chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered the vaccine yesterday after the vaccine's 10 week expiration date; administered the vaccine yesterday after the vaccine's 10 week expiration date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown (maroon cap), single (Lot number: FT9142) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 01Sep2022, outcome "unknown" and all described as "administered the vaccine yesterday after the vaccine's 10 week expiration date".  Additional information: The reporter called regarding the orange cap. Later reporter stated that, he was looking into it a little bit further and actually the children, the magenta cap so not 5 to 11 but 6 months to 4 years. COVID-19 vaccine. He reported that they administered the vaccine day before the reporting day after the vaccine's 10 week expiration date of 31Aug2022. So he wanted to know what they need to do. He wanted to make sure first of all that was the 10 weeks duration for refrigeration from the freezer and also after was there any further study showing whether or not if that counted in a valid administration or not at this point.  No follow-up attempts are possible. No further information is expected.
severe headaches; lower back and stomach pain; lower back and stomach pain; right leg pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 15:15 (Lot number: EN6208) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Penicillin Allergy. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 29Mar2021, outcome "recovered" (Apr2021), described as "severe headaches"; BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 29Mar2021, outcome "recovered" (Apr2021) and all described as "lower back and stomach pain"; PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "recovered" (Apr2021), described as "right leg pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (05Apr2021) unknown. Therapeutic measures were not taken as a result of headache, back pain, abdominal pain upper, pain in extremity.  Clinical course: The patient did not receive other vaccine in four weeks. The patient had not covid prior vaccination. The patient had covid tested post vaccination. The patient reported that two weeks after first dose, he started having severe headaches, lower back and stomach pain, and right leg pain. This lasted for 3 days and then went away. After reading today about the J and J blood clots and the symptoms to look out for he started to wonder if what he felt was similar in any way. The patient also reported that he understood these were completely different vaccines but the symptoms he felt were something he had not felt before.   No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US025081, is an initial spontaneous report received from a healthcare professional (medical assistant) on 25 Nov 2015. This report refers to a 64-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. No adverse event was reported following this administration error (incorrect storage of drug).
Pain under left arm near underarm - so far 12 hours hurts to move and not move dual stabbing pain. NOT THE INJECTION SITE.
ACUTE NON ST ELEVATION MI 1/3/2022 COVID-19 PNEUMONIA ACUTE RESPIRATORY FAILURE 1/11/2022 COVID-19 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/11/2022 COVID-19 PNEUMONIA ACUTE NON ST ELEVATION MI 1/3/2022 DELIRIUM DUE TO METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 1/11/2022 DELIRIUM DUE TO METABOLIC ENCEPHALOPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/11/2022 DELIRIUM DUE TO METABOLIC ENCEPHALOPATHY
Initial report received from a healthcare professional on 14 October 2013. A 03 year-old male patient, whose illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects were unknown, had received an intramuscular dose of FLUZONE (batch number: UH899AE) in the left deltoid on 12 October 2013.  (Expiry date: 14 JUNE 2014, dose number was not reported).  Patient had previously received many doses of influenza vaccine. On 13 October 2013, the patient developed swelling, heat and induration of 14 by 7 cm in diameter in the left arm. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 09:30 as dose 1, single (Lot number: el2964), in left arm and on 09Apr2021 at 09:30 as dose 2, single (Lot number: euj46158) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "htn" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: GLUCOPHAGE oral, start date: 09Mar2021, stop date: 19Dec2022; PRAVASTATIN oral, start date: 21Jan2021, stop date: 19Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
A nurse practitioner reported the occurrence of elevated immunoglobulin G (IgG) in a 31 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B). Medical history or concurrent conditions were not specified. Concomitant medications included a daily multivitamin and oral contraceptive. On 7/8/02, the subject received her 3rd injection of Hep B vaccine recombinant (Engerix B). On an unspecified date in July 02, the subject experienced loss of appetite, lethargy, and had an elevated immunoglobulin G. As of 9/11/02, the events persisted.
Information has been received from a 25 year old female nurse with no drug allergies who in June 2010 and August 2010, was vaccinated IM with the first and the second dose of GARDASIL (lot # not reported). On 08-DEC-2010 her third dose of GARDASIL was given subcutaneously (lot # not reported). Concomitant therapy included vitamins (unspecified) and TRI-SPRINTEC. 30 minutes later (on 08-DEC-2010) the patient felt warm, with a "strange sensation in her left arm, tingling in her mouth and palpitations but on the right side of her chest". All symptoms had since resolved (on 08-DEC-2010). The patient did not seek medical attention. No treatment was given for the events. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a unk patient who received Flu vaccine. On an unknown date, the patient received flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine. Additional information received: Patient had an allergic reaction to the flu vaccine. Reporter thought the allergy may be due to the egg component even though patient can eat eggs on a daily basis. Brand of flu vaccine was unknown. Reporter stated that vaccine was administered several years ago at a different facility, and that she had very limited details and declined to answer questions
A sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History Information was Reported.  Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) for Birth control.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (A sore arm). At the time of the report, PAIN IN EXTREMITY (A sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.   This case was linked to MOD-2021-025587 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History Information was Reported.  Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) for Birth control.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (A sore arm). At the time of the report, PAIN IN EXTREMITY (A sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.   This case was linked to MOD-2021-025587 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Within a few hours, my fingers felt cold to the touch and under my fingernails turned a slight blue. I felt cold to the touch and my lips were also blued. Then, a 106 fever began with severe chills. The following day I had severe head pain
Had Menactra 3 days prior. Hives, dyspnea, ER visit for treatment. Possibly related to vaccine?
The pt complained of a macular rash (papular) to trunk, upper arms and upper thighs. Clear nasal drainage, throat and tympanic membranes are clear, chest is clear, abdomen is soft, heart rats in regular with no murmur. Temp of 99.5, BP 130/90, P - 88, R - 20. Symptoms appeared on 12/15/00 and resolved pm 12/20
pt recv vax;mom reports T of 104 for approx 36 hr;mom states that she gave children's apap;would only bring T down to 101 for approx 1 hr;
Muscle pain; Nerve pain; Leg cramps; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: Muscle pain), nerve pain (Verbatim: Nerve pain) and leg cramps (Verbatim: Leg cramps).  The outcome of the muscle pain, nerve pain and leg cramps were not reported.   It was unknown if the reporter considered the muscle pain, nerve pain and leg cramps to be related to Shingles vaccine.     It was unknown if the company considered the muscle pain, nerve pain and leg cramps to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient stated that, he/she gave a warning to all and said, did not get the shingle shot. The patient received the Shingles shot and had muscle pain from it, and stated that, side effects were worse than shingles.  The patient got nerve pain and leg cramps. The patient said, sorry but it was true, and stated, then they tell you after, part 2 was part of it. The side effects were worse. The patient stated, he/she never had that ever, and said forget the shot. The follow up would not possible as no contact details were available. The case had been linked with US2023AMR038453, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR038453:Same reporter - Friend's case
Sore arm shortly after the vaccination.  Muscle soreness in the area of the injection site, large red bumps, severe itchiness and swollen arm in the injection site (did not appear until 3/17...6 days after the initial shot).
Injection site redness and discomfort for 72 hours, managed with cold compress. Was fine for a few days. On the 7th day the injection site became VERY red and somewhat itchy. The site was over 3 inches in diameter. Treated with topical cortisone cream and cold compress. Today is day 10 and there is still a wide area of redness.
vertigo beginning 8 hours after vaccination, lasting 24 hrs; This is a spontaneous report from a non-contactable consumer, the patient. A 75-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On an unknown date in Mar2021, the patient experienced vertigo beginning 8 hours after the vaccination and lasted for 24 hours. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was recovered on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to influenza vaccine quadrivalent. Additional information was received as follows: The age at vaccination was not reported. Flu vaccine manufacturer and its specificities were unknown. This case has been linked to the case US2018078800 reported for the same patient.
Arm was hurting; Both armpits and breasts were swollen; Breasts were tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), SWELLING (Both armpits and breasts were swollen) and BREAST TENDERNESS (Breasts were tender) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was hurting), SWELLING (Both armpits and breasts were swollen) and BREAST TENDERNESS (Breasts were tender). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), SWELLING (Both armpits and breasts were swollen) and BREAST TENDERNESS (Breasts were tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Three weeks after patient's first Gardasil shot patient started having tremors and shaking in her legs. On 9/11 the school called. She was shaking violently all over and was crying because she couldn't stop. We took her to the doctor who checked for low blood pressure, low blood sugar and a few other tests. After the second and third shots she got worse. She started getting dizzy and many times fainting and having seizures. She even started wandering with pupils fully dialated and wasn't "there". Her legs would often go numb and she has had many migraine headaches that would last as long as a week. Also stomach pains and sickness. Her seizures have lasted up to 45 minutes and she is unconsious the entire time. She has had at least 90 episodes!
12/05/18- Right thigh noted a 5 x 4cm erythema, somewhat tender, no warmth but felt a lump at the needle site of a vaccine, and noticed a 1 cm bluish bruise. DiphenhydrAMINE HCl Elixir, 12.5 MG/5ML, 5 ml as needed, Orally, prn per every 8 hrs per itchiness. Return visit for evaluation scheduled for 12/07/18.
Right arm soreness x2 days  Right arm warm around injection site x2 days swollen lymph nodes in neck right side, noticed next morning and still current No treatment
Swelling 4cm L leg post Prevnar, Varivax. Still 1cm swell.
Acute shoulder/arm pain radiating through elbow and down in fingers. Unable to hold the arm in any position for over 30 secs without pain kicking in. Pain persisting for more than 7 days. No visible wounds. Pain killer meds haven't helped.
Provider notes: "Patient is a 64-year-old female with a past medical history of obesity, type 2 diabetes mellitus who presented with MRSA bacteremia from left upper extremity cellulitis. Completed > 2 week course of daptomycin. Had issues with hypertension which improved mostly with adding diuretic and BB. Unfortunately, became dehydrated and had mild AKI which improved with IV fluids.  Had Issues with dizziness, suspect to be secondary to sinuses (chronic problem) and improved with treatment of sinuses.   Her long-acting insulin regimen has been decreased at this time, with A1 c 7.2.  She has been restarted on her home meds.  This regimen will need to be titrated over time.  The patient has been asked to check her blood sugars 3 times a day and before bed and report these to PCP.   Home care has been arranged, and the patient has been in contact with her caregivers and they plan to meet her at home today."
Initial report received from a healthcare professional (physician) on 17 September 2013 via another manufacturer. An unidentified 38 year old male patient had received an unspecified Tetanus booster, dose, route and site of administration were not reported, approximately 10 years ago, date not specified. On an unreported date, the patient experienced an anaphylactic reaction and wound up on a ventilator in the hospital. The dates of hospitalization were not reported. The patient's concomitant medications and medical history were not reported. Laboratory data was not reported or the duration of his stay in the hospital. The patient outcome was not reported. No further details were available at the time of this report. Documents held by sender: None.
Approximately 8-9 days after receiving her one year old shots which consisted of MMR, Varicella and IPV this child developed a rash at injection site as well as chicken pox like on face, trunk, extremities. The injection site rash occurred on the right leg where she received the MMR vaccine.
fever, erythema, edema, pain radiating distally to hand and chest, back, and neck
ED visit to hospital admission on 12/15/21 for left ureteral stone - PROCEDURE: Cystoscopy, left retrograde pyelogram, placement of 6 x 26cm double j stent. Recovered and sent home in 4 hours. ED visit to hospital admission on 1/16/22 for Hydronephrosis of left kidney - Management with IV Abx and stent Removal in 1 week. an additional week of antibiotics. Discharge when pain is improving and culture results available for antibiotic therapy. ED visits and hospital admissions within 6 weeks of receiving the COVID vaccine.
Chills; Malaise; Anxious; This case was reported by a physician via call center representative and described the occurrence of chills in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date unknown) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills, malaise and anxiety. On an unknown date, the outcome of the chills, malaise and anxiety were unknown.   It was unknown if the reporter considered the chills, malaise and anxiety to be related to Shingrix.  Additional details were provided as follows: The Shingrix had lot number but was unable to see expiration date. The reporter reported chills, malaise, and anxiousness.  The physician called to report that patient received first dose of Shingrix 25Mar2019. She reported chills, malaise, and anxiousness.
Headache started within 15 minutes. Fatigue, flu feelings. 2nd day much worse. Flu feelings, headache, chills, 101 fever. 3rd day headaches on and off, extreme fatigue. Took Tylenol each day. 4th day feel tired and slightly woozy.  Arm swollen 3/4 inch raised up, 3-inch diameter round red mark that is still present on day 4 with soreness.
Swelling of left eye, runny nose and rash all over within 30 min. of vaccination.