chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Afluria Quadrivalent on 08/31/2020 On 09/06/2020 the patient came to the pharmacy in the drive thru, and reported that she was experiencing a throbbing pain and soreness in her left arm where the immunization was given. The patient stated that the pain began a few days after she received the immunization. I examined the patient's arm and there did not appear to be any redness or swelling. The patient said the site was not hot to the touch, the patient did not have a fever, and the only adverse reaction she had to report was soreness and pain at the injection site.
Large raise bump at injection site; about the size of my palm. I have a sleeve tattoo so I can?t t lol if it?s red. Doesn?t feel warm. Area is hyper sensitive. Even a shirt touching it is quite painful.  Can?t lift right arm to even put deodorant on.  Sever muscle and joint pains. Charlie horses up and down legs. It hurts to lay down or put my back on anything. Walking is shaky because of the pain in my legs.  Headache.  101-102 fever without medication.  Ibuprofen lowers the fever but does not touch the pain.  Severe chills/can?t get warm. Exhausted and can barely get out of bed because of it and the pain.
The pt experienced nausea, lightheadedness for 10-15 min. The pt was instructed to lay on her back with feet elevated. Cold compresses were applied to forehead. Pulse and BP were monitored. Symptoms occurred immediately post vax.
pt talked to store manager on Saturday 06-01-2019 and complained of a red swollen and painful injection site area
there were hives; there was biggest lump in my arm; it was itchy; arm hurt badly; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (there were hives), SWELLING (there was biggest lump in my arm), PRURITUS (it was itchy) and MYALGIA (arm hurt badly) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 URTICARIA (there were hives), SWELLING (there was biggest lump in my arm), PRURITUS (it was itchy) and MYALGIA (arm hurt badly). At the time of the report, URTICARIA (there were hives), SWELLING (there was biggest lump in my arm) and PRURITUS (it was itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant and treatment details were provided.
BLOOD PRESSURE 133/88; DIZZINESS; NECK PAIN; STOMACH UNSETTLED; LEGS ARE WOBBLY; WEAKNESS; TIRED; BACK OF HEAD PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 133/88 mmHg. On an unspecified date, the subject experienced blood pressure 133/88, dizziness, neck pain, stomach unsettled, legs are wobbly, weakness, tired, and back of head pain. The action taken with covid-19 vaccine  was not applicable. The outcome of the blood pressure 133/88, weakness, dizziness, neck pain, stomach unsettled, legs are wobbly, tired and back of head pain was not reported. This report was non-serious.
Fever (24hrs), diarrhea (10hrs), nausea (10hrs), tiredness (24hrs), lost of appetite (10hrs)
Swollen lymph node on left side between shoulder and neck; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on 30Mar2021 at 07:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to medication, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 03Mar2021 at 07:00(at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00, the patient experienced swollen lymph node on left side between shoulder and neck. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event swollen lymph node on left side between shoulder and neck was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Pt denied any complaints upon arrival to vaccine site at 1205.  After vaccine, pt states to observation team that she has been dizzy for a few days and is now feeling dizzy at 1225.  ALS assesment at the vaccine site  revealed HTN and pt remained dizzy.  ALS transport was arranged at 1227 and transported pt to Emergency dept.  Medics from vaccine site completed EPCR reporting system.  PFIZER Covid 19 EUA
Pt reports chest pain (pressure in the chest) since the day of the vaccine. Pt cannot tolerate running because the activity triggers chest pain. Prior to vaccine child was asymptomatic.
Information has been received from a nurse concerning a 3 year old male patient who on 03/12/2002 was vaccinated with a dose of varicella virus vaccine live.  On 07/18/2004, the patient developed more than fifty varicella lesions on his chest and legs.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information is not expected.
Pt returned to clinic complaining of left deltoid with 5cm X 8cm erythema, non-tender, (+) induration over 3cm X 4cm. Seen by PA and rx'd with Tylenol po every 4 to 6 hours for pain; Benadryl 1/2 tsp po every 4 to 6 hours. Return to clinic prn.
pt recv vax 1APR96 & on way home pt devel high pitch persistent crying which persisted until fell asleep in afternoon;mom states that pt was nl upon waking from nap;
Severe pain at the site of injection. Round red circle, the size of a baseball at site of injection. Skin at site of injection hot to touch. Pain continued for 7 days. Both skin and muscle underneath were painful. Pain with movement and pain with touch. Patient tried icing the area, tried using heat, and OTC ibuprofen. None of the treatment options were helpful.
Malaise, cold chills, agitation, headache, swelling, redness and stiffness at the injection site. Unable to lift my forearm.
pt slept for 4hr p/vax;mom awakened 230PM to feed baby noted to have a rash;subsequently began having uncontrollable crying;had red rash & very fussy;
This case was reported by a consumer via call center representative and described the occurrence of hives in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (received several years ago with no side effects). Concomitant products included Atorvastatin and irbesartan. On 10th June 2018, the patient received the 1st dose of SHINGRIX. On 12th June 2018, 2 days after receiving SHINGRIX, the patient experienced hives. On 13th June 2018, the outcome of the hives was recovered/resolved. The reporter considered the hives to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The patient received the SHINGRIX vaccine at around noon. The patient experienced bumps on his arms which the reporter believed are hives. The hives had cleared up on the day of reporting. The reporter stated that, her husband was not home to provide additional details.
received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the patient received a 5 days expired dose of Kinrix which led to expired vaccine used. The reporter consented to follow up.
Vaccine Administration Error. The Pfizer vaccine given was outside of the usage date range and was administered to five patients on 2/10/2022. The vaccine was received into inventory on 12/15/2021 and was placed in the refrigerator. Pfizer was contacted and stated that the vaccine wasn't harmful but its efficacy/ potency may be in question and all patients who received it should be contacted and offered to be revaccinated. This was done and all patients declined to be revaccinated and stated that they felt fine.
3 doses administered past the 30 use by date expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-386462, MOD-2021-386455 (Patient Link).
Vaccine #1 Moderna 3/1/2021 Lot # 011A21A  patient died from cardiac arrest on 10/9/2021, not a covid related death
Shortly after getting the vaccine (within the first hour) I started having chest pain. I thought it was just indigestion. My arm was sore, and I had a really bad migraine and was nauseous. My chest pain made it difficult and painful to take deep breaths. I took Benadryl and Tylenol hoping that if it was an adverse reaction or an allergic reaction that would help. I still had chest pain throughout the night and next morning in addition to those other symptoms. I went to the ED the next day per protocol. The ER doctor said I was probably having an inflammatory reaction to the vaccine
pt recvd vax & devel overt flu lke symptoms including fever, achiness, & dry cough; lack of vax effectiveness;
energy level was throught the roof; energy level was throught the roof; no energy and was unable to get out of bed; felt really weak; Appetite lost; Pain; left shoulder felt heavy with first dose; This is a spontaneous report from a contactable consumer.   A 52-years-old male patient started to receive bnt162b2 (BNT162B2) Lot# EL1686 via an unspecified route of administration on 03Jan2021 16:00  1 dose at SINGLE DOSE for covid-19 immunisation. Vaccination Facility Type: Nursing Home. Anatomical Location of vaccine left arm. Medical history included diabetes mellitus from Nov2020 and ongoing.  Concomitant medication included glipizide (GLIPIZIDE), metformin (METFORMIN). The patient experienced left shoulder felt heavy with first dose on 03Jan2021 with outcome of recovered, pain on 06Jan2021 with outcome of recovered  felt really weak on 07Jan2021 with outcome of recovered, appetite lost on 07Jan2021 with outcome of recovered, no energy and was unable to get out of bed on 08Jan2021 with outcome of recovered, energy level was through the roof on 15Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jan2021. The reporter stated "Following the first dose his left shoulder felt heavy. On 06Jan2021 he had pain. It was in his waist. It was constant and was on both sides of his waist. On 07Jan2021 the pain moved from his waist to between his shoulder blades. It was like that for the whole day. He also felt really weak. He was unable to keep his upper body up. He struggled all day while at work. He thought he had Covid but was tested and the result was negative. The pain became worse and moved from his spinal cord to his head. This caused him to miss work. He did not have any energy and was unable to get out of bed. He also lost his appetite. Then on 15Jan2021 his energy level was through the roof like he was on steroids" The action taken was not applicable.
I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I did not take my allergy medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Oct2023, outcome "unknown" and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Oct2023) Positive; (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated that she had 6 of vaccines very pleased with them, lined up in (withheld), (Country name) lined up to get number 7 she was the one who wears the googles, the gloves, the mask, she was a full time flight attendant, she had been very good, not even close to Covid. Last Monday 02Oct2023 she tested positive for Covid, called the (withheld) health, the nurse called the pharmacy and within an hour and a half she testing positive she had Paxlovid, excellent, she knew it was government healthcare but it worked when they did not want you to get sick, so from Monday 02Oct2023 until the 6th Friday, she took her Paxlovid, she did not take her allergy medication the pharmacist recommend she did not take the two together, and all those days she tested herself everyday because she worked for an airline and she had plenty of (inaudible) Saturday, Sunday, Monday, Tuesday she tested negative so she was really happy. She woke up this morning, runny nose, fever 98.6, hands are cold, runny nose and a horrible sinus. She thought my allergies are back, but she thought because she was only taking the pills for 4 days. She tested herself, she was positive, is this unusual to have a rebound after taking Paxlovid for 5 days. and should she started taking it again.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300327166 Same patient/vaccine; different dose/events;US-PFIZER INC-202300325049 Same reproter/patient; different drug/events;
They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen / They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Patient ID reported as 420794. On 08 Sep 2021, vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 8 degree Celsius, total duration of the excursion refrigerated temperature for maximum of 4 hours.  Treatment information was not reported.
Intense pain in left arm and left upper back and pain with movement of left arm. Very Very tired and fatigued. These symptoms are from the second shot. Never had any adverse effects with first shot.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: . reported numbness first jaw to elbow left side then top of head to elbow.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown demographics. The patient's current conditions or medical history were not reported. On 07-DEC-2013, the patient was vaccinated with a single dose of ZOSTAVAX vial (dose, route, lot and expiration date were not reported) for prevention of shingles. On an unknown date, it was reported that the patient experienced an unspecified rash at the injection site. The patient was recovered at the time of the report, the event improved after stopping therapy and the therapy was not reintroduced. This is one of several reports from the same source. Additional information has been requested.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with the cases 2018SA292282, 2018SA292284 and 2018SA292285 (same reporter). This case involves a 56 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ038AA and expiry date: 03-May-2019) via intramuscular route in the right deltoid on 18-Oct-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at the time. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Per pt. woke-up @ 5AM w/ L arm pain, and swelling with blotches "felt like arm was on fire", pt. obtained treatment @ ER. 8/12/09.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA294618 (Same reporter). This case involves a 64 years old male patient who received a 0.5 mL dose of FLUZONE HIGH DOSE (lot UJ042AA) in error, via intramuscular route on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that he did not have any bad reactions or treatment. 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. List of documents held by sender: none.