccine) outcome was unknown.            No Treatment information was reported
FLUBLOK Quadrivalent that was administered to a 12 year old patient with no adverse event; Initial information regarding the valid unsolicited non-serious case received from pharmacist on 08-Oct-2020.  This case involved a 12 years old female who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age) with no adverse event.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug was not reported. No other vaccines were administered.  On 06-Oct-2020, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Lot number-UJ448AB, expiration date unknown) via intramuscular route in the left arm for prophylactic vaccination.  This was a case of actual medication error due to Inappropriate age at vaccine administration. (latency: at the same time of vaccination)  At the time of report, 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.
NO adverse event; Expired dose; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 26-FEB-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot # reported as "1660945", expiration date 13-FEB-2021, for prophylaxis.
Tongue swelling, lip tingling. Rapidly resolved with IM Solumedrol.
Recipient was identified post clinic when report was generated from data on vaccinations given. He was found to be 17 yr 9 months. Contact was made by me with his mother who said she relied on another older son to make appointment and take to clinic. I explained in detail that he was out of the authorized age range and also explained the moderna and now CDC view that the vaccination can proceed with the second dose. Mother agreed to the second dose which is scheduled. 2 others that week were found to have been under 18. It was the 2nd/3rd week Ct opened vaccination to anyone over 16. This age of course was intended for Pfizer only. We don't provide Pfizer. Subsequently signs were placed indicating min age of 18,staff were reinforced to check age and a age calculation based on birthday and date of clinic was completed and included as a column in the daily list of scheduled clinic appointments distributed to front desk personel, vaccinators and vaccinator assistants for review at contact. There were no outcome adverse events associated with this vaccination.
Pt. states that after receiving the 3rd dose of Phizer 12/09/2021, started experiencing symptoms 12/10/2021 of nausea, vomiting, and dizziness. Self-treated with Benadryl and Electrolytes. No noted Primary visit/communications, Symptoms have subsided.
LOCAL REACTION OF ITCHING AND DIFFUSE EDEMA WITH INDURATION (8x10 CM) AT SITE OF INJECTION: LEFT UPPER ARM.
Information has been received from a registered nurse via a physician's assistant concerning a child who was vaccinated with an unknown vaccine that may have been MMRII several years ago. Subsequently, the patient developed autism. Upon internal review, autism was considered to be an other medical event. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy for one day after vaccination), ERYTHEMA (Redness of size 4 inch by 6 inch), VACCINATION SITE PAIN (Soreness and redness of the left arm at site of injection) and INJECTION SITE ERYTHEMA (Soreness and redness of the left arm at site of injection) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy for one day after vaccination), ERYTHEMA (Redness of size 4 inch by 6 inch), VACCINATION SITE PAIN (Soreness and redness of the left arm at site of injection) and INJECTION SITE ERYTHEMA (Soreness and redness of the left arm at site of injection). At the time of the report, PAIN (Achy for one day after vaccination), ERYTHEMA (Redness of size 4 inch by 6 inch), VACCINATION SITE PAIN (Soreness and redness of the left arm at site of injection) and INJECTION SITE ERYTHEMA (Soreness and redness of the left arm at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Patient on the same day (several hours later) vaccine was administered started having generalized seizures and fever.  Patient was admitted to Hospital for 7 days. Other diagnose: pneumonia.
ILLNESS; IMMUNE SYSTEMS ARE LIKELY TO HAVE BEEN COMPROMISED BY SOMETHING; This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced illness, and immune systems are likely to have been compromised by something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the illness and immune systems are likely to have been compromised by something was not reported. This report was non-serious. This case, from the same reporter is linked to 20220146936 and 20220153841.  Version created to amend previously reported information on 21-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Client received the 1st dose of Pfizer COVID vaccine lot #EW0185 and expiration date 6/24/21 at 5:52PM.  Per vaccinator,  reports that client was saying, "Wow that was aniclimactic" after getting vaccine. Per vaccinator, she notices within 1-2 minutes client got quiet and then reported "I am not feeling well."  Client received vaccine in left deltoid. RN requested PHN 1 to get gravity chair.  PHN grabbed gravity chair and asked RN to get BP cuff and pulse ox. PHN arrive to assess client and found client alert and oriented x 4 in chair at 5:53PM. Client was already drinking water given by vaccinator when PHN arrived.  Client reports he was experiencing "dizziness and slight shortness of breath." PHN ask client if he thought he was steady enough to switch to gravity chair. Client stood up slowly and sat in the gravity chair. RN 1 asked client if his throat felt tight-client responds-"No" and coached client to take deep, slow breaths.  At 5:55PM vitals are: blood pressure: 130/90, pulse: 55 and oxygen: 98%.  At 5:57pm client reports no longer feeling shortness of breath.  Client is speaking in full sentences and able to answer all PHN questions about chest pain and headache and client reports having neither. At 6pm vitals: blood pressure:125/90, pulse:75, and oxygen:100%. PHN instruct RN to get Lead PHN  or Co-Lead. Client reports he has slight dizziness and feels lightheaded and reports that earlier he had blurred vision but now is seeing clearly.  At 6:03PM vitals are: blood pressure:160/100, client appears pale and heart rate:140, and oxygen: 100%.  Lead PHN  arrives to take over assessment and PHN starts calling 9-1-1 at 6:04PM as blood pressure is repeated by co-lead :180/90, oxygen100% and pulse 129 and upon auscultation hears clear lungs and heart palpitations.   Client is then reports shortness of breath and dizziness, no headache and no blurred vision.  Parent reports that client has a history of asthma but rarely needs inhaler so she does not have it on her and that client recently had been on antibiotics for Gastrointestinal history and a bad cough (not COVID)-all symptoms had been resolved before receiving vaccine.  At 6:07pm Vitals: blood pressure: 170/90, pulse:100%; no change in symptoms.  At 6:08pm vitals: blood pressure:170/90, pulse: 94, and oxygen: 100%, client reports experiencing tightness in chest and unable to complete breath. Client reports no chest pain. Vitals taken again by RN due to new symptom, blood pressure: 122/70, pulse:93 and oxygen: 100%.  RN auscultate again and hears palpitations have slowed and lungs clear. At 6:10PM, vitals are blood pressure:124/74 and pulse: 96. Client reports feeling "shaky, tightness on chest" and could not take full breaths.  Paramedics assumed care at 6:12pm. Client and parent left on stretcher with paramedics to be transported to Hospital.  Tell security that mother is leaving blue pathfinder in parking lot. Security assures he will not tow vehicle.
This spontaneous case, initially received on 08-Sep-2016, was reported by a health professional and concerns a 56-year-old female patient. Administration of company suspect drug(s): The patient received AFLURIA on 06-SEP-2016. Dose regimen: Not reported, Route of administration: Subcutaneous, Batch number: WT54206. No additional suspect drugs. Adverse reactions/events and outcomes: On 06-Sep-2016, the patient thinks the vaccine was given subcutaneous (outcome: not reported, special circumstances: incorrect route of drug administration). On an unknown date (by 08-Sep-2016), the patient experienced erythema in the area where the injection was given (outcome: not reported).
PATIENT COMPLAINS OF METALIC TASTE IN HER MOUTH AFTER THE VACCINATION. SHE ALSO COMPLAINS OF ITCHY LIPS LIGHTHEADEDNESS AND NAUSEA AT 4:37PM. PATIENT WAS ASSESSED BY RN ODOOM. ON ASSESSMENT PATIENT HAD FLUSHING ON FACE. BP IS 144/73, P- 78, R 19. ORAL BENADRY 25MG WAS OFFERED AT 4:42PM. PATIENT WAS MONITORED ADDITIONALLY FOR 15 MINS. AT 5PM PATIENT STATES SHE IS FINE, EDUCATION WAS REINFORCED ON THE POTENTIAL SIDE EFFECTS AND CLINICAL SITE LEADS WERE NOTIFIED
Had a vaccine on 7/6/17. He developed swollen arm, neck stiffness, fever, chills. Patient went to PCP was told he had allergic reaction and was told to take ibuprofen/TYLENOL. Stated that he feels much better today (7/8/2017).
Palpitations, Skipped Heartbeats, Shortness of Breath...  Possible indication of mild Myocarditis?
Extreme fatigue/muscle soreness and hypersensitive skin concurrent with alternating hot flashes with profuse sweating and cold flashes with shivering.
Patient was given 0.2mL of the pediatric Pfizer BioNTech vaccination that was not diluted. Patient received what would be equal to about triple the original dose being that this was not diluted. Patient has a sore and stiff arm with multiple visible lymph node swelling under the arm and down the torso.
Patient presented for 2nd Covid Vacccine in series. The vaccinator noted the patient received a 10mcg pediatric dose for the 1st vaccine 3 weeks previously. The patient is 12 years old and was 12 years old at the time of the 1st vaccine. The patients mother was aware the patient had received a 10mcg pediatric dose and wanted him to receive the same 10mcg pediatric dose for the 2nd vaccine The 10mcg pediatric dose was documented and administered.
Muscle aches and pains, headache, weakness, dizziness, fever, chills.
This spontaneous report was received from a nurse concerning a 7 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strength, dosage schedule, anatomical location not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111:
sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE, FENOFIBRATE, ARIPIPRAZOLE (ABILIFY) and MONTELUKAST for an unknown indication.    In March 2021, 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 PAIN (sore right arm). At the time of the report, VACCINATION SITE PAIN (sore right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was provided.   This case was linked to MOD-2021-335251.
This spontaneous report as received from a consumer regarding her friend refers to a 66 year old male patient. Concomitant medications of the patient included many unspecified medications (reported as He's taking a mountain of medications All Unspecified). The pertinent medical history of the patient included lot of unspecified medical issues. Approximately on 13-JUN-2014 (reported as about 2 weeks ago) the patient was vaccinated with PNEUMOVAX 23 at his office route injection for vaccine. The reporter stated that approximately on 13-JUN-2014 (reported as for the first couple of days soon after receiving the vaccine) the patient experienced pain at injection site. Approximately on an unknown date in June 2014 (reported as however the last 10 days) the patient developed slight fever, muscle pain in his shoulders, arms, back and quads described as pain level 6 to 7. On an unknown date the patient developed swelling and heat in his thyroid. Lab diagnostic studies included blood work, X-rays which are scheduled. The outcome of pain at injection site, swelling and heat in his thyroid and slight fever is unknown. The outcome of muscle pain in his shoulders, arms, back and quads described as pain level 6 to 7 was reported as recovering/resolving (reported as muscle pain started feeling a little better last night). The patient sough medical attention. No product quality complaint was involved. Additional information is not expected.
PATIENT EXPERIENCED INFLAMMATION AND HEAT AROUND THE ADMINISTRATION SITE WITHIN 5 MINUTES OF IM ADMINISTRATION. PHARMACY PROVIDED ICE FOR COLD COMPRESSIONS. PATIENT STAYED AROUND THE PHARMACY FOR TOTAL OF 20-25 MINUTES. PATIENT LEFT THE PHARMACY IN A STABLE CONDITION.
Diffuse rash w/bullae 7 days post inject; Area around umbilicus showing early signs of necrosis;
On 2/14/2022, I tested positive for COVID-19. I had headaches, runny nose, mild cough, and fatigue. These symptoms lasted from 7-10 days. I still have fatigue and headaches that maybe due to after affects from COVID. I went to Urgent Care and my primary care physician due to vertigo that could be due to post COVID.