chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 30 year old now temporarily retired who had been in her usual health until approximately one week after receiving her primary anthrax vaccination. At that time she began having a constant headache with pain localized over her left eye (9/10) with associated photophobia and blurred vision. She was seen by a doctor who diagnosed her with migraine headaches. She was found fit for deployment and deployed on 04/20/2003, with Loritab 5mg for headache management. After arrival, the heat caused an increase in intensity (10/10). She continued to be photophobic and had GI symptoms of nausea and vomiting. She remained for 5.5 months. She experienced an increase in pain, frequency and intensity following the second anthrax vaccination. She increased her pain medication to 20-40mg to reduce pain and was absent from duty because of the pain. She also experience pain in her bilateral knees and shoulder (5-6/10). She was seen multiple times in medical for this problem. She returned on October 5, 2003. She continued to have headaches and associated symptoms. The neurologist completed an angiogram of the brain (12/12/2003). In November 2003, began counseling with a psychiatrist for complaints of depression with out suicidal ideation. She was diagnosed with a major depressive disorder and an anxiety disorder.  She was placed on convalescent leave in December 2003. During her convalescent period, she experienced a seizure, which she describes as "my whole body locked up" the individuals with her told her that she "was stiff as aboard, teeth were locked, and upper body was jerking". She states that her friends said the episode last about 8-10 minutes. She was exhausted afterwards and slept approximately 16 hours. On another occasion, she was driving and her head started jerking and her arms felt heavy and achy. She could not speak but she remained conscious during the episode which last approximately five minutes. She was seen in the Emergency Department for her headache and "shaking" episodes. She returned approximately one week later (January 2004) and saw her neurologist immediately. He ordered a Tilt Table Test (02/24/2004) and EEG (03/4/2004). These tests were reportedly normal. She was initially given a profile and instructed to wear sunglasses when she was in any bright light, even indoors and self paced physical training. She continued to have headaches and had 2 more "episodes". She was placed on temporary retirement in June 2004. During the week of July 5th 2004, she became very short of breath, swelling in hands and feet and had experienced a 22 pound weight gain in a 5 day period. She was admitted to the hospital. She underwent multiple chest x-rays, laboratory draws and a bronchoscope. The bronchoscope was reportedly normal. She was diagnosed with pneumonia and released on 13 July 2004.
chemical smell; dry mouth worsened; dry throat worsened; Itching on her back; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry mouth and dry throat.   On 8th April 2019, the patient received Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced smell alteration, mouth dry aggravated and dry throat. In April 2019, the patient experienced pain in arm and pruritus. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus was recovering/resolving and the outcome of the smell alteration was not recovered/not resolved and the outcome of the mouth dry aggravated and dry throat were unknown.   It was unknown if the reporter considered the pain in arm, pruritus, smell alteration, mouth dry aggravated and dry throat to be related to Shingrix.  Additional information received were as follows: The reporter received her vaccine at her local pharmacy. The lot number and expiry date was not available. The reporter reported that she received a dose of Shingrix vaccine on unknown arm. The patient experienced sore arm which lasted for a couple of days. A week later, the patient started experiencing itching on her back every morning after getting out of the shower. The patient saw her dermatologist a week later and no rash was seen by the dermatologist. The reporter reported that two weeks ago from the reporting date, the itching had started to subside. The reporter also reported that after receiving Shingrix, the patient had been experiencing a chemical smell through her sinuses when she breathes in. The chemical smell occurs when the air conditioning comes on, when it was windy or when she laid down and it had not subsided. The reporter stated that after receiving Shingrix, the patient dry mouth and dry throat had worsened slightly since her Shingrix vaccine. The reporter would be seeing her family physician in September 2019.  The caller consented to follow up.
Patient had redness, swelling, and itchiness on left deltoid the day after administration. As of 6/22/22, the arm is still red and a little itchy
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a patient who received SHINGRIX for prophylaxis. In April 2019, the patient received SHINGRIX. In April 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness and muscle soreness. On an unknown date, the outcome of the tiredness and muscle soreness were unknown. It was unknown if the reporter considered the tiredness and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient just had the dose of SHINGRIX and experienced very tired and sore muscles. The patient was asking on the normal side effects of Shingles vaccine that how long would the tiredness and muscle aches normally last. The patient was just curious as how to go about the week.
Extreme pain & limited range of motion approx 4 hrs after injection, requiring evaluation in emergency room. Rx: opiods.
2/26  9 pm  Headache, dizziness, fatigue, slight fever 2/27  8 am  Fainted, hit head
8/18/21: The patient has been states that he brought her into the emergency room primarily due to her complaints of progressive back pain over the past 30 days.  He was concerned that she had some symptoms that were consistent with COVID-19 and requested that she be tested.  She tested positive for COVID-19 in the ER. Note: patient had Moderna Covid-19 vaccine on 3/17/21 and 4/14/21.  Diagnosed with viral pneumonia related to Covid 19.  Discharged on 8/24/21.
potential Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (potential Adverse Event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (potential Adverse Event). At the time of the report, ADVERSE EVENT (potential Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
small episode of sciatica; nerve pain in left leg, similar to sciatic; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EP6955) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. The following information was reported: SCIATICA (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "small episode of sciatica"; NEURALGIA (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "nerve pain in left leg, similar to sciatic". The events "small episode of sciatica" and "nerve pain in left leg, similar to sciatic" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information :The patient had not received any other vaccine within 4 weeks. Within 2 weeks of vaccination patient received Vyvanse. If-covid prior vaccination reported as Yes, If-covid test-post-vaccination was reported as yes. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On or around 28-APR-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the prevention of shingles (herpes zoster). On an unknown date in approximately 2017 (reported as shortly after receiving ZOSTAVAX), the patient suffered herpes zoster and vision loss. It was stated that, as a direct or proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using suspected vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the events was unknown. The events were considered to be related to ZOSTAVAX. Upon internal review, the event of vision loss was determined to be medically significant. Additional information has been requested.
I was an athletic hiker and jogger. Suddenly, over a period of a few days, I had pain and weakness in both legs. Nerve pain. Had bloodwork for MS, which came back negative. Had MRI of lumbar spine which was negative. People with spina bifida occulta and other neural tube defects can't convert folic acid to its active form, methyl folate. This keeps their bodies from detoxing normally. This made me more prone to not being able to detox the mercury.
Fever began 2/23/05 then discrete itchy pink papules developed over torso, arms, buttocks, groin, scalp, legs, neck. 2 small spots had crusted. Photo documentation in chart also.
04/21/2021- ct 6-7 wks preg when rec'vd 1st dose Pfizer on 04/16/21, c/o 'little' stomach ache/ dizzy/myalgia that night. 04/17/21-8:30am , vag blding/'little' abd pain,- went to ER- U/S, bld work, urine test done-dx miscarriage. 4/18-4/20-pain in hip/waist, little nausea, today  blding stopped, still a little nausea/ little pain in hip. EOC was approx 12/09/2021, ct has hx cervical medical issues this past year.
ED visit - Bilateral pulmonary embolism EKOS procedure. Patient is a 75 y.o. female presents to hospital for evaluation of Shortness of breath this been going on for a few weeks but suddenly much worse earlier this morning. Patient was afebrile in the emergency department. Saturations were 86% on room air. Arterial blood gas revealed a pH 7.45 PCO2 34 PO2 was 114 bicarbonate was 23. Saturations are 98%. EKG was sinus rhythm with no ST elevation or depression noted. Chest x-ray was negative. CT PE study did reveal bilateral pulmonary emboli with right heart strain. Patient was initiated on a heparin drip. Cardiology was notified in the emergency department and patient Was transferred to a different location for likely EKOS procedure. Bilateral lower Doppler studies were negative for DVT. 2-D echocardiogram did reveal an ejection fraction of 55-60% with mild diastolic dysfunction. Patient remained stable on room air. She improved to the point that she was deemed appropriate for discharge home. She will be discharged home on Lovenox and Coumadin. She is follow-up with primary care and with cardiology in the outpatient setting as previously arranged. She is following with the Coumadin clinic.
No side effects have been shown; HCP called to ask about side effects of GARDASIL 9 given to a 2-month-old female. 2-month-old patient received GARDASIL 9 today in the morning of 7/3/2023. No side effects have been shown. HCP gave permission to contact him. No additional AE reported; This spontaneous report was received from a physician referring to a 2-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 03-JUL-2023, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Felt like something dripping out of her; Felt like something dripping out of her; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine and experienced felt like something dripping out of her.  The patient's medical history was not provided. Concomitant product use was not provided.  On 18 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (batch number not reported) intramuscularly for COVID-19 infection prophylaxis.   The patient reported that when the nurse took the needle out, she then gently squeezed the site where the patient got the shot and the patient felt something dripping out of her. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The event, felt like something dripping out of her, was considered resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a female patient who received the first of two planned doses of mRNA-1273 (batch number not reported) intramuscularly for COVID-19 infection prophylaxis and experienced felt like something dripping out of her. There were no reported adverse events after the vaccine was administered in this case of injection site extravasation and incomplete dose administered
Pallor, irritability, screaming.  Temperature 100.2 in ER.
Severe pelvic pain, nausea, dizziness, weakness lasting about 2 hours. Followed by a decidual cast.
Severe headache the day after ( 8/16/06)  the vaccine was given and lasted through 8/21/06. Also experienced body aches, sore arm, and sore (one sided) shoulder/chest discomfort on the side the vaccine was administered. Slight headache and shoulder/arm muscle soreness are still present.
One year old child received their second dose of FLUZONE QUADRIVALENT 14 days after the first dose with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 1 years old and unknown gender patient where reporter reported one year old child received their second dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] 14 days after the first dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (inappropriate schedule of product administration). There will be no information available on the batch number for this case.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
tested positive for Covid 19 on 12Aug2021/he got tested positive for covid after getting the first dose/felt sick; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX Support. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Left on 01Aug2021 17:30 (at the age of 40-years-old) as dose 1, single for Covid-19 immunization. No Patient history reported and Family history included diabetics- Reporter states his parents are diabetics. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with Covid-19. On 12Aug2021, the patient tested positive for Covid 19 on 12Aug2021/he got tested positive for covid after getting the first dose. Reporter states he tested positive for covid last week on Thursday 12Aug2021 and states he had the first dose of the Pfizer Covid vaccine administered to his left arm on 01Aug2021 and his patient card has lot number EW0169 and states there is not an expiry date or NDC written on the card. Reporter states he had no treatment but just stayed home. The patient underwent lab tests and procedures which included Covid-19 test: positive on 12Aug2021. The outcome of the event was unknown.  Follow-Up (20Aug2021): Follow-up attempts are completed. No further information is expected.
1 1/2 inch diameter hard red area at injection site rt upper thigh- child irritable with above. Not tender CMS good irritability.
Patient came in for an 11 year well and was due for Tdap, MCV4 and HPV, patient received MCV4, HPV and Dtap instead of Tdap.
Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient. The patient had not experienced any adverse events.  The reporter was with provided telephone number for medical information for future reference. The reporter disconnected call whilst transferring to medical information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was one of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065217:Same reporter. US-GLAXOSMITHKLINE-US2022065218:Same reporter. US-GLAXOSMITHKLINE-US2022065222:Same reporter.
I developed bad chills, headache, body aches, fever,  sore and swollen arm, and a feeling of panic  and helplessness for about an hour in the middle of the night. Most of the other symptoms lasted  about 9 hours. After that, I still had a swollen, sore arm and a headache  for about 24 more hours.  Fatigue set in for a couple of days after that.
This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in an 18-month-old subject of unspecified gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site and injection site discomfort. At the time of reporting the outcome of the events was unspecified. These events occurred in three different subjects. It was reported that one of the subject's arms looked like it could have been drained due to the swelling. The swelling area was also described as similar to the palm of the hand. Follow-up was received on 27 November 2007 from the healthcare professional. The subject was an 18-month-old female. The subject had no adverse events following receipt of prior immunizations. On an unspecified date, the subject received a 4th dose of Infanrix (intramuscular, right thigh). Concurrent vaccination included Prevnar (Wyeth Labs; intramuscular; left thigh). On 5 November 2007, at an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site, injection site discomfort and cellulitis. The events improved on 7 November 2007. The healthcare professional considered the events were possibly related to vaccination with Infanrix. Comment: Cellulitis was assessed as medically serious by GSK.
Poking symptom on my left heart; This is a spontaneous report from a contactable consumer (patient). This consumer reported that, a patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced poking symptom on my left heart on Jun2021. It was reported that patient took the Pfizer vaccine (Unspecified vaccine) last, yesterday around 4 pm at one of the locations and from this morning and patient stated to have, it's something, like a poking symptom on his left heart. Patient was wondering if need to be taken care of at the hospital or can just wait to see. Later Consumer stated, so, right now it's already 8 pm, so, don't have any, this phone number patient can't use it. So, do they want the patient to call like hospital or emergency room and ask about symptom or do they happen to know if this was a serious symptom, or the patient don't have to worry about it. Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call. Reporter seriousness for Poking symptom on my left heart: Unspecified. The outcome of event was unknown.  Information about lot/batch number has been requested.
Patient called on 4/8/11 stating she was achy, feverish. Said she got redness, swelling, pain 2 inches from injection site immediately after which had subsided. Fever gone by 4/9/11.