chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Walking and was feeling fine but towards evening pain in my right Achilles tendon ankle on heel. Pain got worse. I contacted doctor's office; put me in a cam boot but then it was feeling worse, and I went again, and he did an MRI, and I was in that for eight weeks. I was in the boot until the end April. From the 10th and then 8 weeks beyond that. Past week I was walking, and I think I have a tear in my left calf now, in my other calf, and it's still sore. I'm assuming I tore something. It's a little swollen and I'm limping around.  I am going to continue to watch it. I had lab work done and all of that seemed fine. No inflammatory markers showing. They are watching me for any kind of auto-immune condition because I've had positive and negative ANA tests and Rheumatoid Factor results; will be high at times and then it goes back to normal, it fluctuates. So, they are watching it. I'm still sore on the left calf. Note: In May, I think, I had the Gardasil vaccine; the third one of the series, need to confirm the exact date.
side effects to vaccine 11 days later; Allergies; Missed second dose; migraine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose), MIGRAINE (migraine), VACCINATION COMPLICATION (side effects to vaccine 11 days later) and HYPERSENSITIVITY (Allergies) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced MIGRAINE (migraine). On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects to vaccine 11 days later) and HYPERSENSITIVITY (Allergies). On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved. At the time of the report, MIGRAINE (migraine), VACCINATION COMPLICATION (side effects to vaccine 11 days later) and HYPERSENSITIVITY (Allergies) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Follow up received on 12-mar-2021, event was updated.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. No treatment details were reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that total 77 Monovalent doses were administered after the BUD to patients 12 and up. 37 doses from lot 059H21, 26 Doses from lot 065K21A and 12 doses from lot 058A22-2A.
Pt seen in office 10/25/04, 10cm erythema, raised lesion left thigh seen for follow up from ER.  Pt seen in ER 02/24/04 @ 8:49am.  Diagnosed with cellulitis, started on Keflex.
About 24 after the vaccine was administered, I started getting nose significant nose bleeds.  Two the day after and another today
Near syncope in shower, weakness, fever 101, malaise, anorexia, loose stool X 1
Patient states that a few hours after shot arm had a large flat raised surface and was warm without redness. She tried BENADRYL and TYLENOL. On December 22 she went to primary care provider as the arm had not improved and had since become more swollen. Doctor prescribed cephalexin 1000 mg twice daily for 5 days and dexamethasone 2 mg once daily.
Patient had no adverse event. We gave the patient primary pfizer vaccine for the patient's 4th dose and then after that we received an email that the primary pfizer vaccine should not be used for booster shot. We let the patient know that he could get another bivalent booster shot after 10/30/2022.
1 day after receiving the vaccine the patient reported extreme fatigue, headaches, diffuse body/joint pain, chills, and nausea.
Patient had hot flash 12 minutes after receiving 1st Covid vaccine dose. SBP 93 sitting upright in chair and face pale. Assisted patient to litter to remain in semi-fowlers position. Recheck SBP 120's. Denies further symptoms and stated hot flash no longer present. returned to chair after 5 minutes. SBP rechecked 120's x2 while upright in chair. Denies further symptoms. Patient remained upright for 15 minutes without symptoms prior to leaving covid clinic.
fatigue after 24 hours - lasting about 6 hours; Soreness in left arm for about 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734 HNMC) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included rosuvastatin calcium (CRESTOR) 10 mg (milligram), colecalciferol (NORDIC NATURALS VITAMIN D3) and New chap (MANUFACTURER UNKNOWN). The patient did not have any known allergy to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 15:00 the patient experienced soreness in left arm for about 36 hours and fatigue after 24 hours which was lasting about 6 hours. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcomes of the events fatigue was resolved on 02Apr2021, while that of soreness in left arm was resolved on 04Apr2021.   No follow-up attempts are needed. No further information is expected.
Chills, Fever,fatigue.  Tested positive for COVID on 3/22 and died on 3/29
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from nurse. This case involves 71-year-old male patient who was vaccinated with dose of FLUZONE HD (0.5 ml) (batch number: UJ024AC, expiration date: 29-Apr-2019, route and site of administration was not reported) on 17 Oct 2018. The patient's medical history was not reported. Concomitant vaccinations included SHINGRIX and PNEUMOCOCCAL VACCINE CONJ (PCV). It was an actual medication error due to extra dose administered as it was reported that patient had already received the dose of FLUZONE HD it 2 weeks ago at a Pharmacy with no adverse reaction then. Patient had no complaints or adverse reaction today and has not had treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Within a minute of receiving the vaccine, I got extremely light-headed, vision went almost totally black, body drenched in sweat. This passed after about 5 minutes. 30 minutes after receiving the vaccine, my throat and tongue started to swell. Went to the ER after benadryl wore off and the swelling returned. Am still managing the swelling of the throat and tongue 4 days later.
Generalized symptoms and side effects of  vaccine 1-3 days after vaccine administration.  Chest pain and worsening shortness of breath 3 days after vaccine. Chest pain began to worsen and became excruciating. Patient was diagnosed with myocarditis and experienced a STEMI verified by EKG on the morning of 8/14/2021.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated for a severe vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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 unknown. Causality assessment was related. Additional information has been requested.
Bells Palsy symptoms appeared the day after the vaccine: Patient could not close her left eye, had a runny nose in her left nostril and felt aches in her left ear and the left side of her neck. The patient visited her physician who started her on Prednisone 20 mg for 10 days on Saturday, December 22. She will begin physical therapy Monday, December 31.
Pt vaccinated with Influenza developed funny feeling in both lower extremities, clumsy with both legs which feel numb and tingly. BP 180/100. Rest of exam  negative. Lungs are clear. Reflexes diminished. IMP: possible GBS.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:29 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.76 for dose administered on 31-Mar-2021 09:29. No concomitant medications were reported. On 31-Mar-2021 at 08:00 A.M., the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr--2021. Product moved to clinic on 31-Mar-2021, and at 09:00 Am the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. Product moved to clinic on 31-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report was received from a healthcare student. The reporter stated that an unspecified physician had an unspecified patient of unknown age and gender. No concurrent or historical medication was reported. In approximately August 2014 (also reported as "1 years ago") the patient was vaccinated with ZOSTAVAX (unspecified lot number and expiration date), dose, route, and anatomical location were unknown. No concomitant medication was reported. On an unknown date (also reported as "recently") the patient experienced shingles. The Varicella-Zoster Virus (VZV) packet was declined. At the time of the report the outcome of shingles was unknown. Additional information has been requested.
Received flu vaccine at drs office at 11:30 on 9-22-11. Several hrs later, felt cold & chills started so went to bed. Woke up at 1 am soaking wet w/sweat. Tried to get out of bed as had stomach ache & needed bathroom. But felt like passing out & fell down several times, very weak, couldn't walk & cont. for next day, then after that, flu symptoms started & lasted 3 wks w/a bad cough, congestion, sinus, etc.
Call from mother on 5/8/2000, stating child is now on a respirator at a hospital and states doctors are unable to find what's wrong with her baby and was told that "maybe it was the shots". On 5/4/2000, child became weak, no fever or seizures. Seen by MD and admitted to the hospital. On 5/8/2000, required intubation.
a stiff neck; During the week it was itchy; The area where I got the shot is red, a big circle that was red; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (a stiff neck), VACCINATION SITE PRURITUS (During the week it was itchy), VACCINATION SITE ERYTHEMA (The area where I got the shot is red, a big circle that was red) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMINS NOS and Cholesterol Medication for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (a stiff neck), VACCINATION SITE PRURITUS (During the week it was itchy), VACCINATION SITE ERYTHEMA (The area where I got the shot is red, a big circle that was red) and HEADACHE (headaches). At the time of the report, MUSCULOSKELETAL STIFFNESS (a stiff neck), VACCINATION SITE PRURITUS (During the week it was itchy), VACCINATION SITE ERYTHEMA (The area where I got the shot is red, a big circle that was red) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she stopped taking aspirin 2 days ago as she read somewhere that it is better not to be taking painkillers.
extremely nauseous; lightheaded; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer and sulfonamide allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ethinylestradiol/levonorgestrel (OGESTREL) and multivitamins (MANUFACTURER UNKNOWN); all for an unspecified indication from an unknown date and were unknown if ongoing. On 28Feb2021, the next day, the patient was extremely nauseous, lightheaded and with general malaise. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely nauseous, lightheaded and general malaise was recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via out of hour services and described the occurrence of inflammation localized in a female patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced inflammation localized and erythema of extremities. On an unknown date, the outcome of the inflammation localized and erythema of extremities were unknown. It was unknown if the reporter considered the inflammation localized and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient's arm had been inflamed and red since. The reporter indicated that she was going to advise the patient to take some ibuprofen. Only pharmacist's first name and telephone number was provided. The reporter called the pharmacy but the pharmacist who left the message was not available. The reporter was able to obtain the pharmacy address.
I had the 2nd dose on a Friday, and by Saturday morning, my ankle had swelled up to about double its normal size. I stayed off of my feet, iced, and elevated, and by Sunday the swelling started to go down and by Monday it was back to normal. I had a fairly persistent pain at those sites over a long period of time and I needed to be in traveling so I sought consultation with original surgeon that determined it was nothing structural or a heel tear. He ordered physical therapy for one month but because I was going to be traveling at that time, They required a local Doctor to order and begin medical treatment. I saw Dr. and he is a non surgical orthopedist. He identified through ultrasound that there were lymphatic pockets in the area of my surgical site (Repair of broken leg) that filled up and engorged and was maybe the reason for the swelling after the vaccine. The continuing shrink/swell syndrome I was having was related to pain in my ankle so he recommended physical therapy and they used a technique for lymphatic drainage which gave me relief. That physical therapy continued until about February 2022 and again I had no inflammation in that area that compared to the 2nd dose reaction. Lymphedema is a persistent problem and it's a chronic thing I have to live with. I flew yesterday and now I have pain today. I know it's something I'm going to have to live with the rest of my life. 2nd dose triggered the lymphatic system to send fluid to an endangered area.
pt presented to ED after a fall at home; laceration to neck and right jaw; while in ED pt went into A Fib with RVR; treated with medication; CT of chest showed left sided pneumonia; acute renal failure; liver cirrhosis; multiple liver lesions, suspicious for malignancy; pt tested positive while in hospital for COVID; poor prognosis; pt changed status to DNR; went into asystole and passed away in the hospital
One full week of rash, with itching and burning and pain. Rash was on upper and mid back and neck.
Localized hives left arm where PNEUMOVAX 23 injection was given by; swelling at the injection site; Redness at the injection site; Muscle soreness at injection site; The consumer also reported having hives, on the upper left arm, as well.; Indication: "Pneumococcal Disease"; This spontaneous report was received from a medical assistant and refers to a 70 year old female patient, her concurrent conditions included  seasonal allergy. The patient's concomitant therapies included fluticasone propionate(FLONASE) and cetirizine hydrochloride(ZYRTEC). The patient's histórical conditions were not provided.     On 23-FEB-2021, the patient was vaccinated with her second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  intramuscular in the left arm (dose and lot # were not reported), for pneumococcal infection.    On 23-FEB-2021, the patient experienced severe swelling (vaccination site swelling), redness (vaccination site erythema), soreness in the muscle (vaccination site pain), at the injection site and having hives, on the upper left arm (urticaria) and localized hives left arm where pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was injected (vaccination site urticaria).   On 26-FEB-2021, the patient had recovered from vaccination site urticaria, urticaria, vaccination site pain, vaccination site erythema and vaccination site swelling. The reporter considered vaccination site swelling, vaccination site urticaria, urticaria, vaccination site pain and vaccination site erythema to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
3 DAYS POST-VACCINATION DEVELOPED DISCRETE LINEAR TO CIRCULAR BLISTER - LIKE RASH (2-5 MM) ON UPPER ARMS/SUBMENTIAL AREA. URI Sx ON VACCINATION DATE. BACTROBAN OINTMENT ON EXDERMATIONS
Vitiligo onset after the vaccine. No history in the family.  White patches around the fingers, hands and below the eyes.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of RECOMBIVAX HB were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly exposed RECOMBIVAX HB (lot# K014548, expiration date 27-AUG-2016, dose and route were unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.