chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During 40 minute drive home client started sweating, having some left arm pain. Client's wife described him as pale, chest pain starting. Client life-flighted, dx with CVA. Surgery 8/12 and 8/14 for stents.  10/10/08 Reviewed hospital medical records of 8/12-8/15/2008. FINAL DX: coronary artery disease w/acute inferior myocardial infarction; HTN; hyperlipidemia Records reveal patient experienced exertional chest pain x several mo & developed severe chest pain on 8/12/08.  Transferred from outlying ER for higher level of care.  Tx w/PTCA, progressed well & d/c to home.
Claims that she had chronic pain, severe arthritis for the past 6 months. Pain was an 8 on scale of 10. After receiving 2nd dose, the next day she felt really ill (chills, body aches, unable to stand up, flu-like symptoms) and then 7-8 hours after felt better. The very next day "feeling better than ever". Stopped taking prescription medications for the pain/arthritis.
I have been without a menstrual cycle for a minimum of 2 years because of the Depo Provera injections.  However, I had vaginal spotting/light bleeding  that started approximately 9 hours after I received the vaccine and lasted for about 48 hours.
diagnosed with breast cancer on the same side she received the vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant) with onset 2021, outcome "unknown", described as "diagnosed with breast cancer on the same side she received the vaccines". Clinical Information: Call transferred by (Withheld) from agency. According to agent,was a nurse and had some questions regarding the Pfizer BioNTech Covid-19 vaccine. Agent states that the caller got her 1st dose of the vaccine in Dec 2020 and her 2nd dose of the vaccine in Jan2021, where 6 months later she was diagnosed with breast cancer on the same side she received the vaccines. Agent states that the caller would like to know if breast cancer has been reported after receiving the vaccine and if it was contraindicated to receiving the booster since she lives in a specified state and they are mandating the booster. Caller states she had no history of breast cancer on either side of her family and she was nervous to receive the booster since she was uncertain if the breast cancer was related to the vaccine. Caller states she was a Nurse that works in hospital and deals with cancer patients Caller states one of her patients held off on getting the Covid-19 vaccine and tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer, which was why the caller was nervous about receiving the booster. Agent also states that she has an inquiry regarding her husband who also received the Pfizer BioNTech Covid-19 vaccines 3 days after her vaccine. Agent states her husband has had hives and a rash consistently for a year now and all of the medications including steroids and creams have not helped.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Breast Cancer and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt devel swelling & tenderness LA approx 2 months post immun; Sore joints intermittently x 2 mo; No temp recorded;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-APR-2016  at a pharmacy, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). This is conflicting information as the events associated were reported in 2015. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUL-2015, the female was treated (by an unspecified healthcare professional) at a medical clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. Between the dates of 05-AUG-2015 and 10-AUG-2015, the female patient was admitted to a medical facility for ongoing and significantly worsening shingles symptoms and pain. On or about 24-AUG-2015, the patient sought subsequent treatment at the same medical clinic (as on or about 28-JUL-2015) for uncontrolled pain and zoster outbreaks that had gotten worse in severity. On or about 31-AUG-2015, the female patient was treated again at the same medical clinic for continued shingles symptoms, nerve pain and scarring from the outbreaks. On or about 02-NOV-2015, the female was treated at the medical clinic for ongoing pain, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster outbreaks. The female patient has been prescribed NEURONTIN, ZORIVAX (as reported), LYRICA, VALTREX and TYLENOL for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
c/o malaise, myalgia, insomnia within 12 hrs of receiving vaccines.
Shingles outbreak 3 days after second vaccine, intestinal inflammation response 3 weeks after
Loss of balance; off balance feelings; Recommendation not to receive the second dose; Muscle Pain; Vertigo; Tinnitus ringing in ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus ringing in ears), VERTIGO (Vertigo), BALANCE DISORDER (Loss of balance; off balance feelings), PRODUCT DOSE OMISSION ISSUE (Recommendation not to receive the second dose) and MYALGIA (Muscle Pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism, PROBIOTICS NOS and VACCINIUM MACROCARPON (CRAN MAX) for an unknown indication.    On 26-Mar-2021 at 1:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (Tinnitus ringing in ears). On 06-Apr-2021, the patient experienced VERTIGO (Vertigo) and MYALGIA (Muscle Pain). On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Recommendation not to receive the second dose). On an unknown date, the patient experienced BALANCE DISORDER (Loss of balance; off balance feelings). On 14-May-2021, PRODUCT DOSE OMISSION ISSUE (Recommendation not to receive the second dose) had resolved. At the time of the report, TINNITUS (Tinnitus ringing in ears), VERTIGO (Vertigo), BALANCE DISORDER (Loss of balance; off balance feelings) and MYALGIA (Muscle Pain) had not resolved.        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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional event- 'Product dose omission issue' was added. Event- tinnitus outcome was updated to not recovered/resolved. On 09-Jul-2021: Patient demographics updated in patient tab, concomitant medications updated in products tab, New events have been added, action taken updated to withdrawn
swelling and hot at site with itching three days after injection. swelling spread to elbow region five days after injection.
Information has been received from a nurse practitioner concerning a 16 year old female with no medical history and no drug allergies, who on 23-AUG-2007 was vaccinated intramuscularly with a 0.5ml dose of GARDASIL vaccine (yeast). Concomitant therapy included an unspecified thyroid replacement. On approximately 06-SEP-2007 the patient developed scattered, red, hive like, plaques on both legs. The patient went to the office. The patient was treated with cetirizine hydrochloride (ZYRTEC) and hydroxyzine hydrochloride (ATARAX). No laboratory diagnostics were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Flu-like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Epilepsy (Childhood epilepsy) and Migraine since an unknown date. Concurrent medical conditions included Peanut allergy (patient has had an anaphylactic reaction to peanuts in the past.). Concomitant products included AMITRIPTYLINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 07-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 130/70 mmHg diastolic reading was approximate. On 03-Apr-2021, Chest X-ray: Inconclusive. On 03-Apr-2021, Electrocardiogram: Inconclusive. On 03-Apr-2021, Heart rate: 133 133 bpm. On 03-Apr-2021, Laboratory test: Inconclusive.         Diagnostic tests are done for the  event happened after second Moderna vaccine dose.   Concomitant product include Birth control pills. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068419 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068419:LINKED WITH DOSE 2
This case was reported by a physician via call center representative and described the occurrence of pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain, malaise and fever. On an unknown date, the outcome of the pain, malaise and fever were recovered/resolved. It was unknown if the reporter considered the pain, malaise and fever to be related to SHINGRIX. Additional details were reported as follows: The patient experienced aches beginning within 24 hours after SHINGRIX and lasting for 5 days. The dose of SHINGRIX was not administered at the healthcare professional's office. The lot number or expiration date and further details of administration were not available.
Had back to back  seizures   2 days after getting the vaccine (1/27/21). Hospitalized for 48 hours. came back and had another seizure after discharging from ICU.
No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1742467, expiration date: 05-OCT-2022, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA000873: US-009507513-2206USA006597: US-009507513-2206USA006598: US-009507513-2206USA006599: US-009507513-2206USA006600:
Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17th February 2025) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: 02-Mar-2023. Reporter's Comment: It was stated that a pediatric dose of Engerix-B was given to an adult patient. The reporter consent to follow up. Patient´s initials were asked and caller look for information but did not have it so it was declined. Additional Supportive Information: An adult patient received pediatric dose of Engerix-B, which led to adult use of a child product and underdose.
Headache fatigue evening of 1st dose/ woke up with a severe right sided headache that lasted intoo the evening Narrative:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The healthcare professional (HCP) stated that, on the day of vaccination, his mother experienced arm pain and flu like symptoms which lasted all weekend. The patient spent the weekend in bed. The patient was recommended to take TYLENOL. The reporting HCP did not administer the vaccine, and did not have vaccine information, or any other information for this adverse event.
This spontaneous case was reported by a patient and describes the occurrence of MENTAL DISORDER (he is having mental problems), MUSCLE ATROPHY (lost 40 pounds, he is losing muscle mass) and IMPAIRED QUALITY OF LIFE (literally deteriorating, his body is going down to nothing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Post-traumatic stress disorder. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (he is having mental problems), MUSCLE ATROPHY (lost 40 pounds, he is losing muscle mass) and IMPAIRED QUALITY OF LIFE (literally deteriorating, his body is going down to nothing). At the time of the report, MENTAL DISORDER (he is having mental problems), MUSCLE ATROPHY (lost 40 pounds, he is losing muscle mass) and IMPAIRED QUALITY OF LIFE (literally deteriorating, his body is going down to nothing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Weight decreased: decreased (Low) He has lost 40 pounds or more. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drug was reported. The patient received Moderna vaccine 8 months ago. The patient wanted to talk to someone, and that he did not wanted to put his side effects online. The patient had mental problems, he wanted to speak with someone immediately. The patient had spoken with his therapist. No treatment drug was reported. It was reported that every time patient had visited hospital tested negative for COVID, everything had come back clear.
I?ve had continuous headaches for 2 weeks now that come and go during the day of the moderate severity type. Difficulty sleeping and nightmares from time to time.
I administered the vaccine and as the patient has a history of childhood anaphylaxis to shellfish, I instructed her to wait for 30 minutes in the observation area, instead of the standard 15 minutes, It was in the observation area, where she was being observed that she began to feel "hot and flushed". The health staff observing will also be submitting a VAERS report, as they provided interventions to the patient.
PATIENT STATED THAT A HIVE TYPE RASH OCCURE WITH 24 HOURS OF VACCINATION LOCATED AROUND LOWER TORSO OF BODY AND LAST FOR APPROXIMATELY 48 HOURS
Patient passed out after administration. While he was unconscious he also urinated. After a minute he came to and was able to walk away without assistance
11 days after the vaccine I developed severe  hives all over my body. Symptoms included swelling of site including inside ears, itching, redness, raised hives, and developed into dermatographia.
I received my 4th Moderna covid shot (and 2nd booster) on June 3, 2022. After two days of fatigue and aches, I continued to have fatigue over the next week. Starting on Friday, June 10th and continuing for 48 hours, I experienced severe leg pains in both legs. On June 12th, I noticed a bubble rash on my fingers. The fatigue continued the week of June 13th and by the end of that week I experienced another 48 hours of severe bone-deep leg aches. On Monday June 20th, I went to go for my daily 5-7 mile walk and my legs felt strange, weak and achy. On Tuesday June 21st, I went to a shopping mall and found myself unable to walk across the hall between stores. I felt like I couldn't signal to my legs that I wanted to walk. My legs felt numbness, tingling, aches, weakness and a lack of motor coordination. I managed to drive myself to the Emergency Room. By Tuesday June 22nd the sensations had spread to my arms and hands. I also noticed short sharp electric sensations in my pelvis. Over the next couple of weeks, this evolved into neurogenic bladder and an inability to void. I also developed tingling and muscle soreness and severe dryness in my eyes.  After too many tests, hospital and doctor visits to count, I have been diagnosed with a "mild" case of transverse myelitis. However, this "mild" case in reality has meant being unable to do my work, barely able to walk let alone exercise (and I had been an avid athlete/exercise enthusiast all of my life), continuous sensory, motor and autonomic problems, ongoing neurogenic bladder, neuropathy, eye problems, etc. I had some improvement in October, but found that the slightest bit of exertion set me back and here I am in December 2022, six months after the shot, still uncertain what my health outcome will be.
Office Visit  10/18/2021  Family Medicine Viral upper respiratory tract infection +  Suspected COVID-19 virus infection  Acute pain of left knee  Cough    Dx Acute   Reason for Visit  10/18/2021 Re: URI When did symptoms start? 2 days  Associated symptoms: dizziness and lung "on fire."  Fever: no  Cough: yes  SOB: yes  Sore throat: yes  Headache: yes  Nausea: no  Vomiting: no  Diarrhea: no  Muscle aches: yes  Fatigue: yes
Gradually developing arthritis, chronic joint pain/stiffness, chronic fatigue. Diagnosed with Lyme disease 7/03 which perhaps indicates the vaccine was not effective.
pt recved booster dose of MMR vax 1MAY91 & 20MAY91 pt devel pain in wrist which was thought to be a sprain; x-ray was found to be neg & pt tx Motrin; MD found evidence of arthritis in pts hand;
SHINGRIX was administered in left deltoid muscle around 11am on 5/9/18 patient reported around 6pm on 5/9/18 fever chills and muscle pain/aches throughout the night for about 12 to 15 hours and then eventually subsided the next morning 5/10/18 around 8am.
Tightness in Calves and Hamstring; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in Calves and Hamstring) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in Calves and Hamstring) and PYREXIA (Fever). On 01-May-2021, PYREXIA (Fever) had resolved. At the time of the report, MUSCLE TIGHTNESS (Tightness in Calves and Hamstring) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
My husband caught it first. Diagnosed with bronchitis then turned into pneumonia. Then I got bronchitis. My husband tested twice for COVID which were negative. I was tested once and it was negative. But I lost my sense of taste and smell so I feel I could have had COVID. They did a chest x-ray on me and diagnosed me with bronchitis and gave me antibiotics, inhaler, cough medicine and steroid shot.