chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt experienced joint pain and swelling. Went to a physician. Lab test were done and the child was diagnosed with juvenile rheumatoid arthritis. Went to a hospital and diagnosis was confirmed. Parents were told that it might be due to the Varicella Vaccine. The annual follow up states child's diagnosis is rheumatoid arthritis. Child is refusing care. Takes medication.
I had my vaccination on 09/21/2022. I started to experience coughing stuffy nose congestions and pressure on 03/06/2023.  On 03/13/2023 I had a Chest Xray. I did start to have horrible ear pain. I did go to the urgent care on 03/18/2023 and was prescribed a Z pack and cough medication. I have not had any drainage from my ear and I will be contacting my primary doctor for a referral to ENT.
Lost of taste around 08:30 AM on 03/31/21.  Recommended COVID-19 testing.
Extreme chills, could not get warm despite multiple blankets in bed and raising room temp to 78 degrees, body aches, extreme fatigue
At approximately 4:30pm bilateral mid-calves to feet turned purple and left lateral hand turned purple; bulging and pulsating fontanelle. (on 2/17/10) witnessed by parents only.
Inflammation; Tenderness; erythema; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): GL-101221-2432.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; hyaluronic acid, lidocaine (RESTYLANE L), from May2021 (Batch/Lot number: unknown) to May2021; hyaluronic acid, lidocaine (JUVEDERM ULTRA PLUS), from May2021 (Batch/Lot number: unknown) to May2021. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Inflammation"; TENDERNESS (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Tenderness"; ERYTHEMA (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "erythema". The action taken for hyaluronic acid, lidocaine and hyaluronic acid, lidocaine was unknown. Therapeutic measures were taken as a result of inflammation, tenderness, erythema.  Additional information: Patient was injected Restylane Kysse in the lip in the chin in May2021. In Oct2021 the patient presented with late onset inflammation in both the lips and the chin. Patient treated with Hylenex and Kenalog. Patient significantly improved after several treatments with Kenalog. Patient had COVID vaccine approximately 8 months prior to reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had the booster COVID shot that afternoon of 11/10/21.  I  was ok until later that day when I began to experience sore arm and then headache, chills and fatigue. I had this feeling constantly  for three days.
Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates the patients were vaccinated with unspecified doses of PNEUMOVAX 23 (lot # N001007, expiration date 19-SEP-2018; lot # N011491, expiration date 04-NOV-2018; lot # M047519, expiration date 04-AUG-2018; dose, route, site of administration unknown) for prophylaxis. On unknown dates the patients experienced one or more of the following adverse effects: redness, swelling of full arm, pain in full arm that radiated to the shoulder neck, or hand, rash at the injection site, and numbness in fingers. The patients sought medical attention by calling the physician office. Treatments were given for the events. The nurse reported that all patients were instructed to take an unspecified over the counter pain reliever and to apply a warm compress to the effected upper extremity. The patients who reported a rash were told to take BENADRYL (dose unspecified). The nurse was unsure which patient received which lot number. The nurse requested a lot check for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # M047519, expiration date 04-AUG-2018 and lot # N011491, expiration date 04-NOV-2018. The outcome of the events was unknown. Causality assessment was not provided. It was reported that no product quality complaint (PQC) was involved. This report is one of four reports received from the same reporter. The lot check request also appears in the linked reports.
Begining on 2/4/22 I had numbness in my upper lip that lasted on and off for 1 week.  Then it went away.  I said to myself I will not be getting that vaccine again.  I may have forgotten to tell my doctor about it because I was glad it went away.  I had so many appointments with doctors and dentist in February I forgot to tell them and I was glad it went away.
Information has been received from a pharmacist concerning an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-MAY-2016, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB, 5/0.5 microgram (mcrg)/ml, lot # M022077, expiration date 10-MAR-2019 (route unspecified). No adverse effect was reported. Additional information has been requested.
Within 10 minutes I had a bad muscle spasm start in my lt. shoulder,lt neck,lt upper back. I did not mention this to anyone because no   one was around and I thought it rather odd. As I was leaving I had an episode of transient lightheadedness. I was all the way down a very long hall when this happened. I have mobility issues so I did not turn around and head back to vaccination area. That passed rather quickly. The muscle spasms continued without letting up for four days. During the next 24 hours after vaccine I had profound fatigue that lasted 5 days and slight nausea and again a few episodes of lightheadedness. I saw my primary on Monday the 19th. I was still having some minor muscle spasms but nothing like I had within 10 minutes of getting the vaccine. The fatigue is gone and also the nausea and lightheadedness. This is my 2nd vaccine. I had no problems after the first vaccine other than a sore arm for a day and a half. I also received that vaccine in my lt. arm.
Information has been received from a RN concerning a male pt who was vaccinated with a dose of varicella virus vaccine live and developed 7-8 lesions. It was noted that there was no further information available at this time. The nurse also reported on another pt who had been vaccinated with varicella virus vaccine live and developed 150-200 lesions (WAES # 0306USA02150).  Additional information has been requested.
Experienced severe pain in chest cavity right side, headache, abdominal pain, feeling very cold. Abdominal and chest pain subsided in early morning following day. Headache subsided around noon. Does not think temp elevated. Was seen by his urologist 5 days later after Cystoscopy and PSA blood work. PSA elevated from 4.6 - 5.6. PSA to be repeated as MD thought flu shot or cystoscopy could account for PSA elevation. Was not 1st flu shot. No adverse reaction in past to flu vaccine.
Approximately 1 minute after receiving vaccine, patient experienced what appeared to be a generalized tonic-clonic seizure, lasting 4-4.5 minutes. The patient regained consciousness and was awake, alert and oriented x3. Patient and father refused transport by EMS to ED for evaluation. The patient's father reported prior history of seizures after needlestick.
Approximately 10 days after receiving the vaccine, I got a red, painful, red, blotchy, raised, circular red rash from my elbow to my shoulder on my left arm, where I received the vaccine.
Slept 10 hours, rather than usual 7.5, and push-mowing the lawn the next day took 3 x normal, and I felt nausea the whole time I was pushing to finish
Foot wound; passed away about a week after becoming immobile; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (passed away about a week after becoming immobile) and LIMB INJURY (Foot wound) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059B21A and D06B7 or 21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, METOPROLOL, LEVOTHYROXINE SODIUM, MEMANTINE HYDROCHLORIDE (MEMANTINE HCL) and DONEPEZIL HYDROCHLORIDE (DONEPEZIL HCL) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMOBILE (passed away about a week after becoming immobile) (seriousness criteria death and medically significant). On an unknown date, the patient experienced LIMB INJURY (Foot wound) (seriousness criterion medically significant). The patient died in May 2021. The reported cause of death was Immobile. It is unknown if an autopsy was performed. At the time of death, LIMB INJURY (Foot wound) outcome was unknown.            Treatment information was not provided.  Concomitant medication include blood thinner medication.  This case concerns a 91-year-old female patient with no relevant medical history, who experienced the unexpected events of Immobile and Limb Injury. The events occurred approximately 9 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring in the following week. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 91-year-old female patient with no relevant medical history, who experienced the unexpected events of Immobile and Limb Injury. The events occurred approximately 9 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring in the following week. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Immobile
Mother reported pt was "zoned out" and staring off into space. No animated reaction to family members. Had serious face. Could not laugh. Increased fussiness. Cried when hungry. Good po intake. Good wet diapers. No fever/N/V/D. 3 days later, regained smiles & laughter.
24 y/o male recieved Antrhax vaccine #3.  On day 2 developed pruritis, erythema and swelling extending from site of injection to elbow.  Mild H/A x 1 day, experienced mild numbness tingling in the tricep muscle.  Afebrile, denies myalgia, arthralgia.
Bivalent booster given as dose #2 instead of second dose of monovalent to complete primary series.  No adverse reactions
This spontaneous report was received from a nurse (patient's mother) concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 03-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dosing details, lot# and expiry date were not reported). The patient received the second and third dose of GARDASIL 9 on 13-APR-2016 and 15-JUN-2016 respectively (inappropriate schedule of drug administration). There was no adverse effect reported. Additional information has been requested.
Flu shot was injected to high on my shoulder so I have had horrible pain trying to move the arm at the shoulder it was injected into.
High frequency of urination starting at night (approx 22:30). At perhaps midnight I got very cold and shivered violently. This occurred again about 30-45 minutes later. At the same time, I developed a slight headache and mild nausea that interrupted my sleep. In the morning I retained the low fever that was readily discernible by my wife. All day I have had a very slight headache, no nausea, but no appetite either,  and the fever seems to have subsided. However, my head feels congested and I have a rushing sound in my ears and have suffered some vertigo. I have been unable to function today and have slept most of the day. Painful shoulder muscle around site of vaccination.
Breast tenderness, flush face hot to touch without fever,  shot site pain. Muscle Aches mainly in back.
below injection site, warm; Redness below at injection site; below injection site, pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (below injection site, warm), INJECTION SITE ERYTHEMA (Redness below at injection site), INJECTION SITE PAIN (below injection site, pain) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 28-Apr-2021, the patient experienced PYREXIA (Fever). On 29-Apr-2021, the patient experienced INJECTION SITE WARMTH (below injection site, warm), INJECTION SITE ERYTHEMA (Redness below at injection site) and INJECTION SITE PAIN (below injection site, pain). At the time of the report, INJECTION SITE WARMTH (below injection site, warm), INJECTION SITE ERYTHEMA (Redness below at injection site), INJECTION SITE PAIN (below injection site, pain) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment information not provided
Day 8  (2/26/2021) post injection....at injection site...pruritus, erythema warmth, tenderness., induration.   Also generalized headache, fatigue and myalgia .  03/05 noted left axillary lymph node.  Treated with benadryl and topical hydrocortisone.  03/05/2021 ras and symptoms persist.
Information regarding Prevnar was received from a healthcare professional regarding a 9 month old female patient who developed idiopathic thrombocytopenic purpura. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was one dose. Concomitant medications were not reported. On 7/10/02, a 9 month old female patient developed idiopathic thrombocytopenic purpura. The reporter considered this event to be immediately life threatening. The patient was hospitalized and treated with IV immunoglobulins. The reporter indicated that the patient has recovered. No additional information was available at the time of this report.
Developed clinical varicella November 7, 2007.Vaccine administered 2/23/2000
Idiopathic thrombocytopenia purpura, possibly related to receipt of numerous vaccines.Petechia on feet noted on PE. Responded to steroids w/slight resolution.
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 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:27 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.74. No concomitant medications were reported. Batch number 030B21A administered on 03-Apr-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient has long history of fainting whenever getting vaccines. No history of seizures, per mom.
Information has been received from a physician via company representative concerning a 20 year old female no pregnant patient who on 20-JAN-2009 was vaccinated with a first 0.5 ml dose of GARDASIL, IM (lot # not provided). On 20-APR-2009 was vaccinated with a second 0.5 ml dose of GARDASIL, IM, (Lot # 661952/1129X, exp date 12-MAR-2011), right arm and on 31-JUL-2009, was vaccinated with 0.5 ml third dose of GARDASIL, IM (lot # 662404/0312Y, exp dose 30-APR-2011), right arm. The physician stated that in January 2014, the patient was diagnosed with HPV after she had a Smear cervix (pap smear test). The representative described that patient informed the physician over the phone "recently" (no dates provided) of the results of her pap smear test from "January 2014". The outcome of HPV positive was reported as not recovered. The representative also reported that the patient informed the physician that she was not sexually active when she received the first and second dose of GARDASIL. Additional information has been requested.
arm was real sore; couldn't almost lift it; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261, Expiration date: 31May2021), via an intramuscular route on 22Jan2021 at 13:00 (at the age of 82-years-old) as 1st dose, single in the deltoid right for covid-19 immunisation. The patient medical history included trigeminal neuralgia diagnosed with this condition at least a good 10 years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included TOPAMAX tablet with dose 150 mg, daily, (one 50 mg, tablet, by mouth, once in the morning; two tablets at night /Total of 150 mg daily) for trigeminal neuralgia. Caller received the COVID vaccine on 22Jan2021 and five days later on 27Jan2021 at 20:00, the patient arm was real sore and she couldn't almost lift her arm which she thought was an unusual reaction. She doesn't believed she did anything to her arm. She doesn't know if she pulled a muscle or anything. By the next morning, 28Jan2021, the soreness was gone and was fine. She hasn't had any problem since. The outcome of the events was recovered on 28Jan2021.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer reporting  for herself. This 44 year-old female patient received pneumococcal vaccine via an unspecified route of administration on 20Apr2016 at 0.5 ml single, as inpatient in hospital. The patient medical history included blood clots and deep vein thrombosis (DVT), concomitant medications were not reported. The patient had received for immunization a pneumonia shot a long time before. After getting pneumococcal vaccine on 20Apr2016, on an unspecified date in 2016, she went in to see her doctor because she was having chest pain. On 10Aug2016 she underwent a heart CT scan because she had a history of blood clots and DVT. The level in clotting was not good and thought she may have had a pulmonary embolism. However then it was found that she did not have a pulmonary embolism, but was diagnosed with having pneumonia. Outcome was unknown. Follow-up (24DEC2016):  Follow-up attempts are completed. No further information is expected.