chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd shot, severe pain that started in hips went to knee and remains in right knee; This is a spontaneous report from a contactable consumer (Patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 11Sep2021 at 10:00 (age at vaccination 55 years old as dose 2, single for COVID-19 immunization. Medical history included Sensitive to gluten and covid-19 from an unknown date. Concomitant medication included ascorbic acid, vitamin d nos and zinc. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: fa7485), via an unspecified route of administration, administered in Arm Right on 21Aug2021 as dose 1, single for COVID-19 immunization and reported adverse reaction as Fatigue, Diarrhoea, Nauseous, Headache and severe arm pain. On 11Sep2021, the patient experienced 2nd shot, severe pain that started in hips went to knee and remains in right knee. The outcome of event was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Patient explained tachycardia in the early morning that came and went following the vaccination. She stated she was going to urgent care for treatment.
PATIENT WAS 15 YEARS OLD ON THE DATE OF VACCINATION.  BOOSTER DOSES ARE ONLY APPROVED FOR 16 YEARS OF AGE AND ABOVE.
Information has been received from a new article via a journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 6.2 percent of the reported problems were considered serious. The exact adverse events were not reported. The outcome of the events was not reported. It was reported that these types or reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
I started feeling more fatigued and out of breath. I left work on Thursday that week and I was so exhausted and was coughing and stuffy. My head was stuffy and I did not feel right. I took a COVID-19 home test and that was negative. I went to urgent care and they tested for COVID and the flu but I was positive for COVID-19. I am not able to take PAXLOVID due to health issues so they said to rest and drink lots of water. I made all of my health care providers of my positive test. I did develop a fever for about three days and then if finally started going down. I lost my voice but it is back and I am very stuffy and coughing a lot but at this point it feels like a bad head cold. I am immunocompromised so I am still sick and recovering as of today.
SWELLING, REDNESS, SORENESS AT INJECTION SITE THAT RESOLVED AFTER 3 DAYS Narrative:
This spontaneous report was received from literature: Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination. This report concerned a 9 decade old female of unspecified race and ethnicity. The objective of this study was to examine the potential association between COVID-19 vaccination and SSNHL (sudden sensorineural hearing loss). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sudden sensorineural hearing loss, 7 days after vaccination. Laboratory data (dates unspecified) before treatment included: Hearing test (NR: not provided) 46 dB HL (decibel hearing level). The patient received treatment of intratympanic steroid. Laboratory data (dates unspecified) after treatment included: Hearing test (NR: not provided) 40 dB HL (decibel hearing level), and word recognition score was 90 % and 100 %. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sudden sensorineural hearing loss was not reported. It was concluded that in this cross-sectional study, findings from an updated analysis of VAERS data and a case series of patients who experienced SSNHL (sudden sensorineural hearing loss) after COVID-19 vaccination did not suggest an association between COVID-19 vaccination and an increased incidence of hearing loss compared with the expected incidence in the general population. This report was serious (Other Medically Important Condition). Sender's Comments: V0- 20220260763-Covid-19 vaccine ad26.cov2.s-Sudden sensorineural hearing loss. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (elderly age). Therefore, this event(s) is considered not related.
Barely able to walk; Pain in both knees; Both knees swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 61-year-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0151)via an unspecified route of administration, administered in Left arm on 06May2021 at 08:30 (at the age of 61-year-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history included high triglycerides, mild arthritis in back. The patient had no allergies. Since the vaccination, the patient has not been tested for COVID-19.Prior to vaccination, the patient  was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS), vitamin D nos. On 13May2021,the patient experienced pain in both knees. Both knees swollen. Barely able to walk, gotten better but had to take ibuprofen for pain and am taking glucosamine sulfate. The patient was not tested positive post vaccination. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0165)via an unspecified route of administration, administered in Left arm on 27May2021 at 08:30 (at the age of 61-year-old) as Dose 2,Single for COVID-19 immunization. No treatment mentioned for all the events. The patient reported gotten better but has to take ibuprofen for pain and am taking glucosamine sulfate. The outcome of the events was not recovered/not resolved.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021 at 4:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 4:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 20.22 for dose administered on 14-Feb-2021. No concomitant medications were reported. Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit from 9 AM to 11 AM, 35 degrees Fahrenheit from 2 PM to 3PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-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 Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Subject is enrolled on a clinical trial that is evaluating the quadrivalent HPV vaccine in cancer survivors. Subject received dose #2/3 of GARDASIL vaccine on 2/5/14. When she was contacted for her 2-week post-vaccine telephone follow-up on 2/20/14, she reported that she had sustained a fracture of her (R) distal femoral condyle on 2/16/14. This reportedly occurred without associated trauma; subject stated that she was walking, her (R) knee "went out" and she could not bear weight on it. She was seen in her local ER where X-rays were taken and the fracture was diagnosed.
Swelling at injection site with mild itching. Started Sunday morning and has been improving since but is still noticeable 24 hours later.  Site is beginning to look slightly bruised
pt recvd vax & had 3 episodes of high pitched crying lasting 1 & 1/2-2 hrs each; t 101 & pt felt clammy & cold;
After 2nd vaccine, every inch of my body was in extreme pain. especially lower extremitys. I was not able & still not able to get out of bed on my own, shower or cloth I have lost 30-35 pounds I weigh 111.2 lbs today before my normal weight was 130-145 I am 5 ft 8in in height. Woke up with extreme muscle spazums in both legs lasting 15 to 20 minutes. My legs, knees & hands are very swollen. I passed out several times until hospital stay. I got the Covid vaccines as soon as possible so I could return to work April 2022 I was put on permenate disability. We/my husband & I went to less than 1/2 an income. I lost my car I purched for my 50th birthday & almost lost the house. I have spent my life trying to keep myself heathy. If there is anything else need, please let me know. Sorry this took so long.
headache pain; menstrual cycle cramps; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (menstrual cycle cramps) and HEADACHE (headache pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A. and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included IBUPROFEN for Menstrual cramps.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DYSMENORRHOEA (menstrual cycle cramps). On 17-May-2021, the patient experienced HEADACHE (headache pain). At the time of the report, DYSMENORRHOEA (menstrual cycle cramps) and HEADACHE (headache pain) outcome was unknown.            Treatment medication included ibuprofen 800 mg.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
This is a spontaneous case, initially received from other health professional (nurse) on 17-Nov-2018, concerning a 55-year-old, adult female patient. The patient was allergic to FLAGYL, nortriptyline, iron fusion, metformin and sulpha drugs (reported as medical history). On 16-Nov-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, influenza  vaccine,  batch number: YF39908, expiry date: 30-Jun-2019 in deltoid). It was reported that, this was the first influenza vaccine patient ever received. On 16-Nov-2018, the same day, a few hours after vaccination, the patient experienced rash and throat closing up. Additionally, the patient also experienced hoarseness and headache. The patient was treated with EPIPEN, BENADRYL and SOLUMEDROL and then sent to emergency room (ER) but was not admitted. The outcome of the events rash and throat tightness was resolved on an unspecified date in Nov-2018 and the outcome of the events hoarseness and headache was not recovered. The reporter assessed the case as serious (medically significant).
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEMIPARESIS (The left side of her body was not functioning.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced HEMIPARESIS (The left side of her body was not functioning.) (seriousness criterion medically significant), LIMB DISCOMFORT (She could not use her arm/She kept her arm at a 50 degree angle) and LIMB DISCOMFORT (She could not use her leg). On 16-Sep-2021, the patient experienced PAIN (Had a shooting pain from her fingertips to the very beginning  of her neck). At the time of the report, HEMIPARESIS (The left side of her body was not functioning.), PAIN (Had a shooting pain from her fingertips to the very beginning  of her neck) and LIMB DISCOMFORT (She could not use her arm/She kept her arm at a 50 degree angle) outcome was unknown and LIMB DISCOMFORT (She could not use her leg) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was given. Laboratory data was mentioned as patient done the bloodwork on 24 Sep 2021 but results were not given. No treatment medication was given. It was reported that on 11 Sep 2021, the left side of her body was not functioning. She could not use her leg or arm. She kept her arm at a 50 degree angle because if she moved it, she had a shooting pain from her fingertips to the very beginning of her neck. The leg got better around 16 Sep 2021. She saw her doctor on 24 Sep 2021 and would have bloodwork done and was being sent to a neurologist to see if a nerve was hit. Date of end of reaction/event for the event the left side of her body was not functioning and she could not use her leg was reported as 16 Sep 2021. Company Comment: This case concerns a 24-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hemiparesis. The event occurred 1 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 24-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hemiparesis. The event occurred 1 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Patient went to dr this moring because his arm was red/rash. It covered a fairly large area extending down upper arm to the back, interior area of left arm. Dr diagnosed as cellulitis and prescribed clindamycin for the patient.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Bump at vaccination site and pain,treated with pain creams ,not improved-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Spouse states that her husband finds it difficult to sleep on his left side,and still has pain on that site. Patient spoke another lanuage  and was comminicting through a pharmacy technician.Spouse left before i could see the bump.
Heavy fever of 103 degree on the 2nd and 3rd day of vaccination. Muscle and body aches and hard to breathe still ongoing for over a week.
Headache, Diarrhea, NauseaVomiting, Is diabetic, elevated blood sugars, fatigue, decreased appetite Narrative:
Information has been received from a physician assistant concerning a 15 year old female who was vaccinated with a 0.5 ml first dose of Gardasil. Subsequently the patient developed "a little rash on the opposite arm (not the injection site arm)". Subsequently the patient recovered. On an unspecified date, the patient was vaccinated with the second dose of Gardasil. The physician assistant reported that the patient did not have a reaction after the second dose of Gardasil. Additional information has been requested.
The patient's daughter came in to get some antibiotics for her mother, and reported that her mother had been diagnosed with COVID pneumonia in both of her lungs. Two (2) days after her second shots, patient began to have an increased heart rate and swelling in her legs. She went to the ER and was told that her blood was "getting thicker". She had not had any clotting issues in the past that she was aware of. She was given IV antibiotics during her hospital visit. She was instructed by her doctor to take over-the-counter aspirin twice a day and finish her antibiotic regimen. The daughter classified her mother has "perfectly healthy" before her second shot.
Patient reported for a nurse visit to receive Prevnar 20 to complete the pneumococcal vaccine series due to the patient having previously received a dose of Prevnar 13.  The nurse administered the wrong vaccine by giving the patient another dose of Prevnar 13. Patient reported no adverse effects from the first or second dose of Prevnar 13.
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for himself. This 82-year-old male patient received PREVNAR 13 at 0.5 ml single dose on 30Aug2016 for immunisation on the right deltoid. Relevant medical history included ongoing high blood pressure, several back operations, he had an electronic nerve stimulator on his back, ongoing diabetes. Concomitant ongoing medications included metformin for diabetes, amlodipine besilate at 10 mg and lisinopril both for high blood pressure and meloxicam at 15 mg. On an unspecified day in Sep2016 the patient experienced severe reaction in his muscle/ had reaction in all the muscles, on his fore arm and around his neck, severe swelling/swelling in right shoulder and severe muscle pain. The patient was hospitalized on an unspecified date in 2016 due to severe swelling/swelling in right shoulder.  The patient took TYLENOL/ACETAMINOPHEN or morphine as treatment for the events and also THERA-GESIC cream for severe muscle pain. The patient was not recovered from the events. Follow-up (15Nov2016): New information reported from the same contactable consumer includes: reaction data (the patient was hospitalized for swelling in right shoulder, updated events onset and outcome), meloxicam as additional concomitant medication. Follow-up attempts are completed. No further information is expected.
Initial report received on 01/16/2006 from the patients parent. A six year old female patient with no significant past medical history had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1814AA, in the arm site nor reported, in Nov 2005 day not reported. Immediately after the injection was administered, the patient had pain and weakness in the right leg and difficulty walking. The patient was admitted to the hospital on 01/06/2006 and was later transported to a hospital on 01/10/2006. The patient was discharged from the hospital on 01/13/2006. Per the reporter, the patient was diagnosed with muscular skeletal pain. Relevant tests performed were MRI's, bone scan, cat scan of the abdomen and spinal tap (date and results not reported). At the time of this report, the patient had not recovered.
Report severe hair loss. Treatment: PCP visit  Outcome:  All test were normal except vitamin D was low and placed on vitamin D supplements.  Scheduled to see a dermatologist.
I am a 56 year old male in good health. I received the first dose of the Shingrix vaccine in late August 2019. I had no side effects. When I went to the pharmacy to have the second dose on October 29, 2019 the pharmacist asked me if I had experienced any flu like symptoms related to the first dose. I replied no. The pharmacist administered the second dose of the Shingrix vaccine on October 29, 2019. Later that night I developed a bad headache, fever and chills, nausea and stomach cramping, and body aches. These symptoms continued throughout the day on October 30. The symptoms have lessened today, October 31 although I have a "worn out" feeling as a result of this.
Case number PHEH2016US026756, is an initial spontaneous report received from a pharmacist on 13 Oct 2016. This report refers to a 58 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with single dose of FLUCELVAX (batch number: 185325A and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 19 Sep 2016. On the same day after vaccination, the patient experienced thumb became numb. It was reported that, thumb was still numb. The outcome of the event was reported as unknown. The seriousness of the event was reported as non-serious. The causality of the event was not reported.
Patient reported basically immediately feeling a ringing of the ears, muscle pain at injection site and nausea.
Client had a full syncopal episode while getting up after his advised post vaccination observation time @0842. Client had an unassisted fall and witness said incident occurred for 45 seconds. Client was then assisted to his seat by our medical staff and evaluated. Client advised for complete medical evaluation at the ER in which he was hesitant at first, but then cooperated. Client verbalized no head trauma or hx of syncopal episodes. EMS arrived to transport client to Emergency care @ 0852.
pt called and stated she had reaction to the site with redness , warmth and 100 degree temp and localized pain