chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm 5 hours after shot, low grade fatigue and fever and blood shot eyes 10 hours after shot, at 12 hours ever to 100.1, body aches, chills, joint pains, sore swollen neck glands, heart rate increased to 98 from 64 and O2 saturation dropped to 93% from 98 %.  After 24 hours, aches and pains were 80% better, heart rate and O2 saturation the same and fever 99.3 orally.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756497A, A0756499A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
2/9/04-mild temperature. 2/11/04 at 9:00 PM redness and swelling at site-no sign of infection. R arm.
Severe pain in right hip, right knee, and the muscles in between.  2 Aleve 220 mg, In the am and pm,  walking very slowly. Symptoms improved after 36 hours.  By 02/13/21 walk with slight limp, but much better.
The reaction experienced was a mast cell flare to the vaccine. Symptoms included elevated pulse, flushing, facial swelling at site of previous hives/anaphylaxis reaction, frequent urination, stomach cramping, and lymph node swelling. Premedicated with 25 mg Benadryl on advice of physician, then took 25 mg Benadryl extra plus extra liquids to flush histamine from system, followed by 25 mg Benadryl 6 hours later when B wore off and facial numbness and swelling returned. This is a typical mast cell flare progression for me. I was placed on mast cell stabilizing medication 10 weeks ago, which has reduced the severity of the tachycardia enough to keep me out of the hospital, and now also take more Zyrtec and Pepcid AC 3x per day plus 1000 mg quercetin daily. Benadryl is taken for breakthrough flares like this one.
lightheadedness; pregnant patient who received the Tdap vaccine; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient who experienced lightheadedness (dizziness), following the administration of  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was reported that she received vaccine while she was pregnant.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On 08-Jun-2020, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE, the patient experienced non-serious event of lightheadedness (dizziness).  It was also the case of vaccine exposure during pregnancy.   Details of laboratory data are not reported.  Final diagnosis was dizziness.   It was not reported if the patient received any corrective treatment.  Outcome of lightheadedness was not reported.  Pregnancy outcome was unknown at the time of report.
approx 3 1/2-4hr p/vax pt became limp, lifeless & pale;had episodic high pitched shrill crying;pt also exp dec feeding;t101 R;
Patient developed left shoulder/arm pain the evening after injection. Was diagnosed with subdeltoid fascial planes and subcromia/subdeltoid bursa with complex fluid. SIRVA - shoulder injury related to vaccine administration. Tendinopathy of rotator cuff with full thickness tearing of posterior supraspinatus tendon. All occurred in left shoulder.
pt was seen on may 7, 2021 for the following Aphasia, weakness, impaired memory.  pt states this started 2 weeks prior to coming to see provider.    all symptoms are worrisome for stroke.  dr ordered the following ct scan, MRI, and Lumbar puncture.
COVID Breakthrough Case  J&J Dose 8/16/21 (203A21A) COVID Positive 10/31/21  10/31/21: Patient is a 51 year old male with past history of obesity who was admitted with respiratory failure and suspected COVID-19 pneumonia.  History is obtained from chart review as well as discussion with the patient and the ED provider.  Patient denies any past medical history although he has not seen a physician in many years.  He is morbidly obese.  He does not take any medications.  Patient received the Johnson and Johnson COVID vaccine in August.  About 1 week ago he started having some fevers and chills along with just feeling poorly.  Has some slight increase in weakness from baseline.  Also has had poor appetite the last few days. He has had some diarrhea.  No nausea or vomiting.  Over the weekend started having some increasing cough and shortness of breath.  He has had a productive cough and a sore throat.  He presented to the ER and was found to have an O2 saturation of 33%.  Initially placed on 15 L and ABG did show PO2 of 54.  Placed on BiPAP and is slightly tachypneic but feeling better.  He had a CT scan which showed bilateral pneumonia and no pulmonary embolism.  11/8/21: Patient is a 51-year-old male admitted to hospital for acute hypoxic respiratory failure secondary to COVID-19 pneumonia, patient was treated with supplemental oxygen, Decadron, remdesivir, Actemra, antibiotics, his hospitalization was noted for newly diagnosis of diabetes with hemoglobin A1c of 11.3, patient was treated with insulin.  As time progressed patient clinically improved, patient will be discharged home recommended follow-up with PCP as scheduled.  Diabetic education was provided to patient prior to discharge.
called stating both arms are red & swollen; 1st time for pneummonia vax but has had flu vax many times; both arms itching;
cont to have neuritis since receiving the vax; hive immed p/; would not provide MD details, or other details on self; no follow poss;
Patient is experiencing arm/shoulder pain. She is currently seeking treatment from an ortho doctor and has an appointment on Friday. I plan on following up with her next week to see how she is progressing/improving.
Pt experienced periorbital swelling, redness, nasal congestion and dyspnea and wheezing within 1 minute post vax. RA sats decreases to 88%, Pt was given Benadryl and EpiPen Jr with in 10 minutes was much better with RA sats 96%
ached really badly; fever about 36 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient received 1st dose in last year 2021 and have not gotten shingles. The patient ached really badly and had a fever about 36 hours after getting the vaccines, but that was it. The patient stated that if you had chickenpox, you could get shingles. The patient decided to take chances with the vaccine. The patient knew people who were not vaccinated, got shingles and still suffer from horrible nerve pain. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR076849.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076849:Same reporter
Patient received Pneumovax 10/25/07 - presented to clinic 10/26/07 with large area of erythema from mid right deltoid circling medially to mid posterior upper arm warmth, and edematous - started on Cephalexin 500mg PO BID x 7 to cover per MD. VS 97 - 82 - 18 140/80
This case was reported by a healthcare professional, via an other manufacturer (#2011090807), and described the occurrence of febrile seizure in a 17-month-old male subject who was vaccinated with Hepatitis A (manufacturer unspecified), (non-gsk) PREVNAR. On 8 April 2011 the subject received unspecified dose of Hepatitis A vaccine (.5 ml, intramuscular, unknown site), unspecified dose of PREVNAR (intramuscular, unknown site). On 8 April 2011, less than one day after vaccination with Hepatitis A and PREVNAR, the subject experienced febrile seizure and high fever at home. The subject was taken to the Emergency Room on 08 April 2011 and was treated for fever. Treatment and laboratory tests were not specified. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved on an unknown date.
Heart racing and pulse increase to 105, during the day felt weak and fatigue. The night of injection arm went completely numb, painful and couldn't raise injected arm above my shoulder. The next day 12/1/21 after no sleep I had weakness in my body and the worse migraine. Body aches and chills all day long. Day 3 had to call off work because my symptoms are still the same with body aches, can not lift my head because how bad my head is pounding and body aching all over. My arm has been painful since vaccine.
pt woke up 430AM 19MAY97 & had hives (varying from very large in size to eraser-tip size) on back of neck, shoulders, waistline & knee caps;intense itching;
Patient received a flu vaccine at 4 months old. Flu vaccine is given for 6 month and older. Vaccine was administered to early. Notified mother and patient is fine.
Symptoms began at approximately 3:00AM on 09/16/2021, 18 hours after the vaccine was administered: Flu like symptoms-fever of 100.7, chills, hot flashes, body aches, fatigue, headache. All lasting approximately 24 hours. Treated with acetaminophen 500mg for fever and pain every 4 hours. Fatigue, loss of appetite, and intermittent nausea lasting for an additional 72 hours. No treatment given.
Immediately after injection I began feeling soreness and injection site. For the next 7 days I experienced erythema, edema - quarter sized, itchiness, and warmth at the injection site. Day 8 the itchiness was worse. Day 9 the area is erythematous and edema- the size of an open hand, warmth to the entire are, itchiness to area and my 1st and 2nd digits of my right hand. My colleague examined the area upon arrival to the clinic 1/7/2021 determined it was infected and provided an Rx for antibiotics.
ACROCYANOSIS OF LEGS & ARMS LASTING LESS THAN 15 MINUTES AT ONE HOUR INTERVALS FOR A FEW HOURS, SPONTANEOUSLY RESOLVING.
Patient reported feeling arm pain almost immediately after the vaccine was administered, but arm pain was not at the injection site it was how the patient described as feeling the pain on the back of her arm from the injection site. The pain went away in a day but the patient then came in and said that her eyes had been very swollen when she woke up the next morning. Swollen to the point of almost shut. The right eye was swollen the most, while the left eye was slightly swollen. She also noted that her eyes were itchy. When she came in to report it to us on 10/20/21 the swelling had gone almost completely away on the left eye and was only slightly swollen and red on the right eye. Neither was itchy any longer.
This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and hives. On an unknown date, the outcome of the anaphylactic reaction and hives were unknown. The reporter considered the anaphylactic reaction and hives to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The sales representative had limited details to share. The nurse stated that one of the patients received FLUARIX QUADRIVALENT on 7th October 2016 and the other patient received FLUARIX QUADRIVALENT vaccine the week before reporting date. One of the patient experienced the events two days after vaccination, but unknown which of the two patients. Also, one patient went to the emergency room, but it was unknown which of the two patients. No further information was provided. This case was linked to case US2016150173, reported by the same reporter.
Fever, muscle ache, pain, swelling, soreness, redness at site. Redness ON site look like hives and worse on 6/13. Took Tylenol 500 mg Q4h prn for 1st 24h then changed to Advil 200mg tabs 2-3 tabs Q 4-6 h prn per advise by Pharmacist.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, dose, frequency, route and indication not reported). On an unknown date, the patients revaccinated the second dose of ZOSTAVAX at an unspecified time 4 years after initial dose. No adverse effects were reported. Additional information has been requested.
The patient was previously un-vaccinated and was diagnosed with pertussis in December along with several siblings. He received his first immunizations on 2/14/20. Patient presented to urgent care on 2/15/20 with right ear pain and was diagnosed with right otitis media and prescribed amoxicillin-clavulanate 875-125 mg/tab (take 1 tablet by mouth two times a day for 7 days).  Patient then presented for evaluation on 2/26/20 with sudden onset of itchy rash on his hands, wrists, face, chest, back and abdomen. For the 2 days previous (2/24/20 & 2/25/20) he was running fevers and feeling achy and tired. Did not feel unwell on 2/26/20. The patient had taken 2 benadryl before arriving on 2/26/20 and it was starting to help. Patient was also discharged with a prescription of hydroxyzine HCL 25 mg tablet (take 25 mg by mouth every 6 hours, as needed for itching). Provider expected improvement in 24-48 hours.
Patient had presumed COVID in Jan 2021. First dose of COVID vaccine, she experienced an exacerbation of her chronic headaches and had an episode of near-syncope. Resulted in a course of treatment for status migrainosus, including outpt IM injections, 3 days of outpt infusions, then a 5 days hospitalization without improvement. Other symptoms included fatigue, exercise intolerance and dizziness. Cardiology eventually diagnosed DYSAUTONOMIA. She remains symptomatic despite increase in salt intake and fludrocortisone. Did receive dose 2 of vaccine on 6/11/2021 without exacerbation of her sx's.
Decreased ROM, red and bump reported pt seeing PCP for FU, pt also received Flu in L arm both in center deltoid halfway between top of humerus and insertion of humerus.
Patient presented to the ED with LUQ pain and was subsequently admitted for acute kidney injury within 6 weeks of receiving COVID vaccination.
Approximately 10 minutes after receiving the Janssen vaccine the patient walked up to the pharmacy counter and asked a technician if it was normal to feel clammy after the vaccine. Immediately after the patient passed out.
two inch lump on the injection site is red, raised, warm to the touch and very itchy; two inch lump on the injection site is red, raised, warm to the touch and very itchy; two inch lump on the injection site is red, raised, warm to the touch and very itchy; two inch lump on the injection site is red, raised, warm to the touch and very itchy; lump on the injection site; injection site was sore; fatigue; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (lump on the injection site), VACCINATION SITE PAIN (injection site was sore), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (two inch lump on the injection site is red, raised, warm to the touch and very itchy) and VACCINATION SITE SWELLING (two inch lump on the injection site is red, raised, warm to the touch and very itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE MASS (lump on the injection site), VACCINATION SITE PAIN (injection site was sore) and FATIGUE (fatigue). On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (two inch lump on the injection site is red, raised, warm to the touch and very itchy), VACCINATION SITE SWELLING (two inch lump on the injection site is red, raised, warm to the touch and very itchy), VACCINATION SITE WARMTH (two inch lump on the injection site is red, raised, warm to the touch and very itchy) and VACCINATION SITE PRURITUS (two inch lump on the injection site is red, raised, warm to the touch and very itchy). On 12-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, INJECTION SITE MASS (lump on the injection site), VACCINATION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (two inch lump on the injection site is red, raised, warm to the touch and very itchy), VACCINATION SITE SWELLING (two inch lump on the injection site is red, raised, warm to the touch and very itchy), VACCINATION SITE WARMTH (two inch lump on the injection site is red, raised, warm to the touch and very itchy) and VACCINATION SITE PRURITUS (two inch lump on the injection site is red, raised, warm to the touch and very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
EE states L arm became very painful by end of day she received Flu vaccine IM. Administration record is for R arm. EE's complaint is L arm.
breakthrough infection/Positive PCR; breakthrough infection/Positive PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administered in arm left, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN. Patient had no relevant past drug history, no known allergies. Patient had no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Nov2021, outcome "recovering" and all described as "breakthrough infection/Positive PCR". Breakthrough infection - congestion, headache, body aches and pains, fatigue, cough. Since the vaccination, the patient had been tested for COVID-19. The event "breakthrough infection/positive pcr" and "breakthrough infection/positive pcr" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: PCR: (30Nov2021) positive, notes: Nasal Swab; Binax: (30Nov2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 with REGEN-COV.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; Feelings of having a fast-beating, fluttering, or pounding heart; his breath sometimes is short, like short in breathe, but not too much; Chest pain; Feelings of having a fast-beating, fluttering, or pounding heart; Feelings of having a fast-beating, fluttering, or pounding heart; This is a spontaneous report from a contactable consumer or other non hcp (Patient). This consumer reported that a 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Age at vaccination 31 years) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : ER8733), via an unknown route of administration on 24Mar2021 (Age at vaccination 31 years) as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; his breath sometimes is short, like short in breathe, but not too much and chest pain. It was reported that caller states that he got his vaccine 3 months ago, clarified later in the call to the COVID vaccine, he had the 1st dose and then the 2nd dose 2 months ago. After that he had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better, and his breath sometimes is short, like short in breath, but not too much. The pain in his heart bothers him. Pain in his heart: He thinks it started like 2 and a half months ago after his 2nd dose. Sometimes it is better and sometimes it is worse, it is back and forth. Short in breath: The short of breath happens not too much, just a few times but right now he doesn't have it. Caller stated that he has experienced the symptoms (Chest pain, Shortness of breath, Feelings of having a fast-beating, fluttering, or pounding heart) and would like to know where he should go to be evaluated and treated. Caller stated after that about two and half months ago he had pain in his heart and occasional shortness of breath. Caller stated that he is still having pain in the heart but no shortness of breath now as it only happened a few times. The clinical outcome of all the events were not resolved while the outcome of the event chest pain was unknown.  Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.